Document:

Exhibit 10.1

Exhibit 10.1

CONFIDENTIAL TREATMENT REQUESTED

SANKYO CO., LTD.

- and -

CYCLACEL LIMITED

CS-682 LICENCE AGREEMENT

 

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	 	 	Page	 
	 
	 	 	 	 
	1. DEFINITIONS
	 	 	1	 
	2. LICENCES
	 	 	11	 
	3. PAYMENTS
	 	 	13	 
	4. DEVELOPMENT AND COMMERCIALISATION
	 	 	18	 
	5. INTELLECTUAL PROPERTY — OWNERSHIP
	 	 	19	 
	6. INTELLECTUAL PROPERTY — PROSECUTION, MAINTENANCE AND ENFORCEMENT
	 	 	19	 
	7. WARRANTIES AND LIABILITY
	 	 	22	 
	8. CONFIDENTIALITY
	 	 	25	 
	9. TERM AND TERMINATION
	 	 	27	 
	10. EFFECTS OF TERMINATION
	 	 	28	 
	11. ASSIGNMENT/SUB-CONTRACTING
	 	 	29	 
	12. FORCE MAJEURE
	 	 	30	 
	13. GOVERNING LAW
	 	 	30	 
	14. JURISDICTION
	 	 	30	 
	15. WAIVER
	 	 	31	 
	16. SEVERANCE OF TERMS
	 	 	31	 
	17. ENTIRE AGREEMENT/VARIATIONS
	 	 	31	 
	18. NOTICES
	 	 	32	 
	19. COUNTERPARTS
	 	 	32	 
	20. THIS AGREEMENT NOT TO CONSTITUTE A PARTNERSHIP
	 	 	33	 
	21. COSTS
	 	 	33	 
	22. PUBLICITY
	 	 	33	 
	SCHEDULE 1 DEVELOPMENT PLAN
	 	 	35	 
	SCHEDULE 2 LICENSED MATERIALS
	 	 	36	 
	SCHEDULE 3 LICENSED PATENT RIGHTS
	 	 	1	 
	SCHEDULE 4 CNDAC PATENT RIGHTS
	 	 	1	 
	SCHEDULE 5 SUCCESSFUL COMPLETION CRITERIA
	 	 	1	 
	SCHEDULE 6 RETAINED TECHNICAL DATA
	 	 	1	 
	SCHEDULE 7 COMMITTED CLINICAL TRIALS
	 	 	1	 
	SCHEDULE 8 ADDRESSES FOR NOTICES
	 	 	2	 
	SCHEDULE 9 EXPERT’S DECISION
	 	 	3	 

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

THIS AGREEMENT is made on the Commencement Date

BETWEEN:

	(1)	 	SANKYO CO., LTD. a company incorporated in Japan whose principal place of business is at 5-1
Nihonbashi-honcho 3-chome Chuo-ku Tokyo 103-8426 Japan (“Sankyo”); and

	(2)	 	CYCLACEL LIMITED a company incorporated in England whose principal place of business is at
Dundee Technopole, James Lindsay Place, Dundee DD1 5JJ, UK (“Cyclacel”).

WHEREAS:

	(A)	 	Sankyo owns certain Patent Rights and Know How (as defined herein) relating to a nucleoside
analogue known as CS-682 and is the non-exclusive licensee of certain Patent Rights relating
to CNDAC.

	(B)	 	Cyclacel is a biotechnology company specialising in the research and development of products
in the field of cancer.

	(C)	 	Cyclacel wishes to have an exclusive licence and non-exclusive sub-licence (as appropriate)
to the Patent Rights and Know How described in (A) above for the purpose of developing,
marketing and selling a product based on CS-682 within the Territory and Sankyo is willing to
grant Cyclacel such a licence on the terms set out herein.

	1.	 	DEFINITIONS

	 	1.1	 	In this Agreement the following definitions shall apply unless the context
requires otherwise:

	 	1.1.1	 	“Affiliate” — any person, corporation, company, partnership,
joint venture, limited liability company and/or other entity which Controls, is
Controlled by, or is under common Control with a Party.

	 	1.1.2	 	“Agreement” — this document including any and all schedules,
appendices and other addenda to it as may be added and/or amended from time to
time in accordance with the provisions of this Agreement.

	 	1.1.3	 	“Blocking IP” — any and all intellectual property owned or
controlled by a Third Party (but not, subject to Clause 3.6, a Cyclacel
Licensee) which would be infringed by the development, manufacture, import,
marketing, distribution, sale or other disposal of Product.

	 	1.1.4	 	“Business Day” — 9.30 am to 5.30 pm local time on a day other
than a Saturday, Sunday, corporate holiday of a Party, or public holiday in the
UK or Japan.

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	1.1.5	 	“Candidate” — the compound known as CS-682 and other compounds
covered by Licensed Patent Rights.

	 	1.1.6	 	“CNDAC” — the compound
1-(2-C-cyano-2-deoxy-β-D-arabino-pentofurano-syl) cytosine, or known as CNDAC.

	 	1.1.7	 	“Clinical Trials” — means any or all of the Phase I Clinical
Trials, Phase II Clinical Trials or Phase III Clinical Trials.

	 	1.1.8	 	“CNDAC Patent Rights” — any Patent Rights relating to
inventions comprised in the CNDAC Patent Rights listed in Schedule 4.

	 	1.1.9	 	“Combination Product” — a product containing Product which
also:

	 	(a)	 	contains a therapeutically active
ingredient that is not Licensed IP or CNDAC Patent Rights; or

	 	(b)	 	is administered through a therapeutically
active administration technology that is not Licensed IP or CNDAC
Patent Rights; or

	 	(c)	 	is administered in accordance with a
diagnostic detection technology that is not Licensed IP or CNDAC
Patent Rights.

each of which shall be an “Other Element”.

	 	1.1.10	 	“Commencement Date” — the date of execution of this Agreement by the Parties,
which is the latest date of signature below.

	 	1.1.11	 	“Competent Authority” — any national or local agency, authority, department,
inspectorate, minister, ministry official, parliament or public or statutory
person (whether autonomous or not) of any government of any country having
jurisdiction over either any of the activities contemplated by this Agreement
or over the Parties, including the European Commission, The Court of First
Instance and the European Court of Justice.

	 	1.1.12	 	“Confidential Information” — in the case of obligations on Cyclacel in
relation to Confidential Information, shall mean Know How and Material forming
part of Licensed IP and, in the case of each of Cyclacel and Sankyo, shall mean
the terms and conditions of this Agreement notwithstanding the provisions of
Clause 22 and any other commercially sensitive information of a Party marked
“confidential” supplied or otherwise made available to them, including but not
limited to those Know How or Material disclosed by Sankyo to Cyclacel under the
Confidential Disclosure Agreement dated February 26, 2002 between the Parties
which relates to the subject matter
hereof, or coming into their possession in relation to the performance of
this Agreement.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	1.1.13	 	“Control” — means the ownership either directly or indirectly of more than
50% of the issued share capital or any other comparable equity or ownership
interest with respect to a business entity or the legal power to direct or
cause the direction of the general management and policies of the Party in
question.

	 	1.1.14	 	“CS-682” — the compound
1-(2-C-cyano-2-deoxy-β-D-arabino-pentofurano-syl)-N(4)-palmitoylcytosine.

	 	1.1.15	 	“Cyclacel Licensee” — an entity or individual other than an Affiliate of
Cyclacel appointed by Cyclacel as a licensee pursuant to Clause 2.3.

	 	1.1.16	 	“Development Plan” — the plan for the development of Candidate and resultant
Product by or on behalf of Cyclacel, an outline of which is attached as
Schedule 1, which plan may be updated or amended from time to time pursuant to
Clause 4.1.

	 	1.1.17	 	“Disclosing Party” — a Party which discloses Confidential Information to
another Party.

	 	1.1.18	 	“Documents” — reports, research notes, charts, graphs, comments,
computations, analyses, recordings, photographs, paper, notebooks, books,
files, ledgers, records, tapes, discs, diskettes, CD-ROM, computer information
storage means and any other media on which Know How can be permanently stored.

	 
	 	1.1.19	 	“EMEA” — European Medicines Evaluation Agency or any successor group thereto.

	 
	 	1.1.20	 	“European Union” the countries of the European Union from time to time.

	 
	 	1.1.21	 	“Exceptional Cause”

	 	(a)	 	scientific or other technical cause
outside Cyclacel’s or Cyclacel Licensee’s reasonable control or
arising through the activities of Third Parties including any
significant, unexpected technical problems experienced with the
development of Candidate including but not limited to chemical
production of Candidate or polymorphic form of Candidate or Product
or significant, unexpected problems which relate to the safety,
efficacy or toxicology of Candidate, CNDAC or Product;

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	(b)	 	difficulty outside Cyclacel’s or Cyclacel
Licensee’s reasonable control in recruitment of patients into
trial(s); or

	 	(c)	 	any significant, unexpected change in the
regulatory requirements in a country concerning the development of
Candidate or Product which comes into existence after the
Commencement Date, for example a new requirement for studies in
specific patient sub-groups.

	 	1.1.22	 	“Excluded Territories” — [***]

	 
	 	1.1.23	 	“Expert’s Decision” — the mechanism set out in Schedule 9.

	 	1.1.24	 	“FDA” — the U.S. Food and Drug Administration or any successor agency
thereto.

	 	1.1.25	 	“Force Majeure” — in relation to either Party, any event or circumstance
which is beyond the reasonable control of that Party which event or
circumstance that Party could not reasonably be expected to have taken into
account at the date of this Agreement and which results in or causes the
failure of that Party to perform any or all of its obligations under this
Agreement including acts of God, lightning, fire, storm, flood, earthquake,
requirement for quarantine due to infectious disease outbreak, accumulation of
snow or ice, lack of water arising from weather or environmental problems,
asteroid or meteor activity, strike, lockout or other industrial or student
disturbance, act of the public enemy, war declared or undeclared, threat of
war, terrorist act, blockade, revolution, riot, insurrection, civil commotion,
public demonstration, sabotage, act of vandalism, prevention from or hindrance
in obtaining in any way materials, energy or other supplies, explosion, fault
or failure of plant or machinery (which could not have been prevented by Good
Industry Practice) provided that lack of funds shall not be interpreted as a
cause beyond the reasonable control of that Party.

	 	1.1.26	 	“Good Industry Practice” — in relation to any undertaking and any
circumstance, the exercise of that degree of skill diligence, prudence and
foresight which would reasonably and ordinarily be expected from a skilled and
experienced person engaged in the same type of undertaking under the same or
similar circumstances.

	 	1.1.27	 	“Insolvency Event” — in relation to either Party or one of its Affiliates,
means any one of the following:

	 	(a)	 	a notice shall have been issued to
convene a meeting for the purpose of passing a resolution to wind up
that Party, or such a
resolution shall have been passed. For the avoidance of doubt a
resolution for the solvent reconstruction or reorganisation of
that Party or for the purpose of inclusion of any part of the
share capital of that Party in the Official List of the London
Stock Exchange or in the list of the American Stock Exchange or
quotation of the same on the National Association of Securities
Dealers Automated Quotation System or other such recognised
securities market shall not constitute an Insolvency Event; or

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	(b)	 	a resolution shall have been passed by
that Party’s directors to seek a winding up, or an administration
order or a petition for a winding up or administration order shall
have been presented against that Party and appeal proceedings have
not been commenced by that Party within seven (7) days from the date
of such petition or such an order shall have been made; or

	 	(c)	 	a receiver, administrative receiver,
receiver and manager, interim receiver, custodian, sequestrator or
similar officer is appointed in respect of that Party or over a
substantial part of its assets or any Third Party takes steps to
appoint such an officer in respect of that Party or an encumbrancer
takes steps to enforce or enforces its security; or

	 	(d)	 	a proposal for a voluntary arrangement
shall have been made in relation to that Party under Part I
Insolvency Act 1986; or

	 	(e)	 	a step or event shall have been taken or
arisen outside the United Kingdom which is similar or analogous to
any of the steps or events listed at (a) to (d) above which shall
include a Chapter XI filing in the USA; or

	 	(f)	 	that Party takes any step outside the
ordinary course of business (including starting negotiations) with a
view to readjustment, rescheduling or deferral of any part of that
Party’s indebtedness, or proposes or makes any general assignment,
composition or arrangement with or for the benefit of all or some of
that Party’s creditors or makes or suspends or threatens to suspend
making payments to all or some of that Party’s creditors or the
Party submits to any type of voluntary arrangement; or

	 	(g)	 	where that Party is resident in the
United Kingdom it is deemed to be unable to pay its debts within the
meaning of Section 123 Insolvency Act 1986.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	1.1.28	 	“Know How” — technical and other information which is not in the public
domain, including information comprising or relating to concepts, discoveries,
data, designs, formulae, ideas, inventions, methods, models, assays, research
plans, procedures, designs for experiments and tests and results of
experimentation and testing (including results of research or development),
processes (including manufacturing processes, specifications and techniques),
laboratory records, chemical, pharmacological, toxicological, clinical,
analytical and quality control data, trial data, case report forms, data
analyses, reports, manufacturing data or summaries and information contained in
submissions to and information from ethical committees and regulatory
authorities. Know How includes Documents containing Know How and shall be
deemed to include any rights of action or intellectual property rights
protecting such Know How. The fact that an item is known to the public shall
not be taken to preclude the possibility that a compilation including the item,
and/or a development relating to the item, is not known to the public.

	 	1.1.29	 	“Legal Requirement” — any present or future law, regulation, directive,
instruction, direction or rule of any Competent Authority or Regulatory
Authority including any amendment, extension or replacement thereof which is
from time to time in force.

	 	1.1.30	 	“Licensed IP” — Licensed Patent Rights, Licensed Know How and Licensed
Materials.

	 	1.1.31	 	“Licensed Know How” — any and all Know How owned by Sankyo relating to the
Candidate.

	 	1.1.32	 	“Licensed Material” — any and all Material owned by Sankyo directly related
to the Candidate as set out in Schedule 2 as of the Commencement Date unless
otherwise specified therein.

	 	1.1.33	 	“Licensed Patent Rights” — any Patent Rights owned by Sankyo relating to
inventions comprised in the Licensed Material or Licensed Know How, the Patent
Rights listed in Schedule 3 and any subsequent Patent Rights owned by Sankyo
directly relating to the inventions of CS-682 comprised in the Patent Rights to
be added to Schedule 3 in accordance with Clause 6.8. For avoidance of doubt,
Licensed Patent Rights exclude the CNDAC Patent Rights.

	 
	 	1.1.34	 	“Material” — any chemical or biological substances including any: -

	 	(a)	 	organic or inorganic element or compound;

 

- 6 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	(b)	 	nucleotide or nucleotide sequence
including DNA and RNA sequence;

	 
	 	(c)	 	gene;

	 	(d)	 	vector or construct including plasmids,
phages or viruses;

	 	(e)	 	host organism including bacteria, fungi,
algae, protozoa and hybridomas;

	 	(f)	 	eukaryotic or prokaryotic cell line or
expression system or any development strain or product of that cell
line or expression system;

	 	(g)	 	protein including any peptide or amino
acid sequence, enzyme, antibody or protein conferring target
properties and any fragment of a protein or a peptide enzyme or
antibody;

	 
	 	(h)	 	drug or pro-drug;

	 
	 	(i)	 	assay or reagent; or

	 	(j)	 	any other genetic or biologic material or
microorganism.

	 	1.1.35	 	“Marketing Authorisation” — any and all consents or other authorisations or
approvals required from a Regulatory Authority to market and sell a Product in
any country, but not any form of pricing or reimbursement approval.

	 	1.1.36	 	“Net Sales” — with respect to Product in relation to which Marketing
Authorisation and, if necessary in such country in the Territory, pricing
approval has been granted by the appropriate Regulatory Authority or other
Competent Authority for any jurisdiction for at least one indication, the gross
total amount originally invoiced by Cyclacel, its Affiliates or Cyclacel
Licensees to Third Parties for Products in the Territory less:

	 	(a)	 	quantity, trade and/or cash discounts
actually granted;

	 	(b)	 	amounts repaid or credited and allowances
including cash, credit or free goods allowances given by reason of
chargebacks, retroactive price reductions (provided that price
adjustments may be retrospectively made for up to two (2)
consecutive fiscal years) or billing errors and rebates (including
government-mandated rebates), actually allowed or paid;

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	(c)	 	amounts refunded or credited for Product
which was rejected, spoiled, damaged, outdated or returned;

	 	(d)	 	freight, shipment and insurance costs
incurred transporting Product to a Third Party purchaser;

	 	(e)	 	taxes, tariffs, customs duties and
surcharges and other governmental charges incurred in connection
with the sale, exportation or importation of Product.

	 	(f)	 	bad debt losses and costs for the
recovery of such bad debts.

The transfer of Product by Cyclacel or one of its Affiliates to another
Affiliate or Cyclacel Licensee shall not be considered a sale. In such cases
Net Sales shall be determined based on the invoiced sale price by the Affiliate
or Cyclacel Licensee to the first Third Party trade purchaser, less the
deductions allowed under this Clause.

Upon the sale or other disposal of Product other than in a bona fide arms length
transaction exclusively for money or upon any use of Product for the purposes
which do not result in a disposal of that Product in consideration of sales
revenue customary in the country of sale, such other sale, disposal or use shall
be deemed to constitute a sale at the relevant open market price in that country
in which the sale, other disposal or use occurs, or, if that price is not
ascertainable, a reasonable price assessed on an arm’s length basis for the
goods or services provided in exchange for the supply. Disposal of Product for,
or use of Product in Clinical Trials for the purpose of obtaining a Marketing
Authorisation or pre-clinical trials or as free samples in quantities common in
the industry for this sort of Product shall not give rise to any deemed sale
under this Clause.

Such amounts shall be determined from the books and records of Cyclacel
maintained in accordance with GAAP (generally accepted accounting principles),
consistently applied.

For the avoidance of doubt it is declared and agreed that if the product can be
marketed and sold without pricing approval nothing in this definition requires
pricing approval for it to be classified as Product for the purposes of this
Agreement.

	 	1.1.37	 	“Party or Parties” — Cyclacel or Sankyo or Cyclacel and Sankyo, as the case
may be.

 

- 8 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	1.1.38	 	“Patent Rights” — patent applications and patents, author certificates,
inventor certificates or certifications of invention, applications for
certificates of invention, utility certificates, improvement patents and
models and certificates of addition and all foreign counterparts of them,
including any divisions or divisional applications and patents,
refilings, renewals, continuations, continuations-in-part, patents of
addition, extensions (including patent term extensions), reissues,
substitutions, confirmations, registrations, revalidations, request for
continued examination, re-examinations or renewals thereof, pipeline and
administrative protections and additions, and any equivalents of the
foregoing in any and all countries of or to any of them including foreign
counterpart applications, as well as any supplementary protection
certificates and equivalent protection rights in respect of any of them.

	 	1.1.39	 	“Phase I Clinical Trial” — a human clinical trial normally conducted in
healthy volunteers or patients with the aim of establishing the
pharmacokinetic, pharmacodynamic and early safety profile of a product (alone
or in combination with another agent).

	 	1.1.40	 	“Phase II Clinical Trial” — a human clinical trial where a product is tested
in a number of patients for the purpose of establishing preliminary data on the
efficacy and safety of a product.

	 	1.1.41	 	“Phase III Clinical Trial” — a human clinical trial conducted in a sufficient
number of patients to establish safety or efficacy for one or more
indication(s) tested and required for the filing of a submission to obtain
Marketing Authorisation.

	 	1.1.42	 	“Product” — a pharmaceutical product comprising the Candidate or otherwise
falling within a Valid Claim of the Licensed Patent Rights.

	 
	 	1.1.43	 	“Professors” — [***]

	 	1.1.44	 	“Quarter” — each period of three months ending on 31 March, 30 June, 30
September or 31 December and “Quarterly” shall be construed accordingly.

	 	1.1.45	 	“Recipient Party” — the Party which receives Confidential Information from
the other Party.

	 	1.1.46	 	“Regulatory Authority” — shall mean any national, supranational, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity including the FDA and EMEA, in each country involved
in the granting of Marketing Authorisation for a Product.

 

- 9 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	1.1.47	 	“Results” — Know How, Patent Rights and Materials arising from any research,
development or commercialisation activity undertaken by or on behalf of
Cyclacel in connection with this Agreement.

	 	1.1.48	 	“Successful Completion” — shall mean that the Phase II Clinical Trial in
question has met the end points set out in Schedule 5.

	 
	 	1.1.49	 	“Territory” — the World excluding the Excluded Territories.

	 	1.1.50	 	“Third Party” — any entity or individual other than Cyclacel or Sankyo or
their respective Affiliates.

	 	1.1.51	 	“Valid Claim” — a claim of an issued and unexpired patent included within
Patent Rights, which has not been permanently revoked, held unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, un-appealable or un-appealed within the time allowed for appeal,
and which has not been admitted to be invalid or unenforceable through reissue
or disclaimer or otherwise.

	 	1.1.52	 	“Year” — twelve (12) months commencing on 1 January and ending on 31
December.

	 	1.2	 	In this Agreement:

	 	1.2.1	 	Unless the context otherwise requires all references to a
particular Clause, Schedule or paragraph shall be a reference to that Clause,
Schedule or paragraph, in or to this Agreement as it may be amended from time
to time pursuant to this Agreement;

	 	1.2.2	 	The table of contents and headings are inserted for
convenience only and shall be ignored in construing this Agreement;

	 	1.2.3	 	Unless the contrary intention appears words importing the
masculine gender shall include the feminine and vice versa and words in the
singular include the plural and vice versa;

	 	1.2.4	 	Unless the contrary intention appears words denoting persons
shall include any individual, partnership, company, corporation, joint venture,
trust, association (incorporated or not incorporated), organisation or other
entity, in each case whether or not having legal personality;

	 	1.2.5	 	Reference to any statute, directive or regulation includes any
modification or re-enactment of that statute or regulation; and

	 	1.2.6	 	References to the word “include” or “including” are to be
construed without limitation to the generality of the preceding words.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	2.	 	LICENCES

	 	2.1	 	Sankyo hereby grants to Cyclacel

	 	2.1.1	 	an exclusive licence under the Licensed IP.

	 	2.1.2	 	a non-exclusive, royalty-free terminable sub-licence under the
CNDAC Patent Rights which are licensed with a right to sub-license by the
Professors to Sankyo.

in each case to research, develop, make, have made, use, import, have imported, market, have
marketed, sell, offer for sale, have sold or otherwise dispose of Candidate (or any
constituent part of the same) and Product, for all indications in the Territory.

	 	2.2	 	The Parties [***] which requires [***] with Product in the [***] and thus
[***]. Sankyo shall use its reasonable efforts [***].

	 	2.2.1	 	[***] relation to the Candidate, Sankyo shall so notify
Cyclacel in writing [***] shall be [***] under the same commercial terms as set
out in this Agreement.

	 	2.2.2	 	[***] in relation to the Candidate, Sankyo shall so notify
[***] discuss in good faith issues relating to [***] including but not limited
to terms for the usage of data generated by Cyclacel [***].

	 	2.2.3	 	Sankyo shall not grant any rights or licences in the Licensed
IP or CNDAC Patent Rights to any Third Party [***], or itself carry out any
activities utilising the Licensed IP or Sub-Licensed IP [***] which would or
would be reasonably expected to have an adverse impact upon the value or scope
of the rights granted to Cyclacel hereunder. [***].

	 	2.3	 	The licences set out in Clause 2.1 shall include the right to grant
sub-licences. Save as otherwise provided in this Agreement, Cyclacel shall procure
that Cyclacel Licensees are bound by the same obligations, to the extent practicable,
as those hereunder, including, but not limited to the obligations of confidentiality
and non-use for unauthorised purpose. Cyclacel shall be responsible to Sankyo for the
acts and omissions, including breach of this Agreement, of any Cyclacel Licensee
provided that in the case of a Cyclacel Licensee committing a material breach that
would constitute a material breach of this Agreement, Cyclacel shall have sixty (60)
days to require such Cyclacel Licensee to remedy the breach or to terminate its
sub-licence before Cyclacel shall be considered to have committed a material breach
under Clause 9.3.1. Cyclacel shall give Sankyo prompt notification of the identity of
each Cyclacel Licensee with whom it concludes a sub-licence.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	2.4	 	As soon as reasonably practicable following the Commencement Date and subject
to the provisions of Clause 3.2.2 Sankyo shall disclose, supply copies of, or otherwise
make available to Cyclacel the Licensed Materials and Documents containing the Licensed
Know How. In particular, and without limiting the foregoing, Sankyo shall supply
Cyclacel with quantities of the Candidate and CNDAC as listed in Schedule 2 and all
synthesis data and methods relating to the Candidate. Cyclacel acknowledges that (i)
save as set out in Clause 7.2 Sankyo does not warrant the quality of any of the
Licensed Materials, and (ii) Sankyo has no further obligation to supply the Candidate
and CNDAC in addition to the quantities listed in Schedule 2. Unless Cyclacel requests
transfer of any or all of those capsules in writing after the Commencement Date, the
Parties shall execute a separate entrustment agreement with respect to the maintenance
and analysis of capsules on stability in Schedule 2, which sets forth that (i) Cyclacel
shall pay the expenses for entrustment to Sankyo and such expenses shall not be subject
to Clause 3.3.2, and that (ii) Sankyo shall perform the analysis after the expiration
dates for storage periods of such capsules on stability. Cyclacel acknowledges that
Sankyo would never be able to further extend expiration dates of such capsules
according to Sankyo’s standards. Sankyo will transfer ownership of all formulated
Candidate as listed in Schedule 2 and the current drug master file of the Candidate to
Cyclacel except for certain amount retained by Sankyo necessary for the technology
transfer or other purposes, including, but not limited to, to comply with regulatory
requirements. Ownership, title and risk of all Licensed Materials provided under this
Clause 2.4 shall be transferred from Sankyo to Cyclacel (i) at shipment if shipped by
Sankyo or its designee to Cyclacel, (ii) upon transfer of [***] in accordance with
Clause 7.4 or (iii) if Licensed Materials otherwise become available to Cyclacel.
Sankyo shall provide Cyclacel with all reasonable assistance requested by Cyclacel in
interpreting and understanding the Licensed IP and in the transfer, including updating
to the FDA, of [***] in accordance with Clause 7.4 at Cyclacel’s cost. Such assistance
by Sankyo for the CMC technology transfer of synthesis and internal process checks
shall be deemed to be completed if either of the following events occurs:

[***]

Sankyo shall maintain its copies of Documents containing the Licensed Know-How for the
lesser of eight (8) years or until requested by Cyclacel under Clause 2.7 or otherwise
agreed by the Parties. Should Sankyo intend to dispose of the Documents it shall so notify
Cyclacel and Cyclacel will be entitled to take ownership of such Documents at Cyclacel’s
discretion and cost.

	 	2.5	 	Sankyo shall at Cyclacel’s request execute or procure the execution of all such
deeds and documents as may be necessary or desirable to record any of the rights
granted to Cyclacel under this Agreement with any patent registry.

 

- 12 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	2.6	 	Sankyo shall notify Cyclacel in the event that Sankyo generates any Patent
Rights or Know How relating to the Candidate or relating to CNDAC which also relates
to the Candidate and if Cyclacel so requests such Patent Rights or Know How shall
then automatically become part of the Licensed IP and shall be licensed to Cyclacel
on the same terms as set out herein.

	 	2.7	 	Sankyo shall maintain those items of technical data listed in Schedule 6 and
shall make the same available to Cyclacel for use in connection with the development or
commercialisation of Product (including, without limitation, for the purposes of
cross-referencing or inclusion in regulatory filings relating to Candidate or Product).
Sankyo shall exert its reasonable efforts to make such data available to Cyclacel
within thirty (30) Business Days of the Commencement Date or the date which such data
become available to Sankyo.

	 	2.8	 	Sankyo shall promptly inform Cyclacel of any significant developments of which
it becomes aware concerning any part of the Licensed IP or CNDAC Patent Rights which
are licensed by Sankyo to Cyclacel.

	3.	 	PAYMENTS

	 	3.1	 	In consideration of the rights granted to Cyclacel under this Agreement
Cyclacel shall pay to Sankyo payments set out in this Clause 3.

	 	3.2	 	Cyclacel shall pay to Sankyo a licence fee and costs comprised of the
following:

	 	3.2.1	 	[***] payable within thirty (30) days of the Commencement
Date;

	 	3.2.2	 	Sankyo’s reasonable costs incurred pursuant to Sankyo’s
technology transfer obligations under Clause 2.4 within 30 days of receipt of
Sankyo’s Quarterly invoice and those costs incurred to Sankyo and reimbursed by
Cyclacel under Clause 6.1 provided that in the event such amounts exceed [***]
any amounts in excess of [***] shall be creditable against the milestone
payments set out in Clause 3.3.1 and provided further that such costs in excess
of [***] shall be subject to an overall maximum of [***]. The Parties
acknowledge that as of the end of June 2003 Sankyo has incurred [***] in
transferring Licensed Know How and Licensed Materials to Cyclacel and that
Sankyo has invoiced Cyclacel for such amount. Notwithstanding the generality
of the foregoing, Cyclacel agrees to pay to Sankyo such [***] within thirty
(30) days of the Commencement Date.

	 	3.3	 	Cyclacel shall pay to Sankyo the following non-refundable payments, provided,
the milestone payments set out in Clauses 3.3.1 to 3.3.5 shall be payable in relation
to the first Product only.

	 	3.3.1	 	subject to any set-off, if applied pursuant to Clause 3.2,
[***] within thirty (30) days of the Successful Completion of the first Phase
II Clinical Trial for Product;

 

- 13 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	3.3.2	 	[***] within thirty (30) days of the commencement of the first
Phase III Clinical Trial for Product, provided, however: (a) if Cyclacel
commenced the first Phase III Clinical Trial for Product without the Successful
Completion of the first Phase II Clinical Trial for Product, the payment under
Clause 3.3.1 above shall become also payable to Sankyo in addition to the
payment under this Clause 3.3.2 and; (b) in the event that Cyclacel is granted
Marketing Authorisation for Product in the USA, any country of the European
Union or Japan on the basis of any clinical trial results generated other than
pursuant to a formal Phase III Clinical Trial, the milestone payment under this
Clause 3.3.2 shall become due and payable by Cyclacel at the same time.

	 	3.3.3	 	[***] within thirty (30) days of the granting of the first
Marketing Authorisation and, if required in order to sell Product, pricing
approval for Product in the USA;

	 	3.3.4	 	[***] within thirty (30) days of the granting of the first
Marketing Authorisation and, if required in order to sell Product, pricing
approval for Product in any country of the European Union;

	 	3.3.5	 	[***] within thirty (30) days of the granting of the first
Marketing Authorisation and, if required in order to sell Product, pricing
approval for Product in Japan;

	 
	 	3.3.6	 	royalties applicable on Net Sales as follows:

	 	3.3.6.1	 	[***] on annual Net Sales less than [***]

	 
	 	3.3.6.2	 	[***] on annual Net Sales greater than or equal to [***] and less
than [***]

	 
	 	3.3.6.3	 	[***] on annual Net Sales greater than or equal to [***]

	 	3.4	 	In the case of sales of Product by Cyclacel, its Affiliates or Cyclacel
Licensees in countries where such sale does not fall within a Valid Claim of a Licensed
Patent Right the royalty payable on Net Sales in such country shall be [***] regardless
of the volume of Net Sales in such country.

	 	3.5	 	In the event a Third Party launches a generic product which directly competes
with the Product and does not infringe Licensed IP and the volume of sales of Product
are less than or equal to [***] of the total volume of sales of Product plus all such
competing generic products in such country as evidenced by data compiled by IMS Health
of 1499 Post Road, Fairfield, CT 06430, USA or, in the event such data by IMS Health is
not available or the Parties agree it is not appropriate to use such data in such
country, a similar market research agency the
royalty payments set out in Clauses 3.3.6.1 to 3.3.6.3 shall no longer be payable to
Sankyo on Net Sales in such country.

 

- 14 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	3.6	 	[***]

	 	3.7	 	The royalties payable by Cyclacel hereunder shall be payable for the following
periods:

	 	3.7.1	 	In those countries where at the time of first commercial sale
in such county the sale of Product falls within a Valid Claim of Licensed
Patent Rights subsisting in that country, royalties shall be payable until the
latter of (i) the last to expire of such Licensed Patent Rights in that country
or (ii) the tenth (10th) anniversary of the date of first commercial sale in
that country;

	 	3.7.2	 	In those countries where at the time of first commercial sale
of Product in that country the sale of Product does not fall within a Valid
Claim of Licensed Patent Rights subsisting in that country, royalties shall be
payable until the tenth (10th) anniversary of the date of first commercial sale
in that country.

	 	3.8	 	Disposal of reasonable quantities of Product for, or use of Product, in
Clinical Trials performed for the purpose of obtaining a Marketing Authorisation or
pre-clinical trials, or as free samples to be in quantities common in the industry for
this sort of Product shall not give rise to liability for payment of a royalty under
this Clause 3.

	 	3.9	 	In the event that Product is sold as a Combination Product containing a
therapeutically active ingredient that is not Licensed IP or CNDAC Patent Rights in a
country, the Net Sales of the Product shall be determined by multiplying [***]. In the
event Cyclacel wishes to develop a Combination Product which (1) is administered
through a therapeutically active administration technology that is not Licensed IP or
CNDAC Patent Rights, (2) is administered in accordance with a diagnostic detection
technology that is not Licensed IP or CNDAC Patent Rights or (3) otherwise depends for
a significant part of its value upon components which are not Licensed IP or CNDAC
Patent Rights, then the Parties shall separately discuss how to determine the Net Sales
applicable for such Combination Product. In the event the Parties fail to agree an
applicable Net Sales price for such combination product within sixty (60) days of
commencing such good faith discussions, such price shall be determined by a reputable
independent auditor appointed by agreement between the Parties or, failing which, the
President (or his or her nominee) for the time being of the Institute of Chartered
Accountants of England and Wales (or any successor body thereto).

 

- 15 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	3.10	 	Cyclacel shall, and shall procure that its Affiliates and Cyclacel Licensees
shall, keep true and accurate records and books of account containing all data
necessary
for the calculation of the amounts payable by it to Sankyo pursuant to this
Agreement. Those records and books of account shall be kept for seven (7) years
following the end of Year to which they relate and shall, upon reasonable notice
having been given by Sankyo or its nominee, be open on Business Days for
examination, under the terms of confidentiality contained in this Agreement, by an
independent firm of accountants appointed by agreement between the Parties or
between Cyclacel and Sankyo’s nominee (as appropriate) or, failing such agreement
within twenty-eight (28) days, by the President (or his or her nominee) for the time
being of the Institute of Chartered Accountants of England and Wales (or any
successor body thereto). Such examination shall take place not later than five (5)
years following the expiration of the period to which it relates and there shall be
no more than one such examination per year. Such independent accountant shall
provide a written report of his findings to each of Cyclacel and Sankyo in which he
certifies the moneys due to Sankyo in respect of the period under review. If such
examination demonstrates that Cyclacel has underpaid royalties due to Sankyo,
Cyclacel shall make a balancing payment within thirty (30) days. The cost of the
examination, review and certification shall be the responsibility of Cyclacel if
Cyclacel is shown to have underestimated the monies payable to Sankyo in any period
being reviewed by more than [***] and the responsibility of Sankyo otherwise.

	 	3.11	 	Cyclacel shall make the royalty payments due to Sankyo under this Clause 3 at
Quarterly intervals. Within thirty (30) days of the end of each Quarter after first
commercial sale in any country, Cyclacel shall prepare a statement which shall show on
a Product by Product and a country by country basis for the previous Quarter all monies
due to Sankyo under Clause 3 and shall, if applicable, contain Cyclacel’s reasonable
estimate of any amounts deductible pursuant to Clauses 3.4 and 3.5. That statement
shall include details of the particular Product description including to the extent it
requires use of Combination Product, sales of the Product and the royalty amount
payable for each country in the Territory. Cyclacel shall pay the royalty due under
Clause 3.3.6 within thirty (30) days of issuance of such statement. Within thirty (30)
days of the end of the final Quarter of each Year Cyclacel shall carry out a
reconciliation in relation to the royalty payments made and the royalty rate applied
during the previous Year and, if applicable, shall apply the formula set out in Clause
3.6. If such reconciliation demonstrates that Cyclacel has underpaid royalties due to
Sankyo it shall make a balancing payment within thirty (30) days and if it is
demonstrated that Cyclacel has overpaid royalties due to Sankyo, Sankyo shall make a
payment to Cyclacel of a balancing refund within thirty (30) days.

 

- 16 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	3.12	 	If Sankyo give notice to Cyclacel within ten (10) Business Days of the receipt
of any statement provided pursuant to Clause 3.11 that it does not accept it, that
statement shall be reviewed and certified by an independent accountant appointed by
agreement between the Parties or, in default of agreement within twenty eight (28)
days, by the President (or his or her nominee) for the time being of the
Institute of Chartered Accountants of England and Wales (or any successor body
thereto). Cyclacel shall make available all books and records required for the
purpose of that review and certification and the statements so certified shall be
final and binding between the Parties. The cost of the examination, review and
certification shall be the responsibility of Cyclacel if Cyclacel is shown to have
underestimated the monies payable to Sankyo in any period being reviewed by more
than [***] and the responsibility of Sankyo otherwise. Following any such
certification under Clause 3.10 or this Clause 3.12 the Parties shall forthwith make
any adjustments necessary in respect of the monies already paid to Sankyo in
relation to the period in question.

	 	3.13	 	Where Product is sold in a currency other than US dollars the rate of exchange
to be used for converting such other currency into US dollars shall be the Telegraphic
Transfer Middle (T.T.M.) rate at which such other currency can be sold for US dollars
at the Bank of England in London at the close of business on the last working date for
the period for which payment is to be made.

	 	3.14	 	If any sums are unpaid by Cyclacel on the dates specified in this Clause then
Sankyo shall be entitled to charge Cyclacel interest on the amount unpaid at the rate
of [***] per annum above the prevailing Bank of England base lending rate from time to
time until payment in full is made.

	 	3.15	 	Royalties or other payments payable under this Clause shall be payable
hereunder without any deduction or set-off save that if any law, regulation or treaty
requires a withholding of income taxes on any milestone, royalty payments or other
payments due to Sankyo, such taxes will be deducted for such payment and paid to the
appropriate taxing authorities. Certificates of such tax payments shall be delivered
to Sankyo along with the balance of the milestone, royalty payment or other payments.

	 	3.16	 	All payments made to Sankyo under the Agreement shall be made by telegraphic
transfer to the account of Sankyo Co. Ltd. at:

[***]

or any other bank account that may be notified by Sankyo to Cyclacel from time to time.

 

- 17 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	4.	 	DEVELOPMENT AND COMMERCIALISATION

	 	4.1	 	Cyclacel shall use commercially reasonable endeavours to pursue the development
and commercialisation of Product. For the purposes of this Clause 4 such reasonable
endeavours shall mean those efforts to develop and commercialise Product which are at
least the same as the efforts used by Cyclacel in relation to the development and
commercialisation of other Cyclacel pharmaceutical products under similar commercial
circumstances that have similar commercial value and development status to the Product.
Cyclacel shall
carry out such development in accordance with the key elements of the Development
Plan which plan may be updated and/or amended from time to time by Cyclacel and
Cyclacel shall provide Sankyo with a copy of any such updated or amended plan.

	 	4.2	 	Without limiting the generality of the foregoing Cyclacel shall use its
reasonable endeavours [***]. If Cyclacel, its Affiliates or Cyclacel Licensees have
not [***] then provided such failure is not due to an Exceptional Cause Sankyo shall be
entitled to notify Cyclacel that it intends to terminate this Agreement, Cyclacel shall
have sixty (60) days to reply to Sankyo’s notification and demonstrate that such
failure was due to an Exceptional Cause. In the event that the Parties agree that no
such Exceptional Cause has been demonstrated then Sankyo will have the right to
terminate this Agreement upon thirty (30) days written notice. [***]. The Parties
shall, no later the fifth (5th) anniversary of the Commencement Date discuss, in good
faith and review such time periods and, if appropriate, extend such period to [***].

	 	4.3	 	Cyclacel shall within thirty (30) days of each anniversary of the Commencement
Date provide Sankyo with a written summary of the progress which Cyclacel, its
Affiliates and/or Cyclacel Licensees has made against the Development Plan in the
previous twelve (12) month period. In addition, Cyclacel shall provide Sankyo within
seven (7) months of each annual written report with a brief update of such progress,
which update may be given in writing by facsimile or by e-mail.

	 	4.4	 	In the event that Cyclacel decides to appoint a Third Party, or if Cyclacel
receives an offer from a Third Party, in either case to develop and/or commercialise
Product solely in Japan or in Japan as part of a multi-territory sub-licence, it shall
so notify Sankyo which notification shall not be made prior to the first Successful
Completion of a [***] Clinical Trial or the decision by Cyclacel or a Cyclacel Licensee
to initiate [***] Clinical Trials and shall be accompanied by (i) details of the terms
upon which Cyclacel is prepared to offer for the appointment of a Third Party licensee
and (ii) the data and evidence on which Cyclacel or Cyclacel Licensee made such
decision. Sankyo shall notify Cyclacel within [***] of receipt of the Cyclacel
notification whether Sankyo wishes to develop and/or commercialise Product in Japan.
If Sankyo notifies Cyclacel that it does wish to develop and/or commercialise Product
in Japan the Parties shall meet and negotiate in good faith the terms of appointment of
Sankyo as Cyclacel Licensee in Japan. If Sankyo notifies Cyclacel that it does not
wish to develop and/or commercialise Product in Japan or, in the case where Sankyo has
notified Cyclacel that it does wish to develop and/or commercialise Product in Japan
but the Parties have failed to agree terms within [***] of commencing negotiations,
then Cyclacel shall be free to appoint a Third Party to develop and/or commercialise
Product in Japan provided that such appointment shall be on terms no more favourable
than those terms which Cyclacel was prepared to offer Sankyo. For the avoidance of
doubt if Cyclacel receives an offer at any time by a
Third Party to commercialise Product on a worldwide basis, Cyclacel shall notify
such Third Party that Sankyo has a first refusal right of Marketing in Japan and
Cyclacel shall propose to such Third Party to accept such condition. In such case,
the conditions imposed under this Clause will be accelerated and Cyclacel will serve
notification to Sankyo who will respond in accordance with the provisions herein.
[***].

 

- 18 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	5.	 	INTELLECTUAL PROPERTY — OWNERSHIP

	 	5.1	 	Sankyo owns the Licensed IP and during the period of this Agreement shall not
assign, transfer, mortgage, charge or otherwise dispose of or encumber the same without
the prior written consent of Cyclacel.

	 
	 	5.2	 	Any and all Results shall vest in and be owned by Cyclacel.

	6.	 	INTELLECTUAL PROPERTY — PROSECUTION, MAINTENANCE AND ENFORCEMENT

	 	6.1	 	Sankyo shall at its own cost and expense file, prosecute and maintain Licensed
Patent Rights, including for the avoidance of doubt all annuity and renewal fees and
shall be responsible for the conduct of any claims or proceedings relating to the
Licensed Patent Rights, including any interference or opposition proceedings. Sankyo
shall keep Cyclacel and/or Cyclacel’s nominated patent attorney fully and promptly
informed of such filing, prosecution and maintenance of the Licensed Patent Rights
including, without limitation, providing Cyclacel and/or Cyclacel’s nominated patent
attorney with copies of all correspondence with any patent office and shall give
Cyclacel the right to comment thereon prior to any response being made to any such
patent office. Sankyo shall ensure that copies of all such patent office
correspondence provided to Cyclacel for comment shall be provided no less that sixty
(60) days prior to the expiry of any patent office deadline for response (if
applicable) and Cyclacel shall ensure that it provides Sankyo with its comments on such
correspondence not less than thirty (30) days prior to the expiry of any such patent
office deadline for response. Without limiting the generality of the foregoing
obligation to keep Cyclacel fully and promptly informed, Cyclacel may itself or through
its patent attorney make a written request to Sankyo or Sankyo’s nominated patent
attorney not more than once per Quarter for a progress report on the filing,
prosecution and maintenance of the Licensed Patent Rights during the previous Quarter
and a summary of the anticipated activities for the next Quarter. Notwithstanding this
Clause 6.1, Cyclacel shall pay the costs and expenses of such filing, prosecution and
maintenance upon Sankyo’s Quarterly invoice prior to its payment of the first
applicable milestone under Clauses 3.3.3, 3.3.4 or 3.3.5 and thereafter such costs
shall be borne by Sankyo, except that such costs borne by Cyclacel after its payment of
the Phase III entry milestone under 3.3.2, will be creditable against the first
applicable milestone under Clauses 3.3.3, 3.3.4 or 3.3.5.

 

- 19 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	6.2	 	If Sankyo fails to prosecute or maintain the Licensed Patent Rights or any part
thereof it must notify Cyclacel in writing at least thirty (30) days prior to the
expiry of any material deadline for the taking of any steps in such action, proceeding
or prosecution and thereafter Cyclacel may in its sole discretion prosecute or maintain
the Licensed Patent Rights or any part thereof. If Cyclacel decides to prosecute or
maintain the Licensed Patent Rights or any part thereof it shall do so at its own cost
and expense and Sankyo shall promptly arrange for its patent attorneys to transfer to
Cyclacel all relevant papers, files and other documents.

	 	6.3	 	If either Party learns of any infringement or threatened infringement by a
Third Party of Licensed IP then such Party shall promptly notify the other Party and
shall provide such other Party with available evidence of such infringement.

	 	6.4	 	In the event of an infringement of the Licensed IP Cyclacel shall have the
first right to bring any action or proceedings in accordance with the following:

	 	6.4.1	 	Sankyo shall have the right to join as a co-plaintiff and be
separately represented by counsel of its own choice and at its own reasonable
cost and expense;

	 	6.4.2	 	Sankyo shall otherwise at Cyclacel’s reasonable request and
sole expense, provide Cyclacel with reasonable assistance in relation to such
action or proceedings;

	 	6.4.3	 	if Cyclacel succeeds in any proceedings whether at trial or by
way of settlement, Cyclacel shall be entitled to retain such award of costs and
damages made in such proceedings or settlement sum after having reimbursed
Sankyo for its costs and expenses incurred in assisting with the proceedings,
subject to Clause 6.4.1 where Cyclacel and Sankyo shall be equally entitled to
retain such award. If Cyclacel should lose such proceedings then Cyclacel
shall on demand reimburse Sankyo its costs and expenses incurred in assisting
with the proceedings;

	 	6.4.4	 	if Cyclacel fails to take any such proceedings Sankyo may give
Cyclacel notice requiring Cyclacel to take such proceedings jointly with Sankyo
within thirty (30) days of the date of the notice and if Cyclacel fails to do
so Sankyo shall be entitled to do so at its own cost and expense and Cyclacel
shall provide all necessary assistance to Sankyo in relation to such
proceedings including lending its name to such proceedings as a co-plaintiff.
If Cyclacel does not join with Sankyo in taking part in such proceedings
Cyclacel shall not be entitled to be separately represented in such
circumstances and Sankyo shall have sole conduct of such proceedings including
the right to settle them. If Sankyo succeeds in any such proceedings it shall
be entitled to retain the whole of any award of costs and damages made or
settlement sum
paid. If Cyclacel joins with Sankyo in taking part in such joint
proceedings Cyclacel shall be entitled to be separately represented in
such circumstances and Sankyo shall jointly conduct such proceedings with
Cyclacel including the right to settle them. If Sankyo and Cyclacel
succeed in any such proceedings they shall share equally any award of
costs and damages made or settlement sum paid.

 

- 20 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	6.5	 	If during the term of this Agreement either Party receives any notice, claim or
proceedings from any Third Party alleging infringement of that Third Party’s
intellectual property or know how as a result of either Party’s activities in relation
to this Agreement or use and exploitation of the Licensed IP the Party receiving that
notice shall:

	 	6.5.1	 	forthwith notify the other Party of such notice, claim or
proceedings;

	 	6.5.2	 	make no admission of liability without the prior consent of
the other Party;

	 	6.5.3	 	subject to Clause 6.6.1 below Cyclacel shall conduct the
defence of such claims or proceedings, including the right to settle them which
shall include taking a licence from such Third Party, and Sankyo shall at
Cyclacel’s cost and expense co-operate with Cyclacel and its legal counsel and
be available at Cyclacel’s reasonable request to assist in such proceedings.
Cyclacel shall keep Sankyo and its legal counsel fully and promptly informed at
all times as to the status of Cyclacel’s defence.

	 	6.6	 	Whilst Cyclacel conducts the defence of such claim or proceedings:

	 	6.6.1	 	Cyclacel shall be responsible for and shall have conduct of
such claims or proceedings but shall fully consult with Sankyo in defending or
settling such claim or proceedings and Cyclacel shall not consent to any
settlement, order or judgment requiring Sankyo to pay costs, damages or provide
other relief without the written consent of Sankyo;

	 	6.6.2	 	if any such proceedings are settled by way of licence, then to
the extent any royalties payable to a Third Party under such licence relate to
Blocking IP they shall be deducted from the royalties payable by Cyclacel to
Sankyo to the same extent and in the same manner as set out in Clause 3.6.

 

- 21 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	6.7	 	At Cyclacel’s request and expense Sankyo shall promptly take all necessary
steps to facilitate any application for a supplementary protection certificate
extension of term or its equivalent, for any of the Licensed Patent Rights.

	 	6.8	 	Within sixty (60) days after each Year-end, Sankyo shall provide Cyclacel with
a report describing the status of the Licensed Patent Rights and Cyclacel shall
provide Sankyo with a report describing the status of the any Patent Rights owned by
Cyclacel under Clause 5.2. Such reports shall include, at a minimum, the patent
country, patent and application numbers, filing date, issue date, expiration date
and any other relevant information, and shall be used to update Schedule 3.

	 	 	 
	Sankyo’s report shall be sent to:

	 	Cyclacel Limited
	 

	 	Dundee Technopole
	 

	 	James Lindsay Place
	 

	 	Dundee DD1 5JJ
	 

	 	UK
	 

	 	Attention: Chief Executive Officer
	 

	 	Telephone: +44 1382 206062
	 

	 	Facsimile: +44 1382 206067
	 
	 	 
	Cyclacel’s report shall be sent to:

	 	Sankyo Company, Limited
	 

	 	[***]

	7.	 	WARRANTIES AND LIABILITY

	 	7.1	 	Each Party represents and warrants to the other Party that:

	 	7.1.1	 	it has the corporate power and authority and the legal right
to enter into this Agreement and that this Agreement is a legal and valid
obligation binding upon such Party and enforceable in accordance with its
terms. The execution, delivery and performance of the Agreement by such Party
does not conflict with any agreement, instrument or understanding, oral or
written, to which it is or by which it is bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it;

	 	7.1.2	 	it has not, and during the term of the Agreement will not,
without the prior written consent of the other Party grant any rights to any
Third Party that would conflict with the rights granted to the other Party
hereunder;

	 	7.1.3	 	it has the right to grant the licenses granted or to be
granted herein;

	 	7.1.4	 	it is a corporation duly organised, validly existing and in
good standing under the laws of the jurisdiction in which it is incorporated;
and

	 	7.1.5	 	the execution and delivery of this Agreement and the
performance of such Party’s obligations do not constitute a default or require
any consent under any other contractual obligation of such Party.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	7.2	 	Sankyo hereby warrants and undertakes that at the Commencement Date:

	 	7.2.1	 	it owns absolutely, co-owns or has the right to licence the
Licensed IP and the CNDAC Patent Rights sufficient to grant the licences
granted herein;

	 	7.2.2	 	it has obtained from each and every inventor of the Licensed
Patent Rights an assignment of all rights such inventors may have in the
Licensed Patent Rights and save as otherwise disclosed to Cyclacel in writing
it has not partially assigned, licensed, mortgaged, charged or otherwise
disposed of or encumbered its right, title or interest in the same;

	 	7.2.3	 	it has disclosed to Cyclacel all information relating to the
Licensed IP and CNDAC Patent Rights and any therapeutic use of the Candidate
which has been generated by Sankyo or Third Parties, provided that in the case
of Third Parties the disclosure of such information is not prohibited under any
confidentiality obligations; and

	 	7.2.4	 	it has disclosed to Cyclacel the identity of the Third Parties
which have generated the information described in Clause 7.2.3; and

	 	7.2.5	 	it has not granted to any other party any licence to research,
develop or commercialise the Candidate or CNDAC or any other compound falling
within a Valid Claim of the Licensed Patent Rights or the CNDAC Patent Rights.

	 	7.2.6	 	it has manufactured the “samples of any capsules in storage”,
which is identified in Schedule 2, under GMP and it had obtained from [***] a
statement that [***] has stored the same under GMP.

	 	7.3	 	Save as is expressly stated in Clause 7.1 or 7.2 NO REPRESENTATION, CONDITION
OR WARRANTY WHATSOEVER IS MADE OR GIVEN, EITHER EXPRESSED OR IMPLIED, BY OR ON BEHALF
OF CYCLACEL OR SANKYO. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE CANDIDATE WILL NOT INFRINGE
ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. ALL CONDITIONS AND
WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE HEREBY EXPRESSLY
EXCLUDED INCLUDING ANY CONDITIONS AND WARRANTIES TO THE EFFECT THAT ANY OF THE LICENSED
IP IS VALID OR ENFORCEABLE.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	7.4	 	Cyclacel shall have the control of and be responsible for all Clinical Trials
conducted in relation to Product after execution of this Agreement including such
ongoing Clinical Trials described in Schedule 7 and shall be the sponsor of such trials
and in such capacity, shall, notwithstanding its indemnity rights under Clause 7.5, be
responsible for the initial payment of any compensation due to any participants in such
trials who suffer death or bodily injury pursuant to any legal
rights or applicable industry guidelines. If it has not already done so prior to
the Commencement Date, Sankyo shall submit to the FDA an Annual Update, including
Information Amendment, to [***] detailing an extension to the shelf-life of Product
and shall transfer [***] for such ongoing Clinical Trial to Cyclacel. In the event
that the FDA does not accept an extension to the shelf life of Product for use in
such ongoing Clinical Trials Cyclacel’s obligations hereunder in relation to such
ongoing Clinical Trials shall be suspended until such time as the FDA has accepted
the use of Product in such trials. Cyclacel (i) shall continue to conduct such
ongoing Clinical Trial after the Commencement Date in compliance with the Phase I
protocol provided by Sankyo, (ii) shall not amend or alter such protocol and (iii)
shall not terminate such ongoing Clinical Trial at least until the end of December
2003 for ethical reasons unless otherwise terminated in accordance with the
protocol.

	 	7.5	 	Subject to the provisions of Clause 7.6 Sankyo shall be responsible for and
shall indemnify Cyclacel and its directors, officers, servants and agents (collectively
“the Indemnified Party”) against any and all liability, loss, damage, cost and expense
(including legal costs) incurred or suffered by the Indemnified Party as a result of a
breach of warranty by Sankyo under Clauses 7.1 or 7.2 or as a result of Sankyo’s
activities in relation to the development of Candidate or Product prior to the
Commencement Date of this Agreement. An Indemnified Party that intends to claim
indemnification under this Clause 7.5 shall promptly notify Sankyo of any Third Party
claim in respect of which the Indemnified Party intends to claim that indemnification.
The Indemnified Party shall not compromise or settle the claim prior to any such
notice. Sankyo may assume and control the defence of any such Third Party claim,
provided however, that an Indemnified Party shall have the right to retain its own
counsel at its own cost and expense, if representation of that Indemnified Party by the
counsel retained by Sankyo would be inappropriate due to actual or potential differing
interests between the Indemnified Party and any other party represented by that counsel
in the proceedings. The Indemnified Party shall co-operate with Sankyo and its legal
representatives in the investigation of any matter covered by this indemnification.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	7.6	 	Cyclacel shall be responsible for and shall indemnify Sankyo and its
Affiliates, directors, officers, servants and agents (collectively “the Indemnified
Party”) against any and all liability, loss, damage, cost and expense (including legal
costs) incurred or suffered by the Indemnified Party as a result of any claim brought
against Sankyo or its Affiliates by a Third Party which arises

	 	7.6.1	 	as a result of the activities by Cyclacel or its Affiliates,
Cyclacel Licensees, agents or distributors under this Agreement in relation to
the development or commercialisation of the Product being a claim that use of
any Product has caused death or bodily injury; or

	 	7.6.2	 	as a result of a breach of warranty by Cyclacel under Clause
7.1.

An Indemnified Party that intends to claim indemnification under this Clause 7.6 shall
promptly notify Cyclacel of any Third Party claim in respect of which the Indemnified Party
intends to claim the indemnification. The Indemnified Party shall not compromise or settle
the claim prior to any such notice. Cyclacel may assume and control the defence of any such
Third Party claim, provided however, that an Indemnified Party shall have the right to
retain its own counsel at its own cost and expense, if representation of that Indemnified
Party by the counsel retained by Cyclacel would be inappropriate due to actual or potential
differing interests between the Indemnified Party and any other party represented by that
counsel in the proceedings. The Indemnified Party shall co-operate with Cyclacel and its
legal representatives in the investigation of any matter covered by this indemnification.

	 	7.7	 	Subject to the indemnities in Clauses 7.5 and 7.6 neither Party shall be liable
to the other in contract, tort, negligence, breach of statutory duty or otherwise for
any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by
the other or its Affiliates:

	 	7.7.1	 	of a direct nature where the same is a loss of turnover,
profits, business or goodwill; or

	 	7.7.2	 	an indirect or consequential nature including any indirect or
consequential economic loss or other indirect or consequential loss of
turnover, profits, business or goodwill.

	8.	 	CONFIDENTIALITY

	 	8.1	 	Subject to Clause 8.6, each of the Parties undertakes and agrees to:

	 	8.1.1	 	only use the Confidential Information for the purposes
envisaged under this Agreement and not to use the same for any other purpose
whatsoever;

	 	8.1.2	 	ensure that only those of their officers, consultants,
employees (including without limitation directors), sublicensees, Affiliates
and such third parties who are directly concerned with the carrying out of this
Agreement have access to the Confidential Information on a strictly applied
“need to know” basis and are informed of the secret and confidential nature of
it;

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	8.1.3	 	keep the Confidential Information secret and confidential and
not directly or indirectly to disclose or permit to be disclosed, make
available or permit to be made available the same to any Third Party for any
reason without the prior written consent of the Disclosing Party (except as set
out in the Development Plan and then under equivalent confidentiality
provisions);

	 
	 	8.1.4	 	clearly identify the Confidential Information as confidential.

	 	8.2	 	The obligations of confidentiality referred to in Clause 8.1 shall not extend
to any Confidential Information which:

	 	8.2.1	 	is or becomes generally available to the public otherwise than
by reason of breach by a Recipient Party of the provisions of that Clause; or

	 	8.2.2	 	is known to the Recipient Party and is at its free disposal
prior to its receipt from the Disclosing Party in circumstances where the
Recipient Party holds evidence that it has not been derived from access to the
Disclosing Party’s Confidential Information; or

	 	8.2.3	 	is mutually agreed in writing by the Parties to no longer be
confidential; or

	 	8.2.4	 	is subsequently disclosed to the Recipient Party without
obligations of confidentiality by a Third Party owing no such obligations to
the Disclosing Party in respect of that Confidential Information; or

	 	8.2.5	 	is required by a Legal Requirement to be disclosed and then
only (subject to Clause 8.3) when prompt written notice of this requirement has
been given to the Disclosing Party so that it may, if so advised, seek
appropriate relief to prevent such disclosure provided always that in such
circumstances such disclosure shall be only to the extent so required and shall
be subject to prior consultation with the Disclosing Party with a view to
agreeing timing and content of such disclosure.

	 	8.3	 	The requirement under Clause 8.2.5 to notify the Disclosing Party when
Confidential Information is required to be disclosed pursuant to Legal Requirement
shall not apply when such disclosure is required as part of any regulatory submission
or approval process.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	8.4	 	All Confidential Information disclosed by the Disclosing Party to the Recipient
Party shall remain the property of the Disclosing Party subject to the use or disposal
of Materials pursuant to the Development Plan. In the event that a court or Competent
Authority assumes partial or complete control over the assets of a Recipient Party
based on the insolvency or bankruptcy of that Party, the Recipient Party shall:

	 	8.4.1	 	promptly notify such court or Competent Authority:

	 	(a)	 	that Confidential Information received
from the Disclosing Party under this Agreement remains the property
of the Disclosing Party; and

	 	(b)	 	of the confidentiality obligations under
this Agreement; and

	 	8.4.2	 	to the extent permitted by law, take all steps necessary or
desirable to maintain the confidentiality and security of the Disclosing
Party’s Confidential Information and to ensure that the court or Competent
Authority maintains that Confidential Information in confidence in accordance
with this Agreement.

	 	8.5	 	The Parties agree that the obligations of confidentiality set out in this
Clause 8 shall continue to apply following the expiration or termination of this
Agreement for so long as there is Confidential Information which is not the subject of
Clause 8.2.

	 	8.6	 	Sankyo acknowledges and agrees that Cyclacel shall be free to publish the
results arising pursuant to the exercise of its rights and licences under this
Agreement. Such publication may also include Licensed Know How comprising data related
to the Candidate and the development thereof provided that Cyclacel shall give Sankyo
prior written notice of any publication containing such Licensed Know How and Sankyo
shall have thirty (30) days to comment upon the same. Cyclacel shall consider any
comments from Sankyo in good faith. Cyclacel shall be free to publish the Licensed
Know How relating to the Candidate and/or its development following such thirty (30)
day period.

	 	8.7	 	Results published under Clause 8.6, will be considered to be covered by Clause
8.2.3 in respect of future publications and Clause 8.6 will no longer apply.

	9.	 	TERM AND TERMINATION

	 	9.1	 	This Agreement shall commence on the Commencement Date and shall continue in
force until no payments are due hereunder or until termination under this Clause 9
whichever is the earlier.

	 	9.2	 	Cyclacel may terminate this Agreement at any time upon six (6) months’ (upon
twelve (12) months’ if after Product launch) written notice to Sankyo for technical,
scientific, efficacy, safety or commercial reasons.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	9.3	 	Cyclacel on the one hand and Sankyo on the other hand (the “Terminating Party”)
shall have the right to terminate this Agreement upon giving thirty (30) days’ written
notice of termination to the other (the “Defaulting Party”) upon the occurrence of any
of the following events at any time during this Agreement:

	 	9.3.1	 	the Defaulting Party committing a material breach of this
Agreement which in the case of a breach capable of remedy shall not have been
remedied within thirty (30) days, or sixty (60) days in case of breach by
Cyclacel Licensee as permitted under Clause 2.3, of the receipt by it of a
notice identifying the breach and requiring its remedy. The Parties
acknowledge that non-payment of sums due by Cyclacel may amount to a material
breach having regard to the level of non-payment
and the reasons given by Cyclacel for such non-payment. The Parties
agree that any notification of material breach pursuant to this Clause
9.3 shall be sent to the chief executive officer of the Defaulting Party;

	 	9.3.2	 	if an Insolvency Event occurs in relation to the Defaulting
Party.

	10.	 	EFFECTS OF TERMINATION

	 	10.1	 	Upon termination of this Agreement by Sankyo pursuant to Clause 4.2 or Clause
9.3 or by Cyclacel pursuant to Clause 9.2:

	 	10.1.1	 	the licences granted by Sankyo pursuant to Clause 2 under the Licensed IP,
and CNDAC Patent Rights shall terminate;

	 	10.1.2	 	if Sankyo so requests in writing, Cyclacel shall immediately deliver up to
Sankyo the Licensed IP, CNDAC Patent Rights and Documents containing or making
any reference to the Licensed IP or CNDAC Patent Rights as soon as reasonably
practicable. Within sixty (60) days of such termination, the Parties shall
negotiate and agree a separate Termination Agreement in regard to the transfer
of ownership and return to Sankyo of all regulatory submissions, and documents
filed with a Regulatory Authority for the Product in the Territory. The
Parties shall cooperate in order to provide the appropriate notice and
documentation to the Regulatory Authority for each submission as required by
applicable law; and

	 	10.1.3	 	if Sankyo wishes to obtain an exclusive licence to the Cyclacel Results it
shall so notify Cyclacel and Cyclacel shall grant to Sankyo an exclusive,
worldwide, sub-licensable licence to the Cyclacel Results the commercial terms
of which shall be negotiated in good faith by the Parties, having regard to the
(i) length of time this Agreement has been in force, (ii) the development
efforts expended by Cyclacel, and (iii) the cause of termination. In the event
the Parties fail to agree the terms of such licence within sixty (60) days of
the date upon which Cyclacel receives written notice from Sankyo that it wishes
to obtain such a licence, the matter shall be referred to Expert’s Decision for
resolution, whilst such exclusive license shall be temporarily granted to
Sankyo during such period.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	10.2	 	In no event shall termination of this Agreement:

(i) relieve the Parties of any liability arising out of events occurring before the
effective date of such termination.

(ii) affect the continued operation or enforcement of any provision of this
Agreement which by its express terms is to survive termination.

(iii) release either Party from the obligation to pay any amounts that become due on
or before the effective date of termination.

	 	10.3	 	Upon termination of this Agreement by Sankyo pursuant to Clause 9.3 and at the
request of any Cyclacel Licensee Sankyo shall enter into a direct licensing arrangement
with such Cyclacel Licensee on terms substantially similar to those contained herein
save that any licence granted by Sankyo to such Cyclacel Licensee shall be consistent
with the terms of the licence granted by Cyclacel in relation to field, territory,
exclusivity/non-exclusivity, whether there is a right to sub-license, and payment
provisions and provided that: (i) such sub-licensee is in good standing under and in
compliance with all material terms and conditions of the sublicence agreement and this
Agreement; (ii) should Sankyo’s ongoing direct costs related to such sublicense
including but not limited to IP costs under Clause 6.1, not be fully reimbursed by
revenue from such sublicensee on an annual basis then Sankyo can require that such
sublicensee reimburse Sankyo’s costs, such reimbursement to be credited against future
revenue payable to Sankyo by such sublicensee; and (iii) Sankyo’s obligations under
such sublicense agreement are no greater than those under this Agreement.

	11.	 	ASSIGNMENT/SUB-CONTRACTING

	 	11.1	 	Neither this Agreement nor any interest hereunder shall be assignable by either
Cyclacel or by Sankyo without the written consent of the other, such consent not to be
unreasonably withheld, provided however that any Party may assign this Agreement to any
corporation with which it may merge or consolidate, or to which it may transfer all or
substantially all of its assets to which this Agreement relates, subject to obtaining a
direct deed of undertaking from such corporation addressed to the other Parties
agreeing to be bound by all the terms of this Agreement.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	12.	 	FORCE MAJEURE

	 	12.1	 	If a Party (the “Affected Party”) is unable to carry out any of its obligations
under this Agreement due to Force Majeure this Agreement shall remain in effect but the
Affected Party’s relevant obligations under this Agreement and the corresponding
obligations of the other Party (“Non-Affected Party”) under this Agreement, shall be
suspended for a period equal to the circumstance of Force Majeure provided that:

	 	12.1.1	 	the suspension of performance is of no greater scope than is required by the
Force Majeure;

	 	12.1.2	 	the Affected Party immediately gives the Non-Affected Party prompt written
notice describing the circumstance of Force Majeure, including the nature of
the occurrence and its expected duration, and continues to furnish regular
reports during the period of Force Majeure and notifies
the Non-Affected Party immediately of the cessation of the Force Majeure;

	 	12.1.3	 	the Affected Party uses all reasonable efforts to remedy its inability to
perform and to mitigate the effects of the circumstance of Force Majeure; and

	 	12.1.4	 	a soon as practicable after the event which constitutes Force Majeure the
Parties discuss how best to continue their operations as far as possible in
accordance with this Agreement.

	13.	 	GOVERNING LAW

	 	13.1	 	The validity, construction and interpretation of this Agreement and any
determination of the performance which it requires shall be governed by the laws of
England.

	14.	 	JURISDICTION

	 	14.1	 	In the event of any material dispute concerning rights or obligations under
this Agreement then the Parties shall comply with the following procedure: the Chief
Executive Officer of Cyclacel and the President of Sankyo or its nominee shall be
notified in writing of the dispute by either Party. The Chief Executive Officer of
Cyclacel and the President of Sankyo or their nominees shall meet to resolve the
dispute in good faith. If such resolution is not reached within sixty (60) days of
such written notice, then the dispute shall be referred to the non-exclusive
jurisdiction of the courts of England and Wales.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	15.	 	WAIVER

	 	15.1	 	Save as expressly provided in this Agreement neither Party shall be deemed to
have waived any of its rights or remedies whatsoever unless the waiver is made in
writing, signed by a duly authorised representative of that Party and may be given
subject to any conditions thought fit by the grantor. Unless otherwise expressly
stated any waiver shall be effective only in the instance and for the purpose for which
it is given.

	 	15.2	 	No delay or failure of any Party in exercising or enforcing any of its rights
or remedies whatsoever shall operate as a waiver of those rights or remedies or so as
to preclude or impair the exercise or enforcement of those rights or remedies. No
single or partial exercise or enforcement of any right or remedy by any Party shall
preclude or impair any other or further exercise or enforcement of that right or remedy
by that Party.

	16.	 	SEVERANCE OF TERMS

	 	16.1	 	If the whole or any part of this Agreement is or becomes or is declared
illegal, invalid or unenforceable in any jurisdiction for any reason (including both by
reason of the provisions of any legislation and also by reason of any decision of any
court or Competent Authority which either has jurisdiction over this Agreement or has
jurisdiction over any of the Parties):

	 	16.1.1	 	in the case of the illegality, invalidity or un-enforceability of the whole
of this Agreement it shall terminate in relation to the jurisdiction in
question; or

	 	16.1.2	 	in the case of the illegality, invalidity or un-enforceability of part of
this Agreement that part shall be severed from this Agreement in the
jurisdiction in question and that illegality, invalidity or un-enforceability
shall not in any way whatsoever prejudice or affect the remaining parts of this
Agreement which shall continue in full force and effect provided that the said
remaining parts continue to satisfy the commercial intentions of the Parties
and provided that the remaining parts do constitute a substantial part of this
Agreement.

	17.	 	ENTIRE AGREEMENT/VARIATIONS

	 	17.1	 	This Agreement constitutes the entire agreement and understanding between the
Parties and supersedes all prior oral or written understandings, arrangements,
representations or agreements between them relating to the subject matter of this
Agreement. The Parties acknowledge that no claims shall arise in respect of any
understandings, arrangements, representations or agreements so superseded. No
director, employee or agent of any Party is authorised to make any representation or
warranty to another Party not contained in this Agreement, and each Party acknowledges
that it has not relied on any such oral or written representations or warranties.
Nothing in this Agreement removes or overrides any right of action by any Party in
respect of any fraudulent misrepresentation, fraudulent concealment or other fraudulent
action.

	 	17.2	 	No variation, amendments, modification or supplement to this Agreement shall be
valid unless agreed in writing in the English language and signed by a duly authorised
representative of each Party.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	18.	 	NOTICES

	 	18.1	 	Any notice or other communication given pursuant to or made under or in
connection with the matters contemplated by this Agreement shall be in writing in the
English language and shall be delivered by hand or by courier or shall be sent by post
or recorded delivery to the address of the recipient set out in Schedule 8 or as
specified by the recipient from time to time in accordance with Clause 18.3. Notices
sent by fax or E-Mail shall not be valid of themselves and must be confirmed in hard
copy form by hand or by recorded delivery.

	 
	 	18.2	 	Any notice given pursuant to this Clause shall be deemed to have been received:

	 	18.2.1	 	if delivered by hand or by courier, at the time of delivery; or

	 
	 	18.2.2	 	if sent by recorded delivery, at the time of delivery.

	 	18.3	 	A Party may notify the other Parties to this Agreement of a change of its name,
relevant addressee, address or facsimile number for the purposes of

	 
	 	18.4	 	8 provided that such notification shall only be effective on:

	 	18.4.1	 	the date specified in the notification as the date on which the change is to
take place; or

	 	18.4.2	 	if no date is specified or the date specified is less than five (5) clear
Business Days after the date on which the notice is given, the date falling
five (5) clear Business Days after notice of any such change has been given.

	 	18.5	 	For the avoidance of doubt, the Parties agree that the provisions of this
Clause shall not apply in relation to the service of Service Documents (as defined in
Clause 18.5).

	 	18.6	 	“Service Document” means a writ, summons, order, judgement or other document
related to or in connection with any Court proceeding, cause, matter or action arising
out of or connected in any way with this Agreement.

	19.	 	COUNTERPARTS

	 	19.1	 	This Agreement may be executed in any number of counterparts and by the Parties
on separate counterparts, each of which when so executed shall be an original of this
Agreement, and all of which shall together constitute one and the same instrument.
Complete sets of counterparts shall be lodged with each Party.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	20.	 	THIS AGREEMENT NOT TO CONSTITUTE A PARTNERSHIP

	 	20.1	 	Nothing in this Agreement and no action taken by the Parties pursuant to this
Agreement shall constitute or be deemed to constitute a partnership, association, joint
venture or other co-operative entity between the Parties and neither Party shall have
any authority to bind the other in any way except as provided in this Agreement.

	21.	 	COSTS

	 	21.1	 	Each Party shall bear its own costs, legal fees and other expenses incurred in
the negotiation, preparation, execution and implementation of this Agreement and the
documents referred to herein unless otherwise set forth in this Agreement.

	22.	 	PUBLICITY

	 	22.1	 	No public announcements or other disclosure to third parties concerning the
financial or other terms of this Agreement shall be made, whether directly or
indirectly, by either Party to this Agreement, except as may be legally required or as
may be required for recording purposes, without first obtaining the approval of the
other Party and agreement upon the nature and text of such announcement or disclosure,
with the exception that:

	 	22.1.1	 	a Party may disclose the full terms of this Agreement to its investment
bankers, lawyers, accountants and other professional advisors or a Third Party
seeking to invest in, lend funds to acquire or merge with or be acquired by
such Party without the other Party’s prior approval provided that such
disclosure is made under terms of confidentiality whether express or implied;
and

	 	22.1.2	 	a Party may disclose the terms of this Agreement to any securities exchange
or regulatory authority or government body to which either Party is subject or
submits, wherever situated, including (without limitation) the US Securities
Exchange Commission, the London Stock Exchange or the Panel on Take-overs and
Mergers, if and to the extent required by the force of law provided that it
takes advantage of all provisions to keep confidential as many terms of this
Agreement as possible.

 

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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	22.2	 	In respect of those public announcements and disclosures not permitted by
Clause 22.1 the Party desiring to make any such public announcement or other disclosure
shall inform the other Party of the proposed announcements or disclosure in reasonably
sufficient time prior to public release, and shall provide the other Party with a
written copy thereof, in order to allow such Party to comment upon such announcement or
disclosure, which comments shall be provided by such other Party within five (5)
Business Days. The Parties shall jointly develop press releases and information
materials that can be used by either Party for presentations to financial advisers, the
UK Stock Exchange, and similar recipients.

IN WITNESS WHEREOF the Parties have executed this Agreement as of the Commencement Date.

	 	 	 	 	 
	SIGNED by
	 	)	 	 
	for and on behalf of
	 	)	 	Takashi Shoda, President and Representative Director
	SANKYO CO. LTD.
	 	)	 	 
	Date:
	 	)	 	 
	 
	 	 	 	 
	SIGNED by
	 	)	 	 
	for and on behalf of
	 	)	 	Spiro Rombotis, Chief Executive Officer
	CYCLACEL LIMITED
	 	)	 	 
	Date:
	 	)	 	 

 

- 34 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 1

DEVELOPMENT PLAN

[***]

 

- 35 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 2

LICENSED MATERIALS

[***]

 

- 36 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 3

LICENSED PATENT RIGHTS

Patent Rights owned by Sankyo

A. Licensed Patent Rights

	 	 	 
	[*] (Crystal of CS-682)

	 	Publication No. WO 02/064609 A1 (22.08.2002)
	Crystal of pyrimidine nucleoside derivative
	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Country	 	Appln. No.	 	Appln. Date	 	Patent No.	 	 	Patent Date	 	 	Expiry Date	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	PCT
	 	[*]	 	06/02/2002	 	 	 	 	 	 	 	 	 	 	 	 
	Australia
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Brazil
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Canada
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	China
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Colombia
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Czech Republic
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	EPC
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Austria, Belgium, Switzerland & Liechtenstein, Cyprus, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Ireland, Italy, Luxembourg, Monaco, Netherlands, Portugal, Sweden, Turkey,

	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Hungary
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Israel
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	India
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Korea
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Mexico
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	New Zealand
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Russia
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	U. S. A.
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Japan
	 	[*]	 	[*]	 	 	 	 	 	 	 	 	 	 	 	 

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

B. Licensed Patent Rights

[*] (CS-682)

Pyrimidine nucleoside derivatives having anti-tumor activity, their preparation and use

	 	 	 	 	 	 	 	 	 	 	 
	Country	 	Appln. No.	 	Appln. Date	 	Patent No.	 	Patent Date	 	Expiry Date
	 
	 	 	 	 	 	 	 	 	 	 
	Australia
	 	[*]	 	30/09/1992	 	654212	 	15/02/1995	 	[*]
	Brazil (pipeline)
	 	[*]	 	13/05/1997	 	PI 1100621-8	 	07/12/1999	 	[*]
	Canada
	 	[*]	 	29/09/1992	 	 	 	 	 	 
	China
	 	[*]	 	30/09/1992	 	92113067.8	 	03/08/1996	 	[*]
	Czech Republic
	 	[*]	 	30/09/1992	 	289477	 	29/11/2001	 	[*]
	EPC
	 	92308904.9	 	30/09/1992	 	0536936	 	14/08/1996	 	[*]
	Austria, Belgium, Switzerland & Liechtenstein, Germany, Denmark, Spain, France, Great Britain, Greece, Ireland, Italy, Luxembourg, Monaco, Netherlands, Portugal, Sweden

	Finland
	 	[*]	 	[*]	 	105556	 	15/09/2000	 	[*]
	Hong Kong
	 	[*]	 	 	 	2042/96	 	14/08/1996	 	[*]
	Hungary
	 	[*]	 	30/09/1992	 	[*]	 	[*]	 	[*]
	Hungary (pipeline)
	 	[*]	 	[*]	 	211851	 	13/08/1996	 	[*]
	Indonesia
	 	[*]	 	[*]	 	ID0002812	 	22/06/1998	 	[*]
	Israel
	 	[*]	 	[*]	 	103301	 	14/10/1997	 	[*]
	Korea
	 	[*]	 	[*]	 	255491	 	15/02/2000	 	[*]
	Mexico
	 	[*]	 	[*]	 	 	 	 	 	 
	Norway
	 	[*]	 	[*]	 	179675	 	27/11/1996	 	[*]
	New Zealand
	 	[*]	 	[*]	 	244574	 	14/06/1994	 	[*]
	[*]
	 	[*]	 	[*]	 	 	 	 	 	 
	Russian Fed.
	 	[*]	 	[*]	 	2085557	 	27/07/1997	 	[*]
	Thailand
	 	[*]	 	[*]	 	9368	 	[*]	 	[*]
	Taiwan
	 	[*]	 	[*]	 	[*]	 	[*]	 	29/09/2012
	U. S. A.
	 	[*]	 	[*]	 	[*]	 	 	 	 
	U. S. A.
	 	[*]	 	[*]	 	5691319	 	25/11/1997	 	25/11/2014
	South Africa
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	Japan
	 	[*]	 	[*]	 	2569251	 	03/10/1996	 	[*]

 

- 2 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 4

CNDAC PATENT RIGHTS

C. CNDAC Patent Rights

			
	 	 	 
	[*]
	 	2002. 8.30
	(CNDAC: Active form of CS-682)	 	 
	Pyrimidine nucleoside derivatives	 	 

	 	 	 	 	 	 	 	 	 	 	 
	Country	 	Appln. No.	 	Appln. Date	 	Patent No.	 	Patent Date	 	Expiry Date
	 
	 	 	 	 	 	 	 	 	 	 
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	 
	 	 	 	[*]	 	 	 	 	 	 
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]
	[*]
	 	[*]	 	[*]	 	[*]	 	 	 	 
	U. S. A.
	 	[*]	 	[*]	 	5616567	 	01/04/1997	 	01/04/2014
	U. S. A.
	 	[*]	 	[*]	 	5654420	 	05/08/1997	 	05/08/2014
	[*]
	 	[*]	 	[*]	 	[*]	 	[*]	 	[*]

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 5

SUCCESSFUL COMPLETION CRITERIA

[***]

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 6

RETAINED TECHNICAL DATA

[***]

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 7

COMMITTED CLINICAL TRIALS

[***]

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 8

ADDRESSES FOR NOTICES

Cyclacel

Chief Executive Officer

Dundee Technopole

James Lindsay Place

Dundee DD1 5JJ

UK

Tel: +44 1382 206062

Fax: +44 1382 206067

Sankyo Co., Ltd.

Director, Licensing Department

5-1 Nihonbashi-honcho 3-chome,

Chuo-ku, Tokyo 103-8426

JAPAN

Tel: [***]

Fax: [***]

 

- 2 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

SCHEDULE 9

EXPERT’S DECISION

	1	 	In the event the Parties fail to agree upon an appropriate level of consideration pursuant to
Clause 10.1.3, the matter shall be determined by an expert (“Expert”) which Expert shall be
suitably qualified to determine that particular matter and who shall be nominated jointly by
the Parties or, failing agreement between the Parties within twenty (20) business days of a
written request by either Party to the other seeking to initiate the Expert’s decision
procedure, either Party may request the International Chamber of Commerce (Paris) to nominate
the Expert.

	2	 	The Parties shall within fourteen (14) days of the appointment of the Expert file written
submissions setting out their respective view on appropriate levels of consideration and
appropriate accompanying documents.

	3	 	In determining the matter referred pursuant to Clause 10.1.3 the Expert shall take into
account (i) the length of time this Agreement has been in force, (ii) the development efforts
expended by Cyclacel; and (iii) the cause of termination of the Agreement.

	 
	4	 	In all cases the terms of appointment of the Expert by whomsoever appointed shall include:

	 	4.1	 	a commitment by the Parties to share equally the Expert’s fee;

	 	4.2	 	a requirement on the Expert to act fairly as between the Parties and according
to the principles of natural justice;

	 	4.3	 	a requirement on the Expert to hold professional indemnity insurance both then
and for three years following the date of his determination;

	 	4.4	 	a commitment by the Parties to supply to the Expert all such assistance,
documents and information as he or she may require for the purpose of his or her
determination.

	 	4.5	 	a commitment by the Parties that all negotiations connected with the dispute
shall be conducted in confidence and without prejudice to the rights of the Parties in
any future proceedings.

 

- 3 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	5	 	The Expert’s decision shall be final and binding on the Parties (save in the case of
negligence or manifest error).

	6	 	The Parties expressly acknowledge and agree that they do not intend the reference to the
Expert to constitute an arbitration within the scope of any arbitration legislation, the
Expert’s decision is not a quasi judicial procedure and the Parties shall have no right of
appeal against the Expert’s decision provided always that this shall not be construed as
waiving any rights the Parties might have against the Expert for breaching his or her terms
of appointment or otherwise being negligent.

 

- 4 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	 	 
	

	 	Licensing Department

SANKYO CO., LTD.

3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8476, Japan

Phone: 81-3-5255-7084, Fax: 81-3-5255-7086

Spiro Rombotis

Chief Executive Officer

Cyclacel Limited

Dundee Technopole

James Lindsay Place

Dundee, DD1 5JJ

Scotland, United Kingdom

	Re: 	 	 Amendment to CS-682 License Agreement

Between Sankyo Co., Ltd. and Cyclacel Limited

Dear Mr. Rombotis,

As per your request, this letter is to confirm that we have agreed to amend the CS-682 License
Agreement as follows:

	1.	 	Clause 2.1.2 of CS-682 License Agreement is hereby amended by deleting the word
“terminable” from that Clause. As amended, the said Clause shall read as follows:

	 	2.1.2	 	a non-exclusive, royalty-free sub-license under the CNDAC Patent Rights
which are licensed with a right to sub-license by the Professors to Sankyo.

	2.	 	Cyclacel agrees to be responsible for and to indemnify Sankyo and its Affiliates,
directors, officers, servants and agents (collectively “the Indemnified Party”) against any
and all liability, loss, damage, cost and expense (including legal costs) incurred or suffered
by the Indemnified Party as a result of claim brought against Sankyo or its Affiliates by a
Third Party which arises as a result of the activities by Cyclacel or its Affiliates, Cyclacel
Licensees, agents or distributors under the CS-682 License Agreement in relation to the
deletion of “terminable” from Clause 2.1.2 thereof.

	3.	 	Sankyo agrees that in the event that Cyclacel’s ability to exercise the said sub-license
is jeopardized or lost it will cooperate with Cyclacel, upon Cyclacel’s request and at
Cyclacel’s expenses, in taking any steps which Sankyo considers reasonably required to
preserve or restore the said sub-license and the rights granted under the CS-682 License
Agreement.

	4.	 	Notwithstanding with the items above, Cyclacel hereby acknowledges that Sankyo does not
amend its warranty as set forth in CS-682 License Agreement with respect to CNDAC Patent
Rights.

	5.	 	This Amendment supersedes all prior oral or written understandings, arrangements,
representations or agreements, if any, between the parties relating to the subject matter of
this Amendment to the extent that they conflict with this Amendment.

	6.	 	The validity, construction and interpretation of this Amendment to CS-682 License
Agreement and any determination of the performance which it requires shall be governed by the
laws of England.

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

These agreements are made in consideration of the mutual covenants contained herein. Could you
please indicate your agreement by countersigning at the space indicated below and returning this
agreement to the undersigned.

	 	 	 	 	 
	 	Sincerely yours and agreed,

 	 
	 	/s/ Akira Morita
 	 
	 	Akira Morita 	 
		Corporate Officer,

Director, Licensing Department

Date: April 28, 2004 	 
	 

	 	 	 
	AGREED:
	 	 
	 
	 	 
	/s/ Spiro Rombotis
	 	 
	 

Spiro Rombotis

	 	 
	Chief Executive Officer
	 	 
	Date: 28 April 2004
	 	 

 

- 2 -

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	 	 
	

	 	Licensing Department

SANKYO CO., LTD. 

3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8476, Japan

Phone: 81-3-5255-7084, Fax: 81-3-5255-7086

1st April, 2004

	 	 	 
	Dr. Spiro Rombotis
	 	 
	Chief Executive Officer
	 	 
	Cylacel
	 	 
	Dundee Technopole
	 	 
	James Lindsay Place
	 	 
	Dundee DD1 5JJ

	 	Tel: +44 1382 206062
	U K

	 	Fax: +44 1382 206067

Re: Territory of the CS-682 Licensing Agreement

Dear Dr. Rombotis;

I am happy to inform you that, in accordance with Clause 2.2.1 of the CS-682 License Agreement
dated 10th September 2003 (the “Agreement”) the license set out in Clause 2.1 of the Agreement is
hereby extended to the “Excluded Territories” under the same commercial terms as set out in the
Agreement.

[***]

This letter agreement is to amend the Agreement in accordance with Clause 17.2 thereof.
Please sign two copies of this letter agreement and send one copy to us for our record.

	 	 	 	 	 
	 	Sincerely yours,

 	 
	 	/s/ Akira Morita
 	 
	 	Akira Morita 	 
	 	Corporate Officer,

Director, Licensing Department 	 
	 

	 	 	 
	Agreed and acknowledged this:
	 	 
	 
	 	 
	/s/ Spiro Rombotis
	 	 
	 

Spiro Rombotis

	 	 
	Chief Executive Officer
	 	 
	Date:Exhibit 10.2

Exhibit 10.2

CONFIDENTIAL TREATMENT REQUESTED

Amendment No. 4

THIS AMENDMENT NO. 4 is made on 11 day of July, 2011

BETWEEN:

	(1)	 	DAIICHI SANKYO COMPANY, LIMITED a company incorporated in Japan whose principal place of
business is at 5-1 Nihonbashi-honcho 3-chome Chuo-ku Tokyo 103-8426 Japan (“Daiichi Sankyo”);
and

	(2)	 	CYCLACEL LIMITED a company incorporated in England whose principal place of business is at
Dundee Technopole, James Lindsay Place, Dundee DD1 5JJ, UK (“Cyclacel”).

WHEREAS:

	(A)	 	Daiichi Sankyo (successor of SANKYO CO., LTD) and Cyclacel are Parties to the CS-682 LICENSE
AGREEMENT dated September 10, 2003, as amended by letter amendments dated April 1, 2004, April
28, 2004 and January 13, 2005 (the “License Agreement”).

	(B)	 	Cyclacel asked Daiichi Sankyo to waive its termination right under the Clause 4.2 of the
License Agreement in consideration of the investment that Cyclacel has made in the Product (as
defined in the License Agreement).

	(C)	 	Cyclacel and Daiichi Sankyo wish to amend certain terms and conditions of the License
Agreement in consideration of Daiichi Sankyo’s waiver of the Clause 4.2 termination right.

NOW, therefore both Parties agree as follows:

	1.	 	Clause 3.3.6 of the License Agreement is hereby entirely deleted and replaced with:

	 	3.3.6	 	royalties applicable on Net Sales as follows:

	 	3.3.6.1	 	[***] on annual Net Sales less than [***];

	 	3.3.6.2	 	[***] on annual Net Sales greater than or equal to [***] and less than
[***];

	 
	 	3.3.6.3	 	[***] on annual Net Sales greater than or equal to [***]

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	2.	 	Clause 3.4 of the License Agreement is hereby entirely deleted and replaced with:

	 	3.4	 	In the case of sales of the Product by Cyclacel, its Affiliates
or Cyclacel Licensees in countries where such sale does not fall within a Valid
Claim of a Licensed Patent Right the royalty payable on Net Sales in such
country shall be [***] regardless of the volume of the Net Sales in such
country.

	3.	 	Clause 3.6 of the License Agreement is hereby entirely deleted and replaced with:

[***]

	4.	 	Subject to the terms and conditions of this Amendment No. 4, Daiichi Sankyo hereby
irrevocably waives its termination right under the Clause 4.2 of the License Agreement as
defined in (A) and releases Cyclacel and its officers, directors, employees and agents, and
their respective successors, heirs and assigns, from all claims and liability of any kind,
whether presently known or unknown, arising out of Cyclacel’s performance or lack of
performance under Clause 4.2 of the License Agreement prior to the effective date of this
Amendment No. 4. Clause 4.2 of the License Agreement is hereby entirely deleted as of the
effective Date of this Amendment No. 4.

	5.	 	The remainder of the License Agreement shall remain in full force and effect unless otherwise
modified by both Parties in writing.

IN WITNESS WHEREOF the Parties have executed this Amendment No. 4 as of the date first written
above.

SIGNED by

for and on behalf of

Daiichi Sankyo.

Date: July 5, 2011

 

 

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Securities and Exchange Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

	 	 	 
	/s/ Noriaki Ishida
	 	 
	 

Noriaki Ishida, Corporate Officer, Vice President, Business Development & Licensing

	 	 
	 
	 	 
	SIGNED by
	 	 
	for and on behalf of
	 	 
	Cyclacel.
	 	 
	Date: July 11, 2011
	 	 
	 
	 	 
	/s/ Paul McBarron
	 	 
	 

Paul McBarron, Chief Operating Officer, Executive Vice President, Finance

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