Exhibit 10.1

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

CLINICAL COLLABORATION AGREEMENT

 

This Clinical Collaboration Agreement (“Agreement”), effective as of the 21 day
of August, 2018 (“Effective Date”), is entered into by and between The
University of Texas M. D. Anderson Cancer Center, with a place of business
located at 1515 Holcombe Blvd., Houston, TX 77030, USA (“MD Anderson”), a member
institution of The University of Texas System (“System”) and Cyclacel Limited,
with a place of business located at 1 James Lindsay Place, Dundee, Scotland, DD1
5JJ, United Kingdom, (“Cyclacel”) (MD Anderson and Cyclacel each a “Party,” and
collectively, the “Parties”).

 

WITNESSETH

 

Whereas, Cyclacel is clinical-stage biopharmaceutical using cell cycle control,
transcriptional regulation and DNA damage response biology to develop
innovative, targeted medicines for cancer and other proliferative diseases and
is involved in the field of research and development of such pharmaceutical
products, including the sponsorship of clinical trials.

 

Whereas, MD Anderson is a comprehensive cancer research, treatment, and
prevention center, with scientists and technicians in substantive fields
relating to cancer research.

 

Whereas, the Parties hereby wish to establish a clinical collaboration, as
further described herein, (“Collaboration”) whereby Cyclacel will provide
support for one or more clinical research studies to be conducted by MD Anderson
pursuant to this Agreement using Cyclacel’s drug candidates, including CYC065
and CYC140 (each, a “Cyclacel Drug Candidate,” and collectively, the “Cyclacel
Drug Candidates”), each such study a “Study,” and all such Studies the
“Studies”).

 

Whereas, MD Anderson and Cyclacel shall have the right to carry out any
obligation set out in this Agreement through an Affiliate, where an “Affiliate”
means any individual, MD Anderson, partnership or other entity which directly or
indirectly, at present or in the future, controls, is controlled by or is under
common control of a Party, and “control” will mean direct or indirect beneficial
ownership of at least fifty per cent (50%) of the voting share capital in such
MD Anderson or other business entity, or to hold the effective power to appoint
or dismiss members of the management.

 

Now therefore, in consideration of the premises and the mutual covenants and
conditions hereinafter recited, the Parties do hereby agree as follows:

 

1Subject and Scope of Agreement

 

1.1The Parties intend that the scope of the Collaboration will consist of the
Studies included in Appendix I, attached hereto, the details of which are to be
mutually agreed upon by the Parties. Cyclacel and MD Anderson agree to jointly
design and write the Protocols for the Studies based on a first draft provided
by Cyclacel. MD Anderson will use reasonable efforts to conduct the work under
each Study. Studies may be changed as agreed upon by the Parties in writing.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

1.2The Agreement is a Collaboration agreement which shall govern the performance
of Studies by MD Anderson and one or more Principal Investigator(s), as defined
below, on the basis of Study specific documents (“Study Orders”) as agreed upon
by the Parties. Once the Parties have agreed to the precise nature of each Study
to be performed, MD Anderson shall review the Protocol for such Study as
proposed by Cyclacel. It is understood between the Parties that the sample size
of each Study will not exceed [***] Subjects unless otherwise agreed in writing
by the Parties. “Subject” shall mean, as the term is defined in the U.S. Code of
Federal Regulations 21 CFR §312.3(b), a human who participates in the Study,
either as a recipient of the investigational new drug or as a control. Once the
Protocol has been agreed and has been approved by MD Anderson’s Institutional
Review Board (“Institutional Review Board” or “IRB”) under Section 2.2 below,
(i) Cyclacel, as Study sponsor, shall obtain regulatory approval for the Study
as required by FDA; and (ii) the detailed provisions for performance of the
Study by the Parties including by MD Anderson and the MD Anderson principal
investigator(s) responsible for the performance of such Study (“Principal
Investigator(s)” or “Investigator(s)”), shall be set out in a Study Order to be
agreed between the Parties but substantially in the form attached as Appendix
III to this Agreement which shall detail the specifics of the Study to be
performed under such Study Order including, without limitation, (i) the detailed
Protocol, (ii) the Principal Investigator, (iii) identify any project-specific
resources or support provided by Cyclacel including quantities of Cyclacel Drug
Candidate and timing of delivery. Any changes to the Protocol must be agreed
upon in writing in advance by Cyclacel unless necessary to protect the safety,
rights or welfare of the Subjects.

 

1.3In the event of any conflict of terms of this Agreement and the terms of a
Study Order, the terms of this Agreement shall govern, unless the Study Order
specifically and expressly supersedes this Agreement with respect to a specific
term, and then only with respect to the particular Study Order and specific
term. If there is any discrepancy or conflict between the terms contained in a
Protocol and this Agreement and/or the relevant Study Order, the terms of the
Protocol shall govern and control with respect to clinical and/or scientific
matters and the terms of the Agreement and/or the relevant Study Order shall
govern and control with respect to all other matters, e.g., legal and financial
matters.

 

2Responsibilities and Compliance

 

2.1Each Study shall be subject to review and approval of the Study protocol
(“Protocol”) as required by the IRB and/or any relevant authorities prior to
commencement of the Study.

 

2.2The scope of the Study to be performed shall be set forth in the Protocol(s)
referenced in the Study Order, which shall be incorporated by reference into
such Study Order. These Protocol(s) shall be considered final after being agreed
to by MD Anderson and Cyclacel, including approval by MD Anderson’s IRB. The
Principal Investigator shall submit the Protocol and reports of the ongoing
conduct of the Study to the IRB as required by the IRB, obtain written approval
from the IRB, and inform the IRB of Study closure.

 

2.3Cyclacel is the regulatory “sponsor” of the Studies. Cyclacel shall be
responsible for IND filing and will supervise monitoring for each Study.
Cyclacel shall be responsible, directly or through third parties, for the
preparation, filing and maintenance of all regulatory documents with respect to
the Studies. The Parties shall reasonably share and exchange relevant Study
information with the aim of ensuring that regulatory compliance is obtained for
the Studies. Investigator shall timely have completed, signed and delivered to
Cyclacel all forms, documents and regulatory documentation required by
applicable law to be completed in connection with the initiation of each Study.
For purposes of this Section 2.3, Investigator agrees to disclose to Cyclacel,
in a timely fashion and in writing on an appropriate form, any financial
arrangement or interest involving any Investigator or sub-investigator who
performs services pursuant to this Agreement, or any spouse or dependent child
of such person (“Investigator Personnel”) that is required to be disclosed
pursuant to applicable law. Investigator shall update such disclosure as
necessary to maintain its accuracy and completeness during the term of this
Agreement and for any other period required by applicable law. To the extent
that samples are required to be analyzed and tested as part of a Study pursuant
to the Protocol, such samples shall be shipped to Cyclacel, analyzed and tested
by Cyclacel or a designee in accordance with the Protocol at Cyclacel’s cost and
expense. Cyclacel shall promptly provide the results and data generated from
such Study samples to MD Anderson. Promptly upon MD Anderson’s request, Cyclacel
shall return such samples to MD Anderson. Cyclacel and/or its designee shall not
have the right to use such samples for any purpose other than testing for the
Study and shall not further distribute or disclose such samples.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

2.4MD Anderson represents that each Principal Investigator shall use reasonable
efforts to conduct a Study in accordance with (a) the terms and conditions of
this Agreement and the relevant Study Order, (b) the provisions of the Protocol,
(c) applicable Good Clinical Practice requirements as incorporated by FDA
regulations (“GCP”), and (d) any and all applicable orders and mandates of
relevant authorities and IRB, and applicable MD Anderson policies. MD Anderson
shall use diligent efforts to conduct the Study in accordance with specific and
detailed performance milestones to be agreed between the Parties and to be set
out in the Study Order. If such mutually agreed upon performance milestones are
not met, MD Anderson and Cyclacel shall promptly discuss a strategy to cure the
performance issues. If MD Anderson has not cured such performance issues within
ninety (90) days of such discussion, Cyclacel shall have the right to expand the
affected Study to other sites. The costs incurred at other sites shall not be
part of this Agreement, shall not affect any aspect of this Agreement and shall
be borne solely by Cyclacel. MD Anderson shall use reasonable efforts to enroll
a total of approximately 170 Subjects in the Studies within three (3) years of
the Effective Date.

 

2.5MD Anderson and Cyclacel shall comply with all federal, state, and local laws
and regulations as well as ethical codes applicable to the conduct of each such
Study.

 

2.6MD Anderson and/or Principal Investigator shall forward to Cyclacel evidence
of approval of each Study by MD Anderson’s IRB. Cyclacel shall serve as
“sponsor” within the meaning of such term under applicable laws and regulations
and shall promptly forward to MD Anderson evidence of approval of the Study by
relevant regulatory authorities (or exemption from such regulatory authority/ies
review and approval).

 

2.7If, in the course of a Study at MD Anderson, a Subject is injured by such
Subject’s participation in the Study, MD Anderson and/or Principal Investigator
shall inform Cyclacel of any such injury by fax or email in case of serious and
unexpected adverse reactions and/or serious and unexpected adverse events
arising from the use of Study Drug Candidate(s) within the timelines stipulated
in the Protocol, or if such is not stipulated in the Protocol, within ten (10)
business days following MD Anderson or Principal Investigator becoming aware of
such event.

 

2.8MD Anderson represents that: (a) it has not been debarred by the FDA pursuant
to its authority under Sections 306(a) and (b) of the U.S. Food, Drug, and
Cosmetic Act (21 U.S.C. § 335(a) and (b)) and is not the subject of any
investigation or proceeding which may result in debarment by the FDA, and to the
extent applicable, it shall not use any Principal Investigator or Study team
member in the performance of a Study that has been so debarred or subject to any
such investigation or proceeding, and; (b) it is not included in the List of
Excluded Individuals/Entities (maintained by the U.S. Department of Health and
Human Services Office of Inspector General) or the List of Parties Excluded from
Federal Procurement and Non-procurement maintained by the U.S. General Services
Administration, and is not the subject of any investigation or proceeding which
may result in inclusion in any such list, and to the extent applicable, it shall
not use any Principal Investigator or Study team member in the performance of a
Study that is so included or the subject of any such investigation or
proceeding. MD Anderson agrees to promptly notify Cyclacel in writing if it
becomes aware of any such debarment, exclusion, investigation or proceeding of
MD Anderson or, to the extent applicable, any Principal Investigator or Study
team member.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

2.9MD Anderson and Cyclacel shall comply with all applicable federal, state and
local laws pertaining to confidentiality and disclosure of all information or
records obtained and reviewed in the course of the Study, and shall permit
access to such information or records only as authorized by a relevant Study
subject, the IRB, and as authorized by law. Each Party agrees to comply with all
provisions of the Health Insurance Portability and Accountability Act (“HIPAA”)
regulations (45 C.F.R. Parts 160 and 164) as to the protection and security of
Protected Health Information (“PHI”). Prior to participation of each subject in
a Study, MD Anderson will ensure that (a) it has obtained a signed written
informed consent document from the subject (“Consent”) and (b) it has obtained a
signed, written, HIPAA authorization that adequately discloses the circumstances
under which the subject’s personal data might be disclosed, as applicable, and
documents the subject’s express written authorization for use and disclosure of
the subject’s PHI for Study purposes, as applicable, pursuant to the HIPAA
regulations (“Authorization”). MD Anderson agrees to supply Cyclacel with
evidence of IRB approval of the Study, a copy of the Consent form which is
IRB-approved, and a copy of any modified Consent form later approved by the IRB
and used by MD Anderson. To the extent permitted by the IRB, the Consent form
and related Authorizations shall provide for (i) access to the Subject’s medical
records by Cyclacel, its designees, and applicable regulatory agencies such as
the FDA and (ii) use of de-identified Data for any purpose consistent with
applicable law that Cyclacel deems appropriate. MD Anderson shall submit to
Cyclacel for comment all forms of Consent forms prior to enrolling Subjects.
Cyclacel will only obtain, access, use and disclose the individually
identifiable health information of each Study subject in accordance with and to
the extent permitted by the IRB, Consent and the Authorization document and in
accordance with this Agreement and applicable laws. Cyclacel shall not transmit
any information or records from a Study outside the USA except in a
de-identified form.

 

2.10MD Anderson and Cyclacel will promptly notify each other upon identifying
any aspect of a Protocol, including information discovered during site
monitoring visits, or Study results that may adversely affect the safety,
well-being, or medical care of the Subjects, or that may affect the willingness
of Subjects to continue participation in a Study, influence the conduct of the
Study, or that may alter the IRB’s approval to continue the Study. MD Anderson
will promptly notify the IRB of any such events. When Study subject safety or
medical care could be directly affected by Study results, then notwithstanding
any other provision of this Agreement, MD Anderson will send Subjects a written
communication about such results.

 

2.11Cyclacel shall promptly provide MD Anderson with any materials and
documentation and all pre-clinical data reports and summaries in Cyclacel’s
possession and necessary, in Cyclacel’s reasonable judgement, for MD Anderson’s
conduct of the Studies.

 

2.12MD Anderson represents and certifies: (i) that it has the legal authority to
enter into this Agreement for the Studies and (ii) to the best of its knowledge,
that the terms of the Studies and this Agreement do not conflict with and do not
result in a breach under any agreement to which MD Anderson is a party that
would have a material adverse effect on its ability to perform its obligations
under this Agreement. During the term of this Agreement, MD Anderson will not
enter into any agreement to provide services that would in any way result in a
breach of this Agreement and materially impair its ability to complete the
Studies in a timely fashion.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

3Personnel, Materials and Equipment

 

3.1Except as set forth in this Agreement, MD Anderson shall provide all
reasonable necessary personnel, facilities, and resources to accomplish its
responsibilities under this Agreement and the relevant Study Order.

 

3.2Cyclacel agrees to promptly provide, or arrange to provide, MD Anderson with
the required quantities of CYC065, CYC140 or other mutually agreed Cyclacel Drug
Candidate that will be utilized and/or required in accordance with the
provisions of the Protocol applicable to the Study, Collaboration Funding solely
applicable to the Study, and/or support services to the extent required for the
conduct of a Study as specified in the Protocol or this Agreement. Any Cyclacel
Drug Candidate provided by Cyclacel will be used solely in accordance with the
applicable Study and the Protocol. MD Anderson will not use such Cyclacel Drug
Candidate outside of the scope of the Study. Except to a Subject, MD Anderson
will not transfer the Cyclacel Drug Candidate to any third party for any
purpose.

 

3.3It is recognized that the design of some Studies includes administration to
the Subject of a Cyclacel Drug Candidate in combination with another drug
(“Other Drug”). If the cost of Other Drug is not reimbursed under insurance or
in any other manner, Cyclacel shall reimburse MD Anderson the costs associated
with MD Anderson obtaining such Other Drug within thirty (30) days of receipt of
an invoice from MD Anderson for such cost. The indication that is the subject of
each Study, including if applicable, for the combination of the Other Drug and a
Cyclacel Drug Candidate, shall be referred to as “Study Indication”.

 

3.4Cyclacel will deliver the Cyclacel Drug Candidate DAP (INCOTERMS 2010) to MD
Anderson’s, or its designee’s, location as specified by MD Anderson (“Delivery”
with respect to such Cyclacel Drug Candidate). Title and risk of loss for the
Cyclacel Drug Candidate shall transfer from Cyclacel to MD Anderson at Delivery.
MD Anderson will, or will cause its designee to: (i) take delivery of the
Cyclacel Drug Candidate supplied hereunder and if applicable, promptly ship the
Cyclacel Drug Candidate to the Study sites for use in the Study, in compliance
with cGMP, GCP and other applicable statutes. After receipt, MD Anderson is
solely responsible, at its own cost, for subsequent handling, storage,
transportation, warehousing and distribution of Cyclacel Drug Candidate supplied
by Cyclacel hereunder. MD Anderson shall ensure that all such activities are
conducted in compliance with cGMP, GCP and other applicable law.

 

3.5MD Anderson or its designated agent shall, within ten (10) business days
following receipt of a shipment of Cyclacel Drug Candidate hereunder, carry out
a Visual Inspection (as defined below) of such shipment in association with the
certificate of conformity and certificate of analysis. If following Visual
Inspection MD Anderson determines in its sole discretion (exercised reasonably)
that the shipment is defective or deficient it shall promptly notify Cyclacel in
writing rejecting the shipment and specifying in detail the reasons therefor
(“Notice of Rejection”). If MD Anderson does not notify Cyclacel in this manner
within such ten (10) day period, such shipment of Cyclacel Drug Candidate shall
be deemed to have been accepted by MD Anderson. For the purposes of this
Agreement, “Visual Inspection” shall mean:

 

3.5.1 comparing the shipment against the documentation accompanying the shipment
to verify that the delivery date, identity, quantity and exterior shipment
labelling comply;

 3.5.2 verifying that the certificate of analysis for the shipment states that
the Cyclacel Drug Candidate conforms in all material respects to the applicable
specifications and GMP;

 3.5.3 visually inspecting the exterior of the shipment to verify that the
shipment appears to be in good condition;

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

3.5.4 verifying that the temperature of the shipment has remained within
specification by reviewing the data logger information;

3.5.5 for the avoidance of doubt, Visual Inspection does not include laboratory
analysis.

 

3.6Upon completion of the applicable Study, any unused quantities of the
applicable Cyclacel Drug Candidates (whether returned by Subjects, remaining at
the conclusion of the Study, or otherwise) shall, at the direction of Cyclacel,
be returned to Cyclacel or disposed of properly by MD Anderson. If Cyclacel
requests that such quantities of Study Drug Candidates be destroyed, MD Anderson
shall promptly destroy the same and provide to Cyclacel a certificate evidencing
such destruction. If, within thirty (30) days after completion of the applicable
Study, Cyclacel does not provide MD Anderson with its decision regarding whether
to have the Cyclacel Drug Candidate returned or destroyed, MD Anderson shall
have the right to destroy the Cyclacel Drug Candidate.

 

3.7Decisions regarding the strategy and course of further clinical development
progression of a Cyclacel Drug Candidate alone or in combination after
completion of each Study shall be at the sole discretion and responsibility of
Cyclacel, but in consultation with MD Anderson. Following completion of each
Study the Parties and their clinical representatives including the Principal
Investigator for the Study shall meet to discuss the results in good faith. If
it is concluded in good faith that the results are positive, Cyclacel shall use
its Commercially Reasonable Efforts to further develop and commercialize the
Cyclacel Drug candidate for the Study Indication. In this Section 3.7
“Commercially Reasonable Efforts” shall mean efforts and resources commonly used
by Cyclacel to develop and commercialize a product owned by it or to which it
has rights, which product is at a similar stage in its development or product
life and is of similar market potential to the product for the Study Indication
in question and taking into account the patent and other proprietary position of
the product.

 

3.8From time to time during the term, either Party (the “Transferring Party”)
may supply the other Party (the “Receiving Party”) with proprietary materials of
the Transferring Party (other than Cyclacel Drug Candidate) (“Proprietary
Materials”) for use in the Study as further listed in the Study Order. In
connection therewith, each Receiving Party hereby agrees that: (a) the Receiving
Party will not use the Proprietary Materials for any purpose other than
exercising its rights orperforming its obligations hereunder; (b) it will use
such Proprietary Materials only in compliance with all applicable laws; (v) it
will not transfer any such Proprietary Materials to any Third Party without the
prior written consent of the Transferring Party; (d) it will not acquire any
rights of ownership, or title in or to such Proprietary Materials as a result of
such supply by the Transferring Party; and (e) upon the expiration or
termination of this Agreement or a Study Order, if requested by the Transferring
Party, it will destroy or return any such Proprietary Materials that are not the
subject of the grant of a continuing license hereunder.

 

3.9Nothing in this Agreement shall be construed to limit the freedom of MD
Anderson or of any Principal Investigator or Study team member to engage in
similar clinical trials or research performed independently under other grants,
contracts, or agreements with parties other than Cyclacel.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

4Financials

 

4.1Any costs and expenses incurred by Cyclacel in the performance of its own
roles and responsibilities shall be exclusively borne by Cyclacel including
clinical supply of the Cyclacel Drug Candidates, as well as costs for the Other
Drug if they cannot be reimbursed (as provided in Section 3.3) and any
additional laboratory costs as requested by Cyclacel at Cyclacel’s sole
discretion. Cyclacel will reimburse MD Anderson as specified in Sections 3.3,
4.2 and 4.3.

 

4.2Cyclacel shall pay MD Anderson for research staff, including study nurse,
compensation in the amount of $[***] per contract year for three (3) years
following the Effective Date payable as follows:

 

Effective Date:   $[***]         1st anniversary of Effective Date:   $[***]    
    2nd anniversary of Effective Date:   $[***] 

 

4.3If the cumulative total amount of Evaluable Subjects enrolled according to
each Protocol on all four Studies exceeds a total of [***] Subjects, then
Cyclacel will pay MD Anderson $[***] for each additional Evaluable Subject.
“Evaluable Subject” means a Subject properly enrolled in the Study and who has
completed Study procedures as required by the Protocol and whose case report
forms (“CRFs”) have been completed.

 

4.4If any given Study has more than [***] Evaluable Subjects enrolled, Cyclacel
will pay MD Anderson $[***] for each additional Evaluable Subject.

 

4.5The items the subject of Sections 3.3, 4.2 and 4.3 are collectively,
“Collaboration Funding”. Payment for Collaboration Funding shall be due within
thirty (30) days of Cyclacel’s receipt of an invoice from MD Anderson. If the
Parties extend the term of this Agreement by mutual agreement as set forth
herein, the Parties shall negotiate in good faith the amount of future Study
funding commitments by applicable to such extended term.

 

4.6Cyclacel shall pay to MD Anderson the milestone payments listed in Appendix
II relative to the total number of Subjects actually dosed in the three-year
period (each, a “Milestone Payment”), upon achievement of the milestones listed
in Section 4.6 below, regardless of whether the milestone event is achieved by
Cyclacel or an Affiliate, or a licensee of Cyclacel.

 

4.7Milestone event:

 

·Upon a Cyclacel Drug Candidate achieving first commercial Sale [***] for a
Study Indication described in Study Work Order or Appendix I (this Milestone
Payment will be paid up to four times);

·Upon a Cyclacel Drug Candidate achieving first commercial Sale [***] for a
Study Indication described in Study Work Order or Appendix I (this Milestone
Payment will be paid up to four times);

·Upon a Cyclacel Drug Candidate achieving first commercial Sale [***] for a
Study Indication described in Study Work Order or Appendix I (this Milestone
Payment will be paid up to four times);

·Cumulative $[***] in Sales of either or all Cyclacel Drug Candidates for Study
Indications described in Study Work Order or Appendix I;

·Cumulative $[***] in Sales of either or all Cyclacel Drug Candidates for Study
Indications described in Study Work Order or Appendix I;

·Cumulative $[***] in Sales of either or all Cyclacel Drug Candidates for Study
Indications described in Study Work Order or Appendix I.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

4.8Cyclacel shall notify MD Anderson in writing immediately upon achievement of
any of the foregoing milestones. Each of the foregoing Milestone Payments shall
be made by Cyclacel to MD Anderson (and following receipt of an invoice from MD
Anderson) within forty-five (45) calendar days of achieving the milestone event
and shall not reduce the amount of any other payment provided for in this
Agreement.

 

4.9The cumulative Sales milestones are each payable only once in respect of the
Sales for all Study Indications in countries where the Cyclacel Drug Candidate
is protected by valid and non-expired composition of matter patents.

 

4.10The amount paid in respect of milestones earned shall be subject to a cap
such that in a given calendar year Cyclacel pays MD Anderson no more than [***].

 

4.11For purposes of this Agreement, “Sales” shall mean “Net Sales” which mean
the gross amount invoiced by Cyclacel, its Affiliates, or licensees for sale of
Cyclacel Drug Candidate for a Study Indication to third parties, less the
following deductions attributable solely to sales of such Cyclacel Drug
Candidate:

 

4.11.1normal and customary trade, cash and quantity discounts actually given,
credits, price adjustments or allowances for damaged products, returns or
rejections of products;

 

4.11.2chargeback payments and rebates (or the equivalent thereof) for the
Cyclacel Drug Candidate granted to group purchasing organizations, managed
health care organizations or to federal, state/provincial, local and other
governments, including their agencies, or to trade customers;

 

4.11.3reasonable and customary freight, shipping insurance and other
transportation expenses directly related to the sale of the Cyclacel Drug
Candidate (if actually borne by Cyclacel, its Affiliates or licensees without
reimbursement from any third party);

 

4.11.4required distribution commissions/fees payable to any third party
providing distribution services to Cyclacel or its Affiliates;

 

4.11.5sales, value-added, excise taxes, tariffs and duties, and other taxes and
government charges directly related to the sale, to the extent that such items
are included in the gross invoice price of the Cyclacel Drug Candidate and
actually borne by Cyclacel, its Affiliates or licensees or without reimbursement
from any third party (but not including taxes assessed against the income
derived from such sale).

 

4.12In circumstances where Cyclacel, its Affiliates or licensees further develop
and commercialize a Cyclacel Drug Candidate for a Study Indication, within
thirty (30) calendar days following each anniversary after completion of the
last Study and until the first Milestone Payment for such Study Indication is
paid, Cyclacel will, will require its Affiliate, or in the case of a licensee
use reasonable efforts to require license to, deliver to MD Anderson a written
progress report as to Cyclacel’s (and any Affiliate’s and licensees) efforts and
accomplishments during the preceding year in relation to such development and
commercialization together with commercialization plans for the upcoming year.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

4.13Commencing with the first sale of a Cyclacel Drug Candidate for a Study
Indication by Cyclacel, an Affiliate or licensee of Cyclacel, Cyclacel shall
make a written report to MD Anderson within one hundred and twenty (120) days of
each Cyclacel fiscal year which ends in December, reporting the amount of all
Sales received in respect of Cyclacel Drug Candidates for the Study Indication.
Cyclacel shall keep accurate records and books of accounting in accordance with
good accounting practice with respect to the patenting and commercialization of
Study Drug Candidate (including by it, its Affiliates and licensees). Cyclacel
agrees to permit a representative of MD Anderson during normal business hours to
inspect any or all parts of the books, ledgers and records kept by Cyclacel
which are relevant to a determination of the accuracy of any report required to
be rendered to MD Anderson. If any amounts due MD Anderson are determined to
have been underpaid in an amount equal to or greater than five percent (5%) of
the total amount due during the period so examined, then Cyclacel will pay the
cost of the examination plus accrued interest at the highest allowable rate.

 

4.14If Cyclacel or its Affiliate licenses its rights to the Cyclacel Drug
Candidates for a Study Indication, Cyclacel will diligently collect all amounts
due Cyclacel from licensees.

 

4.15All payments made pursuant to this Agreement shall be made in U.S. Dollars
by wire payable to the Study Center at:

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

Such payments shall be made free and clear of any deduction or withholding,
except that Sponsor may deduct or withhold (i) any taxes, surcharges or other
governmental charges or levies that Sponsor is required by Applicable Law to
deduct or withhold and (ii) any monies that are the subject of a bona fide
dispute between MD Anderson and Cyclacel. All amounts paid to MD Anderson by
Cyclacel, are expressed to be inclusive of any value added taxes or other
similar taxes or levies that might be imposed by a governmental authority on
amounts paid by Cyclacel pursuant hereto.

 

5Confidential Information

 

5.1In conjunction with each Study, the Parties may wish to disclose confidential
information to each other. For purposes of this Agreement, “Confidential
Information” means confidential, non-public information, know-how and data
(technical or non-technical) that is disclosed in writing, orally, graphically,
in machine readable form, or in any other manner by or on behalf of a disclosing
Party to a receiving Party or its Affiliates for purposes of this Agreement or
any Study Order (“Purpose”). For clarity, Confidential Information excludes Data
as defined under Section 7.4 as there are separate provisions of this Agreement
governing Data. Confidential Information may be disclosed in any form (e.g.
oral, written, graphic, electronic or sample) by or on behalf of disclosing
Party or its Affiliates, or may be otherwise accessible to receiving Party or
its Affiliates. Exchanges of Confidential Information directly between the
Affiliates are also covered by this Agreement

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

5.2Without disclosing Party’s prior written consent, and subject always to
Section 5.5, receiving Party will: (a) not use any part of or the whole of the
Confidential Information for any purpose other than the Purpose; (b) restrict
the dissemination of Confidential Information to individuals within its own
organization and disclose the Confidential Information only to those of its
officers, employees and Affiliates who have a legitimate need to have access to
the Confidential Information, who will be bound by confidentiality and non-use
commitments no less restrictive than those of this Agreement, and who will have
been made aware of the confidential nature of the Confidential Information; (c)
protect the Confidential Information by using the same degree of care, but not
less than a reasonable degree of care, to prevent the unauthorized use,
dissemination, or publication of the Confidential Information as receiving Party
uses to protect its own confidential information of a like nature; (d) preserve
the confidentiality of the Confidential Information, not disclose it to any
third party, and take all necessary and reasonable precautions to prevent such
information from being accessible to any third party; (e) not combine any part
of or the whole of the Confidential Information with any other information; and
(f) promptly notify the disclosing Party upon becoming aware of evidence or
suspicion of any unauthorized use or disclosure of the Confidential Information.
The foregoing obligations will exist for a period of seven (7) years from the
date of completion of the last Study in relation to which the Confidential
Information is disclosed or used.

 

5.3The obligations of confidentiality and non-use listed in this Article 5 will
not apply to information: (a) which is in the public domain or public knowledge
at the time of disclosure, or which subsequently enters the public domain
through no fault of receiving Party; (b) which was rightfully in the possession
of receiving Party at the time of disclosure by disclosing Party; (c) which is
independently developed by receiving Party without use of disclosing Party’s
Confidential Information; (d) which the receiving Party receives legally from
any third party and which is not subject to an obligation of confidentiality;
(e) receiving Party is required to disclose pursuant to applicable law or the
order of a court or other tribunal; provided, however, that receiving Party will
make reasonable efforts, if legally permissible, to notify disclosing Party
prior to the disclosure of any part of or the whole of the Confidential
Information and allow disclosing Party the opportunity to contest and avoid such
disclosure, and provided, further, that receiving Party will disclose only that
portion of such Confidential Information that it is legally required to
disclose; (f) is communicated to the receiving party’s IRB or other scientific
committee; (g) is required to be disclosed in order to obtain informed consent
from patients or subjects who may wish to enroll in the Study, provided,
however, that the information will be disclosed only to the extent necessary and
will not be provided in answer to unsolicited inquiries by telephone or to
individuals who are not eligible to be Subjects; (h) is disclosed to a Subject
for the safety or well-being of the Subject; or (j) is required to be disclosed
in publicly filed financial or other public statements under rules governing a
stock exchange provided that to the extent possible the Party making such filing
shall provide the other Party a copy of the proposed text for such filing not
less than two (2) business days prior to the proposed filing to enable such
other Party to review the same and provide comments.

 

5.4For the purposes of this Article 5, any combination of features disclosed to
the receiving Party will not be deemed to be within the foregoing exceptions
merely because individual features are. Moreover, specific disclosures made to
the receiving Party will not be deemed to be within the foregoing exceptions
merely because they are embraced by general disclosures.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

5.5The receiving Party shall also have the right to use and/or disclose
Confidential Information in the following circumstances:

 

(i) to its actual or potential investment bankers; (ii) to existing and
potential investors in connection with an offering or placement of securities
for purposes of obtaining financing for its business and to actual and
prospective lenders for the purpose of obtaining financing for its business; and
(iii) to a bona fide potential acquirer or merger partner for the purposes of
evaluating entering into a merger or acquisition and (iv) disclose Confidential
Information to its legal advisers for the purpose of seeking legal advice,
provided, however, any such persons must be obligated to abide by
confidentiality and non-use obligations as least as strict as set forth in
Section 5 to hold in confidence and not make use of such Confidential
Information for any purpose other than those permitted by this Agreement; and

 

5.6All Confidential Information disclosed to receiving Party pursuant to this
Agreement will be and remain the disclosing Party’s property. Nothing contained
herein will be construed as granting to receiving Party any proprietary right on
or in relation to any part of or the whole of the Confidential Information, or
any right to use any of the Confidential Information except for purposes of this
Agreement and the Collaboration. Receiving Party will return to disclosing Party
all documents and other materials which constitute Confidential Information, as
well as all copies thereof, promptly upon request or upon termination of this
Agreement (whichever is earlier); provided, however, that receiving Party may
keep one copy of the Confidential Information received under this Agreement in
its secure files in accordance with the terms of this Agreement for the sole
purpose of maintaining a record of the Confidential Information received
hereunder and for compliance with this Agreement and/or applicable laws.

 

5.7MD Anderson will not disclose any “Protected Health Information” (as such
term is defined under HIPAA) to Cyclacel under this Agreement and Cyclacel will
not require MD Anderson to disclose any Protected Health Information.
Notwithstanding the foregoing, if Cyclacel comes into knowledge or possession of
any Protected Health Information by or through MD Anderson or any information
that could be used to identify any Subject or other MD Anderson patients or
research subjects, Cyclacel will maintain any such Protected Health Information
or other information confidential in accordance with laws and regulations as
applicable to MD Anderson, including without limitation HIPAA, will use any such
Protected Health Information solely to the extent permitted by applicable laws,
the IRB and the Consent/Authorization of the patient/research subject, and will
not use or disclose any such Protected Health Information or other information
in any manner that would constitute a violation of any applicable laws or
regulation if such use or disclosure was made by MD Anderson.

 

5.8Improper use or disclosure of the Confidential Information by receiving Party
is likely to cause substantial harm to disclosing Party. Therefore, in the event
of a breach, threatened breach, or intended breach of this Agreement by
receiving Party, in addition to any other rights and remedies available to it at
law or in equity, disclosing Party will be entitled to seek preliminary and
final injunctions enjoining and restraining such breach, threatened breach, or
intended breach.

 

6Clinical Data / Monitoring

 

6.1Oral reports or interim written status reports of the progress of the Studies
will be provided by the Principal Investigator to Cyclacel no less than once per
three (3) months during the course of a Study. Significant developments arising
out of Studies will be communicated promptly to Cyclacel.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended. 

 

6.2As applicable to and appropriate for a Study, Cyclacel may monitor the
conduct of a Study in accordance with Good Clinical Practice requirements of FDA
Regulations, and may visit MD Anderson for the purpose of such monitoring. Any
such monitoring visits shall be scheduled in coordination with MD Anderson
and/or Principal Investigator during normal administrative business hours, and
shall be subject to compliance with MD Anderson’s reasonable measures for
confidentiality, safety and security, and shall also be subject to compliance
with generally applicable premises rules at MD Anderson.

 

6.3MD Anderson and Principal Investigator shall, during a Study, permit
inspections by responsible legal and regulatory authorities with respect to such
Study. To the extent permitted by law and to the extent practicable, MD Anderson
shall notify Cyclacel of such inspection. Upon notification of an impending
inspection concerning the Study by the FDA or other regulatory authority, MD
Anderson shall, to the extent permitted by law to the extent practicable notify
Cyclacel immediately and shall permit representatives of Cyclacel to be present
during such inspection.

 

6.4Cyclacel and MD Anderson agree to maintain adequate and accurate records as
required under Applicable Law relating to the disposition of the Cyclacel Drug
Candidate and the treatment of the Subjects. Investigator specifically agrees to
timely prepare and maintain complete, accurately written medical records,
accounts, notes, reports, and data of all Studies performed under this
Agreement, including patient CRFs, for each Subject. All Study Information will
be furnished to Cyclacel or a representative of Cyclacel in a de-identified
format. “Study Information” means all results, data, documents and information
generated by MDACC as a result of conducting the Study, but shall not include
Inventions, laboratory notebooks, source documents, patient records, business
and compliance documents or any other documents that MD Anderson is required to
retain per Applicable Law or its policies. Cyclacel has the right to review
Subject records to verify entries in the CRFs during normal administrative
business hours, and subject to compliance with MD Anderson’s reasonable measures
for confidentiality, safety and security, and shall also be subject to
compliance with generally applicable premises rules at MD Anderson. Cyclacel
shall not at any time disclose the name of any subject or any information which
identifies a Subject to a third party unless specifically required to do so by
Applicable Law or the FDA. Cyclacel, MD Anderson and Investigator agree to
comply with applicable FDA reporting requirements, including those related to
adverse event reporting and all reporting requirements set forth in the Protocol
or as required by applicable law.

 

6.5Cyclacel and MD Anderson agree to maintain the records described in Section
6.4 above for the time period required by applicable laws. Prior to destroying
or otherwise disposing of any such records, MD Anderson will provide Cyclacel a
reasonable opportunity to reimburse MD Anderson to retain such records for a
longer period of time or take possession of the records at Cyclacel’s own
expense.

 

7Data & Inventions

 

7.1In this Section 7 (i) “Invention” means any invention or discovery, whether
patentable or not, that is conceived and first reduced to practice during
performance of a Study and which directly arises from the conduct of the Study;
and (ii) “Research and Academic Purposes” includes, but is not limited to, all
forms of research funded by MD Anderson itself, or under a grant, or in
collaboration with another not-for-profit entity but expressly excludes any
research funded by or in collaboration with a for-profit commercial entity.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended. 

 

7.2MD Anderson shall promptly disclose to Cyclacel, on a confidential basis, any
Inventions. MD Anderson hereby assigns to Cyclacel all its right, title and
interest in and to all Inventions and it agrees to take further reasonable acts
as may be reasonably required to convey ownership in all Inventions to Cyclacel,
including executing, or causing its employees (including the Investigator),
officers or agents to execute, any documents necessary to effectuate the
foregoing, each of the foregoing, at Cyclacel’s sole cost and expense.

 

7.3All right, title and interest in and to Inventions shall be owned solely by
Cyclacel and shall be assigned to Cyclacel. Cyclacel shall grant and hereby
grants to MD Anderson a non-exclusive, worldwide, perpetual, irrevocable, fully
paid-up license to use Inventions for Research and Academic Purposes.

 

7.4All data and results generated in the conduct of the Studies (“Data”) shall
be promptly disclosed by MD Anderson to Cyclacel and will be owned by Cyclacel
subject to MD Anderson’s right to use Data for Research and Academic Purposes as
specified in Section7.3, as well as for publication purposes. The Parties will
keep the Data confidential until the earlier of (a) publication of the Data by
MD Anderson, as provided in Section 12, or (b) publication of the Data by
Cyclacel. Cyclacel shall promptly provide MD Anderson with a copy of any Data
generated by, or on behalf of Cyclacel in connection with a Study.

 

7.5Cyclacel shall have the first right to prepare, file, prosecute, maintain,
enforce and defend all U.S. and foreign Patents, registrations and other forms
of intellectual property in Inventions at the sole cost and expense of Cyclacel.
Cyclacel shall keep MD Anderson reasonably informed of all such filings and the
prosecution of such filings.

 

7.6MD Anderson represents and certifies that its employees and agents (including
the Investigator) are obliged to convey to MD Anderson all right, title and
interest to Inventions.

 

7.7MD Anderson shall provide assurance that no federal funding will be used by
MD Anderson for the Studies.

 

8Term and Termination

 

8.1This Agreement will be effective as of the Effective Date and will remain in
effect for so long as any payments are due to MD Anderson hereunder.

 

8.2A Party will have the right to terminate this Agreement if the other Party
commits a material breach of the Agreement and fails to cure such breach within
ninety (90) days of receiving notice from the non-breaching Party of such
breach. Any expiration or termination of this Agreement under this Section 8
will not affect any then existing Study Orders, and any such Study Orders will
continue after the expiration or termination of this Agreement in accordance
with their respective provisions. Upon any expiration or termination of this
Agreement, provisions of this Agreement that are incorporated by reference into
any then outstanding Study Orders and all other provisions of the Agreement
relevant to the conduct of a Study Order or regulating the relationship of the
Parties in relation thereto will survive termination of this Agreement and will
continue to apply to such Study Orders until termination or expiration of each
such Study Orders.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended. 

 

8.3A Party may terminate a Study Order: (a) if the other Party commits a
material breach of the Study Order and fails to cure such breach within thirty
(30) days of receiving notice from the non-breaching Party of such breach; or
(b) due to health and safety concerns related to the Cyclacel Drug Candidate or
procedures in the Study (including regulatory holds due to the health and safety
of the Subjects). The Parties agree that any termination of a Study Order shall
allow for: (i) the wind down of the Study to ensure the safety of Subjects; and
(ii) Cyclacel’s final reconciliation of Data related to the Study in addition to
Cyclacel’s final monitoring visit. All reasonable fees associated with the
wind-down activities and final monitoring visit shall be paid by Cyclacel.
Termination of one or more Study Orders will not automatically result in the
termination of this Agreement or termination of any other Study Orders. Upon
termination of a Study Order, MD Anderson will immediately return at Cyclacel’s
cost any unused quantities of Cyclacel Drug Candidate provided by Cyclacel for
such Study as directed by Cyclacel.

 

8.4In case any regulatory or legal authorization necessary for the conduct of
the Study is (i) finally rejected or (ii) withdrawn, the relevant Study Order
shall terminate automatically at the date of receipt of such final rejection.
Termination, relinquishment, expiration or cancellation of this Agreement or a
Study Order will not affect the rights and obligations of the Parties that have
accrued prior to termination relinquishment, expiration or cancellation,
including, without limitation, any and all damages arising from any breach
hereunder, and any provisions of this Agreement or a particular Study Order that
by their nature extend beyond expiration or termination will survive the
expiration or termination of this Agreement and/or that particular Study Order.
In particular, the provisions of Sections 2-15as applicable will survive any
expiration or termination of this Agreement.

 

8.5In the event the Parties cannot reach agreement on a new Principal
Investigator pursuant to Section 8.2 or such new Principal Investigator does not
agree to the terms of this Agreement and the relevant Study Order, either Party
may terminate such Study Order upon notice to the other Party.

 

8.6In addition, in order to accommodate the review and approval of this
Agreement by the Office of General Counsel of UT System (the “OGC”), for a
period of sixty (60) days following the Effective Date (the “Limited Unilateral
Termination Period”), MD Anderson will have the right to terminate this
Agreement without cause upon ten (10) days’ notice to Cyclacel; provided,
however, that (i) a termination by MD Anderson will be effective if notice of
termination is sent by MD Anderson any time within the Limited Unilateral
Termination Period even if the ten day notice period extends beyond the Limited
Unilateral Termination Period and (ii) the Limited Unilateral Termination Period
will expire on the earlier to occur of (x) the end of the sixty days, or (y)
written notice to Cyclacel from MD Anderson that the Agreement has been approved
by the OGC.

 

8.7For each Study, Cyclacel shall make all payments due for Study performance
reasonably incurred or obligated in good faith hereunder which have accrued up
to the date of termination of a Study Order or this Agreement, or, in case of a
termination of this Agreement or the relevant Study Order pursuant to Section
7.5, up to the date of receipt of such final rejection.

 

8.8If at the time of any termination of a Study Order or this Agreement MDACC
and Cyclacel shall conclude, based upon an evaluation of the risks to the
Subjects, that some or all of the Subjects should not immediately be withdrawn
from Cyclacel Drug Candidate treatment, the Parties will cooperate to safely
withdraw Subjects from Cyclacel Drug Candidate treatment over a mutually
agreeable period of time.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

9Indemnification

 

9.1Cyclacel agrees to defend, indemnify, and hold harmless MD Anderson, System
each Principal Investigator and its/their Regents, trustees, officers,
directors, staff, employees, students, faculty members, and its/their Affiliates
and other parties as may be listed on a Study Order (“Indemnified Party/ies”):
(a) from and against any and all liability, claims, lawsuits, losses, demands,
damages, costs, and expenses (“Indemnified Losses”) resulting from (i) the
design or manufacture of the Cyclacel Drug Candidate or defects in the Cyclacel
Drug Candidate (including failure to manufacture the Cyclacel Drug Candidate in
accordance with current Good Manufacturing Practices in the United States of
America), (ii) the use of the Data or results of the Study (iii) Cyclacel’s
negligence or intentional misconduct in connection with a Study or this
Agreement, (iv) Cyclacel’s breach of any representations and/or warranties
provided hereunder, and (v) Cyclacel’s failure to comply with applicable law or
regulation; (b) from and against any Indemnified Losses arising from an injury
to a Subject caused by the Cyclacel Drug Candidate or any procedure required by
the Protocol. The completion or termination of a Study shall not affect’s
Cyclacel’s obligation to indemnify with respect to any claim or suit based upon
the aforementioned Indemnified Losses. Notwithstanding the foregoing, Cyclacel
will not be responsible for any Indemnified Losses to the extent that they arise
from (i) non-adherence to the Protocol by any of the Indemnified Parties (except
permitted deviations for health and safety reasons); or (ii) negligence,
intentional misconduct, or malpractice of the Indemnified Parties, it being
understood that the proper administration of the Cyclacel Drug Candidate in
accordance with the Protocol (including permitted deviations for health and
safety reasons) shall not constitute negligence, intentional misconduct, or
malpractice for the purposes of this Agreement.

 

9.2To the extent authorized by the constitution and laws of the State of Texas,
MD Anderson, agrees to indemnify, and hold harmless Cyclacel and its/their
officers, directors, staff, employees, students, and its/their Affiliates (also,
“Indemnified Party”): from and against any and all Indemnified Losses resulting
from (i) non-adherence to the Protocol by MD Anderson, each Principal
Investigator and its/their Regents, trustees, officers, directors, staff,
employees, students, faculty members, and its/their Affiliates (except permitted
deviations for health and safety reasons); or (ii) the negligence, intentional
misconduct, or malpractice of MD Anderson, each Principal Investigator and
its/their Regents, trustees, officers, directors, staff, employees, students,
faculty members, and its/their Affiliates in conducting the Study, it being
understood that the proper administration of the Cyclacel Drug Candidate in
accordance with the Protocol (including permitted deviations for health and
safety reasons) shall not constitute negligence, intentional misconduct, or
malpractice for the purposes of this Agreement. The completion or termination of
a Study shall not affect MD Anderson’s obligation to indemnify with respect to
any claim or suit based upon the aforementioned Indemnified Losses.
Notwithstanding the foregoing, MD Anderson will not be responsible for any
Indemnified Losses to the extent that they arise from the negligence,
intentional misconduct, or malpractice of Cyclacel or its/their officers,
directors, staff, employees, students, and its/their Affiliates.

 

9.3Subject to the statutory duties of the Texas State Attorney General, any
Indemnified Party shall: (a) notify the indemnifying Party in writing as soon as
is reasonably possible after receipt of notice of any and all claims, lawsuits,
and demands, or any action, suit, or proceeding giving rise to the right of
indemnification; (b) permit the indemnifying Party to retain counsel to
represent the named Indemnified Party; and (c) permit the indemnifying Party to
retain control of any such claims, lawsuits, and demands, including the right to
make any settlement, except that the indemnifying Party shall not make any
settlement or take any other action which would be deemed to confess wrongdoing
by any of the Indemnified Parties without the prior written consent of the
applicable Indemnified Party.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

10Subject Injury Medical Costs

 

10.1Cyclacel shall assume responsibility for reasonable medical expenses
incurred by a Subject for reasonable and necessary treatment if the Subject
experiences an illness, adverse event or injury that is proven to result from
the administration of the Cyclacel Drug Candidate or any procedure required by
the Protocol that the Subject would not have undergone were it not for such
Subject’s participation in the Study. Cyclacel shall not be responsible for
expenses to the extent that they are (i) the result of a foreseeable side effect
as expressly and specifically indicated in the Protocol, (ii) covered by the
Subject’s medical or hospital insurance, or any similar third-party payor
providing such medical or hospital coverage (excluding Medicare, to the extent
required by law), (iii) attributable to a failure of MD Anderson, or any of its
personnel conducting the Study, to adhere to the terms of the Protocol,
provided, however, that emergency medical care shall not be deemed a violation
of the Protocol, (iv) attributable to the negligence or misconduct of MD
Anderson or any of the personnel conducting the Study, including the Principal
Investigator, or (v) attributable to a pre-existing abnormal medical condition
or underlying disease of the Subject, or (vi) treatment that would have been
provided to the Subject in the ordinary course notwithstanding participation of
the Study.

 

11Insurance

 

11.1During the term of any Study Order under this Agreement, Cyclacel shall
maintain in full force and effect insurance for its liabilities arising from the
Study with limits of not less than $[***]per loss and $[***] annual aggregate.
Cyclacel shall provide MD Anderson with evidence of such insurance upon request.

 

11.2MD Anderson is self-insured pursuant to The University of Texas Professional
Medical Liability Benefit Plan under the authority of Chapter 59, Texas
Education Code. MD Anderson has and will maintain in force during the term of
this Agreement adequate insurance or financial resources to cover its
obligations pursuant to this Agreement.

 

12Publications

 

12.1Publication or public disclosure of Study results may be based on the entire
Study or Study interim results but shall occur only after Study results have
been provided to Cyclacel with an opportunity to review. In light of the
critical importance of such results to Cyclacel’s survival and success and the
Parties extensive history of joint publications, the Parties will jointly agree
in good faith with respect to the Study manuscript, abstracts/presentations at
meetings and such publication and the journal submission strategy.

 

12.2Any such communication, presentation or publication by MD Anderson shall not
contain Confidential Information, other than Study Information, Study results or
Data. Investigator may not disclose to third parties or otherwise make public
the raw data or CRFs obtained in the Study with respect to any proposed
publication or presentation of the Study.

 

12.3With respect to any proposed publication or presentation of the Study
results pursuant to Section 12.1 above, Investigator will submit to Cyclacel a
copy of the proposed publication or presentation and the name of the scientific
journal or forum to which the proposed publication or presentation will be
submitted at least sixty (60) days prior to the submission thereof for
publication or presentation. Investigator shall comply with Cyclacel’s request
to delete references to Confidential Information, other than Study information,
Study results or Data, in any such publication or presentation, and agrees to
delay publication or presentation of the same for up ninety (90) additional
days, in order to permit Cyclacel to obtain patent protection or other similar
protection as Cyclacel deems it necessary.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

12.4MD Anderson and/or Principal Investigator shall give Cyclacel acknowledgment
for its sponsorship of a Study in all applicable Study publications. Authorship
and acknowledgements for scientific publications shall be consistent with the
principles embodied in the International Committee of Medical Journal Editors
(“ICMJE”) Uniform Requirements for Manuscripts.

 

12.5Cyclacel shall register the Study if required by, and in accordance with,
Section 801 of the Food and Drug Administration Amendments Act of 2007 on
www.clinicaltrials.gov and on any other database required by laws or regulations
in accordance with applicable standards regarding scope, form and content and in
accordance with ICMJE guidelines such that the Study will be eligible for
publication in those publications.

 

13Use of Name/Public Statements/Disclosure

 

13.1Except as expressly set forth in this Agreement, each Party agrees that it
will not at any time during the term of this Agreement or following termination
of this Agreement use any name of the other Party or any other names, insignia,
mark(s), symbol(s), or logotypes associated with the other Party or any variant
or variants thereof in any advertising, or promotional materials without the
prior written consent of the other Party.

 

13.2Except as expressly set forth in this Agreement, to the extent required by
law or regulation, or to the extent necessary for MD Anderson for the
recruitment of subjects to any Study hereunder, the Parties agree to make no
public presentations about any Cyclacel Drug Candidate or any Study conducted
under this Agreement. Any advertisements directed at recruitment of study
subjects for a Study must comply with all applicable laws, rules and regulations
(including the need for IRB review), the confidentiality obligations herein, and
shall not include the trademarked insignia, symbol(s), or logotypes, or any
variant or variants thereof, of the other Party. Except as required by law or
for regulatory purposes, neither Party will use the name (including trademark or
other identifier) of the other Party or such other Party’s employee or staff
member (except in an acknowledgment of sponsorship) in publications,
advertising, press releases or for any other commercial purpose without the
written approval of the other Party. Cyclacel will not state or imply in any
publication, advertisement, or other medium that any Cyclacel Drug Candidate or
service bearing any of Cyclacel’s names or trademarks and/or manufactured, sold
or distributed by Cyclacel has been tested, approved, or endorsed by MD
Anderson.

 

13.3Either Party may use the name of the other Party in any document filed with
any governmental authority or regulatory agency applicable to a Study, and to
comply with any applicable legal or regulatory requirements. Further, each Party
is permitted to disclose the other Party’s name, the title of the Study, the
name of the Principal Investigator, and an overall Study Budget amount projected
to be paid/actual total amount paid for conducting the Study, provided that this
information is presented together as part of mandatory disclosure in accordance
with and to the extent required applicable law.

 

14Principal Investigator

 

14.1If a designated Principal Investigator resigns from or otherwise leaves MD
Anderson, or in the event of the death, chronic illness or other
non-availability of the Principal Investigator, MD Anderson shall use reasonable
efforts to designate a duly qualified person to act as new Principal
Investigator, subject to the reasonable agreement of Cyclacel. If the Parties
are unable to agree on a new Principal Investigator or if the new Principal
Investigator is unwilling to agree to the terms and conditions of this Agreement
and the relevant Study Order, either Party shall be entitled to terminate the
respective Study Order in accordance with Section 8.5.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

15General Provisions

 

15.1Cyclacel hereby represents and warrants that:

 

(a)       It is duly authorized, by all requisite corporate action, to execute
and deliver this Agreement and to perform its obligations hereunder and
thereunder;

(b)       this Agreement, and the execution and delivery hereof constitute
legal, valid and binding obligations of Cyclacel that are enforceable against it
in accordance with their terms;

(c)       the execution, delivery and performance of this Agreement by Cyclacel
does not violate any agreement or instrument to which Cyclacel is a party or by
which Cyclacel is bound and does not violate any applicable law

(d)       it will perform its obligations in accordance with applicable laws.

 

EXCEPT AS EXPRESSLY PROVIDED HEREIN, NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS
OR IMPLIED, CONCERNING THE DATA OR RESULTS OF ANY STUDY OR THE CYCLACEL DRUG
CANDIDATE, OR OF THE MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF
SUCH DATA, RESULTS OR CYCLACEL DRUG CANDIDATE. NEITHER PARTY SHALL BE LIABLE FOR
ANY INDIRECT OR CONSEQUENTIAL DAMAGES SUFFERED BY THE OTHER PARTY AS A RESULT OF
PERFORMANCE OF ANY STUDY UNDER THIS AGREEMENT. Notwithstanding the foregoing,
Cyclacel represents and warrants that each Cyclacel Drug Candidate hereunder
shall have been manufactured in accordance with applicable current Good
Manufacturing Practices in the United States and that it has not received any
claim that use of any Cyclacel Drug Candidate in the performance of a Study
would infringe the rights of any third party Recognising that each Cyclacel Drug
Candidate is an investigational drug, and that the results of any study are
unpredictable, at the Effective Date Cyclacel represents that it knows of no
defects in a Cyclacel Drug Candidate that cause personal injury going beyond
known side effects. Cyclacel understands and acknowledges that the development
and dissemination of scientific knowledge is a fundamental component of MD
Anderson’s mission, and that MD Anderson makes no representations, warranties,
or guarantees with respect to any specific results of the Studies.

 

15.2Assignment. This Agreement and/or any Study Order may not be assigned by
either Party except as agreed upon in writing by the other Party provided always
that either Party may assign this Agreement in whole or in part to a corporate
Affiliate on reasonable prior written notice to the other Party of such
assignment on the condition that the assigning Party shall remain liable
hereunder for the prompt payment and performance of all obligations of the
assignee; (ii) this Agreement may be assigned by a Party to a third party in
connection with a sale or transfer of all or substantially all of such Party’s
business or assets to which this Agreement relates or in connection with a
merger or consolidation transaction involving such third party provided always
that such third party gives a written deed of undertaking to the non-affected
Party agreeing to abide by all the obligations under this Agreement of the
assigning Party. Any assignment or attempt to assign not in accordance with this
Section shall be void and without effect.

 

15.3Independent Contractors. MD Anderson and Cyclacel shall be independent
parties and nothing contained in this Agreement shall be construed or implied to
create an agency or partnership. No Party shall have the authority to agree to
or incur expenses on behalf of another except as may be expressly authorized by
this Agreement or a Study Order.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

15.4Notices. Any notice or communication required or permitted to be given or
made under this Agreement by one of the Parties hereto to the other shall be in
writing and shall be deemed to have been sufficiently given or made for all
purposes on the date of mailing by certified mail, postage prepaid, overnight
courier service, and/or fax to be followed by mailed original addressed to such
other Party at its respective address as referenced in the Study Order.

 

15.5Severability. If any one or more of the provisions of this Agreement shall
be held to be invalid, illegal or unenforceable, the validity, legality or
enforceability of the remaining provisions of this Agreement shall not in any
way be affected or impaired thereby.

 

15.6Entirety. This Agreement represents the entire agreement of the Parties with
respect to the subject matter hereof and it expressly supersedes all previous
written and oral communications between the Parties. No amendment, alteration,
or modification of this Agreement or any Study Orders attached hereto shall be
valid unless executed in writing by authorized signatories of all Parties.

 

15.7Waiver. The failure of any Party hereto to insist upon strict performance of
any provision of this Agreement or to exercise any right hereunder will not
constitute a waiver of that provision or right.

 

15.8Force Majeure. In the event that performance of the obligations of a Party
hereunder are prevented by events beyond their reasonable control, including,
but not limited to, acts of God, regulations or acts of any governmental
authority, war, civil commotion, strikes, or other labor disturbances,
epidemics, fire, earthquakes, storms or other catastrophes of a similar nature,
the affected Party will promptly notify the other Party of such event using the
procedure defined herein, and the Parties shall be relieved of their respective
obligations hereunder to the extent that the performance of such obligations is
actually prevented thereby. During the existence of any such condition, the
affected Party shall, nevertheless, use its best efforts to remove the cause
thereof and resume performance of its obligations hereunder. The period of
performance shall be extended for the Party who is unable to perform due to
Force Majeure reasons by a period of time equal to the length of the period
during which the Force Majeure reason exists or for a longer period if required
to meet the requirements of the Study Protocol.

 

15.9Counterparts. It is understood that this Agreement may be executed in one or
more counterpart copies, each of equal dignity, which when joined, shall
together constitute one Agreement. In the event of execution by exchange of
facsimile or electronic signed copies, the Parties agree that, upon being signed
by both Parties, this Agreement shall become effective and binding and that
facsimile or .pdf signed copies will constitute evidence of this Agreement.

 

15.10Export Control. Notwithstanding any other provision of this Agreement, it
is understood that the Parties are subject to, and shall comply with, applicable
United States laws, regulations, and governmental requirements and restrictions
controlling the export of technology, technical data, computer software,
laboratory prototypes, and other commodities, information and items
(individually and collectively, “Technology and Items”), including without
limitation, the Arms Export Control Act, the Export Administration Act of 1979,
relevant executive orders, and United States Treasury Department embargo and
sanctions regulations, all as amended from time to time (“Restrictions”) and
that the Parties’ obligations hereunder are contingent on compliance with
applicable Restrictions.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

15.11Choice of Law. Any disputes or claims arising under this Agreement shall be
governed by the laws of the State of Texas. MD Anderson is an agency of the
State of Texas and under the constitution and the laws of the State of Texas
possesses certain rights and privileges, is subject to certain limitations and
restrictions, and only has such authority as is granted to it under the
constitution and laws of the State of Texas. Notwithstanding any provision
hereof, nothing in this Agreement is intended to be, nor will it be construed to
be, a waiver of the sovereign immunity of the State of Texas or a prospective
waiver or restriction of any of the rights, remedies, claims, and privileges of
the State of Texas. Moreover, notwithstanding the generality or specificity of
any provision hereof, the provisions of this Agreement as they pertain to MD
Anderson are enforceable only to the extent authorized by the constitution and
laws of the State of Texas; accordingly, to the extent any provision hereof
conflicts with the constitution or laws of the State of Texas or exceeds the
right, power or authority of MD Anderson to agree to such provision, then that
provision will not be enforceable against MD Anderson or the State of Texas.

 

In witness whereof, the Parties hereto have caused this Agreement to be executed
by their duly authorized representatives to be effective as of the Effective
Date.

 

The University of Texas M. D. Anderson Cancer Center Cyclacel Limited

 

Date:     Date:  

 

      Name   Name Title:   Title:

 

21 August 2018

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

Appendix I

 

Four studies planned; the listed studies are subject to Principal
Investigator/Cyclacel discussion and may vary from the final protocols agreed

 

1.CYC065 and venetoclax in relapsed/refractory CLL

2.[***]

3.[***]

4.CYC140 first-in-human study in relapsed/refractory AML or MDS

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

Appendix II

 

MILESTONE AND SALES PAYMENTS

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

Appendix II

Milestone and Sales Payments 

 

 

[***]

[***]

 

[***]

[***]

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

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

Appendix III

 

CLINICAL COLLABORATION AGREEMENT - STUDY ORDER

 

This Study Order (“Study Order”), effective as of the ___ day of XXXX
(“Effective Date”), is entered into by and between The University of Texas MD
Anderson Cancer Center, with a place of business located at 1515 Holcombe Blvd.,
Houston, TX 77030, USA (“MD Anderson”), a member institution of The University
of Texas System (“System”) and Cyclacel Limited, with a place of business
located at 1 James Lindsay Place, Dundee, Scotland, DD1 5JJ, United Kingdom,
(“Cyclacel”). (MD Anderson and Cyclacel each a “Party” and collectively the
“Parties”). This Study Order is a part of, and is subject to, the terms and
conditions of the Clinical Collaboration Agreement entered into between MD
Anderson and dated August ___ 2018 (“Agreement”).

 

1.       The Parties enter into this Study Order in connection with:

 

The Study entitled_________________ , to be conducted pursuant

 

to Protocol No. [Insert Protocol number] which may be attached hereto in Exhibit
A and is incorporated herein.

 

2.       _______ is the Principal Investigator (as defined in the Agreement) for
the Study which will be conducted at MD Anderson.

 

Cyclacel Drug Candidate for the above referenced Study is_____________ .

 

Other Drug for the above referenced Study is______________ .

 

The Study Indication is XXXXXX

 

The quantity and delivery dates of Cyclacel Drug Candidate are XXXX

 

[if applicable] The quantity and delivery dates of Other Drug are XXXX

 

3.       The parties may further exchange the following Proprietary Materials
(other than Cyclacel Drug Candidate) with each other in connection with the
Study:

 

______ being provided by [Insert name of providing party]

 

______ being provided by [Insert name of providing party]

 

4.       Term: This Study Order will continue until the Study is completed,
which is expected to be (__) months after the Effective Date, or until
terminated early as provided in the Agreement.

 

5.       Notices.

 

Any notice or other formal communication related to this Agreement must be in
writing and will be deemed given only if: (a) delivered in person; or (b) sent
by internationally recognized overnight delivery service or air courier
guaranteeing next day delivery. Until a change of address is communicated, as
provided below, all notices and other communications must be sent to the Parties
at the following addresses or facsimile numbers:

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

If to MD Anderson:

 

The University of Texas

MD Anderson Cancer Center

1515 Holcombe Boulevard, Box 1643

Houston, TX 77030

Attn: Vice President, Strategic Industry Ventures

 

With a copy to:

 

The University of Texas

MD Anderson Cancer Center

Legal Services—Unit 1674

PO Box 301407

Houston, TX 77230-1407

Attn: Chief Legal Officer

 

And to:

 

[insert investigator information]

 

If to Cyclacel Limited:

 

Cyclacel Limited

1 James Lindsay Place

Dundee, Scotland, DD1 5JJ

United Kingdom

Attn: Chief Operating Officer

 

With a copy to:

Cyclacel Pharmaceuticals, Inc.

200 Connell Drive #1500

Berkeley Heights, NJ 07922

Attn: Chief Executive Officer

 

All notices will be effective and will be deemed delivered: (a) if by personal
delivery, delivery service or courier, on the date of delivery; and (b) if by
electronic facsimile communication, on the date of transmission of the
communication. Either Party may change its notice address by sending notice of
the change to the other Party in the manner set forth above.

 

6.       Specific superseding terms: N/A.

 

[Signatures on Following Page]

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

In witness whereof, the Parties hereto have caused this Study Order to be
executed by their duly authorized representatives to be effective as of the
Effective Date.

 

The University of Texas M. D. Anderson Cancer Cyclacel Limited Center

 

Date:     Date:  

 

      Name   Name Title:   Title:

 

READ AND UNDERSTOOD:

 

I confirm that I have received a copy of the Agreement under which this Study
Order is issued, and that I have read and understand the Agreement and this
Study Order.

 

Principal Investigator

 

Date:    

 

    Name  

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

 

Exhibit A

 

[Protocol]