Blueprint





 





 
[***] = Confidential
Information has been omitted and filed separately with the
Securities and Exchange Commission. 



  Confidential treatment has been requested with respect to
the omitted information


 


 


 


CANCER
RESEARCH UK


 


and


 


CANCER RESEARCH
TECHNOLOGY LIMITED


 


and


 


MONOPAR
THERAPEUTICS LLC


 


 


CLINICAL TRIAL
AND OPTION AGREEMENT


(CTOA)

 





 


 




 


 


 



 







 






 





TABLE OF CONTENTS


 


	

1

	

DEFINITIONS AND
INTERPRETATION

	

4


	

2

	

CONDITIONS
PRECEDENT

	

12


	

3

	

CONDUCT OF THE
CLINICAL TRIAL AND SPONSORSHIP

	

12


	

4

	

COMPANY’S
OBLIGATIONS

	

14


	

5

	

CONFIDENTIALITY/PUBLICATION

	

16


	

6

	

INTELLECTUAL
PROPERTY RIGHTS

	

19


	

7

	

OPTION

	

20


	

8

	

WARRANTIES AND
LIMITS OF LIABILITY

	

21


	

9

	

INDEMNITIES

	

22


	

10

	

ASSIGNMENT

	

24


	

11

	

TERM
AND TERMINATION

	

24


	

12

	

CONSEQUENCES OF
TERMINATION

	

25


	

13

	

DISPUTE
RESOLUTION

	

26


	

14

	

NOTICES

	

27


	

15

	

WAIVER

	

28


	

16

	

FORCE
MAJEURE

	

28


	

17.

	

INSOLVENCY

	

28


	

18

	

SEVERABILITY

	

28


	

19

	

ENTIRE
AGREEMENT

	

29


	

20

	

AMENDMENT

	

29


	

21

	

PUBLIC
ANNOUNCEMENTS

	

29


	

22

	

PAYMENTS

	

30


	

23

	

DATA
PROTECTION

	

30


	

24

	

THIRD
PARTY RIGHTS

	

30


	

25.

	

EXECUTION

	

30







 


 


	

Schedule
1

	

Company
Patent Rights


	

Schedule
2

	

Report
Synopsis Headings


	

Schedule
3

	

Licence
from CRT to Company


	

Schedule
4

	

No
Fault Compensation Scheme


	

Schedule
5

	

Assignment
and Licence from Company to CRT


	

Schedule
6

	

Protocol


	

Schedule
7

	

Company
Materials


	

Schedule
8

	

Back-Up
Antibodies


	

Schedule
9

	

XOMA
Licence


	

Schedule
10

	

Progress
Reports


	

Schedule
11

	

Clinical
Protocol Summary


	

Schedule
12

	

Escrow
Agreement


	

Schedule
13

	

Technical
Agreement







 


 




 








 










 



THIS AGREEMENT is made the 15th day of May 2015


 



BETWEEN:


 



CANCER RESEARCH UK a company limited by guarantee
registered under number 4325234 and a charity registered under number
1089464 of Angel Building, 407 St. John Street, London, EC1V 4AD,
England (the “Charity”);


 



CANCER RESEARCH TECHNOLOGY LIMITED a company registered in
England and Wales with number 1626049 and registered office at
Angel Building, 407 St. John Street, London, EC1V 4AD, England
(“CRT”);
and


 



MONOPAR THERAPEUTICS LLC, a limited liability company
registered in/incorporated in/ established under the laws of The
State of Delaware, U.S.A., with registered office/principal place
of business at 598 Rockefeller Road, Lake Forest, Illinois, U.S.A.,
60045 (the “Company”).


 



WHEREAS:


 



(A) 

The Company has the right to conduct research and
clinical testing on the Antibody (as defined below). At this time,
the Company does not intend to undertake any further development
of the Antibody.






 



(B) 

The Charity's
charitable objects are to protect and promote the health of the
public in particular by research into the nature, causes,
diagnosis, prevention, treatment and cure of cancer, including
development of findings of research into practical
applications.






 



(C) 

The Charity has
expertise in the clinical evaluation of novel anti-cancer agents
and considers that the Antibody has the potential to be a valuable
drug that could be applied for the treatment of cancer.
Accordingly, the Charity is interested in undertaking the
development of the Antibody at its own cost. As the development is
to be undertaken in pursuance of the Charity's charitable objects,
the Charity will have the right to publish the results of such
development work.






 



(D) 

On completion of
the Charity’s development work, the Company will have the
option to take a licence to the results thereof with a view to the
Company developing the drug further. If the Company does not wish
to take a licence to such results, then CRT shall have the right to
an assignment of rights owned by the Company and a licence to the
rights licensed to the Company, in both cases in and to the
Antibody, to enable CRT to find an alternative partner to develop
the Antibody further.






 



(E) 

CRT is a wholly
owned subsidiary of the Charity and is, by arrangement with the
Charity, responsible for the management, exploitation and
commercialisation of intellectual property generated by the Charity
or using funding from the Charity and the Charity has assigned and
will assign such intellectual property to CRT for such purpose. CRT
remits all its taxable profits to the Charity.






 



(F) 

The Company, CRT
and the Charity have therefore agreed to enter into this Agreement
to enable the Charity to undertake the development of the
Antibody subject to the following
terms and conditions:






 




 








 






 
[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 


 
Confidential
treatment has been requested with respect to the omitted
information.


 



NOW IT IS HEREBY AGREED as follows:

 




1.

DEFINITIONS
AND INTERPRETATION





 




1.1

In this Agreement
the words and phrases set out below shall, unless the context
requires otherwise, have the corresponding meaning attributed to
them below. In addition, any words and phrases in this Agreement
which are not defined below, but which are defined in the CTD,
shall have the meaning attributed to them in the CTD.





 


	


 “Additional Studies”


 

	

means
any biomarker, manufacturing, purity, toxicology, imaging or
combination studies, or any other exploratory or pre-clinical
in vitro or in vivo studies commenced after the
Commencement Date and associated with any part of the Antibody, or
carried out in support of the clinical trial conducted pursuant to
this Agreement, where such studies are performed by or on behalf of
the Charity (as the same may be amended from time to time by the
Charity).


 


	


“Additional Results”


 

	

means
all Know-How, data, information and results Controlled by the
Charity or CRT and arising from the Additional
Studies.


 


	


“Affiliate”


 

	

means
an entity that, whether now or in the future, Controls, is
Controlled by or is under common Control with a Party. For the
purpose of this definition only, “Control” means the
possession (directly or indirectly) of fifty per cent or more of
the voting stock or other equity interest of a subject entity with
the power to vote, or the power in fact to control the management
decisions of such entity through the ownership of securities or by
contract or otherwise and “Controls” and
“Controlled by” shall be construed
accordingly.


 


	


“Antibody”


 

	

means
the humanised anti-uPAR monocolonal antibody known as HuATN-658
and/or any monoclonal antibody derived directly or indirectly from
the Cell Line, including any fragment or conjugated
antibody.


 


	


“this Agreement”


 

	

means
this agreement and each of the Schedules to it as amended from time
to time in accordance with Clause 20.


 







	


“Back-Up Antibodies”


 

	

means
any and all antibodies, other than the anti-uPAR
monocolonal antibody known as HuATN-658, that have been or
are discovered, generated or developed by or on behalf of the
Company or any of its Affiliates in the course of the [***]
including, but not limited to, the compounds identified in Schedule
8.


 


	


“Case Report Forms”


 

	

means
a record of the data and other information gathered on each
Clinical Trial Subject pursuant to the Protocol.


 


	


“Cell line”


 

	

means
[***].


 


	



“Charity’s Standard Operating
Procedures”


 

	

means
the documents in use by the Centre for Drug Development of the
Charity from time to time that are designated as standard operating
procedures and which describe the procedures that must be followed
to complete various tasks.


 








 







 





 


	


“Chief Investigator”


 

	

means
the person who will lead and co-ordinate the work of the Clinical
Trial overall where the Clinical Trial is to be carried out at more
than one site.


 


	


“Clinical Trial”


 

	

means
the Phase I clinical trial described in the Protocol to be
conducted under the Sponsorship of the Charity and any Additional
Studies.


 


	



“Clinical Trial Database Lock Date”


 

	

means
the date when the clinical research database relating to the
Clinical Trial is locked (after the Clinical Trial Results have
been cleaned but excluding any Long Term Survival Data) in
accordance with the Charity’s Standard Operating
Procedures.


 







	



“Clinical Trial Legislation”


 

	

means
all laws and regulations from time to time in force applicable to
the performance of the Clinical Trial, including the CTD, the Human
Rights Act 1998, the Data Protection Act 1998, the Medicines Act
1968, the Medicines for Human Use (Clinical Trials) Regulations
2004, and the Human Tissue Act 2004.


 


	



“Clinical Trial LPFV Date”


 

	

means
the date when the final Clinical Trial Subject in the Clinical
Trial attends their first study visit. The Clinical Trial LPFV Date
may be further defined in the Protocol.


 


	


“Clinical Trial Results”


 

	

means
all Know-How, data, information, results and improvements
Controlled by the Charity or CRT and arising from the Clinical
Trial, including the contents of each Progress Report, the Final
Report, Case Report Forms and associated Data Listings and any
other updates that may be agreed by the Parties from time to
time.


 


	


“Clinical Trial Subject”


 

	

means
any person who is enrolled in the Clinical Trial either as a
recipient or planned recipient of the Investigational Medicinal
Product or as a control.


 


	


“Commencement Date”


 

	

means
the date on which the Conditions Precedent have been
satisfied.


 


	


“Company GMP Materials”


 

	

means
those Company Materials listed in Part 2 of Schedule
7.


 


	



“Company Intellectual



Property”

	

means
the Company Patent Rights, and all rights in the Company Know-How,
the Investigational Medicinal Product and the Company
Materials.


 


	


“Company Know-How”


 

	

means
such Know-How in the Company’s Control relating to the
Antibody and/or Investigational Medicinal Product (and any
constituents thereof), including: (i) any safety and toxicological
data; (ii) information relating to the manufacturing/production;
(iii) information relating to quality; (iv) information relating to
safe and proper handling, storage and use; (v) any other data which
is relevant to the efficient performance of the Clinical Trial
and/or would make the Investigational Medicinal Product in any way
easier to make; and (vi) any other data that would make the
Antibody more useful, more valuable or in any way improve its
prospects for development or commercialisation.


 








 







 





 


	


“Company Materials”


 

	

means
the Cell Line and Materials identified in Schedule 7 that are to be
provided by the Company to the Charity pursuant to this
Agreement.


 


	


“Company Patent Rights”


 

	

means
(i) those Patent Rights listed in Schedule 1; (ii) those Patent
Rights owned by or licensed to the Company which would be infringed
by the unauthorised manufacture, use or sale in, or importation
into, the relevant country of the Antibody, Back-Up Antibodies
and/or Investigational Medicinal Product; and (iii) all Patent
Rights deriving priority from (i) and (ii).


 


	


“Conditions Precedent”


 

	

have
the meaning given to them in Clause 2.1.


 


	


“Confidential Information”


 

	

means
all information designated as confidential by any Party in writing
together with all other information which relates to the business,
affairs, technology, products, developments, trade secrets,
Know-How, personnel, customers, agents, distributors and suppliers
of any Party or information which may reasonably be regarded as the
confidential information of the Disclosing Party. Subject to the
terms of any licence agreement entered into in relation to them,
the Clinical Trial Results shall be the Confidential Information of
the Charity and CRT.


 


	


“Control”


 

	

means,
with respect to Intellectual Property Rights, possession of the
ability (whether through ownership or licence, other than a licence
granted under this Agreement) to access and provide the Know-How
and Material or grant the licences or sublicences or make the
assignments as provided herein without violating the terms of any
agreement or other arrangement with any third party.


 


	


“Contributors”


 

	

means
the Chief Investigator, the Principal Investigator(s), the
Sub-Investigators, the Experts, the NHS Trust(s) involved in the
Clinical Trial, any sub-contractor of the Charity and/or any
academic or not-for-profit entity involved in the Clinical
Trial.


 


	


“Costs”


 

	

means
all actual prepaid and committed costs and expenses incurred from
time to time in connection with the Clinical Trial, including, for
the avoidance of doubt, the internal personnel costs of the Charity
and the Charity’s Biotherapeutics Development Unit (BDU) and
Formulation Unit.


 


	


“CTD”


 

	

means
the European Clinical Trials Directive (Directive 2001/20/EC) and
national legislation implementing such Directive, as the same may
be amended from time to time.


 


	


“Data Listings”


 

	

means
the computer generated data listings produced by the Charity
detailing all anonymised patient data collected under the Clinical
Trial other than the Long Term Survival Data.


 








 







 





 

 


	


“Declaration of Helsinki”


 

	

means
the 2008 version of the Helsinki Declaration of the World Medical
Association.


 


	


“Disclosing Party”


 

	

has
the meaning specified in Clause 5.1.


 


	

“Escrow
Account”


 

	

means
an investment account established by the Company with the Escrow
Agent under the provisions of the Escrow Agreement.


 


	

“Escrow
Agent”


 

	

means
Fifth Third Bank, a United States banking corporation with
registered address at Fifth Third Square, 38 Fountain Square Plaza,
Cincinnati, OH, 45263, or any other substantially comparable United
States banking corporation selected by mutual agreement of the
Parties.


 


	

“Escrow
Agreement”


 

	

means
a written agreement between the Parties and the Escrow Agent in
substantially the form attached as Schedule 12, and under which the
Company is obliged to cause the Escrow Agent to open the Escrow
Account, and deposit the Escrow Amount in the Escrow Account,
before the Long Stop Date.


 


	


“Escrow Amount”


 

	

means
a sum of of eight hundred thousand US dollars (US
$800,000).


 


	


“Ethics Committee”


 

	

has
the meaning given to it in the CTD.


 


	


“Exclusive Results”


 

	

means
those Clinical Trial Results and the Intellectual Property Rights
therein that directly relate to and only to the IMP. Exclusive
Results shall not include any assay methodology,
formulation-related results or biomarker results which do not
directly relate to and only to the Investigational Medicinal
Product.


 


	


“Exercise Notice”


 

	

has
the meaning specified in Clause 7.1.


 


	


“Expert”


 

	

means
any member of the Charity’s expert committees or any other
person not being an employee of the Charity whom the Charity may
engage from time to time to advise the Charity on the Clinical
Trial.


 


	


“Final Report”


 

	

means
a Report Synopsis, unless, pursuant to Clause 3.10, a Full Clinical
Study Report is prepared by the Charity instead of a Report
Synopsis.


 


	


“Financial Year”


 

	

means
the period commencing on January 1 and ending on December
31.


 


	



“Full Clinical Study Report”


 

	

means
a full clinical study report in relation to the Clinical Trial
written by or on behalf of the Charity in accordance with the
Charity’s Standard Operating Procedures and which meets the
standards of the ICH Guidelines for Structure and Content of
Clinical Study reports as per ICH Topic E3 dated July 1996 except
that Long Term Survival Data will not be included in the
report.


 


	


“Full CS Report Fee”


 

	

has
the meaning given to
it in Clause 3.10.


 








 







 





 


	





	
 


	



“Good Manufacturing Practice”


 

	

means
the principles and guidelines of good manufacturing practice in
respect of medicinal products for human use and investigational
medicinal products for human use as defined in: (i) the CTD; (ii)
European Community Directive 2003/94/EC; (iii) European Community
Directive 2005/28/EC; (iv) Eudralex Volume 4: ‘EU Guidelines
to Good Manufacturing Practice, Medicinal Products for Human and
Veterinary Use, Part II Basic Requirements for Active Substances
used as Starting Materials’, ICHQ7a Good Manufacturing
Practice Guidance for Active Pharmaceutical Ingredients and
‘EU Guidelines to Good Manufacturing Practice Medicinal
Products for Human and Veterinary Use, Annex 13: Investigational
Medicinal Products’; and (v) any national legislation
implementing the aforementioned Directives and any relevant
guidance relating thereto.


 


	


“ICH GCP”


 

	

means
the latest version from time to time of the International
Conference on Harmonisation (ICH) Tripartite Guidelines, Good
Clinical Practice (CPMP/ICH/135/95) together with such other good
clinical practice requirements as are specified in the CTD and in
Commission Directive 2005/28/EC and in any other regulations
relating to medicinal products for human use and in any guidance
published by the European Commission pursuant to such Directives or
regulations.


 


	


“Independent Opinion”


 

	

means
the opinion of an independent expert in the field of valuation of
intellectual property in a similar field to the Company
Intellectual Property, appointed by agreement between the Parties
or in default of such agreement within twenty one (21) days of a
Party seeking in writing to the others to appoint such expert, by
the President for the time being of the Association of the British
Pharmaceutical Industry (ABPI) in England and Wales, referred to at
Clause 13.1.


 


	



“Intellectual Property Rights”


 

	

means
all Patent Rights, Know-How, copyright, database rights, design
rights, moral rights, rights in trade names, logos and trade and
service marks, domain names, rights in Materials and all rights or
forms of protection of a similar nature or having equivalent or
similar effect to any of them which may subsist anywhere in the
world, whether or not any of them are registered, including any
application for registration of any of them.


 


	



“Investigational Medicinal Product” or
“IMP”


 

	

means
the pharmaceutical formulation of the Antibody suitable for use in
the Clinical Trial.


 


	



“Investigational Medicinalor 

Product Dossier” or “IMPD”


 

	

means
a dossier relating to the Investigational Medicinal Product which
accompanies a request for clinical trial authorisation to conduct
the Clinical Trial from a Regulatory Authority. The Investigational
Medicinal Product Dossier shall include a specification of the
IMP.


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Know-How”


 

	

means
all 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, designs for experiments and tests and results of
experimentation and testing, processes, specifications and
techniques, laboratory records, clinical data, reports,
manufacturing data and information contained in submissions to
Regulatory Authorities.


 


	


“Licence”


 

	

means
a licence to the Clinical Trial Results and any Intellectual
Property Rights therein in the form attached at Schedule 3. Such
licence shall be exclusive in respect of the Exclusive Results, and
non-exclusive in relation to the Non-Exclusive
Results.


 


	


“Long Stop Date”


 

	

has
the meaning given to it in Clause 2.2.


 


	


“Long Term Survival Data”


 

	

means
any ongoing survival data for Clinical Trial Subjects that the
Charity collects after the completion of the interventional
component of the Clinical Trial.


 


	


“Losses”


 

	

means losses, damages, costs and
expenses (including reasonable legal costs and expenses), in each
case directly incurred by a Party.


 


	


“Materials”


 

	

means
any chemical or biological substances including any: organic or
inorganic element or compound; nucleotide or nucleotide sequence
including DNA and RNA sequences gene; vector or construct including
plasmids, phages, bacterial vectors, bacteriophages and viruses;
host organism including bacteria, fungi, algae, protozoa and
hybridomas; eukaryotic or
prokaryotic cell line or expression system or any development
strain or product of that cell line or expression systems; protein
including any peptide or amino acid sequence, enzyme, antibody or
protein conferring targeting properties and any fragment of a
protein or a peptide enzyme or antibody; drug or pro-drug; assay or
reagent; any plasma or tissue; or any other genetic or biological
material or micro-organism or any transgenic
animal.


 


	


“Non-Exclusive Results”


 

	


means those Clinical Trial Results that are not Exclusive Results
(and all Intellectual Property Rights therein), including all assay
methodology, formulation-related results or biomarker
results.


 


	


“Option”


 

	


has the meaning specified in Clause 7.1.


 


	


“Option Fee”


 

	

means the sum of [***] less the
amount of any Full CS Report Fee actually paid by the Company to
CRT under Clause 3.10 and excluding VAT or other applicable sales
tax.


 


	


“Option Period”


 

	


has the meaning specified in Clause 7.1.


 








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Party”


 

	

means
any party to this Agreement and “Parties” means all of
them.


 


	


“Patent Rights”


 

	

means
any patent applications, patents, author certificates, inventor
certificates, utility models, and all foreign counterparts of them
and includes all divisionals, renewals, continuations,
continuations-in-part, extensions, reissues, substitutions,
confirmations, registrations, revalidations and additions of or to
them, as well as any Supplementary Protection Certificate, or any
like form of protection (including any pediatric, orphan drug or
other exclusivity granted by a Regulatory Authority beyond the
expiry of the original patent expiration date).


 


	


“Principal Investigator”


 

	

means
the person who will lead and co-ordinate the work of the Clinical
Trial at a particular Clinical Trial site.


 


	


“Progress Report”


 

	

means
a report on the status of the Clinical Trial in the format set out
in Schedule 10, or in such other format as is the Charity’s
standard practice at the relevant time in respect of a clinical
trial at the same stage, and of the same scope, as the Clinical
Trial.


 


	


“Protocol”


 

	

means
the clinical trial protocol to be prepared by the Charity and the
Chief Investigator as may be amended from time to time by the
Charity in accordance with Clause 3.6.


 


	


“Recipient Party”


 

	

has
the meaning specified in Clause 5.2.


 


	


“Regulatory Authority”


 

	

means
any local, national or supra-national agency, authority,
department, inspectorate, minister, ministry official or public or
statutory person (whether autonomous or not) or any government of
any country as shall have jurisdiction over the Clinical Trial or
any part of it or over any activity of the Parties in connection
with the Clinical Trial. Regulatory Authority includes, but is not
limited to, the United Kingdom Medicines and Healthcare products
Regulatory Agency (MHRA), the United States Food and Drug
Administration (FDA) and the European Medicines Agency
(EMEA).


 


	


“Report Synopsis”


 

	

a
summary of the results of the Clinical Trial written by or on
behalf of the Charity in accordance with the Charity’s
Standard Operating Procedures in a form substantially similar to
the format set out in Schedule 2 and the format of the clinical
study synopsis set out in Annex I of ICH Topic E3 of the ICH
Guidelines for Structure and Content of Clinical Study reports
dated July 1996. The Report Synopsis shall not include or contain
any additional documents or any appendices, exhibits or annexes nor
shall it include or contain any Data Listings, Case Report Forms or
any raw data comprised within the Clinical Trial Results or cover
any Long Term Survival Data.


 


	


“uPAR”


 

	

means
[***].


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	




	
 


	





[***]


 

	

means
any and all research programmes undertaken by or on behalf of the
Company, Tactic Pharma LLC or by Attenuon, LLC, or any of their
Affiliates, and in the course of which the Antibody or the antibody
known as ATN-658 or any of the Back-Up Antibodies were discovered,
generated or developed (including but not limited to development
activities conducted after the Commencement Date).


 


	


 “Signature Period”


 

	

means
the period of [***] commencing on:


 


	





 

	

(i) in the
event that the Charity does not prepare a Full Clinical Study
Report pursuant to Clause 3.10, the Company’s receipt of the
Data Listings pursuant to Clause 7.3; or


	





 

	

(ii) in the
event that the Charity prepares a Full Clinical Study Report
pursuant to Clause 3.10, the date of the Exercise
Notice.


 


	


“Sub-Investigator”


 

	

means
a clinician appointed and supervised by the Chief Investigator or
Principal Investigator to assist in the carrying out of the
Clinical Trial at the same trial site as the Principal
Investigator.


 


	


“Supplementary

	
 


	


Protection Certificate”


 

	

means
a right based on a patent pursuant to which the holder of the right
is entitled to exclude third parties from using, making, having
made, selling or otherwise disposing or offering to dispose of,
importing or keeping the product to which the right relates, such
as supplementary protection certificates in Europe, and any similar
right anywhere in the world.


 


	

“Tactic”


 

	

Tactic
Pharma LLC, an Illinois limited liability company based at
[***].


 


	

“Tobacco
Party”


 

	

means:
(i) any entity who develops, sells or manufactures tobacco
products; and/ or (ii) any entity which makes the majority of its
profits from the importation, marketing, sale or disposal of
tobacco products. Furthermore, Tobacco Party shall include any
entity that is an Affiliate of any entity referred to in (i) or
(ii).


 


	


“Transfer Documents”


 

	

means
the following documents: (i) the asset contribution agreement
between the Company and Tactic dated 20 January 2015 (and as
amended on 20 January 2015); the assignment and assumption of
licence agreement between the Company and Tactic dated 20 January
2015; and (iii) the letter from Tactic to the Parties dated 12
March 2015 in respect of the Cell Line and related Intellectual
Property Rights.


 


	


“XOMA IP”


 

	

means
any and all Intellectual Property Rights licensed to the Company
under the XOMA Licence.


 


	


“XOMA Licence”


 

	

means
the agreement entered into between XOMA (US) LLC and Tactic on 24
September 2014 in respect of the Antibody, which was assigned to
the Company by Tactic pursuant to an agreement dated 20 January
2015. Both agreements are attached in Schedule 9.


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	

“XOMA Licence
Payments”


	
means
those milestone payments set out in the XOMA Licence.







 


 




1.2

In this
Agreement:





 




1.2.1

unless the context
requires otherwise, all references to a particular Clause,
paragraph or Schedule shall be references to that clause, paragraph
or schedule, of or 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, organisation or other entity, in each case
whether or not having separate legal personality;





 




1.2.5

reference to any
statute or regulation includes any modification or re-enactment of
that statute or regulation, provided that the modification or
re-enactment does not diminish the rights or extend the obligations
of any Party; and





 




1.2.6

references to the
words “include” or “including” shall be
construed without limitation to the generality of the preceding
words.





 

 




2.

CONDITIONS
PRECEDENT





 




2.1

Notwithstanding
anything to the contrary in this Agreement, the Charity and CRT
shall have no obligations, nor have any liability, of any nature
howsoever arising under or in connection with this Agreement unless
and until the following conditions precedent have been
satisfied:





 




2.1.1

the valid execution
of the Escrow Agreement; and





 




2.1.2

the Company’s
performance of its obligations under the Escrow Agreement to open
the Escrow Account and deposit the Escrow Amount in it;
and





 




2.1.3

the Company’s
delivery to the Charity of written evidence to the Charity’s
reasonable satisfaction that the Company has obtained insurance
described in Clause 9.5,





 


(the
“Conditions
Precedent”).

 




2.2

If the Conditions
Precedent have not been satisfied by 14:00pm (BST) on the date
falling [***] after the date of signature of this Agreement (the
“Long Stop
Date”), the Agreement shall expire on the Long Stop
Date.





 




2.3

The Company shall
use its best endeavours to satisfy the Conditions Precedent before
the Long Stop Date.





 

 




3.

CONDUCT
OF THE CLINICAL TRIAL AND SPONSORSHIP





 




3.1

Subject to: (i) the
Company’s compliance with its obligations hereunder; and (ii)
the Ethics Committee and the Regulatory Authority granting consent
for the Clinical Trial, the Charity will use its reasonable
endeavours to carry out or procure the carrying out of the Clinical
Trial in accordance with the Protocol.







 







 





 




3.2

Once the Clinical
Trial has been opened to Clinical Trial Subjects, the Charity shall
use reasonable endeavours to provide to the Company at least one
Progress Report per month (or with the frequency that is the
Charity’s standard practice at the relevant time in respect
of a clinical trial at the same stage, and of the same scope, as
the Clinical Trial, but no less frequently than quarterly). The
Company may use the Progress Reports for the purpose of determining
whether or not to exercise the Option. All Progress Reports and any
supplementary information provided under them shall be the
Confidential Information of the Charity and the provisions of
Clause 5 shall apply. The Company acknowledges that information or
data provided under this Clause 3.2 may not be verified, clean or
accurate, and is provided “as is”. Without prejudice to
the generality of Clause 8.7, neither CRT nor the Charity make any
representation or warranty (express or implied) of any nature in
respect of such data or information, including as to its accuracy,
quality, usefulness or comprehensiveness.





 




3.3

The Charity may, at
its sole discretion: (i) sub-contract to third parties any part of
the Clinical Trial; and (ii) engage such Experts and such persons
to fulfil the roles of Chief Investigator and/or Principal
Investigator as the Charity deems appropriate. Company shall be
notified of any such third parties, Experts and persons set forth
in this clause 3.3, and the Charity may make such notification by
email.





 




3.4

The Charity shall,
at its own expense, be responsible for seeking approval of the
Clinical Trial and the Protocol from the Regulatory Authority and
Ethics Committee prior to commencing the Clinical Trial. For the
avoidance of doubt, the Charity shall not be held liable or
responsible for any failure and/or refusal by the Ethics Committee
or the Regulatory Authority to grant consent for the Clinical Trial
or any change required therein.





 




3.5

The Charity shall
use reasonable endeavours to carry out, or procure the carrying out
of, the Clinical Trial in accordance with the relevant aspects
of:





 




3.5.1

Clinical Trial
Legislation; and





 




3.5.2

ICH GCP and the
Declaration of Helsinki.





 


Any
breach of this Clause 3.5 shall be a material breach.

 




3.6

The Charity shall
be free to amend the Protocol or to change the third party
undertaking any part of the Clinical Trial as it deems appropriate,
provided that such Protocol or change to the Protocol has first
been approved by the Ethics Committee and, if required by law or
regulation, the Regulatory Authority; and further provided
that:





 




3.6.1

prior to submission
for Ethics Committee approval, the Charity shall provide to the
Company a copy of the first final version of the Protocol at least
fourteen (14) days before seeking Ethics Committee approval and
give due consideration to any comments received from the Company by
the Charity within such time.





 




3.6.2

the Charity shall
notify the Company in writing of any proposed changes to the
Protocol at least fourteen (14) days before seeking Ethics
Committee approval for such changes, and shall give due
consideration to any comments that the Company might make within
such time. In an emergency (such as patient safety needs) the said
fourteen (14) day time period may be reduced to such time period as
the Charity is actually able to give to the Company in the
circumstances and the Charity may, if in its reasonable opinion it
is required, submit such changes to the Ethics committee prior to
notifying the Company of such. The Charity will try to reach a
consensus with the Company on all issues arising out of the
Company’s review of any Protocol pursuant to this Clause
3.6.2, but the Charity shall have the final decision.






 



 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




3.6.3

in the event that
the Ethics Committee and/or the Regulatory Authority does not
approve the original Protocol and/or agree to any amendment to the
Protocol, the Charity shall have the right to terminate this
Agreement forthwith upon written notice to the
Company.





 




3.7

The Charity shall
have sole responsibility for the conduct and control of the
Clinical Trial and shall accept the obligations of the sponsor of
the Clinical Trial in accordance with the requirements of the
Medicines for Human Use (Clinical Trials) Regulations
2004.





 




3.8

The Charity shall
use reasonable endeavours to procure that Clinical Trial Subjects
are recruited in accordance with the selection procedures and
criteria set out in the Protocol.





 




3.9

The Charity shall
promptly advise the Company, in writing, of the occurrence of the
Clinical Trial LPFV Date.





 




3.10

The Company may
elect to receive a Full Clinical Study Report instead of a Report
Synopsis by:





 




3.10.1

providing the
Charity with written notice of its election to receive a Full
Clinical Study Report, which written notice must be received by the
Charity before the expiration of thirty (30) days from the date the
Charity advised the Company of the occurrence of the Clinical Trial
LPFV Date; and





 




3.10.2

paying the Charity
the sum of [***] excluding VAT
or other applicable sales tax (the “Full CS Report Fee”) within twenty
one (21) days after service of such notice.





 


If the
Company does not serve a written notice and pay the Full CS Report
Fee as specified in this Clause 3.10, the Charity shall prepare a
Report Synopsis and shall have no obligation to prepare or provide
the Company with a Full Clinical Study Report.

 




3.11

The Charity shall
provide the Final Report to the Company and CRT within [***] after
the Clinical Trial Database Lock Date.





 




3.12

The Charity shall
only use the Investigational Medicinal Product for the purposes of
carrying out the Clinical Trial and shall not permit any third
party to use the Investigational Medicinal Product except as
required for the purpose of carrying out the Clinical Trial or as
set out in this Agreement.





 

 




4.

COMPANY’S
OBLIGATIONS





 




4.1

The Company shall
at the Company’s sole cost, provide the Charity
with:





 




4.1.1

such information
and Know-How relating to the manufacture of the IMP as is relevant
to the efficient production of sufficient quantity of the IMP to
conduct the Clinical Trial, as soon as practicable following the
Commencement Date;





 




4.1.2

all Company
Know-How and the Company Materials as soon as practicable following
the Commencement Date;





 




4.1.3

any other
information in the Company’s Control pertaining to the safety
of the IMP or which in the reasonable opinion of the Company may
have a bearing on the conduct of the Clinical Trial as soon as the
same comes to the attention of the Company.





 




4.1.4

such scientific and
technical guidance as the Charity may reasonably request to enable
the Charity and the Contributors to conduct and manage the Clinical
Trial in a safe and proper manner; and







 







 





 




4.1.5

all information
(including information for inclusion in the Investigational
Medicinal Product Dossier) and co-operation reasonably requested by
the Charity at any time from the Commencement Date to enable the
Charity to compile an Investigational Medicinal Product Dossier;
provided that such requested information is in the Company’s
Control (which shall include all information transferred, and all
information which the Company is entitled to request or Control,
under the Transfer Documents). In the case of co-operation
requested under this Clause 4.1.5, the Company shall procure (at
its own cost) that any subcontractor which has performed activities
or produced documents on its behalf under this Agreement is made
available to the Charity on such notice, for such time and with
such frequency as may be reasonably requested by the Charity. The
Company shall provide information requested by the Charity within
fourteen (14) days of request (or such other period as may be
reasonable given the nature of the request).





 




4.2

The Company shall
provide to the Charity any and all data, documentation, information
and Know-How described in Clauses 4.1.1 to 4.1.5 on an ongoing
basis within a reasonable time after the same comes to the
attention of the Company (if already in the Company’s
Control), or into the Company’s Control, after the
Commencement Date.





 




4.3

The Company will
keep the Charity informed of the scope and results of any
pre-clinical or other non-clinical studies being undertaken by it
or with third parties in relation to the Antibody or Back-Up
Antibodies. If the Company is intending to transfer the Antibody or
undertake any new research in relation to the Antibody or a Back-Up
Antibody with a third party, it will consult with the Charity on
the scope of the intended research and the identity of the third
party and take into good faith consideration any comments the
Charity may have in respect to the same. This Clause should not be
interpreted to limit any restrictions on the Company’s use of
the Antibody or any Back-Up Antibody under Clause 6.1 or elsewhere
in this Agreement.





 




4.4

The Company shall
submit to CRT:





 




4.4.1

a copy of its
detailed operating budget for
development of the Antibody (including a quarterly cash flow
and expenditure forecast) in respect of each Financial Year as
adopted by the Company’s board (the “Annual Budget”), at least thirty
(30) days prior to the commencement of the Financial Year to which
the Annual Budget relates; and





 




4.4.2

quarterly
management accounts of the Company (to include, inter alia, a
(consolidated) profit and loss account, balance sheet and cash flow
statement and shall indicate where such management accounts differ
to any material extent from the Annual Budget for such period),
within sixty (60) days of the end of the period to which they
relate; save that the accounts relating to the final quarter in any
calendar year may be provided within ninety five (95) days, rather
than sixty (60) days, of the end of that quarter. Such quarterly
management accounts shall be prepared on a basis which is
consistent with those adopted in the preparation of all previous
management accounts of the Company.





 




4.5

The Company shall
generally keep CRT informed of the progress of the Company's
business and affairs and shall promptly supply CRT with written
details of any circumstances which will or might cause any actual
or prospective material adverse change in the financial position,
prospects or business of the Company.





 




4.6

As between the
Parties, the Company will be solely responsible for any and all
payments due under the XOMA Licence that may become due as a result
of the grant of rights to the Charity under this Agreement or the
carrying out the Clinical Trial in accordance with this
Agreement.







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




4.7

Following its
receipt of the Company GMP Material, the Charity will assess
whether or not it wishes to use the Company GMP Material to
manufacture IMP. At the Charity’s request, the Charity and
the Company shall negotiate in good faith the terms of a technical
agreement that sets out the responsibilities of each Party in
respect of IMP and the GMP aspects of manufacturing IMP (the
“Technical
Agreement”). Negotiations shall take place and be
concluded within [***] of the Charity’s request for a
Technical Agreement. If required, the Technical Agreement will be
in a form substantially similar to that set out in Schedule
13.





 

 




5.

CONFIDENTIALITY/PUBLICATION





 




5.1

Subject to Clause
5.5, each Party shall keep confidential and not disclose to any
third party (other than the Experts, Contributors, Ethics
Committee, Regulatory Authority and staff involved in carrying out
the Clinical Trial on a need to know basis) any Confidential
Information disclosed to it by another Party (the
“Disclosing
Party”) without the prior written consent of the
Disclosing Party. For the avoidance of doubt, the Charity shall be
permitted to disclose Confidential Information disclosed to it to
CRT and CRT shall be permitted to disclose Confidential Information
disclosed to it to the Charity. Any party to whom Confidential
Information is disclosed in accordance with this Clause 5.1 shall
be:





 




5.1.1

subject to no less
onerous obligations than those contained in this Clause 5 to keep
such information confidential; and





 




5.1.2

advised of its
confidential nature.





 




5.2

The obligations of
confidence referred to in Clause 5.1 shall not apply to any part of
the Confidential Information which can be proved by evidence in
writing:





 




5.2.1

was known to the
recipient Party (the “Recipient Party”) before its
disclosure by the Disclosing Party;





 




5.2.2

was available to
the public before that date or was otherwise in the public
domain;





 




5.2.3

becomes available
to the public or enters the public domain after that date otherwise
than as a result of an act or default of the Recipient
Party;





 




5.2.4

is received by the
Recipient Party from a third party not bound to the Disclosing
Party by any obligation of secrecy;





 




5.2.5

is independently
developed or generated by the Recipient Party in circumstances
where it has not been derived directly or indirectly from the
Disclosing Party’s Confidential Information; or





 




5.2.6

is required to be
disclosed by: (i) law, (ii) a Regulatory Authority; or (iii) an
order of any court, provided however, that in each such event the
Recipient Party required to disclose the Confidential Information
shall give prompt notice to the Disclosing Party of such
requirement so that such Disclosing Party may seek a protective
order or other appropriate remedy to the extent of such
disclosure.





 




5.3

The obligations of
the Parties under Clause 5.1 shall survive the expiry or
termination of this Agreement for whatever reason for a period of
ten (10) years from the date of such expiry or
termination.





 




5.4

Each of the Parties
agrees that the provisions of this Clause 5 are fair and reasonable
and that money damages are not a sufficient remedy for any breach
of this Clause 5 and therefore, in addition to all other remedies,
all Parties shall be entitled to seek injunctive or other equitable
relief as a remedy for such breach.





 




5.5

Notwithstanding any
confidentiality obligations assumed by the Parties hereunder, the
Parties acknowledge: i) the importance of publications to the
academic standing of the Charity and the Contributors; and ii) the
capital raising, transactional, and licensing prospects of the
Company; and iii) the reporting and disclosure obligations of the
Company to its investors and to XOMA under the XOMA Licence.
Accordingly, the Parties have agreed as follows as regards
publication of Clinical Trial Results and Progress
Reports:







 







 





 




5.5.1

The Charity shall
use reasonable endeavours to publish, or procure the publication by
the Contributors of, the Clinical Trial Results in a timely manner
in accordance with generally accepted academic practice, whether
during the course of or after completion of the Clinical
Trial.





 




5.5.2

The Company may
disclose the content of Progress Reports to XOMA only to the extent
it is required to do so under the XOMA Licence, provided that the
disclosure will exclude all information regarding clinical
responses and shall be limited to only information regarding the
clinical indication, anticipated timelines of the trial, the number
of patients dosed, and such other information of a similar nature
as may be reasonably required by the XOMA Licence.





 




5.5.3

The Company may
disclose:





 




(a)

the content of
Progress Reports to a third party in connection with capital
raising, financing, transactional, and/or licensing activities or
prospects for the benefit of the Company. Prior to making such
disclosure, the Company shall give notice to the Charity, including
details of the content of the proposed disclosure and the reason
for wishing to make such disclosure, and shall inform the Charity
of the identity of the third party in its notice unless it is
prevented from doing so due to express confidentiality restrictions
owed to, and requested by, the third party, in which case the
Company shall state the main business area within which the third
party operates. The Company may, without the Charity’s prior
approval, disclose only the clinical indication, anticipated
timelines of the trial, and the number of patients dosed, but shall
obtain the Charity’s approval before proceeding with any
other disclosure under this Clause 5.5.3(a);





 




(b)

the Final Report to
the Company’s consultants and professional advisors, solely
for the purpose of assisting in the evaluation of the results with
a view to exercise of the Option and provided that no patient data
shall be disclosed unless it has been cleansed; and





 




(c)

the content of
Progress Reports to persons holding investments in the Company,
solely for the purpose of a status update, such as periodic
disclosure of recruitment numbers to investors in the Company by
way of demonstration of progress in the Clinical
Trial.





 




5.5.4

It is further
provided that each disclosure of the content of Progress Reports by
the Company under this Clause 5.5 shall be subject to the following
conditions:





 




(a)

all recipients
shall be informed in writing beforehand of the confidential nature
of the information being disclosed and shall have agreed in writing
to obligations of confidentiality in favour of the Company no less
onerous than those contained in this Clause 5 (but without any
right of further disclosure) to keep such information confidential;
and





 




(b)

only the content of
the documents containing the relevant information which has been
processed into a suitable format may be disclosed but not copies of
the actual documents themselves.







 







 





 




5.6

The Charity will
include provisions in its contracts with the Contributor(s) that
require such Contributor(s) to notify the Charity in advance of
submission of any abstract, presentation or manuscript
incorporating Clinical Trial Results that the Contributor(s) wish
to publish or have published or to present or have
presented.





 




5.7

Upon receipt of
such notification from a Contributor or if the Charity wishes
itself to publish or have published or to present or have presented
an abstract, presentation or manuscript incorporating Clinical
Trial Results the Charity shall so notify the Company and CRT and
provide (in so far as it is able to do so in the case of a
Contributor’s notification) in response to the
Company’s and/or CRT’s reasonable request a copy or
summary thereof at least seven (7) days prior to submission for
publication of an abstract or presentation or at least thirty (30)
days prior to submission for publication of a manuscript (or twenty
one (21) days prior to submission for publication of a manuscript
in the case of a Contributor’s notification). Any such copy
or summary shall provide sufficient details to enable the
Company and CRT to ascertain whether it contains Confidential
Information of the Company or CRT respectively or whether Patent
Rights or other proprietary protection should be
sought.





 




5.8

The Company and CRT
shall review and make any comments on such intended publication or
presentation of an abstract to the Charity within seven (7) days
and/or shall review and make any comments on such intended
publication or presentation of a manuscript within thirty (30)
days. The Company and/or CRT may request that:





 




5.8.1

Confidential
Information of the Company (not including Clinical Trial Results
nor information directly relating to the Investigational Medicinal
Product) or Confidential Information of CRT (not including Clinical
Trial Results) be removed from the proposed publication or
presentation; and/or





 




5.8.2

any such
publication or presentation be delayed if in the Company’s or
CRT’s reasonable opinion it is necessary to delay publication
or presentation in order to file a patent application or
application for other proprietary protection in respect of any
invention made in the course of the Clinical Trial. Any such delay
will be kept to the minimum period practicable and will in no event
extend beyond thirty (30) days from the date the proposed
publication or presentation was provided to the
Company.





 


In the
event of a request pursuant to Clauses 5.8.1 or 5.8.2, the Company
or CRT (as the case may be) shall provide the Charity with a
written explanation of the reasons why it believes information
should be removed or a delay is necessary. For the avoidance of
doubt, any Patent Rights filed pursuant to Clause 5.8.2 shall be
filed in CRT’s name unless any Company personnel are deemed
inventors on any such filing, in which case such Patent Right shall
be filed in both CRT’s and Company’s names. As used
herein, inventorship shall be determined in accordance with English
law.


 




5.9

The Charity and CRT
shall be entitled to publish information in relation to the
proposed Clinical Trial, including that it is or will be a trial
conducted by the Clinical Development Partnerships initiative set
up by the Charity and CRT, the pre-requisites for patient
recruitment, a brief description of the Clinical Trial, including
the name of the Company, the reference number and class of the
Investigational Medicinal Product and the location(s) at which the
trial is taking place.





 




5.10

In addition to the
disclosures under Clause 5.5, the Company may disclose the
commercial terms of this Agreement to any actual or potential
investors, bankers, acquirers, acquirees or merger partners, in
each case under appropriate confidentiality provisions
substantially equivalent to those of this Agreement.







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




5.11

Except as expressly
permitted in Clause 5, the Company shall not disclose the Clinical
Trial Results to any potential investors, licensees or
sub-licensees of the Company (or any other person) until the
Company has been granted the Licence.





 




6.

INTELLECTUAL
PROPERTY RIGHTS





 




6.1

The Company hereby
grants to the Charity with a right to sub licence to
Contributors:





 




6.1.1

the [***] of the
Investigational Medicinal Product;





 




6.1.2

the [***] relating
to the Investigational Medicinal Product;





 




6.1.3

an [***] under the
Company Intellectual Property; and





 




6.1.4

a [***] under the
XOMA IP,





 


   
           on a [***] basis
for the purpose of preparing for and carrying out (and having
prepared or carried out for the Charity) the Clinical Trial. The
Company shall not be entitled to (and shall (i) procure that its
Affiliates do not, and (ii) not authorise any other third party to)
conduct any clinical trials in respect of the Antibody or any
Back-Up Antibody during the term of this Agreement.

 




6.2

The Company shall
use commercially reasonable endeavours to continue to prosecute and
maintain, at its own cost, all of the Company Patent Rights. If the
Company intends to substantially narrow the scope of the claims of
any Patent Rights within the Company Patent Rights it will first
consult with CRT and take into good faith consideration any
concerns or views expressed by CRT. If the Company elects not to
prosecute or maintain any part of the Company Patent Rights, the
Company shall notify CRT in writing within a reasonable period and
no less than [***] prior to the expiration of any applicable time
bars. After receipt of such notice, CRT may elect, before the
expiry of any such time bars, by written notice to the Company, to
take an assignment to any Company Patent Rights identified in such
notice at CRT’s sole discretion and for consideration not
exceeding [***]. In the event that CRT elects to take such an
assignment, the Company shall, at CRT’s expense, promptly
transfer to CRT (or any person nominated by CRT) copies of any and
all documents in the Company’s Control relating to the
filing, prosecution, maintenance, enforcement and defence of such
Company Patent Rights. The Company shall not assign, charge,
encumber or dispose of any interest in any of the Company
Intellectual Property to a Tobacco Party or in a manner that limits
or impairs the Charity’s or CRT’s rights under the
licence (or assignment, where applicable) of Company Intellectual
Property pursuant to this Agreement without the Charity’s or
CRT’s prior written consent.





 




6.3

As between the
Company and the Charity, [***]. The Charity hereby [***]. CRT
hereby [***].





 




6.4

Subject to [***],
the Company shall [***].







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




6.5

Solely in
connection with the Charity’s and the Contributors’
activities performed pursuant to the Clinical Trial, where carried
out in accordance with the terms of this Agreement, the Company
shall not, and shall procure that its Affiliates shall not,
anywhere in the world, institute or prosecute (or, other than as
required by law, in any way aid any third party in instituting or
prosecuting) any claim, demand, action or cause of action for
damages, costs, expenses or compensation, or for an enjoinment,
injunction, or any other equitable remedy, alleging the
infringement by the Charity and/or any Contributors of any Patent
Rights of the Company and/or any Patent Rights of the
Company’s Affiliates. For the avoidance of doubt, the
foregoing shall not apply in respect of: (i) development, at any
time, of products other than the IMP; or (ii) any activity in
relation to the IMP which constitutes a breach of the terms of this
Agreement.





 




6.6

Any breach of
Clause 6.5 shall be a material breach and shall accordingly entitle
the Charity to terminate this Agreement under Clause
11.2.





 




6.7

CRT hereby reserves
and excludes from the Option, the worldwide, perpetual and
irrevocable right in and to the Exclusive Results for the
Contributors and the Charity (including scientists funded and/or
employed by the Charity) to:





 




6.7.1

use the Exclusive
Results for the purpose of non-commercial scientific research
carried out by or for or under their respective direction in
accordance with their respective charitable and/or academic status,
whether alone or in collaboration with a third party or third
parties; and





 




6.7.2

grant licences
under, and make available, the Exclusive Results solely to the
extent necessary to exercise the rights under Clause 6.7.1, but not
otherwise.





 




6.8

For the avoidance
of doubt, CRT shall be entitled, at its discretion, at any time
(including during the Option Period) to grant non-exclusive
licences to the Non-Exclusive Results to any person and for any
purpose.





 




6.9

Neither Charity nor
CRT, or any affiliate or agent of Charity or CRT, shall institute
any type of proceeding in a court, governmental agency, or patent
office anywhere throughout the world for the purposes of
invalidating, narrowing, or reducing the term of one or more claim
in an issued patent or pending patent application. The institution
of any such proceeding during the term of this agreement and
afterwards during the term of Company’s Patent Rights shall
be a material breach and shall accordingly entitle the Company to
terminate this Agreement under Clause 11.2.





 

 




7.

OPTION





 




7.1

CRT grants to the
Company the option, exercisable by notice to CRT in writing (the
“Exercise
Notice”) at any time during the [***] period after the
Company receives the Final Report (the “Option Period”), to enter into the
Licence (the “Option”). Subject to Clause 6.7,
the Option shall be [***]









7.2

Upon exercise of
the Option, the Company shall pay the Option Fee to CRT within the
Option Period.





 




7.3

Save where the
Charity has provided a Full Clinical Study Report, CRT shall
procure the provision of the Data Listings to the Company following
the exercise of the Option and the receipt by CRT of the Option
Fee.





 




7.4

If the Company
exercises the Option, CRT and the Company shall execute the Licence
within the Signature Period.





 




7.5

If:





 




7.5.1

the Company does
not exercise the Option within the Option Period; or







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




7.5.2

following the
exercise of the Option, the Company does not enter into the Licence
within the Signature Period, then the Company
shall, within [***] of the expiry of the Option Period or Signature
Period (as applicable):





 




a)

assign the Company
Intellectual Property and sub-license the XOMA IP to CRT by
executing an agreement in the form attached at Schedule 5, and CRT
shall be free to license or otherwise grant rights in respect of
the Clinical Trial Results and the Intellectual Property Rights in
the Clinical Trial Results on such terms and to such third parties
as it shall see fit; and





 




b)

provide CRT with
such assistance as CRT may reasonably request in liaising with XOMA
for the purpose of obtaining direct contractual rights with XOMA in
respect of the XOMA IP.





 

 




8.

WARRANTIES
AND LIMITS OF LIABILITY





 




8.1

The Charity
warrants that:





 




8.1.1

it will procure the
discharge of its obligations hereunder with reasonable care and
skill; and





 




8.1.2

it will use its
reasonable endeavours to procure that each Contributor that carries
out part of the Clinical Trial ensures that the relevant Chief
Investigator and/or the Principal Investigator discharge their
obligations in respect of that part of the Clinical Trial in
accordance with applicable ICH GCP provisions.





 




8.2

The Company
warrants and represents that:





 




8.2.1

it is entitled to
make the Company Materials available to the Charity for the
purposes of this Agreement;





 




8.2.2

to the best of its
knowledge and belief the use and possession of the Company
Materials and/or the Antibody by the Charity and/or the
Contributors shall not infringe the rights (including without
limitation any Intellectual Property Rights) of any third
party;





 




8.2.3

the Company
Materials have been manufactured, handled and stored at all times
in compliance with relevant legislation and, in the case of
relevant Company Materials (including the Company Materials
identified in Part 2 of Schedule 7), in accordance with Good
Manufacturing Practice;





 




8.2.4

it is a party to
the XOMA Licence, which is in full force and effect;





 




8.2.5

it has, and will
maintain throughout the Term, the full right, power and authority,
and has obtained all assignments, approvals or consents necessary
to grant the rights, including under the Transfer Documents and the
XOMA Licence, as provided under this Agreement;





 




8.2.6

the XOMA Licence is
the only third party licence held by the Company in respect of the
manufacture, possession and use of the Antibody, IMP and the rights
granted to the Charity under this Agreement;





 




8.2.7

the XOMA Licence
set out in Schedule 9 is a true and correct copy of the XOMA
Licence;





 




8.2.8

to the best of its
knowledge and belief, there are no outstanding breaches of the XOMA
Licence by any party (or any predecessor parties) to the XOMA
Licence;







 







 





 




8.2.9

to the best of its
knowledge and belief there are no acts, facts, circumstances or
omissions at the Commencement Date which would give XOMA the right
to terminate the XOMA Licence, either now or at a later
date;





 




8.2.10

it shall maintain,
and shall not amend or terminate the XOMA Licence without
CRT’s prior written consent; and





 




8.2.11

it shall notify the
Charity and CRT as soon as possible if it becomes aware of any
facts, circumstances or omissions which may give XOMA the right to
terminate the XOMA Licence.





 


References to the
“best of its knowledge and belief” in Clause 8.2 shall
include any knowledge within the Company or its Affiliates, and,
where relevant, of any predecessor party to the XOMA Licence,
having made due and proper enquiries.

 




8.3

The Company
warrants and represents that all information and Know-How supplied
to the Charity and/or CRT pursuant to this Agreement (including any
safety information) shall be accurate and complete and shall be
supplied as soon as practicable following the Commencement Date to
enable the Charity to conduct and manage the Clinical Trial in a
safe and proper manner.





 




8.4

Nothing in this
Agreement shall exclude or limit the liability of any Party for
death or personal injury resulting from its negligence or the
negligence of its employees while acting in the course of their
employment or shall exclude or limit the liability of any Party for
fraud.





 




8.5

Subject to Clause
8.4, the entire aggregate liability, for any loss or damage arising
from any act or omission relating to this Agreement regardless of
the form of action, whether in contract or tort (including in each
case negligence), strict liability or otherwise:





 




8.5.1

 of the Charity and
CRT to the Company shall be limited to £1,000,000 (one
million Pounds Sterling) in aggregate; 





 




8.5.2

 of the Company to
CRT and the Charity shall be limited to US $7,500,000 (7.5
million US dollars) in aggregate. The Escrow Amount is not,
and shall not be deemed to operate in any manner as, a cap or limit
on the Company’s liability to the other Parties. 





 




8.6

To the fullest
extent permissible by law, no Party shall under any circumstances
be liable to any other for any loss of revenue, business,
contracts, anticipated savings, profits, data or information, or
any indirect or consequential loss howsoever arising whether from
negligence, breach of contract or otherwise.





 




8.7

Save to the extent
otherwise provided in this Agreement, each Party specifically
excludes to the extent permitted by law all warranties,
representations, and conditions regarding the performance of its
obligations under this Agreement including those implied by law,
whether as to suitability, quality or fitness for any purpose or
otherwise.





 

 




9.

INDEMNITIES





 




9.1

 Subject to Clause
8.5, the Charity shall indemnify and hold the Company its officers,
and employees (the “Company
Indemnitees”) harmless from and against

all
Losses arising from any claims and proceedings made or brought
(whether successfully or otherwise) on behalf of Clinical Trial
Subjects for personal injury (including death), arising out of the
conduct of the Clinical Trial, save where such claims, proceedings
and/or Losses arise as a consequence of (i) any wrongful act or
omission and/or negligence of any of the Company Indemnitees; (ii)
a breach of this Agreement by the Company; or (iii) a
misrepresentation by the Company.
 







 







 





 




9.2

 Notwithstanding the
provisions of Clause 9.1 above and any other restrictions on
liability contained in this Agreement, but subject to Clause 8.5
above, the Company shall indemnify and hold the Charity, CRT, the
Contributors, the Experts and their respective officers, employees
and agents (the “Charity
Indemnitees”) harmless from and against
all Losses arising
from any claims and proceedings made or brought (whether successful
or otherwise): 





 




9.2.1

 on behalf of
Clinical Trial Subjects for personal injury (including death),
arising out of: (i) any failure or delay on the part of the Company
to provide relevant or accurate Company Know­How and other
information relating to the storage, use and safety of any of the
Company Materials. and/or (ii) any wrongful act or omission and/or
negligence of the Company (or any third party engaged by the
Company) in the supply and/or manufacture of any of the Company
Materials; and 





 




9.2.2

  alleging
infringement of a third party’s Patent Rights or other
Intellectual Property Rights resulting from use of Company
Intellectual Property or Company Materials in the course of or in
consequence of the performance of the Clinical Trial or by
importation, storage, supply or use of any of the Company Materials
and/or Antibody as permitted by this Agreement. provided always
that; 





 




9.2.3

it is a condition
of the indemnity that the Charity and CRT hand over or procure the
hand over (as the case may be) of control of the matter to the
Company, and give or procure (as the case may be) such information
and assistance as the Company may reasonably request in connection
with the matter, and allow or procure, (as the case may be) that
the Company has exclusive conduct of the matter and any ensuing
legal proceedings.





 




9.3

The indemnities set
out in Clauses 9.1 and 9.2 shall survive the expiration or
termination of this Agreement for whatever reason. Each
Party’s agreement to indemnify, defend, and hold the other
Party and its respective indemnitees harmless is conditioned upon
the indemnified Party: (a) providing written notice to the
indemnifying Party of any claim or proceeding arising out of the
indemnified activities within thirty (30) days after the
indemnified Party has knowledge of such claim or proceeding; (b)
permitting the indemnifying Party to assume full responsibility and
authority to investigate, prepare for, and defend against any such
claim or proceeding; and (c) assisting the indemnifying Party, at
the indemnifying Party's reasonable expense, in the investigation
of, preparation for and defence of any such claim or proceeding. If
the indemnifying Party assumes the defence of a third party claim,
the indemnifying Party will not be subject to any liability for any
settlement of such claim made by the indemnified Party without the
indemnifying Party’s consent (which consent may not be
unreasonably withheld, delayed or conditioned).





 




9.4

The Charity shall
ensure that all Clinical Trial Subjects receive the benefit of a
no-fault compensation scheme substantially in the form attached at
Schedule 4 hereto. Subject to the indemnity in Clause 9.2, the
Charity shall bear all costs associated with the provision of such
compensation scheme including in relation to all claims received
pursuant to such scheme.





 




9.5

The Company shall
carry insurance coverage on an "occurrence" or "claims made" basis
for potential liabilities which the Company may have under this
Agreement, and ensure that the Charity and CRT are each named
additional insureds on each such policy and may claim directly
under them. The Company shall maintain such insurance in full force
throughout the term of the Agreement (and in the case of insurance
coverage on a "claims made" basis, for a further two years after
the term of the Agreement) and shall upon request of the Charity
provide such evidence of compliance as the Charity deems
sufficient. The initial insurance policy of the Company which
satisfied the condition under Clause 2.1.3 is agreed to provide the
minimum coverage required for the policy to be carried by the
Company under this Clause 9.5. The Company’s obligations, and
the Charity’s and CRT’s rights, under this Clause 9.5
shall apply in addition to, and not instead of, the obligations of
the Company, and rights of the Charity and CRT, under the Escrow
Agreement. Neither the existence of the Escrow Agreement nor any of
its contents shall limit the obligations imposed or rights granted
under this Clause 9.5.





 



 







 





 




10.

ASSIGNMENT





 




10.1

No Party shall
assign its rights under this Agreement or any part thereof.
provided that the Company may assign its rights and obligations to
a third party in connection with any merger or consolidation of the
Company with another business entity, or in connection with the
sale of all or a substantial part of its business and related
assets that includes its business in relation to the Licensed
Product (including, among other things, all XOMA IP and
Intellectual Property licensed under this Agreement), other than a
merger or consolidation with or a sale of assets to a Tobacco Party
and provided that the Company obtains a direct covenant from the
acquiring party to CRT and the Charity undertaking to be bound by
the terms of this Agreement. Save as set out in this Agreement, no
Party shall sub-contract the performance of all or any of its
obligations under this Agreement without the prior written consent
of the other Parties.





 

 




11.

TERM
AND TERMINATION





 




11.1

Unless terminated
earlier pursuant to the provisions hereunder, and except as
otherwise provided hereunder, this Agreement shall remain in full
force and effect from the Commencement Date until the earlier of
the date that:





 




11.1.1

the Agreement
expires pursuant to Clause 2.2 due to a failure to satisfy the
Conditions Precedent before the Long Stop Date;





 




11.1.2

the Company enters
into the Licence pursuant to Clause 7.4; or





 




11.1.3

the Company assigns
the Company Intellectual Property and sub-licenses the XOMA IP to
CRT pursuant to Clause 7.5.





 




11.2

Any of the Parties
hereto may at any time terminate this Agreement, but shall not be
obliged to do so, upon written notice to the other Party (being the
Charity and CRT where the terminating Party is the Company, or the
Company where the terminating Party is the Charity or CRT) under
the following circumstances:





 




11.2.1

in the event that
the other Party commits a material breach of this Agreement and
does not fully remedy, if capable of remedy, the same within sixty
(60) days of its receipt of written notice of the breach from any
other Party; or





 




11.2.2

in the event, in
respect of a Party: that respective Party proposes a voluntary
arrangement for that respective Party or a voluntary arrangement is
approved for that respective Party; or an administration order is
made as to such Party; or a receiver or administrative receiver is
appointed of any of such Party’s assets; or undertakings or a
winding-up resolution or petition is passed as to such Party
(otherwise than for the purpose of solvent reconstruction or
amalgamation); or if any circumstances arise which entitle a court
or a creditor to appoint a receiver, administrative receiver or
administrator or make a winding-up order or similar; or equivalent
action is taken against or by such Party by reason of its
insolvency. A Party shall notify the other Parties immediately upon
becoming aware that any of the events identified in this Clause
11.2.2 has or is likely to take place in relation to
it.





 




11.3

The Charity shall
have the right to terminate this Agreement forthwith, upon written
notice to the Company:







 







 





 




11.3.1

if the Charity has
an insufficient quantity of IMP of the standard required to perform
the activities envisaged under this Agreement (whether due to a
breach by the Company of Clause 8.2 or otherwise);





 




11.3.2

in accordance with
Clause 3.6; or





 




11.3.3

if the Charity
considers in its sole discretion that it would be unethical or
otherwise undesirable for any reason to proceed or continue with
the Clinical Trial.





 




11.4

The Charity shall
have the right to terminate this Agreement forthwith, upon written
notice to the Company if, by way of merger, acquisition or
otherwise, the Company becomes a Tobacco Party.





 




11.5

The Parties may by
mutual written agreement terminate this Agreement for any reason,
including, if in their opinion the objectives of the Clinical Trial
cannot be achieved.





 

 




12.

CONSEQUENCES
OF TERMINATION





 




12.1

In the event of
termination of this Agreement by the Company:





 




12.1.1

without prejudice
to Clause 12.1.4, the Company shall have no obligation to enter
into the Option or any other licence with CRT or the Charity, or to
licence or assign its Intellectual Property Rights to
CRT;





 




12.1.2

subject to Clause
12.1.4 and 12.6, the Charity shall, within ninety (90) days after
written request of the Company, return to the Company or destroy
(by a method specified by the Company) and at the Company’s
cost and expense any remaining quantities of the Company Materials
and/or Confidential Information of the Company in the
Charity’s possession or control;





 




12.1.3

where the Charity
has commenced the Clinical Trial, the Charity shall within thirty
(30) days of finalisation of the last Case Report Form submit to
the Company copies of all completed Case Report Forms and Data
Listings for the Clinical Trial. The Charity shall be entitled to
retain the original Case Report Forms for its own records;
and





 




12.1.4

where the Charity
has commenced the Clinical Trial, the Charity shall nonetheless be
entitled to make (or have made) the Investigational Medicinal
Product and continue to provide it to: (i) any particular Clinical
Trial Subject who has commenced treatment; and/or (ii) any Clinical
Trial Subject where the Regulatory Authority and/or Ethics
Committee request or require that such provision
occurs.





 




12.2

In the event of any
termination of this Agreement pursuant to Clause 11.2 or 11.4 by
CRT or the Charity:





 




12.2.1

the Option shall
lapse forthwith;





 




12.2.2

the Company shall
within thirty (30) days of the date of such termination reimburse
the Charity all Costs;





 




12.2.3

the Parties shall
within thirty (30) days of the date of such termination execute the
agreement set out in Schedule 5; and





 




12.2.4

the Charity shall
be entitled to (as applicable) commence and complete the Clinical
Trial and the Company shall provide the Charity with the necessary
assistance to allow the Charity to do so. For the avoidance of
doubt, the licence granted by the Company under Clause 6.1 shall
continue to the extent necessary to allow the Charity to commence
and complete the Clinical Trial, provided that upon completion or
termination of the Clinical Trial the Charity shall, within thirty
(30) days written notice by the Company return to the Company or
destroy (by a method specified by the Company) and at the
Company’s cost and expense any remaining quantities of the
Company Materials and/or Confidential Information of the Company in
the Charity’s possession or control.







 







 





 




12.3

In the event of
termination of this Agreement pursuant to Clause 11.3 by the
Charity or pursuant to Clause 11.5:





 




12.3.1

subject to Clause
12.3.2 and 12.6, the Charity shall, within thirty (30) days written
request by the Company, return to the Company or destroy (by a
method specified by the Company) and at the Company’s cost
and expense any remaining quantities of the Company Materials
and/or Confidential Information of the Company in the
Charity’s possession or control;





 




12.3.2

where the Charity
has commenced the Clinical Trial, the Company shall nonetheless
continue to permit the Charity to continue to provide such
Investigational Medicinal Product to: (i) any particular Clinical
Trial Subject who has commenced treatment; and/or (ii) any Clinical
Trial Subject where the Regulatory Authority and/or Ethics
Committee request or require that such provision occurs;
and





 




12.3.3

where the Charity
and CRT consider it appropriate to do so in light of the reason for
termination, for a period of thirty (30) days from the date of
termination (or such longer period as CRT may notify) CRT shall
offer the Company the option, exercisable by written notice to CRT,
to enter into the Licence in respect of those Clinical Trial
Results in existence at the date of termination and subject to
agreement between CRT and the Company on amended financial and
other terms for the Licence to reflect that the Clinical Trial was
not completed. If the Parties are not able to agree amended
financial terms within thirty (30) days of the date CRT receives
the Company’s exercise notice, the Parties at their joint
cost and expense shall obtain an Independent Opinion on a fair and
reasonable reduction to the financial terms which will be binding
on both Parties.





 




12.4

Termination of this
Agreement for whatever reason shall not affect the accrued rights
of the Parties arising out of this Agreement as at the date of its
termination.





 




12.5

The provisions of
the following Clauses shall survive the expiration or termination
of this Agreement: 5 (Confidentiality/Publication), 6.3 (Assignment
of Clinical Trial Results to CRT), 6.5 (Covenant not to sue), 6.9
(invalidation of Company’s IP rights), 8.4 to 8.6 inclusive
(Limits or exclusion of liability), 8.7 (Exclusion of other
warranties), 9 (Indemnities), 10 (Assignment), 12 (Consequences of
termination), 13 to 23 inclusive (Dispute Resolution to Third Party
Rights inclusive).





 




12.6

The Charity shall
retain copies of the Company’s Confidential Information and
the Clinical Trial Results in accordance with ICH GCP and as
otherwise required under the Charity’s obligations as Sponsor
of the Clinical Trial.





 

 




13.

DISPUTE
RESOLUTION





 




13.1

Insofar as this
Agreement provides that a matter shall be resolved by Independent
Opinion, the opinion of the appointed independent expert (who shall
act as an expert and not as an arbitrator) shall be final and
binding on the Parties. In the event of a Party seeking an
Independent Opinion under this Agreement, each Party shall make
written submissions to the expert and to the other Parties within
fourteen (14) days of the appointment. Each Party shall have seven
(7) days to respond to the others’ submissions. The expert
shall be requested to deliver his Independent Opinion within a
further thirty (30) days. The costs of any Independent Opinion
shall be borne in such proportions as the expert may determine in
his Independent Opinion to be fair and reasonable in all the
circumstances or, if no such determination is made in the
Independent Opinion, by the Parties in equal
proportions.







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




13.2

It shall be a
condition precedent to the commencement of any action in court or
other tribunal (save an action for an interim injunction or an
Independent Opinion sought under Clause 13.1) in respect of any
dispute relating to this Agreement that the Parties have sought to
resolve the dispute by one Party notifying the others in writing
for resolution to the Chief Executive Officer of CRT, the Director
of Drug Development of the Charity and the CEO of the Company (or
their express delegates) (the “Representatives”) who shall meet
(whether in person or via teleconference) within twenty one (21)
days of such notice to seek resolution in good faith. If the
Representatives are unable to resolve the dispute at such meeting,
any Party may pursue any remedy available to such Party at law or
in equity, subject to the terms and conditions of this Agreement
and the other agreements expressly contemplated
hereunder.





 




13.3

This Agreement
shall be governed by and construed in accordance with English Law
and, subject to the provisions of Clause 13.1 and 13.2, each Party
agrees to submit to the exclusive jurisdiction of the English
Courts (except in respect of disputes under Clause 5 where
jurisdiction is non-exclusive).





 

 




14.

NOTICES





 




14.1

Any notice or other
document to be given under this Agreement shall be in writing and
shall be deemed to have been given:





 




14.1.1

upon delivery if
given in person; or





 




14.1.2

upon confirmation
of receipt if sent by facsimile or email; or





 




14.1.3

 (if posted to
an inland destination) three (3) business days after deposit into
First Class post; or





 




14.1.4

(If posted to an
overseas destination) five (5) days after deposit into airmail
post; or





 




14.1.5

upon delivery by
air delivery service;





 


to a
Party at the address set out below (or, if provided below or so
notified, such facsimile or electronic communication) for such
Party or such other address as the Party may from time to time
designate by written notice to the other Parties.

 



Address of the Company

 


Monopar
Therapeutics LLC

 


598
Rockefeller Road

 


Lake
Forest, IL USA 60045

 


Contact: Chief
Executive Officer

 


Email:
[***]

 


 

 



Address of the Charity

 


Cancer
Research UK

 


Angel
Building

 


407 St.
John Street

 


London
EC1V 4AD

 


England

 


Contact: Director
of Drug Development

 


Fax:
+44 (0) 20 7121 6700

 



 







 






 

 


With a
copy to:

 


Cancer
Research UK

 


Angel
Building

 


407 St.
John Street

 


London
EC1V 4AD

 


England

 


Contact: Caroline
Foxton

 


Fax:
+44 (0) 20 7121 6700

 


 

 



Address of CRT

 


Cancer
Research Technology Limited

 


Angel
Building

 


407 St.
John Street

 


London

 


EC1V
4AD

 


United
Kingdom

 


Contact: Chief
Executive Officer

 


Fax:
+44 (0) 20 3014 8633

 

 




15.

WAIVER





 




15.1

No failure or delay
on the part of any Party hereto to exercise any right or remedy
under this Agreement shall be construed as or operate as a waiver
thereof nor shall any single or partial exercise of any right or
remedy under this Agreement preclude the exercise of any other
right or remedy or preclude the further exercise of such right or
remedy as the case may be.





 

 




16.

FORCE
MAJEURE





 




16.1

No Party shall be
liable to any other Party or shall be in default of its obligations
hereunder if such default is the result of any cause beyond the
reasonable control of the Party affected including war,
hostilities, revolution, civil commotion, strike, epidemic,
accident, fire, wind, flood or because of any act of God . The
Party affected by such circumstances shall promptly notify the
other Parties in writing when such circumstances cause a delay or
failure in performance (a “Delay”) and where they cease to do
so. In the event of a Delay lasting for twenty six (26) weeks or
more either of the non-affected Parties shall have the right to
terminate this Agreement immediately by notice in writing to the
affected Party.





 

 




17.

INSOLVENCY





 




17.1

All rights and
licenses granted under or pursuant to this Agreement by the Company
to CRT and the Charity are for all purposes of Section 365(n) of
Title 11 of the U.S. Bankruptcy Code (“Title 11”), licenses of rights to
“intellectual property” as defined in Section 101 of
Title 11.







 







 





 




17.2

The Company agrees
that CRT and the Charity shall retain and may fully exercise all of
its rights and elections under the U.S. Bankruptcy Code. If a case
under Title 11 is commenced by or against the Company, CRT and the
Charity shall have all rights of licensees set out in Section
365(n) of Title 11.





 




17.3

Without limiting
CRT’s and the Charity’s rights under Section 365(n) of
Title 11, if a case under Title 11 is commenced by or against the
Company, and this Agreement is rejected by the Company in any
bankruptcy proceeding by or against the Company under the U.S.
Bankruptcy Code, (i) the Company shall provide CRT and the Charity
with a complete duplicate of (and complete access to, as
appropriate) any IP and embodiments of IP not already in their
possession; and (ii) the Company shall not interfere with
CRT’s and the Charity’s rights to IP and embodiments of
IP, and shall facilitate and assist with CRT and the Charity
obtaining IP and embodiments of IP (including from a third
party).





 




17.4

The term
“embodiments” of IP includes all tangible, intangible,
electronic or other embodiments of rights and licenses, including
antibodies, compounds and products embodying IP and related rights
and technology. All rights of CRT and the Charity under this Clause
and under Section 365(n) of Title 11 are in addition to, not in
substitution of, any other rights and remedies that they may have
under this Agreement, Title 11 and any other applicable
law.





 

 




18.

SEVERABILITY





 




18.1

If and to the
extent that any court or tribunal of competent jurisdiction holds
any of the terms, provisions or conditions or parts thereof of this
Agreement, or the application hereof to any circumstances, to be
invalid or to be unenforceable in a final non-appealable order, the
remainder of this Agreement and the application of such term,
provision or condition or part thereof to circumstances other than
those as to which it is held invalid or unenforceable shall not be
affected thereby, and each of the other terms, provisions and
conditions of this Agreement shall be valid and enforceable to the
fullest extent permissible by law.





 

 




19.

ENTIRE
AGREEMENT





 




19.1

This Agreement
embodies and sets forth the entire agreement and understanding of
the Parties and supersedes all prior oral or written agreements,
understandings or arrangements relating to the subject matter of
this Agreement. No Party shall be entitled to rely on any
agreement, understanding or arrangement which is not expressly set
forth in this Agreement unless otherwise agreed between the Parties
and recorded in writing. In the event of any inconsistency between
this Agreement and the Protocol, the terms of this Agreement shall
govern.





 

 




20.

AMENDMENT





 




20.1

This Agreement
shall not be amended, modified, varied or supplemented except in
writing signed by duly authorised representatives of the
Parties.





 




20.2

The Charity shall
at all times be free to amend, modify, vary or supplement any of
its own Standard Operating Procedures.





 

 




21.

PUBLIC
ANNOUNCEMENTS





 




21.1

The text of any
press release, shareholders’ report or other communication to
be published or
disclosed in any way by or on behalf of the Company by or in the
media concerning the Charity, the Contributors or the Experts, the
subject matter of this Agreement or concerning this Agreement
itself, other than as required by law or by any regulatory or
government authority, shall be submitted to the Charity and CRT at
least seven (7) days in advance of publication or disclosure for
approval, such approval not to be unreasonably withheld; provided
that insofar as a disclosure repeats or restates a prior public
disclosure permitted by this Agreement, such disclosure need not be
submitted to the Charity or CRT for approval.







 







 





 

 




22.

PAYMENTS





 




22.1

All payments due to
CRT and the Charity under this Agreement shall be made in cleared
funds in pounds sterling to the bank accounts nominated by CRT and
the Charity respectively from time to time. All costs of
transmission shall be borne by the Company.





 




22.2

All payments under
this Agreement are expressed to be exclusive of value added tax
howsoever arising, which the Company shall pay in addition to those
payments.





 




22.3

Save as expressly
set out in Clause 7.2, all amounts due under this Agreement shall
be paid in full without any deduction or withholding other than as
required by law and the Company shall not be entitled to assert any
credit, set-off or counterclaim against CRT or the Charity in order
to justify withholding payment of any such amount in whole or in
part.





 




22.4

Where a Party does
not receive payment of any sums due to it by the due date, interest
shall accrue both before and after any judgement on the sum due and
owing to such Party at the rate equivalent to an annual rate of two
percent (2%) over the then current base rate of Natwest Bank,
calculated on a daily basis, until the full amount is paid, without
prejudice to such Party’s right to receive payment on the due
date.





 

 




23.

DATA
PROTECTION





 




23.1

The Parties’
attention is drawn to the Data Protection Act 1998, Directive
95/46/EC of the European Parliament and any national or European
legislation and/or regulations implementing them or made in
pursuance of them (all referred to together as the
“Data Protection
Requirements”).





 




23.2

Each Party warrants
that it will observe all its obligations under the Data Protection
Requirements which arise in connection with the performance of this
Agreement and in particular that it will process and use any
personal data fairly and lawfully.





 

 




24.

THIRD
PARTY RIGHTS





 




24.1

Save for the third
parties identified in Clauses 5.5 (Contributors’ right to
publish), 6.5 (Covenant not to sue), 9.1 and 9.2 (Indemnities) and
9.3 (No fault compensation scheme), who shall have the benefit of
those respective Clauses, this Agreement shall not create any
rights that shall be enforceable by anyone other than the Parties
to this Agreement. The rights created in Clauses 5.5, 6.5, 9.1, 9.2
and 9.3 may be altered or extinguished by the Parties without
consent of any third party beneficiary of such rights.





 

 




25.

EXECUTION





 




25.1

This Agreement may
be executed in any one or more number of counterpart agreements,
and as scanned email attachments, and all signatures and
counterparts so exchanged shall be considered as original and shall
be deemed to form part of and together constitute this
Agreement.





 


 


 




 








 






 



IN WITNESS whereof this Agreement has been executed by duly
authorised officers of the Parties on the day first above
written.


 


	

Signed
by:

	

/s/ PJ
L’Hullier

	
 


	

Name:

	

PJ
L’Hullier

	
 


	

Title:

	

Director,
Business Management

	
 


	
 

	
 

	
 


	
 

	

For and
on behalf of

	
 


	
 

	


CANCER RESEARCH TECHNOLOGY LIMITED

	
 


	
 

	
 

	
 


	

Signed
by:

	

/s/ Dr.
Nigel Blackburn

	
 


	

Name:

	

Dr.
Nigel Blackburn

	
 


	

Title:

	

Director
of Drug Development CRUK Centre for Drug Development

	
 


	
 

	
 

	
 


	
 

	

For and
on behalf of

	
 


	
 

	


CANCER RESEARCH UK

	
 


	
 

	
 

	
 


	

Signed
by:

	

/s/
Chandler Robinson

	
 


	

Name:

	

Chandler
Robinson

	
 


	

Title:

	

CEO and
Manager

	
 


	
 

	
 

	
 


	
 

	

For and
on behalf of

	
 


	
 

	


MONOPAR THERAPEUTICS LLC

	
 







 




 








 














 


 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 



Schedule 1



Company Patent Rights


(details
of company patent rights to be inserted here)


 


 


B&
N Ref    Country   
Status    Comments    Applicaiton
#    Filing Date    Patent
#    Grant Date


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


 




 


 




 








 






 


Schedule
2


Report
Synopsis


 


	

Name of
Sponsor/Company:

 


 

 


 

	

Individual Study
Table


Referring to
Part


of the
Dossier

 


 

 


Volume:

 


 

 


Page:


 


	

Name of
Finished Product:

 


 

 


 


	

Name of
Active Ingredient:

 


 

 


 


	

Title
of Study:

 


 

 


 


	

Investigators:

 


 

 


 


	

Study
Centre(s):

 


 

 


 


	

Publication
(reference):

 


 

 


 


	

Studied
period (years):


(date
of first enrolment)


(date
of last completed)


 

	

Phase
of development:


 


	

Objectives:

 


 

 


 


	

Methodology:

 


 

 


 


	

Number
of Patients (planned and analysed):

 


 

 


 


	

Diagnosis
and main criteria for inclusion:

 


 

 


 


	

Test
product, dose and mode of administration, batch
number:

 


 

 


 


	

Duration
of treatment:

 


 

 


 


	

Reference
therapy, dose and mode of administration, batch
number:

 


 

 


 







 




 








 






 


	

Name of
Sponsor/Company:

 


 

 


 

	

Individual Study
Table


Referring to
Part


of the
Dossier

 


 

 


Volume:

 


 

 


Page:


 


	

Name of
Finished Product:

 


 

 


 


	

Name of
Active Ingredient:

 


 

 


 


	

Criteria
for evaluation:


 



Efficacy:


 



[Drafting Note: The sub-heading of “Efficacy” can be
adapted to “Pharmacokinetics”,
“Pharmacodynamics”, “Immunogenicity”,
“Pharmacogenomics” etc, as dictated by the study
objectives. If there is more than one major area of evaluation,
further top-level headings can be added here.]

 


 

 



Safety:


 



[Drafting Note: The sub-heading of “Safety” must always
be included.]

 


 

 


 


	

Statistical
methods:

 


 

 


 


	

SUMMARY
– CONCLUSIONS


 



EFFICACY RESULTS:


 



[Drafting Note: The sub-heading of “Efficacy Results”
can be adapted to “Pharmacokinetics”,
“Pharmacodynamics”, “Immunogenicity”,
“Pharmacogenomics Results” etc, as dictated by the
study endpoints. If there is more than one major area of
evaluation, further top-level headings can be added
here.


 



Efficacy (and/or other similar) result CONCLUSIONS ONLY should be
summarised. The summaries can be superficial if the study was
uncontrolled, seriously flawed or aborted such that this data
cannot be analysed.]

 


 

 



SAFETY RESULTS:


 



[Drafting Note: The subheading of “Safety Results” must
always be included. Safety result CONCLUSIONS ONLY must always be
presented.]

 


 

 



CONCLUSION:

 


 

 

 


 

 

 


 

 


Date of
the report:


 









 








 






 


Schedule
3



Licence from CRT to Company


 


 



THIS AGREEMENT is made the________ day of
____________________20[●●]


 



BETWEEN:


 




(1)

CANCER RESEARCH TECHNOLOGY LIMITED, a
company registered in England and Wales under number 1626049 with
registered office at Angel Building, 407 St. John Street, London,
EC1V 4AD, England] (“CRT”); and






 




(2)

[MONOPAR THERAPEUTICS LLC, a limited
liability company registered in/incorporated in/ established under
the laws of The State of Delaware, U.S.A., with registered
office/principal place of business at 598 Rockefeller Road, Lake
Forest, Illinois, U.S.A., 60045] (the “Company”).]






 



RECITALS


 



(A) 

CRT is a wholly
owned subsidiary of Cancer Research UK (the “Charity”) and is, by arrangement
with the Charity, responsible for the management, exploitation and
commercialisation of intellectual property generated by the Charity
or using funding from the Charity.






 



(B) 

Pursuant to a
Clinical Trial and Option Agreement between CRT, the Charity and
the Company dated [●●●] attached at Appendix 2
(the “CTOA”) the
Charity has conducted the Clinical Trial (as defined below) and
assigned the results of such Clinical Trial and all intellectual
property therein to CRT.






 



(C) 

CRT has agreed to
grant the Company a licence under the Licensed Intellectual
Property (as defined below) upon the terms and conditions set out
in this Agreement.






 



OPERATIVE PROVISIONS

 




1.

INTERPRETATION





 




1.1

In this Agreement
except where the context requires otherwise, the following words
and expressions shall have the following meanings:





 


	

“Accountancy
Opinion”


 

	

means
the opinion of an independent United Kingdom chartered accountant
appointed by agreement between the Parties or in default of such
agreement within twenty one (21) days of either Party seeking in
writing to the other to appoint such accountant, at the request of
either Party, by the President for the time being of the Institute
of Chartered Accountants in England and Wales, referred to in
Clauses 1, 6.3 and 24.1.


 


	


“Affiliate”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 








 







 





 


	


“Affordable Price”


 

	

means
in relation to a Licensed Product: (i) a determination by the UK
Pricing Authority that such Licensed Product should be used within
the NHS; and/or (ii) approval by the UK Pricing Authority of the
price proposed by the Company or its Sub-Licensee in relation to
sales of that Licensed Product in the United Kingdom (or one or
more constituent countries thereof).


 


	


“Agreement”


 

	

means
this agreement and each of the Appendices as amended from time to
time in accordance with Clause 21.


 


	


“Clinical Trial”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Clinical Trial Results”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Company Intellectual Property”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Company Patent Rights”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Competing Programme”


 

	

means a
research and development programme under which human subjects in a
clinical trial have or are to be administered a treatment or
compound directed towards the same target molecule as the
Antibody.


 


	


“Confidential Information”


 

	

means
the Clinical Trial Results and all information relating to the
customers, suppliers, business partners, clients, finances,
business plans and products (in each case actual or prospective) of
a Party which is not in the public domain and which is acquired by
the other Party pursuant to this Agreement.


 


	

“Contributors”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	

“Control”


 

	

means:

a) with respect to
corporate ownership, the possession (directly or indirectly) of
fifty per cent or more of the voting stock or other equity interest
of a subject entity with the power to vote, or the power in fact to
control the management decisions of such entity through the
ownership of securities or by contract or otherwise;
and

 

b) with respect to
Intellectual Property Rights, possession of the ability (whether
through ownership or licence, other than a licence granted under
this Agreement) to provide the information or grant the licences or
sublicences or make the assignments as provided herein without
violating the terms of any agreement or other arrangement with any
third party,

 


and
“Controls” and
“Controlled by”
shall be construed accordingly.


 








 







 





 


	


“Currency”


 

	

means
pounds sterling or such other currency as CRT may reasonably
specify from time to time.


 


	


“Data Exclusivity Period”


 

	

means
any period of clinical trial data or other regulatory exclusivity,
together with any such periods under national implementations in
the European Union of Article 10.1 of Directive 2001/EC/83 and all
equivalents elsewhere in the Territory.


 


	


“Data Listings”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Development Plan”


 

	

means
the development plan at Appendix 1 (as the same shall be updated in
accordance with Clause 3.1) which describes: (i) the steps to be
taken to develop Licensed Products within the Territory; and (ii)
the relevant timescales within which such steps will be
taken.


 


	


“Effective Date”


 

	

means
the date this Agreement is made.


 


	


“Exclusive Results”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Expert Opinion”


 

	

means
the opinion of an independent expert appointed by agreement between
the Parties or in default of such agreement within twenty one (21)
days of either Party seeking in writing to the other to appoint
such expert, by the President for the time being of the Association
of the British Pharmaceutical Industry referred to in Clauses 12.3
and 24.1.


 


	


“Field”


 

	

means
the treatment, prophylaxis, diagnosis, prevention and/or cure of
human disease and conditions.


 


	


“Final Report”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


	


“First Commercial Sale”


 

	

means,
with respect to a Licensed Product, the first transfer or
disposition for value of such Licensed Product by or on behalf of
the Company or a Sub-Licensee or an Affiliate of either of them,
after all relevant Regulatory Authorisations for the transfer or
disposition of such Licensed Product have been obtained in respect
of the relevant region or country.


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Indication”


 

	

means a
disease classification block as defined within the
‘International Statistical Classification of Diseases and
Related Health Problems’ as published from time to time by
the World Health Organization (e.g. “C50 Malignant neoplasm
of Breast”, “C92 Myeloid leukaemia”, “B20
Human immunodeficiency virus [HIV] disease resulting in infectious
and parasitic diseases”, “M34 Systemic
sclerosis”).


 


	


“Investigational Medicinal Product” or
“IMP”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Intellectual Property Rights”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Licensed Intellectual Property”


 

	

means
the Clinical Trial Results and all Intellectual Property Rights
therein.


 


	


“Licensed Product”


 

	

means
any product:

a) whose application
for Regulatory Authorisation from a Regulatory Authority in any
jurisdiction included the Clinical Trial Results and/or the Final
Report and/or the Data Listings or any part of any of them,
and/or

 

b) that contains the
Antibody or a Back-Up Antibody (or any part of either), in each
case whether or not as the sole active ingredient,
and/or

 

c) the unauthorised
manufacture, sale or use of which would infringe a valid claim of
the Company Patent Rights.

 


 


	


“Major Markets”


 

	

means
[***]


	


“Milestone Event”


 

	

has the
meaning specified in Clause 4.1.2.


 


	


“Milestone Payments”


 

	

has the
meaning specified in Clause 4.1.2.


 


	

“NDA”


 

	

means,
in relation to any Licensed Product, a biologics license
application, new drug application, supplementary new drug
application, abbreviated new drug application or any of their
equivalents filed with the United States Food and Drugs
Administration (FDA) or any successor to it, a marketing
authorisation application or its equivalent filed with the European
Medicines Agency (EMEA) or any successor to it, or a marketing
authorisation application or a product licence application or
equivalent filed with the relevant Regulatory Authority in any one
or more countries or regions within the Territory.


 








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Net Sales Value”


 

	

means,
in relation to Licensed Product the gross amount invoiced
by the Company or SubLicensee or Affiliate of the Company or a
SubLicensee [***] 
to the extent that any of those items are included as separate
items in the amount so invoiced, and
[***].



	


“New Company IP”


 

	

means
any Intellectual Property Rights developed by or on behalf of the
Company on or after the Effective Date that directly relate to the
IMP and its use.


 


	


“Non-Exclusive Results”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	


“Oncology Indication”


 

	

means
an Indication in the range C00 – D48 (e.g. “C50
Malignant neoplasm of Breast”, “C92 Myeloid
leukaemia”).


 


	


“Party”


 

	

means
either party to this Agreement and “Parties” means both of
them.


 


	


“Patent Rights”


 

	

has the
same meaning as ascribed to that phrase in the CTOA.


 


	


“Phase II Clinical Trial Commencement”


 

	

means
the first dosing of a human subject in a clinical trial of a
Licensed Product (or in the adaptation of an existing clinical
trial) in any country that would satisfy the requirements of 21 CFR
§312.21(b) and is intended to establish dose response and/or
preliminary data on the efficacy of Licensed Product and/or route
of administration of the Licensed Product.


 


	


“Phase III Clinical Trial Commencement”


 

	

means
the first dosing of a human subject in a clinical trial of a
Licensed Product (or the adaptation of an existing clinical trial)
to be a larger scale (than Phase I or Phase II), usually
multi-centred trial in any country that would satisfy the
requirements of 21 CFR §312.21(c) and is intended to establish
the efficacy and safety of the Licensed Product or any other human
clinical trial of the Licensed Product intended as a pivotal trial
for regulatory approval purposes whether or not such trial is a
traditional Phase III trial.


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“pound” and “£”


 

	

means
British pound sterling or if England changes its currency during
the Term, then a sum equivalent in the new currency based on the
spot exchange rate at the date of adoption of the new
currency.


 


	


“Price Approval”


 

	

means,
in those countries in the Territory where Regulatory Authorities
may approve or determine pricing and/or pricing reimbursement for
pharmaceutical products, such approval or
determination.


 


	


“Quarter”


 

	

means
any of the three-monthly periods commencing on the first day of any
of the months of January, April, July, and October in any year and
“Quarterly” has
a corresponding meaning.


 


	


“Regulatory Authorisations”


 

	

means
all marketing authorisations, approvals, clearances and
authorisations that may be required by a Regulatory Authority in
any country or region within the Territory prior to Phase II
Clinical Trial Commencement and/or Phase III Clinical Trial
Commencement and/or commercial sale of the Licensed Product,
including any necessary variations thereto, but excluding always
any Price Approvals.


 


	


“Regulatory Authority”


 

	

means
any local or national agency, court, authority, department,
inspectorate, minister, ministry official or public or statutory
person (whether autonomous or not) of, or of any government of, any
country having jurisdiction over this Agreement or either of the
Parties or over the development or marketing of medicinal products
including, the European Medicines Agency and the European Court of
Justice.


 


	


“Signature Fee”


 

	

means
the sum of [***].


 








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Sub-Licence Revenue”


 

	

means
any monies or non-monetary consideration (including securities)
receivable from time to time by the Company or any of its
Affiliates in respect of: (i) any sub-licence granted by the
Company or any of its Affiliates under this Agreement; (ii) any
licence granted by the Company or any of its Affiliates (whether
under the Company Intellectual Property or otherwise) to sell
Licensed Products anywhere in the Territory; and/or (iii) the grant
of the right to acquire such a sub-licence or licence, including,
in each case, option fees, licence issue fees or other up-front
payments, annual licence fees, milestone or other lump sum payments
which are attributable to the grant of the rights in question,
excluding royalties and Net Sales Value as referred to in Clause
4.4 (in the case of non-monetary Sub-Licence Revenue such as
company stocks and shares, such non-monetary consideration shall
not form Sub-Licence Revenue until Company or relevant Affiliate
has received cash proceeds from the disposal or other realisation
of such consideration. [***]


	


“Sub-Licensee”


 

	

means
any person who is granted: (i) a sub-licence in accordance with
Clause 2.3 in respect of the rights granted under this Agreement
(and any further tiers of sub-licence thereunder); and/or (ii) a
licence by the Company (whether under the Company Intellectual
Property or otherwise) to sell Licensed Products anywhere in the
Territory, but shall not mean distributors, wholesalers, and sales
agents (sales to whom will be sales for the purpose of Net Sales
Value).


 


	


“Term”


 

	

means
the term of this Agreement as determined under Clause
12.1.


 


	


“Territory”


 

	

means
worldwide.


 


	


“Tobacco Party”


 

	

means:
(i) any entity who develops, sells or manufactures tobacco
products; and/ or (ii) any entity which makes the majority of its
profits from the importation, marketing, sale or disposal of
tobacco products. Furthermore, Tobacco Party shall include any
entity that is an Affiliate of any entity referred to in (i) or
(ii).


 


	


“UK Pricing Authority”


 

	

means
any supra-national, national or regional government department,
authority, agency or entity (including a non-departmental public
body or similar entity) with responsibility for evaluating the cost
effectiveness of medicinal products in the United Kingdom (or one
or more constituent countries thereof) or otherwise determining
whether the NHS (or constituent parts thereof) should purchase
medicinal products.


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“XOMA”


 

	

has the
meaning ascribed to that phrase in the CTOA.


 


	


“XOMA Licence”


 

	

has the
same meaning ascribed to that phrase in the CTOA.


 


	


“Year”


 

	

means a
calendar year.


 









1.2

In this
Agreement:





 




1.2.1

unless the context
requires otherwise, all references to a particular Clause,
paragraph or Appendix shall be references to that clause, paragraph
or appendix, in or to this Agreement;





 




1.2.2

the 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, organisation or other entity, in each case
whether or not having separate legal personality; and





 




1.2.5

references to the
words ‘include’ or ‘including’ shall be
construed without limitation to the generality of the preceding
words.





 

 




2.

GRANT
OF LICENCE





 




2.1

Subject to the
provisions of this Agreement and the surviving provisions of the
CTOA, CRT hereby grants to the Company:





 




2.1.1

[***];
and





 




2.1.2

[***],





 


in each
case to research, develop, make, have made, import, use and sell
Licensed Products for any and all uses in the Territory and to
apply for Regulatory Authorisation for such Licensed Products in
any jurisdiction.

 




2.2

CRT hereby reserves
and excepts from the [***] under Clause 2.1.1 the worldwide,
perpetual and irrevocable right for the Contributors and the
Charity (including use by scientists funded and/or employed by the
Charity) to:





 




2.2.1

use the Licensed
Intellectual Property for the purpose of non-commercial scientific
research carried out by or for or under their respective direction
in accordance with their respective charitable and/or academic
status, whether alone or in collaboration with a third party or
third parties and whether sponsored or funded, in whole or in part,
by any third party including any commercial entity;
and





 




2.2.2

make publications
in relation to the Licensed Intellectual Property and any results
of research using the same in accordance with generally accepted
academic practice.







 







 





 




2.3

The Company shall
be entitled to grant sub-licences in respect of the rights granted
under this Agreement, provided that:





 




2.3.1

any sub-licence
granted by the Company shall be expressed to terminate
automatically on the termination of this Agreement for any
reason;





 




2.3.2

any sub-licence
granted by the Company beyond the first tier of sub-licensing shall
expressly prohibit further sub-licensing without CRT’s prior
written consent, which consent may not be unreasonably conditioned,
delayed, or withheld.





 




2.3.3

the Company shall
ensure that there are included in the terms of any sub-licence like
obligations and undertakings on the part of the Sub-Licensee as are
contained in this Agreement (except this Clause 2.3, but including
Clause 9 (indemnity) and Clause 14 (confidentiality)) and shall
further ensure that all Sub-Licensees duly comply with the
same;





 




2.3.4

no sub-licence
shall be granted to a Tobacco Party;





 




2.3.5

the sub-licence
shall be entered into on an arms-length basis reflecting the market
value of the rights granted; and





 




2.3.6

the Company shall
provide CRT with a copy of such sub-licence within thirty (30) days
of entering into it.





 




2.4

Any breach of
Clause 2.3 shall be deemed to be a material breach.





 




2.5

The grant of any
sub-licence shall be without prejudice to the Company’s
obligations under this Agreement. Any act or omission of any such
Sub-Licensee which, if it were the act or omission of the Company
would be a breach of any of the provisions of this Agreement, will
be deemed to be a breach of this Agreement by the Company who will
be liable to CRT accordingly.





 




2.6

CRT will provide
the Company with any Long Term Survival Data as and when the
Charity has completed collection of the same.





 




2.7

The Company may not
publish or publicly disclose any Clinical Trial Results in the one
(1) year period beginning on the Effective Date without the prior
written consent of CRT, which will be given at CRT’s sole
discretion. All publications by the Company of the Clinical Trial
Results and results of research using the same will be made in
accordance with generally accepted academic practice, including in
respect of the role played by the Contributors. The foregoing
provisions of this Clause 2.7 shall not apply to disclosure of
Clinical Trial Results, or any portion thereof, by the Company to
the extent required for (a) satisfying mandatory reporting and
disclosure obligations under United States and other securities
laws. or (b) to existing licensors or sublicensors of the Company
in order to comply with reporting obligations in existence as at
the date of this agreement under the XOMA Licence, provided that in
the case of (b) the disclosure shall be limited to only information
as may be reasonably required by the XOMA Licence and subject to
XOMA being bound by confidentiality obligations that are no less
restrictive than those that the Company is bound by under this
Agreement in respect of confidential information disclosed to
it.





 




2.8

The Charity shall,
within thirty (30) days written request by the Company, return to
the Company or destroy (by a method specified by the Company) and
at the Company’s cost and expense any remaining quantities of
the Company Materials in the Charity’s possession or
control.





 

 




3.

PERFORMANCE





 




3.1

The Company shall
provide an updated Development Plan to CRT on at least a
six-monthly basis before the first approval of an NDA in respect of
a Licensed Product, and on an annual basis thereafter.







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




3.2

The Company shall
procure the achievement of Phase II Clinical Trial Commencement
within [***] of the Effective Date.





 




3.3

The Company shall
use its commercially reasonable efforts at all times during the
Term to:





 




3.3.1

comply with the
most up-to-date version of the Development Plan;





 




3.3.2

develop and pursue
Regulatory Authorisation for a Licensed Product for use in [***] in
each of the [***];





 




3.3.3

introduce a
Licensed Product for use in [***] into each of the [***] as soon as
reasonably and commercially practical following receipt of the
corresponding Regulatory Authorisations and subsequently use
commercially reasonable efforts to market the Licensed Product and
pursue maximum market penetration throughout the Major Markets for
such Licensed Product;





 




3.3.4

launch each
Licensed Product in the United Kingdom as soon as practicable and
in any event no later than [***] after the date the first
Regulatory Authorisation is granted by the European Medicines
Agency; and





 




3.3.5

make Licensed
Products that are launched in the United Kingdom available at an
Affordable Price if required by a Regulatory Authority in order to
obtain a Price Approval for such Licensed Products in the United
Kingdom.





 




3.4

Subject to Clause
3.5.2, the Company shall provide CRT with reports as to the
progress of the development of each Licensed Product, the progress
of any applications for Regulatory Authorisation and Price
Approval, and the progress of and plans for the marketing and sale
of the Licensed Product and its compliance with the Development
Plan, in such form and detail as CRT may reasonably require. The
Company shall provide such reports on at least a six-monthly basis
before first approval of an NDA in respect of a Licensed Product,
and on an annual basis thereafter.





 




3.5

If, prior to the
First Commercial Sale in the United Kingdom and two (2) other Major
Markets, the Company undergoes a change of Control, or acquires or
begins (whether independently or with a third party) a Competing
Programme:





 




3.5.1

it shall notify CRT
in writing within thirty (30) days after the change of Control
occurring, or its commencement or acquisition of the Competing
Programme; and





 




3.5.2

for the [***]
period following the change of Control, or commencement or
acquisition of the Competing Programme, it shall provide CRT with a
report described in Clause 3.4 at least once every three (3)
months.





 




3.6

The Company shall
give CRT prompt notice upon the occurrence of any Milestone
Event.





 




3.7

The Company shall
submit to CRT:





 




3.7.1

a copy of its
detailed operating budget (including a semi-annual cash flow and
expenditure forecast) for the Licensed Product in respect of each
Financial Year as adopted by the Company’s board (the
“Annual
Budget”), at least thirty (30) days prior to the
commencement of the Financial Year to which the Annual Budget
relates;





 




3.7.2

semi-annual
management accounts of the Company (to include, inter alia, a
(consolidated) profit and loss account, balance sheet and cash flow
statement and shall indicate where such management accounts differ
to any material extent from the Annual Budget for such period),
within sixty (60) days of the end of the period to which they
relate; save that the accounts relating to the final quarter in any
calendar year may be provided within ninety five (95) days, rather
than sixty (60) days, of the end of that quarter. Such semi-annual
management accounts shall be prepared on a basis which is
consistent with those adopted in the preparation of all previous
management accounts of the Company.







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




3.8

The Company shall
generally keep CRT informed of the progress of the Company's
business and affairs and shall supply CRT with written details of
any circumstances which will or might cause any actual or
prospective material adverse change in the financial position,
prospects or business of the Company.





 




3.9

Any breach of
Clause 3 shall be deemed to be a material breach of this
Agreement.





 

 




4.

CONSIDERATION





 




4.1

The Company shall
pay the Signature Fee to CRT within thirty (30) days of the
Effective Date.





 




4.2

Subject to clause
4.5, the Company shall pay the following payments
(“Milestone
Payments”) to CRT each time the following events
(“Milestone
Events”) occur in relation to any Licensed
Product:





 




4.2.1

[***];





 




4.2.2

[***];





 




4.2.3

[***];





 




4.2.4

[***];





 




4.2.5

[***];





 




4.2.6

[***];





 




4.2.7

[***];
and





 




4.2.8

[***]





 


Upon
the occurrence of each Milestone Event, any Milestone Event listed
before it in this Clause 4 which has not occurred shall be deemed
to have occurred. For the avoidance of doubt, a Milestone Event may
be triggered by the actions of the Company, a Sub-Licensee or any
third party acting on behalf of the Company or any
Sub-Licensee.

 




4.3

Subject to Clause
4.5, the Company shall pay to CRT:








4.3.1

[***];





 




4.3.2

[***];
and







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




4.3.3

[***].





 


For the
avoidance of doubt, Sub-Licence Revenue expressly excludes royalty
payments due under Clause 4.4 or Net Sales Value.

 




4.4

The Company shall
pay royalties to CRT on a Licensed Product by Licensed Product, and
country by country basis until the later of:





 




4.4.1

[***];





 




4.4.2

t[***];
and





 




4.4.3

[***],





 




4.5

In the event that
any Milestone Event is triggered by any Sub-Licensee, the Company
shall pay to CRT the greater of: (i) [***]; and (ii)
[***].





 

 




5.

PAYMENT
AND STATEMENT





 




5.1

All payments due to
CRT under this Agreement shall be made in the Currency in cleared
funds to the following bank account:





 


	


[***]


 

	


[***]


 


	


[***]


 

	


[***]


 


	


[***]


 

	


[***]


 


	


[***]


 

	


[***]


 


	


[***]


 

	


[***]



 


	


[***]



 

	


[***]


 







 


or such
other account as CRT may notify to the Company from time to
time.

 




5.2

The Company shall
pay to CRT:





 




5.2.1

the Signature Fee
on the date specified in Clause 4.1;





 




5.2.2

each of the
Milestone Payments within thirty (30) days of the relevant
Milestone Event occurring; and





 




5.2.3

each payment that
is due under Clause 4.3 or 4.4, within thirty (30) days of the
Company or any relevant Affiliate receiving the corresponding
Sub-Licence Revenue or percentage of Net Sales Value. All sums due
to CRT under Clause 4.3 or 4.4 shall belong to CRT upon the
Company’s or its Affiliate’s receipt of the revenue to
which such payment corresponds (and is a percentage of) and such
sums shall be held on trust for CRT until paid to CRT in accordance
with this Clause 5.2.3. The Company shall take all steps necessary
to ensure, and to procure that any relevant Affiliate ensures, that
sums held on trust are separate and identifiable from other monies
of the Company or Affiliate, including holding such sums in a
separate account to monies that belong to the Company and/or
Affiliate. At CRT’s reasonable request, the Company shall
provide written evidence of the arrangements required under this
Clause 5.2.3.







 







 





 




5.3

Where Licensed
Products are sold or Sub-Licence Revenue or royalties are received
by the Company (or a Sub-Licensee) in a currency other than the
Currency, the rate of exchange to be used for converting such other
currency into the Currency shall be the relevant mid-spot rate for
the currency quoted by the Financial Times on the last day of the
Quarter to which they relate.





 




5.4

All costs of
transmission and currency conversion shall be borne by the
Company.





 




5.5

All payments to CRT
under this Agreement are expressed to be exclusive of value added
tax howsoever arising, and the Company shall pay to CRT in addition
to those payments or, if earlier, on receipt of a tax invoice or
invoices from CRT, all value added tax for which CRT is liable to
account in relation to any supply made or deemed to be made for
value added tax purposes pursuant to this Agreement.





 




5.6

All sums payable
under this Agreement shall be paid without deduction or deferment
in respect of any claims whatsoever and of any taxes except any tax
which the Company is required by law to deduct or withhold. If the
Company is required by law to make any such tax deduction or
withholding, the Company shall pay to CRT such amount as shall,
after deduction, amount to the sum referred to in this Agreement
give reasonable assistance to CRT to claim exemption from or (if
that is not possible) a credit for the deduction or withholding
under any applicable double taxation or similar agreement from time
to time in force, and shall promptly give CRT proper evidence as to
the deduction or withholding and payment over of the tax deducted
or withheld.





 




5.7

Where CRT does not
receive payment of any sums due to it by the due date, interest
shall accrue both before and after any judgment on the sum due and
owing to CRT at the rate equivalent to an annual rate of two
percent (2%) over the then current base rate of the Bank of
England, calculated on a daily basis, until the full amount is paid
to CRT, without prejudice to CRT’s right to receive payment
on the due date.





 




5.8

Within thirty (30)
days after the end of each Quarter, the Company shall send to CRT a
written statement detailing in respect of that Quarter (including a
nil report if appropriate):





 




5.8.1

any Milestone
Payments which became due to CRT;





 




5.8.2

for each
sub-licence, details of each item of Sub-Licence Revenue received
by the Company during that Quarter and the Sub-Licence Revenue
payable to CRT thereon;





 




5.8.3

the quantity of
each type of Licensed Product sold or otherwise disposed of by the
Company or any Sub-Licensees in each country in the
Territory;





 




5.8.4

the Net Sales Value
in respect of each such type of Licensed Product in each country of
the Territory;





 




5.8.5

the aggregate Net
Sales Value in respect of that Quarter for Licensed
Product;





 




5.8.6

the type and value
of deductions made in the calculation of Net Sales Value by type of
Licensed Product and country;





 




5.8.7

any currency
conversions, showing the rates used;







 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




5.8.8

any further
information necessary for the calculation of Sub-Licence Revenue
and Net Sales Value of Licensed Products and/or the royalties due
to CRT; and





 




5.8.9

the amount of the
royalties due to CRT in respect of that Quarter.





 

 




6.

ACCOUNTS





 




6.1

The Company
shall:





 




6.1.1

keep and
notwithstanding termination of this Agreement, maintain and shall
procure that each Sub-Licensee keeps and maintains, for at least
six (6) years, true and accurate accounts and records (including
any underlying documents supporting such accounts and records) in
sufficient detail to enable the amount of all sums payable under
this Agreement to be determined; and





 




6.1.2

during the Term and
thereafter until the said period of six (6) years relevant to the
accounts and records has expired, at the reasonable request of CRT
and (subject to Clause 6.2) at the expense of CRT from time to
time, permit or procure permission for a qualified accountant
nominated by CRT to inspect and audit those accounts and records
and, to the extent that they relate to the calculation of those
sums, to take copies of them. Subject to receiving not less than
thirty (30) days written notice, the Company shall at the request
of CRT assemble in one location that is respectively convenient to
the Company and Sub-Licensee(s) all such relevant accounts and
records of the Company and all Sub-Licensee(s).





 




6.2

If, following any
inspection pursuant to Clause 6.1.2, CRT’s nominated
accountant certifies to CRT that the payments in respect of any
Quarter or Year fall short of the sums which were properly payable
in respect of that Quarter or Year under this Agreement, CRT shall
send a copy of the certificate to the Company and the Company shall
(subject to Clause 6.3) within thirty (30) days of the date of
receipt of the certificate pay the shortfall to CRT [***], the
Company shall also reimburse to CRT the reasonable costs and
expenses of CRT in making the inspection.





 




6.3

If within fifteen
(15) days of the date of receipt by the Company any certificate
produced pursuant to Clause 6.2 the Company notifies CRT in writing
that it disputes the certificate, the dispute shall be referred for
resolution by Accountancy Opinion in accordance with Clause
24.1.





 

 




7.

INTELLECTUAL
PROPERTY PROTECTION, PROCEEDINGS AND COSTS





 




7.1

The Company shall
throughout the Term continue to use commercially reasonable efforts
to prosecute and maintain the Company Patent Rights.
Notwithstanding the foregoing, if the Company elects not to
prosecute or maintain any part of the Company Patent Rights in any
of the Major Markets, the Company shall notify CRT in writing at
least ninety (90) days prior to the expiration of any applicable
time bars. After receipt of such notice, CRT may elect, before the
expiry of any such time bars, by written notice to the Company, to
take an assignment of the relevant Company Patent Rights such that
CRT may continue to prosecute and/or maintain the Company Patent
Rights at CRT’s sole discretion and expense.





 

 




8.

WARRANTY





 




8.1

Each Party warrants
that it has the legal capacity to enter into this
Agreement.





 




8.2

Each Party
acknowledges that, in entering into this Agreement, it does not do
so in reliance on any warranty or other provision except as
expressly provided in this Agreement, and any conditions,
warranties or other terms implied by statute or common law are
excluded to the fullest extent permitted by law.







 







 





 




8.3

Without limiting
the scope of Clause 8.2, CRT does not give any warranty,
representation or undertaking:





 




8.3.1

as to the efficacy
or usefulness or accuracy of the Clinical Trial Results;
or





 




8.3.2

that the exercise
of rights granted under this Agreement will not infringe the
intellectual property or other rights of any other
person.





 

 




9.

INDEMNITY





 




9.1

 The Company shall
indemnify and hold harmless CRT, the Contributors and the Charity
and their respective officers, employees and agents (each, an
“Indemnified
Party”) from and against any and all third
party claims, demands, losses, damages and expenses (including,
without limitation, legal fees) arising from or in
connection with the exercise of the rights granted in Clause 2 by
the Company or a Sub-Licensee or the actions of any Affiliate of
any of them in relation to the Licensed Product. This Clause 9 is
without prejudice to and shall not limit the rights of the Company,
and is without prejudice to and shall not limit the liabilities of
the Charity, under Clause 9.1 of the CTOA. 





 




9.2

Promptly after
receipt by CRT of any written claim or alleged claim or notice of
the commencement of any action, administrative or legal proceeding,
or investigation to which the indemnity provided for in this Clause
9 may apply, CRT shall give written notice to the Company of such
fact and specifying that the Company shall have the option to
assume the defence thereof by election in writing within seven (7)
days of receipt of such notice. If the Company fails to make such
election, the Indemnified Party may assume such defence and the
Company will be liable for the legal and other expenses
consequently incurred in connection with such defence. If CRT fails
to notify Company within thirty (30) days of receipt of any written
claim or alleged claim or notice of the relevant commencement, then
the Company shall not be liable for the legal and other expenses
consequently incurred in connection with such defence. The Parties
will co-operate in good faith in the conduct of any defence,
provide such reasonable assistance as may be required to enable any
claim properly to be defended and the Party with conduct of the
action shall provide promptly to the other Party copies of all
correspondence and documents and notice in writing of the substance
of all oral communications relating to such action.





 




9.3

Should the Company
assume conduct of the defence:





 




9.3.1

the Indemnified
Party may retain separate legal advisers, at its sole cost and
expense save that if the Company denies the applicability of the
indemnity or reserves its position in relation to the same, the
indemnity in this Clause 9 shall extend to the Indemnified
Party’s costs and expenses so incurred unless it is
subsequently resolved between the Parties or determined by a court
of competent jurisdiction (after exhaustion or expiration of all
rights of appeal) that the indemnity under this Clause 9 was not
available to the Indemnified Party in the terms claimed by the
Indemnified Party;





 




9.3.2

the Company will
not, except with the written consent of the Indemnified Party
consent to the entry of any judgment or enter into any settlement
provided always, that if the Indemnified Party unreasonably refuses
to consent to such entry of judgment or settlement and the matter
proceeds to trial at which a greater amount is ordered by the Court
then the amount which the Indemnified Party shall be entitled to
recover from the Company pursuant to this Clause 9 shall be limited
to the amount for which the action would otherwise have been
settled or compromised and the Indemnified Party shall assume all
costs of defending the claim or proceeding from the date of the
Indemnified Party’s refusal;







 







 





 




9.3.3

CRT shall not admit
liability in respect of, or compromise or settle any such action
without the prior written consent of the Company, such consent not
to be unreasonably withheld, conditioned or delayed;
and





 




9.3.4

the Company shall
not be responsible for or bound by any settlement made by CRT in
breach of Clause 9.3.3.





 

 




10.

INSURANCE





 




10.1

The Company shall
maintain, at its own cost, comprehensive product liability
insurance and general commercial liability insurance, and shall
ensure that each insurance policy maintained under this Clause 10.1
is held in the joint names of the Parties as co-insureds. Within
thirty (30) days of the Effective Date and of the beginning of each
policy period, the Company shall provide CRT with a certificate
evidencing the coverage required hereby, and the amount thereof.
Such insurance shall be with a reputable insurance company and
shall be maintained for not less than six (6) years following the
expiration/termination of this Agreement for any reason or if such
coverage is of the ‘claims made’ type, for ten (10)
years following the expiration or termination of this Agreement for
any reason.





 

 




11.

LIMITATION
OF LIABILITY





 




11.1

Neither Party nor
the Charity, nor their respective officers, employees and agents
shall have liability whether under statute or in tort (including
negligence), contract or otherwise to the other Party in respect of
any consequential, indirect or pure economic loss nor in any event
for loss of goodwill, opportunity, profit or contract.





 




11.2

Nothing in this
Agreement shall be construed as excluding or limiting the liability
of either Party or the Charity or any of their respective officers,
employees and agents to the other Party for death or personal
injury of any person resulting from the negligence of such
persons.





 

 




12.

TERM
AND TERMINATION





 




12.1

This Agreement will
become effective on the Effective Date and, subject to the
provisions of this Clause 12, will remain effective in each country
of the Territory until expiry of the obligation of the Company to
pay royalties under Clause 4.4 in relation to that country pursuant
to this Agreement.





 




12.2

Without prejudice
to any other rights of the Parties this Agreement may be terminated
by notice in writing:





 




12.2.1

by either Party
forthwith if the other Party shall be in material breach of any of
its obligations under this Agreement and in the case of a
remediable breach fails to remedy the breach within ninety (90)
days of written notice containing full particulars of the breach
and requiring it to be remedied;





 




12.2.2

by CRT if a
voluntary arrangement is proposed or approved or an administration
order is made, or a receiver or administrative receiver is
appointed of any of the Company’s assets or undertakings or a
winding-up resolution or petition is passed (otherwise than for the
purpose of solvent reconstruction or amalgamation) or if any
circumstances arise which entitle the Court or a creditor to
appoint a receiver, administrative receiver or administrator or
make a winding-up order or similar or equivalent action is taken
against or by the Company by reason of its insolvency;





 




12.2.3

by CRT forthwith in
the event that, by way of merger, acquisition or otherwise, the
Company becomes a Tobacco Party; or







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




12.2.4

by CRT upon ninety
(90) days written notice to the Company if the
Company:





 




(a)

discontinues the
development (including prosecuting application for Regulatory
Authorisation) of all Licensed Products; or





 




(b)

discontinues the
development (including prosecuting application for Regulatory
Authorisation) of a Licensed Product in relation to one or more
Oncology Indications (in which case termination shall not apply to
the whole Agreement but shall be limited to such Licensed Product
and such Oncology Indications); or





 




(c)

discontinues the
development (including prosecuting application for Regulatory
Authorisation) of all Licensed Products in Oncology Indications (in
which case termination shall not apply to the whole Agreement but
shall be limited to Oncology Indications); or





 




(d)

fails to use its
commercially reasonable efforts to obtain Regulatory Authorisation
in all of the Major Markets within fifteen (15) years, taking into
account the unique aspects of the development and regulatory path
for the Licensed Product, indication and market (in which case
termination shall not apply to the whole Agreement but shall be
limited to that Major Market); or





 




(e)

having obtained
Regulatory Authorisation for a Licensed Product in a Major Market,
ceases to actively market and sell such Licensed Product in such
Major Market (in which case termination shall not apply to the
whole Agreement but shall be limited to that Licensed Product in
that Major Market); or





 




(f)

ceases to carry on
business in the Field; or





 




(g)

without reasonable
cause fails to commence sales of any Licensed Product in a Major
Market within two (2) years of obtaining Regulatory Authorization
to market such Licensed Product in such market (in which case
termination shall not apply to the whole Agreement but shall be
limited to that Licensed Product in that Major
Market).





 




12.3

The Company shall
notify CRT in writing immediately upon any of the events described
in Clause 12.2 occurring. However, CRT’s right to terminate
under Clause 12.2 shall not be conditional upon the Company’s
such notice.





 




12.4

In the event of
disagreement between the Parties as to whether entitlement to
terminate has arisen under Clause 12.2.1 or 12.2.4, the Parties at
their joint cost and expense shall obtain an Expert Opinion which
shall be final as to whether it has arisen.





 

 




13.

EFFECTS
OF TERMINATION





 




13.1

Subject to Clause
13.2, upon the termination of this Agreement for any
reason:





 




13.1.1

other than
termination by CRT pursuant to Clause 12.2.1, 12.2.2, or 12.2.3
subject to all the terms of this Agreement (including without
limitation payment of royalties), the Company shall be entitled for
a period not exceeding [***] following such termination
to:





 




(a)

manufacture any of
the Licensed Products to the extent necessary to satisfy orders
accepted before termination; and





 




(b)

sell, use or
otherwise dispose of any unsold stocks of the Licensed
Products.







 







 





 




13.1.2

subject to Clause
13.1.1, the Company shall, and shall procure that all Sub-Licensees
shall, cease to exploit the Licensed Intellectual Property in any
way, either directly or indirectly;





 




13.1.3

subject to Clause
13.1.1, the Company shall, at the request and option of CRT, return
or destroy CRT’s Confidential Information;





 




13.1.4

notwithstanding any
provision of this Agreement allowing the Company credit, payment of
royalties and all other sums to CRT shall become due and payable to
CRT immediately upon notice of termination of this
Agreement;





 




13.1.5

the Company shall,
within thirty (30) days of notice of termination of this Agreement
provide CRT with a final written statement detailing, in respect of
the time elapsed since the last statement under Clause 5.8, the
matters set out in Clause 5.8;





 




13.1.6

other than
termination by the Company pursuant to Clause 12.2.1, the
Company:





 




(a)

hereby grants to
CRT an exclusive, perpetual, worldwide, sub-licensable licence
under the Company Intellectual Property, Company Patent Rights and
New Company IP to research, develop, make, have made, market, use
and sell Licensed Products, on revenue share and, if appropriate,
royalty terms to be agreed; provided that such licence shall only
become effective upon termination, and not before. If, having
regard to the nature and status of the rights licensed, the
products to which they relate, the likely market for such products,
the nature and standing of potential sub-licensees and actual or
potential competing products, the Parties cannot agree such revenue
share and, if appropriate, royalty terms within three (3) months of
the date of termination then either Party may refer the matter,
subject to Clause 24.2, for determination by an Accountancy
Opinion;





 




(b)

in the case of XOMA
IP, hereby grants to CRT a sub-licence to the full extent of the
Company‘s rights under the XOMA Licence; provided that such
licence shall only become effective upon termination, and not
before;





 




(c)

at CRT’s
request, shall promptly transfer to CRT (or any person nominated by
CRT) any and all documents and information in the Company’s
Control relating to the Patent Rights exclusively licensed to CRT
under clause 13.1.6 above and CRT may assume responsibility for the
prosecution, maintenance and enforcement of the same;
and





 




(d)

at CRT’s
request, shall transfer to CRT (or its nominee) any Regulatory
Authorisations, Price Approvals and other permits and applications
relating to Licensed Products.





 




13.2

This Clause 13.2
shall not apply in the case of termination of this Agreement under
Clause 12.1. In the event that this Agreement is terminated solely
in respect of particular Licensed Product and/or Indication and/or
Major Market, the provisions of Clause 13.1 shall apply, but solely
in respect of the relevant Licensed Product, Indication and/or
Major Market.





 




13.3

Insolvency:





 




13.3.1

All rights and
licenses granted under or pursuant to Clause 13.1.6 by the Company
to CRT are for all purposes of Section 365(n) of Title 11 of the
U.S. Bankruptcy Code (“Title
11”), licenses of rights to “intellectual
property” as defined in Section 101 of Title 11.







 







 





 




13.3.2

the Company agrees
that CRT shall retain and may fully exercise all of its rights and
elections under the U.S. Bankruptcy Code. If a case under Title 11
is commenced by or against the Company, CRT shall have all rights
of licensees set out in Section 365(n) of Title 11;





 




13.3.3

without limiting
CRT’s rights under Section 365(n) of Title 11, if a case
under Title 11 is commenced by or against the Company, and this
Agreement is rejected by the Company in any bankruptcy proceeding
by or against the Company under the U.S. Bankruptcy Code, (i) the
Company shall provide CRT with a complete duplicate of (and
complete access to, as appropriate) any IP and embodiments of IP
not already in their possession; and (ii) the Company shall not
interfere with CRT’s rights to IP and embodiments of IP, and
shall facilitate and assist with CRT obtaining IP and embodiments
of IP (including from a third party); and





 




13.3.4

the term
“embodiments” of IP includes all tangible, intangible,
electronic or other embodiments of rights and licenses, including
antibodies, compounds and products embodying IP and related rights
and technology. All rights of CRT under this Clause and under
Section 365(n) of Title 11 are in addition to, not in substitution
of, any other rights and remedies that they may have under this
Agreement, Title 11 and any other applicable law.





 




13.2

The termination of
this Agreement howsoever arising will be without prejudice to the
rights and duties of either Party accrued prior to termination. The
following Clauses will continue to be enforceable notwithstanding
termination: Clauses 1 (Definitions), 6 (Accounts), 7.2 (XOMA
Licence), 9 (Indemnity), 10 (Insurance), 11 (Limitation of
Liability), 12 (Termination), 13 (Effects of Termination), 14
(Confidentiality), 19 (Severability), 24 (Dispute Resolution) and
25 (Law and Jurisdiction).





 

 




14.

CONFIDENTIALITY





 




14.1

Each Party
undertakes with the other that it shall keep and it shall procure
that its respective directors and employees keep secret and
confidential all Confidential Information belonging to or
Controlled by the other Party and shall not disclose the same or
any part of the same to any person whatsoever other
than:





 




14.1.1

in the case of the
Company: (i) to Sub-Licensees subject to compliance with Clause
2.3.3, (ii) to potential development partners, sublicensees, and
investors bound by terms of confidentiality at least as strict as
those herein, and (iii) as necessary in communications with
Regulatory Authorities in the Territory relating to the Licensed
Products;





 




14.1.2

in the case of CRT
to the Charity; and





 




14.1.3

in the case of each
Party, to its directors or employees directly or indirectly
concerned in the exercise of the rights granted under this
Agreement.





 




14.2

The provisions of
Clause 14.1 shall not apply to Confidential Information which CRT
or the Company (as the case may be):





 




14.2.1

can prove to have
been in its possession (other than under an obligation of
confidence to the other or to a third party) at the date of receipt
or which enters the public domain otherwise than through a breach
of any obligation of confidentiality owed to the Party
communicating such information to the other;





 




14.2.2

can prove it has
independently developed; or





 




14.2.3

is required to
disclose by law or by the order of a competent court, solely to the
extent of such disclosure.





 




14.3

The provisions of
this Clause 14 shall remain in force for a period of five (5) years
from the expiry or termination of this Agreement





 



 







 





 




15.

ASSIGNMENT





 




15.1

The Company shall
not without CRT’s consent assign its rights under this
Agreement except in conjunction with a merger or consolidation of
the Company with another business entity or the sale of all or
substantially all or a substantial part of its business and related
assets that includes its business in relation to the Licensed
Products other than a merger or consolidation with, or a sale of
assets to, a Tobacco Party and provided that Company obtains a
direct covenant from the acquiring party to CRT undertaking to be
bound by the terms of this Agreement.





 

 




16.

NOTICES





 




16.1

Any notice or other
document to be given under this Agreement shall be in writing and
shall be deemed to have been given:





 




16.1.1

upon delivery if
given in person; or





 




16.1.2

upon confirmation
of receipt if sent by facsimile (or other similar means of
electronic communication, such as email); or





 




16.1.3

(if posted to an
inland destination) three (3) business days after deposit into
First Class post; or





 




16.1.4

(If posted to an
overseas destination) five (5) days after deposit into airmail
post; or





 




16.1.5

upon delivery by
air delivery service,





 


to a
Party at the address set out below (or, if provided below or so
notified, such facsimile or electronic communication) for such
Party or such other address as the Party may from time to time
designate by written notice to the other Party. [As may be updated at the Effective
Date.]

 



Address of the Company

 


Monopar
Therapeutics LLC

 


598
Rockefeller Road

 


Lake
Forest, IL USA 60045

 


Contact: 
Chief Executive Officer

 



Address of CRT

 


Angel
Building

 


407 St.
John Street

 


London
EC1V 4AD

 


United
Kingdom

 


Contact: Chief
Executive Officer

 


Fax:
+44 (0) 20 3014 8633

 

 




17.

WAIVER





 




17.1

No failure or delay
on the part of either Party hereto to exercise any right or remedy
under this Agreement shall be construed as or operate as a waiver
thereof nor shall any single or partial exercise of any right or
remedy under this Agreement preclude the exercise of any other
right or remedy or preclude the further exercise of such right or
remedy as the case may be.







 







 





 

 




18.

FORCE
MAJEURE





 




18.1

Except in relation
to obligations pursuant to Clauses 4 and/or 5, neither Party shall
be liable to the other Party or shall be in default of its
obligations hereunder if such default is the result of war,
hostilities, revolution, civil commotion, strike, epidemic,
accident, fire, wind, flood or because of any act of God or other
cause beyond the reasonable control of the Party affected. The
Party affected by such circumstances shall promptly notify the
other Party in writing when such circumstances cause a delay or
failure in performance (a “Delay”) and where they cease
to do so. In the event of a Delay lasting for twenty six (26) weeks
or more the non-affected Party shall have the right to terminate
this Agreement immediately by notice in writing to the affected
Party.





 

 




19.

SEVERABILITY





 




19.1

If and to the
extent that any court or tribunal of competent jurisdiction holds
any of the terms, provisions or conditions or parts thereof of this
Agreement, or the application hereof to any circumstances, to be
invalid or to be unenforceable in a final non-appealable order, the
remainder of this Agreement and the application of such term,
provision or condition or part thereof to circumstances other than
those as to which it is held invalid or unenforceable shall not be
affected thereby, and each of the other terms, provisions and
conditions of this Agreement shall be valid and enforceable to the
fullest extent permissible by law.





 

 




20.

ENTIRE
AGREEMENT





 




20.1

This Agreement and
the surviving clauses of the CTOA, embodies and sets forth the
entire agreement and understanding of the Parties and supersedes
all prior oral or written agreements, understandings or
arrangements relating to the subject matter of this Agreement.
Without prejudice to any liability for fraudulent misrepresentation
or fraudulent misstatement neither Party shall be entitled to rely
on any agreement, understanding or arrangement which is not
expressly set forth in this Agreement unless otherwise agreed
between the Parties and recorded in writing.





 

 




21.

AMENDMENT





 




21.1

This Agreement
shall not be amended, modified, varied or supplemented except in
writing signed by duly authorised representatives of the
Parties.





 

 




22.

PUBLIC
ANNOUNCEMENTS





 




22.1

The text of any
press release, shareholders’ report or other communication to
be published or disclosed to the public in any way by or in the
media concerning CRT or the Charity, the subject matter of this
Agreement or concerning this Agreement itself, other than as
required by law or by any Regulatory Authority or the rules of any
securities exchange, shall be submitted to CRT at least seven (7)
days in advance of publication for approval, such approval not to
be unreasonably withheld, conditioned, or delayed, provided that
insofar as a disclosure repeats or restates a prior public
disclosure permitted by this Agreement, such disclosure need not be
submitted to the Charity or CRT for approval.





 

 




23.

FURTHER
ASSURANCE





 




23.1

The Parties hereby
undertake to do all such other acts and things, and execute and
provide all such documents at the requesting Party’s cost as
may be necessary or desirable to give effect to the purposes of
this Agreement.







 







 





 

 




24.

DISPUTE
RESOLUTION





 




24.1

Insofar as this
Agreement provides that a matter shall be resolved by Accountancy
Opinion or Expert Opinion the opinion of such expert (who shall act
as an expert and not as an arbitrator) shall be final and binding
on the Parties. In the event of a Party seeking an Accountancy
Opinion or Expert Opinion under this Agreement, each Party shall
make written submissions to the expert so appointed and to the
other Party within fourteen (14) days of the appointment. Each
Party shall have seven (7) days to respond to the other’s
submissions. The expert shall be requested to deliver his
Accountancy Opinion or Expert Opinion within a further thirty (30)
days. The costs of any Accountancy Opinion or Expert Opinion shall
be borne in such proportions as the expert may determine in his
opinion to be fair and reasonable in all the circumstances or, if
no such determination is made in the opinion, by the Parties in
equal proportions.





 




24.2

It shall be a
condition precedent to the commencement of any action in court or
other tribunal (save an action for an interim injunction or an
Expert Opinion sought under Clause 12.1) in respect of any dispute
relating to this Agreement that the Parties have sought to resolve
the dispute by either Party notifying the other Party in writing
for resolution to the Chief Executive Officer (in the case of CRT)
and the Chief Executive Officer (in the case of the Company) (or
their express delegates) (the “Senior Executives”) who
shall meet (whether in person or via teleconference) within twenty
one (21) days of such notice to seek resolution in good faith. If
the Senior Executives are unable to resolve the dispute at such
meeting, either Party may pursue any remedy available to such Party
at law or in equity, subject to the terms and conditions of this
Agreement and the other agreements expressly contemplated
hereunder.





 

 




25.

LAW
AND JURISDICTION





 




25.1

This Agreement
shall be governed by and construed in accordance with English Law
and, subject to the provisions of Clauses 24.1 and 24.2, each Party
agrees to submit to the exclusive jurisdiction of the English
Courts (except in respect of disputes under Clause 14 where
jurisdiction is non-exclusive).





 

 




26.

EXECUTION





 




26.1

This Agreement may
be executed in any one or more number of counterpart agreements,
and as scanned email attachments, and all signatures and
counterparts so exchanged shall be considered as original and shall
be deemed to form part of and together constitute this
Agreement.





 

 




27.

CONTRACTS
(RIGHTS OF THIRD PARTIES) ACT 1999





 




27.1

Save that the
Charity, the Contributors and their and CRT’s respective
officers, employees and agents in respect of Clauses 9 and 11 may
enforce those respective terms, no term of this Agreement is
enforceable under the Contracts (Rights of Third Parties) Act 1999
by a person who is not a Party to this Agreement. Notwithstanding
the provisions of this Clause, the Parties shall be entitled to
amend, suspend, cancel or terminate this Agreement or any part of
it in accordance with Clause 21, without the consent of any third
party including those referred to in this Clause.







 







 





 


The
Parties hereby execute this Agreement by their duly authorised
representatives:

 


 


	

Signed
by:

	

_____________________________________


	
 

	
 


	

Name:

	

_____________________________________


	
 

	
 


	

Title:

	

_____________________________________


	
 

	
 


	
 

	

For
and on behalf of


	
 

	


CANCER RESEARCH TECHNOLOGY LIMITED


	
 

	
 


	
 

	
 


	
 

	
 


	
 

	
 


	
 

	
 


	
 

	
 


	

Signed
by:

	

_____________________________________


	
 

	
 


	

Name:

	

_____________________________________


	
 

	
 


	

Title:

	

 _____________________________________


	
 

	
 


	
 

	

For
and on behalf of


	
 

	


MONOPAR THERAPEUTICS LLC







 




 








 










 



Appendix 1



Development Plan


 


 


 


 



Appendix 2



Executed CTOA


 


 


 


 




 








 










 



Schedule 4



No Fault Compensation Scheme


 



Preamble


 


The
Association of the British Pharmaceutical Industry favours a simple
and expeditious procedure in relation to the provision of
compensation for injury caused by participation in clinical trials.
The Association therefore recommends that a member company
sponsoring a clinical trial should provide without legal commitment
a written assurance to the investigator — and through him to
the relevant research ethics committee — that the following
Guidelines will be adhered to in the event of injury caused to a
patient attributable to participation in the trial in
question.


 


 



1      

Basic
Principles






 



1.1 

Notwithstanding the
absence of legal commitment, the company should pay compensation to
patient-volunteers suffering bodily injury (including death) in
accordance with these Guidelines.






 



1.2 

Compensation should
be paid when, on the balance of probabilities, the injury was
attributable to the administration of a medicinal product under
trial or any clinical intervention or procedure provided for by the
protocol that would not have occurred but for the inclusion of the
patient in the trial.






 



1.3 

Compensation should
be paid to a child injured in utero through the participation of
the subject’s mother in a clinical trial as if the child were
a patient-volunteer with the full benefit of these
Guidelines.






 



1.4 

Compensation should
only be paid for the more serious injury of an enduring and
disabling character (including exacerbation of an existing
condition) and not for temporary pain or discomfort or less serious
or curable complaints.






 



1.5 

Where there is an
adverse reaction to a medicinal product under trial and injury is
caused by a procedure adopted to deal with that adverse reaction,
compensation should be paid for such injury as if it were caused
directly by the medicinal product under trial.






 



1.6 

Neither the fact
that the adverse reaction causing the injury was foreseeable or
predictable, nor the fact that the patient has freely consented
(whether in writing or otherwise) to participate in the trial
should exclude a patient from consideration for compensation under
these Guidelines, although compensation may be abated or excluded
in the light of the factors described in paragraph 4.2
below.






 



1.7 

For the avoidance
of doubt, compensation should be paid regardless of whether the
patient is able to prove that the company has been negligent in
relation to research or development of the medicinal product under
trial or that the product is defective and therefore, as the
producer, the company is subject to strict liability in respect of
injuries caused by it.






 


 



2      

Type
of Clinical Research Covered






 



2.1 

These Guidelines
apply to injury caused to patients involved in Phase II and Phase
III trials, that is to say, patients under treatment and
surveillance (usually in hospital) and suffering from the ailment
which the medicinal product under trial is intended to treat but
for which a product licence does not exist or does not authorise
supply for administration under the conditions of the
trial.






 



2.2 

These Guidelines do
not apply to injuries arising from studies in non-patient
volunteers (Phase I), whether or not they are in hospital, for
which separate Guidelines for compensation already
exist.







 







 






 



2.3 

These Guidelines do
not apply to injury arising from clinical trials on marketed
products (Phase IV) where a product licence exists authorising
supply for administration under the conditions of the trial, except
to the extent that the injury is caused to a patient as a direct
result of procedures undertaken in accordance with the protocol
(but not any product administered) to which the patient would not
have been exposed had treatment been other than in the course of
the trial.






 




2.4

These Guidelines do
not apply to clinical trials which have not been initiated or
directly sponsored by the company providing the product for
research. Where trials of products are initiated independently by
doctors under the appropriate Medicines Act 1968 exemptions,
responsibility for the health and welfare of patients rests with
the doctor alone (see also paragraph 5.2 below).






 



3            

Limitations






 



3.1 

No compensation
should be paid for the failure of a medicinal product to have its
intended effect or to provide any other benefit to the
patient.






 



3.2 

No compensation
should be paid for injury caused by other licensed medicinal
products administered to the patient for the purpose of comparison
with the product under trial.






 



3.3 

No compensation
should be paid to patients receiving placebo in consideration of
its failure to provide therapeutic benefit.






 



3.4 

No compensation
should be paid (or it should be abated as the case may be) to the
extent that the injury has arisen:






 




3.4.1 


through
a significant departure from the agreed protocol;






 



3.4.2 

through the
wrongful act or default of a third party, including a
doctor’s failure to deal adequately with an adverse
reaction;






 




3.4.3


through
contributory negligence by the patient.






 



4        

Assessment
of Compensation






 



4.1 

The amount of
compensation paid should be appropriate to the nature, severity and
persistence of the injury and should in general terms be consistent
with the quantum of damages commonly awarded for similar injuries
by an English Court in cases where legal liability is
admitted.






 



4.2 

Compensation may be
abated, or in certain circumstances excluded, in the light of the
following factors (on which will depend the level of risk the
patient can reasonably be expected to accept):






 




4.2.1

the seriousness of
the disease being treated, the degree of probability that adverse
reactions will occur and any warnings given;






 




4.2.2

the risks and
benefits of established treatments relative to those known or
suspected of the trial medicine.






 


This
reflects the fact that flexibility is required given the particular
patient’s circumstances. As an extreme example, there may be
a patient suffering from a serious or life-threatening disease who
is warned of a certain defined risk of adverse reaction.
Participation in the trial is then based on an expectation that the
benefit/risk ratio associated with participation may be better than
that associated with alternative treatment. It is, therefore,
reasonable that the patient accepts the high risk and should not
expect compensation for the occurrence of the adverse reaction of
which he or she was told.


 



4.3 

In any case where
the company concedes that a payment should be made to a patient but
there exists a difference of opinion between company and patient as
to the appropriate level of compensation, it is recommended that
the company agrees to seek at its own cost (and make available to
the patient) the opinion of a mutually acceptable independent
expert, and that his opinion should be given substantial weight by
the company in reaching its decision on the appropriate payment to
be made.







 







 






 



5       

Miscellaneous






 



5.1 

Claims pursuant to
the Guidelines should be made by the patient to the company,
preferably via the investigator, setting Out details of the nature
and background of the claim and, subject to the patient providing
on request an authority for the company to review any medical
records relevant to the claim, the company should consider the
claim expeditiously.






 



5.2 

The undertaking
given by a company extends to injury arising (at whatever time)
from all administrations, clinical interventions or procedures
occurring during the course of the trial but not to treatment
extended beyond the end of the trial at the instigation of the
investigator. The use of unlicensed products beyond the trial
period is wholly the responsibility of the treating doctor and in
this regard attention is drawn to the advice provided to doctors in
MAL 3Q2 concerning the desirability of doctors notifying their
protection society of their use of unlicensed
products.






 



5.3 

The fact that a
company has agreed to abide by these Guidelines in respect of a
trial does not affect the right of a patient to pursue a legal
remedy in respect of injury alleged to have been suffered as a
result of participation. Nevertheless, patients will normally be
asked to accept that any payment made under the Guidelines will be
in full settlement of their claims.






 



5.4 

A company
sponsoring a trial should encourage the investigator to make clear
to participating patients that the trial is being conducted subject
to the ABPI Guidelines relating to compensation for injury arising
in the course of clinical trials and have available copies of the
Guidelines should they be requested.






 



References


 



1            

Guidelines
for Medical Experiments in
Non-patient Human Volunteers, ABPI March 1988, as amended May
1990.







2            

MAL 30— A
Guide to the Provisions affecting Doctors and Dentists, DHSS,
(Revised June 1985)






 




 



The Association of the British Pharmaceutical Industry


12
Whitehall London SW1


 


 


 




 








 







Schedule 5



Assignment and Licence from Company to CRT


 


 


 



THIS AGREEMENT is made the________ day of
_______________________20[●●]


 



BETWEEN:


 




(1)

CANCER RESEARCH TECHNOLOGY LIMITED, a
company registered in England and Wales with number 1626049 with
registered office at Angel Building, 407 St. John Street, London,
EC1V 4AD, England (“CRT”); and






 




(2)

[MONOPAR THERAPEUTICS LLC, a limited
liability company registered in/incorporated in/ established under
the laws of The State of Delaware, U.S.A., with registered
office/principal place of business at 598 Rockefeller Road, Lake
Forest, Illinois, U.S.A., 60045] (the “Company”).






 



WHEREAS


 




(A)

CRT, the Company
and the Charity (as defined below) are parties to a Clinical Trial
and Option Agreement dated [●●●] (the
“CTOA”) relating
to the Investigational Medicinal Product (as defined in the
CTOA).






 




(B)

Pursuant to clause
7.5 of the CTOA, the Company has agreed to assign the Company
Intellectual Property and sub-license the XOMA IP in return for a
royalty and a share of any revenue generated by CRT from the
commercial exploitation of such intellectual property rights upon
the terms and conditions set out below.






 



NOW IT IS HEREBY AGREED as follows:


 

 

 




1.

INTERPRETATION





 




1.1

In this Agreement
except where the context requires otherwise, the following words
and expressions shall have the following meanings:





 


	


“Affiliate”


 

	

has the
same meaning as that ascribed to that phrase in the
CTOA.


 


	

“Accountancy
Opinion”


 

	

means
the opinion of an independent United Kingdom chartered accountant
appointed by agreement between the Parties or in default of such
agreement within twenty one (21) days of either Party seeking in
writing to the other to appoint such accountant, at the request of
either Party, by the President for the time being of the Institute
of Chartered Accountants in England and Wales, referred to in
Clauses 6.3 and 12.1.


 


	


“Charity”

	

means
Cancer Research UK, a charity registered under number 1089464 of
Angel Building, 407 St. John Street, London EC1V 4AD,
England.


 








 







 





 


	


“Clinical Trial”

	

has the
meaning given in the CTOA.


	


“Company Intellectual Property”

	

means
the Company Patent Rights and all rights in the Company Materials,
the Investigational Medicinal Product and the Company
Know-How.


 


	


“Company Know-How”

	

means:
(a) any Know How that was disclosed by the Company to the Charity
pursuant to the CTOA; (b) any Know How described in Annex 2; and
(c) such other Know How in the Company’s Control relating to
the Investigational Medicinal Product (and any constituents
thereof) or any Back-Up Antibody including but not limited to: (i)
any safety and toxicological data; (ii) information relating to
manufacturing/production; (iii) information relating to quality;
(iv) information relating to safe and proper handling, storage and
use; and (v) any information which would in any way improve the
prospects for its commercialisation.


 


	


“Company Materials”

	

means
Materials Controlled by the Company which include and relate to the
Investigational Medicinal Product, the Antibody and the Back-Up
Antibodies, more particularly described in Annex 3.


 


	


“Company Patent Rights”

	

means
(i) those Patent Rights listed in Annex 1A; (ii) those Patent
Rights Controlled by the Company which would be infringed by the
unauthorised manufacture, use or sale in, or importation into, the
relevant country of the Investigational Medicinal Product, Antibody
or Back-Up Antibodies; and (iii) all Patent Rights deriving
priority from (i) and (ii).


 


	


“Control”

	

has the
meaning given in the CTOA.


	


“Data Exclusivity Period”


 

	

means
any period of clinical trial data or other regulatory exclusivity,
together with any such periods under national implementations in
the European Union of Article 10.1 of Directive 2001/EC/83 and all
equivalents elsewhere in the Territory.


 


	


“Direct Costs”

	

means
XOMA Licence Payments paid by CRT pursuant to Clause
7.2.


 


	


“Effective Date”

	

means
the date of this Agreement.


 


	


“First Commercial Sale”


 

	

means,
with respect to a Licensed Product, the first transfer or
disposition for value of such Licensed Product by or on behalf of
CRT or a Sub-Licensee or an Affiliate of either of them, after all
relevant Regulatory Authorisations for the transfer or disposition
of such Licensed Product have been obtained in respect of the
relevant region or country.


 








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Gross Revenue”

	

means
any and all monies or non-monetary consideration (including
securities) received by CRT from time to time in respect of the
commercial exploitation of the Investigational Medicinal Product,
Antibody, Back-Up Antibodies, or any Licensed Product; [***]. For
the avoidance of doubt, any developmental and/or sales milestone
revenue shall constitute Gross Revenue, and not
Royalties.


 


	


“Investigational Medicinal Product” or
“IMP”


 

	

has the
meaning given in the CTOA.


	


“Intellectual Property Rights”

	

means
all Patent Rights, Know-How, copyright, database rights, design
rights, moral rights, rights in trade names, logos and trade and
service marks, domain names, rights in Materials and all rights or
forms of protection of a similar nature or having equivalent or
similar effect to any of them which may subsist anywhere in the
world, whether or not any of them are registered including any
application for registration of any of them.


 


	


“Know-How”

	

has the
meaning given in the CTOA.


	


“Licence”

	

has the
meaning given in the CTOA.


	


“Licensed Product”


 

	

means
any product:

a) whose application
for a Regulatory Authorisation from a Regulatory Authority in any
jurisdiction included the Clinical Trial Results and/or the Final
Report and/or the Data Listings or any part of any of them,
and/or

 

b) that contains the
Antibody or a Back-Up Antibody (or any part of either), in each
case whether or not as the sole active ingredient,
and/or

 

c) the unauthorised
manufacture, sale or use of which would infringe a valid claim of
the Company Patent Rights,

 


where
“Clinical Trial
Results”, “Final
Report” and “Data Listings” have the meaning
given to them in the CTOA and “Regulatory Authorisation” has the
meaning given to it in the Licence.


 








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Materials”

	

has the
meaning given in the CTOA.


	

“NDA”


 

	

means,
in relation to any Licensed Product, a biologics license
application, new drug application, supplementary new drug
application, abbreviated new drug application or any of their
equivalents filed with the United States Food and Drugs
Administration (FDA) or any successor to it, a marketing
authorisation application or its equivalent filed with the European
Medicines Agency (EMEA) or any successor to it, or a marketing
authorisation application or a product licence application or
equivalent filed with the relevant Regulatory Authority in any one
or more countries or regions within the Territory.


 


	


“Net Revenue”

	

means
Gross Revenue less Direct Costs.


	


“Net Sales Value”

	

means,
in relation to Licensed Product, the gross amount invoiced by CRT
or Sub-Licensee or Affiliate of CRT or a Sub-Licensee [***] to the
extent that any of those items are included as separate items in
the amount so invoiced, and [***]


 


	


“Party”


 

	

means
either party to this Agreement and “Parties” means both of
them.


 


	


“Patent Rights”

	

has the
meaning given in the CTOA.


	


“Royalties”

	

means
any monies that CRT receives from a Sub-Licensee which are a
percentage of Net Sales Value only, and are paid to CRT on a
Licensed-Product by Licensed-Product and country-by-country
basis.


 


	


“Sub-Licensee”


 

	

means
any person who is granted a sub-licence in respect of the Company
Intellectual Property under this Agreement; and/or any person who
is granted a sub-licence (whether under the Company Intellectual
Property or otherwise) to sell Licensed Products anywhere in the
Territory, but shall not mean distributors, wholesalers, and sales
agents (sale to whom will be sales for the purpose of Net Sales
Value).


 








 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	


“Territory”

	

means
worldwide.


	


“XOMA IP”

	

has the
meaning given in the CTOA.


	


“XOMA Licence”

	

has the
meaning given in the CTOA.


	


“XOMA Licence Payments”

	

has the
meaning given in the CTOA.







 




1.2

The headings in
this Agreement are for convenience only and shall not affect its
interpretation. Unless the contrary intention appears, words
denoting persons shall include any individual, partnership,
company, corporation, joint venture, trust, association,
organisation or other entity, in each case whether or not having
separate legal personality. References to the words
“include” or “including” shall be construed
without limitation to the generality of the preceding
words.





 




2.

ASSIGNMENT
AND LICENCE FROM COMPANY TO CRT





 




2.1

Pursuant to clause
7.5 of the CTOA, and in consideration of the provisions of Clause
4, the Company hereby assigns to CRT with full title
guarantee:





 




2.1.1

[***] the Company
Patent Rights (and the inventions disclosed in such Company Patent
Rights) and the [***];





 




2.1.2

[***] the Company
Intellectual Property and [***];





 




2.1.3

[***] the Company
Intellectual Property [***];





 




2.1.4

[***] the Company
Patent Rights; and





 




2.1.5

[***].





 




2.2

Effective only upon
a written request from CRT and to the extent it is entitled to do
so under the XOMA Licence, the Company hereby grants to CRT [***]
to research, develop, make, have made, import, use and sell the
Investigational Medicinal Product and products incorporating the
Antibody or any Back-Up Antibody. The licence granted under this
Clause 2.2 shall become effective upon written notice from CRT to
the Company (such notice to be given within thirty (30) days of the
Effective Date).





 




2.3

The Company shall
disclose to CRT any Company Know-How that was not already disclosed
to CRT pursuant to the CTOA within three (3) months of the
Effective Date and agrees that the Company Know-How may be used by
CRT and anyone to whom CRT discloses the Company Know-How, and that
the Company shall not disclose the Company Know-How to any third
party or use the Company Know-How in any internal research
programme.





 




2.4

The Company either
has or shall transfer, or procure the transfer of, the Company
Materials and any and all rights therein to CRT (or any third party
nominated by CRT) within three (3) months of the Effective Date and
agrees that the Company Materials may be used by CRT and any third
party authorised by CRT and that the Company shall not transfer any
Company Materials to any third party or use the Company Materials
in any internal research programme.





 




2.5

At CRT’s
request, the Company shall negotiate with CRT in good faith on
reasonable commercial terms a [***] the Company and not already
licensed or assigned under this Agreement which may be necessary
and/or useful for the development and/or commercial exploitation of
the Company Intellectual Property.







 







 





 

 




3.

ASSISTANCE
AND FURTHER ASSURANCE





 




3.1

The Company shall
promptly provide to CRT or its nominated patent agent all documents
relating to the filing, prosecution and maintenance of the Company
Patent Rights.





 




3.2

The Company shall
execute, sign and do all instruments, applications, documents, acts
and things that may reasonably be required by CRT to enable CRT to
enjoy the full benefit of the property and rights hereby assigned
or licensed and (if requested to do so by CRT) to apply for any
patents or other forms of protection in respect of the
Investigational Medicinal Product throughout the world and fully
and effectively to assign the same to CRT or as CRT shall
direct.





 




3.3

The Company shall
assist CRT and any third party that CRT may nominate in
understanding and using the Company Know-How and the Company
Materials and assist CRT and any such third party in relation to
any further development of the Investigational Medicinal Product
and any regulatory application in relation thereto (including
without limitation and to the extent that the Company may lawfully
do so by the provision of information that may be requested from
time to time in relation to the origin, development, and
distribution by the Company to any third parties of the Licensed
Product).





 




3.4

The Company shall
maintain the XOMA Licence, and not terminate it without the prior
written agreement of CRT.





 




3.5

To the extent it
has the rights under the XOMA Licence to Control Patent Rights
which are XOMA IP, the Company shall transfer to CRT control of the
filing, prosecution, maintenance, enforcement and defence of any
such Patent Rights to CRT.







 







 





 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 

 




4.

CONSIDERATION





 




4.1

Subject to Clause
4.5, CRT and the Company shall share Net Revenue in the following
proportions:





 


CRT
[***];


Company
[***].


 




4.2

In the event that
any Gross Revenue is received by CRT as part of the consideration
for the grant of rights which include rights other than those in
respect of Company Intellectual Property, CRT shall apportion the
consideration as between on the one hand, the rights granted in
respect of the Company Intellectual Property and, on the other, any
other rights granted, in such manner as is fair and
reasonable.





 




4.3

If CRT receives any
non-monetary consideration in respect of the commercial
exploitation of the Company Intellectual Property (such as company
stocks and shares), such non-monetary consideration shall not form
Gross Revenue until CRT has received cash proceeds from the
disposal or other realisation of such consideration. CRT shall not
determine the timing of and price for any realisation of the
Company’s share of non-monetary consideration without first
having notified and consulted the Company, but shall otherwise seek
to realise such non-monetary consideration at the earliest
opportunity that is consistent with securing a reasonable return.
For the avoidance of doubt, any dividend or similar monetary
consideration received in respect of such non-monetary
consideration shall form Gross Revenue.





 




4.4

Subject to Clause
4.5, CRT and the Company shall share any Royalties received by CRT
in each calendar quarter of the Royalty Term in the following
proportions:







 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


CRT
[***];


Company
[***],

 


provided that under
no circumstance other than that set out in Clause 4.5 shall CRT pay
the Company under this Clause 4.4 [***] in each such calendar
quarter. CRT shall include in any and all sub-licenses granted
under this Agreement obligations on its sub-licensee(s) to make
timely payments (on not less than a quarterly basis) of sufficient
royalties to CRT to ensure that CRT can meet its obligations under
this Clause 4.4.

 


In this
Clause 4.4, “Royalty
Term” means a period, on a Licensed
Product-by-Licensed Product, country-by-country basis, beginning on
the Effective Date and ending upon the later to occur
of:

 




4.4.1

the expiry of any
Data Exclusivity Period in respect of the data submitted for the
NDA for such Licensed Product in such country;





 




4.4.2

the expiry of ten
(10) years from the First Commercial Sale; and





 




4.4.3

the date when
unauthorised manufacture, sale or use of the Licensed Product would
no longer infringe a valid claim of the Company Patent Rights in
the country of sale or manufacture.





 




4.5

Without restricting
or limiting any of the Charity’s or CRT’s rights under
the CTOA, CRT may deduct as a first charge and set off from sums
due to the Company under this Clause 4 any and all sums of any
nature that are due and payable, but not yet paid, by the Company
to CRT or the Charity under or in connection with the CTOA
(including, without limitation, any sums due pursuant to Clause 9.2
or 12.2 of the CTOA).





 


 




5.

PAYMENT
AND STATEMENT





 




5.1

All payments due to
the Company under this Agreement shall be made in United States
Dollars in cleared funds to such bank account as Company may notify
to CRT from time to time.





 




5.2

CRT shall pay to
Company:





 




5.2.1

payments due under
Clause 4.1, Clause 4.2, and Clause 4.3 within thirty (30) days of
CRT receiving the revenue; and





 




5.2.2

the payments due
pursuant to Clause 4.4 Quarterly within thirty (30) days of the end
of each Quarter in which the corresponding Royalties are received
by CRT.





 




5.3

Where Licensed
Products are sold or Sub-Licence Revenue or Royalties are received
by CRT (or a Sub-Licensee) in a currency other than United States
Dollars, the rate of exchange to be used for converting such other
currency into United States Dollars shall be the relevant mid-spot
rate for the currency quoted by the Financial Times on the last day
of the Quarter to which they relate.





 




5.4

All costs of
transmission and currency conversion shall be borne by
CRT.





 




5.5

All payments to the
Company under this Agreement are expressed to be exclusive of value
added tax howsoever arising, and CRT shall pay to the Company in
addition to those payments or, if earlier, on receipt of a tax
invoice or invoices from the Company, all value added tax for which
the Company is liable to account in relation to any supply made or
deemed to be made for value added tax purposes pursuant to this
Agreement.





 




5.6

All sums payable
under this Agreement shall be paid without deduction or deferment
in respect of any claims whatsoever and of any taxes except any tax
which CRT is required by law to deduct or withhold. If CRT is
required by law to make any such tax deduction or withholding, CRT
shall pay to the Company such amount as shall, after deduction,
amount to the sum referred to in this Agreement give reasonable
assistance to the Company to claim exemption from or (if that is
not possible) a credit for the deduction or withholding under any
applicable double taxation or similar agreement from time to time
in force, and shall promptly give the Company proper evidence as to
the deduction or withholding and payment over of the tax deducted
or withheld.







 







 





 




5.7

Where the Company
does not receive payment of any sums due to it by the due date,
interest shall accrue both before and after any judgment on the sum
due and owing to the Company at the rate equivalent to an annual
rate of two percent (2%) over the then current base rate of the
Bank of England, calculated on a monthly basis, until the full
amount is paid to the Company, without prejudice to the
Company’s right to receive payment on the due
date.





 




5.8

Within thirty (30)
days after the end of each Quarter, CRT shall send to the Company a
written statement detailing in respect of that Quarter (including a
nil report if appropriate):





 




5.8.1

any payments which
became due to Company;





 




5.8.2

for each
sub-licence, details of each item of Sub-Licence Revenue received
by CRT during that Quarter and the Sub-Licence Revenue payable to
Company thereon;





 




5.8.3

the quantity of
each type of Licensed Product sold or otherwise disposed of by CRT
or any Sub-Licensees in each country in the Territory;





 




5.8.4

the Net Sales Value
in respect of each such type of Licensed Product in each country of
the Territory;





 




5.8.5

the aggregate Net
Sales Value in respect of that Quarter for Licensed
Product;





 




5.8.6

the type and value
of deductions made in the calculation of Net Sales Value by type of
Licensed Product and country;





 




5.8.7

any currency
conversions, showing the rates used;





 




5.8.8

any further
information necessary for the calculation of Sub-Licence Revenue
and Net Sales Value of Licensed Products and/or the Royalties due
to Company; and





 




5.8.9

the amount of the
Royalties due to Company in respect of that Quarter.





 

 




6.

ACCOUNTS





 




6.1

CRT
shall:





 




6.1.1

keep and
notwithstanding termination of this Agreement, maintain and shall
procure that each Sub-Licensee keeps and maintains, for at least
three (3) years, true and accurate accounts and records (including
any underlying documents supporting such accounts and records) in
sufficient detail to enable the amount of all sums payable under
this Agreement to be determined; and





 




6.1.2

during the Term and
thereafter until the said period of three (3) years relevant to the
accounts and records has expired, at the reasonable request of
Company and (subject to Clause 6.2) at the expense of the Company
from time to time, permit or procure permission for a qualified
accountant nominated by the Company to inspect and audit those
accounts and records and, to the extent that they relate to the
calculation of those sums, to take copies of them. Subject to
receiving not less than thirty (30) days written notice, CRT shall
at the request of the Company assemble in one location that is
respectively convenient to CRT and Sub-Licensee(s) all such
relevant accounts and records of CRT and all
Sub-Licensee(s).







 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 




6.2

If, following any
inspection pursuant to Clause 6.1.2, the Company’s nominated
accountant certifies to the Company that the payments in respect of
any Quarter or Year fall short of the sums which were properly
payable in respect of that Quarter or Year under this Agreement,
the Company shall send a copy of the certificate to CRT and CRT
shall (subject to Clause 6.3) within thirty (30) days of the date
of receipt of the certificate pay the shortfall to the Company and,
[***] of the sum properly payable, CRT shall also reimburse to the
Company the reasonable costs and expenses of the Company in making
the inspection.





 




6.3

If within fifteen
(15) days of the date of receipt by CRT any certificate produced
pursuant to Clause 6.2 CRT notifies the Company in writing that it
disputes the certificate, the dispute shall be referred for
resolution by Accountancy Opinion in accordance with Clause
12.1.





 

 




7.

XOMA
LICENCE





 




7.1

As of the Effective
Date and subject to any notices served pursuant to Clause 8.2.11 of
the CTOA, the Company hereby restates and gives the warranties and
representations set out in Clause 8.2 of the CTOA (save that
references in such provisions to: (i) the “Agreement”
shall mean this Agreement not the CTOA; (ii) to rights granted to
the Charity shall mean rights granted to CRT; and (iii) to the
“Commencement Date” shall mean the Effective Date). In
addition, the Company shall give as much notice as practicable to
CRT if the XOMA Licence is liable to be, or is summarily
terminated, and at CRT’s request use its commercially
reasonable endeavours to facilitate a continuance and an assignment
of the XOMA Licence to CRT.





 




7.2

CRT will be
responsible for paying directly to XOMA (US) LLC any XOMA Licence
Payments incurred after the Effective Date, in each case in
accordance with the terms of the XOMA Licence insofar as such XOMA
Licence Payments are triggered by, and only by, CRT or any of its
Sub-Licensee(s) or Affiliates. Each XOMA Licence Payment paid by
CRT shall be a Direct Cost. The Company will remain solely
responsible for all XOMA Licence Payments incurred prior to the
Effective Date.





 

 




8.

MANAGEMENT
AND EXPLOITATION





 




8.1

The filing,
prosecution, maintenance, enforcement and defence of any Company
Intellectual Property and further development and commercial
exploitation thereof shall be at the sole discretion of
CRT.





 

 




9.

CONFIDENTIALITY





 




9.1

Subject to the
other provisions of this Clause 9, each Party undertakes that both
during and after termination of this Agreement, it will keep
confidential and not disclose to any person other than to its
officers, employees or professional advisors whose province it is
to know, any confidential proprietary information of the other
Party disclosed to or obtained by it in connection with this
Agreement. For these purposes, Company Know-How shall be deemed to
be the confidential information of CRT but only to the extent such
Company Know-How pertains solely or directly to the Licensed
Product and the Field. Additionally, subject to the provisions of
Clause 9.2, any information of the Charity (and any charitable body
succeeding to it) disclosed to or obtained by the Company in
connection with this Agreement shall be deemed to be the
confidential information of the Charity.







 







 





 




9.2

With the exception
of Company Know-How which the Company shall keep confidential in
accordance with Clause 9.1, Clause 9.1 shall not apply
to:





 




9.2.1

information which
is or was already known to the receiving Party at the time of
disclosure under this Agreement, as shown by the receiving
Party’s written records, without any obligation to keep it
confidential;





 




9.2.2

information which
at the time of being disclosed or obtained by the receiving Party
under this Agreement or at any time thereafter, is published or
otherwise generally available to the public other than due to
default by the receiving Party of its obligations hereunder;
or





 




9.2.3

information which
is required to be disclosed by a competent Court or regulatory
authority or otherwise by applicable law or statute or any rule or
regulation of any Regulatory Authority or other government or
administrative agency or authority, to the extent of such
disclosure, provided that the receiving Party shall give notice of
such disclosure as soon as reasonably practicable.





 




9.3

Clause 9.1 above
shall not apply to the use or disclosure of any information by any
Party for the purpose of exercising or enforcing its rights under
this Agreement.





 




9.4

Each Party will
ensure that all personnel and third parties to whom confidential
information of another Party is disclosed are informed of the
provisions of this Clause 9.





 




9.5

So long as this
Agreement remains in effect, as between CRT and the Company only,
clause 5 of the CTOA shall cease to operate and this Clause 9 shall
replace and supersede the obligations and rights of CRT and the
Company only under such clause 5 of the CTOA.





 

 




10

WARRANTIES





 




10.1

The Company
represents and warrants to CRT that to the best of its knowledge
and belief:





 




10.1.1

it is not aware of
any inventors of the Company Patent Rights other than the inventors
named therein;





 




10.1.2

it is the legal and
beneficial owner of the Company Intellectual Property free of any
third party rights or encumbrances;





 




10.1.3

it has not and will
not enter into any Agreement which prevents it fulfilling its
obligations under this Agreement;





 




10.1.4

it has not done
anything whereby the whole or any part of the rights assigned or
licensed under the Agreement might be invalidated or registration
of them refused;





 




10.1.5

the manufacture,
use and possession of the Investigational Medicinal Product by CRT
or any person authorised by CRT shall not infringe the rights
(including without limitation any Intellectual Property Rights) of
any third party; and





 




10.1.6

it has not done or
omitted to do anything with respect to the Investigational
Medicinal Product which may materially prejudice the further
development of the Investigational Medicinal Product or adversely
affect any application which may be made to any regulatory
authority concerned with the approval of medicinal products and
their sale.





 




10.2

Nothing in this
Agreement shall be treated as imposing on CRT any liability to the
Company in relation to the further development and commercial
exploitation of the Investigational Medicinal Product or the
Company Intellectual Property.







 







 





 

 




11.

DURATION





 




11.1

This Agreement
shall come into force on the Effective Date and shall extend for so
long as CRT has the potential to receive Gross Revenue and/or
Royalties.





 

 




12.

DISPUTE
RESOLUTION





 




12.1

Insofar as this
Agreement provides that a matter shall be resolved by Accountancy
Opinion or Expert Opinion the opinion of such expert (who shall act
as an expert and not as an arbitrator) shall be final and binding
on the Parties. In the event of a Party seeking an Accountancy
Opinion or Expert Opinion under this Agreement, each Party shall
make written submissions to the expert so appointed and to the
other Party within fourteen (14) days of the appointment. Each
Party shall have seven (7) days to respond to the other’s
submissions. The expert shall be requested to deliver his
Accountancy Opinion or Expert Opinion within a further thirty (30)
days. The costs of any Accountancy Opinion or Expert Opinion shall
be borne in such proportions as the expert may determine in his
opinion to be fair and reasonable in all the circumstances or, if
no such determination is made in the opinion, by the Parties in
equal proportions.





 




12.2

It shall be a
condition precedent to the commencement of any action in court or
other tribunal (save an action for an interim injunction or an
Expert Opinion sought under Clause 12.1) in respect of any dispute
relating to this Agreement that the Parties have sought to resolve
the dispute by either Party notifying the other Party in writing
for resolution to the Chief Executive Officer (in the case of CRT)
and the Chief Executive Officer (in the case of the Company) (or
their express delegates) (the “Senior Executives”) who
shall meet (whether in person or via teleconference) within twenty
one (21) days of such notice to seek resolution in good faith. If
the Senior Executives are unable to resolve the dispute at such
meeting, either Party may pursue any remedy available to such Party
at law or in equity, subject to the terms and conditions of this
Agreement and the other agreements expressly contemplated
hereunder.





 

 




13.

GENERAL





 




13.1

The surviving terms
and conditions of the CTOA shall, in accordance with its terms,
continue in full force and effect.





 




13.2

This Agreement
shall be governed by and construed in accordance with English law
and each Party agrees to submit to the exclusive jurisdiction of
the English courts (except in respect of disputes under Clause 9
where jurisdiction is non-exclusive).





 




13.3

This Agreement may
be executed in any one or more number of counterpart agreements, as
scanned email attachments, and all signatures and counterparts so
exchanged shall be considered as original and shall be deemed to
form part of and together constitute this Agreement.





 


 

 


 


 

 


 




 








 







IN WITNESS whereof this document is executed by the parties
on the date stated at the beginning of this Agreement through their
authorised signatories


 


	

Signed
by:

	

_____________________________________

	
 


	
 

	
 

	
 


	

Name:

	

_____________________________________

	
 


	

Title:

	

_____________________________________

	
 


	
 

	
 

	
 


	
 

	

For
and on behalf of

	
 


	
 

	


CANCER RESEARCH TECHNOLOGY LIMITED

	
 


	
 

	
 

	
 


	
 

	
 

	
 


	
 

	
 

	
 


	
 

	
 

	
 


	
 

	
 

	
 


	
 

	
 

	
 


	

Signed
by:

	

_____________________________________

	
 


	
 

	
 

	
 


	

Name:

	

_____________________________________

	
 


	
 

	
 

	
 


	

Title:

	

 _____________________________________

	
 


	
 

	
 

	
 


	
 

	

For
and on behalf of

	
 


	
 

	


MONOPAR THERAPEUTICS LLC

	
 







 


 




 








 










 



ANNEX 1A



COMPANY PATENT RIGHTS


 



[Drafting note – Annex 1A to include those patents identified
in schedule 1 of the CTOA and any applications made during the term
of the CTOA relating to the Investigational Medicinal Product and
its use (e.g. formulation, manufacturing, etc.)]


 


	


PATENT/



APPLICATION NUMBER

	


TITLE

	


TERRITORY

	


FILING



DATE


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 







 


 


 



ANNEX 1B



COMPANY COMBINATION PATENT RIGHTS


 


	


PATENT/



APPLICATION NUMBER

	


TITLE

	


TERRITORY

	


FILING



DATE


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 







 


 


 


 



ANNEX 2



COMPANY KNOW-HOW


 


 


 


 



ANNEX 3



COMPANY MATERIALS


 


 


 


 


 


 




 








 







Schedule 6



Protocol


(copy
of protocol to be inserted here)


 




 








 










 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

Schedule
7



Company Materials


(insert
list of materials to be provided by the Company to the
Charity)


 


[***];
purified huATN-658 reference material.


 


 



Schedule 7 - Part 2



Company GMP Materials


(insert
list of GMP materials to be provided by the Company to the
Charity)


 


[***].



Schedule 8



Back-Up Antibodies


 


 


The
[***] known as [***], each of which is owned by the Company but, as
at the Commencement Date, are held by XOMA at its
premises.


 


 


 


 


 


 




 








 







Schedule 9



XOMA Licence


(copy
of XOMA Licence to be inserted here)


 


 




 








 






 



Schedule 10



Progress Reports


 


 









 







 






 



Schedule 11



Clinical Protocol Summary



(To be added to this Agreement within 3 months of
signing)




 








 







Schedule 12



Escrow Agreement


 




 








 






 



ESCROW AGREEMENT

 


 

 



THIS AGREEMENT is made the ________ day of ________ 2015
(the “Effective
Date”)

 



AMONG:

 



CANCER RESEARCH UK a company limited by guarantee registered
under number 4325234 and a charity registered under number 1089464
of Angel Building, 407 St. John Street, London, EC1V 4AD, England
(the “Charity”);

 



CANCER RESEARCH TECHNOLOGY LIMITED a company registered in
England and Wales with number 1626049 and registered office at
Angel Building, 407 St. John Street, London, EC1V 4AD, England
(“CRT”);

 



MONOPAR THERAPEUTICS LLC, a limited liability company
registered in/incorporated in/ established under the laws of The
State of Delaware, U.S.A., with registered office/principal place
of business at 598 Rockefeller Road, Lake Forest, Illinois, U.S.A.,
60045 (the “Company”); and

 



[NAME], as the escrow agent (the “Escrow Agent”).

 



WHEREAS:

 



(A) The Charity, CRT and the Company have entered into that
certain CLINICAL TRIAL AND OPTION
AGREEMENT (the “CTOA”), a true copy of which (as
executed) is attached hereto as Exhibit A, incorporated herein by
reference and made a part of this Agreement;

 



(B) The Charity, CRT and the Company further intend that the
Company shall hold in escrow, throughout the Escrow Period, Eight
Hundred Thousand Dollars ($800,000.00 USD) as collateral for the
liabilities of the Company under the CTOA (“Escrow
Consideration”);

 



NOW IT IS HEREBY AGREED as follows:

 


1. Escrow.

 


1.1
Escrow Fund. The
Escrow Agent shall immediately establish and open an account to
receive, invest, hold and disburse the funds that constitute (i)
the Escrow Consideration (the “Escrow Fund”) and (ii) the Escrow
Earnings (defined below). That account is referred to as the
“Escrow
Account”.

 


1.2
Appointment. CRT,
the Charity, and the Company hereto hereby appoint, and the Escrow
Agent hereby accepts such appointment as, and agrees to act
throughout the Escrow Period as, the escrow agent to hold,
safeguard and disburse the Escrow Fund and the Escrow Earnings
(defined below) pursuant to the terms and conditions
hereof.

 


1.3
Deposit. Within
fourteen (14) days of the Effective Date, the Company shall deposit
the Escrow Consideration in the Escrow Account and provide written
evidence of the same to CRT and the Charity.

 


1.4
Investment of the Escrow
Consideration.

 


(a) The
Escrow Agent agrees to invest and reinvest funds in the Escrow
Account, but only upon written instruction signed by an authorized
agent of the Company, and only in one or more of the following
investments (the “Permitted
Investments”) from time to time: (i) bank accounts;
(ii) bank money-market accounts; (iii) short-term certificates of
deposit; or (iv) short-term securities issued or guaranteed by the
United States government.



 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


(b) The
Company, the Charity, and CRT recognize and agree that the Escrow
Agent will not provide supervision, recommendations or advice
relating to either the investment of moneys held in the Escrow
Account or the purchase, sale, retention or other disposition of
any Permitted Investment. Interest and other earnings on Permitted
Investments shall be added to the Escrow Account and disbursed in
accordance with Sections 4 and 5 hereof. Without prejudice to
Section 2, any loss or expense incurred as a result of an
investment will be borne by the Escrow Account. In the event that
the Escrow Agent does not receive directions to invest funds held
in the Escrow Account, the Escrow Agent shall invest such funds in
bank money-market accounts.

 


(c) The
Escrow Agent is hereby authorized to execute purchases and sales of
Permitted Investments through the facilities of its own trading or
capital markets operations or those of any affiliated entity. The
Escrow Agent shall send statements to the Company hereto on a
monthly basis reflecting activity in the Escrow Account for the
preceding month. Although the Company recognizes that it may obtain
a broker confirmation or written statement containing comparable
information at no additional cost, the Company hereby agrees that
confirmations of Permitted Investments are not required to be
issued by the Escrow Agent for each month in which a monthly
statement is rendered. No statement need be rendered for the Escrow
Account if no activity occurred for such month. The Company shall
send statements to CRT hereto on a quarterly basis stating the
balance of funds in the Escrow Account for the preceding
quarter.

 


(d) The
Escrow Agent shall sell or redeem any Permitted Investments as
necessary to make any payments or distributions required under this
Agreement. The Escrow Agent shall have no responsibility or
liability for any loss which may result from any investment made
pursuant to, and in accordance with, this Agreement, or for any
loss resulting from the authorized sale of such
investment.

 


(e)
Proceeds of the sale of investments will be delivered on the
business day on which the appropriate instructions are received by
the Escrow Agent if received prior to the deadline for same day
sale of such permitted investments. If such instructions are
received after the applicable deadline, proceeds will be delivered
on the next succeeding business day.

 


(f)
Investments will be made promptly following the availability of
such funds to the Escrow Agent taking into consideration the
regulations and requirements (including investment cut-off times)
of the Federal Reserve wire system, any investment provider and the
Escrow Agent.

 


(g) The
Company, the Charity, and CRT shall furnish the Escrow Agent with a
completed Form W-8 or Form W-9, as applicable.

 


1.5
Purpose of the Escrow
Fund. The Escrow Fund shall be held by the Escrow Agent to
provide a source of collateral for the liabilities of the Company
under the CTOA.

 


1.6
Escrow Period. The
“Escrow Period”
shall mean the period commencing on the Effective Date and ending
on the earlier of:

 


(i) the
date that [***];

 


(ii) by
mutual written agreement between the Company, CRT, and the Charity
to terminate this Agreement for any reason; or



 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


(iii)
five (5) years from the Effective Date of the CTOA;

 


(the
“Claim Expiration
Date”); provided that if there are any Claims that are
not Resolved at the end of such period, the Escrow Period shall
extend automatically beyond the Claim Expiration Date and continue
until such time as all Claims have been Resolved.

 


The
Company, CRT, and the Charity shall jointly deliver to Escrow Agent
written notice upon the end of the Escrow Period, unless it has
been five (5) years since the Effective Date of the CTOA, in which
case no notice is required.

 


“Resolved” shall mean, in respect
of a Claim, that the Claim has been (i) agreed in writing between
the Company, the Charity and CRT as to both liability and quantum;
(ii) finally determined (as to both liability and quantum) pursuant
to Section 5 or, if applicable, by a court of competent
jurisdiction from which there is no right of appeal, or from whose
judgment the relevant Party is debarred (by passage of time or
otherwise) from making an appeal, including in situations where the
Claim relates to a third party claim brought against the Charity,
CRT or a Charity Indemnitee; or (iii) unconditionally withdrawn by
the Charity and CRT in writing; and, in each case, all sums due to
the Charity or CRT under this Agreement in respect of such Claim
have been paid.

 


1.7
Instructions. All
instructions required under this Agreement will be delivered to
Escrow Agent in writing, in either original or facsimile form,
executed by an authorized person of each of the Company, CRT, and
the Charity. Escrow Agent reserves the right to telephone an
authorized person to confirm the details of such instructions or
documents.

 


1.8
Taxes and Income
Distributions.

 


(a)
Ownership of Funds in
Escrow. For U.S. federal income tax purposes, the parties
hereto agree that the Company shall be treated as owning the funds
in the Escrow Fund.

 


(b)
Treatment of Escrow Fund
Earnings. The Company shall include in its taxable income
all interest, dividends and other income earned on the amounts in
the Escrow Fund (the “Escrow
Earnings”), and the Escrow Agent shall make
distributions to the Company (“Income Distributions”), at the end
of each calendar quarter and upon the final distribution out of the
Escrow Fund, [***]; provided that in no circumstance shall Income
Distributions result in the Escrow Fund falling below eight hundred
thousand US dollars ($800,000 USD).

 


2.
Maintenance of Escrow
Fund.

 


2.1
Minimum. The
Company shall ensure at all times during the Escrow Period that the
Escrow Fund is at least equal to the difference between (i) the
amount of eight hundred
thousand US dollars ($800,000 USD), and (ii) [***] in
connection with Claims made under Section 5.1 (the
“Escrow
Balance”). The Company shall also ensure at all times
during the Escrow Period that the Escrow Balance is available for
payment to the Charity or CRT in connection with Claims allowed
under Section 5.

 


2.2
Additional
Deposits. If, for any reason, at any time during the Escrow
Period the Escrow Fund is less than the Escrow Balance, the Company
shall immediately make any additional deposits in the Escrow
Account, and take any other steps, needed to ensure that it meets
its obligations under Section 2.1.



 







 





 


3.
Fees. The Escrow
Agent shall be entitled to receive a fee for its services under
this agreement. The fee shall be ____________________. Fees are
payable by the Company and shall not be paid out of or deducted
from the Escrow Fund.

 


4.
Disbursement.
Promptly after the Escrow Period, the Escrow Agent shall deliver to
the Company all funds remaining in the Escrow Fund.

 


5.
Claims Upon the Escrow
Fund; Objections to
Claims; Resolution
of Conflicts.

 


5.1
Claims Upon Escrow
Fund. By written notice to the Escrow Agent and the Company,
CRT and the Charity shall have the right to make a Claim upon the
Escrow Fund at any time during the Escrow Period before 5:00 p.m.
Eastern Standard Time on the Claim Expiration Date upon any failure
by the Company to fully discharge any of its obligations under, or
fully meet its liabilities arising under or in connection with, the
CTOA (each, a “Claim”), including
if:

 


(a) the
Company fails to fully discharge its obligations under Clause 9.2
of the CTOA. Subject to Clause 13 of the CTOA, CRT or the Charity,
but not both, shall have the right to receive from the Escrow Agent
an amount out of the Escrow Fund equal to the amount the Company
has failed to cover to fully discharge its obligations under Clause
9.2 of the CTOA. Such right shall include the right of the Charity
or CRT to make Claims on behalf of Charity Indemnitees, and receive
from the Escrow Agent an amount out of the Escrow Fund equal to the
amount payable by the Company to Charity Indemnitees, under the
CTOA; and

 


(b) the
Company fails to pay amounts owed to the Charity under Clause
12.2.2 of the CTOA upon termination of the CTOA by CRT or the
Charity pursuant to Clause 11.2 or 11.4. Subject to Clause 13 of
the CTOA, CRT or the Charity, but not both, shall have the right to
receive from the Escrow Agent an amount out of the Escrow Fund
equal to the amount the Company owes the Charity.

 


The
Charity’s and CRT’s rights under this Section 5.1 are
subject to Section 5.4.

 


5.2
Objections to
Claims.

 


(a) At
the time of delivery of a written notice of a Claim to the Escrow
Agent and the Company by CRT or the Charity, and for a period of
twenty (20) days after such delivery is made to the Company, the
Escrow Agent shall make no delivery to CRT, the Charity, or the
Charity Indemnitees of any amount from the Escrow Fund pursuant to
Section 5.1 hereof unless the Escrow Agent shall have received
written authorization from the Company to make such delivery. After
the expiration of such twenty (20) day period, the Escrow Agent
shall pay and deliver funds (in US dollars) claimed by the Charity
or CRT from the Escrow Fund to an account designated by the Charity
or CRT; provided, however, that no such payment or delivery may be
made if the Company shall object in a written statement to the
Claim made in the written notice, and such statement shall have
been delivered to the Escrow Agent, the Charity and CRT prior to
the expiration of such twenty (20) day period.

 


(b) The
Company shall furnish CRT and the Charity with detailed written
reason(s) for its objection at the same time as it delivers its
objection to any Claim.

 


(c) The
Company shall not unreasonably object to any Claim made to the
Escrow Agent by CRT or the Charity, including by making any
objection that has no reasonable prospect of being upheld if
referred to arbitration.



 







 





 

 


5.3
Resolution of
Conflicts; Arbitration.

 


(a) In
case the Company shall object in writing to any Claim or Claims
made in any written notice by CRT or the Charity, the Company, CRT,
and the Charity shall attempt in good faith to agree upon the
rights of the respective parties with respect to each of such
Claims. If the Company, CRT, and the Charity should so agree, a
memorandum setting forth such agreement shall be prepared and
signed by the parties and shall be furnished to the Escrow Agent.
The Escrow Agent shall be entitled to rely on any such memorandum
and distribute funds or withhold payments from the Escrow Fund in
accordance with the terms thereof.

 


(b) If
no such agreement can be reached within twenty (20) business days
after delivery of the Company’s written objection to CRT or
the Charity’s Claim in the written notice notwithstanding
good faith negotiation, any of the Company, CRT or the Charity may
demand arbitration of the matter. The Company, CRT, or the Charity
shall, within twenty (20) days of the demand, mutually select one
independent arbitrator with at least five (5) years relevant
experience; provided, however, that if the Company, CRT, and the
Charity cannot agree upon one arbitrator during such twenty (20)
day period, the Company, on the one hand, and CRT and the Charity,
on the other, shall, within five (5) days following such twenty
(20) day period, each select one arbitrator and the two arbitrators
so selected shall select a third arbitrator, each of which
arbitrators shall be independent and have at least five (5) years
relevant experience. The arbitrator(s) shall set a limited time
period and establish procedures designed to reduce the cost and
time for discovery to the extent possible while allowing the
parties an opportunity, adequate in the sole judgment of the
arbitrators, to discover relevant information from the opposing
parties about the subject matter of the dispute. The arbitrator(s)
shall rule upon motions to compel or limit discovery and shall have
the authority to impose sanctions, including attorneys’ fees
and costs, should the arbitrator(s) determine that discovery was
sought without substantial justification or that discovery was
refused or objected to without substantial justification. The
decision of the arbitrator (or, in the case of three arbitrators, a
majority of the three arbitrators) as to the validity and amount of
any Claim in such written notice shall be binding and conclusive
upon the parties to this Agreement, and notwithstanding anything in
Section 5.2 hereof, the Escrow Agent shall act in accordance with
such decision and make or withhold payments out of the Escrow Fund
in accordance therewith. Such decision shall be written and shall
be supported by written findings of fact and conclusions which
shall set forth the award, judgment, decree or order awarded by the
arbitrator(s). The arbitrator(s) shall also have the authority to
award additional sums to the Charity and CRT, and reimbursement of
attorneys’ fees and costs, should the arbitrator(s) determine
that the objection had no reasonable prospect of being
upheld.

 


(c)
Judgement upon any award rendered by the arbitrators may be entered
in any court having jurisdiction. Any such arbitration shall be
held in London, England, under the International Arbitration Rules
of the International Centre for Dispute Resolution then in
effect.

 


(d)
Each party shall bear its own fees and costs in connection with the
arbitration. The fees, costs and expenses of the arbitrator(s), if
any, shall be apportioned between the Company, on the one hand, and
CRT and the Charity, on the other, based upon the inverse
proportion of the amount of disputed items resolved in favor of
such party (i.e., so that the prevailing party bears a lesser
amount of such fees and expenses).

 


5.4
Limit. The maximum
aggregate amount that the Charity and CRT may claim, and that is
payable to them, from the Escrow Account to satisfy any and all
Claims made under this Agreement shall be eight hundred
thousand US dollars ($800,000 USD). The rights granted under
this Agreement are in addition to, and not instead of, any rights
of the Charity and CRT under or in connection with the CTOA,
whether under contract, statute or tort. Nothing in this Agreement
shall, or is intended to, limit such rights, including where sums
paid under this Agreement do not fully discharge the
Company’s liabilities.



 







 





 


6.
Limitation on Escrow
Agent’s Liability. The Escrow Agent’s
responsibilities and liabilities shall be limited as
follows:

 


6.1 The
Escrow Agent shall not be responsible for or be required to enforce
any of the terms or conditions of the CTOA or any other agreement
between the parties thereto. The Escrow Agent shall not be
responsible or liable in any manner whatsoever for the performance
by the Company, CRT, or the Charity of their respective obligations
under the CTOA or this Agreement, nor shall the Escrow Agent be
responsible or liable in any manner whatsoever for the failure of
any party to the CTOA to honor any of the provisions of the
CTOA.

 


6.2 The
duties and obligations of the Escrow Agent shall be limited to and
determined solely by the express provisions of this Agreement and
the CTOA, and no implied duties or obligations shall be read into
this Agreement against the Escrow Agent. The Escrow Agent shall
neither be responsible for, nor chargeable with, knowledge of the
terms and conditions of any other agreement, instrument or document
other than this Escrow Agreement or the CTOA, whether or not a copy
and/or original of such agreement is held by Escrow Agent; and, the
Escrow Agent shall have no duty to know or inquire as to the
performance or nonperformance of any provision of any such
agreement, instrument or document. This Escrow Agreement sets forth
all matters pertinent to the escrow contemplated hereunder, and no
additional obligations of the Escrow Agent shall be inferred from
the terms of this Escrow Agreement or any other agreement,
instrument or document. All references in this Escrow Agreement to
any other agreement (other than the CTOA) are for the convenience
of the parties other than the Escrow Agent, and the Escrow Agent
has no duties or obligations with respect thereto.

 


6.3 The
Escrow Agent shall be entitled to rely upon and shall be protected
in acting in reliance upon any instruction, notice, information,
certificate, instrument or other document which is submitted to it
in connection with its duties under, and in accordance with, this
Agreement and which the Escrow Agent in good faith believes to have
been signed or presented by the proper party or parties. The Escrow
Agent shall have no liability with respect to the form, execution,
validity or authenticity thereof.

 


6.4 The
Escrow Agent shall be entitled to consult, at its own cost, with
independent counsel of its own selection and the opinion of such
counsel shall be full and complete authorization and protection to
the Escrow Agent in respect of any action taken or omitted by the
Escrow Agent hereunder in good faith and in accordance with the
opinion of such counsel, unless caused by or arising from its own
fraud, gross negligence or willful misconduct.

 


6.5 The
Escrow Agent shall have no responsibility or liability for any
diminution in value of any assets held under this agreement which
may result from any investments or reinvestments made in accordance
with any provision which may be contained in this
agreement.

 


6.6 The
Escrow Agent shall not be liable for any action taken or omitted
under this Agreement while acting in good faith, unless caused by
or arising from its own fraud, negligence or
misconduct.

 


6.7 The
Escrow Agent shall have the right to perform any of its duties
hereunder through custodians or nominees, and shall be liable for
all acts and omissions of such custodians or nominees as if they
were acts or omissions of the Escrow Agent.



 







 





 


6.8 Any
banking association or corporation into which the Escrow Agent may
be merged, converted or with which the Escrow Agent may be
consolidated, or any corporation resulting from any merger,
conversion or consolidation to which the Escrow Agent shall be a
party, or any banking association or corporation to which all or
substantially all of the corporate trust business of the Escrow
Agent shall be transferred, shall succeed to all of the Escrow
Agent’s rights, obligations and immunities hereunder without
the execution or filing of any paper or any further act on the part
of any of the parties hereto, anything herein to the contrary
notwithstanding.

 


6.9 The
Escrow Agent shall have the right at any time to resign for any
reason and be discharged of its duties as Escrow Agent hereunder by
giving written notice of its resignation to the parties hereto at
least thirty (30) calendar days prior to the date specified for
such resignation to take effect. In addition, the Company, the
Charity and CRT may remove the Escrow Agent as escrow agent at any
time with or without cause, by an instrument given to the Escrow
Agent, which instrument shall be signed by each of the Company, the
Charity and CRT and shall designate the effective date of such
removal. In the event of any such resignation or removal, a
successor escrow agent which, unless the Company, CRT, and the
Charity otherwise agree in writing, shall be a bank or trust
company organized under the laws of the United States of America or
of the State of Illinois shall be appointed by Company with the
approval of CRT and the Charity, which approval shall not be
unreasonably delayed, conditioned, or withheld. Any such successor
escrow agent shall deliver to Company, CRT and the Charity a
written instrument accepting such appointment, and thereupon it
shall succeed to all the rights and duties of the Escrow Agent
hereunder and shall be entitled to receive the Escrow Fund. All
responsibilities of the Escrow Agent hereunder shall cease and
terminate on the effective date of its resignation or removal and
its sole responsibility thereafter shall be to hold the Escrow Fund
for a period of thirty (30) calendar days following the effective
date of resignation or removal, at which time:

 


(1) if
a successor Escrow Agent shall have been appointed and written
notice thereof shall have been given to the resigning or removed
Escrow Agent by parties hereto and the successor Escrow Agent, then
the resigning Escrow Agent shall deliver the remaining Escrow Fund
to the successor Escrow Agent; or

 


(2) if
a successor Escrow Agent shall not have been appointed, for any
reason whatsoever, the resigning or removed Escrow Agent shall
deliver the Escrow Fund to a court of competent jurisdiction in the
County of New York, New York and give written notice of the same to
Company, CRT, and the Charity.

 


6.10 In
the event that the Escrow Agent shall be uncertain as to its duties
or rights hereunder or shall receive instructions with respect to
the Escrow Fund, which, in its sole discretion, are in conflict
either with other instructions received by it or with any provision
of this Agreement, the Escrow Agent shall have the absolute right
to suspend all further performance under this Agreement (except for
the safekeeping and investment of the Escrow Fund) until such
uncertainty or conflicting instructions have been resolved by
alternative dispute resolution, to the Escrow Agent’s sole
satisfaction, pursuant to Section 7 hereof or by final judgment of
a court of competent jurisdiction, joint written instructions
executed by all parties hereto, or otherwise. In the event that any
controversy arises between one or more of the parties hereto or any
other party with respect to this Agreement and/or the Escrow Fund,
the Escrow Agent shall not be required to determine the proper
resolution of such controversy or the proper disposition of the
Escrow Fund.  In such event, and without the consent or
approval of any other party, (i) the Escrow Agent shall have the
absolute right, in its sole discretion, to deposit; and (ii) the
Company shall have the absolute right, in its sole discretion, to
require the Escrow Agent to deposit, the cash remaining in the
Escrow Fund with the clerk of a court of competent jurisdiction
specified in Section 6 hereof, file a suit in interpleader in that
court and obtain an order from that court requiring all parties
involved to resolve their respective claims to the Escrow Fund
pursuant to Section 6. Upon the deposit by the Escrow Agent of the
Escrow Fund with the clerk of that court in accordance with this
provision, the Escrow Agent shall be relieved of all further
obligations, and the Company shall have no obligation to restore
the Escrow Balance under Section 2.



 







 





 


6.11
The Company shall indemnify and hold the Escrow Agent harmless from
and against all liabilities, causes of action, claims, demands,
judgments, damages, reasonable costs and expenses that may arise
out of or in connection with the Escrow Agent’s good faith
acceptance of and performance of its duties and obligations under
this Agreement, except to the extent related to acts or omissions
of the Escrow Agent in bad faith constituting fraud, gross
negligence or willful misconduct or otherwise in breach of this
Agreement. The provisions of this Section 6.11 shall survive the
resignation or removal of the Escrow Agent and the termination of
this Agreement.

 


7.
Dispute
Resolution/Governing Law.

 


7.1
This Agreement shall be governed by and construed in accordance
with the laws of the State of New York without giving
effect to the principles of conflicts of laws (other than Section
5-1401 of the New York General Obligations
Law). 

 


7.2
Subject to Section 5.3(c), the parties hereto intend that all
disputes between the parties arising out of or related to this
Agreement shall be settled by the parties amicably through
good-faith discussions upon the written request of any
party.

 


7.3 In
the event that any such dispute cannot be resolved thereby within a
period of twenty (20) days after such notice has been given, such
dispute shall be resolved by binding arbitration, which shall take
place in the County of New York, New York,
administered by and in accordance with the then-existing
International Arbitration Rules of the International Centre for
Dispute Resolution. 

 


7.4 An
award rendered in connection with an arbitration pursuant to this
Section 7 shall be final and binding upon the parties, and the
parties agree and consent that the arbitral award shall be
conclusive proof of the validity of the determinations of the
arbitrations set forth in the award, and judgment upon any award
rendered by the arbitrators may be entered by any state or federal
court having jurisdiction thereof.

 


7.5
This Section 7 is subject to the terms of Section 10
hereof.

 


8.
Notices. All
notices and other communications given or made pursuant hereto
shall be in writing and shall be deemed to have been duly given or
made as of the date delivered, mailed or transmitted, and shall be
effective upon receipt, if delivered personally, mailed by
registered or certified mail (postage prepaid, return receipt
requested) or sent by fax (with immediate confirmation) or
internationally recognized overnight courier service, as
follows:

 


If to
the Company, to:

 


Monopar
Therapeutics LLC

 


598
Rockefeller Road

 


Lake
Forest, IL USA 60045

 


Contact:
Chief Executive Officer

 


 

 


If to
the Charity or CRT, to:

 


Angel
Building

 


407 St.
John Street

 


London
EC1V 4AD

 


United
Kingdom

 


Contact:
Chief Executive Officer and Director of Centre for Drug
Development

 


Fax:
+44 (0) 20 3014 8633



 







 





 


If to
the Escrow Agent, to:

 


[]

 


[]

 


[]

 


Attn:

 


Fax:

 


9.
Interpretation and
Construction of Agreement.

 


9.1
Unless the context shall otherwise require, any pronoun herein
shall include the corresponding masculine, feminine, and neuter
forms, and words using the singular or plural number shall also
include the plural or singular number, respectively. The words
“include,” “includes” and
“including” herein shall be deemed to be followed by
the phrase “without limitation” and the word
“or” shall include the meaning “either or
both.” All references herein to sections, exhibits, and
schedules shall be deemed to be references to sections of, and
exhibits and schedules to, this Agreement unless the context shall
otherwise require. The headings of the sections herein are inserted
for convenience of reference only and are not intended to be a part
of or to affect the meaning or interpretation of this Agreement.
Unless the context shall otherwise require, any reference herein to
any agreement, other instrument, statute or regulation is to such
agreement, instrument, statute or regulation as amended and
supplemented from time to time (and, in the case of a statute or
regulation, to any successor provision).

 


9.2 The
Company, CRT, and the Charity acknowledge that each has
participated in the drafting of this Agreement and that any rule of
construction to the effect that ambiguities are to be resolved
against the drafting party shall not be applied in the construction
or interpretation of this Agreement.

 


9.3 Any
reference herein to a “day” or a number of
“days” (without the explicit qualification of
“business”) shall be interpreted as a reference to a
calendar day or number of calendar days. If any action or notice is
to be taken or given on or by a particular calendar day, and such
calendar day is not a business day, then such action or notice
shall be deferred until, or may be taken or given on, the next
business day.

 


10.
Specific
Performance. Each party agrees that irreparable harm, for
which there may be no adequate remedy at law and for which the
ascertainment of damages would be difficult, would occur in the
event any of the provisions of this Agreement were not performed in
accordance with its specific terms or were otherwise breached. Each
party accordingly agrees that the other parties shall be entitled
to specifically enforce this Agreement and to obtain an injunction
or injunctions to prevent breaches of the provisions of this
Agreement and to enforce specifically the terms and provisions
hereof or thereof, in each instance without being required to post
bond or other security and in addition to, and without having to
prove the adequacy of, other remedies at law.

 


11.
Counterpart Signatures,
Electronic Communication Delivery. This Agreement may be
executed in one or more counterparts and delivered by electronic
communication, all of which shall be considered one and the same
agreement, and shall become effective when one or more counterparts
have been signed by each of the parties and delivered to the other
parties, it being understood that all parties need not sign the
same counterpart.



 







 





 


12.
Entire Agreement.
This Agreement and the documents, instruments and other agreements
specifically referred to herein or delivered pursuant hereto (a)
constitute the entire agreement among the parties with respect to
the subject matter hereof and (b) supersede all prior agreements
and understandings, both written and oral, among the parties with
respect to the subject matter hereof.

 


13.
Amendment; Waiver;
Requirement of Writing. This Agreement may be amended,
modified, superseded, rescinded, or canceled only by a written
instrument executed by the Company, CRT, the Charity, and the
Escrow Agent. Any term or condition of this Agreement may be waived
at any time by the party hereto entitled to the benefit thereof,
and any such term or condition may be modified at any time by an
agreement in writing executed by each of the parties hereto
entitled to the benefit thereof. No delay or failure on the part of
any party in exercising any rights hereunder, and no partial or
single exercise thereof, will constitute a waiver of such rights or
of any other rights hereunder.

 


14.
Expenses. Each of
the parties hereto shall bear, without right of reimbursement from
any other party, all the costs incurred by it incident to the
preparation, execution, and delivery of this Agreement or the
performance of its obligations hereunder, whether or not the
transactions contemplated by this Agreement shall be
consummated.

 


15.
No Third-Party
Beneficiaries. Nothing in this Agreement will be construed
as giving any person, other than the parties, their successors and
permitted assigns, any right, remedy, or claim under or in respect
of this Agreement or any provision hereof; it being acknowledged
that (i) this Section 15 is without prejudice to the rights of the
Charity Indemnitees under the CTOA; (ii) the Charity and CRT may
make Claims under this Agreement on behalf of the Charity
Indemnitees in respect of Claims made by the Charity Indemnitees
under the CTOA; and (iii) the Escrow Agent may make payments to the
Charity and/or CRT on behalf of such Charity Indemnitees in respect
of such Claims, but only after the Escrow Agent has received
written confirmation from such Charity Indemnitees of the authority
of the Charity and/or CRT to receive such payments on behalf of
such Charity Indemnitees..

 


16.
Disclaimer of
Agency. Except for any provisions herein expressly
authorizing one party to act for another, this Agreement shall not
constitute any party as a legal representative or agent of any
other party, nor shall a party have the right or authority to
assume, create, or incur any liability of any kind, expressed or
implied, against or in the name or on behalf of any other party or
any of such other party’s affiliates.

 


17.
Relationship of the
Parties. Nothing contained in this Agreement is intended to,
or shall be deemed to, create a partnership or joint venture
relationship among the parties hereto or any of their affiliates
for any purpose, including tax purposes.

 


18.
Assignment. This
Agreement and the rights and obligations of each party hereunder or
thereunder shall be binding upon, and inure to the benefit of, the
parties hereto and their respective successors and permitted
assigns. None of the Company, CRT or the Charity shall assign this
Agreement without the prior written consent of each other, which
consent may not be unreasonably conditioned, delayed, or withheld.
Assignment by Escrow Agent shall be governed by Section 6
hereof.

 


19.
Severability. In
the event that any provision of this Agreement, or the application
thereof, becomes or is declared by a court of competent
jurisdiction to be illegal, void or unenforceable, the remainder of
this Agreement will continue in full force and effect, and the
application of such provision to other persons or circumstances
will be interpreted so as reasonably to effect the intent of the
parties hereto. The parties further agree to replace such void or
unenforceable provision of this Agreement with a valid and
enforceable provision that will achieve, to the extent possible,
the economic, business and other purposes of such void or
unenforceable provision.



 







 





 


20.
Several Liability.
The obligations and liabilities of each party under this Agreement
are several, not joint.

 



[Signatures on following page]

 


 

 


 




 








 






 



IN WITNESS whereof this Agreement has been executed by duly
authorised officers of the parties on the day first above
written.

 


 

 



Signed
by:                                 


_____________________________________





 



Name:                                 


_____________________________________





 



Title:                                 


_____________________________________





 


For and
on behalf of

 


CANCER
RESEARCH TECHNOLOGY LIMITED

 


 

 



Signed
by:                                 


_____________________________________





 



Name:                                 


_____________________________________





 



Title:                                 


_____________________________________





 


For and
on behalf of

 


CANCER
RESEARCH UK

 


 

 



Signed
by:                                 


_____________________________________





 



Name:                                 


_____________________________________





 



Title:                                 


_____________________________________





 


For and
on behalf of

 


MONOPAR
THERAPEUTICS LLC

 


 

 



Signed
by:                                 


_____________________________________





 



Name:                                 


_____________________________________





 



Title:                                 


_____________________________________





 


For and
on behalf of

 


[ESCROW
AGENT]

 



Signature Page to Escrow Agreement

 


 

 



Exhibit A

 


Clinical
Trial and Option Agreement

 


 




 








 







Schedule 13

 



Technical Agreement (Standard Form)


 




 








 






 


	
 


	
 

	
 

	
 

	
 


	


 TECHNICAL AGREEMENT


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	

between


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	


Cancer Research UK


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	


and


	
 

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	


MONOPAR THERAPEUTICS LLC


	
 

	
 

	
 


	
 

	
 

	
 

	
 


	

The
Cancer Research UK Centre for Drug Development is the Sponsor of
clinical trials where the investigational medicinal product (IMP,
including the master cell bank and bulk drug substance where
applicable) is manufactured, and/or analysed, and/or labelled,
and/or stored, and/or shipped by Cancer Research UK The Sponsor has
obligations with respect to all aspects of the management of the
IMP in the clinical trial.This document is a technical agreement
that meets the requirements of European Good Manufacturing Practice
(GMP) legislation 2003/94/EC. This document should also be
interpreted with respect to the European Clinical Trials
legislation 2001/20/EC and Eudralex Volume 4, Annex 13, paragraph
36 and 37 regarding reference and retention samples.


	

The
technical agreement takes the form of a detailed check list of all
the activities associated with manufacturing, packaging, storage
and distribution of the huATN-658 master cell bank  It defines the individual
responsibilities of Monopar
Therapeutics and of Cancer
Research UK and in particular defines who is responsible for
the GMP aspects of the activities listed. Responsibility for each
activity is assigned to either party in the appropriate tick box.
If any element of the check list does not apply, it should be
clearly crossed through not left blank. More detail may be added as
necessary to clarify particular points to ensure that only one
party is responsible for each point.


	

	

	

	

	

	

	

	
 


	
 

	
 

	
 

	
 


	


Technical Agreement Signatures


	
 

	
 

	
 

	
 


	


Contract Giver


	

Company
Name

	


Cancer Research UK Biotherapeutics Development Unit

	
 

	
 


	

Address

	


Clare Hall

	
 

	
 








 







 





 


	
 

	


Potters Bar

	
 

	
 


	
 

	


Hertfordshire

	
 

	
 


	
 

	


EN6 3LD

	
 

	
 


	

Position

	


Qualified Person

	
 

	
 


	

Name

	


Dr Robert Scott

	
 

	
 


	

Authorised
signatory

	
 

	
 

	
 


	

Date

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	

Company
Name

	


Cancer Research UK Centre of Drug Development (Contract
Giver)

	
 


	

Address

	


Angel Building

	
 

	
 


	
 

	


407 St John Street

	
 

	
 


	
 

	


London EC1V 4AD

	
 

	
 


	
 

	
 

	
 

	
 


	

Position

	


Drug Supply Manager

	
 

	
 


	

Name

	


Dr Nigel Westwood

	
 

	
 


	

Authorised
signatory

	
 

	
 

	
 


	

Date

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	


CONTRACT ACCEPTOR


	

Company
Name

	


MONOPAR THERAPEUTICS LLC

	
 

	
 


	

Address

	


598 Rockefeller Road

	
 

	
 


	
 

	


Lake Forest, Illinois

	
 

	
 


	
 

	


U.S.A., 60045

	
 

	
 


	
 

	
 

	
 

	
 


	

Position

	
 

	
 

	
 


	

Name

	
 

	
 

	
 


	

Authorised
signatory

	
 

	
 

	
 


	

Date

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	

Authorised
signatory

	
 

	
 

	
 


	

Date

	
 

	
 

	
 


	
 

	
 

	
 

	
 


	


Purpose

	

This
Technical Agreement assigns the responsibilities of Monopar
Therapeutics and Cancer Research UK with respect to the huATN-658
master cell bankNote: Monopar Therapeutics has outsourced the
manufacture and storage of the master cell bank. Therefore, some
aspects of these activities may be delegated by Monopar
Therapeutics to third parties. However, Monopar Therapeutics
remains responsible for oversight of those functions as outlined in
the Technical Agreement.








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	
 

	
 

	
 

	
 


	


Definitions and Acronyms


	

BDU

	

Biotherapeutics
Development Unit

	
 

	
 


	

CA

	

Contract
Acceptor

	
 

	
 


	

CG

	

Contract
Giver

	
 

	
 


	

GMP

	

Good
Manufacturing Practice

	
 

	
 


	

EU

	

European
Union

	
 

	
 


	

EU
GMP

	

European
Union current Good Manufacturing Practice as defined in directive
2003/94/EC

	
 

	
 


	

IMP

	

Investigational
Medicinal Product = drug product (unless otherwise stated IMP means
manufactured to EU cGMP or its equivalent)

	
 

	
 


	

MCB

	

[***]



	
 

	
 


	

QP

	

Qualified
Person

	
 

	
 


	

Retention

	

A
sample of a packaged unit from a batch of finished

	
 

	
 


	

sample

	

product
for each packaging run/trial period. It is stored for

	
 

	
 


	
 

	

identification
purposes

	
 

	
 


	

Reference

	

A
sample of a batch in its primary packaging or finished

	
 

	
 


	

sample

	

product
container which is stored for the purpose of being
analysed

	
 

	
 


	
 

	

should
the need arise

	
 

	
 


	
 

	
 

	
 

	
 


	


Strikethrough text where responsibility is not applicable to either
party


	


1.00

	


RESPONSIBILITIESMaster Cell Bank (MCB)

	


Monopar (CA)

	


Cancer Research UK (CG)


	

1.01

	

Supply
to the CG copies of audit reports plus associated
corrective/preventative actions and close out documentation for the
CA's GMP contract manufacturer used to manufacture and store the
MCB

	

X

	
 


	

1.02

	

Supply
to the CG a statement from QA confirming what GMP standard the MCB
was produced in compliance with including reference to EU GMP if
appropriate

	

X

	
 


	

1.03

	

Supply
to the CG a Certificates of Analysis for the MCB approved, signed
and dated by QA

	

X

	
 


	

1.04

	

CA
confirms that ≥200 of sealed vials have been stored at
-140°C (LN) that form the QA approved MCB CG provides
documentation to confirm that the vials have been stored in an area
dedicated to GMP appropriately documented and secure and completely
separate from any non tested cell banks

	

X

	
 


	

1.05

	

Supply
copies of completed QA reviewed batch manufacturing records used in
the manufacture of the MCB

	

X

	
 


	

1.06

	

Supply
copies to the CG of all deviations recorded during the manufacture
and storage of the MCB and any associated corrective/preventative
actions taken and documentation closing out the
deviation

	

X

	
 


	

1.07

	

Supply
copies to CG of storage records for the MCB demonstrating that the
MCB has been stored correctly at all times since it was
frozen

	

X

	
 








 







 





 

 



[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 


Confidential
treatment has been requested with respect to the omitted
information.

 


	

1.08

	

Supply
copies to the CG of all out of specifications reported either
during the manufacture, testing or storage of the MCB and related
corrective/preventative and/or close out documentation

	

X

	
 


	

1.09

	

Supply
to the CG a material Safety Data Sheet (if applicable) to the CG
including biological safety classification of the
[***]

	

X

	
 


	

1.10

	

Shipment
of packaged, MCB to sponsor's licenced facility as notified by the
CG with temperature monitoring of the MCB using a suitably
qualified shipper

	

X

	
 


	

1.11

	

Supply
to the CG data to confirm that the MCB is both mycoplasma free and
sterile when tested using validated pharmacopoieal
methods

	

X

	
 


	

1.12

	

Supply
to the CG data on the stability and recovery of the MCB. Trended
stability data generated from the MCB shall be supplied to the CG
if available

	

X

	
 


	

1.13

	

Confirm
receipt of the MCB on delivery to the CG and notify the CA
immediately of any breakages, packaging issues, temperature alarms
or documentation discrepancies

	
 

	

X


	

1.14

	

CG
confirms that ≥100 of sealed vials received will be stored at
-140°C (LN) which form the QA approved CA supplied MCB CG will
store the vials in an area dedicated to GMP, which is appropriately
documented and secure and completely separate from any non tested
cell banks

	
 

	

X


	

1.15

	

CA will
notify the CG of any Competent Authority inspection findings
directly related to the MCB when stored at the CA's
contractor

	

X

	
 


	
 

	
 

	
 

	
 


	


Distribution List

	
 

	
 


	


Cancer Research UK Formulation Unit

	
 

	
 


	


Name/Title/Duties


	

Dr
Robert Scott - QA/QC Manager Cancer Research UK Biotherapeutics
Development Unit, Responsible for quality assurance at the BDU and
quality control of biologicals QP certification and release of
IMP


	

Dr
Heike Lentfer - Head of BDU. Responsible for delivering the
development and manufacture of biological IMPs


	

Dr
Nigel Westwood - Drug Supply ManagerAccountable for ensuring API
and IMP are available for the clinical trials Sponsored by Cancer
Research UK


	
 

	
 

	
 

	
 


	


Monopar Therapeutics

	
 

	
 


	


Name/Title/Duties


	

Please
add names here