Exhibit 10.54


 


 


***
Confidential treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.


 


Dated 22
September 2005


 


 


(1) UNIVERSITY COLLEGE LONDON


 


(2)  UCL BIOMEDICA PLC


 


(3) CIPHERGEN BIOSYSTEMS, INC


 


 


COLLABORATIVE RESEARCH
AGREEMENT


 

















 


THIS
AGREEMENT dated 22 September 2005 is made BETWEEN:


 


(1)         UNIVERSITY
COLLEGE LONDON, whose administrative offices are at
Gower Street London, WC1E 6BT (“the University”); and


 


(2)        UCL
BIOMEDICA PLC, a company registered in England
under number 02776963 whose registered office is at c/o Finance Division,
University College London, Gower Street, London WC1E 6BT (“UCL Biomedica”); and


 


(3)        CIPHERGEN
BIOSYSTEMS, INC, a company registered in the United
States whose registered office is at 6611 Dumbarton Circle, Fremont, California
94555 (“the Sponsor”)


 


hereinafter each known as “Party” or
collectively as “the Parties”


 


WHEREAS,



 


(A)
Professor Ian Jacobs of the University (the “Principal
Investigator”) has research objectives that encompass the discovery,
validation, and characterization of novel Biomarkers related to ovarian cancer;


 


(B) The
Principal Investigator desires to further such research objectives by
collaborating with the Sponsor, a company that has developed a
number of technologies that are uniquely enabling in the investigation of
Biomarkers,  such technologies including,
without limitation, Surface Enhanced Laser Desorption/Ionization (“SELDI”), as
described in United States Patent Application 08/068,896 and all patents and
applications claiming priority thereto including, but not limited to, U.S.
Patent No. 5,719,060 and U.S. Patent No. 6,225,047;


 


(C) The Sponsor
is willing to engage in the Principal Investigator’s desired collaboration in
exchange for UCL Biomedica’s grant of an option to an exclusive licence on
terms as further set out in this Agreement with respect to use of discovered
Biomarkers in all areas, including without limitation, research, diagnostic,
therapeutic, theranostic and/or prophylactic areas throughout the world; and


 


(D) UCL
Biomedica was established for the purpose of protecting and commercially
exploiting the results arising from research undertaken by University
researchers in the University, or by University researchers in collaboration
with other academic institutions or commercial entities;


 


(E) It
is the intention of the University and UCL Biomedica that all Resulting
Intellectual Property generated in the course of the Project hereunder that are
(1) invented solely by the University shall be owned solely by the University
and assigned to UCL Biomedica and (2) jointly invented by the Sponsor
and the University, shall be assigned to UCL Biomedica for the purposes of
protection and commercial exploitation.


 


(F) In      light of the Sponsor’s
willingness to collaborate in the discovery, purification, identification
and/or validation of Biomarkers and the University’s and UCL Biomedica’s desire
to facilitate the use of the discovered, purified, identified and/or validated
Biomarkers in generally available health care products and services, UCL
Biomedica is willing to grant to the


 


2

















 


Sponsor an option to an
exclusive licence on the terms specified in Schedule 3 with respect to the
aforementioned Biomarkers throughout the world;


 


NOW, THEREFORE, in consideration of the foregoing
premises and of the faithful performance of the covenants herein contained, the
Parties agree as follows:


 


1.             DEFINITIONS


 


In this Agreement the following expressions have the
meaning set opposite:


 


	
  Academic Publication:

  	
   

  	
  the
  publication of an abstract, article or paper in a journal, or its
  presentation at a conference or seminar; and in clauses 6 and 7 “to Publish”
  and “Publication” are to be construed as references to Academic Publication;

  
	
   

  	
   

  	
   

  
	
  this Agreement:

  	
   

  	
  this
  document, including its Schedules, as amended from time to time in accordance
  with clause 11.9;

  
	
   

  	
   

  	
   

  
	
  a Business Day:

  	
   

  	
  Monday
  to Friday (inclusive) except bank or public holidays;

  
	
   

  	
   

  	
   

  
	
  Biomarker

  	
   

  	
  a
  substance or characteristic that, measured in certain absolute or relative
  amounts in blood, other body fluids, or tissues may suggest or be linked with
  a certain biological, pathogenic, and/or pharmacological process. Examples of
  known Biomarkers used for the purpose of diagnosing cancer include CA 125
  (ovarian cancer), CA 15-3 (breast cancer), CEA (ovarian, lung, breast,
  pancreas, and GI tract cancers), and PSA (prostate cancer);

  
	
   

  	
   

  	
   

  
	
  Confidential Information:

  	
   

  	
  each
  Party’s confidential information is: any Background Intellectual Property
  disclosed by that Party to the other for use in the Project and identified as
  confidential before or at the time of disclosure; business information; and
  any Resulting Intellectual Property in which that Party owns the Intellectual
  Property;

  
	
   

  	
   

  	
   

  
	
  the Effective Date:

  	
   

  	
  1
  October 2005;

  
	
   

  	
   

  	
   

  
	
  External Funding:

  	
   

  	
  any
  funding or assistance provided for the Project, or to any Party for use in
  the Project by any third party, including without limitation, any state or
  public body;

  
	
   

  	
   

  	
   

  
	
  the Financial Contribution:

  	
   

  	
  the
  financial contribution to be provided by the 

  



 


3

















 


	
   

  	
   

  	
  Sponsor
  set out in Schedule 1;

  
	
   

  	
   

  	
   

  
	
  the Research Field:

  	
   

  	
  the
  field of research and development activities that is directed at the
  discovery, purification, identification and/or validation of Biomarkers
  related to breast and ovarian cancer;

  
	
   

  	
   

  	
   

  
	
  the Licensed Field:

  	
   

  	
  the
  research, development and commercialization of Licensed Products (as that
  term is defined in Schedule 3) for Diagnostics and Therapeutics for cancer,
  as more particularly specified in Schedule 3;

  
	
   

  	
   

  	
   

  
	
  a Group Company:

  	
   

  	
  any
  undertaking which is, on or after the date this Agreement is last signed by a
  Party hereto from time to time, a subsidiary undertaking of the Sponsor, a
  parent undertaking of the Sponsor or a subsidiary undertaking of a parent
  undertaking of the Sponsor, as those terms are defined in section 258 of the
  Companies Act 1985;

  
	
   

  	
   

  	
   

  
	
  Intellectual Property:

  	
   

  	
  any intellectual property rights in patents, registered
  designs, copyrights, database rights, design rights, trade marks, application
  to register any of the aforementioned rights, trade secrets, know-how, rights
  of confidence and inventions or discoveries;

  
	
   

  	
   

  	
   

  
	
  Resulting Intellectual Property:

  	
   

  	
  any Intellectual Property which is conceived, created,
  discovered, developed, identified or first reduced to practice in the
  course of the Project, derived directly from the use of SELDI or from the use
  of SELDI together with any other technology(ies) and any patents and patent
  applications, including any continuations, continuations in part, extensions,
  reissues or divisions thereof and any patents, supplementary protection
  certificates and similar rights that are based on or derive priority from the
  foregoing.

  
	
   

  	
   

  	
   

  
	
  Background Intellectual Property:

  	
   

  	
  any
  Intellectual Property other than Resulting Intellectual Property, used in, or
  disclosed in connection with the performance of, the Project;

  
	
   

  	
   

  	
   

  
	
  the Key Personnel:

  	
   

  	
  the
  Principal Investigator, Sponsor’s Supervisor and any other key personnel
  identified in Schedule 2;

  
	
   

  	
   

  	
   

  
	
  the Location:

  	
   

  	
  the
  location(s) at which the Project will be 

  



 


4

















 


	
   

  	
   

  	
  carried
  out as set out in Schedule 2;

  
	
   

  	
   

  	
   

  
	
  the Principal Investigator:

  	
   

  	
  Ian
  Jacobs or his successor appointed under clause 10.2;

  
	
   

  	
   

  	
   

  
	
  the Project:

  	
   

  	
  the
  programme of work described in Schedule 2, as amended from time to time in
  accordance with clause 11.9;

  
	
   

  	
   

  	
   

  
	
  the Project Period:

  	
   

  	
  the
  period described in clause 2.1;

  
	
   

  	
   

  	
   

  
	
  Samples

  	
   

  	
  any
  material provided by the University for use within the Project that is
  biological or of biological origin;

  
	
  SELDI

  	
   

  	
  Surface
  Enhanced Laser Desorption/Ionization, as set forth in Recital B;

  
	
   

  	
   

  	
   

  
	
  the Sponsor’s Supervisor:

  	
   

  	
  Dr.
  Eric Fung or his successor appointed under clause 10.2;

  
	
   

  	
   

  	
   

  
	
  the Territory:

  	
   

  	
  worldwide

  



 


2.             THE PROJECT


 


2.1           The Project will begin on the Effective Date and will continue for
one (1) year or until this Agreement is terminated in accordance with clause 9
or 10, provided that the Sponsor shall have the option of renewing the Project
Period for an additional one (1)-year. If this Agreement is entered into after
the Effective Date, it will apply retrospectively to work carried out in
relation to the Project on or after the Effective Date. 


 


2.2           Each of the parties will carry out the tasks allotted to it in
Schedule 2, and will provide the human resources, materials, facilities and
equipment that are designated as its responsibility in Schedule 2. The Project
will be carried on under the direction and supervision of the Principal
Investigator. The Project will be carried out at the Location.


 


2.3           Although the University will use reasonable endeavours to carry out
the Project in accordance with Schedule 2, the University does not undertake
that any research will lead to any particular result, nor does it guarantee a
successful outcome to the Project.


 


2.4           The University will provide the Sponsor with quarterly written
reports summarising the progress of the Project and a copy of all Resulting
Intellectual Property.


 


2.5           The University warrants to the Sponsor that the University has full
power and authority under its constitution, and has taken all necessary actions
and obtained all authorisations, licences, consents and approvals, to allow it
to enter into this Agreement and to carry out the Project.


 


5

















 


3.             FINANCIAL
CONTRIBUTION AND EXTERNAL FUNDING


 


3.1           The Sponsor will pay the Financial Contribution to the University in
accordance with the budget set out in Schedule 1 within 30 days after receipt
by the Sponsor of quarterly invoices.


 


3.2           The Sponsor will also support the Project
by providing, where and when appropriate, proprietary operational,
bioinformatics software and data analysis support, including data mining using
advanced non-linear statistics, pattern recognition algorithms, Deep ProteomeTM
tools, neural network analyses for the discovery and validation of diagnostic
biomarkers and/or profiles, and the supply of standard ProteinChip® Arrays and
custom ProteinChip Arrays incorporating surfaces with enhanced binding
performance characteristics for discovery and assay development and in
acccordance with the budget set out in Schedule 1.


 


3.3           The University will own all equipment purchased and/or constructed
by it, or for it, for use on the Project, using the Financial Contribution or
any External Funding.


 


3.4           All amounts payable to the University under this Agreement are
exclusive of VAT (or any similar tax) which the Sponsor will have no obligation
to pay.


 


3.5           External Funding: The University and the
Principal Investigator shall be free, at any time: 


 


(a) to
engage in internal, non-commercial research outside of the Research Field using
SELDI  and to seek funding for such
research from any source, including without limitation, a commercial sponsor
other than the Sponsor. The University acknowledges that use of SELDI is
subject to Ciphergen’s standard “Label License,” which restricts the University’s
use of SELDI to internal research and specifically prohibits the University’s
use of SELDI for the benefit of third parties; and 


 


(b) to
engage in research inside the Research Field without the use of SELDI, and to
seek funding for such research from any source, including without limitation, a
commercial sponsor other than the Sponsor; and 


 


(c) to
seek additional funding for the Project hereunder from any state or federal
agency, private or public foundation (other than foundations owned or operated
by a commercial entity other than the Sponsor), provided that the terms and
conditions of such additional funding are not in conflict with the terms and
conditions of this Agreement including, but not limited to, the Sponsor’s
rights in and to the Resulting Intellectual Property as defined in Clause 1. 


 


3.6           Governmental Interest. The Parties acknowledge that the
University has received, and expects to continue to receive, funding in support
of the University’s research activities from the national, state and/or local
governments where the University is located (“Government Entities”). The
Parties acknowledge and agree that their respective rights and obligations
pursuant to this Agreement shall be subject to the University’s obligations to
Government Entities that arise or result from the University’s receipt of
research support from such Government Entities including, without limitation,
the possible University and/or UCL Biomedica obligation to grant to such
Government 


 


6

















 


Entities a non-exclusive, irrevocable, royalty-free
license to utilize the  Resulting
Intellectual Property hereunder for governmental purposes.


 


4.             EXCHANGE OF SAMPLES


 


In connection with the Project, should the University be required to
provide Samples to the Sponsor, the University shall promptly and
systematically provide those Samples, under the terms and conditions of the
Material Transfer Agreement as set out at Schedule 4. The University represents
and warrants that, to the best of its knowledge, the University has obtained
and is obtaining Samples in accordance with all applicable laws, regulations
and ethical standards and that the University has all necessary rights to
dispose of Samples as contemplated herein. 


 


5.             USE AND EXPLOITATION OF INTELLECTUAL PROPERTY


 


5.1           This Agreement does not affect the ownership of any Background
Intellectual Property. The Background Intellectual Property will remain the
property of the Party that contributes said Background Intellectual Property to
the Project (or its licensors). No licence to use any Intellectual Property is
granted or implied by this Agreement except as expressly granted in this
Agreement.


 


5.2           Each Party grants the other a royalty-free, non-exclusive licence to
use its Background Intellectual Property for the purpose of carrying out the
Project, but for no other purpose. Neither Party may grant any sub-licence to
use the other’s Background Intellectual Property except that the Sponsor may
allow its Group Companies, and any person working for, or on behalf of the
Sponsor or any Group Company, to use the University’s Background Intellectual
Property for the purpose of carrying out the Project, but for no other purpose.


 


5.3           Each Party will notify the other promptly after identifying any
Resulting Intellectual Property that the disclosing Party believes is
patentable, and will supply the other with copies of that Resulting
Intellectual Property. UCL Biomedica will notify the Sponsor of other Resulting
Intellectual Property in the reports provided under clause 2.4.


 


5.4    5.4.1               The Resulting
Intellectual Property will be owned by the University, who shall assign its
rights in it to UCL Biomedica, as specified in Recital E. Where any third party
such as a student or contractor is involved in the Project, the University, UCL
Biomedica or the Party engaging that contractor (as the case may be) will
ensure that that student and that contractor assign any Intellectual Property
they may have in the Resulting Intellectual Property in order to be able to
give effect to the provisions of this clause 5.


 


5.4.2             As partial consideration for the grant of the exclusive licence
hereunder, the Sponsor may take such steps as it may decide from time to time,
but in accordance with clause 5.4.3 below, and at its own expense, to register
and maintain in UCL Biomedica’s name, any protection for the Resulting
Intellectual Property including filing and prosecuting patent applications for
any of the Resulting Intellectual Property. Where any employee of the Sponsor
is a


 


7

















 


co-inventor of such Resulting Intellectual Property,
he or she shall be named on said patent applications, as appropriate.


 


5.4.3             The Sponsor agrees to send UCL Biomedica, in a timely manner, copies
of all material correspondence with the Sponsor’s patent counsel concerning all
patent applications pursuant to clause 5.4.2 above and shall give UCL Biomedica
an opportunity to comment thereon before filing with any patent office. The Sponsor
shall act upon such solicited UCL Biomedica comments in good faith in the
prosecution and maintenance of the patent applications and patents.


 


5.5     5.5.1              UCL Biomedica grants to
the Sponsor an option to take an exclusive licence under all of UCL Biomedica’s
rights in  the Resulting Intellectual
Property for any purpose within the Licensed Field and Territory, as defined in
clause 1, on the terms specified in Schedule 3 to this Agreement.


 


5.5.2           [***] This Option Period
can be extended by mutual written agreement of the Parties. The Sponsor shall
exercise the option by giving written notice thereof to UCL Biomedica at any
time during the Option Period.


 


5.5.3           UCL Biomedica will not,
during the Option Period, negotiate with any third party with a view to
granting a licence to use the Resulting Intellectual Property or assigning the
Intellectual Property in the Resulting Intellectual Property. 


 


5.5.4           Should the Sponsor decide
not to take the option to the licence in clause 5.5.1, within the Option Period,
UCL Biomedica shall be free to licence the Resulting Intellectual Property as
it deems appropriate, save that UCL Biomedica shall not offer a licence to the
Resulting Intellectual Property to any other party on more favourable terms
than those last offered to the Sponsor, for a period of six (6) months after
the Sponsor declines to take the option. 


 


5.6           Subject to clause 3.5, the Principal Investigator shall be free to
use the SELDI technology to carry out other work on samples outside the
Research Field in the course of his internal, non-commercial research
activities at the University to the full extent of the Sponsor’s right to use
such technology for such purposes. During the term of this Agreement and for a
period of 2 (two) years after the termination hereof (the “Sponsor’s Rights
Period”), the Sponsor shall have the following rights in relation to that work:


 


5.6.1           Where SELDI is used for
other work on Samples collected in the course of carrying out Research Workplan
#1 in Schedule 2  (adnexal mass study)
outside the Research Field, the Sponsor shall be informed in advance of the
nature and scope of the work to be undertaken and shall have the option to
sponsor that work. [***] Should the Sponsor elect to exercise such option, the
Sponsor shall also have an option to licence the results of the work it
sponsors under this clause 5.6.1, on terms identical to those set out in above
in this clause 5. 


 






***
Confidential treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.


 


8

















 


5.6.2           Where SELDI is used for any
other work outside the Research Field, the Sponsor shall be informed in advance
of the nature and scope of the work to be undertaken and shall have the option
to sponsor that work. [***] Should the Sponsor elect to exercise such option,
the Sponsor shall also have an option to licence the results of the work it
sponsors under this clause 5.6.2, on fair and reasonable terms to be agreed by
the Parties in a separate written agreement. 


 


All
obligations of the University pursuant to this clause 5.6 shall cease upon
termination of the Sponsor’s Rights Period.


 


5.7           The University and each employee and student of the University will
have the irrevocable, royalty-free right to use the Resulting Intellectual
Property of the Project for the purposes of academic teaching and academic
research only. The rights in this clause are subject to the rules on Academic
Publication in clause 6.


 


6.             ACADEMIC
PUBLICATION 


 


6.1           The Project is undertaken in pursuance of a primary charitable
purpose of the University; that is the advancement of education through
teaching and research. Therefore, any employee or student of the University
(whether or not involved in the Project) may, provided the University has not
received a Confidentiality Notice under clause 6.2:


 


6.1.1        discuss work undertaken as part of the Project in University
seminars, tutorials and lectures; and


 


6.1.2        Publish any of the Resulting Intellectual Property.


 


6.2           The University will submit to the Sponsor, in writing, details of
any Resulting Intellectual Property that any employee or student of the
University intends to Publish, at least 30 days before the date of the proposed
Publication. The Sponsor may, by giving written notice to the University (“a
Confidentiality Notice”), require the University to delay the proposed
Publication for a maximum of 3 months after receipt of the Confidentiality
Notice if, in the Sponsor’s reasonable opinion, that delay is necessary in
order to seek patent or similar protection for any Resulting Intellectual
Property that is to be Published; or prevent the Publication of any of the
Sponsor’s Confidential Information. The Sponsor must give that Confidentiality
Notice within 15 days after the Sponsor receives details of the proposed
Publication. If the University does not receive a Confidentiality Notice within
that period, its employee or student may proceed with the proposed Publication,
provided that, whether or not it has received a Confidentiality Notice, any of
the Sponsor’s Background Intellectual Property or Confidential Information may
not be published.


 


6.3           Where, with the agreement
of the Sponsor, any registered student of the University has been involved in
the Project he will follow the University’s regulations for the submission of
any thesis or theses for examination. In any event the University will procure
that the student will submit a draft thesis to the Principal Investigator and
the Sponsor’s Supervisor at least 30 days before the date for submission for
examination. The Student may not, without the Sponsor’s express written
consent, include in any


 






***
Confidential treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.


 


 


9

















 


thesis any of
the Sponsor’s Background Intellectual Property or Confidential Information, or
Resulting Intellectual Property belonging to Sponsor.


 


7.             CONFIDENTIALITY


 


7.1           Subject to clause 6, neither Party will disclose to any third party,
other than to its Group Companies, nor use for any purpose except carrying out
the Project, any of the other Party’s Confidential Information.


 


7.2           Neither Party will be in breach of any obligation to keep any
Background Intellectual Property, Resulting Intellectual Property or other
information confidential or not to disclose it to any other party to the extent
that it:


 


7.2.1        is known to the Party making the disclosure before its receipt from
the other Party, and not already subject to any obligation of confidentiality
to the other Party;


 


7.2.2        is or becomes publicly known without any breach of this Agreement or
any other undertaking to keep it confidential;


 


7.2.3        has been obtained by the Party making the disclosure from a third
party in circumstances where the Party making the disclosure has no reason to
believe that there has been a breach of an obligation of confidentiality owed
to the other Party;


 


7.2.4        has been independently developed by the Party making the disclosure;


 


7.2.5        is disclosed pursuant to the requirement of any law or regulation
(provided, in the case of a disclosure under the Freedom of Information Act
2000, none of the exceptions to that Act applies to the information disclosed)
or the order of any Court of competent jurisdiction, and the Party required to
make that disclosure has informed the other, within a reasonable time after
being required to make the disclosure, of the requirement to make the
disclosure and the information required to be disclosed; or


 


7.2.6        is approved for release in writing by an authorised representative
of the other Party.


 


7.3           The University will not be in breach of any obligation to keep any
of the Resulting Intellectual Property owned by or licensed to the Sponsor, or
other information, confidential or not to disclose them to any third party, by
Publishing any of the same if the University has followed the procedure in
clause 6.2 and has received no Confidentiality Notice within the period stated
in that clause.


 


7.4           The Sponsor will not be in breach of any obligation to keep any of
the Resulting Intellectual Property owned by the University, the University’s
Background Intellectual Property, or other information, confidential or not to
disclose them to any third party, by making them available to any Group Company
or any person working for or on behalf of the Sponsor or a Group Company, who
needs to know the same in order to exercise the rights granted in clause 5.5,
provided they are not used except as expressly permitted by this Agreement and
the recipient undertakes to keep that


 


10

















 


Background
Intellectual Property, the Resulting Intellectual Property or that information
confidential.


 


7.5           If the University receives a request under the Freedom of
Information Act 2000 to disclose any information that, under this Agreement, is
the Sponsor’s Confidential Information, it will notify the Sponsor and will
consult with the Sponsor. The Sponsor will respond to the University within 10
days after receiving the University’s notice if that notice requests the
Sponsor to provide information to assist the University to determine whether or
not an exemption to the Freedom of Information Act applies to the information
requested under that Act. 


 


7.6           Neither the University nor the Sponsor will use the other’s name or
logo in any press release or product advertising, or for any other promotional
purpose, without first obtaining the other’s written consent; except that the
University may identify the sums received from the Sponsor in the University’s
Annual Report and similar publications.


 


8.             LIMITATION OF
LIABILITY


 


8.1           Each of the parties warrants to the other that, to the best of its
knowledge and belief as of the Effective Date (having made reasonable enquiry
of those of its employees involved in the Project or likely to have relevant
knowledge, and in the case of the University any student involved in the
Project, but not having made any search of any public register)  any advice or information given by it or any
of its employees or students who work on the Project, or the content or use of
any Resulting Intellectual Property, Background Intellectual Property or
materials, works or information provided in connection with the Project, will
not constitute or result in any infringement of third-party rights.


 


8.2           Except under the warranty in clause 8.1 and the indemnity in clause
8.3, and subject to clause 8.6, neither Party accepts any responsibility for
any use which may be made by the other Party of any Resulting Intellectual
Property, nor for any reliance which may be placed by that other Party on any
Resulting Intellectual Property, nor for advice or information given in
connection with any Resulting Intellectual Property.


 


8.3           The Sponsor will indemnify the University and UCL Biomedica (the UCL
Indemnified Parties), and keep them fully and effectively indemnified, against
each and every claim made against any of the UCL Indemnified Parties as a
result of the Sponsor’s use of any of the Resulting Intellectual Property or
any materials, works or information received from them pursuant to the terms of
this Agreement. The University and UCL Biomedia will indemnify the Sponsor and
its Group Companies (the Sponsor Indemnified Parties), and keep them fully and
effectively indemnified, against each and every claim made against any of the Sponsor
Indemnified Parties as a result of any breach of the University’s
representations and warranties hereunder or the University’s provision or use
of any of the Samples, Resulting Intellectual Property or any materials, works
or information received from the Sponsor pursuant to the terms of this
Agreement. The Indemnified Party must:


 


8.3.1        promptly notify the indemnifying Party of details of the claim;


 


8.3.2        not make any admission in relation to the claim;


 


8.3.3        allow the indemnifying Party to have the conduct of the defence or
settlement of the claim; and


 


11

















 


8.3.4        give the indemnifying Party all reasonable assistance (at the
indemnifying Party’s expense) in dealing with the claim.


 


The indemnity in this clause will not apply to the
extent that the claim arises as a result of any Indemnified Party’s negligence,
breach of clause 7 or the deliberate breach of this Agreement.


 


8.4           Subject to clause 8.6, and except under the indemnity in clause 8.3,
the liability of either Party to the other for any breach of this Agreement,
any negligence or arising in any other way out of the subject matter of this
Agreement, the Project and the Resulting Intellectual Property, will not extend
to any indirect damages or losses, or any loss of profits, loss of revenue,
loss of data, loss of contracts or opportunity, whether direct or indirect,
even if the Party bringing the claim has advised the other of the possibility
of those losses, or if they were within the other Party’s contemplation.


 


8.5           Subject to clause 8.6, and except under the indemnity in clause 8.3,
the aggregate liability of each Party to the other for all and any breaches of
this Agreement, any negligence or arising in any other way out of the subject
matter of this Agreement, the Project and the Resulting Intellectual Property,
will not exceed in total the Financial Contribution.


 


8.6           Nothing in this Agreement limits or excludes either Party’s
liability for:


 


8.6.1        death or personal injury;


 


8.6.2        any fraud or for any sort of liability that, by law, cannot be
limited or excluded; or


 


8.6.3        any loss or damage caused by a deliberate breach of this Agreement
or a breach of clause 7.


 


8.7           The express undertakings and warranties given by the parties in this
Agreement are in lieu of all other warranties, conditions, terms, undertakings
and obligations, whether express or implied by statute, common law, custom,
trade usage, course of dealing or in any other way. All of these are excluded
to the fullest extent permitted by law.


 


9.             FORCE MAJEURE


 


If the
performance by either Party of any of its obligations under this Agreement
(except a payment obligation) is delayed or prevented by circumstances beyond
its reasonable control, that Party will not be in breach of this Agreement
because of that delay in performance. However, if the delay in performance is
more than 6 months, the other Party may terminate this Agreement with immediate
effect by giving written notice.


 


10.           TERMINATION 


 


10.1         Either Party may terminate this Agreement with immediate effect by
giving notice to the other Party if: 


 


12

















 


10.1.1      the other Party is in breach of any material provision of this
Agreement and (if it is capable of remedy) the breach has not been remedied
within 30 days after receipt of written notice specifying the breach and
requiring its remedy; or


 


10.1.2      the other Party becomes insolvent, or if an order is made or a
resolution is passed for its winding up (except voluntarily for the purpose of
solvent amalgamation or reconstruction), or if an administrator, administrative
receiver or receiver is appointed over the whole or any part of the other Party’s
assets, or if the other Party makes any arrangement with its creditors.


 


10.2         Each of the parties will notify the other in writing within 5 (five)
business days after receipt of formal notice that any of the Key Personnel
appointed by that Party (the “Notifying Party”) is unable or unwilling to
continue to be involved in the Project. Such notice will also state the date of
termination of such Key Personnel’s involvement in the Project and nominate a
successor to replace such departing Key Personnel. If the parties are unable to
agree on a successor acceptable to the other Party, either Party may terminate
this Agreement by giving the other not less than 3 months’ written notice.


 


10.3         The Sponsor may also terminate this Agreement, by giving the
University not less than 3 months’ written notice, if the Sponsor determines,
in its reasonable judgment, that the Resulting Intellectual Property does not
justify continuing the Project.


 


10.4         Clauses 1, 4, 5 (except clause 5.5 if the University terminates this
Agreement under clause 10.1), 6, 7, 8, 9, 10.4, 10.5 and 11 will survive the
expiry of the Project Period or the termination of this Agreement for any
reason and will continue indefinitely.


 


10.5         On the termination of this
Agreement, the Sponsor will pay the University for all work done prior to
termination, as mutually agreed by the Parties, including any uncancellable or
unavoidable expenditures to which the Sponsor has agreed in advance of such
expenditure. Subject to 10.6 below, if the Sponsor has paid any of the
Financial Contribution in advance and the whole of that contribution has not,
by the end of the Project Period or the termination of this Agreement, been
used by the University for the purposes for which that Financial Contribution
was provided, the University will return to the Sponsor the unused portion of
that contribution.


 


10.6         If the Sponsor terminates this Agreement under clause 10.3[***] The
University shall take all reasonable steps to minimise those costs.


 


11.         GENERAL


 


11.1         Notices:  Any notice to be given under this Agreement
must be in writing, may be delivered to the other Party or parties by any of
the methods set out in the left hand


 






***
Confidential treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.


 


13

















 


column
below, and will be deemed to be received on the corresponding day set out in
the right hand column:


 


	
  Method of service

  	
   

  	
  Deemed day of receipt

  
	
  By
  hand or courier

  	
   

  	
  the
  day of delivery

  
	
   

  	
   

  	
   

  
	
  By
  pre-paid first class post

  	
   

  	
  the
  second Business Day after posting

  
	
   

  	
   

  	
   

  
	
  By
  recorded delivery post

  	
   

  	
  the
  next Business Day after posting

  
	
   

  	
   

  	
   

  
	
  By
  fax (provided the sender’s fax machine confirms complete and error-free
  transmission of that notice to the correct fax number)

  	
   

  	
  the
  next Business Day after sending or, if sent before 16.00 (sender’s local
  time) on the Business Day it was sent

  



 


The parties’ respective representatives for the receipt of notices are,
until changed by notice given in accordance with this clause, as follows:


 


 


	
  For the University:

  	
   

  	
  For the Sponsor:

  
	
  Trish
  Monaghan

  Contract Manager

  Contract Research Office

  UCL Business

  The Network Building

  97 Tottenham Court Road

  London

  W1T 4TP



  	
   

  	
  Gail
  Page

  President Diagnostics Division

  Ciphergen Biosystems, Inc.

  6611 Dumbarton Circle

  Fremont, California 94555

  USA



  
	
  Fax
  number:00 44 20 7679 9801

  	
   

  	
  Fax
  number: 510.505.2101

  



 


11.2         Headings:  The headings in this Agreement are for ease
of reference only; they do not affect its construction or interpretation.


 


11.3         Assignment:  Neither Party may assign or transfer this
Agreement as a whole, or any of its rights or obligations under it, without
first obtaining the written consent of the other Party, which consent may not
be unreasonably withheld or delayed. Notwithstanding the above, the Sponsor may
at its own discretion, and without approval by the University or UCL Biomedica,
transfer its interest or any part thereof under this Agreement to a
wholly-owned subsidiary or partnership of which the Sponsor is the general
partner or any assignee or purchaser of the portion of the Sponsor’s business
associated with the licences and rights granted under this Agreement. In the
event of any such transfer, the transferee shall assume and be bound by the
provisions of this Agreement.


 


11.4         Illegal/unenforceable provisions:  If the whole or any part of
any provision of this Agreement is void or unenforceable in any jurisdiction,
the other provisions of this Agreement, and the rest of the void or
unenforceable provision, will continue in force in


 


14

















 


that jurisdiction, and the validity and
enforceability of that provision in any other jurisdiction will not be
affected.


 


11.5         Waiver of rights:  If a Party fails
to enforce, or delays in enforcing, an obligation of the other Party, or fails
to exercise, or delays in exercising, a right under this Agreement, that
failure or delay will not affect its right to enforce that obligation or
constitute a waiver of that right. Any waiver of any provision of this
Agreement will not, unless expressly stated to the contrary, constitute a
waiver of that provision on a future occasion.


 


11.6         No agency:  Nothing in this Agreement creates, implies or
evidences any partnership or joint venture between the parties, or the
relationship between them of principal and agent. Neither Party has any
authority to make any representation or commitment, or to incur any liability,
on behalf of the other.


 


11.7         Entire agreement: This Agreement constitutes the entire agreement between the parties
relating to its subject matter. Each Party acknowledges that it has not entered
into this Agreement on the basis of any warranty, representation, statement,
agreement or undertaking except those expressly set out in this Agreement. Each
Party waives any claim for breach of this Agreement, or any right to rescind
this Agreement in respect of, any representation which is not an express
provision of this Agreement. However, this clause does not exclude any
liability which either Party may have to the other (or any right which either
Party may have to rescind this Agreement) in respect of any fraudulent
misrepresentation or fraudulent concealment prior to the execution of this
Agreement.


 


11.8         Formalities: Each
Party will take any action and execute any document reasonably required by the
other Party to give effect to any of its rights under this Agreement, or to
enable their registration in any relevant territory provided the requesting
Party pays the other Party’s reasonable expenses.


 


11.9         Amendments:  No
variation or amendment of this Agreement will be effective unless it is made in
writing and signed by each Party’s representative.


 


11.10       Third parties:  No one except a
Party to this Agreement has any right to prevent the amendment of this
Agreement or its termination, and no one except a Party to this Agreement may
enforce any benefit conferred by this Agreement, unless this Agreement
expressly provides otherwise.


 


11.11       Governing law:  This Agreement is governed by, and is to be
construed in accordance with, English law. The English Courts will have
exclusive jurisdiction to deal with any dispute which has arisen or may arise
out of, or in connection with, this Agreement, except that either Party may
bring proceedings for an injunction in any jurisdiction.


 


11.12       Escalation: If the
parties are unable to reach agreement on any issue concerning this Agreement or
the Project within 14 days after one Party has notified the other of that
issue, they will refer the matter to the Commercial Director, UCL Business in
the case of the University, and to the President, Diagnostics Division in the
case of the Sponsor in an attempt to resolve the issue within 14 days after the
referral. Either Party may bring proceedings in accordance with clause 11.11 if
the matter has not been resolved within that 14 day period, and either Party
may apply to the court for an injunction, whether or not any issue has been
escalated under this clause.


 


15

















 


 


	
  SIGNED for and on behalf of the
  University:

  	
   

  	
  SIGNED for and on behalf of the
  Sponsor:

  
	
   

  	
   

  	
   

  
	
  Name

  	
  Dr.
  J.D. Skinner

  	
   

  	
  Name

  	
  Gail
  Page

  
	
   

  	
   

  	
   

  
	
  Position
  

  	
  Commercial
  Director

  	
   

  	
  Position

  	
  President
  and COO

  
	
   

  	
   

  	
   

  
	
  Signature

  	
   

  	
  Signature

  
	
   

  	
   

  	
   

  
	
  Date

  	
   

  	
  Date

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SIGNED for and on behalf of UCL
  Biomedica:

  
	
   

  
	
  Name

  	
  C.A.
  Tarhan

  
	
   

  	
   

  
	
  Position

  	
  Managing
  Director

  
	
   

  	
   

  
	
  Signature

  	
   

  
	
   

  	
   

  
	
  Date

  	
   

  
						



 


16

















 


SCHEDULE 1


 


The Financial Contribution


 


 


1. ADNEXAL MASS STUDY - COLLECTION INCLUDING SAMPLE PREPARATION


 


A. CONTRIBUTION TO STAFF COSTS


 


	
  Staff

  	
   

  	
  Annual

  salary

  with on

  costs

  	
   

  	
  FTE

  	
   

  	
  No of

  yrs

  	
   

  	
  Total Cost

  	
   

  	
  Ciphergen

  Contribution

  YR1

  	
   

  	
  Ciphergen

  Contribution

  YR2

  	
   

  
	
  Research fellow

  	
   

  	
  40000

  	
   

  	
  2

  	
   

  	
  2

  	
   

  	
  £

  	
  160,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Research Nurses (G 27)

  	
   

  	
  33348

  	
   

  	
  0.5

  	
   

  	
  2

  	
   

  	
  £

  	
  33,348.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Research assistant (1A)

  	
   

  	
  40000

  	
   

  	
  1

  	
   

  	
  2

  	
   

  	
  £

  	
  80,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Laboratory manager (MTO4 Spinal 34)

  	
   

  	
  35000

  	
   

  	
  0.5

  	
   

  	
  2

  	
   

  	
  £

  	
  35,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Laboratory technician (MLA)

  	
   

  	
  18000

  	
   

  	
  1

  	
   

  	
  2

  	
   

  	
  £

  	
  36,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Database manager (ALC3 Sp 17)

  	
   

  	
  44558

  	
   

  	
  0.2

  	
   

  	
  2

  	
   

  	
  £

  	
  17,823.20

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Research Nurses (G 27)

  	
   

  	
  33348

  	
   

  	
  0.5

  	
   

  	
  2

  	
   

  	
  £

  	
  333,480.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Laboratory technician (MTO2 Sp Point 22)

  	
   

  	
  24906.5

  	
   

  	
  1

  	
   

  	
  2

  	
   

  	
  £

  	
  49,813.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Consultant histopathologist

  	
   

  	
  80000

  	
   

  	
  0.2

  	
   

  	
  2

  	
   

  	
  £

  	
  32,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Ciphergen contribution

  	
   

  	
   

  	
   

  	
  Over two
  years

  	
   

  	
  2

  	
   

  	
  £

  	
  777,464

  	
   

  	
  £

  	
  100,000

  	
   

  	
  £

  	
  100,000

  	
   

  
																	



 


17

















 


 


B. CONTRIBUTION TO CONSUMABLES COSTS


 


	
  Consumables

  	
   

  	
  Comments

  	
   

  	
  Cost per

  unit (£)

  	
   

  	
  No of

  units

  	
   

  	
  Total Cost

  	
   

  	
  Total

  Ciphergen

  contribution

  	
   

  
	
  Pt information

  	
   

  	
   

  	
   

  	
  0.2

  	
   

  	
  9000

  	
   

  	
  £

  	
  1,800.00

  	
   

  	
  £

  	
  900.00

  	
   

  
	
  Pt consent form

  	
   

  	
   

  	
   

  	
  0.15

  	
   

  	
  9000

  	
   

  	
  £

  	
  1,350.00

  	
   

  	
  £

  	
  0.00

  	
   

  
	
  Office supplies

  	
   

  	
  For GCRC

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  3,000.00

  	
   

  	
  £

  	
  2,000.00

  	
   

  
	
  ONS flagging of cancer pts

  	
   

  	
  For operator
  flagging and copy of death certificate

  	
   

  	
  2.15

  	
   

  	
  2000

  	
   

  	
  £

  	
  4,300.00

  	
   

  	
  £

  	
  0.00

  	
   

  
	
  Recruitment costs

  	
   

  	
  Adverts

  	
   

  	
  1200

  	
   

  	
  6

  	
   

  	
  £

  	
  7,200.00

  	
   

  	
  £

  	
  7,200.00

  	
   

  
	
  Blood tubes for cases

  	
   

  	
  Maybe less -
  cannot use Beckton Dickson tube which costs approx £6 per tube

  	
   

  	
  3

  	
   

  	
  5000

  	
   

  	
  £

  	
  15,000.00

  	
   

  	
  £

  	
  13,800.00

  	
   

  
	
  Transport of case samples

  	
   

  	
  4
  collections on dry ice per centre (every 6 months)

  	
   

  	
  250

  	
   

  	
  80

  	
   

  	
  £

  	
  20,000.00

  	
   

  	
  £

  	
  14,000.00

  	
   

  
	
  Sample storage consumables

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  26,250.00

  	
   

  	
  £

  	
  26,250.00

  	
   

  
	
  TRL lab supplies (Eppendorf, pipette etc)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  4,000.00

  	
   

  	
  £

  	
  4,000.00

  	
   

  
	
  DNA extraction kits

  	
   

  	
   

  	
   

  	
  10

  	
   

  	
  8000

  	
   

  	
  £

  	
  80,000.00

  	
   

  	
  £

  	
  0.00

  	
   

  
	
  Paraffin slide section / tissue block for cases

  	
   

  	
   

  	
   

  	
  15

  	
   

  	
  2500

  	
   

  	
  £

  	
  37,500.00

  	
   

  	
  £

  	
  37,500.00

  	
   

  
	
  Travel budget

  	
   

  	
  Between
  centres for set up and occasionally data audit

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  5,000.00

  	
   

  	
  £

  	
  1,000.00

  	
   

  
	
  Meetings etc

  	
   

  	
   

  	
   

  	
  3000

  	
   

  	
  4

  	
   

  	
  £

  	
  12,000.00

  	
   

  	
  £

  	
  12,000.00

  	
   

  
	
  PCs

  	
   

  	
   

  	
   

  	
  1000

  	
   

  	
  20

  	
   

  	
  £

  	
  20,000.00

  	
   

  	
  £

  	
  13,000.00

  	
   

  
	
  80 freezer at each centre

  	
   

  	
   

  	
   

  	
  5400

  	
   

  	
  10

  	
   

  	
  £

  	
  54,000.00

  	
   

  	
  £

  	
  54,000.00

  	
   

  
	
  Refrigerated centrifuge

  	
   

  	
   

  	
   

  	
  2200

  	
   

  	
  10

  	
   

  	
  £

  	
  22,000.00

  	
   

  	
  £

  	
  0.00

  	
   

  
	
  Webbased database

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  25,000.00

  	
   

  	
  £

  	
  25,000.00

  	
   

  
	
  Total

  	
   

  	
  Over two
  years

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  338,400

  	
   

  	
  £

  	
  210,650

  	
   

  
																



 


18

















 


2. PROTEOMICS TEAM + EQUIPMENT     (studies involving UKCTOCS and adnexal mass) 


 


A. CASH AWARD


 


	
  Staff

  	
   

  	
  FTE

  	
   

  	
  Salary

  (approx)*

  	
   

  	
  Total Cost

  YR1

  	
   

  	
  Total Cost YR2

  	
   

  	
  Ciphergen

  Contribution

  YR1

  	
   

  	
  Ciphergen

  Contribution

  YR2

  	
   

  
	
  Proteomics Team

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Senior scientist

  	
   

  	
  1

  	
   

  	
  £

  	
  45,000.00

  	
   

  	
  £

  	
  45,000.00

  	
   

  	
  £

  	
  45,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PhD student

  	
   

  	
  1

  	
   

  	
  £

  	
  15,000.00

  	
   

  	
  £

  	
  15,000.00

  	
   

  	
  £

  	
  15,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Biostatistician

  	
   

  	
  1

  	
   

  	
  £

  	
  60,000.00

  	
   

  	
  £

  	
  60,000.00

  	
   

  	
  £

  	
  60,000.00

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total salary costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  120,000

  	
   

  	
  £

  	
  120,000

  	
   

  	
  £

  	
  60,000

  	
   

  	
  £

  	
  60,000

  	
   

  
	
  For consumables

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  £

  	
  30,000

  	
   

  	
  £

  	
  30,000

  	
   

  	
  £

  	
  30,000

  	
   

  	
  £

  	
  30,000

  	
   

  



 


B. In kind AWARD


 


	
   

  	
   

  	
   

  	
   

  	
  YR1

  	
   

  	
  YR2

  	
   

  
	
  ProteinChip reader, arrays, and associated
  consumables and software

  	
   

  	
  For carryiny
  out SELDI analysis

  	
   

  	
  £

  	
  300,000.00

  	
   

  	
  £

  	
  70,000.00

  	
   

  
										



 


TOTAL RESEARCH AWARD FROM CIPHERGEN


 


	
   

  	
   

  	
  TOTAL

  	
   

  	
  Ciphergen

  Contribution

  YR1

  	
   

  	
  Ciphergen

  Contribution

  YR2

  	
   

  
	
  CASH

  	
   

  	
  £

  	
  590,650.00

  	
   

  	
  £

  	
  295,325.00

  	
   

  	
  £

  	
  295,325.00

  	
   

  
	
  UCL OVERHEAD heading 1A

  	
   

  	
  £

  	
  200,000.00

  	
   

  	
  £

  	
  100,000.00

  	
   

  	
  £

  	
  100,000.00

  	
   

  
	
  UCL OVERHEAD heading 2A

  	
   

  	
  £

  	
  120,000.00

  	
   

  	
  £

  	
  60,000.00

  	
   

  	
  £

  	
  60,000.00

  	
   

  
	
  IN KIND

  	
   

  	
  £

  	
  370,000.00

  	
   

  	
  £

  	
  300,000.00

  	
   

  	
  £

  	
  70,000.00

  	
   

  
	
  TOTAL

  	
   

  	
  £

  	
  1,280,650.00

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


19

















 


SCHEDULE
2


 


The
Project


 


RESEARCH
WORKPLAN #1


 


Title
of Research Workplan: University College
London (UCL)-Ciphergen collaboration in the field of gynecologic disease. This
Research Workplan #1 is intended to identify biomarkers that may aid in the
diagnosis of an adnexal mass. Research Workplan #2 is intended to determine the
pre-analytical variables and quality of serum integrity of samples taken under
the UK screening trial; it is intended to provide the preliminary data required
to justify a larger analysis of samples taken from this trial. 


 


For the
avoidance of doubt University College London will be the custodians of the
samples collected using funding provided under this Agreement, for the adnexal
mass study described in Research Workplan #1. No rights of ownership in respect
of these samples will pass to Ciphergen.


 


Objectives: This project aims to find diagnostic biomarkers for the
differential diagnosis of an adnexal mass. 


 


Location: Translational Research Laboratory and Clinical Research Centre,
Institute for Women’s Health, UCL


 


UCL
Researchers: Dr. Ian Jacobs and Dr. Usha
Menon. 


 


Ciphergen
Researchers: 
Dr. Eric Fung. 


 


Diagnostic Biomarkers Discovery Study


 


Monetary
or In-kind Contributions: Ciphergen will
contribute cash and in-kind support, as outlined in the budget in Schedule 1
and clause 3.2 of this Agreement. The values for array consumables are
estimates; Ciphergen will provide the arrays necessary to complete the project.


 


Samples
or Materials to be Transferred: 


 


1. Preliminary
Analysis to Ascertain Most Effective Method of Sample Collection and Transport
to Laboratory. UCL will collect blood from a set of 50 healthy volunteers
and collect serum and plasma under varying conditions from each patient,
including one tube of serum in standard SST tubes, one tube of serum in the
Becton Dickinson proteomics serum sample collection tube, and one tube of EDTA
plasma. UCL and Ciphergen will perform analyses of these samples to determine
the effect of tube type, incubation at room temperature, and other
pre-analytical variables on proteomic profiles. Ciphergen will provide
expertise in the form of factorial design of experiments to plan this study. 


 


20

















 


2. Initial
Biomarker Discovery Study. Based on this preliminary analysis, UCL will
collect blood (pre- and post-op), urine, and baseline data from women
presenting with an adnexal mass. 


 


The
urine will be collected according to the following parameters:


 


Urine will be collected at the day of
surgery.


The patients will be NPO commencing at
midnight on the day of surgery.


The urine samples will be aliquotted in 2
ml cryovials and stored in a -80 freezer.


 


Patients
will be monitored so that a final anatomic diagnosis can be obtained. It is
expected that no fewer than 500 women (patients with malignant and benign
ovarian neoplasms and healthy controls) will be enrolled in this study by the
end of the first year of the project.


 


Work to
be Conducted:  UCL and Ciphergen will perform protein
expression profiling according to Ciphergen’s best practices, including novel
proteomic technologies such as Ciphergen’s Deep ProteomeTM tools. Ciphergen
will, in collaboration with the UCL adnexal mass study group, perform
univariate and multivariate statistical analyses to determine the optimal
multi-marker panel for the differential diagnosis of an adnexal mass. The
adnexal mass study group will take active part in the evaluation of the
performed protein expression profiles.


 


2. Diagnostic
Biomarkers Purification and Identification Study


 


Samples
or Materials to be Transferred: UCL will
provide adequate amounts of the required serum samples (approximately 5-10
samples, 400-1ml of each) for the purification and identification of biomarkers
resulting from the Diagnostic Biomarkers Discovery Study in Part 1 above based
on evaluation of the results of such study by Ciphergen and the adnexal mass
study group.


 


Work to
be Conducted: Ciphergen and UCL will purify
the biomarkers using chromatography procedures and identify the biomarkers
using peptide fingerprinting and/or tandem mass spectrometry. The number of
biomarkers and the specific biomarkers to be purified will be mutually agreed
upon by UCL and Ciphergen, and will consist of the markers that are deemed to
provide the highest classification power.


 


3. Diagnostic
Biomarkers Validation Study


 


Samples
or Materials to be Transferred: 


 


Work to
be Conducted: Ciphergen staff will work with
the UCL scientist(s) to co-develop a high-throughput diagnostic assay for
biomarkers mutually agreed upon in the Diagnostic Biomarkers Discovery Study.
This assay will then be performed in the research setting at UCL on samples
maintained within the adnexal mass program.


 


Anticipated
Timeline: The study will start as soon as
possible after execution of the Collaborative Research Agreement after
completion of recruitment of a mutually agreed on number of women for the
Diagnostic Biomarkers Discovery Study. Recruitment is scheduled to last for 2
years from the start at any particular centre. At such time as an adequate
number of samples have been collected, protein expression profiling may
commence. Samples may continue to be collected for purposes of independent and
prospective validation.


 


21

















 


RESEARCH
WORKPLAN #2


 


Title
of Research Workplan: Preliminary analysis
of pre-analytical variables and integrity of samples obtained from the UKCTOCS.
Research Workplan #1 is intended to identify biomarkers that may aid in the
diagnosis of an adnexal mass. This Research Workplan #2 is intended to
determine the pre-analytical variables and quality of serum integrity of samples
taken under the UK screening trial; it is intended to provide the preliminary
data required to justify a larger analysis of samples taken from this trial.
For the avoidance of doubt University College London will be the custodians of
the samples referred to in Research Workplan #2. No rights of ownership in
respect of these samples will pass to Ciphergen.


 


Location: Translational Research Laboratory and Clinical Research Centre,
Institute for Women’s Health, UCL


 


UCL
Researchers: Dr. Ian Jacobs and Dr. Usha
Menon. 


 


Ciphergen
Researchers: 
Dr. Eric Fung. 


 


Monetary
or In-kind Contributions: Ciphergen will
contribute cash and in-kind support, as outlined in the budget in Schedule 1
and clause 3.2 of this Agreement. The values for array consumables are estimates;
Ciphergen will provide the arrays necessary to complete the project.


 


	
  Age

  	
   

  	
  50-54

  	
   

  	
  55-59

  	
   

  	
  60-64

  	
   

  	
  65-69

  	
   

  	
  70-74

  	
   

  
	
  No. of women

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  
	
  2001 samples

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  
	
  2002 samples

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  
	
  2003 samples

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  	
  20

  	
   

  
	
  Total samples/assays

  	
   

  	
  60

  	
   

  	
  60

  	
   

  	
  60

  	
   

  	
  60

  	
   

  	
  60

  	
   

  



 


Samples will be chosen
randomly to include representative samples from various collecting institutions
and time in transit to the central repository.


 


Analysis: Proteomic
studies will provide spectral data sets for data analysis to identify
consistent features in the ‘normal’ proteomic pattern in healthy postmenopausal
women (sample set Ia) and variations in the ‘normal’ proteomic pattern which
are attributable to age, increasing years post menopause and use of hormone
replacement therapy (sub groups of sample set Ia). Once the ‘normal’ serum
proteomic pattern has been characterised, further analysis will document the
changes in the proteomic pattern over time in the same women (serial samples in
set Ia from 2001, 2002 and 2003). As the time (hours) between venepuncture and
serum separation UKCTOCS is well documented (range 2 hours – 56 hours it will
also be possible to assess the impact of this variable. In addition the
performance of each proteomic technology in terms of intraassay and interassay
variability for spectral peaks identified as consistent features in the ‘normal’
SELDI pattern will be assessed based on replicate analysis of these samples. 


 


22

















 


SCHEDULE
3


Agreed
Licence Terms


 





 


Licence
agreement 


 


THIS
AGREEMENT is made the 22nd day of September 2005.


 


BETWEEN:


	
   

  	
   

  	
   

  
	
  (1)

  	
   

  	
  UCL BIOMEDICA PLC, (the ‘Owner’) a company incorporated in
  England and Wales under company registration number 02776963 whose principal
  place of business is at C/o Finance Division, University College London,
  Gower Street, London WC1E 6BT, UK and

  
	
   

  	
   

  	
   

  
	
  (2)

  	
   

  	
  CIPHERGEN BIOSYSTEMS, INC., (the ‘Licensee’) a Delaware
  corporation having its principal place of business at 6611 Dumbarton Circle,
  Fremont, California 94555, U.S.A

  
	
   

  	
   

  	
   

  
	
  RECITALS:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  (1)

  	
   

  	
  The Owner is the registered proprietor of, or applicant
  for, the Patents and possesses related Resulting Intellectual Property.

  
	
   

  	
   

  	
   

  
	
  (2)

  	
   

  	
  The Owner is willing to grant to the Licensee, and the
  Licensee is willing to accept, a licence under the Patents and a licence to
  use the Resulting Intellectual Property, in accordance with the provisions of
  this Agreement.

  



 


IT IS AGREED
as follows:


 


1.         Definitions


 


In this
Agreement, the following words shall have the following meanings:


 


	
  ‘Analyte Specific Reagents’

  	
   

  	
  means any antibodies, both polyclonal
  and monoclonal, specific receptor proteins, protein ligands, nucleic acid
  sequences, and similar reagents which, through specific binding or chemical reaction
  with substances in a specimen,

  



 


23

















 


	
   

  	
   

  	
  are intended for use in a diagnostic
  application for identification and quantification of an individual chemical
  substance or ligand in biological specimens

  
	
   

  	
   

  	
   

  
	
  ‘Biomarker’

  	
   

  	
  means a substance or characteristic
  that, measured in certain absolute or relative amounts in blood, other body
  fluids, or tissues may suggest or be linked with a certain biological,
  pathogenic, and/or pharmacological process. Examples of known Biomarker used
  for the purpose of diagnosing cancer include CA 125 (ovarian cancer), CA 15-3
  (breast cancer), CEA (ovarian, lung, breast, pancreas, and GI tract cancers),
  and PSA (prostate cancer).

  
	
   

  	
   

  	
   

  
	
  ‘Collaborative Research Agreement’

  	
   

  	
  Means the Collaborative Research
  Agreement between University College London, UCL BioMedica Plc and Ciphergen
  Biosystems, Inc dated 22 September 2005.

  
	
   

  	
   

  	
   

  
	
  ‘Commencement Date’

  	
   

  	
  1 October 2005.

  
	
   

  	
   

  	
   

  
	
  ‘Disposable Component’

  	
   

  	
  means any item that is either a General
  Purpose Reagent or an Analyte Specific Reagent and specifically excluding any
  capital equipment or software of any kind. Such capital equipment or software
  includes, any ProteinChip® Systems, ProteinChip® Software, Biomarker PatternsTM
  Software, CiphergenExpressTM Software and any software that
  embodies a classification algorithm that is used in performing a Diagnostic
  Test

  
	
   

  	
   

  	
   

  
	
  ‘Diagnostics’

  	
   

  	
  means any product or service that is
  optimized for specific biomarker or biomarker pattern detection or otherwise
  optimized to perform a specific assay, purification or separation process
  including, without limitation, for diagnostic or theranostic purposes
  including, without limitation, for purposes of diagnosis of disease,
  prognosis of disease, prognosis of treatment, monitoring of disease and
  monitoring of treatment. “Theranostic” means a diagnostic test intended to
  predict the utility of a therapeutic regimen in managing a condition, by way
  of example but not of limitation, for disease risk prediction, disease diagnosis,
  disease prognosis, patient stratification, 

  



 


24

















 


	
   

  	
   

  	
  therapeutic stratification and
  monitoring therapeutic response.

  
	
   

  	
   

  	
   

  
	
  ‘Diagnostic Test’

  	
   

  	
  means any test method performed for
  Diagnostic purposes. ‘

  
	
   

  	
   

  	
   

  
	
  ‘Diagnostic Test Kit’

  	
   

  	
  means a collection of Disposable
  Components with instructions for performing one or more Diagnostic Test,
  which collection is approved for sale by the relevant government regulatory
  agency in the jurisdiction of sale.

  
	
   

  	
   

  	
   

  
	
  ‘General Purpose Reagent’

  	
   

  	
  means any chemical reagent that has
  general laboratory application, that is used to collect, prepare, and examine
  specimens from the human body for diagnostic purposes, and that is not
  labelled or otherwise intended for a specific diagnostic application. It may
  be either an individual substance, or multiple substances reformulated,
  which, when combined with or used in conjunction with an appropriate Analyte
  Specific Reagent and other General Purpose Reagents, is part of a diagnostic
  test procedure or system constituting a finished in vitro diagnostic (IVD)
  test. General Purpose Reagents are appropriate for combining with one or more
  than one Analyte Specific Reagent in producing such systems and include
  labware or disposable constituents of tests; but they do not include
  laboratory machinery, automated or powered systems. General Purpose Reagents
  include cytological preservatives, decalcifying reagents, fixatives and
  adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents
  used in tests for more than one (1) individual chemical substance or ligand
  are General Purpose Reagents [e.g., Thermus aquaticus (TAQ) polymerase,
  substrates for enzyme immunoassay (EIA)].

  
	
   

  	
   

  	
   

  
	
  ‘a
  Group Company’

  	
   

  	
  any
  undertaking which is, on or after the Commencement Date of this Agreement, a
  subsidiary undertaking of the Licensee, a

  



 


25

















 


	
   

  	
   

  	
  parent
  undertaking of the Licensee or a subsidiary undertaking of a parent
  undertaking of the Licensee, as those terms are defined in section 258 of the
  Companies Act 1985;

  
	
   

  	
   

  	
   

  
	
  ‘Issued Licensed Patents’

  	
   

  	
  means Licensed Patents that have issued
  and that are not in any manner still pending.

  
	
   

  	
   

  	
   

  
	
  ‘Laboratory’

  	
   

  	
  The laboratory of the ‘Principal
  Investigator’ (Professor Ian Jacobs) within University College London’s
  Department of Gynaecological Oncology.

  
	
   

  	
   

  	
   

  
	
  ‘Licensed Field’

  	
   

  	
  The research, development and
  commercialization of Licensed Products for Diagnostics and Therapeutics for
  cancer.

  
	
   

  	
   

  	
   

  
	
  ‘Licensed Products’

  	
   

  	
  Any and all processes, products and
  services practiced, sold or otherwise supplied by the Licensee or a Group
  Company of Licensee or its sub-licensee, and which Licensed Products or the
  use of such Licensed Products are within any Valid Claim of the Licensed Patents
  in the jurisdiction in which such Licensed Products are sold. A Licensed
  Product may include, without limitation a Diagnostic Test Kit, a Diagnostic
  Test, a Medical Implement or a Therapeutic.

  
	
   

  	
   

  	
   

  
	
  ‘Licensed Technology’

  	
   

  	
  means Resulting Intellectual Property
  and Licensed Patents.

  
	
   

  	
   

  	
   

  
	
  ‘Medical Implement’

  	
   

  	
  means a medical implement used in the
  delivery of a Therapeutic or in Theranostic or Diagnostic applications, and
  which may include, specialized probes, catheters, imaging equipment, or
  similar process.

  
	
   

  	
   

  	
   

  
	
  ‘Net Receipts’

  	
   

  	
  The amounts received by the Licensee or
  its Group Companies from the grant of sub-licences under the Licensed
  Patents, less any Value Added Tax or other sales tax, based on the timing of
  cash received and irrespective of whether the amounts may be immediately
  recognized as revenue or must be treated as deferred under the accounting
  principles generally accepted in

  



 


26

















 


	
   

  	
   

  	
  the United States of America. Net
  Receipts shall not include any (a) up-front non-recurring payments, (b)
  annual and/or milestone payments and (c) amounts received by Licensee or its
  Group Companies from a sub-licensee in consideration of conducting research
  or development work.

  
	
   

  	
   

  	
   

  
	
  ‘Net Sales Value’

  	
   

  	
  The gross revenue (as recognized under
  accounting principles generally accepted in the United States of America),
  which has been actually collected (in the form of cash or equivalent) by the
  Licensee or its Group Companies on direct sales of Licensed Products to
  independent third parties in arm’s length transactions exclusively for money
  or, where the sale is not at arm’s length, the price that would have been so
  invoiced if it had been at arm’s length, after deduction of normal trade
  discounts actually granted and any credits actually given, and, provided the
  amounts are separately charged on the relevant invoice any costs of
  packaging, insurance, carriage and freight, any value added tax or other
  sales tax, and any import duties or similar applicable government levies.

  

  Notwithstanding the above:

  

  Transfer or provision of a product or service by the Licensee to a Group
  company for later sale, use or further licensing by such Group Company for
  the use, consumption by or benefit of an end customer shall not be considered
  a sale for the purpose of calculating Net Sales Value; and in the case of
  such a transfer, the only amount to be included in the calculation of Net
  Sales Value shall be the net sales price (calculated in accordance with
  exclusions and exceptions analogous to those set forth herein with respect to
  determining Net Sales Value) received by the Group Company from its end
  customer for such product or service; and

  

  The following types of transfers or provision of any product or service, and
  any associated consideration received therefore, shall not be included in Net
  Sales Value: (a) transfers for the assurance of product testing or control,
  (b) promotional 

  



 


27

















 


	
   

  	
   

  	
  distribution to potential users,
  provided that the Licensee shall use reasonable commercial efforts to limit
  distribution of Licensed Products for promotional purposes to no more than
  25% (twenty-five percent) of the total volume of Licensed Products sold
  during any calendar year during the term of this Agreement, (c) distribution
  to researchers by or on behalf of the Licensee or any of its Group Companies
  or (4) disclosure or dissemination for obtaining regulatory approvals.

  
	
   

  	
   

  	
   

  
	
  ‘Parties’

  	
   

  	
  The Owner and the Licensee, and ‘Party’
  shall mean either of them.

  
	
   

  	
   

  	
   

  
	
  ‘Licensed Patents’

  	
   

  	
  Any and all of the patents and patent
  applications referred to in Schedule 1, including any continuations,
  continuations in part, extensions, reissues, divisions, and any patents,
  supplementary protection certificates and similar rights that are based on or
  derive priority from the foregoing.

  
	
   

  	
   

  	
   

  
	
  ‘Project’

  	
   

  	
  the
  programme of work described in Schedule 3, as amended from time to time in
  accordance with clause 10.9 of the Collaborative Research Agreement.

  
	
   

  	
   

  	
   

  
	
  ‘Resulting
  Intellectual Property’

  	
   

  	
  has
  the meaning given such term in Clause 1 of the Collaborative Research
  Agreement;

  
	
   

  	
   

  	
   

  
	
  ‘SELDI’

  	
   

  	
  Surface Enhanced Laser
  Desorption/Ionization, as set forth in Recital B of the Collaborative
  Research Agreement.

  
	
   

  	
   

  	
   

  
	
  ‘Territory’

  	
   

  	
  The World.

  
	
   

  	
   

  	
   

  
	
  ‘Therapeutic’

  	
   

  	
  means any drug, pharmaceutical,
  protein, polypeptide, peptide, nucleic acid, small molecule, gene therapy,
  vaccine, other substance or process that is used for the treatment of a
  disease or health condition.

  
	
   

  	
   

  	
   

  
	
  ‘Valid Claim’

  	
   

  	
  A claim of a patent or patent
  application that has not expired or 

  



 


28

















 


 


	
   

  	
   

  	
  been held invalid or unenforceable by a
  court of competent jurisdiction in a final and non-appealable judgement.

  



 


 


2. Grant of
rights


 


	
  2.1

  	
   

  	
  Licences

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  The Owner hereby grants to the Licensee, subject to the
  provisions of this Agreement, an exclusive licence, with the right to
  sub-license, subject to clause 2.3 below, under the Licensed Technology to
  develop, manufacture, use, sell, offer for sale and/or import Licensed
  Product(s) and any improvement thereto, or have done any of these on its
  behalf and otherwise exploit the Licensed Technology, but only in the
  Licensed Field in the Territory.

  
	
   

  	
   

  	
   

  
	
  2.2

  	
   

  	
  Formal licences

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  The Parties
  shall execute such formal licences as may be necessary or appropriate for
  registration with Patent Offices and other relevant authorities in particular
  territories. In the event of any conflict in meaning between any such licence
  and the provisions of this Agreement, the provisions of this Agreement shall
  prevail wherever possible. Prior to the execution of the formal licence(s)
  (if any) referred to in clause 2.2, the Parties shall so far as possible have
  the same rights and obligations towards one another as if such licence(s) had
  been granted. The Parties shall use reasonable endeavours to ensure that, to
  the extent permitted by relevant authorities, this Agreement shall not form
  part of any public record.

  



 


2.3       Sub-licensing


 


The Licensee shall be
entitled to grant sub-licences of its rights under this Agreement to any
person, provided that:


 


2.3.1    the royalties and other
consideration provided for in the sub-licence shall be at an amount or rate
which is not less than the amount or rate applicable to direct sales or
sublicensing, as appropriate, provided for in this Agreement;


 


2.3.2    the sub-licence shall include
obligations on the sub-licensee which are equivalent to the obligations on the
Licensee under this Agreement;


 


2.3.3    the Licensee shall not
undertake any obligations pursuant to any sub-licence granted by the Licensee
hereunder which, in the Licensee’s reasonable judgment, would be deemed unduly
onerous by the Owner; 


 


2.3.4    within 60 days of the grant of
any sub-licence the Licensee shall provide to the Owner a true copy of it; and


 


2.3.5    the Licensee shall be
responsible for any breach of the sub-licence by the sub-licensee, as if the
breach had been that of the Licensee under this Agreement, and the Licensee


 


29

















 


shall
indemnify the Owner against any loss, damages, costs, claims or expenses which
are awarded against or suffered by the Owner as a result of any such breach by
the sub-licensee.


 


2.3.6        Any sublicence granted by the
Licensee as part of a sublicence agreement made between the Licensee and a
sublicensee in accordance with the provisions of this Clause 2.3
("Sublicence Agreement") shall survive the termination of this
Agreement as a direct licence between the Owner and the sublicensee subject to
the provisions of such sublicence agreement and the following conditions:


 


(a)        at the time of such
termination the sublicensee is not in breach of any material provision of
its sublicense agreement with the Licensee and none of the situations referred
to in Clause 8.2.2(b) of this Agreement applies to the sublicensee; and


 


(b)       within 60 days of receiving notice of the
termination of this Agreement, the sublicensee notifies the Owner in writing
that it wishes the sublicence agreement to continue in effect in accordance
with the terms thereof and undertakes to the Owner to comply with the
sublicensee's obligations under such sublicence agreement.


 


2.4       Reservation
of rights


 


The Owner
reserves the non-exclusive right to use the Licensed Technology in the Licensed
Field solely for the purposes of academic research and teaching.


 


2.5       No
other licence


 


It is
acknowledged and agreed that no licence is granted by the Owner to the Licensee
other than the licence(s) expressly granted by the provisions of this clause 2.



 


2.6       Quality


 


The Licensee
shall ensure that all of the Licensed Products sold by it and its sub-licensees
are of satisfactory quality and comply with all applicable laws and regulations
in each part of the Territory.


 


30

















 


3. Confidential
information


 


3.1       Responsibility
for development of Licensed Products


 


The Licensee
shall be exclusively responsible for the technical and commercial development
and manufacture of Licensed Products and for incorporating any modifications or
developments thereto that may be necessary or desirable and for all Licensed
Products sold or supplied, and accordingly the Licensee shall indemnify the
Owner in accordance with the terms of clause 7.3.


 


3.2       Confidentiality
obligations


 


Each Party
(‘Receiving Party’) undertakes:


 


3.2.1    to maintain as secret and
confidential all Resulting Intellectual Property and other technical,
scientific or commercial information (collectively “Confidential Information”)
obtained directly or indirectly from the other Party (‘Disclosing Party’) in
the course of or in anticipation of this Agreement and to respect the
Disclosing Party’s rights therein,


 


3.2.2    to use the same exclusively
for the purposes of this Agreement, and


 


3.2.3    to disclose the same only to those
of its Group Companies, employees, contractors and sub-licensees pursuant to
this Agreement (if any) to whom and to the extent that such disclosure is
reasonably necessary for the purposes of this Agreement provided that any such
recipients are bound by obligations of non-use and confidentiality at least as
stringent as those contained herein.


 


3.3       Exceptions
to obligations


 


The provisions of clause
3.2 shall not apply to Confidential Information which the Receiving Party can
demonstrate by reasonable, written evidence:


 


3.3.1    was, prior to its receipt by
the Receiving Party from the Disclosing Party, in the possession of the
Receiving Party and at its free disposal; or


 


3.3.2    is subsequently disclosed to
the Receiving Party without any obligations of confidence by a third party who
has not derived it directly or indirectly from the Disclosing Party; or


 


3.3.3    is or becomes generally
available to the public through no act or default of the Receiving Party or its
agents, employees, Group Company or sub-licensees; or


 


3.3.4    the Receiving Party is
required to disclose to the courts of any competent jurisdiction, or to any
government regulatory agency or financial authority, provided that the
Receiving Party shall:


 


(a)        inform
the Disclosing Party as soon as is reasonably practicable, and


 


31

















 


(b)        at
the Disclosing Party’s request use reasonable efforts to seek to persuade the
court, agency or authority to have the information treated in a confidential
manner, where this is possible under the court, agency or authority’s
procedures; or


 


3.3.5    in the case of information
disclosed by the Owner to the Licensee, is disclosed to actual or potential
customers for Licensed Products in so far as such disclosure is reasonably
necessary to promote the sale or use of Licensed Products, provided that the
customers sign a written confidentiality undertaking substantially similar to
clauses 3.2 and 3.3.


 


3.4       Disclosure
to employees


 


The Receiving Party
shall procure that all of its Group Companies, employees, contractors and
sub-licensees pursuant to this Agreement (if any) who have access to any of the
Disclosing Party’s information to which clause 3.2 applies, shall be made aware
of these obligations and shall have entered into written undertakings of
confidentiality substantially similar to clauses 3.2 and 3.3 and which apply to
the Disclosing Party’s information.


 


4. Payments


 


4.1       Royalties.  Subject to This Agreement, the Licensee shall
pay royalties to the Owner as follows: 


 


4.1.1    Sale of Diagnostic Test Kits.  If the Licensee or its Group Company sells to
a third party a Diagnostic Test Kit that is a Licensed Product covered by an
Issued Licensed Patent, then the Licensee shall pay to the Owner a [***]
percent ([***]%) royalty on Net Sales Value of such Diagnostic Test Kits.


 


4.1.2    Sale of Disposable Components for Inclusion in Diagnostic Test Kits. If (i) the Licensee or its Group Company sells, either directly or
indirectly, to a third party any Disposable Component, (ii) such third party,
pursuant to any necessary sublicense from the Licensee or its Group Company
under an Issued Licensed Patent, includes such Disposable Component in a
Diagnostic Test Kit for sale, and (iii) such Diagnostic Test Kit is a Licensed
Product covered by an Issued Licensed Patent, then the Licensee shall pay to
the Owner a [***] percent ([***]%) royalty on Net Sales Value of such
Disposable Components.


 


4.2.3    Sale of Disposable Components for use in performing a Diagnostic
Test, but not for inclusion in a Diagnostic Test Kit offered for sale.  If (i) the Licensee or its
Group Company sells, either directly or indirectly, to a third party any
Disposable Component, (ii) such third party does not include such Disposable
Component in a Diagnostic Test Kit for sale, but instead uses such Disposable
Component in performing a Diagnostic Test as part of a service for a fee, (iii)
such third party has obtained any necessary sublicense


 






*** Confidential treatment request pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the Commission.


 


32

















 


to perform such Diagnostic Test from the Licensee or
its Group Company under an Issued Licensed Patent, and (iv) such Diagnostic
Test is a Licensed Product covered by an Issued Licensed Patent, then the
Licensee shall pay to the Owner a [***] percent ([***]%) royalty on Net Sales
Value of such Disposable Components.


 


4.2.4    Grant of a sublicense to manufacture and sell a Diagnostic Test Kit
with no associated sale of Disposable Components. If
(i) the Licensee or its Group Company grants to a third party a sublicense to
manufacture and sell a Diagnostic Test Kit, (ii) such Diagnostic Test Kit is a
Licensed Product covered by an Issued Licensed Patent, and (iii) neither the
Licensee nor any of its Group Companies sells either directly or indirectly to
such third party any Disposable Components that are sold as part of such
Diagnostic Test Kit, then the Licensee shall pay to the Owner [***] percent ([***]%)
of the Net Receipts for such sublicense.


 


4.2.5    Grant of a sublicense to
perform a Diagnostic Test with no Associated Sale of Diagnostic Test Kits or
Disposable Components. If: (i) the Licensee or its
Group Company grants to a third party a sublicense to sell a service involving
the performance of a Diagnostic Test, (ii) such Diagnostic Test is a Licensed
Product covered by an Issued Licensed Patent, and (iii) neither the Licensee nor
any of its Group Companies sells either directly or indirectly to such third
party any Diagnostic Test Kits or Disposable Components for use in the
performance of such Diagnostic Test, then the Licensee shall pay to the Owner
[***] percent ([***]%) of the Net Receipts for such sublicense.


 


4.2.6    Performance of Diagnostic Test by the Licensee or its Group Company. If the Licensee or its Group Company sells a service involving the
performance of a Diagnostic Test, which Diagnostic Test is a Licensed Product
covered by an Issued Licensed Patent, then the Licensee shall pay to the Owner
[***] ([***]%) on Net Sales Value of such Diagnostic Test


 


4.2.7    Grant of sublicense to commercialise a Therapeutic or Medical
Implement. If the Licensee or its Group Company
grants to a third party a sublicense to commercialise a Therapeutic or a
Medical Implement that is a Licensed Product covered by an Issued Licensed
Patent, then the Licensee shall pay to the Owner [***] percent ([***]%) of the
Net Receipts for such sublicense. 


 






***
Confidential treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.


 


33

















 


4.2.8     Exclusions and Limitations


 


(a)   No Royalties on Software or Capital Equipment. In no case shall Licensee or its Group Company pay to UCL
Biomedica any royalties or other fees for the sale of capital equipment or
software, including without limitation: ProteinChip® Readers, ProteinChip®
Software, Biomarker PatternsTM software, CiphergenExpress TM Software
and any software that embodies a classification algorithm that is used in
performing a Diagnostic Test. The full amounts received in connection with
periodic deliveries of Disposable Components or Diagnostic Test Kits under a
“Reagent Rental Plan” (a method for customers to pay for capital equipment or
software over a series of periodic amortized payments in connection with
periodic shipments of specialized Diagnostic Test Kits or Disposable Components
that are used on or in connection with the capital equipment and software) shall not be used in determining Net
Sales. Instead, in determining Net Sales of such Diagnostic Test Kits or
Disposable Components, the full amounts received in connection with periodic
deliveries under a “Reagent Rental Plan” shall be adjusted so as to deduct the
amortized cost of software and capital equipment that have been allocated along
with the true charges for such Diagnostic Test Kits or Disposable Components in
the Reagent Rental Plan. Ultimately, Net Sales of Diagnostic Test Kits or
Disposable Components should reflect only those amounts actually attributable
to such products, as if such products were sold on a stand-alone basis.


 


(b)   No Royalties on Licenses to Patents or Licensed Patents that are Not
Issued Licensed Patents. 


(i) In no case shall Licensee or its Group Company pay
to UCL Biomedica any royalties for the grant of a license to any patent that is
not an Issued Licensed Patent. For example, but not by way of limitation, any
consideration received for a license grant under a Baylor University-owned
SELDI patent or a Licensee-owned Retentate Chromatography patent shall not
trigger any royalty obligation to UCL Biomedica, even if such grant may be
necessary in the manufacture, sale or use of any Diagnostic Test Kit or in the
performance of any Diagnostic Test.


 


(ii) In no case shall Licensee or its Group Company
pay UCL Biomedica any royalties for the grant of a license to any Licensed
Patent that is not an Issued Licensed Patent. Notwithstanding the above, once
there is an Issued Licensed Patent in a given country or jurisdiction, the
Licensee shall pay royalties to UCL Biomedica on sales of Licensed Products in
such country or jurisdiction (i) retroactively on a lump sum basis from the
date of first commercial sale of such


 


34

















 


Licensed Products, if any, through the date of
issuance of such Issued Licensed Patent Patent (“Licensed Patent Issue Date”)
and (ii) on a prospective basis, in accordance with this clause 4.2. Licensee
shall make such retroactive payment in accordance with subclause (i) above
within 60 (sixty) days after such Licensed Patent Issue Date. Ciphergen shall
use take reasonable steps to ensure that its patent counsel prosecute Licensed
Patents in a diligent manner.


 


(c)   No Royalty owed on Revenue Received in Exchange for Performance of
Product or Service Development and/or Marketing Activities. Under no circumstances shall Licensee or its Group Companies be
liable to UCL Biomedica for royalties on revenue received in consideration of
product or service development and/or marketing activities.


 


(d)   One Royalty Per Transaction. Only one
royalty shall be due and payable to UCL Biomedica by the Licensee on the sale
of any product or service subject to a royalty under this Agreement regardless
of the number of Licensed Patents or Licensed Patent claims that may cover any
such product or service, its manufacture and/or use. Moreover, if the
performance of any service that triggers a royalty hereunder requires the use
of a product, the sale of which triggers a royalty hereunder, only the one
royalty of higher value among the two royalties triggered shall be due and
payable to UCL Biomedica by the Licensee.


 


(e)   No Other Royalties Owed. Except as
explicitly set forth herein, neither the Licensee nor its Group Companies shall
pay to UCL Biomedica any royalties under this Agreement.


 


4.3       Combination
Products


 


Proportional sharing of royalties in cases of
multi-Biomarker-based Diagnostic Tests with multiple intellectual property
owners. In the event that any
royalty-bearing event hereunder involves a Diagnostic Test that employs any
Biomarkers (as defined herein below) on which royalties are owed to a third
party (a “Third Party Licensor”), Net Sales (or Net Receipts from sublicensing,
as applicable) for such royalty-bearing event shall be reduced to reflect the
proportion of Biomarkers on which royalties are owed to a Party hereunder
(“Collaborative Research Biomarkers”)  as
opposed to Biomarkers on which royalties are owed to a Third Party Licensor
(“Third Party Biomarkers”). Specifically, Net Sales (or Net Receipts, as applicable)
for such royalty-bearing event shall be reduced by multiplying the fraction A
over A+B where “A” is


 


35

















 


the number of Collaborative Research Biomarkers
covered by Issued Licensed Patents and “B” is the number of Third Party
Biomarkers.


 


4.4       In the event that, due to market conditions, the royalty paid to the
Owner constitutes a reduction in the return realised by the Licensee such that
the reduction diminishes the Licensee’s capability to be profitable or
competitive with respect to the sale, provision or use of any Licensed Product,
the Owner agrees to consider a reasonable reduction in the royalty paid to the
Owner in such cases for the period during which such market condition exists.
Factors determining the size of the reduction will include, without limitation,
the Licensee’s then-current profit margin on such Licensed Products. 


 


4.5       If the Licensee or any of its Group Companies is required to pay a
royalty or royalties to any obtain a licence from any third party licensor
(“Third Party Licence”) for technology that is not a Biomarker in connection
with the manufacture, use, practice, sale, or marketing of a Licensed Product
hereunder, at the Licensee’s sole discretion, the royalties payable under this
Agreement shall be reduced by (a) the amount of royalties paid under the Third
Party Licence or (b) 50% or (c) royalties paid under the Third
Party Licence shall be treated as a deductible item when calculating Net Sales
Value provided that the amount of royalty payable by the Licensee to the Owner
in any semi-annual period shall not be reduced by more than 50% of the amount
which would have been payable in the absence of this clause.


 


4.6       Payment
terms


 


Royalties due
under this Agreement shall be calculated and paid semiannually as of June 30th
and December 31st for the six (6)-month period prior to such
respective date and shall be paid semiannually within 60 days next following
such respective date, in respect of sales of Licensed Products made during such
six (6)-month period and within 60 days of the termination of this Agreement.


 


4.7       All
sums due under this Agreement:


 


4.7.1    are exclusive of Value Added
Tax which will be paid by the Licensee only if the Licensee is required to do
so pursuant to applicable law;


 


4.7.2    shall be paid in pounds
sterling by bank transfer:


 


Barclays Bank Plc – Bloomsbury &
Tottenham Court Road Branch


PO Box 11345


London W12 8GG 


 


Sort Code: 20 10 53


Account No: 30782270


 


36

















 


Account name: UCL BioMedica Plc


Swift Code BARCGB22


 


or cheque
made payable to UCL BioMedica Plc and in the case of sales or sub-licence
income received by the Licensee in a currency other than pounds sterling, the
royalty shall be calculated in the other currency and then converted into equivalent
pounds sterling at the buying rate of such other currency as quoted by Barclays
Bank plc in London as at the close of business on the last business day of the
quarterly period with respect to which the payment is made;


 


4.7.3    subject to clause 1 (definition
of “Net Sales Value”) shall be made without deduction of income tax or other
taxes charges or duties that may be imposed, except insofar as the Licensee is
required to deduct the same to comply with applicable laws. The Parties shall
co-operate and take all steps reasonably and lawfully available to them, at the
expense of the Owner, to avoid deducting such taxes and to obtain double
taxation relief. If the Licensee is required to make any such deduction it
shall provide the Owner with such certificates or other documents as it can
reasonably obtain to enable the Owner to obtain appropriate relief from double
taxation of the payment in question; and


 


4.7.4    shall be made by the due date,
failing which the Owner may charge interest on any outstanding amount on a
daily basis at a rate equivalent to 1% above the most favourable Bank of
England base rate then in force.


 


4.8       If
at any time during the continuation of this Agreement the Licensee is
prohibited from making any of the payments required hereunder by a governmental
authority in any country then the Licensee will within the prescribed period
for making the said payments in the appropriate manner use its best endeavours
to secure from the proper authority in the relevant country permission to make
the said payments and will make them within 30 (thirty) days of receiving such
permission. If such permission is not received within 30 (thirty) days of the
Licensee making a request for such permission then, at the option of the Owner,
the Licensee shall deposit the royalty payments due in the currency of the
relevant country either in a bank account designated by the Owner within such
country or such royalty payments shall be made to an associated company of the
Owner designated by the Owner and having offices in the relevant country
designated by the Owner.


 


4.9       Royalty
statements


 


The Licensee shall send
to the Owner at the same time as each royalty payment is made in accordance
with clause 4.2 a statement setting out, in respect of each territory or region
in which Licensed Products are sold, the types of Licensed Product sold, the
quantity of each type sold,


 


37

















 


and the total Net Sales
Value in respect of each type, expressed both in local currency and pounds
sterling and showing the conversion rates used, during the period to which the
royalty payment relates.


 


4.10     Records


 


4.10.1  The Licensee shall keep at its
normal place of business detailed and up to date records and accounts showing
the quantity, description and value of Licensed Products sold by it, and the
amount of Net Receipts received by it in respect of Licensed Products, on a
country by country basis, and being sufficient to ascertain the royalties due
under this Agreement.


 


4.10.2  The Licensee shall make such
records and accounts available, on reasonable notice but no more than once each
year, for inspection during business hours by an independent chartered
accountant nominated by the Owner for the purpose of verifying the accuracy of
any statement or report given by the Licensee to the Owner under this clause
4.10. The accountant shall be required to keep confidential all information
learnt during any such inspection, and to disclose to the Owner only such
details as may be necessary to report on the accuracy of the Licensee’s
statement or report. The Owner shall be responsible for the accountant’s
charges unless the accountant certifies that there is an inaccuracy of more
than 5% per
cent in any royalty statement, in which case the Licensee shall pay his charges
in respect of that inspection.


 


4.10.3  The Licensee shall ensure that
the Owner has the same rights as those set out in this clause 4.10 in respect
of any sub-licensee of the Licensee which is sub-licensed under the Licensed
Patents pursuant to this Agreement.


 


5.         Commercialisation



 


5.1       The
Licensee shall diligently proceed to develop and commercially exploit Licensed
Products to the maximum extent worldwide.


 


5.2       Without
prejudice to the generality of the Licensee’s obligations under clause 5.1, the
Licensee shall provide at least annually to the Owner an updated, written
Development Plan, showing all past, current and projected activities taken or
to be taken by the Licensee to bring Licensed Products to market and maximise
the sale of Licensed Products worldwide. The Owner’s receipt or approval of any
such plan shall not be taken to waive or qualify the Licensee’s obligations
under clause 5.1.


 


38

















 


5.3       If
the Owner considers at any time during the period of this Agreement that the
Licensee has without legitimate reason failed to proceed diligently to develop
and commercially exploit Licensed Products, the Owner shall so notify the
Licensee in writing. By not later than 10 (ten) days after Licensee’s receipt
of such notice, the parties shall commence informal discussions with the goal
of reaching a mutually acceptable resolution of the matter. If the parties have
not been able to arrive at such resolution within 3 (three) months after commencement
of such negotiations, either Party shall be entitled to refer the matter to an
alternative dispute resolution (“ADR”) process, in accordance with Schedule 2. 


 


6          Intellectual
property


 


6.1       Maintain
the Licensed Patents


 


The Licensee
shall at his own cost and expense pay all expenses associated with the
preparation and filing of patent applications in accordance with clause 5.4 of
the Collaborative Research Agreement and pay all maintenance and renewal fees
in respect of the Licensed Patents as and when due; provided that if the
Licensee wishes to abandon any patent application or not to maintain any such
Licensed Patent (or to cease funding any such application or Licensed Patent)
it shall give 3 months’ prior written notice thereof to the Owner and on the
expiry of such notice period the Licensee shall cease to be licensed under the
patent application or Licensed Patent identified in the notice.


 


6.2       Infringement
of the Licensed Patents


 


6.2.1    Each Party shall inform the
other Party promptly if it becomes aware of any infringement or potential
infringement of any of the Licensed Patents, and the Parties shall consult with
each other to decide the best way to respond to such infringement.


 


6.2.2    If the Parties fail to agree
on a joint programme of action, including how the costs of any such action are
to be borne and how any damages or other sums received from such action are to
be distributed, then the Licensee shall be entitled to take action in its own
name against the third party at its sole expense and it shall be entitled to
all damages or other sums received from such action, after reimbursing the
Owner for any reasonable expenses incurred in assisting it in such action. The
Owner may agree to be joined in any suit to enforce such rights and shall have
the right to be separately represented by its own counsel at its own expense.
If the alleged infringement is both within and outside the Licensed Field, the
Parties shall also co-operate with the Owner’s other licensees (if any) in
relation to any such action.


 


39

















 


6.3       Infringement
of third party rights


 


6.3.1    If any warning letter or other
notice of infringement is received by a Party, or legal suit or other action is
brought against a Party, alleging infringement of third party rights in the
manufacture, use or sale of any Licensed Product, that Party shall promptly
provide full details to the other Party, and the Parties shall discuss the best
way to respond.


 


6.3.2    The Licensee shall have the
right but not the obligation to defend such suit and shall have the right to
settle with such third party, provided that if any action or proposed
settlement involves the making of any statement, express or implied, concerning
the validity of any Patent, the consent of the Owner must be obtained before
taking such action or making such settlement.


 


7.         Warranties
and liability


 


7.1       Warranties
by owner


 


The Owner warrants, represents and undertakes as follows:


 


7.1.1    it is the absolute and
unencumbered owner of the Licensed Patents and has caused its directors and
employees to execute such assignments of the Licensed Patents as may be
necessary to give title to the Licensed Patents to the Owner; and


 


7.1.2    it has not done, and will not
do nor agree to do during the continuation of this Agreement, any of the
following things if to do so would be inconsistent with the exercise by the
Licensee of the rights granted to it under this Agreement, namely:


 


(a)        grant
or agree to grant any rights in the Licensed Patents or any improvements
thereto; or


 


(b)        assign,
mortgage, charge or otherwise transfer any of the Licensed Patents or (subject
to clause 7.2 below) any of its rights or obligations under this Agreement; and


 


(c)        it
is not aware that any third party owns or claims any rights in the Licensed
Patents; and


 


(d)        it
is not aware (but without having carried out any investigation other than
asking the Principal Investigator and the Owner’s patent agents for their
understanding of the position) that any third party owns or claims that it owns
any rights which would be infringed by use of the Licensed Patents in
accordance with the provisions of this Agreement.


 


40

















 


7.2       No
other warranties


 


7.2.1    Each of the Licensee and the
Owner acknowledges that, in entering into this Agreement, it does not do so in
reliance on any representation, 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 from this Agreement to the
fullest extent permitted by law.


 


7.2.3    Without limiting the scope of
clause 7.2.1, the Owner does not give any warranty, representation or
undertaking:


	
   

  	
   

  	
   

  
	
  (a)

  	
   

  	
  as to the efficacy or usefulness of the Licensed Technology;
  or

  
	
   

  	
   

  	
   

  
	
  (b)

  	
   

  	
  that any of the Licensed Patents is or will be valid or
  subsisting or (in the case of an application) will proceed to grant; or

  
	
   

  	
   

  	
   

  
	
  (c)

  	
   

  	
  that the use of any of the Licensed Technology, the
  manufacture, sale or use of the Licensed Products or the exercise of any of
  the rights granted under this Agreement will not infringe any other
  intellectual property or other rights of any other person; or

  
	
   

  	
   

  	
   

  
	
  (d)

  	
   

  	
  that the Resulting Intellectual Property or any other
  information communicated by the Owner to the Licensee under or in connection
  with this Agreement will produce Licensed Products of satisfactory quality or
  fit for the purpose for which the Licensee intended; or

  
	
   

  	
   

  	
   

  
	
  (e)

  	
   

  	
  as imposing any obligation on the Owner to bring or
  prosecute actions or proceedings against third parties for infringement or to
  defend any action or proceedings for revocation of any of the Licensed
  Patents; or

  
	
   

  	
   

  	
   

  
	
  (f)

  	
   

  	
  as imposing any liability on the Owner in the event that
  any third party supplies Licensed Products to customers located in the
  Territory.

  



 


7.3       Indemnity


 


The Licensee
shall indemnify the Owner against any loss, damages, costs or expenses which
are awarded against or incurred by the Owner as a result of any claim
concerning the use by the Licensee or any of its sub-licensees of the Licensed
Technology or otherwise in connection with the manufacture, use or sale of or
any other dealing in any of the Licensed Products by the Licensee or its Group
Companies or any of its sub-licensees.


 


7.4       Liability


 


Notwithstanding
any other provision of this Agreement, no Party shall be liable to any other
Party to this Agreement in contract, tort, negligence, breach of statutory duty
or otherwise for any loss, damage, costs or expenses of any nature whatsoever
incurred or suffered by that


 


41

















 


other Party
or its Group Companies of an indirect or consequential nature including without
limitation any economic loss or other loss of turnover, profits, business or
goodwill. Each Party’s liability for direct damages hereunder shall be limited
to the total amount of royalties paid by the Licensee to the Owner at the time
the event giving rise to any such liability occurs.


 


8          Duration
and termination


 


8.1       Commencement
and termination by expiry


 


This
Agreement, and the licences granted hereunder, shall come into effect on the
Commencement Date and, unless terminated earlier in accordance with this clause
8, shall continue in force on a country by country basis until the later of:


	
   

  	
   

  	
   

  
	
  8.1.1

  	
   

  	
  The date of expiration of the last to expire patent
  included within the Issued Licensed Patents in each such country, or

  
	
   

  	
   

  	
   

  
	
  8.2.2

  	
   

  	
  The tenth anniversary of the Commencement Date;

  
	
   

  	
   

  	
  and on such
  date the licences granted hereunder with respect to the affected country
  shall terminate automatically.

  
	
   

  	
   

  	
   

  



8.2       Early
termination


 


8.2.1    The Licensee may terminate
this Agreement at any time on 90 days’ prior notice in writing to the Owner.


 


8.2.2    Without prejudice to any other
right or remedy, either Party may terminate this Agreement at any time by
notice in writing to the other Party (‘Other Party’), such notice to take
effect as specified in the notice:


 


(a)        if
the Other Party is in breach of any material provision of this Agreement and,
in the case of a breach capable of remedy within 90 days, the breach is not
remedied within 90 days of the Other Party receiving notice specifying the
breach and requiring its remedy; or


 


(b)        if
the Other Party becomes insolvent, or if an order is made or a resolution is
passed for the winding up of the Other Party (other than voluntarily for the
purpose of solvent amalgamation or reconstruction), or if an administrator,
administrative receiver or receiver is appointed in respect of the whole or any
part of the Other Party’s assets or business, or if the Other Party makes any
composition with its creditors or takes or suffers any similar or analogous
action in consequence of debt.


 


42

















 


8.2.3    The Owner may forthwith
terminate this Agreement by giving written notice to the Licensee if the
Licensee or its Affiliate or sub-licensee commences legal proceedings, or
assists any third party to commence legal proceedings, to challenge the
validity of any of the Licensed Patents.


 


8.3       Consequences
of termination


 


8.3.1    Upon termination of this
Agreement by expiry under clause 8.1 above, the Licensee shall have the
non-exclusive right to use the Resulting Intellectual Property without charge
or other obligation to the Owner.


 


8.3.2    Upon termination of this
Agreement for any reason:


 


(a)        the
Licensee and its sub-licensees shall be entitled to sell, use or otherwise
dispose of (subject to payment of royalties under clause 4) any unsold or
unused stocks of the Licensed Products for a period of 1 (one) year following
the date of termination;


 


(b)        subject
to clauses 8.1 and 8.3.1 above, the Licensee shall no longer be licensed to use
or otherwise exploit in any way, either directly or indirectly, the Licensed
Patents, in so far and for as long as any of the Licensed Patents remains in
force or the Resulting Intellectual Property;


 


(c)        subject
to paragraph 8.3.1 above, the Licensee shall consent to the cancellation of any
formal licence granted to it, or of any registration of it in any register, in
relation to any of the Licensed Patents; and


 


(d)        Except
as provided in this clause 8.3.2 and 8.3.3 and 8.3.4, and except in respect of
any rights that may have accrued prior to termination of this Agreement,
neither Party shall be under any further obligation to the other.


 


	
  9.

  	
  General

  
	
   

  	
   

  	
   

  
	
   

  	
  9.1

  	
  Force majeure

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Neither
  Party shall have any liability or be deemed to be in breach of this Agreement
  for any delays or failures in performance of this Agreement which result from
  circumstances beyond the reasonable control of that Party, including without
  limitation labour disputes involving that Party. The Party affected by such
  circumstances shall promptly notify the other Party in writing when such
  circumstances cause a delay or failure in performance and when they cease to
  do so.

  
	
   

  	
   

  	
   

  
	
   

  	
  9.2

  	
  Amendment

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  This
  Agreement may only be amended in writing signed by duly authorised
  representatives of the Owner and the Licensee.

  
	
   

  	
   

  	
   

  



43

















 


9.3       Assignment
and third party rights


 


9.3.1    Subject to clause 9.3.2 below,
neither Party shall assign, mortgage, charge or otherwise transfer any rights
or obligations under this Agreement, nor any of the Licensed Patents or rights
under the Licensed Patents, without the prior written consent of the other
Party, which consent shall not unreasonably be with held.


 


9.3.2    Either Party may assign all
[or part] of its rights and obligations under this Agreement together with its
rights in the Licensed Patents to a wholly-owned subsidiary or partnership of
which such Party is the general partner or any company to which it transfers
all [or part] of its assets or business, PROVIDED that the assignee undertakes
to the other Party to be bound by and perform the obligations of the assignor
under this Agreement. However a Party shall not have such a right to assign
this Agreement if it is insolvent or any other circumstance described in clause
8.2.2(b) applies to it.


 


9.4       Waiver


 


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


 


9.5       Invalid
clause


 


If any
provision or part of this Agreement is held to be invalid, amendments to this
Agreement may be made by the addition or deletion of wording as appropriate to
remove the invalid part or provision but otherwise retain the provision and the
other provisions of this Agreement to the maximum extent permissible under
applicable law.


 


9.6       No
agency


 


Neither Party
shall act or describe itself as the agent of the other, nor shall it make or
represent that it has authority to make any commitments on the other’s behalf.


 


9.7       Interpretation


 


In this
Agreement:


 


9.7.1    the headings are used for
convenience only and shall not affect its interpretation;


 


9.7.2    references to persons shall
include incorporated and unincorporated persons; references to the singular
include the plural and vice versa;
and references to the masculine include the feminine;


 


9.7.3    references to clauses and
Schedules mean clauses of, and schedules to, this Agreement; and


 


44

















 


9.7.4    references to the grant of
‘exclusive’ rights shall mean that the person granting the rights shall neither
grant the same rights (in the same Licensed Field and Territory) to any other
person, nor exercise those rights directly to the extent that and for as long
as the Licensed Products are within Valid Claims of unexpired Licensed Patents.


 


9.8       Notices


 


9.8.1    Any notice to be given under
this Agreement shall be in writing and shall be sent by express courier or
personal delivery, first class mail or air mail, or by fax (confirmed by first
class mail or air mail) to the address of the relevant Party set out at the
head of this Agreement, or to the relevant fax number set out below, or such
other address or fax number as that Party may from time to time notify to the
other Party in accordance with this clause 9.8. The fax numbers of the Parties
are as follows: Owner +44 (0) 20 7679 9838; Licensee 510.505.2101, attention
President Diagnostics Division.


 


9.8.2    Notices sent as above shall be
deemed to have been received on the date delivered if sent via express courier
or otherwise delivered personally, three working days after the day of posting
(in the case of inland first class mail), or seven working days after the date
of posting (in the case of air mail), or on the next working day after transmission
(in the case of fax messages, but only if a transmission report is generated by
the sender’s fax machine recording a message from the recipient’s fax machine,
confirming that the fax was sent to the number indicated above and confirming
that all pages were successfully transmitted).


 


9.9       Law
and Jurisdiction


 


The validity,
construction and performance of this Agreement shall be governed by English law
and shall be subject to the exclusive jurisdiction of the English courts to
which the parties hereby submit, except that a Party may seek an interim
injunction in any court of competent jurisdiction.


 


9.10     Further
action


 


Each Party
agrees to execute, acknowledge and deliver such further instruments, and do all
further similar acts, as may be necessary or appropriate to carry out the
purposes and intent of this Agreement.


 


9.11     Announcements


 


Neither Party
shall make any press or other public announcement concerning any aspect of this
Agreement, or make any use of the name of the other Party in connection with or
in consequence of this Agreement, without the prior written consent of the
other Party.


 


45

















 


9.12     Entire
agreement


 


This
Agreement, including its Schedules, sets out the entire agreement between the
Parties relating to its subject matter and supersedes all prior oral or written
agreements, arrangements or understandings between them relating to such
subject matter. The Parties acknowledge that they are not relying on any
representation, agreement, term or condition which is not set out in this
Agreement.


 


10.  Third
parties


 


This
Agreement does not create any right enforceable by any person who is not a
party to it ('Third Party') under the Contracts (Rights of Third Parties) Act
1999, but this clause does not affect any right or remedy of a Third Party
which exists or is available apart from that Act.


 


AGREED
by the Parties through their authorised signatories:


 


	
  For and on behalf of UCL Biomedica plc

  	
   

  	
   

  	
  For and on behalf of Ciphergen
  Biosystems, Inc.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  signed

  	
   

  	
   

  	
  signed

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  print name

  	
   

  	
   

  	
  print name

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  title

  	
   

  	
   

  	
  title

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  date

  	
   

  	
   

  	
  date

  	
   

  



 


46

















 


Schedule 1


 


The Licensed Patents


 


47

















 


Schedule 2


 


Alternative Dispute Resolution


 


Alternative Dispute
Resolution. For any and all claims, disputes, or
controversies arising under, out of, or in connection with this Agreement,
including any dispute relating to patent validity or infringement, which the
Parties shall be unable to resolve within sixty (60) days, the Party raising
such dispute shall promptly advise the other Party of such claim, dispute or
controversy in a writing that describes in reasonable detail the nature of such
dispute. By not later than ten (10) business days after the recipient has
received such notice of dispute, each Party shall have selected for itself a
representative who shall have the authority to bind each such Party and shall
additionally have advised the other Party in writing of the name and title of
such representative. By not later than twenty (20) business days after the date
of such notice of dispute, such representatives shall select a mutually agreed
upon independent expert schedule a date for engaging in an ADR process. Thereafter,
the representatives of the Parties shall engage in good faith in an ADR process.
If the representatives of the Parties have not been able to resolve the dispute
within thirty (30) business days after the termination of the ADR, the Parties
shall have the right to pursue any other remedies legally available to resolve
such dispute in the English courts, to whose jurisdiction for such purposes the
Owner and the Licensee each irrevocably consents and submits. Notwithstanding
the foregoing, nothing in this Schedule 2 shall be construed to waive any
rights or timely performance of any obligations existing under this Agreement.
The costs of such ADR process shall be borne equally by the Parties.


 


48

















 


SCEHDULE 4


 


Material Transfer Agreement


 


UNIVERSITY COLLEGE LONDON





Gower Street London WC1E 6BT


 


 


MATERIAL TRANSFER AGREEMENT


 


UNIVERSITY COLLEGE LONDON has collected and/or developed the materials known as: (Insert description of materials below)


 


[To be completed]               (“Materials”)


 


Providing University College London Scientist is: (Insert name and department)


 


Professor Ian Jacobs Department of Gynaecological
Oncology


(the
“Provider”)


 


Company Scientist is: (Insert name)


 


[To
be completed]


(the
“Company Scientist”)


 


The Company Scientist is an employee of: (Insert company name and full address)


 


Ciphergen
Biosystems, Inc. a Delaware corporation having its principal place of business
at

6611 Dumbarton Circle, Fremont, California 94555, U.S.A 


(the
“Company”)


 


The Company wishes to acquire a sample of the Materials for academic
research relating to: (Insert

description of academic research for which Materials are to be used)


 


The
“Project” as defined in clause 1 of the Collaborative Research Agreement between
UCL,

UCL BioMedica Plc and Ciphergen Biosystems, Inc dated           2005 


 


(the “Collaborative Research
Agreement”)


 


49

















 


	
  UCL is willing
  to provide a sample of the Materials for the Project Period (the “Term”) as
  defined in clause 2.1 of the Collaborative Research Agreement on the Terms
  and Conditions shown overleaf provided the Company agrees to comply with
  those Terms and Conditions.

  



 


 


Standard Terms and Conditions for Release of Materials


 


	
  UCL represents and
  warrants to Company that, to the best of its knowledge (a) the Materials have
  been obtained by UCL in accordance with all applicable laws, rules and
  regulations, (b) UCL has
  all necessary rights to transfer and dispose of the Materials as contemplated
  herein and (c) the transfer, shipment and delivery of the Materials to
  Company shall be made in such a manner and by such means as to ensure the
  biological and/or chemical integrity of the Materials and the safety of
  Company’s employees, agents and contractors.

  
	
   

  	
   

  	
   

  
	
  Company shall
  keep the Materials secure at the Company’s laboratory and ensure that access
  to the Materials is restricted to the Company Scientist and his authorised
  co-workers. In this Agreement “the Materials” shall include any and all materials,
  documents and information that UCL may provide to the Company under or in
  connection with this Agreement, and any derivatives, portions, progeny or
  improvements.

  
	
   

  	
   

  	
   

  
	
  The Company
  shall use the Materials only for the Project and not for any other purpose
  even if those purposes are being pursued in the Company’s laboratory without
  the prior written consent of UCL.

  
	
   

  	
   

  	
   

  
	
  The Company
  shall not supply the Materials to any party other than its Group Companies
  (as defined in the Collaborative Research Agreement).

  
	
   

  	
   

  	
   

  
	
  The Term may be extended with the written
  agreement of the parties.

  
	
   

  	
   

  	
   

  
	
  The
  Company shall acknowledge UCL as the source of the materials in any
  publication that mentions them. The Company shall send UCL a copy of any
  reports or publications which describe work carried out using the Materials,
  and UCL shall be entitled to use all such reports and publications subject to
  the provisions of the Collaborative Research Agreement.

  
	
   

  	
   

  	
   

  
	
  The Materials and any copies
  thereof made by or in the possession of or under the control of the Company
  pursuant to this Agreement shall remain under the custody of UCL and shall be immediately
  returned or if UCL so requires, destroyed, provided that UCL acknowledges and understands
  that (a) the Materials may be partially or totally damaged, destroyed,
  consumed or otherwise rendered unusable for any other purpose in the course
  of the Project and (b) Company may not be able to return some or all of the
  received Materials upon completion of the Project.

  



 


 


	
  on termination of this Agreement, and

  
	
   

  
	
  in the event that the Company is in breach of any
  of the conditions of this Agreement, and

  
	
   

  
	
  at any other time on request of UCL and request
  and any copies thereof made by or in the

  



 


50

















 


	
   

  	
  possession of or under the control of the Company
  pursuant to this Agreement. If UCL so dictates the Material should be
  destroyed under the circumstances that might arise under this Clause 6.

  
	
   

  
	
  UCL shall at
  all times remain the custodian of the materials and which will not be removed
  from the Company’s address. No licence under any UCL intellectual property is
  granted or implied by this Agreement.

  
	
   

  
	
  In the event
  that the Company makes or observes any new discovery, improvement or
  invention (“Invention”) relating to the Materials or as a direct result of
  the Project then the Company will bring this to the attention of UCL and such
  Invention shall be subject to the provisions of the Collaborative Research
  Agreement.

  
	
   

  
	
  The Company
  shall use the Materials in accordance with good laboratory practice and the
  highest standards of skill and care and shall ensure compliance with any
  applicable laws and regulations governing the transportation, keeping or use
  of the Materials.

  
	
   

  
	
  The Company
  shall reimburse UCL for any reasonable shipping and related costs that may be
  incurred when preparing and sending the Materials to the Company.

  
	
   

  
	
  The Materials
  are experimental in nature and, subject to UCL’s representations and
  warranties set forth above, UCL makes no representation and gives no warranty
  or undertaking, in relation to them. As examples, but without limiting the
  foregoing, UCL give no warranty:

  
	
   

  
	
   

  	
  that use of the
  Materials will not infringe any patent, copyright, trade mark or other right
  owned by any third party; or

  
	
   

  
	
   

  	
  that the
  Materials are of merchantable or satisfactory quality or fit for any
  particular purpose, have been developed with reasonable care and skill or
  tested, for the presence of pathogens or otherwise, or are viable, safe, or
  non-toxic.

  
	
   

  
	
  UCL shall have
  no liability to the Company, whether in contract, tort or otherwise, in
  relation to the supply of the Materials to the Company or their use or
  keeping by the Company Scientist and/or Company or by any other person, or
  the consequences of their use, to the maximum extent permitted under
  applicable law. The Company shall indemnify and hold harmless the Indemnified
  Parties from and against all Claims and Losses arising from such supply, use
  or keeping, including without limitation Claims and Losses arising from:

  
	
   

  
	
   

  	
  injury to the Company's employees and third
  parties;

  
	
   

  
	
   

  	
  infringement of third party intellectual property
  rights; and

  
	
   

  
	
   

  	
  use of the Materials within or outside the scope
  of this Agreement.

  



 


For the purposes
of this Agreement: 


 


“Indemnified
Parties” shall
mean UCL and its directors, officers, employees,


 


51

















 


representatives and
associated undertakings; 


 


“Claims” shall mean all demands, claims,
proceedings, penalties, fines and liability (whether criminal or civil, in
contract, tort or otherwise); and 


 


“Losses” shall mean all losses including
without limitation financial losses, damages, legal costs and other expenses of
any nature whatsoever.


 


The Company
agrees to be bound by this Agreement in consideration of UCL making the
Materials available to the Recipient.


 


English law shall
apply to this Agreement, and the English courts shall have exclusive
jurisdiction.


 


AGREED by the parties
through their authorised signatories:-


 


 


	
  For and on behalf of

  	
   

  	
  For and on behalf of

  	
   

  
	
  University College
  London

  	
   

  	
  Ciphergen Biosystems,
  Inc.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Signed

  	
   

  	
  Signed

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Print Name

  	
   

  	
  Print Name

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title

  	
   

  	
  Title

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Date

  	
   

  	
  Date

  	
   

  



 


***
Confidential treatment request pursuant to a request for confidential treatment
filed with the Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.


 


52