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

 

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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

 

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		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

 

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		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.

 

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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 Proteome™ 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

 

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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

 

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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.

 

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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.

 

 

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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

 

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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

 

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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:

 

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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.

 

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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

 

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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 fo