exv10w11






Exhibit 10.11




CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION UNDER A
CONFIDENTIAL TREATMENT REQUEST, PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED, AND RULE 24b-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED. THE REDACTED TERMS HAVE BEEN MARKED
IN THIS EXHIBIT AT THE APPROPRIATE PLACE WITH THREE ASTERISKS [***].






Collaboration and License Agreement




This Agreement is entered into with effect as of the Effective Date (as defined below)




by and between




F. Hoffmann-La Roche Ltd



a company
having its principal place of business at Grenzacherstrasse 124, 4070
Basel, Switzerland
(“Roche Basel”)




and




Hoffmann-La Roche Inc.



a company
having its principal place of business at 340 Kingsland Street, Nutley, New Jersey 07110,
U.S.A. (“Roche Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”)



on the one hand




and




Psynova Neurotech Ltd



a company
having its principal place of business at St. John’s Innovation
Centre, Cowley Road,
Cambridge, CB4 OWS, United Kingdom 

(hereinafter “Partner”).



on the other hand




 









 






Recitals





	1.	 	The Partner possesses considerable expertise and intellectual property in the field of
discovering CNS biomarkers.
	 
	2.	 	Roche has considerable expertise in pharmaceutical research, development and
commercialization of pharmaceutical and diagnostic products; and
	 
	3.	 	The Parties have agreed to combine their expertise in order to perform research
collaboration as set forth in the Work Plan with the aim of discovering, developing and
commercializing diagnostic immunoassays to aid the clinical development and commercial
differentiation of novel drugs targeting the [***].




NOW, THEREFORE, in consideration of the premises and mutual covenants contained in this Agreement
and other good and valuable considerations, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:




- 2 -









 








License Agreement




	 	 	 	 	 
	1. Definitions
	 	 	6	 
	1.1 Affiliate
	 	 	6	 
	1.2 Agreement
	 	 	6	 
	1.3 Agreement Term
	 	 	6	 
	1.4 Appendix
	 	 	6	 
	1.5 Assay
	 	 	6	 
	1.6 Background
	 	 	6	 
	1.7 Baseline Data
	 	 	6	 
	1.8 Blocking Third Party Intellectual Property
	 	 	6	 
	1.9
Candidate Set
	 	 	6	 
	1.10 Change of Control
	 	 	7	 
	1.11 Confidential Information
	 	 	7	 
	1.12 Commercial Agreement
	 	 	7	 
	1.13 Commercially Reasonable Efforts
	 	 	7	 
	1.14 Companion Diagnostic
	 	 	8	 
	1.15 Compound
	 	 	8	 
	1.16 Compound Multiplex Panel
	 	 	8	 
	1.17 Control
	 	 	8	 
	1.18 Cover
	 	 	8	 
	1.19 Deliverables
	 	 	8	 
	1.20 Diagnostic Net Sales
	 	 	8	 
	1.21 Diagnostic Product
	 	 	9	 
	1.22 Effective Date
	 	 	9	 
	1.23 EU
	 	 	9	 
	1.24 FDA
	 	 	9	 
	1.25 Field
	 	 	9	 
	1.26 First Commercial Sale
	 	 	9	 
	1.27 Insolvency Event
	 	 	9	 
	1.28 JSC
	 	 	10	 
	1.29 Intellectual Property
	 	 	10	 
	1.30 Inventions
	 	 	10	 
	1.31 Know-How
	 	 	10	 
	1.32 Licensee
	 	 	10	 
	1.33 Multiplex Technology
	 	 	10	 
	1.34 Party
	 	 	10	 
	1.35 Partner Patent Rights
	 	 	10	 
	1.36 Patent Rights
	 	 	10	 
	1.37 Reagent Rental Expenses
	 	 	11	 
	1.38 Regulatory Authority
	 	 	11	 
	1.39 Regulatory Approval
	 	 	11	 
	1.40 Research Results
	 	 	11	 
	1.41 Research Term
	 	 	11	 
	1.42 Roche Group
	 	 	11	 
	1.43 Royalty Term
	 	 	11	 
	1.44 Sales Expenses
	 	 	11	 
	1.45 Sample
	 	 	12	 
	1.46 Section
	 	 	12	 
	1.47 Target
	 	 	12	 
	1.48 Technology Transfer
	 	 	12	 






- 3 -









 






	 	 	 	 	 
	1.49 Territory
	 	 	12	 
	1.50 Therapeutic Product
	 	 	12	 
	1.51 Third Party
	 	 	12	 
	1.52 Third Party Royalty Expenses
	 	 	12	 
	1.53 TP Net Sales
	 	 	12	 
	1.54 Valid Claim
	 	 	13	 
	1.55 Work Plan
	 	 	13	 
	2. License grant
	 	 	13	 
	2.1 Licenses granted to Partner by Roche
	 	 	13	 
	2.2 Licenses granted to Roche by Partner
	 	 	13	 
	3. Research Collaboration
	 	 	14	 
	3.1 Conduct of the Work Plan
	 	 	14	 
	3.2 Reports
	 	 	15	 
	3.3 Development of Companion Diagnostic
	 	 	15	 
	4. Diligence
	 	 	16	 
	4.1 Diligence of Partner under the Work Plan
	 	 	16	 
	4.2 Diligence of Partner after initiation of Step 2 of the Work Plan
	 	 	16	 
	4.3 Diligence of Roche
	 	 	16	 
	5. Governance
	 	 	16	 
	5.1 Joint Steering Committee
	 	 	16	 
	5.2 Members
	 	 	16	 
	5.3 Responsibilities of the JSC
	 	 	17	 
	5.4 Meetings
	 	 	17	 
	5.5 Minutes
	 	 	17	 
	5.6 Decisions
	 	 	17	 
	5.7 Alliance Director
	 	 	17	 
	5.8 Limitations of Authority
	 	 	18	 
	5.9 Expenses
	 	 	18	 
	5.10 Lifetime
	 	 	18	 
	6. Funding by Roche during the Research Term
	 	 	18	 
	6.1 Funding by Roche during Step 1 of the Work Plan
	 	 	18	 
	6.2 Funding by Roche during Step 2 of the Work Plan
	 	 	18	 
	6.3 Funding by Roche during Step 3 of the Work Plan
	 	 	18	 
	7. Consideration for Companion Diagnostic
	 	 	19	 
	7.1 Development of Companion Diagnostic by Roche or its Licensee
	 	 	19	 
	7.2 Development of Companion Diagnostic by Partner
	 	 	20	 
	8. Accounting and reporting
	 	 	20	 
	8.1 Timing of payments
	 	 	20	 
	8.2 Late payment
	 	 	20	 
	8.3 Method of payment
	 	 	21	 
	8.4 Currency conversion
	 	 	21	 
	8.5 Reporting
	 	 	21	 
	9. Taxes
	 	 	21	 
	10. Auditing
	 	 	21	 
	10.1 Partner right to audit
	 	 	21	 
	10.2 Sharing of draft reports
	 	 	22	 
	10.3 Overpayment or Underpayment
	 	 	22	 
	10.4 Duration of audit rights
	 	 	22	 
	11. Intellectual Property
	 	 	22	 
	11.1 Ownership of Background Intellectual Property
	 	 	22	 
	11.2 Ownership of Arising Intellectual Property
	 	 	22	 
	11.3 Ownership of Inventions
	 	 	23	 






- 4 -









 






	 	 	 	 	 
	11.4 Prosecution of Patent Rights claiming Inventions
	 	 	23	 
	11.5 Infringement
	 	 	24	 
	11.6 Hatch-Waxman
	 	 	24	 
	12. Representations and Warranties
	 	 	24	 
	12.1 Ownership of Background IP
	 	 	24	 
	12.2 Grants
	 	 	24	 
	12.3 Authorization
	 	 	24	 
	12.4 No Claims
	 	 	24	 
	12.5 No Conflict
	 	 	25	 
	12.6 No Other Representations
	 	 	25	 
	12.7 Personnel
	 	 	25	 
	13. Indemnification
	 	 	25	 
	13.1 Indemnification by Roche
	 	 	25	 
	13.2 Procedure
	 	 	25	 
	13.3 Disclaimer
	 	 	25	 
	14. Obligation Not to Disclose Confidential Information
	 	 	26	 
	14.1 Non-Use and Non-Disclosure
	 	 	26	 
	14.2 Commercial Considerations
	 	 	26	 
	14.3 Publication
	 	 	26	 
	14.4 Press release
	 	 	26	 
	15. Term and termination
	 	 	27	 
	15.1 Commencement and term
	 	 	27	 
	15.2 Termination
	 	 	27	 
	15.3 Consequences of termination
	 	 	28	 
	15.4 Survival
	 	 	29	 
	16. Miscellaneous
	 	 	29	 
	16.1 Governing Law
	 	 	29	 
	16.2 Arbitration
	 	 	29	 
	16.3 Assignment
	 	 	30	 
	16.4 Independent Contractor
	 	 	30	 
	16.5 Unenforceable Provisions and Severability
	 	 	30	 
	16.6 Waiver
	 	 	30	 
	16.7 Appendices
	 	 	30	 
	16.8 Amendments
	 	 	30	 
	16.9 Debarment
	 	 	30	 
	16.10 Notice
	 	 	31	 
	16.11 Regulation and ethic:
	 	 	32	 
	Appendix 1:
	 	 	33	 
	Appendix 2:
	 	 	37	 






- 5 -









 





1. Definitions



As used in this Agreement, the following terms, whether used in the singular or plural, shall have
the following meanings:




1.1 Affiliate



The term “Affiliate” shall mean any individual, corporation, association or other business entity,
which directly or indirectly controls, is controlled by, or is under common control with the Party
in question. As used in this definition of “Affiliate,” the term “control” means the direct or
Indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for
directors thereof or the ability to otherwise control the management of the corporation or other
business entity whether through the ownership of voting securities, by contract, resolution,
regulation or otherwise. Anything to the contrary in this paragraph notwithstanding Chugai
Pharmaceutical Co., Ltd, a Japanese corporation, (“Chugai”) shall not be deemed an Affiliate of
Roche unless Roche provides written notice to Partner of its desire to include Chugai as an
Affiliate of Roche.




1.2 Agreement



The term “Agreement” shall mean this document including any and all Appendices and amendments to
it as may be added and/or amended from time to time in accordance with the provisions of this
Agreement.




1.3 Agreement Term



The term “Agreement Term” shall mean the term of this Agreement as set forth in Section 15.1.




1.4 Appendix



The term “Appendix” shall mean an appendix to this Agreement.




1.5 Assay



The term “Assay” shall mean the 190 panel ELISA based multiplexing bead platform.




1.6 Background



The term “Background” shall mean information, techniques, Know-how, software and materials
(regardless of the form or medium in which they are disclosed or stored) that are provided by one
Party to the other (whether before or after the Effective Date) to conduct the Work Plan in
accordance with this Agreement, excluding the Research Results. Roche Background shall include the
Baseline Data.




1.7 Baseline Data



The term “Baseline Data” shall mean the data specifically Identified in writing by Roche as being
baseline data and provided by Roche to Partner under this Agreement.




1.8 Blocking Third Party Intellectual Property



The term “Blocking Third Party Intellectual Property” shall mean, Patent Rights in such country
owned or controlled by a Third Party that Cover specific reagents or assays related to markers
required for use or sale of a Companion Diagnostic if the manufacture, use or sale of such
Companion Diagnostic would, in the absence of a license granted by such Third Party in such
country, infringe such Patent Rights.




1.9 Candidate Set



The term “Candidate Set” shall mean the set of best candidate biomarkers identified by Partner as
part of the Step 1 Deliverables




- 6 -









 





1.10 Change of Control



The term “Change of Control” shall mean, with respect to a Partner:





	 	a)	 	The acquisition by any Third Party of beneficial ownership of fifty percent
(50%) or more of the then outstanding common shares or voting power
of Partner, other
than acquisitions by employee benefit plans sponsored or maintained
by Partner;
	 
	 	b)	 	The consummation of a business combination involving Partner,
unless, following
such business combination, the stockholders of Partner immediately prior to such
business combination beneficially own directly or indirectly more than fifty percent
(50%) of the then outstanding common shares or voting power of the entity resulting
from such business combination.





1.11 Confidential Information



The term
“Confidential Information” shall mean any and all information, data or know-how
(including Know-How), whether technical or non-technical, oral or
written, that is disclosed by
one Party or its Affiliates (“Disclosing Party”) to the other Party or its Affiliates (“Receiving
Party”). Information shall not include any information, data or know-how which:





	 	a)	 	was generally available to the public at the time of disclosure, or
information which becomes available to the public after disclosure by the Disclosing
Party other than through fault (whether by action or inaction) of the Receiving Party,
	 
	 	b)	 	can be shown by cogent written records to have been already known to the
Receiving Party prior to its receipt from the Disclosing Party,
	 
	 	c)	 	is obtained at any time lawfully from a Third Party under circumstances
permitting its use or disclosure,
	 
	 	d)	 	is developed independently by the Receiving Party as evidenced by written
records other than through knowledge of Confidential Information,
	 
	 	e)	 	is required to be disclosed by the Receiving Party to comply with a court or
administrative order providing the Receiving Party furnishes prompt notice (in no
event less than three (3) days) to the Disclosing Party to enable it to resist such
disclosure, or
	 
	 	f)	 	is approved in writing by the Disclosing Party for release by the Receiving Party.




The terms of this Agreement shall be considered Confidential Information of both Parties.




1.12 Commercial Agreement



The term “Commercial Agreement” shall mean the agreement to be signed between the Parties
in application of Section 3.3.2.3 of this Agreement.




1.13 Commercially Reasonable Efforts



The term
“Commercially Reasonable Efforts” shall mean such level of efforts required to carry out
such obligation in a sustained manner consistent with the efforts
that Roche or Partner, as
applicable, devotes at the same stage of research or development, as
applicable, for its own
internally developed products in a similar area with similar market
potential, at a similar stage
of their product life taking into account the existence of other competitive products in the
market place or under development, the proprietary position of the
product, the regulatory
structure involved, the anticipated profitability of the product and
other relevant factors. It is
understood that such product potential may change from time to time based upon changing
scientific, business and marketing and return on investment considerations.




- 7 -









 






1.14 Companion Diagnostic



The term “Companion Diagnostic” shall mean a Diagnostic Product for which the intended use is the:





	 	a)	 	Prediction of drug response; and/or
	 
	 	b)	 	Monitoring of drug efficacy; and/or
	 
	 	c)	 	Prediction and monitoring of drug safety; and/or
	 
	 	d)	 	Prognosis of disease progression




and which is developed under the Agreement with the objective of having it approved by the
regulatory authorities in the label of a Therapeutic Product.




1.15 Compound



The term
“Compound” shall mean [***], a pharmaceutically active compound which has a mechanism
of action against the Target.




1.16 Compound Multiplex Panel



The term “Compound Multiplex Panel” shall mean a new multiplex biomarker panel specific to
Compound, developed under this Agreement from the Candidate Set.




1.17 Control



The term “Control” shall mean (as an adjective or as a verb including conjugations and variations
such as “Controls” “Controlled” or “Controlling”) with respect to Patent Rights and/or Know-How,
the possession by a Party of the ability to grant a license or sublicense of such Patent Rights
and/or Know-How without violating the terms of any agreement or arrangement between such Party and
any Third Party.




1.18 Cover



The term “Cover” shall mean (as an adjective or as a verb including conjugations and variations
such as “Covered,” “Coverage” or “Covering”) that the developing, making, using, offering for
sale, promoting, selling, exporting or importing of a given compound, formulation or product would
infringe a Valid Claim in the absence of a license under the Patent Rights to which such Valid
Claim pertains. The determination of whether a compound, formulation, process or product is
Covered by a particular Valid Claim shall be made on a country-by-country basis.




1.19 Deliverables



The term
“Deliverables” shall mean the deliverables as defined in the Work Plan.




1.20 Diagnostic Net Sales



The term “Diagnostic Net Sales” shall mean, with respect to worldwide sales or other dispositions
of a Companion Diagnostic, the total gross amount invoiced by Roche, Roche’s Affiliates or Roche’s
Licenses to end users, distributors or agents in a bona fide arms-length transaction with an
unrelated third party after deduction of (a) actual volume
discounts, sales rebates, allowances,
deduction of returns, (b) sales taxes (e.g. value added taxes) and other taxes directly linked to
the sales (provided that such taxes are separately invoiced to such end users, distributors or
agents) less the following lump sum deductions for:





	 	a)	 	Sales Expenses in the amount of [***]
	 
	 	b)	 	Reagent Rental Expenses in the amount of [***]
	 
	 	c)	 	Third Party Royalty Expenses





- 8 -









 




In the event one or more Companion Diagnostic(s) is/are sold together with one or more other
diagnostic or therapeutic product(s) at a single price (such combination is hereinafter referred
to as “Diagnostic Combination Product”), such single price shall be allocated among the Companion
Diagnostic and the other product(s) in the Diagnostic Combination Product based on the market
price for such products when sold separately. If any such Companion Diagnostic is not being sold
alone with a market price, Partner and Roche shall agree upon a fair market price for that
Companion Diagnostic, and said agreed price shall solely be used to calculate Diagnostic Net
Sales.




1.21 Diagnostic Product



The term “Diagnostic Product” shall mean any product in the form of a device, compound, kit or
service useful in the Field that is discovered, created, developed, or made during or as part of
or as a direct result of the Agreement and which:





	 	a)	 	contains a component which is able to detect and/or quantify the
presence or amount of an analyte in body fluids or tissue that affects the
pathogenesis of a disease or a biological marker or a set of biological markers
shown to indicate a predisposition to a disease that is relevant to a therapeutic
product; or
	 
	 	b)	 	is useful for the measurement or prediction of individual patient
response to a therapeutic product and contains a component which is able to detect
and/or quantify the presence of an analyte in body fluids or tissue.





1.22 Effective Date



The term “Effective Date” shall mean November 25, 2009.




1.23 EU



The term “EU” shall mean the European Community and all its present and future member countries.




1.24 FDA



The term “FDA” shall mean the Food and Drug Administration of the United States of America.




1.25 Field



The term “Field” shall mean the prophylaxis, diagnosis, and treatment of all human diseases by
Compound and compounds active against the Target.




1.26 First Commercial Sale



The term “First Commercial Sale” shall mean the first invoiced sale of the Companion Diagnostic
to a Third Party by the Roche Group following the receipt of any Regulatory Approval required for
the sale of such Product, if any.




1.27 Insolvency Event



The term “Insolvency Event” shall mean circumstances under which a Party:





	 	a)	 	has a receiver or similar officer appointed over all or a material part of its
assets or undertaking;
	 
	 	b)	 	passes a resolution for Winding-up (other than a winding-up for the purpose of,
or in connection with, any solvent amalgamation or reconstruction) or a court makes an
order to that effect or a court makes an order for administration (or any equivalent
order in any jurisdiction);
	 
	 	c)	 	enters into any composition or arrangement with its creditors (other than
relating to a solvent restructuring);





- 9 -









 






	 	d)	 	ceases to carry on business; or
	 
	 	e)	 	is unable to pay its debts as they become due in the ordinary course of business.





1.28 JSC



The term “JSC” shall mean the joint steering committee further described in Section 4.3.




1.29 Intellectual Property



The term “Intellectual Property” shall mean patents, trade marks, service marks,
registered designs, copyrights, database rights, design rights, confidential
Information, applications for any of the above, and any similar right recognised from
time to time in any jurisdiction, together with all rights of action in relation to the
infringement of any of the above.




1.30 Inventions



The term “Invention” shall mean an invention that is conceived or reduced to practice in
connection with any activity carried out pursuant to the Work Plan. Under this
definition, an Invention may be made by employees of Partner solely or jointly with a
Third Party, by employees of the Roche Group solely or jointly with a Third Party, or
jointly by employees of Partner and a member of the Roche Group with or without a Third
Party.




1.31 Know-How



The term “Know-How” shall mean unpatented technical information, data, and knowledge,
including without limitation materials, samples, chemical manufacturing data,
toxicological data, pharmacological data, preclinical data, assays, platforms,
formulations, specifications and quality control testing data, that is not in the public
domain.




1.32 Licensee



The term “Licensee” shall mean a Third Party to which Roche, based on the Step 2
Deliverables as detailed in the Work Plan in Appendix 1, granted rights to develop a
Companion Diagnostic.




1.33 Multiplex Technology



The term “Multiplex Technology” shall mean the technology to measure multiple protein
analytes in a single analysis, for example the technology used by Rules Based Medicine
Inc. (RBM).




1.34 Party



The term “Party” shall mean Partner or Roche, as the case may be, and “Parties” shall
mean Partner and Roche collectively.




1.35 Partner Patent Rights



The term “Partner Patent Rights” shall mean the Patent Rights Partner Controls as of the
Effective Date and during the Agreement Term, Covering the use,
import, offering for
sale, or sale of a Companion Diagnostic.




1.36 Patent Rights



The term
“Patent Rights” shall mean all rights under any patent or patent application, in
any country of the Territory, including any patents issuing on such
patent application,
and further including any substitution, extension or supplementary protection
certificate, reissue, re-examination, renewal, division, continuation or
continuation-in-part of any of the foregoing.




- 10 -









 








1.37 Reagent Rental Expenses



The term “Reagent Rental Expenses” shall mean a lump sum deduction of fees for all
services which are included in reagent prices such as instrument service costs,
instrument depreciation, finance costs, disposables and rental fees.




1.38 Regulatory Authority



The term
“Regulatory Authority” shall mean any national,
supranational (e.g., the European
Commission, the Council of the European Union, the European Medicines Agency), regional,
state or local regulatory agency, department, bureau, commission, council or other
governmental entity including the FDA, in each country involved in the granting of
Regulatory Approval for a Companion Diagnostic.




1.39 Regulatory Approval



The term “Regulatory Approval” shall mean any approvals (including pricing and
reimbursement approvals), licenses, registrations or authorizations by Regulatory
Authority, necessary for the manufacture and sale of a Companion Diagnostic in the Field
in a regulatory jurisdiction in the Territory.




1.40 Research Results



The term
“Research Results” shall mean all information, Know-how,
results, inventions,
software and other Intellectual Property identified or first reduced to practice or
writing in the course of the conduct of the Work Plan, excluding any Partner Inventions.




1.41 Research Term



The term “Research Term” shall mean, unless terminated earlier by Roche, the period of
time commencing upon the date of delivery of the Step 1 Samples by Roche to Partner, as
detailed in the Work Plan in Appendix 1, and ending upon the delivery by Partner to
Roche of the Step 3 Deliverables as detailed in the Work Plan in Appendix 1.




1.42 Roche Group



The term Roche Group shall mean collectively Roche, its Affiliates and Licensees.




1.43 Royalty Term



The term “Royalty Term” shall mean, with respect to a Companion Diagnostic and for a
given country, the period of time commencing on the date of First Commercial Sale of the
Companion Diagnostic in such country and ending on the later of: (a) the date of
expiration of the last issued
Partner Patent Right in such country containing a Valid Claim that would be infringed by
the sale of such Companion Diagnostic in such country; and (b) a period of five (5)
years from the First Commercial Sale of the Companion Diagnostic.




1.44 Sales Expenses



The term “Sales Expenses” shall mean a lump sum deduction in lieu of deductions for actual internal
expenses of Roche or Roche’s Affiliates such as for
(a) tariffs, duties and taxes imposed upon the
production, sale, delivery or use of Companion Diagnostic (excluding taxes that are separately
invoiced to end users, distributors or agents) and (b) distribution and other
customary expenses, such as freight, transportation and insurance expenses and for (c) cash discounts, retroactive price reductions or credits to customers on account of settlement of
complaint.




- 11 -









 








1.45 Sample



The term “Sample” shall mean an aliquoted serum sample provided from Roche to Partner collected
from patients to a clinical trial/s conducted by Roche in relation to the Compound.




1.46 Section



The term “Section” shall mean a section of this Agreement.




1.47 Target



The term “Target” shall mean the [***]



1.48 Technology Transfer



The term “Technology Transfer” means the transfer of the technology from Partner to Roche which is
to be agreed between the Parties.




1.49 Territory



The term “Territory” shall mean all countries of the world.




1.50 Therapeutic Product



The term “Therapeutic Product” shall mean any pharmaceutical formulations containing Compound as
an active pharmaceutical ingredient.




1.51 Third Party



The term “Third Party” shall mean a person or entity other than (i) Partner or any of its
Affiliates or (ii) Roche or any of its Affiliates.




1.52 Third Party Royalty Expenses



The term “Third Party Royalty Expenses” shall mean royalties paid to third parties on Diagnostic
Net Sales by Roche, Roche’s Affiliates or Licenses to obtain rights and licenses under the
Blocking Third Party Intellectual Property. The deduction excludes any portion of the royalties
paid to third parties which is allocatable to rights and licenses not
related to, or necessary, for
Roche, Roche’s Affiliates or Licenses to make such Diagnostic Net Sales.




1.53 TP Net Sales



The term “TP Net Sales” shall mean the amount calculated by subtracting from the amount of
TP Adjusted Gross Sales (as defined below) a lump sum deduction of four percent 4%) of TP Adjusted
Gross Sales in lieu of those sales-related deductions which are not accounted for by Roche, its
Affiliates and Sublicensees on a Therapeutic Product-by-Therapeutic Product basis (e.g. outward
freights, postage charges, transportation insurance, packaging materials for dispatch of goods,
custom duties, bad debt expense);

For the purposes of this definition of “TP Net Sales”, “TP Adjusted Gross Sales” shall mean the
amount of gross sales of the Therapeutic Product invoiced by Roche, its Affiliates and its
Sublicensees to Third Parties less deductions such as:





	 	a)	 	Governmental price reductions and changes to reserves of governmental price
reductions, such as price reductions, rebates to managed care organizations or social
and welfare systems, charge backs or reserves for chargebacks, cash sales incentives
(but only to the extent it is a sales related deduction which is accounted for within
Roche on a Therapeutic Product-by-Therapeutic Product basis), government mandated
rebates and similar types of rebates (e.g., Pharmaceutical Price Regulation Scheme,
Medicaid, clawback schemes and any other such scheme)




- 12 -









 












	 	b)	 	Contract pricing chargebacks and changes to reserves of contract pricing
chargebacks, such as periodic charges of wholesalers and chargebacks for price capping
programs
	 
	 	c)	 	Customer rebates and changes to reserves of customer rebates, such as volume
(quantity) discounts or price discounts
	 
	 	d)	 	Returns and return reserves, such as in cases for spoiled, damaged, out-dated,
rejected, returned sold Therapeutic Product, withdrawals and recalls, covering both
resellable products and goods which have to be destroyed
	 
	 	e)	 	Cash discounts
	 
	 	f)	 	Taxes, such as value added or sales taxes, government mandated exceptional taxes and
other taxes directly linked to the gross sales amount.




For the avoidance of doubt, the “TP Adjusted Gross Sales” on a Therapeutic Product-by-Therapeutic
Product basis, means the same methodology as Roche consistently uses to recognize sales in its
financial reporting, which is in accordance with the then used International Financial Reporting
Standards (IFRS), and is reviewed and approved by Roche’s external auditors.




1.54 Valid Claim



The term “Valid Claim” shall mean, as applicable, a claim in any unexpired and issued Partner
Patent Rights that have not been disclaimed, revoked or held invalid by a final non-appealable
decision of a court of competent jurisdiction or government agency.




1.55 Work Plan



The term
“Work Plan” shall mean the work plan attached to this Agreement as Appendix 1.




2. License grant




2.1 Licenses granted to Partner by Roche




2.1.1 License grant to Partner during the Research Term



During the Research Term Roche hereby grants to Partner a non-exclusive, non-sublicensable right
and license in the Territory to use Roche Background and the Research Results solely and
exclusively for the performance of the tasks allocated to Partner under the Work Plan.




2.1.2 Commercial license



Upon the sooner of:





	 	a)	 	the Partner’s completion of the activities designated to it in the Work Plan; or
	 
	 	b)	 	the end of the Agreement Term (except where such termination is the result of a
breach of this Agreement by Partner).




Roche hereby grants to Partner a royalty free, non-exclusive sublicensable, fully-paid up perpetual
license to use the Baseline Data to develop, have developed, make, have made, import, export, sell
and have sold Diagnostic Products other than Companion Diagnostics in the Territory. For the
avoidance of any misunderstanding, the commercial license granted to Partner by Roche shall not
include any rights related to any Research Results.




2.2 Licenses granted to Roche by Partner



During the
Agreement Term and thereafter Partner grants to Roche a non-exclusive,
sublicensable license to the Background Intellectual Property Controlled by Partner that is





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necessary or useful for Roche to develop, have developed, make, have made, import, export, sell
and have sold Companion Diagnostics in the Territory.



 3.
Research Collaboration 




 3.1
Conduct of the Work Plan 




3.1.1 Scope




Partner and Roche shall cooperate during the Research Term and perform their respective
obligations under this Agreement according to the Work Plan.



The objective of the Work Plan is for Partner to identify candidate serum protein biomarkers with
utility in prognosis of disease progression and predicting or monitoring efficacy and safety of
Compound in improving negative symptoms and potentially cognitive deficits and/or residual symptoms
in schizophrenia.



Partner and Roche shall undertake the following three steps as set out in detail in the Work Plan:




	 	a)	 	Step 1: Analysis of Roche Phase 2 clinical trial Samples by Partner for
identification of candidate biomarkers (“Step 1”);
	 
	 	b)	 	Step 2: Re-analysis of Roche Phase 2 clinical trials Samples by Partner with
Multiplex Technology (“Step 2”); and
	 
	 	c)	 	Step 3: Analysis of Roche Phase 3 clinical trial Samples by Partner (“Step 3”).





Partner shall be required to provide Deliverables at the conclusion of each step as set out in the
Work Plan.



3.1.2 End of Step 1 decision by Roche




Based on the Step 1 Deliverables as defined in the Work Plan, Roche shall at its sole discretion
decide whether or not to proceed to Step 2 of the Work Plan. Roche shall advise Partner in writing
of its decision in this regard within one hundred and twenty (120) days following the completion
of Step 1.



3.1.3 End of Step 2 decision by Roche




Based on the Step 2 Deliverables as defined in the Work Plan, Roche shall in its sole discretion
decide whether or not:




	 	a)	 	to have developed from the Candidate Set a Compound Multiplex Panel
as
candidate Companion Diagnostic; and
	 
	 	b)	 	to have such Compound Multiplex Panel developed by either (i) Roche
or its
Licensee or (ii) Partner, on the same or on another platform.





Roche shall advise Partner in writing of its decision in this regard within one hundred and twenty
(120) days following the completion of Step 2. If Roche upon its sole discretion decides to develop
the Compound Multiplex Panel but not to develop it by itself then Partner shall be the preferred
developer and the Parties will carry-out Step 3 of the Work Plan. If Roche decides to choose to
develop the Compound Multiplex Panel in collaboration with a Licensee, rather than Partner, then
Roche shall provide Partner with its rationale for such decision which shall be based on:




	 	a)	 	the reproducibility of the Assay;
	 
	 	b)	 	the technical capability of the Assay to be fit for purpose for clinical use;






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	 	c)	 	the path to achieve Regulatory Approval; and
	 
	 	d)	 	the ability to use the antibodies linked to each analyte of the
Candidate Set
without infringing any Third Party Patent Rights.





Roche shall inform Partner of its decision in writing. If Roche has chosen a Licensee and Partner
does not agree with the rationale provided by Roche, then such dispute shall be referred to the
respective executive officers of the Parties designated below or their designees, for good faith
negotiations attempting to resolve the dispute within twenty-one (21) days. The designated
executive officers are as follows:




	 	 	For Partner:      Director
	 
	 	 	For Roche:       Global Head of Pharma Partnering





Should the Parties after such twenty-one (21) days still not have come to an agreement then Roche
shall have the final say.



 3.2
Reports 




Within thirty (30) days of completion of each step of the Work Plan, Partner shall have the
obligation to prepare and provide to the JSC a detailed written report summarizing the progress of
the work performed by Partner during such step.



 3.3
Development of Companion Diagnostic 




3.3.1 Development of Companion Diagnostic by Roche or its Licensee




If Roche in application of Section 3.1.2 in its sole discretion decides to develop by itself or by
its Licensee the Compound Multiplex Panel as Companion Diagnostic, then Roche will have full
responsibility for the implementation and funding of such development.



3.3.2 Development of Companion Diagnostic by Partner




3.3.2.1 Responsibility of Partner during development




If Roche in application of Section 3.1.2 in its sole discretion decides to have Partner develop
the Compound Multiplex Panel as FDA approvable Companion Diagnostic then Partner shall have the
full responsibility for the implementation and funding of the non-clinical development of the
Companion Diagnostic.



3.3.2.2 Responsibility of Roche during development




Notwithstanding Section 3.3.2.1 it is agreed and understood that Roche shall keep full
responsibility for designing, conducting, funding and implementing the clinical development
programs and regulatory strategies for development of Companion Diagnostics. If Roche decides to
seek Regulatory Approval of the Companion Diagnostic, then the Parties shall enter into a
Commercial Agreement.



3.3.2.3 Commercial Agreement




If Roche has informed Partner in writing of its decision to appoint Partner as the developer of the
Companion Diagnostic, then the Parties shall have sixty (60) days in which to conclude a Commercial
Agreement governing the exploitation of the Companion Diagnostic, Such agreement will specify usage
rights to be granted to Roche and the consideration for such rights payable to Partner, for
example, a fee for service to use Multiplex Technology or agreed purchase prices for a kit or beads
developed by Partner as a Companion Diagnostic. The Commercial Agreement shall not stipulate a
signing fee or event payments as such fee and




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payments are reflected in Section 6.3 of this Agreement. The Commercial Agreement shall be agreed
on commercially reasonable terms and negotiated in good faith between the Parties. Should the
Parties, within such sixty (60) days, not reach agreement on the commercial terms of the
Commercial Agreement, then the terms last offered to Partner shall be reviewed within twenty-one
(21) days by the Parties respective executive officers as set forth in Section 3.1.2 of this
Agreement. Should the terms last offered by Roche still not be accepted by Partner, then Roche
shall have the right to enter into a commercial agreement with a Third Party, provided however
that the terms offered to such Third Party shall, when taken as a whole, not be more favourable
than those last offered to Partner. Roche shall have an obligation to share the financial terms of
Roche’s agreement with such Third Party with Partner, such terms being Confidential Information of
Roche.



 4. Diligence 




 4.1 Diligence of Partner under the Work Plan 




Partner shall use Commercially Reasonable efforts to perform its responsibilities under the Work
Plan and to provide Deliverables to Roche in the most expeditious timeframe as reasonably
feasible.



 4.2 Diligence of Partner after initiation of Step 2 of the Work Plan 




If Roche in application of Section 3.1.2 decides to initiate Step 3 of the Work Plan, then Partner
shall use Commercially Reasonable Efforts to perform its responsibilities for the development of a
Companion Diagnostic both during and beyond the Research Term.



 4.3 Diligence of Roche 




Roche shall use Commercially Reasonable Efforts to:




	 	a)	 	provide Partner with the Samples necessary for Partner to perform
Steps 1 and
2 of the Work Plan , provided that the supply of Samples is subject to Roche’s
unilateral decision to perform and complete the ongoing clinical studies;
	 
	 	b)	 	to analyze the Deliverables and make go/no go decisions in the
most
expeditious timeframe as reasonably feasible, and in any event within the time
frames specified in clause 3.





 5. Governance 




 5.1 Joint Steering Committee 




Within sixty (60) days after the Effective Date of this Agreement, the Parties shall establish a
Joint Steering Committee (“JSC”) to oversee the progress of the Work Plan during the Research
Term.



 5.2 Members 



The JSC shall be composed of four (4) persons (“Members”). Roche and Partner each shall be
entitled to appoint two (2) Members with appropriate seniority and functional expertise. Each
Party may replace any of its Members and appoint a person to fill the vacancy arising from each
such replacement. A Party that replaces a Member shall notify the other Party at least ten (10)
days prior to the next scheduled meeting of the JSC. Both Parties shall use Commercially
Reasonable Efforts to keep an appropriate level of continuity in representation. Both Parties may
invite a reasonable number of additional experts and/or advisors to attend part or the whole JSC
meeting with prior notification to the JSC. Members may be represented at any meeting by another
person designated by the absent Member. The JSC shall be chaired by a Roche Member
(“Chairperson”), the Chairperson will be nominated by Roche when the JSC is appointed.



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 5.3 Responsibilities of the JSC 




The JSC shall have the responsibility and authority to:




	 	a)	 	oversee the progress of the Work Plan;
	 
	 	b)	 	review the Deliverables of each step of the Work Plan; and
	 
	 	c)	 	serve as a time keeper with respect to the Work Plan;





The JSC shall have no responsibility and authority other than that expressly set forth in this
Section 5.3.



 5.4 Meetings 




The Chairperson or his/her delegate is responsible for sending invitations and agendas for all JSC
meetings to all Members at least 10 (ten) days before the next scheduled meeting of the JSC. The
venue for the meetings shall be agreed by the JSC. The JSC shall hold meetings at least twice per
calendar year, either in person or by tele-/video-conference, and in any case as frequently as the
Members of the JSC may agree shall be necessary. Any group of three (3) members from the JSC shall
have the right to request the Chairperson to call for an unscheduled meeting of the JSC.



 5.5 Minutes 




The Chairperson is responsible for designating a Member to record in reasonable detail and
circulate draft minutes of JSC meetings to all members of the JSC for comment and review within
twenty (20) days after the relevant meeting. The Members of the JSC shall have ten (10) days to
provide comments. The Party preparing the minutes shall incorporate timely received comments and
distribute finalized minutes to all Members of the JSC within thirty-five (35) days of the
relevant meeting. The Chairperson approves the final version of the minutes before its
distribution.



 5.6 Decisions 




5.6.1 Decision making authority




The JSC shall decide matters within its responsibilities set forth in Section 5.3.



5.6.2 Consensus; Good faith




The Members of the JSC shall act in good faith to cooperate with one another and seek agreement
with respect to issues to be decided by the JSC. The Parties shall endeavor to make decisions by
consensus.



5.6.3 Escalation




If the JSC is unable to decide a matter by consensus, then such matter shall be referred to the
one senior representative of each Party for resolution, who together shall use reasonable and good
faith efforts to reach a decision by consensus within twenty-one (21) days after the date such
matter is referred to them. If the Parties still fail to reach a decision within such twenty-one
(21) days, then the final decision shall be Roche’s. Any such decision shall constitute a decision
of the JSC.



 5.7 Alliance Director 




Each Party shall appoint an alliance Director (“Alliance Director”). The Alliance Directors shall
be the point of contact within each Party with responsibility for facilitating communication and
collaboration between the Parties. They are permanent participants of the JSC meetings, but not
members of the JSC. The Alliance Directors shall facilitate resolution of potential and




- 17 -









 










pending issues and potential disputes to enable the JSC to reach consensus and avert escalation of
such issues or potential disputes.



 5.8 Limitations of Authority 




The JSC shall have no authority to amend or waive any terms of this Agreement.



 5.9 Expenses 




Each Party shall be responsible for its own expenses including travel and accommodation costs
incurred in connection with the JSC. Members of the JSC will decide together the venue of their
oncoming meetings. In the absence of a consensus, the meeting of the JSC may be organized by video
conference.



 5.10 Lifetime 




The JSC shall exist until the earlier of:




	 	a)	 	Roche’s decision to develop the Compound Multiplex Panel itself; or
	 
	 	b)	 	the first submission for regulatory approval of a Companion
Diagnostic
developed by Partner; or
	 
	 	c)	 	termination of the Agreement in application of Section 15.2.





 6. Funding by Roche during the Research Term 




 6.1 Funding by Roche during Step 1 of the Work Plan 




As compensation for the work to be performed by Partner during Step 1 of the Work Plan, Roche
shall pay Partner the amount of [***]  per Sample provided by Roche to
Partner. Fifty percent (50%) of the amount due by Roche to Partner under this Section
6.1 shall be paid by Roche to Partner within thirty (30) days upon initiation of the Work Plan and
receipt of an invoice by Roche from Partner. The remaining fifty percent (50%) to be paid by
Roche to Partner under this Section 6.1 shall be paid by Roche to Partner within thirty (30) days
upon delivery of the Step 1 Deliverables as set forth in the Work Plan and receipt of an invoice
by Roche from Partner.



 6.2 Funding by Roche during Step 2 of the Work Plan 




As compensation for the work to be performed by Partner during Step 2 of the Work Plan, Roche shall
pay Partner the amount of [***] per Sample provided by Roche to Partner. Fifty
percent (50%) of the amount due by Roche to Partner under this Section
6.2 shall be paid by Roche to Partner within thirty (30) days upon initiation of Step 2 of the Work
Plan and receipt of an invoice by Roche from Partner. The remaining fifty percent (50%) to be
paid by Roche to Partner under this Section 6.2 shall be paid by Roche to Partner within thirty
(30) days upon delivery of the Step 2 Deliverables as set forth in the Work Plan and receipt of
an invoice by Roche from Partner.



For the avoidance of any misunderstanding it is understood and agreed between the Parties that the
payment to be made by Roche to Partner includes the compensation for the development and
validation of the Compound Multiplex Panel.



 6.3 Funding by Roche during Step 3 of the Work Plan 




6.3.1 Initiation fee




If Roche upon its sole discretion decides to initiate Step 3 of the Work Plan, then Roche shall
pay Partner the onetime, non refundable amount of [***]. Such amount shall be due and payable by Roche to partner within thirty (30) days from
Roche’s decision to initiate Step 3 of the Work Plan and upon receipt of a respective




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invoice by Roche from Partner. Such amount shall compensate for all costs incurred by Partner for
further validation of the Compound Multiplex Panel, scale-up and assay maintenance.



6.3.2 Complementary funding during Step 3 of the Work Plan




In addition to the amount as mentioned under Section 6.3.1 and as an additional compensation for
the work to be performed by Partner during Step 3 of the Work Plan, Roche shall pay Partner a
complementary amount which price per Sample will depend on the size of the Compound Multiplex
Panel, as follows:




	 	a)	 	If the Compound Multiplex Panel is a ten (10) multiplex then the
amount to be
paid by Roche to Partner shall be [***] per Sample.
For illustration purposes if the Compound Multiplex Panel is a ten (10) multiplex
and the amount of Samples is ten thousand (10,000), then the total amount to be
paid by Roche to Partner shall be [***]; or
	 
	 	b)	 	If the Compound Multiplex Panel is a twenty (20) multiplex then the
amount to
be paid by Roche to Partner shall be [***]  per Sample.
For illustration purposes if the Compound Multiplex Panel is a twenty (20)
multiplex and the amount of Samples is five thousand (5,000) then the total amount
to be paid by Roche to Partner shall be [***]; or
	 
	 	c)	 	If the Compound Multiplex Panel is a thirty (30) multiplex then the
amount to be
paid by Roche to Partner shall be [***] per Sample.
For illustration purposes if the Compound Multiplex Panel is a thirty (30)
multiplex and the amount of Samples is ten thousand (10,000) then the total amount
to be paid by Roche to Partner shall be [***].





The amount calculated as set forth in this Section 6.3.2 shall be payable by Roche to Partner as
follows:




	 	a)	 	thirty-three percent (33%) of the amount shall be due and payable by
Roche to
Partner upon submission of the first batch for analysis and upon receipt of a
respective invoice by Roche from Partner.
	 
	 	b)	 	thirty-three percent (33%) of the amount shall be due and payable by
Roche to
Partner upon submission of the second batch for analysis and upon receipt of a
respective invoice by Roche from Partner.
	 
	 	c)	 	thirty-four percent (34%) of the amount shall be due and payable by
Roche to
Partner upon delivery of the Step 3 Deliverables by Partner and upon receipt of
a respective invoice by Roche from Partner.





 7. Consideration for Companion Diagnostic 




 7.1 Development of Companion Diagnostic by Roche or its Licensee 




7.1.1 Development event payments




If Roche or its Licensee independently develops the Compound Multiplex Panel as a Companion
Diagnostic, then Roche shall pay Partner up to a total of [***] in development event payments, upon first occurrence of the applicable events for a Companion
Diagnostic, in one-time non-refundable payments, as follows:




	 	a)	 	[***] upon completion of the
Technology Transfer from Partner to Roche or its Licensee as applicable; and





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	 	b)	 	[***] upon First Commercial Sale of a
Companion Diagnostic in the USA; and
	 
	 	c)	 	[***] upon First Commercial Sale of
a
Companion Diagnostic in a first country of the EU.





Each development event mentioned in this Section 7.1.1 shall be paid during the Agreement Term
only once the first time the first Companion Diagnostic reaches such development events and the
total amount to be paid by Roche to Partner shall not exceed [***].



7.1.2 Royalties




During the
Royalty Term, Roche shall pay to Partner for each Companion Diagnostic fixed royalties of [***] on aggregate worldwide calendar year Diagnostic Net Sales, on a Companion
Diagnostic-by- Companion Diagnostic basis and country-by-country basis. Upon the expiry of the
Royalty Term the licenses granted to Roche by Partner in this Agreement are fully paid up and
irrevocable for such Companion Diagnostic.



 7.2 Development of Companion Diagnostic by Partner 




If Roche based on the Step 2 Deliverables decides to confirm Partner as developer of the Compound
Multiplex Panel, then Roche shall pay Partner up to a total of [***] upon first occurrence of the applicable events for a Companion Diagnostic, in
one-time non-refundable payments, as follows:




	 	a)	 	[***] upon signing of the Commercial
Agreement (as the signing fee);
	 
	 	b)	 	[***] upon First Commercial Sale
of a
Companion Diagnostic in the USA;
	 
	 	c)	 	[***] upon First Commercial Sale of
a
Companion Diagnostic in a first country of the EU; and
	 
	 	d)	 	[***] upon the Therapeutic Product first
achieving
world-wide calendar year TP Net Sales greater than [***].





Each development event mentioned in this Section 7.2 shall be paid during the Agreement Term only
once the first Companion Diagnostic reaches such development events and the total amount to be
paid by Roche to Partner shall not exceed [***].



 8. Accounting and reporting 




 8.1 Timing of payments 




Roche shall calculate royalties on Diagnostic Net Sales quarterly as of March 31, June 30,
September 30 and December 31 (each being the last day of an “Accounting Period”) and shall pay
royalties on Diagnostic Net Sales within ninety (90) days after the end of each Accounting Period
in which such Diagnostic Net Sales occurs.



 8.2 Late payment 




Any payment under this Agreement that is not paid on or before the date such payment is due shall
bear interest, to the extent permitted by applicable law, at one (1) percentage point above the
average one-month London Interbank Offered Rate (LIBOR), as reported by Reuters from time to time,
calculated on the number of days such payment is overdue.




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8.3 Method of payment




Royalties on Diagnostic Net Sales shall be paid by Roche in Pounds (£).



8.4 Currency conversion




For the
purpose of calculating consolidated Diagnostic Net Sales on a global basis, Diagnostic Net
Sales in local currencies shall be converted into Swiss Francs using (i) for computational
purposes, the Roche’s Central Swiss Francs Sales Statistics for the countries concerned and (ii)
for internal foreign currency translation, the Roche’s then-current standard practices actually
used on a consistent basis in preparing its audited financial statements which currently consist
of using, on a daily basis, the relevant average bid and ask exchange rates published by Reuters.



For the
purpose of calculating royalty payments on Diagnostic Net Sales in pounds (£), any
conversion of Swiss Francs to pounds (£) shall be made using the same rates as those used for the
applicable period under the standard practises described above.



8.5 Reporting




With each payment Roche shall provide Partner in writing for the relevant calendar quarter on a
Companion Diagnostic-by- Companion Diagnostic basis the following information:




	 	a)	 	Diagnostic Net Sales in CHF;
	 
	 	b)	 	total royalty payment to be made in pounds (£).





9. Taxes




Partner shall pay all sales, turnover, income, revenue, value added, and other taxes levied on
account of any payments accruing or made to Partner under this
Agreement. 


If provision is made in
law or regulation of any country for withholding of taxes of any type, levies or other charges with
respect to any royalty or other amounts payable under this Agreement to Partner, then Roche shall
promptly pay such tax, levy or charge for and on behalf of Partner to the proper governmental
authority, and shall promptly furnish Partner with receipt of payment. Roche shall be entitled to
deduct any such tax, levy or charge actually paid from royalty or other payment due Partner or be
promptly reimbursed by Partner if no further payments are due Partner. Each Party agrees to
reasonably assist the other Party in claiming exemption from such deductions or withholdings under
double taxation or similar agreement or treaty from time to time in force and in minimizing the
amount required to be so withheld or deducted.



10. Auditing




10.1 Partner right to audit




Roche
shall keep, and shall require its Licensees to keep, full, true and accurate books of
accounts, containing all particulars that may be necessary for the
purpose of calculating all
royalties payable under this Agreement. Such books of accounts shall be kept at their principal
place of business. At the expense of Partner, Partner has the right to engage Roche’s officially
appointed worldwide independent public accountant to perform, on behalf of Partner an audit of
such books and records of Roche and its Licensees, that are deemed necessary by Roche’s
independent public accountant to report on Diagnostic Net Sales of Companion Diagnostic for the
period or periods requested by Partner and the correctness of any report or payments made under
this Agreement.



Upon
timely request and at least sixty (60) working days’ prior written notice from Partner, such
audit shall be conducted in the countries specifically requested by
Partner, during regular
business hours in such a manner as to not unnecessarily interfere with Roche’s normal business
activities, and shall be limited to results in the two (2) calendar years prior to audit
notification.



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Such audit shall not be performed more frequently than once per calendar year nor more
frequently than once with respect to records covering any specific
period of time.


All
information, data documents and abstracts herein referred to shall be used only for the purpose
of verifying royalty statements, shall be treated as Roche Confidential Information subject to
the obligations of this Agreement and need neither be retained more than one (1) year after
completion of an audit hereof, if an audit has been requested; nor
more than two (2) years from the
end of the calendar year to which each shall pertain; nor more than
one (1) year after the date of
termination of this Agreement.



10.2 Sharing of draft reports




The auditors shall share all draft reports with Roche before the draft report is shared with
Partner and before the final document is issued; the auditors shall
not interpret the Agreement.
The final report shall be shared by Roche and Partner.



10.3 Overpayment or Underpayment




If the audit reveals an overpayment, Roche shall:




	 	a)	 	deduct the amount of the overpayment from the next royalty
payment due to Partner after receipt by Partner of the final report; or
	 
	 	b)	 	promptly be reimbursed by Partner, if future royalties due under
this Agreement are not expected to cover the overpayment performed by Roche.





Similarly, if the audit reveals an underpayment, Roche shall:




	 	a)	 	make up such underpayment with the next royalty payment
occurring after receipt by Roche of the final report; or
	 
	 	b)	 	promptly reimburse Partner, if future royalties due under this
Agreement are not expected to cover the underpayment performed by Roche.





Roche
shall pay for the audit costs if the underpayment of Roche exceeds five percent (5%) of the
aggregate amount of royalty payments owed with regard to the royalty statements subject of the
audit. Section 8.2 shall apply to this Section 10.3.



10.4 Duration of audit rights




The failure of Partner to request verification of any royalty calculation within the period
during which corresponding records must be maintained under this
Section 10 will be deemed to be
acceptance of the royalty payments and reports.



11. Intellectual Property




11.1 Ownership of Background Intellectual Property




This Agreement does not affect the ownership of any Intellectual Property in any Background or in
any other technology, design, work, invention, software, data,
technique, know-how or materials
that are not Research Results. The Intellectual property in them will remain the property of the
Party that contributes them to the performance of the Work Plan under
this Agreement. No license to
use any Intellectual property is granted or implied by this Agreement except the rights expressly
granted in this Agreement.



11.2 Ownership of Arising Intellectual Property




Roche will
own all rights to Intellectual Property in the Research Results. The Research Results shall include the Deliverables.



For the avoidance of any misunderstanding it is agreed that in no case shall Partner have the
right to use the Research Results, except as contemplated under the
Work Plan. The Research



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Results
will be stored in separate databases at Partner. At Roche’s request, all Research Results
will be destroyed by Partner and Partner shall not keep any copy of
such data. Partner shall
confirm the destruction of all Research Results to Roche in writing.



11.3 Ownership of Inventions




11.3.1 Inventions owned by Partner




Any Inventions related to Partner Background (“Partner Inventions”) shall be the sole and
exclusive property of Partner, irrespective of inventorship.



11.3.2 Inventions owned by Roche




Any Inventions related to Roche Background (“Roche Inventions”) shall be the sole and exclusive
property of Roche, irrespective of inventorship.



11.3.3 Jointly owned Inventions




Any Invention related to both Partner Background and Roche Background (“Joint Inventions”) shall
be jointly owned by the Parties. Each Party shall have the right to
use and exploit any Joint
Invention without the express permission of the other Party.



11.4 Prosecution of Patent Rights claiming Inventions




11.4.1 Prosecution of Patent Rights claiming an Invention owned by Roche




Roche shall, at its own expense and discretion, (i) prepare, file, prosecute and maintain
(including their issuance, reissuance, reexamination and the defense
of any interference,
revocation or opposition proceedings) (collectively, “Handle”) all Patent Rights claiming an
Invention owned by Roche in accordance with Section 11.3.2. At Roche’s expense and reasonable
request, Partner shall cooperate, in all reasonable ways with the Handling of all such Patent
Rights.



11.4.2 Prosecution of Patent Rights claiming an Improvement owned by Partner




Partner shall, at its own expense and discretion, Handle all Patent Rights claiming an Invention
owned by Partner in accordance with Section 11.3.1. At Partner’s expense and reasonable request,
Roche shall cooperate, in all reasonable ways with the Handling of all such Patent Rights.



11.4.3 Prosecution of Joint Patent Rights




The Parties shall jointly determine in good faith the filing and prosecution strategy for Joint
Inventions, including which Party is best suited to file and prosecute or if a Third Party patent
agent should be used, and the sharing of costs for such filing and prosecution.



11.4.4 Other prosecution




Should a Party decide that it does not desire to Handle a Patent Right or patent application
resulting from an Invention owned by such Party (hereafter the “Owning Party”) in accordance
with Section 11.3, then the Owning Party shall promptly advise
the other Party thereof. At the
written request of the other Party, and except where such decision was made on the basis of a
legal reason (e.g. antitrust), the Owning Party shall, at the expense
of the other Party, assign
such Patent Right or patent application in such country or countries in the Territory to the other
Party, and such other Party may thereafter Handle such Patent Right or patent application at its
own cost.



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11.5 Infringement




Each Party shall promptly provide written notice to the other Party during the Agreement Term of
any (i) known infringement or suspected infringement by a Third Party of any Patent Right claiming
an Invention, or (ii) known or suspected unauthorized use or misappropriation by a Third Party of
any Partner Know-How, and shall provide the other Party with all evidence in its possession
supporting such infringement or unauthorized use or misappropriation.



11.6 Hatch-Waxman




Notwithstanding anything herein to the contrary, should a Party receive a certification for a
Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law
98-417), as amended, or its equivalent in a country other than the US (the “Hatch-Waxman Act”),
then such Party shall immediately provide the other Party with a copy of such certification. Roche
shall have thirty (30) days from date on which it receives or provides a copy of such
certification to provide written notice to Partner (“H-W Suit Notice”) whether Roche will bring
suit, at its expense, within a forty-five (45) day period from
the date of such certification.
Should such thirty (30) day period expire without Roche bringing suit or providing such H-W Suit
Notice, Partner shall be free to immediately bring suit in its name.



12. Representations and Warranties




12.1 Ownership of Background IP




Each Party represents and warrants to the other Party that (i) it is exclusively entitled to act
on behalf of the owners of all right, title and interest in its Background, and (ii) no Third
Party has any right, title or interest in or to the Background Controlled by it, which would
prevent it from exercising its rights granted under this Agreement.



12.2 Grants




Each Party represents and warrants that it has the right to grant the other Party the rights and
licenses described in this Agreement.



12.3 Authorization




Each Party represents and warrants that the execution, delivery and performance of this Agreement
by it and all instruments and documents to be delivered by it hereunder:




	 	a)	 	are within the corporate power of that Party;
	 
	 	b)	 	have been duly authorized by all necessary or proper corporate action;
	 
	 	c)	 	are not in contravention of any provision of the certificate of formation or
limited liability company agreement;
	 
	 	d)	 	to its knowledge, will not violate any law or regulation or any order or decree
of any court of governmental instrumentality;
	 
	 	e)	 	will not violate the terms of any indenture, mortgage, deed
of trust, lease,
agreement, or other instrument to which it is a party or by which it or any of its
property is bound, which violation would have an adverse effect on the financial
condition of it or on the ability of it to perform its obligations hereunder; and
	 
	 	f)	 	do not require any filing or registration with, or the
consent or approval of,
any governmental body, agency, authority or any other Person, which has not been made
or obtained previously.





12.4 No Claims




There are no claims or investigations pending or threatened against Partner and any of its
Affiliates or Roche or any of its Affiliates, at law or in equity, or before or by any
governmental



- 24 -









 





authority relating to the matters contemplated under this Agreement or that would materially
adversely affect either Parties ability to perform its obligations hereunder.



12.5 No Conflict




Neither Partner, nor Roche, nor any of their Affiliates is or will be under any obligation to any
person, contractual or otherwise, that is conflicting with the terms of this Agreement or that
would impede the fulfillment of Partner or Roche’s obligations hereunder.



12.6 No Other Representations




EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS OR
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THIS AGREEMENT.



12.7 Personnel




Personnel
of one Party may work in the premises of the other Party to perform the Work Plan. Each
Party shall be solely responsible for the acts and/or omissions of its agents and employees who
are acting within the scope of their employment and this Agreement.



13. Indemnification




13.1 Indemnification by Roche




Roche
shall indemnify, hold harmless and defend Partner and its directors,
officers, employees and
agents from and against any and all losses, expenses, cost of defense (including without
limitation attorneys’ fees, witness fees, damages, judgments, fines and amounts paid in
settlement) and any amounts Partner becomes legally obligated to pay because of any claim or
claims against it to the extent that such claim or claims arise out of activities related to a
Companion Diagnostic (e.g. product liability claims) or any development activities conducted in
accordance with this Agreement by or on behalf of Roche, except to
the extent such losses,
expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to
act of Partner.



13.2 Procedure




In the event of a claim by a Third Party against Partner entitled to indemnification under this
Agreement (“Indemnified Party”), the Partner shall promptly notify Roche in writing of the claim
and Roche shall undertake and solely manage and control, at its sale
expense, the defense of the
claim and its settlement. Partner shall cooperate with Roche and may, at its option and expense, be
represented in any such action or proceeding by counsel of its choice. Roche shall not be liable for
any litigation costs or expenses incurred by Partner without Roche’s written consent. The Partner
shall not settle any such claim unless such settlement fully and unconditionally releases Roche
from all liability relating thereto, unless Roche otherwise agrees
in writing.



13.3 Disclaimer




THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND
WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. PARTNER AND ROCHE DISCLAIM
ALL OTHER WARRANTIES, WHETHER
EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION
EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY
DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL
VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE
KNOW-HOW AND THE PRODUCTS, IN NO EVENT SHALL EITHER PARTNER OR ROCHE
BE LIABLE FOR SPECIAL,
INDIRECT,



- 25 -









 





INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY
OTHER LEGAL THEORY.



14. Obligation Not to Disclose Confidential Information




14.1 Non-Use and Non-Disclosure




During the Term of this Agreement and for 10 (ten) years thereafter, a Receiving Party shall (i)
treat Confidential Information provided by Disclosing Party as it would treat its own information
of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential
Information to Third Parties, without the Disclosing Party’s
prior written consent, and (iii) not
use such Confidential Information other than for fulfilling its obligations under this
Agreement.



14.2 Commercial Considerations




Nothing in this Agreement shall prevent Roche or Its Affiliates from disclosing Confidential
Information of Partner to:




	 	a)	 	governmental agencies to the extent required or desirable to secure government
approval for the development, manufacture or sale of a Companion Diagnostic in the
Territory,
	 
	 	b)	 	Third Parties acting on behalf of Roche, to the extent reasonably necessary
for the development, manufacture or sale of Companion Diagnostic in
the Territory,
provided that such Third Party is bound by obligations of confidentiality no less
onerous than those in this Agreement; or
	 
	 	c)	 	Third Parties to the extent reasonably necessary to market Companion
Diagnostic in the Territory, provided that such Third Party is bound by obligations of
confidentiality no less onerous than those in this Agreement.





The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent
that such Confidential Information is required to be disclosed by the Receiving Party to comply
with applicable laws, to defend or prosecute litigation or to comply with governmental
regulations, provided that the Receiving Party provides prior written notice of such disclosure to
the Disclosing Party and, to the extent practicable, takes reasonable and lawful actions to
minimize the degree of such disclosure.



14.3 Publication




Partner
shall not make any publications relating to the use of (i) Background Controlled by
Partner, to the extent related to the work performed during the
Research Term, or (ii) Background
Controlled by Roche. Roche shall not make any publications relating Background Controlled by
Partner, without prior approval of Partner.



14.4 Press release




14.4.1 Procedure




Neither
Party shall issue a press release related to this Agreement, including its terms, without
the prior written consent of the other Party (such consent not to be unreasonably delayed or
withheld) unless release of such information is required by law or
regulated authorities. Press
releases shall be jointly drafted by the Parties and approved before
release. Partner will provide
Roche with written notice sufficiently before the intended release of any external communication
regarding the Agreement in order to allow Roche time for commenting on the release according to
the Roche’s ongoing standard review and approval procedures.



- 26 -









 





14.4.2 Initial press release




The initial press release set forth as Appendix 2 is approved by both Parties.



15. Term and termination




15.1 Commencement and term




The Agreement Term shall commence upon the Effective Date and, unless this Agreement is terminated
sooner as provided in this Section, expire on the date when no payment obligations under this
Agreement are or will become due. After the Agreement Term, all licenses granted to either Party by
the other Party shall be fully paid up, irrevocable and perpetual.



15.2 Termination




15.2.1 Termination for breach




A Party (“Non-Breaching Party”) shall have the right to terminate this Agreement in the event the
other Party (“Breaching Party”) is in breach of any of its material obligations under this
Agreement. The non-Breaching Party shall provide written notice to
the Breaching Party, which
notice shall identify the breach. The Breaching Party shall have a period of sixty (60) days
after such written notice is provided to cure such breach
(“Peremptory Notice Period”). If such
breach is not cured within the Peremptory Notice Period, this Agreement shall effectively
terminate, unless there exists a bona fide dispute as to whether such breach occurred or has been
cured.



15.2.2 Termination for Insolvency Event




A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency
Event; provided, however, in the case of any involuntary bankruptcy
proceeding, such right to
terminate shall only become effective if the Party that incurs the Insolvency Event consents to
the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the
filing thereof.



15.2.3 Termination by Roche without a cause during the Research Term




Roche shall have the right to terminate the Agreement without cause and with immediate effect at
the following moments:




	 	a)	 	after delivery of the Step 1 Deliverables, but prior to Roche’s
decision to initiate Step 2 of the Work Plan
	 
	 	b)	 	after delivery of the Step 2 Deliverables, but prior to Roche’s
decision to initiate Step 3 of the Work Plan
	 
	 	c)	 	after delivery of the Step 3 Deliverables, but before Roche’s
decision whether or not to confirm Partner as developer of the Compound
Multiplex Panel beyond the Research Term.





15.2.4 Termination by Roche without a cause after the Research Term




After the Research Term Roche shall have the right to terminate this Agreement in its entirety or
with respect to a given Product and/or with respect to a given country without cause by giving
Partner a three (3) months prior written notice.



- 27 -









 






15.2.5 Change Of Control




If there
is a Change Of Control at Partner then Roche may, in its sole discretion immediately
terminate the Agreement in its entirety by giving Partner a respective written notice.



15.3 Consequences of termination




15.3.1 Termination by Partner for breach by Roche




If the
Agreement has been terminated by Partner in accordance with
Section 15.2.1 for breach by
Roche, then Partner shall retain a royalty free, non-exclusive
sublicensable, fully-paid up
perpetual license to use the Baseline Data to develop, have
developed, make, have made, import,
export, sell and have sold Diagnostic Products other than Companion Diagnostics in the Territory.
All licenses granted to Roche by Partner shall terminate on the effective date of termination.



15.3.2 Termination by Roche for breach by Partner or Change Of Control




If the
Agreement has been terminated by Roche in application of
Section 15.2.1 for breach of
Partner or for Change of Control in application of Section 15.2.5, then Roche shall retain a
non-exclusive, sublicensable license to Background IP Controlled by Partner necessary or useful for
Roche to develop, have developed, make, have made, import, export, sell and have sold Companion
Diagnostics in the Territory. All licenses granted to Partner by Roche shall terminate on the
effective date of termination and Partner shall, upon Roche’s request destroy all Baseline Data
and confirm to Roche in writing accordingly.



15.3.3 Termination by Roche without cause during the Research Term




If Roche terminates this Agreement during the Research Term for no cause in application of Section
15.2.3 then:




	 	a)	 	all licenses granted to Roche by Partner shall terminate on the
effective date of termination; and
	 
	 	b)	 	all licenses granted to Partner by Roche shall terminate on the
effective date of termination.





15.3.4 Termination by Roche without cause after the Research Term




If Roche terminates this Agreement after the Research Term for no cause in application of Section
15.2.4, then:




	 	a)	 	all licenses granted to Roche by Partner in the country for which
the Agreement is terminated shall terminate on the effective date of
termination; and
	 
	 	b)	 	Partner shall retain a royalty free, non-exclusive
sublicensable,
fully-paid up perpetual license to use the Baseline Data to develop, have
developed, make, have made, import, export, sell and have sold Diagnostic Products
other than Companion Diagnostics in the Territory.




- 28 -









 











15.4 Survival




Sections 11
(Intellectual Property;) 13 (Indemnification),14 (Obligation not to Use and Not to
disclose Confidential Information), 15 (Termination), 16 (Governing Law and Arbitration) shall
survive any expiration or termination of this Agreement for any reason.



16. Miscellaneous




16.1 Governing Law




This
Agreement shall be governed by and construed in accordance with the laws of Switzerland,
without reference to its conflict of laws principles, and shall not be governed by the United
Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention).



16.2 Arbitration




All disputes arising out of or in connection with the present contract shall be finally settled
under the rules of arbitration of the International Chamber of Commerce (ICC) by three
arbitrators.



Each Party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in
the request for arbitration within thirty (30) days of being
requested to do so, or if the
respondent should fail to appoint an arbitrator in its answer to the request for arbitration
within thirty (30) days of being requested to do so, the other Party shall request the ICC court
to make such appointment.



The
arbitrators nominated by the Parties shall, within thirty (30) days from the appointment of
the arbitrator nominated in the answer to the request for arbitration, and after consultation with
 the Parties, agree and appoint a third arbitrator, who will act as a chairman of the arbitral
tribunal. Should such procedure not result in an appointment within the thirty (30) day time
limit, either Party shall be free to request the ICC court to appoint the third arbitrator.



Where there is more than one claimant and/or more than one respondent, the multiple claimants or
respondents shall jointly appoint one arbitrator. In other respects the provisions of this
Section shall apply.



If any
party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a
replacement shall be appointed in accordance with the arrangements provided for in this Section.



Zurich shall be the seat of the arbitration.



The language of the arbitration shall be English. Documents submitted in the arbitration (the
originals of which are not in English) shall be submitted together with an English translation.



This
arbitration agreement does not preclude either Party seeking
conservatory or interim measures
from any court of competent jurisdiction including, without
limitation, the courts having
jurisdiction by reason of either Party’s domicile. Conservatory or interim measures sought by
either Party in any one or more jurisdictions shall not preclude the arbitral tribunal granting
conservatory or interim measures. Conservatory or interim measures
sought by either Party before the
arbitral tribunal shall not preclude any court of competent jurisdiction granting
conservatory or interim measures.



- 29 -









 





In the event that any issue shall arise which is not clearly provided for in this arbitration
agreement the matter shall be resolved in accordance with the ICC arbitration rules.



16.3 Assignment




Neither Party shall have the right to assign the present Agreement or any part thereof to any
Third Party other than Affiliates without the prior written approval of the other Party.



16.4 Independent Contractor




No employee or representative of either Party shall have any authority to bind or obligate the
other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any
contractual or other liability on the other Party without said
Party’s prior written approval. For
all purposes, and not- withstanding any other provision of this
Agreement to the contrary, the
legal relationship of Partner to Roche under this Agreement shall be that of an independent
contractor.



16.5 Unenforceable Provisions and Severability




If any of the provisions of this Agreement are held to be void or unenforceable, then such void
or unenforceable provisions shall be replaced by valid and enforceable provisions which will
achieve as far as possible the economic business intentions of the
Parties. However the remainder
of this Agreement will remain in full force and effect, provided that the material interests of
the Parties are not affected, i.e. the Parties would presumably have concluded this Agreement
without the unenforceable provisions.



16.6 Waiver




The
failure by either Party to require strict performance and/or observance of any obligation,
term, provision or condition under this Agreement will neither constitute a waiver thereof nor
affect in any way the right of the respective Party to require such performance and/or observance.
The waiver by either Party of a breach of any obligation, term, provision or condition hereunder
shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term,
provision or condition.



16.7 Appendices




All Appendices to this Agreement shall form an integral part to this Agreement.



16.8 Amendments




No amendments of the terms and conditions of this Agreement shall be binding upon either Party
hereto unless in writing and signed by both Parties.



16.9 Debarment




Partner hereby certifies that it has not been debarred under the provisions of the Generic Drug
Enforcement Act of 1992, 21 U.S.C. Sec. 335a(a) and (b). In the event that during the term of
this Agreement Partner or any of its employees (i) becomes debarred; or (ii) receives notice of
an action or threat of an action with respect to its debarment, Partner agrees to immediately
notify Roche. Partner also agrees that in the event that it becomes debarred it shall immediately
cease all activities relating to this Agreement.



- 30 -









 





In the
event that Partner becomes debarred, this Agreement shall automatically terminate, without
any further action or notice by either party. In the event that Roche receives notice from Partner
or otherwise becomes aware that (i) a debarment action has been brought against Partner or any of
its employees; or (ii) Partner has been threatened with a
debarment action, then Roche shall have
the right to terminate this Agreement immediately.



Partner hereby certifies that it has not and will not use in any capacity the services of any
individual, corporation, partnership or association which has been
debarred under 21 U.S.C. Sec.
335(a) or (b). In the event that Partner becomes aware of the debarment or threatened debarment of
any individual, corporation, partnership or association providing services to Partner which
directly or indirectly relate to the activities under this Agreement, Partner shall notify Roche
immediately. Upon the receipt of such notice by Roche or if Roche otherwise becomes aware of such
debarment or threatened debarment, Roche shall have the right to terminate this Agreement
immediately.



16.10 Notice




All
notices which are required or permitted hereunder shall be in writing
and sufficient if
delivered personally, sent by facsimile (and promptly confirmed by
personal delivery, registered or
certified mail or overnight courier), sent by nationally recognized
overnight courier or sent by
registered or certified mail, postage prepaid, return receipt
requested, addressed as follows:



	 	 	 
	if to Partner, to:

	 	Psynova Neurotech Ltd
	 

	 	St. John’s Innovation Centre,
Cowely Road, Cambridge
	 

	 	CB4 0WS, United Kingdom
	 
	 	 
	And:
	 	 
	 
	 	 
	if to Roche, to:

	 	F. Hoffmann-La Roche Ltd
	 

	 	Grenzacherstrasse 124
	 

	 	4070 Basel
	 

	 	Switzerland
	 

	 	Attn: Legal Department
	 

	 	Facsimile No.: +41 61 688 13 96
	 
	 	 
	And:

	 	Hoffmann-La Roche Inc.
	 

	 	340 Kingsland Street
	 

	 	Nutley, New Jersey 07110
	 

	 	U.S.A.
	 

	 	Attn. Corporate Secretary
	 

	 	Facsimile No.: +1 973 235-3500
	 
	 	 
	Invoices to Roche

	 	F. Hoffmann-La Roche AG
	should be addressed as

	 	Kreditorenbuchhaltung
	follows:

	 	4070 Basel
	 

	 	Switzerland






- 31 -









 






or to such other address as the Party to whom notice is to be given may have furnished to the
other Party in writing in accordance herewith.



16.11 Regulation and ethic:




Each Party is fully and solely responsible for complying with regulatory authorizations
according to local laws and ethical constraints.



IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.



	 	 	 	 	 	 	 	 	 	 	 
	Psynova Neurotech Ltd	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Paul Rodgers	 	 	 	By:	 	/s/ Dr. S. Bain	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Paul Rodgers	 	 	 	Name:	 	Dr. S. Bain	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Director	 	 	 	Title:	 	Director	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	26th November, 2009	 	 	 	 	 	26th November, 2009	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	F. Hoffmann-La Roche Ltd	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Christophe Carissimo
	 	 	 	By:
	 	/s/ Ruben Perren	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	Name:

	 	Christophe Carissimo
	 	 	 	Name:
	 	Dr. Ruben Perren	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Global Licensing Director
	 	 	 	Title:
	 	Legal Counsel	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	Nov 23rd, 2009
	 	 	 	 	 	November 23, 2009	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Hoffmann-La Roche Inc.	 	 	 	Apprv’d As To
Form LAW DEPT.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Ivor Macleod
	 	 	 	By:
	 	/s/ KG	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	Name:

	 	Ivor Macleod	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	Vice President & CFO	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	November 24, 2009	 	 	 	 	 	 	 	 







- 32 -











 






Appendix 1:




Work Plan




Step 1:




	 	 	 	 	 	 	 
	No	 	TASK	 	Content
	1

	 	Roche to provide
randomized samples to
Psynova
	 	•
	 	Approx. 250 patients
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	[***]
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Run controls
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Serum
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	2 x 250 μl
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Shipped on dry ice to RBM facility
in Austin, Texas using World Courier
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Samples will be kept at 70C in a controlled freezer. The vials will be
shipped back to Roche in case Step 2
will not be performed with a
documentation on the history of the
vials opened
	 
	 	 	 	 	 	 
	2

	 	Psynova to measure samples
	 	•
	 	Approx. 500 samples
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Measure samples on RBM 189-analyte panel
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	RBM will include 3 levels of
controls, run in duplicate, for all
analytes. These will be assayed with
each group of samples (<72). The
results of the samples will only be
reported if the controls pass their
QC acceptance criteria, which are
based on Westgard rules using
Levey-Jennings analysis.
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Measurement of samples in the
order of patients as randomized by
Roche in the clinical trial
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Measurement of baseline and 8
week treatment sample of a patient
in a single batch
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Samples will be re-run if they fail QC.






 - 33 - 









 






	 	 	 	 	 	 	 
	No	 	TASK	 	Content
	3

	 	Psynova to provide
raw data from
measurement to Roche
	 	•
	 	Values from sample measurement
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Values from controls
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	All relevant information on
date/run/batch/ instrument for
each assay and each sample/control
measurement
	 
	 	 	 	 	 	 
	4

	 	Roche to provide clinical
data per patient to
Psynova
	 	•
	 	PANNS
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	[***]
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Cognitive assessment
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Baseline characteristics
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Any other relevant clinical information
	 
	 	 	 	 	 	 
	5

	 	Data analysis at Psynova
	 	•
	 	On Psynova’s proprietary schizophrenia panel
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	On Psynova’s proprietary treatment response panel
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Identify marker candidates and algorithm for prognosis, disease progression, monitoring of efficacy and safety.
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Agree with Roche a statistical analysis plan. Provide results and interpretation to Roche within agreed timelines.






Step 2:




	 	 	 	 	 	 	 
	No	 	TASK	 	Content
	 

	 	 	 	•	 	 
	 
	 	 	 	 	 	 
	1

	 	Psynova to measure samples
	 	•
	 	Approx. 500 samples
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Measure samples on RBM Candidate Set
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	RBM will include 3 levels of controls, run in duplicate, for all
analytes. These will be assayed with each group of samples (<72). The
results of the samples will only be reported if the controls pass their QC
acceptance criteria, which are based on Westgard rules using Levey-Jennings analysis






 - 34 - 









 






	 	 	 	 	 	 	 
	No	 	TASK	 	Content
	 

	 	 	 	•
	 	Measurement of samples in the order of
patients as randomized in the clinical
trial
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Measurement of baseline and 8 week
treatment sample of a patient in a
single batch
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Samples will be re-run if they fail QC.
	 
	 	 	 	 	 	 
	2

	 	Psynova to provide raw
data from measurement to Roche
	 	•

•

	 	Values from sample measurement 



Values from controls
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	All relevant information on
date/run/batch/ instrument for each
assay and each sample/control
measurement
	 
	 	 	 	 	 	 
	3

	 	Data analysis at Psynova
	 	•
	 	Correlate analytical result of Candidate Set to results of 189-Analyte Panel (step 1)
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Confirm marker candidates/algorithm developed in step 1
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Agree a statistical analysis plan
with Roche. Provide results and
interpretation to Roche within agreed
timelines.






Step 3




	 	 	 	 	 	 	 
	No	 	TASK	 	Content
	1

	 	Roche to provide samples to Psynova
	 	•
	 	Approx. 1500 patients
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	[***]
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Serum
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	250 μl
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Roche to randomize samples and
shipped on dry ice to RBM for testing.
	 
	 	 	 	 	 	 
	2

	 	Psynova to measure samples
	 	•
	 	Measure samples on RBM Candidate Set
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Including appropriate controls into
the process Measurement of samples in
the order of patients as randomized in
the clinical trial
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Measurement of baseline and






 - 35 - 









 






	 	 	 	 	 	 	 
	No	 	TASK	 	Content
	 

	 	 	 	 	 	treatment/follow-up sample of a patient
in a single batch
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Samples will be re-run if they fail QC.
	 
	 	 	 	 	 	 
	3

	 	Psynova to provide raw data
from measurement to Roche
	 	•
	 	Values from sample measurement
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Values from controls
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	All relevant information on
date/run/batch/ instrument for each
assay and each sample/control
	 
	 	 	 	 	 	 
	4

	 	Roche to provide clinical data per patient
to Psynova
	 	•
	 	PANNS
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	[***]
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Cognitive assessment
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Baseline characteristics
	 
	 	 	 	 	 	 
	 

	 	 	 	•
	 	Any other relevant clinical information
	 
	 	 	 	 	 	 
	5

	 	Data analysis at Psynova
	 	•
	 	To be elaborated based on Step
1/Step 2 results






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Appendix 2:




Initial press release



PSYNOVA ANNOUNCES COMPANION DIAGNOSTIC COLLABORATION WITH ROCHE

 — Utilizing Psynova’s schizophrenia
biomarker portfolio and RBM’s DiscoveryMAPTM technology —



CAMBRIDGE, U.K., November XX, 2009 — Psynova Neurotech Limited (Cambridge UK), a
subsidiary of Rules-Based Medicine, Inc. (RBM), today announced an exclusive research and
licensing agreement with Roche to collaborate on the discovery, development, validation, and
commercialization of diagnostic immunoassays to aid the clinical development and commercial
differentiation of novel treatments for schizophrenia.



Under the terms of the agreement, Roche will contract Psynova to identify candidate serum protein
biomarkers that have utility in prognosis of disease progression and predicting or monitoring the
efficacy and safety of a compound from Roche’s central nervous system (CNS) pipeline. Psynova will
utilise its proprietary schizophrenia biomarker panels, its extensive CNS disease database and its
access to RBM’s DiscoveryMAPTM technology to identify a specific biomarker signature that could
serve as a companion diagnostic. Any resulting companion diagnostic will be developed either by
Psynova and RBM (as the preferred developer in partnership with Roche), or independently by Roche,
which would result in milestone and royalty payments to Psynova.



“We are excited to enter into this partnership with Roche,” said Dr. Sabine Bahn, Chief Scientific
Officer and founder of Psynova. “This alliance is part of an ongoing strategy to leverage the
value of our biomarker portfolio in both the development of novel diagnostic aids for physicians
and the accelerated development and delivery of novel therapeutics for patients.”




NOTES TO EDITORS




About Schizophrenia



Schizophrenia is a complex, seriously debilitating psychiatric disorder affecting approximately 4
million people in the EU and 2.4 million people in the US. Each year as many as 2 million new
patients in the EU and 1.3 million in the US are estimated to present with early signs of
psychosis. While most of these patients do not have schizophrenia, the medical evaluation is time
consuming and expensive, due to its subjective nature. Symptoms can include hallucinations,
delusions, disordered thinking, movement disorders, flat affect, social withdrawal, and cognitive
deficits, are often undistinguishable from those of other mental health or central nervous system
illnesses. Available treatments can relieve many symptoms of schizophrenia and allow people to
live independent lives. Biomarkers have the potential to facilitate identification of patients
that will benefit from specific treatments and monitor their responses during treatment.




About Psynova Neurotech Ltd.



Psynova Neurotech Limited was established in 2005 by Dr. Sabine Bahn, MD, PhD, MRCPsych, and
Professor Chris Lowe, PhD of the University of Cambridge, to build on 12 years of ground-breaking research by Dr. Bahn
in identifying novel biomarkers for neuropsychiatric illnesses.
Psynova Neurotech, together with the Bahn laboratory, and Rules Based Medicine, Inc. recently
announced the discovery and characterisation of a combination of protein biomarkers that
demonstrate utility as an adjunctive aid in the differential diagnosis of schizophrenia. As a
result of this clinical milestone, RBM made an additional investment in Psynova resulting in
Psynova




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becoming a subsidiary of RBM. Psynova and RBM are developing several products in related
therapeutic areas and are also actively exploring the potential of these biomarker panels as
companion diagnostics and therapy monitoring tools. Additional information on Psynova Neurotech is
available via the worldwide web at www.psynova.com.




About Rules-Based Medicine, Inc.



Rules-Based Medicine, Inc. (RBM) is a CLIA-certified biomarker testing laboratory that solves
complex therapeutic development, diagnostic and treatment challenges with innovative products and
services. The Company’s proprietary multi-analyte profiling (MAP) platform makes the drug discovery
and development process more efficient and effective by providing pre-clinical and clinical
researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins
from small sample volumes. Building on the MAP platform, RBM has developed a host of solutions
including: (i) a self-contained whole-blood culture system that brings reproducibility and
simplicity to ex vivo immune response measurement, (ii) novel and companion diagnostic tests for
complex diseases and therapies, (iii) therapeutic-specific MAPs custom designed for late-stage
clinical development, and (iv) new assays for the early detection of renal damage. Additional
information on RBM is available via the worldwide web at www.rulesbasedmedicine.com.





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