exv10w1





Exhibit 10.1


RESEARCH, DEVELOPMENT

AND COMMERCIALIZATION AGREEMENT




     This Research, Development and Commercialization Agreement (“Agreement”) is entered
into as of this 18th day of December, 2008, by and between:



     on the one hand,


Hoffmann-La Roche Inc., with its principal place of business at 340 Kingsland Street, Nutley, New
Jersey 07110 USA (“Roche Nutley”), and F. Hoffmann-La Roche Ltd, a Swiss corporation, with
its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”;
Roche Nutley and Roche Basel are collectively referenced as “Roche”),




     and on the other hand,



     VIA Pharmaceuticals, Inc., with its principal place of business at 750 Battery Street, Suite
330, San Francisco California 94111 USA (“VIA”). VIA and Roche each may be referred to
herein as a “Party,” and collectively as “Parties.”



     WHEREAS, Roche owns certain patent rights, know-how and regulatory filings with respect to the
Compound (as defined below);



     WHEREAS, Roche believes that the Compound has the potential to be incorporated into a drug
with significant worldwide annual sales, and that VIA has the ability to realize the potential of
this compound;



     WHEREAS, VIA desires to develop the Compound and ensure that it is diligently developed and
commercialized worldwide so as to realize promptly its therapeutic and commercial potential;



     WHEREAS, VIA desires to obtain an exclusive license under Roche’s patent rights, know-how and
regulatory filings to begin development and commercialization of products containing the Compound;
and



     WHEREAS, Roche is willing to grant an exclusive license to VIA under such patent rights and
know-how.



     NOW THEREFORE, in consideration of the foregoing and of the mutual covenants hereinafter set
forth and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties mutually agree as follows:



1.









 





ARTICLE 1




DEFINITIONS




     As used in this Agreement, the following terms shall have the following meanings, and singular
forms, plural forms and derivative forms, (i.e. other parts of speech) shall be interpreted
accordingly:



     1.1 “Additional Licensed Compound” means any compound other than the Compound or a
Derivative, the composition or use of which is claimed in the Roche Patent Rights, including any
salt, ester, non-covalent complex, chelate, hydrate, and stereoisomer thereof, and other forms of
any such compound.



     1.2 “Affiliate” means any corporation or non-corporate business entity that directly
or indirectly controls, is controlled by, or is under common control with a Party to this
Agreement. As used in this definition, the term “control” (with correlative meanings for the terms
“controlled by” and “under common control with”) means that an entity owns greater than fifty
percent (>50%) of the voting stock of the subject entity with the ability to elect a majority of
the board (or managing members) of such entity, or otherwise has the power to govern and control
the financial and the operating policies and management of the subject entity, whether through the
ownership or control of voting securities, by contract or otherwise. With respect to Roche, the
term “Affiliate” shall not include Genentech, Inc. or Chugai Pharmaceutical Co., Ltd, unless Roche
opts for such inclusion by giving written notice to VIA. With respect to VIA, the term “Affiliate”
shall not include any corporation or non-corporate business entity that VIA does not directly or
indirectly control.



     1.3 “Commencement” means, with respect to a clinical trial, the date upon which the
first patient receives the first dose of an item that is the subject of such clinical trial.



     1.4 “Commercialize” means to make, have made, develop, use, sell, have sold, offer for
sale, and import.



     1.5 “Compound” means the compound ***, also known as RO***. . 



     1.6 “Derivative” means any salt, ester, non-covalent complex, chelate, hydrate, and
stereoisomer of the Compound, and any compound generated by modifying the structure of the Compound
so as to optimize its activity.



     1.7 “Development Plan” means the plan for guiding development of Licensed Products.



     1.8 “Dollars” or “$” means US dollars.





 




			
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2.









 










     1.9 “Effective Date” means January 5, 2009.



     1.10 “FDA” means the United States Food and Drug Administration and any successor
entity thereto.



     1.11 “FD&C Act” means the US Federal Food, Drug, and Cosmetic Act, as amended, and the
equivalent laws and regulations in any foreign countries or jurisdictions.



     1.12 “Field” means all therapeutic, prophylactic, and other pharmaceutical uses and
applications.



     1.13 “First Commercial Sale” means the first invoiced sale by the VIA Group of a
Licensed Product in a particular country to a Third Party in such country.



     1.14 “Global Liaison” means an employee of Roche who is selected by Roche to be the
point person with primary responsibility for communications and interactions with VIA.



     1.15 “IND” means an Investigational New Drug Application filed with the FDA and
covering administration of a Compound, Derivative or Additional Licensed Compound.



     1.16 “Inventions” means any and all useful ideas, concepts, methods, procedures,
processes, improvements, inventions, discoveries, and reductions to practice, whether or not
patentable, which arise from or are first made, conceived or first reduced to practice in the
course of the activities conducted pursuant to or in exercise of a right granted under this
Agreement.



     1.17 “Know-How” means all non-patented data, information, methods, procedures,
processes, materials and other know-how.



     1.18 “Licensed Product” means any product containing a Compound, a Derivative or an
Additional Licensed Compound, including all formulations, dosages, and dosage forms thereof.



     1.19 “Major Market” means any of the US, Japan, the United Kingdom, Germany, France,
Spain or Italy.



     1.20 “NDA” means a new drug application, including all necessary documents, data, and
other information concerning a Licensed Product, required for Regulatory Approval of the Licensed
Product as a pharmaceutical product by the FDA or an equivalent application to the equivalent
agency in any other country or group of countries (e.g. the marketing authorization application
(MAA) in the European Union).



     1.21 “Net Sales” means, with respect to VIA, the amount of gross sales of all Licensed
Products in the Territory invoiced by the VIA Group to Third Parties, as reduced by the following
deductions to the extent actually allowed or incurred with



3.









 







respect to such sales: (a) transportation charges, and other shipping charges, such as
insurance, (b) sales, value-added and excise taxes, customs, duties, and any other governmental
charges, to the extent imposed upon the sale of the Licensed Product and paid by the selling party,
provided that no income taxes shall be deducted from gross sales of Licensed Product to calculate
Net Sales, (c) distributor fees, rebates or allowances actually granted, allowed or incurred,
including government and managed care rebates, (d) quantity discounts, cash discounts or
chargebacks actually granted, allowed or incurred, and (e) allowances or credits to customers or
write offs of invoiced amounts, not in excess of the selling price of Licensed Product, on account
of governmental requirements, rejections, recalls, or returns.


If Licensed Product is sold as part of a Combination Product (as defined below), then the parties
shall meet approximately one (1) year prior to anticipated First Commercial Sale to negotiate, on a
country-by-country basis, in good faith and agree to an appropriate adjustment to Net Sales, on a
country-by-country basis, to reflect the relative significance of the Compound, Derivative or
Additional Licensed Compound and other pharmaceutically active ingredients contained in the
Combination Product. If the parties cannot reach agreement, then the Net Sales of the Combination
Product, for the purposes of determining royalty payments, shall be determined by multiplying the
Net Sales of the Combination Product (as defined in the portion of the Net Sales definition
preceding this paragraph) on a country-by-country basis, during the applicable royalty reporting
period, by the fraction, A/(A+B), where A is the average sale price of the Licensed Product when
sold separately in finished form and B is the average sale price of the other pharmaceutical
product(s) included in the Combination Product when sold separately in finished form, in each case
during the applicable royalty reporting period or, if sales of both the Licensed Product and the
other product(s) did not occur in such period, then in the most recent royalty reporting period in
which sales of both occurred.



In the event that such average sale price cannot be determined for both the Licensed Product and
all other pharmaceutical products(s) included in the Combination Product, Net Sales for the
purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the
Combination Product by the fraction of C/(C+D) where C is the fair market value of the Licensed
Product and D is the fair market value of all other pharmaceutical product(s) included in the
Combination Product.



“Combination Product” shall mean any product that contains, in addition to a Compound, a Derivative
or an Additional Licensed Compound, one or more other pharmaceutically active ingredients.




     1.22 “Patent” means (a) any patent, including re-examinations, reissues, renewals,
extensions and term restorations thereof, and any foreign counterpart of any of the foregoing, and
(b) any pending application for patent, including, without limitation, provisional applications,
continuations, continuations-in-part, divisional and substitute applications, inventors’
certificates, and extensions, and any foreign counterpart of any of the foregoing.



4.









 





     1.23 “Phase I” means, with respect to the United States, the first phase of human
clinical trials using a limited number of human subjects to gain evidence of the safety and
tolerability of a Licensed Product and information regarding pharmacokinetics and potentially
pharmacological activity for such Licensed Product, Compound, Derivative or Additional Licensed
Compound, which human clinical trials are completed prior to the initiation of Phase II, as
described in 21 C.F.R. § 312.21(a), as may be amended, or, with respect to any other country or
jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.



     1.24 “Phase II” means, with respect to the United States, the second phase of human
clinical trials of a Licensed Product in human subjects to gain evidence of the efficacy in one or
more indications and expanded evidence of the safety of such Licensed Product, Compound, Derivative
or Additional Licensed Compound, as well as an indication of the dosage regimen required, as
described in 21 C.F.R.§ 312.21(b), as may be amended, or, with respect to any other country or
jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction.



     1.25 “Phase III” means, with respect to the United States, the third phase of human
clinical trials of a Licensed Product, which are large-scale trials to gain evidence of the
efficacy and safety in a number of human subjects sufficient to support Registration for such
Licensed Product, Compound, Derivative or Additional Licensed Compound with the FDA, as described
in 21 C.F.R. § 312.21(c), as may be amended, or, with respect to any other country or jurisdiction,
the equivalent of such a clinical trial in such other country or jurisdiction.



     1.26 “Registration” in relation to any Licensed Product means such approvals by the
applicable Regulatory Agency in a country (or community or association of countries) included in
the Territory (including, where applicable, price approvals) that are required to be obtained prior
to marketing and selling such Licensed Product in such country or jurisdiction.



     1.27 “Regulatory Agency” means, with respect to any particular country or
jurisdiction, the governmental authorities, bodies, commissions, agencies and/or other
instrumentalities of such country or jurisdiction (the EMEA with respect to the EU), with the
primary responsibility for the evaluation or approval of pharmaceutical products before such
product can be tested, marketed, promoted, distributed or sold in such country, including such
governmental bodies that have jurisdiction over the conduct of clinical trials and/or the pricing
of such pharmaceutical product. The term “Regulatory Agency” includes the FDA.



     1.28 “Regulatory Filing” means any filing with a Regulatory Agency relating to or to
permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product.
Regulatory Filings include without limitation INDs and NDAs.



     1.29 “Roche Know-How” means all Know-How which on the Effective Date is owned or
controlled by, or licensed to, Roche and in which Roche has a cost-free transferable interest.



5.









 





     1.30 “Roche Patent Rights” means all Patents in the Territory listed on Appendix A,
and any future Patents that claim priority from or the benefit of the filing date of any of the
Patents listed in Appendix A, and including any and all extensions, supplementary protection
certificates and the like with respect to any of the foregoing. 



     1.31 “Signing Date” means December 18, 2008.



     1.32 “Territory” means the entire world, subject to Section 12.7(a).



     1.33 “Third Party” means any party other than Roche, Roche’s Affiliates, or a member
of the VIA Group.



     1.34 “Transfer Know-How” means the Roche Know-How identified on Appendix B.



     1.35 “VIA Group” means VIA, its Affiliates and sublicensees under this Agreement.



     1.36 “VIA Know-How” means all Know-How that is related to the Compound, a Derivative,
an Additional Licensed Compound or a Licensed Product, and is owned or controlled by VIA Group and
in which VIA has a transferable interest.



     1.37 “VIA Patent Rights” means all Patents in the Territory that (a) claim a Compound,
Derivative, Additional Licensed Compound or Licensed Product, or the manufacture or use thereof,
and (b) are owned or controlled by VIA during the term of this Agreement.



     1.38 “US” means the United States of America, its territories and possessions.



     1.39 “Valid Claim” means a claim contained in (i) an issued and unexpired patent
included within the Roche Patent Rights or VIA Patent Rights that has not been held unenforceable,
unpatentable or invalid by a decision of a court or other governmental agency of competent
jurisdiction, which decision is not subject to any further appeal, and that has not been admitted
to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise or (ii) a
patent application which is included within the Roche Patent Rights or VIA Patent Rights and has
been pending for less than *** (***) years from the priority date. If a claim of a patent
application that ceased to be a Valid Claim under item (ii) because of the passage of time later
issues as a part of a patent within item (i), then it shall again be considered to be a Valid Claim
effective as of the issuance of such patent.






 




			
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6.









 







ARTICLE 2




GRANT OF LICENSE






     2.1 Grants.



          (a) Subject to the terms and conditions of this Agreement, Roche hereby grants to VIA and its
Affiliates, and VIA hereby accepts on its and their behalf, a sole and exclusive license, with full
rights to sublicense as provided in Section 2.2, under the Roche Patent Rights and Roche Know-How,
to (a) develop, use, sell, offer for sale, and import Licensed Products containing the Compound,
Derivative or Additional Licensed Compound in the Field, in the Territory, and (b) make and have
made Licensed Products in the Territory for such development, use, sale, offering for sale, and
importation.



          (b) Roche shall retain all rights under the Roche Patent Rights and Roche Know-How for any
other purpose.



     2.2 Right to Sublicense. After the Commencement of a Phase I clinical trial with a
Licensed Product containing the Compound (“Lead Product”) or replacement of the Lead
Product by another Licensed Product, VIA and its Affiliates shall have the right to sublicense the
rights granted under Section 2.1 to Third Parties, subject to Section 2.5. If VIA grants such
sublicenses, then all such sublicenses shall conform to and be in accordance with the terms of this
Agreement. VIA assumes full responsibility for the performance of all obligations under this
Agreement and will remain obligated to Roche for all royalties due under this Agreement by reason
of the operations of any such sublicense. VIA shall have the right to use Third Party contract
research and development organizations at any time during the term of this Agreement. If, prior to
expiration or termination of this Agreement, VIA has or would like to sublicense a Third Party
under Roche Know-How and Roche Patent Rights and would prefer that Roche grant a direct license to
such Third Party under Roche Know-How and Roche Patent Rights, then Roche will not unreasonably
deny granting such a direct license under Roche Know-How and Roche Patent Rights, provided that
such Third Party agrees to the applicable terms and conditions of this Agreement and covenants to
make the applicable financial payments under this Agreement to Roche.



     2.3 Covenant Not to Sue. If the making, having made, using, offering for sale,
selling, or importing in any country in the Territory in the Field by the VIA Group of any
composition described in the Patent Rights which contains Compound manufactured using a process set
forth in the Patent Rights would, during the term of the Agreement in such country, infringe a
claim of an issued patent owned or controlled by Roche (other than the Roche Patent Rights), Roche
hereby grants to the VIA Group, to the extent Roche is legally able to do so, a covenant not to sue
under such patent, as may be necessary to enable the VIA Group to make, have made, use, offer for
sale, sell and import such composition in such country. Roche shall cause such covenant to be
binding on any assignee of any such patent and VIA shall have the right to grant or assign its
rights under such covenant to any of its permitted sublicensees or assignees.



7.









 





     2.4 Covenant Regarding License Scope. VIA hereby covenants and agrees that it and its
Affiliates shall not, during the term of this Agreement, in the absence of any other valid right or
license granted to VIA or its Affiliates, knowingly practice any Roche Patent Rights or Roche
Know-How outside the scope of the licenses granted by Roche in Section 2.1.



     2.5 Minimal Diligence. If VIA has not completed a Phase I clinical trial within three
(3) years after the Effective Date with respect to the Lead Product, then either (i) VIA shall
commit to developing an Additional Licensed Compound or a Derivative or (ii) Roche may terminate
this Agreement. VIA shall have the burden of proving it has complied with its diligence
obligations under Section 6.1. If VIA did not comply with such obligations, then Roche may
terminate all licenses granted herein. Following such termination by Roche under this Section 2.5
and if requested by Roche within thirty (30) days after such termination, VIA shall negotiate in
good faith with Roche, for a period of sixty (60) days from the date of Roche’s request, regarding
granting a license to Roche on commercially reasonable terms for the VIA Patent Rights and VIA
Know-How related solely to the Licensed Products.



     2.6 Roche Right of First Negotiation. If VIA seeks to out-license any Licensed
Product to a Third Party (“Out-License”), then, before approaching any such Third Party,
VIA shall inform Roche and afford Roche the opportunity to negotiate an Out-License under which
Roche would obtain a sole and exclusive license to such Licensed Product. If Roche is interested
in such negotiation, then Roche shall inform VIA of its interest within forty-five (45) days
(“Review Period”). If Roche indicates that it is not interested in negotiation or if
Review Period expires, then VIA shall have the right to grant an Out-License to a Third Party. If
Roche indicates that it is interested in negotiation within the Review Period, then Roche and VIA
shall negotiate in good faith for a period of time not to exceed sixty (60) days for an Out-License
(“Negotiation Period”). If Roche indicates that it is not interested in continuing
negotiation or if the Negotiation Period expires, then VIA shall have the right to grant a license
to a Third Party.



     2.7 Section 365(n) of the Bankruptcy Code. The licenses granted under this Article 2
shall be treated as licenses of rights to “intellectual property” (as defined in Section 101(56) of
Title 11 of the United States Code, as amended (the “Bankruptcy Code”)) for purposes of Section
365(n) of the Bankruptcy Code. The Parties agree that VIA may elect to retain and may fully
exercise all of its rights and elections under the Bankruptcy Code; provided that
VIA complies with the terms of this Agreement.



8.









 





ARTICLE 3




RESEARCH AND DEVELOPMENT REIMBURSEMENT AND MILESTONE PAYMENTS




     3.1 Fees. VIA shall pay to Roche in consideration for the rights granted herein a fee
of *** Dollars ($***) which shall be non-refundable, and non-creditable, and payable by VIA within
thirty (30) days after receipt of an invoice from Roche after the Signing Date.



     3.2 Milestone Payments. VIA shall pay to Roche non-refundable, non-creditable
milestone payments in the amounts specified in tabular form below (each a “Milestone Payment”) no
later than thirty (30) days after the first occurrence of each of the following events, as they
occur:



	 	 	 	 	 
	Milestones	 	Payments (Dollars)
	Commencement of Phase I
	 	$	***	 
	Commencement of Phase II
	 	$	***	 
	Commencement Phase III
	 	$	***	 
	NDA Approval in the USA
	 	$	***	 
	NDA Approval in a Major Market country in Europe
	 	$	***	 





Each milestone payment set forth under this Section 3.2 shall be paid to Roche no more than once,
and once paid shall be non-refundable. For clarity, once any milestone payment is paid to Roche
under this Section 3.2, such payment shall not be owed with respect to any other Licensed Product
even if such milestone is subsequently achieved again by any Licensed Product.




ARTICLE 4




ROYALTIES




     4.1 Royalties in General. For each Licensed Product, the obligation of VIA to pay
Roche royalties based on sales of the Licensed Product in a given country shall commence on the
date of the First Commercial Sale of such Licensed Product by the VIA Group in such country and
shall continue until the later of (a) the date upon which





 




			
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9.









 








there no longer exists in such country Roche Patent Rights having a Valid Claim that claims
the manufacture, use or sale of such Licensed Product in such country, or (b) the date which is ten
(10) years after the date of First Commercial Sale of such Licensed Product in such country. VIA
shall pay or cause to be paid to Roche a royalty based on Net Sales made by the VIA Group in the
Territory, on a country-by-country basis, at the applicable incremental royalty rate as provided
for in the table below in this Section 4.1, subject to reduction as provided in Sections 4.3, 4.4,
4.5 and 4.6.




	 	 	 	 	 
	Total, Territory-wide Annual Net Sales in a single calendar year	 	Royalty Rate
	Amount of Net Sales up to and including $***
	 	 	***	%
	Amount of Net Sales over $*** and up to and including $***
	 	 	***	%
	Amount of Net Sales over $*** and up to and including $***
	 	 	***	%
	Amount of Net Sales over $***
	 	 	***	%






     4.2 Accrual of Royalties. No royalty shall be due or owing from the use or
distribution of a Licensed Product in transactions where no consideration is received by the VIA
Group, such as when a Licensed Product is made or used for tests or development purposes or is
distributed as samples. No royalties shall be payable on sales among entities within the VIA
Group, but royalties shall be payable on the first subsequent sale by entities within the VIA Group
to a Third Party. No multiple royalties shall be payable under this Agreement because a
commercialized Licensed Product is covered by more than one Valid Claim or is covered by both a
claim with respect to Know-How and a Valid Claim.



     4.3 Reduction for No Patent. If, but for this Agreement, no Valid Claim of Roche
Patent Rights would be infringed by the making, using or selling of a Licensed Product in a country
in the Territory, then the Net Sales of such Licensed Product in such country shall be reduced by
*** percent (***%) for the purpose of determining the royalties payable under Section 4.1.



     4.4 Reduction for Third Party License Fees. VIA shall be entitled to deduct from its
payment obligations under Section 4.1 hereunder *** percent (***%) of any license fees, milestone
payments and royalties that VIA pays to a Third Party in respect of any license to Third Party
Patents that VIA reasonably concludes is required for the manufacture, use, offer for sale, sale or
importation of the Compound, any Derivative or any Additional Licensed Compound; provided
that no such deduction shall reduce the amount of any quarterly royalty payment under
Section 4.1 by more than *** percent (***%) of the amount otherwise payable. If VIA is prevented
from deducting any amount by the proviso in the immediately preceding sentence, then VIA shall be
entitled to carry





 




			
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10.









 









forward such amount for deduction from subsequent payments to Roche under Section 4.1.




     4.5 Reduction for Generic Competition. If a Third Party sells a product that contains
the same Compound, Derivative or Additional Licensed Compound as found in the Licensed Product sold
in a country in the Territory, then VIA’s royalty obligations to Roche under Sections 4.1 and 4.3
with respect to sales in such country shall be reduced as follows: ***.



     4.6 Cap on Royalty Reductions. In no case shall the royalties otherwise payable under
Section 4.1 be reduced by more than *** percent (***%) regardless of the number of reductions
otherwise available under Sections 4.3-4.5.



ARTICLE 5




ROYALTY REPORTS AND ACCOUNTING




     5.1 Royalty Payments; Royalty Reports. After the First Commercial Sale and for the
remaining term of this Agreement, VIA shall submit with each payment of royalties to Roche a
written royalty report (“Royalty Report”) covering sales of Licensed Product for each VIA
fiscal quarter (currently ending on or about the last day of March, June, September, and December)
with the following information provided on a country-by-country basis for the Major Market
countries and for the rest of the world as a whole:



          (a) gross sales;



          (b) Net Sales;



          (c) the royalties, payable in Dollars, which shall have accrued hereunder in respect to such
Net Sales;



          (d) withholding taxes, if any, required by law to be deducted in respect of such sales;



          (e) the exchange rates used in determining the amount of Dollars; and



          (f) the royalty rates applied to calculate royalties due hereunder.



     Royalty Reports shall be due for the entire Territory no later than sixty (60) days after the
end of the fiscal quarter to which they pertain. The Parties will cooperate with each other with
regard to the handling of withholding taxes.





 




			
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11.









 










     5.2 Exchange Rate; Manner of Payment. All payments due under this Agreement shall be
made in Dollars via wire transfer of immediately available funds, or by such other commercially
reasonable means as may be designated by Roche. Royalty payments due on Net Sales in countries in
the Territory outside the US shall be made in Dollars, after being converted by VIA using the
average rate of exchange for such currencies during the applicable calendar quarter, as retrieved
from Reuters’ system for the applicable period. If by law, regulations or fiscal policies,
remittance of royalties in Dollars, or removal of currency from the country, is prohibited or
restricted, VIA will notify Roche and payment of the royalty obligation shall be made by deposit
thereof in local currency to the credit of Roche in a recognized banking institution in such
country designated by Roche. If in any country or jurisdiction, the law, regulations or fiscal
policies prohibit both the transmittal and deposit of royalties on sales in such country, royalty
payments calculated as a percentage of Net Sales in that country shall be suspended for as long as
such prohibition is in effect, and as soon as such prohibition ceases, all royalties that Roche
would have otherwise been entitled to shall be transmitted or deposited to the extent allowable.



     5.3 Payment Due Dates. Royalties shown to have accrued by each Royalty Report
provided for under Article 5 of this Agreement shall be due and payable sixty (60) days after the
end of the fiscal quarter to which they pertain. Payment of royalties in whole or in part may be
made in advance of such due date. All royalty and other payments due to Roche hereunder, shall be
made in Dollars and delivered to the account specified below or to any other account specified by
Roche:



	 	 	 	 	 
	Bank Name:

	 	Citibank, n.a.

	 

	 	New York, NY

	ABA Routing No.:

	 	xxxxxxxxx
	Account Name:

	 	Hoffmann-La Roche Inc.

	Account No.:

	 	xxxxxxxx





VIA shall provide Roche with an annual non-binding forecast of anticipated Net Sales for each
calendar year by September 30 of the preceding calendar year.




     5.4 Right to Audit. During the Term and for a period of *** (***) years thereafter,
VIA shall keep (and shall cause its Affiliates, licensees and sublicensees to keep) complete and
accurate records pertaining to the purchase, storage, sale, or other disposition of Licensed
Products in sufficient detail to permit Roche to confirm the accuracy of all royalty and other
payments due hereunder. Records will include, at a minimum, master files, product numbers,
description, quantities purchased, shipped, sold and on-hand at period end, customer or supplier
name, address, customer agreements, date of purchase or sale, cost of purchase or sale price, and
delivery address. Roche shall have the right to cause an independent, certified public accountant
to audit such records to confirm gross sales, Net Sales, royalty reductions,





 




			
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12.








 









royalty payments, and milestone payments related to Net Sales for a period covering not more
than the preceding *** (***) years. Such audits may be exercised no more than once per calendar
year during normal business hours upon reasonable prior written notice to VIA. Prompt adjustments
shall be made by the parties to reflect the results of such audit. Roche shall bear the full cost
of such audit unless such audit discloses an underpayment by VIA of more than five percent (5%) of
the amount of royalty or other payments due under this Agreement, in which case, VIA shall bear the
full cost of such audit and shall promptly remit to the auditing party the amount of any
underpayment, plus interest calculated at the three month US Dollar LIBOR rate plus *** percent
(***%). If requested by Roche, VIA shall provide to Roche within thirty (30) days after such
request any and all financial information relating to VIA that is controlled by VIA and necessary
for Roche to prepare its financial statements and to make governmental filings, including full
monthly reporting of data to Roche by the third work day of each month and maintaining a set of
accounting records, based on Roche Financial Group Accounting and Reporting Requirements (“FGAR”)
and International Financial Reporting Standards (“IFRS”).




     5.5 Late Payments. In the event that any payment due under this Agreement is not made
when due, the payment shall accrue interest from the date due at the rate of the one-month LIBOR
plus *** percent (***%); provided, however, that in no event shall such rate exceed the maximum
legal annual interest rate. The payment of such interest shall not limit Licensor from exercising
any other rights it may have as a consequence of the lateness of any payment.



     5.6 Confidentiality of Records. Roche agrees that all information subject to review
under this Article 5 or under any sublicense agreement (other than the reported results of such
review) is confidential and that Roche and the auditor shall retain all such information in
confidence, although this condition is not intended to restrict Roche from enforcing any term or
provision of this Agreement in arbitration or court.



ARTICLE 6




RESEARCH, DEVELOPMENT AND MARKETING




     6.1 Development. Prior to the Effective Date, Roche has conducted research and
development of the Compound. VIA shall use commercially reasonable efforts to develop and
commercialize Licensed Products, including obtaining the necessary approvals from Regulatory
Agencies. In no case shall commercially reasonable efforts





 




			
	***	 	Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been requested with
respect to the omitted portions.




13.









 







be less than those efforts that would be exerted by a comparable biotech company with a drug
of similar commercial potential.




          (a) At the Effective Date of this Agreement, Roche shall assign a Global Liaison to be the
liaison with VIA. The Global Liaison will be the Roche point person with primary responsibility
for communications and interactions with VIA related to:



               i) General Inter-Company Communication



               ii) VIA Group due diligence



               iii) Technology and Data Transfer.



          (b) Similarly and for reasons including those set out in Section 6.2(a). VIA shall assign a
liaison with Roche.



     6.2 Development Program.



          (a) VIA shall, at its expense, conduct a clinical and commercial development program relating
to the use of a Licensed Product using commercially reasonable efforts (“Development
Program”) consistent with a Development Plan that is to be provided to Roche as soon as
practicable after creation by VIA. VIA shall provide on a once yearly basis written reports to the
Global Liaison on the progress of the Development Program, and annually shall provide to the Global
Liaison a written overview of material Development Program activities.



          (b) VIA shall maintain a clinical trials database in accordance with the standards of
Regulatory Agencies.



          (c) The Development Plan may be reasonably modified and updated at any time as is deemed
necessary at the discretion of VIA.



          (d) Upon completion of a Phase I clinical trial for each Licensed Product, VIA shall present
to Roche (i) a summary presentation of the data generated by such Phase I clinical trial, and (ii)
a Development Plan for Phase II.



          (e) Notwithstanding anything to the contrary hereunder (including without limitation under
Section 6.1 and this Section 6.2), VIA’s sole and exclusive liability and Roche’s sole and
exclusive remedy for any failure by VIA to exercise any required level of efforts to research,
develop, obtain Registrations or commercialize the Licensed Products shall be for Roche to exercise
any termination right that Roche might have pursuant to Section 12.3 on account of such failure.



14.









 





     6.3 Reversion to Roche. Notwithstanding anything in this Agreement to the contrary,
if at any time and for any reason, whether scientific, technical, medical, economic, commercial or
otherwise, VIA shall determine that it is not reasonable to continue clinical trials or other
development of Licensed Products (whether directly or through one or more Affiliates or
sublicensees), it may deliver a written notice of such determination to Roche, and its election to
cease further development, in which event, Roche may terminate the Agreement and all licenses
granted herein pursuant to Section 12.3(b). Likewise, if VIA determines not to pursue the
development or commercialization of a Licensed Product (whether directly or through one or more
Affiliates or sublicensees) in any of the following sub-territories: (i) the US, (ii) Japan, (iii)
the European Union (in such case at least three (3) of the Major Markets in the European Union),
then VIA shall provide Roche with written notice of its decision and shall terminate this Agreement
with respect to such sub-territory, within thirty (30) days following Roche’s receipt of such
notice, in which event, Roche may terminate all licenses granted herein solely for such
sub-territory pursuant to Section 12.3(b).



ARTICLE 7




PATENT RIGHTS




     7.1 Patent Prosecution and Maintenance.



          (a) Roche shall, at its sole expense, prosecute any and all patent applications within the
Roche Patent Rights to obtain patents thereon and to maintain all patents included in the Roche
Patent Rights. Interferences, nullification proceedings and oppositions shall be considered a part
of the prosecution and maintenance of the Roche Patent Rights.



          (b) VIA shall, at its sole expense, prosecute any and all patent applications within the VIA
Patent Rights, to obtain patents thereon and to maintain all patents included in the VIA Patent
Rights using patent counsel of its choice. Interferences, nullification proceedings and
oppositions shall be considered a part of the prosecution and maintenance of the VIA Patent Rights.



          (c) Roche shall keep VIA reasonably informed of its prosecution of the Roche Patent Rights.
Roche agrees to provide VIA with a written report no less frequently than once each year updating
VIA with respect to the status of its prosecution of the Roche Patent Rights. Prior to making any
submissions, such as patent applications and responses to office actions, to a patent office
wherein Roche Patent Rights are being prosecuted, Roche shall allow VIA to comment on such
submissions.



     7.2 Discontinuance/Abandonment. Notwithstanding Section 7.1, Roche shall have the
right to discontinue the prosecution of any patent application, or to abandon any patent,
encompassed within the Roche Patent Rights. If Roche decides to abandon or allow to lapse any
patent application or patent within the Roche Patent Rights, then



15.









 







Roche shall inform VIA at least thirty (30) days prior to such abandonment or lapse and VIA
shall be given the opportunity to have such Patent assigned to it from Roche. If a Roche patent
application or patent is assigned to VIA, then such Patent shall cease to be considered Roche
Patent Rights for purposes of royalty payments under Article 4.



     7.3 Status of Patent Rights. Within thirty (30) days after each anniversary of the
Effective Date, Roche shall advise VIA as to the then-current status of any patent applications or
patents within the Roche Patent Rights.



     7.4 Ownership of Future Inventions and Know-How.



          (a) Patentable and unpatentable Inventions or Know-How made, developed or conceived by VIA
personnel alone (or jointly with one another) shall be the sole property of VIA (“VIA
Inventions”). VIA shall have sole discretion and responsibility to prepare file, prosecute and
maintain patent applications for VIA Inventions, and shall be responsible for related interference
proceedings.



          (b) Patentable and unpatentable Inventions or Know-How made, developed or conceived by Roche
personnel alone (or jointly with one another) shall be the sole property of Roche (“Roche
Inventions”). Roche shall have sole discretion and responsibility to prepare file, prosecute
and maintain patent applications for Roche Inventions, and shall be responsible for related
interference proceedings.



          (c) Patentable or unpatentable Inventions or Know-How jointly made, developed or conceived by
VIA and Roche personnel shall be jointly owned, unless the Parties agree otherwise. Patent
applications for joint inventions shall be prepared and prosecuted jointly. Subject to any
exclusivity obligations set forth in this Agreement, each Party shall be free to use and exploit
jointly owned Inventions, Patents and Know-How without the consent of, or any duty to account to,
the other Party.



          (d) In no event shall any disclosure of compounds, inventions or other information in
accordance with this Section 7.4 be construed as an offer to sell those compounds, inventions or
other information. Any disclosure under this Section 7.4 shall be subject to the confidentiality
provisions of this Agreement.



ARTICLE 8




INFRINGEMENT




     8.1 Applicability. The provisions of this Article 8 shall govern the Parties’ rights
and obligations, as between themselves, with respect to actions against Third Parties for
infringement of the Patents or misappropriation of the Know-How licensed under this Agreement.



     8.2 Third Party Infringement.



          (a) If either VIA or Roche becomes aware of any product made, used, sold or imported in the
Territory which it believes to (i) infringe a Valid Claim within the



16.









 







Roche Patent Rights (“Roche Patent Infringement”) or the VIA Patent Rights, (ii) or
constitute a misappropriation of Know-How owned by either Party covering or relating to a Licensed
Product or its manufacture or use, then such Party (the “Notifying Party”) shall promptly
(and, in the event of receiving a Paragraph IV Certification described in 21 C.F.R. §
314.50(i)(A)(4), within ten (10) days) advise the other Party of all the relevant facts and
circumstances known by the Notifying Party in connection with the infringement or misappropriation.



          (b) Roche shall have the right, at its own expense, but not the obligation, to enforce Roche
Patent Rights against Roche Patent Infringement and VIA shall have the right, at its own expense,
but not the obligation, to enforce VIA Patent Rights against infringement. VIA and its Affiliates
shall, at Roche’s sole expense, fully cooperate with Roche with respect to the investigation and
prosecution of such alleged Roche Patent Infringement or misappropriation including (without
limitation) the joining of VIA and its Affiliates as a party to such action, as may be required by
the law of the particular forum where enforcement is being sought. Roche and its Affiliates shall,
at VIA’s sole expense, fully cooperate with VIA with respect to the investigation and prosecution
of such alleged infringement of the VIA Patent Rights or misappropriation including (without
limitation) the joining of Roche and its Affiliates as a party to such action, as may be required
by the law of the particular forum where enforcement is being sought.



          (c) If Roche elects to proceed with an enforcement action pursuant to Section 8.2(b) with
respect to infringement of the Roche Patent Rights that is or can reasonably be expected to be
competitive with a Licensed Product (“Competitive Infringement”), then VIA shall have the
right to intervene and pursue its own damages claim against any alleged Competitive Infringement,
and Roche shall, at VIA’s sole expense, take all such actions and execute all such documents as may
be necessary to enable VIA to pursue such claim, including by taking actions and executing
documents at VIA’s direction on VIA’s behalf. Any such intervention by VIA under this Section
8.2(c) shall be controlled by VIA with respect to such damages claim; however, Roche shall remain
in control of the defense against any claim, counterclaim or defense of patent invalidity or
unenforceability related to any such Roche Patent Infringement. Notwithstanding the foregoing
provisions of this Section 8.2(c), if VIA is unable to intervene and pursue its own damages claim
because VIA lacks standing (e.g., because VIA does not own the Roche Patent Rights) or for any
other reason, Roche shall pursue such damages claim directly for VIA’s benefit as VIA may
reasonably request.



          (d) Roche grants to VIA the right to enforce the Roche Patent Rights against Competitive
Infringement, if:



               (i) Roche fails, within sixty (60) days (twenty (20) days in the event of the filing of a
Paragraph IV Certification) after receiving notice from VIA of the Roche Patent Infringement to (1)
notify VIA that Roche elects to proceed with an enforcement action pursuant to Section 8.2(b), (2)
take reasonable action to investigate such alleged infringement, and (3) promptly thereafter,
institute an action to abate such alleged infringement and to prosecute such action diligently, or



17.









 





               (ii) Roche earlier notifies VIA that Roche does not plan to terminate the infringement or
institute such action solely pursuant to Section 8.2(b).


If VIA notifies Roche that there are circumstances that require the enforcement of the Roche Patent
Rights against a Competitive Infringement within a shorter period than contemplated by Section
8.2(d)(i) above in order to avoid any loss of rights or compromising any potential claims, then
Roche shall in good faith discuss with VIA avenues for instituting an action (or allowing VIA to
institute an action) more rapidly than contemplated by Section 8.2(d)(i) above.



Roche and its Affiliates shall fully cooperate with VIA, at VIA’s expense, with respect to the
investigation and prosecution of such alleged infringement including (but not limited to) the
joining of Roche and its Affiliates as a party to such action, as may be required by the law of the
particular forum where enforcement is being sought. Any such enforcement action by VIA under Roche
Patent Rights shall be limited to enforcement against Competitive Infringement.




          (e) If Roche is prosecuting an infringement action under Section 8.2(b), then Roche shall have
the right to control such litigation and shall bear all legal expenses (including court costs and
legal fees and expenses), including settlement thereof. If a claim for damages is brought by VIA
or VIA requests that Roche pursue such a claim for VIA’s benefit pursuant to Section 8.2(c), then
VIA shall have such right to control (or direct, if VIA is not able to intervene and pursue its own
damages claim and requests that Roche pursue such claim for VIA’s benefit) such claim for damages
and shall bear all its and Roche’s legal expenses (except as provided otherwise in the event that
Roche should join as a party to such action). No settlement or consent judgment or other voluntary
final disposition of any infringement action brought by a Party pursuant to this Section 8.2 may be
entered into without the prior written consent of the other Party if such settlement would require
the other Party to be subject to an injunction or to make a monetary payment or would restrict the
claims in or admit any invalidity of any of the Roche Patent Rights or VIA Patent Rights or
significantly adversely affect the rights of the other Party to this Agreement.


Roche shall be entitled to keep, out of all damages or costs recovered by Roche in connection with
any action filed by Roche under Section 8.2(b), and after first reimbursing both parties for any
out-of-pocket costs and expenses incurred in bringing the action (“Roche Net Recovery”), an amount
equal to (i) one hundred percent (100%) of such Roche Net Recovery for actions against Roche Patent
Infringement that are not Competitive Infringement, and (ii) twenty-five percent (25%) of the Roche
Net Recovery from any action to the extent involving Competitive Infringement, and the rest of such
Roche Net Recovery shall be provided to VIA. VIA shall be entitled to keep seventy-five percent
(75%) of all damages or costs recovered by VIA in connection with any claim for damages brought by
VIA under Section 8.2(c) or 8.2(d), after first reimbursing both parties for any out-of-pocket
costs and expenses incurred in bringing the action (“VIA Net Recovery”), and the rest of such VIA
Net Recovery (25%) shall be provided to Roche. If the Parties agree to jointly prosecute such
infringement action and jointly share expenses, then the Parties will split 50:50 all damages or
costs recovered, after


18.









 






first reimbursing each Party for any out-of-pocket expenses in such action. If the recovery of a
Party or Parties prosecuting an action solely under this Section 8.2 does not exceed the Parties’
costs in such action, then each Party shall be reimbursed pari passu for any out-of-pocket expenses
incurred in such action.




          (f) Sections 8.2(b)-(e) shall apply mutatis mutandis to trade secret misappropriation actions
relating to competitive Third Party activities involving Roche Know-How as it does to enforcement
of Roche Patent Rights against Competitive Infringement.



          (g) Neither Party shall be entitled to grant covenants not to sue or other similar rights
under Patents owned by the other Party, provided, however, VIA may grant licenses
and sublicenses in accordance with Section 2.2.



ARTICLE 9




REPRESENTATIONS AND WARRANTIES




     9.1 Representations of Roche. Roche hereby represents to VIA as of the Effective Date
that:



          (a) Roche is duly formed and/or incorporated, validly existing and in good standing, with the
corporate power and authority to enter into this Agreement and to perform its obligations
hereunder. The execution and delivery of this Agreement and the consummation of the transactions
contemplated hereby have been duly authorized by all requisite corporate action on the part of
Roche. This Agreement has been duly executed and delivered by Roche and constitutes the valid,
binding and enforceable obligation of Roche, subject to applicable bankruptcy, reorganization,
insolvency, moratorium and other laws affecting creditors’ rights generally from time to time in
effect and to general principles of equity.



          (b) Roche owns the Roche Patent Rights and owns, controls, or licenses the Roche Know-How and
owns all of the Transfer Know-How (as defined in Section 11.1);



          (c) Except for the Roche Patent Rights, Roche and its Affiliates do not own or control any
Patents claiming the Compound;



          (d) Roche has the right to grant VIA the rights and licenses granted under this Agreement; and



          (e) Roche is not subject to, or bound by, any provision of:



               (i) any articles or certificates of incorporation or by-laws;



19.









 





               (ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture,
license, permit, trust, custodianship, or other instrument, agreement or restriction; or



               (iii) any judgment, order, writ, injunction or decree or any court, governmental body,
administrative agency or arbitrator;


that would prevent, or be violated by, or under which there would be a default as a result of, nor
is the consent of any Third Party required for, the execution, delivery and performance by Roche of
this Agreement and the obligations contained herein, including without limitation, the grant to VIA
of the license described in Section 2.1 hereof.




     9.2 Representations of VIA. VIA hereby represents to Roche as of the Effective Date
that:



          (a) VIA is a corporation duly incorporated, validly existing and in good standing under the
laws of the jurisdiction of its organization, with the corporate power and authority to enter into
this Agreement and to perform its obligations hereunder. The execution and delivery of this
Agreement and the consummation of the transactions contemplated hereby have been duly authorized by
all requisite corporate action on the part of VIA. This Agreement has been duly executed and
delivered by VIA and constitutes the valid, binding and enforceable obligation of VIA, subject to
applicable bankruptcy, reorganization, insolvency, moratorium and other laws affecting creditors’
rights generally from time to time in effect and to general principles of equity.



          (b) VIA is not subject to, or bound by, any provision of:



               (i) any articles or certificates of incorporation or by-laws;



               (ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond, indenture,
license, permit, trust, custodianship, or other instrument, agreement or restriction, or



               (iii) any judgment, order, writ, injunction or decree or any court, governmental body,
administrative agency or arbitrator,


that would prevent, or be violated by, or under which there would be a default as a result of, nor
is the consent of any Third Party required for, the execution, delivery and performance by VIA of
this Agreement and the obligations contained herein.




     9.3 Disclaimer of Warranties. EXCEPT AS SET FORTH EXPRESSLY IN THIS AGREEMENT, EACH
PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL RIGHTS OF THIRD PARTIES. WITHOUT LIMITING THE
GENERALITY OF THE FOREGOING, BOTH PARTIES ACKNOWLEDGE AND DISCLAIM ANY WARRANTY AS TO: (I) THE



20.









 







SUCCESS OF ANY DEVELOPMENT OR CLINICAL TRIAL, STUDY OR TEST COMMENCED BY UNDER THIS AGREEMENT;
OR (II) REGULATORY APPROVAL, PRODUCT INTRODUCTION, SAFETY, USEFULNESS OR COMMERCIAL SUCCESS OF ANY
LICENSED PRODUCT.



21.









 





ARTICLE 10




CONFIDENTIALITY




     10.1 Treatment of Confidential Information. Except as otherwise provided in this
Article 10, during the term of this Agreement and for a period of five (5) years thereafter, VIA
and its Affiliates will retain in confidence and use only for purposes of this Agreement any
information, data, and materials supplied by Roche or on behalf of Roche to VIA and its Affiliates
under this Agreement, and Roche will retain in confidence and use only for purposes of this
Agreement any information, data, and materials supplied by VIA or on behalf of VIA to Roche under
this Agreement. For purposes of this Agreement, all such information and data which a Party is
obligated to retain in confidence shall be called “Confidential Information” of the disclosing
Party.



     10.2 Right to Disclose. To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement or any rights which survive
termination or expiration hereof, VIA and Roche each may disclose the Confidential Information of
the other Party to their respective Affiliates, sublicensees, consultants, outside contractors,
clinical investigators or other Third Parties provided that such entities or persons agree in
writing (a) to keep the Confidential Information confidential for the same time periods and to the
same extent as VIA and Roche are required to keep the Confidential Information confidential and (b)
to use the Confidential Information only for such purposes as VIA and Roche (as applicable) are
entitled to use the Confidential Information. Each Party or its Affiliates or sublicensees may
disclose such Confidential Information of the other Party to government or other regulatory
authorities to the extent that such disclosure (i) is reasonably necessary to obtain Patents or
authorizations to conduct clinical trials with or to market commercially the Licensed Products,
provided such Party is otherwise entitled to engage in such activities under this Agreement; (ii)
is otherwise legally required; (iii) is in facilitation of a Party’s relationship with its existing
or prospective investors; or (iv) is permitted pursuant to Section 14.7; provided that if a Party
is legally required to make such a disclosure under (ii), it shall, if practicable under the
circumstances, first have given prompt notice to the other Party hereto to enable it to seek any
available exemptions from or limitations on such a disclosure, or to apply for confidential
treatment or a protective order.



     10.3 Release From Restrictions. The foregoing obligations in respect of disclosure
and use of Confidential Information shall not apply to any part of such Confidential Information
that the receiving Party, or its Affiliates (all collectively referred to as the “Receiving Party”)
can demonstrate by competent evidence:



          (a) is or becomes publicly available other than by acts of the Receiving Party in breach of
this Agreement;



          (b) is disclosed to the Receiving Party or its Affiliates or sublicensees by a Third Party who
had the right to disclose such Confidential Information to the Receiving Party;



22.









 





          (c) prior to disclosure under this Agreement, was already in the possession of the Receiving
Party or its Affiliates or sublicensees, provided such Confidential Information was not obtained,
directly or indirectly, from the other Party under this Agreement; or



          (d) was independently discovered or developed by the Receiving Party without resort to or use
of any Confidential Information of the disclosing Party.



     10.4 Confidentiality of Agreement. Except as otherwise required by law or the terms
of this Agreement or mutually agreed upon by the Parties hereto, each Party shall treat as
confidential the terms, and conditions of this Agreement, except that Roche and VIA may each
disclose such terms and conditions and the achievement of milestone and other significant events
under this Agreement to its Affiliates and sublicensees, and to current, and potential investors,
merger partners or acquirors. Furthermore, either Party in connection with its current or future
status as a public company (or in connection with its initial public offering registration
activities) may disclose the terms of this Agreement to the extent required by the federal
securities laws or regulations or the rules or regulations of any stock exchange or NASDAQ, and
provided, that the disclosing Party shall seek confidential treatment of key business terms
contained in this Agreement, including but not limited to the royalty rates; provided further, that
the disclosing Party shall duly consider reasonable and timely suggestions, advice and input from
the non-disclosing Party with respect to seeking confidential treatment of key business terms
contained in the Agreement. After execution of this Agreement, the Parties shall release the joint
press release, the text of such shall be mutually agreeable to each Party, announcing the execution
of the Agreement. In addition, the Parties have agreed to the publicity-related provisions that
are set forth in Section 14.7.



     10.5 Return of Confidential Information. Upon termination of this Agreement by either
Party for any reason, the rights of each Party to retain and use the Confidential Information of
the other shall be as provided in Article 12, provided, however, that each Party may retain a
single archival copy of the other Party’s Confidential Information solely for the purpose of
determining the extent of disclosure of Confidential Information hereunder and assuring compliance
with the surviving provisions of this Agreement.



ARTICLE 11




TRANSFERS AND ACCESS; REGULATORY




     11.1 Transfer of Know-How. Immediately after the Effective Date, but not later than
sixty (60) days after the Effective Date, Roche shall transfer (originals or copies) to VIA all of
the Roche Know-How listed in Appendix B (the “Transfer Know-How”). If Roche identifies any Roche
Know-How in the future that should have been included in the Transfer Know-How, then Roche shall
provide such Roche Know-How to VIA in a timely manner. Roche agrees to provide to VIA upon VIA’s
reasonable request and at VIA’s sole expense copies of the prosecution files and histories of the
Roche Patent Rights that are not publicly available. At VIA’s request, Roche shall participate in
up to two (2) telephone conferences designed to answer questions related to the Roche



23.









 







Know-How, provided that Roche shall not be obligated to provide more that one (1) person day
of effort related to these telephone conferences.



     11.2 Tissue Samples. Roche has certain tissue samples related to the subject matter
of this Agreement (“Samples”). Upon the request of VIA, Roche shall provide VIA with access to
these Samples or transfer such Samples to VIA. Once Roche’s right of first negotiation under
Section 2.6 is exhausted, Roche shall have the right to transfer such Samples to VIA.



     11.3 Regulatory Affairs.



          (a) During the Term, VIA shall (i) control and be solely responsible for making all needed
Regulatory Filings relating to the development of Licensed Products and for seeking and maintaining
Registrations of Licensed Products developed by VIA throughout the Territory, in such countries as
it selects; and (ii) own and be responsible for preparing and submitting all Regulatory Rulings,
including preparing all applications and reports necessary as part of an IND, NDA, DMF (“Drug
Master File”), or other necessary filing required for Registration. Roche shall assign to VIA all
rights, title and interest in and to all Regulatory Filings that Roche has made with respect to any
Compound or Derivative and all licenses, authorizations and permits that Roche has obtained with
respect to clinical trials of any Compound or Derivative. Roche shall permit VIA to access, and
shall provide VIA with sufficient rights to reference and use in association with exercising its
rights and performing its obligations under this Agreement, all records pertaining to Compounds,
Derivatives or Licensed Products as are in the possession of Roche and are reasonably necessary for
obtaining Registrations for Licensed Products.



          (b) In conducting any research or development activities under this Agreement, VIA shall (i)
ensure that its employees, agents, clinical institutions and clinical investigators comply with all
Regulatory Agency statutory and regulatory requirements with respect to Licensed Products,
including but not limited to the Federal Food, Drug and Cosmetic Act, as amended, the Public Health
Service Act, Institutional Review Boards, GCP, GLP, IND regulations, and any conditions imposed by
a reviewing IRB or Regulatory Agency; and (ii) not utilize, in conducting studies on Licensed
Products, any person or entities that at such time are debarred by a Regulatory Agency, or that, at
such time, are under investigation by the FDA for debarment action pursuant to the provisions of 21
U.S.C. § 335.



ARTICLE 12




TERM AND TERMINATION




     12.1 Term. This Agreement shall become binding upon the Effective Date. This
Agreement shall continue thereafter in full force and effect, unless terminated sooner pursuant to
Sections 12.2 or 12.3 below, until it expires upon the expiration of VIA’s obligation to pay
royalties to Roche hereunder (such expiration of the term of this Agreement without termination,
“Expiration”).



24.









 





     12.2 VIA’s Right to Terminate.



          (a) For Material Breach at any Time. VIA may terminate this Agreement, as a whole, at
any time if (i) Roche materially breaches the Agreement and (ii) such material breach is not cured
by Roche within ninety (90) days after VIA provides Roche with written notice of such breach, or,
if such breach cannot be cured through commercially reasonably efforts within such ninety (90)
days, and Roche has (within such time period) submitted a plan for cure as promptly as is
reasonably practicable through the application of commercially reasonable efforts with a cure date
reasonably acceptable to VIA, after the earlier of the cure date agreed to by VIA or the date Roche
ceases commercially reasonable efforts to cure such breach.



          (b) For Convenience. VIA may terminate this Agreement for convenience, upon sixty
(60) days prior written notice to Roche, provided that such notice of termination may not occur
until after the one year anniversary of the Effective Date. VIA may commence to wind down all of
its activities under this Agreement immediately upon such notice.



     12.3 Roche’s Right to Terminate.



          (a) For Material Breach at any Time. Roche may terminate this Agreement, as a whole,
at any time if (i) VIA materially breaches the Agreement and (ii) such material breach is not cured
by VIA within ninety (90) days after Roche provides VIA with written notice of such breach, or, if
such breach cannot be cured through commercially reasonably efforts within such ninety (90) days,
and VIA has (within such time period) submitted a plan for cure as promptly as is reasonably
practicable through the application of commercially reasonable efforts with a cure date reasonably
acceptable to Roche, after the earlier of the cure date agreed to by Roche or the date VIA ceases
commercially reasonable efforts to cure such breach. If VIA files a petition for bankruptcy,
dissolution, liquidation or winding up of affairs, then such petition shall not relieve VIA of its
obligation for continued performance under this Agreement pending a decision on such petition.



          (b) For VIA’s Discontinuance of the Development Plan. Notwithstanding anything in
this Agreement to the contrary, Roche may terminate the Agreement and all licenses granted herein
following receipt of written notice from VIA of VIA’s decision to discontinue all of VIA’s
activities under the Development Plan pursuant to Section 6.3 in either the Territory or a
sub-territory (as defined in Section 6.3), as applicable; provided that any such
termination for a sub-territory shall only be effective for such sub-territory (i.e., this
Agreement shall remain in force for all remaining sub-territories that are not subject to such
termination). Following such termination and at Roche’s request within thirty (30) days after such
termination, VIA shall negotiate in good faith with Roche, for a period of sixty (60) days from the
date of Roche’s request, to license on commercially reasonable terms to Roche the VIA Patent Rights
and VIA Know-How related solely to the Licensed Products in the Territory or terminated
sub-territory, as applicable.



25.









 





     12.4 General Effect of Expiration or Termination. Upon Expiration or termination of
this Agreement for any reason, all rights and obligations of the Parties hereunder shall cease,
except as explicitly provided for below in this Article 12 or elsewhere in this Agreement.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation to make
payments or otherwise to the extent related to events or other facts in existence prior to such
Expiration or termination.



     12.5 Rights Upon Expiration or Any Termination.



          (a) Upon Expiration of this Agreement in any country, VIA shall continue to have a
royalty-free, perpetual right to Commercialize Licensed Products in the Territory, as the license
granted VIA in Section 2.1 shall automatically become royalty-free, non-exclusive and perpetual in
the country of Expiration.



          (b) Upon Expiration or termination of this Agreement for any reason, the following Sections
and Articles shall survive such expiration or termination, subject to any later termination dates
provided for therein: Sections 5.1 and 5.2 (with respect to payments having accrued during the
term of this Agreement); Sections 5.4; 5.5; and 9.3, and Articles 1, 8 (as relates to infringement
occurring during the term of this Agreement), 10, 12, 13 and 14.



     12.6 Rights Upon Certain VIA Terminations.



          (a) Upon termination by VIA for Roche’s uncured material breach of this Agreement pursuant to
Section 12.2(a), the following Sections shall survive such termination in addition to the Sections
and Articles set forth to survive in Section 12.5(b): Sections 2.1; and 3.1, 3.2 and 3.3 (with
continued milestone payments reduced by *** percent (***%)); Article 4 (with continued royalty
payments reduced by *** percent (***%)) and all other Sections and Articles governing the mechanics
of milestone and royalty payments hereunder. The licenses granted by Roche to VIA shall become
perpetual and irrevocable if VIA terminates under Section 12.2(a).



          (b) If VIA terminates this Agreement for any reason other than Roche’s uncured material breach
of this Agreement pursuant to Section 12.2(a), then VIA’s obligations pursuant to Section 3.1 shall
survive such termination.



          (c) Termination of this Agreement by VIA shall not limit VIA’s ability to seek any remedies
that may be available for any breaches of the terms hereof by Roche prior to such termination.



     12.7 Rights Upon Roche Termination for Cause and Other VIA Terminations. If Roche
terminates this Agreement pursuant to Section 12.3, or VIA terminates this Agreement for
convenience pursuant to Section 12.2(b),then:





 




			
	***	 	Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been requested with
respect to the omitted portions.




26.









 










          (a) Reverted Territory; Reverted Products. The Territory, in the case of a
termination in whole, and the terminated country or countries (together with their territories and
possessions) in the case of a partial termination, shall be deemed to be the “Reverted Territory”
effective as of the effective date of such termination. In the case of a partial termination, the
Reverted Territory shall thereafter be excluded from the Territory for all purposes under this
Agreement, but this Agreement will remain in effect in the remaining Territory. All Licensed
Products in the Reverted Territory shall, effective upon the effective date of such termination, be
deemed “Reverted Products.”



          (b) No Further Representations. The VIA Group shall discontinue making any
representation regarding its status as a licensee of or distributor for Roche in the Reverted
Territory, for all Reverted Products. The VIA Group shall cease conducting any activities with
respect to the marketing, promotion, sale or distribution of the Reverted Products in the Reverted
Territory.



          (c) Technology License. VIA hereby grants to Roche, if Roche notifies VIA within
thirty (30) days after such termination that Roche desires to negotiate such a license, the right
to negotiate for a period of sixty (60) days thereafter a license on commercially reasonable terms
under (i) any patent or patent application owned by VIA (or any VIA Affiliate) covering the
Reverted Products having been developed or commercialized by the VIA Group during the term of this
Agreement, and (ii) all Know-How owned or controlled by VIA and its Affiliates relevant to Reverted
Products, solely for Roche to commercialize Reverted Products in the Reverted Territory, and to
manufacture Reverted Products anywhere in the world for such Commercialization, and (iii) any
Regulatory Filings of VIA in the Reverted Territory.



          (d) No Further Sales. VIA covenants that promptly upon such termination it and its
Affiliates and former sublicensees hereunder shall cease to sell, and thereafter shall not sell,
any Reverted Product in the Reverted Territory prior to three (3) years after the effective date of
termination.



27.









 





ARTICLE 13




INDEMNIFICATION




     13.1 Indemnification by VIA. Subject to Sections 13.3 and 14.14 hereof, VIA hereby
agrees to defend, indemnify and hold harmless Roche and its Affiliates and licensors, and their
directors, officers, employees and agents (“Roche Indemnitees”) from and against any liabilities,
losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and expenses and
expenses incurred in connection with the enforcement of this provision), resulting from any Third
Party suits, actions, or claims brought or threatened after the Effective Date of this Agreement
and which arise out of claims against Roche Indemnitees brought by Third Parties after the
Effective Date of this Agreement, including but not limited to, any actions in contract (including
breach of warranty) tort (including negligence, strict liability or commercial torts) which arise,
result from, or relate to:



               (i) any breach of any of the representations of VIA contained in Section 9.2 hereof,



               (ii) the gross negligence, recklessness or willful misconduct of the VIA and its Affiliates;
and



               (iii) any development or commercialization (including without limitation, any manufacture,
storage, use or possession) of Compound, Derivatives, Additional Licensed Compounds or Licensed
Product by VIA, its Affiliates, sublicensees and distributors.


Items (i) through (iii) are hereinafter collectively referred to as a “Roche Loss.” VIA shall have
no obligation to indemnify Roche, to the extent that any Roche Loss arises out of the gross
negligence or willful misconduct of any Roche Indemnitee or Roche’s breach of this Agreement.




     13.2 Indemnification by Roche. Subject to Sections 13.3 and 14.14 hereof, Roche
hereby agrees to defend, indemnify and hold harmless VIA, its Affiliates and sublicensees, and
their directors, officers, employees and agents (“VIA Indemnitees”) from and against any
liabilities, losses, fines, penalties, damages, expenses (including reasonable attorney’s fees and
expenses and expenses incurred in connection with the enforcement of this provision), resulting
from any Third Party suits, actions, or claims which arise out of claims against VIA Indemnitees
brought by Third Parties after the Effective Date of this Agreement, including but not limited to,
any actions in contract (including breach of warranty), tort (including negligence, strict
liability or commercial torts) which arise, result from, or relate to:



               (i) any breach of any of the representations of Roche contained in Section 9.1 hereof,



28.









 





               (ii) the gross negligence, recklessness or willful misconduct of Roche, its Affiliates or
agents, and



               (iii) any development or commercialization (including without limitation, any manufacture,
storage, use or possession) of Compound, Derivatives, Additional Licensed Compounds or Licensed
Product by Roche or its Affiliates.


Items (i) through (iii) are hereinafter collectively referred to as an “VIA Loss.” Roche shall
have no obligation to indemnify VIA, to the extent that any VIA Loss arises out of the gross
negligence or willful misconduct of any VIA Indemnitee or VIA’ breach of this Agreement.




     13.3 Indemnification Procedures With Respect to Third Party Claims.



          (a) To be eligible to seek indemnification under this Article 13 in respect to a liability,
loss, fine, penalty, damage, expense, action, or claim brought against such Indemnitee by a Third
Party (such claim hereinafter referred to as a “Third Party Claim”), a VIA Indemnitee or Roche
Indemnitee (each, an “Indemnitee”) shall promptly give written notice thereof to the Party from
whom indemnification is sought (such Party hereinafter referred to as the “Indemnitor”) within a
reasonable period of time after the assertion of such Third Party Claim by such Third Party;
provided, however, that the failure to provide written notice of such Third Party Claim within a
reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder,
except to the extent that the Indemnitor is prejudiced by such failure. The Indemnitor shall have
the right to assume the complete control of the defense, compromise or settlement of any Third
Party Claim (provided that no settlement of any Third Party Claim shall include any admission of
wrongdoing on the part of an Indemnitee, without the prior written consent of such Indemnitee,
which consent shall not be unreasonably withheld), including, at its own expense, employment of
legal counsel. At any time thereafter the Indemnitor shall be entitled to exercise, on behalf of
the Indemnitee, any rights which may mitigate the extent or amount of such Third Party Claim;
provided, however, that if the Indemnitor shall have exercised its right to assume control of such
Third Party Claim, the Indemnitee (i) may, in its sole discretion and at its own expense (which
expense shall not be subject to indemnification hereunder), employ legal counsel to represent it
(in addition to the legal counsel employed by the Indemnitor) in any such matter, and in such event
legal counsel selected by the Indemnitee shall be required to confer and cooperate with such
counsel of the Indemnitor in such defense, compromise or settlement for the purpose of informing
and sharing information with the Indemnitor; (ii) shall, at its own expense, make available to
Indemnitor those employees, officers and directors or Indemnitee whose assistance, testimony or
presence is necessary or appropriate to assist the Indemnitor in evaluating and in defending any
such Third Party Claim (provided, however, that any such access shall be conducted in such a manner
as not to interfere unreasonably with the operations of the businesses of Indemnitee); and (iii)
shall otherwise fully cooperate with the Indemnitor and its legal counsel in the investigation and
defense of such Third Party Claim.



29.









 





          (b) If the Parties acting in good faith cannot agree as to the applicability of Section 13.1
and/or 13.2 to a particular Third Party Claim, then each Party (and its respective Indemnitees)
reserves the right to conduct its own defense of such Third Party Claim and seek indemnification
from the applicable Party upon its resolution.



ARTICLE 14




GENERAL PROVISIONS




     14.1 Force Majeure. Neither Party shall be held liable or responsible to the other
Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement, other than an obligation to make payments
hereunder, when such failure or delay is caused by or results from fire; flood; earthquake;
tornado; embargo; government regulation; prohibition or intervention; war; act of war (whether war
be declared or not); insurrection; act of terrorism; riot; civil commotion; strike; lockout; act of
God or any other cause beyond the reasonable control of the affected Party to anticipate, prevent,
avoid or mitigate (a “Force Majeure Event”) so long as the affected Party uses commercially
reasonable efforts to overcome the effects of the Force Majeure Event; provided, however, that any
failure or delay in fulfilling a term of this Agreement shall not be considered a result of a Force
Majeure Event if it arises from a knowing failure of VIA or Roche to comply with applicable laws
and regulations.



     14.2 Further Assurances. Each Party hereto agrees to perform such acts, execute such
further instruments, documents or certificates, and provide such cooperation in proceedings and
actions as may be reasonably requested by the other Party in order to carry out the intent and
purpose of this Agreement, including without limitation the registration or recordation of the
rights granted hereunder.



     14.3 Severability. Both Parties hereby expressly acknowledge and agree that it is the
intention of neither Party to violate any public policy, statutory or common law, rules,
regulations, treaty or decision of any government agency or executive body thereof of any country
or community or association of countries and specifically agree that if any word, sentence,
paragraph, clause or combination thereof in this Agreement is found by a court or executive body
with judicial powers having jurisdiction over this Agreement or any of the Parties hereto in a
final unappealed order, to be in violation of any such provisions in any country or community or
association of countries, then in such event such words, sentences, paragraphs, clauses or
combination shall be inoperative in such country or community or association of countries (or
reformed, for example but without limitation, to apply for a shorter period of time, such that
their effect is in compliance with law) and the remainder of this Agreement shall remain binding
upon the Parties hereto.



     14.4 Notices. Any notice required or permitted to be given hereunder shall be in
writing and shall be deemed to have been properly given if delivered in person, or if mailed by
registered or certified mail (return receipt requested) postage prepaid, or by a nationally
recognized overnight courier, or by facsimile (and promptly confirmed by



30.









 







registered, certified mail, overnight courier or fax receipt), to the addresses given below or
such other addresses as may be designated in writing by the Parties from time to time during the
term of this Agreement. Any notice sent by overnight courier or facsimile shall be deemed received
on the first business day after posted with the courier or transmittal. Any notice sent by
registered, certified mail shall be deemed received on the fourth (4th) business day
following the date of posting.



	 	 	 
	In the case of VIA:

	 	VIA Pharmaceuticals, Inc.

750 Battery Street, Suite 330

San Francisco California 94111 USA

Attention: President
	 
	 	 
	In the case of Roche:

	 	Hoffmann-La Roche Inc.

340 Kingsland Street

Nutley, New Jersey 07110

Attention: Corporate Secretary


	 
	 	 
	and:

	 	F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124

CH-4070 Basel

Switzerland

Attention: Corporate Law






     14.5 Assignment. All of the terms and provisions of this Agreement shall be binding
upon and inure to the benefit of and be enforceable by the respective successors and permitted
assigns of the Parties hereto, but neither this Agreement nor any of the rights, interests or
obligations hereunder of any Party hereto shall be assigned without the prior written consent of
the other Party (which may be withheld for any reason), provided, however, that either Party may,
without such consent, assign this Agreement in whole or in part (i) to a successor corporation in
connection with the transfer or sale of all or substantially all of its business or assets to which
this Agreement pertains or in the event of the merger or consolidation with another corporation;
and (ii) to an Affiliate. Any purported assignment in violation of the preceding sentence shall be
void. Any permitted assignee shall assume all obligations of its assignor under this Agreement.



     14.6 Performance by Affiliates. Each of Roche and VIA acknowledge that their
obligations and rights under this Agreement may be performed and exercised by Affiliates of Roche
and VIA, respectively. Obligations of the Party for which one of its Affiliates is performing
hereunder shall be deemed to extend to such performing Affiliate. Each of Roche and VIA guarantee
performance of this Agreement by its Affiliates. Wherever in this Agreement the Parties delegate
responsibility to Affiliates or local operating entities, the Parties agree that such entities
shall not make decisions inconsistent with this Agreement, amend the terms of this Agreement or act
contrary to its terms in any way. Further, if a Party’s Affiliate breaches any aspect of this
Agreement performance of which has been delegate to such Affiliate or acts in any way



31.









 







inconsistently with the foregoing sentence, then the other Party shall be entitled to proceed
against the Party whose Affiliate so breached, and shall not first be required to proceed against
the Affiliate that so breached.



     14.7 Publicity. Except for the details in the press release to be agreed upon by the
Parties, and as required by the rules or regulations of any stock exchange or regulatory authority
or otherwise required by law or regulation, neither Party, nor any of its Affiliates, shall
originate any publicity, news release or other public announcement that identifies the other Party,
written or oral, relating to the confidential terms or conditions contained in this Agreement
without the prior written approval of such other Party. In addition, VIA shall have the right to
originate publicity, news releases and other public announcements relating to Licensed Products if
such publicity, news releases and other public announcements do not identify Roche;
provided that VIA shall provide Roche with an opportunity to review a draft of any
such publicity, news release or other public announcement at least five (5) business days prior to
releasing such publicity, news release or other public announcement (unless a quicker release is
mandated by law).



     14.8 Roche Publications. The Parties recognize the importance of allowing Roche
scientists to have the ability to publish their results but recognize that such publications have
the potential for disclosing intellectual property. Accordingly, Roche shall have the right to
publish all documents that (i) have been approved for publication in compliance with Roche’s
internal procedures and (ii) submitted for publication prior to the Effective Date (drafts of which
were disclosed to VIA). After the Effective Date, Roche shall not submit for publication any
document without the written consent of VIA, which consent shall be at VIA’s sole discretion.



     14.9 Amendment. The Parties hereto may amend, modify or alter any of the provisions
of this Agreement, but only by a written instrument that explicitly refers to this Agreement and is
duly executed by both Parties hereto.



     14.10 Entire Agreement. This Agreement contains the entire understanding of the
Parties with respect to the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made with respect to such subject matter are
expressly superseded by this Agreement.



     14.11 Waiver. The failure of a Party to enforce at any time for any period any of the
provisions hereof shall not be construed as a waiver of such provisions or of the rights of such
Party thereafter to enforce each such provisions.



     14.12 No Implied Licenses. Except as expressly and specifically provided under this
Agreement, the Parties agree that neither Party is granted any implied rights to or under any of
the other Party’s current or future Patents, trade secrets, copyrights, moral rights, trade or
service marks, trade dress, or any other intellectual property rights.



     14.13 No Joint Venture. The Parties agree that the relationship of Roche and VIA
established by this Agreement is that of independent licensee and licensor.



32.









 




Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not
be construed to, establish a partnership or joint venture, and nor shall this Agreement create or
establish an employment, agency or any other relationship. Except as may be specifically provided
herein, neither Party shall have any right, power or authority, nor shall they represent themselves
as having any authority to assume, create or incur any expense, liability or obligation, express or
implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any
purpose.




     14.14 No Third Party Beneficiaries. Except as otherwise set forth in Article 13, all
rights, benefits and remedies under this Agreement are solely intended for the benefit of Roche and
VIA, and no Third Party shall have any rights whatsoever to (i) enforce any obligation contained in
this Agreement; (ii) seek a benefit or remedy for any breach of this Agreement; or (iii) take any
other action relating to this Agreement under any legal theory, including but not limited to,
actions in contract, tort (including but not limited to negligence, gross negligence and strict
liability), or as a defense, setoff or counterclaim to any action or claim brought or made by the
Parties.



     14.15 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OF ANY KIND, EVEN If
SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES. IN NO CASE SHALL EITHER
PARTY BE LIABLE FOR ANY REPRESENTATION OF WARRANTY MADE BY THE OTHER PARTY TO ANY THIRD PARTY.



     14.16 Governing Law. This Agreement is to be construed in accordance with, and
governed by, the laws of the state of Delaware, except in relation to the principles governing
conflict of laws. This Agreement shall not be governed by the United Nations Convention of
International Contracts on the Sale of Goods. Notwithstanding the foregoing, questions affecting
the construction and effect of any Patent shall be determined by the laws of the country in which
such Patent has been granted.



     14.17 Headings. The article, section and paragraph headings contained in this
Agreement are for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.



     14.18 Counterparts. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original but all of which together shall constitute one and the
same document.



     14.19 Dispute Resolution. The Parties recognize that disputes, controversies or claims
arising out of or relating to this Agreement, or the breach, termination, or invalidity thereof
(each, a “Dispute”) which relate to either Party’s rights and/or obligations hereunder may from
time to time arise during the term of this Agreement. The Parties shall seek to amicably resolve
such a Dispute in an expedient manner by mutual cooperation. To reach amicable resolution, the
Parties agree to first refer the Dispute to their respective senior-level management, or their
designees, for attempted resolution through good faith negotiations.



33.









 





     If the Dispute cannot be resolved within sixty (60) days after the referral to the
senior-level management referred to above, all such disputes shall be finally resolved and settled
in accordance with the provisions of this section:



          (a) Arbitration Request. If a party intends to begin arbitration it must provide
written notice (the “Arbitration Request”) to the other party that the Dispute arising under this
Agreement is to be referred to arbitration administered by the American Arbitration Association
(the “AAA”). From the date of the Arbitration Request and until such time as any matter has been
finally settled, the running of the time periods as to which party must cure a breach of this
Agreement shall be suspended as to the subject matter of the Dispute.



          (b) No Arbitration of Patent Issues. Unless otherwise agreed by the parties, a
Dispute relating to the validity, infringement or enforceability of Patents shall not be subject to
arbitration, and shall be submitted to a court of competent jurisdiction.



          (c) Arbitration Procedure. The Arbitration shall be held in New York, New York in
accordance with the Commercial Arbitration Rules of the AAA. The Parties shall each be responsible
for one-half of any fees or other amounts payable to the AAA or the arbitrator, and each Party
shall bear its own attorneys’ fees and other expenses in connection with the arbitration.



     The Parties agree that the procedures set forth in this paragraph shall be the sole and
exclusive means of resolving any and all Disputes. Judgment on any award rendered by the
arbitrator may be entered in any court having competent jurisdiction thereof.



Remainder of this page intentionally left blank.





34.









 




     In Witness Hereof, the Parties have executed this Agreement effective as of the Effective
Date.


	 	 	 	 	 
	Hoffmann-La Roche Inc.

 	 	 
	By:  	 /s/ Frederick C Kentz III	 	 
	 	Name: 	Frederick C Kentz III 	 	 
	 	Title: 	VP SECY & GE	 	 



	 	 	 	 	 	 	 	 	 
	F. Hoffmann-La Roche Ltd	 	 	 	F. Hoffmann-La Roche Ltd
	 
	 	 	 	 	 	 	 	 
	By:
	 	/s/ Nigel Shedil	 	 	 	By:	 	/s/ Stefan Arnold
	 

	 	 
	 	 	 	 	 	 
	 
	 	Name: Nigel Shedil	 	 	 	 	 	Name: Stefan Arnold
	 
	 	Title: Vice President 

        Global Head Licensing	 	 	 	 	 	Title: Legal Counsel






	 	 	 	 	 
	VIA Pharmaceuticals, Inc.

 	 	 
	By:  	/s/ Lawrence Cohen	 	 
	 	Name: 	Lawrence Cohen, PHD	 	 
	 	Title: 	Chief Executive Officer	 	 



 









 




Appendix
A


List of
Roche Patent Rights









 





	 	 	 	 	 	 	 	 	 	 	 	 	 
	Case 22191	 	Application Date	 	Application No.	 	Grant Date	 	Patent No.	 	Expiry Date	 	Holder
	AR
	 	19.07.2006	 	P060103084	 	 	 	 	 	19.07.2026	 	Roche Basel
	AU
	 	11.07.2006	 	2006271721	 	 	 	 	 	11.07.2026	 	Roche Basel
	BR
	 	11.07.2006	 	PI0613754-7	 	 	 	 	 	11.07.2026	 	Roche Basel
	CA
	 	11.07.2006	 	2614529	 	 	 	 	 	11.07.2026	 	Roche Basel
	CL
	 	18.07.2006	 	1863-2006	 	 	 	 	 	 	 	Roche Basel
	CN
	 	11.07.2006	 	200680026731.7	 	 	 	 	 	11.07.2026	 	Roche Basel
	CO
	 	11.07.2006	 	08-002.797	 	 	 	 	 	 	 	Roche Basel
	CR
	 	11.07.2006	 	9644	 	 	 	 	 	 	 	Roche Basel
	EC
	 	11.07.2006	 	08-8120	 	 	 	 	 	 	 	Roche Basel
	EG
	 	21.01.2008	 	PCT108/2008	 	 	 	 	 	11.07.2026	 	Roche Basel
	EP
	 	11.07.2006	 	06792493.6	 	 	 	 	 	11.07.2026	 	Roche Basel
	GC
	 	19.07.2006	 	6611	 	 	 	 	 	 	 	Roche Basel
	IN
	 	11.07.2006	 	658/DELNP/2008	 	 	 	 	 	11.07.2026	 	Roche Basel
	ID
	 	11.07.2006	 	W-00200800220	 	 	 	 	 	11.07.2026	 	Roche Basel
	IL
	 	11.07.2006	 	188476	 	 	 	 	 	11.07.2026	 	Roche Basel
	JP
	 	11.07.2006	 	2008-521935	 	 	 	 	 	 	 	Roche Basel
	MY
	 	19.07.2006	 	PI20063456	 	 	 	 	 	 	 	Roche Basel
	MX
	 	11.07.2006	 	MX/A/2008/000818	 	 	 	 	 	 	 	Roche Basel
	MA
	 	11.07.2006	 	30618	 	 	 	 	 	11.07.2026	 	Roche Basel
	NZ
	 	11.07.2006	 	565190	 	 	 	 	 	11.07.2026	 	Roche Basel
	NO
	 	11.07.2006	 	20080058	 	 	 	 	 	11.07.2026	 	Roche Basel
	PH
	 	11.07.2006	 	1-2008-500147	 	 	 	 	 	 	 	Roche Basel
	RU
	 	11.07.2006	 	2008106058	 	 	 	 	 	11.07.2026	 	Roche Base!
	SG
	 	11.07.2006	 	200800416-0	 	 	 	 	 	 	 	Roche Basel
	ZA
	 	11.07.2006	 	2008/00405	 	 	 	 	 	 	 	Roche Basel
	KR
	 	11.07.2006	 	2008-7001480	 	 	 	 	 	11.07.2026	 	Roche Basel
	TW
	 	18.07.2006	 	095126242	 	 	 	 	 	 	 	Roche Basel
	TH
	 	19.07.2006	 	0601003388	 	 	 	 	 	 	 	Roche Basel
	US
	 	21.07.2005	 	60/701215 Priority	 	 	 	 	 	21.07.2006	 	Roche Nutley
	US1
	 	18.07.2006	 	11/488870	 	 	 	 	 	 	 	Roche Nutley
	US2
	 	20.08.2008	 	12/194643	 	 	 	 	 	 	 	Roche Nutley
	UA
	 	11.07.2006	 	A200801933	 	 	 	 	 	 	 	Roche Basel
	VE
	 	20.07.2006	 	1684-06	 	 	 	 	 	 	 	Roche Basel
	VN
	 	11.07.2006	 	1-2008-00403	 	 	 	 	 	11.07.2026	 	Roche Basel
	WO
	 	11.07.2006	 	PCT/EP2006/064093	 	 	 	 	 	 	 	Roche Basel






 









 






	 	 	 	 	 	 	 	 	 	 	 	 	 
	Case 24361	 	Application Date	 	Application No.	 	Grant Date	 	Patent No.	 	Expiry Date	 	Holder
	US
	 	20.09.2007	 	60/973846 Priority	 	 	 	 	 	20.09.2008	 	Roche Nutley
	US1
	 	02.09.2008	 	12/202552	 	 	 	 	 	 	 	Roche Nutley
	wo
	 	11.09.2008	 	PCT/EP2008/062017	 	 	 	 	 	 	 	Roche Basel






 









 




Appendix B


Transfer of Know How









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Document	 	 	 	 	 	Document	 	 	 	 	 	 
	Document No	 	Title	 	Author(s)	 	Date	 	Pages	 	Class	 	Center	 	Division	 	Language
	1015946
	 	Results of the in vitro
micronucleus test (MNT)
with RO*** using a
microscale screening
protocol with L5178Y tk
mouse lymphoma cells
(Study Plan No. 2057M04,
NON-GLP)
	 	Kirchner S
	 	7/21/2004
	 	 	16	 	 	research
	 	Basel
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1004034

	 	Results of the Ames
microsuspension assay
with RO*** (Study No.
2060M04, non-GLP
screening test for
genotoxic activity)
	 	Muster W
	 	1/5/2005
	 	 	10	 	 	research
	 	Basel
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1024256

	 	RO*** THRA: A Two-Week
Oral (Intubation)
Toxicity and
Toxicokinetic
Range-Finding Study in
Dogs (Study No. 09925)
	 	Visalli T, Lamb M,

Pamidimukkala A,

Herrott C, Braen A
	 	11/20/2007
	 	 	280	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1023567

	 	RO*** [THR]: A Two-Week
Oral (Intubation) Range-
Finding Toxicity and
Toxicokinetic Study in
Rats (Study No.09924)
	 	Rusin G, Lamb M,

Pamidimukkala A,

Herrott C, Braen A
	 	12/18/2007
	 	 	337	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1028177

	 	RO*** [THR Agonist]:
Evaluation of the
Covalent Protein Binding
in Rat, Dog, Monkey and
Human Liver Microsomal
Incubations Using
[14C]RO*** (Study No.
09757)
	 	Nangia A, Olejnik

N, Yang T J
	 	1/14/2008
	 	 	16	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1024674

	 	RO***: In Vitro Plasma
Protein Binding, Blood to
Plasma Ratios and
Partitioning to Red Blood
Cells in Human and
Various Animal Species
(Study No. 10018).
	 	Costanza S, Cotler S
	 	1/24/2008
	 	 	19	 	 	regular
	 	Nutley
	 	Pharma
	 	English






 





	 	 	 
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	 	 	 	 	 	 	Document	 	 	 	 	 	Document	 	 	 	 	 	 
	Document No	 	Title	 	Author(s)	 	Date	 	Pages	 	Class	 	Center	 	Division	 	Language
	1028100
	 	RO*** [THR Agonist]:
Evaluation of the
Cytochrome P450
Inhibition (Study No.
10315) and Time-Dependent
Inactivation by RO***
Using Human Liver
Microsomal Incubations
(Study No. 10315)
	 	Chang M, Olejnik N,

Yang T J
	 	1/28/2008
	 	 	30	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1025882

	 	RO***: Evaluation of
Thyroid Hormone Agonist
for In Vitro Induction
Potential in Primary
Human Hepatocyte Cultures
(Study No 10182)
	 	Frank K B, Ryan A L
	 	2/14/2008
	 	 	24	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1027865

	 	RO***: Respiratory
Assessment of Orally
Administered RO*** to
Plethysmograph-Restrained
Male Wistar Rats (WIL
Study No. WIL-30039,
Roche Study Reference No.
10349)
	 	Staudner H A
	 	3/3/2008
	 	 	164	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1028777

	 	RO*** (THRA): In Vitro
Effect on hERG Current
(IKr) Expressed in Human
Embryonic Kidney (HEK)
Cells (Roche Study No.
08757)
	 	Staudner H A
	 	3/4/2008
	 	 	13	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1027864

	 	RO***: The Acute Central
Nervous System
Pharmacological Study of
RO*** Following Oral
Administration in Rats
Using a Modified
Functional Observational
Battery (Roche Study No.
10348, WIL Research Study
No. WIL-30040)
	 	Staudner H A
	 	3/5/2008
	 	 	217	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1027916

	 	RO***: Bacterial reverse
mutation test (Ames test)
- Study No. 2363M07; RCC
Analytic phase No. B69096
	 	Gocke E, Flade D
	 	5/5/2008
	 	 	56	 	 	regular
	 	Basel
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1026150

	 	RO*** (THRA):
Cardiovascular Assessment
in Conscious
Radiotelemetry-Implanted
Beagle Dogs Following
Oral Gavage
Administration (Study No.
09979)
	 	Staudner H A,

Hirkaler G,

Pamidimukkala A,

Braen A
	 	6/4/2008
	 	 	251	 	 	regular
	 	Nutley
	 	Pharma
	 	English






 





	 	 	 
	***	 	Certain information on this page has been omitted and filed
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	 	 	 	 	 	 	Document	 	 	 	 	 	Document	 	 	 	 	 	 
	Document No	 	Title	 	Author(s)	 	Date	 	Pages	 	Class	 	Center	 	Division	 	Language
	1026453

	 	RO*** (THRA): A Two-Week
Oral (Intubation)
Exploratory Metabolic and
Pharmacokinetic Study of
RO*** with a 2-Week
Recovery Period (Study
No. 10135)
	 	Visalli T,

Pamidimukkala A,

Herrott C, Braen A

P J M
	 	7/8/2008
	 	 	310	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1025069

	 	RO*** (THR): Evaluation
of the Interaction
between Drug Efflux
Transporters and RO***
(Study No. 09989)
	 	Veerasammy S, Guo A
	 	7/30/2008
	 	 	27	 	 	regular
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1026833

	 	Induction of chromosome
aberrations in cultured
human peripheral blood
lymphocytes
	 	Lloyd M, Flade D,

Chételat A A
	 	8/7/2008
	 	 	65	 	 	regular
	 	Basel
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1025400

	 	Method for determination
of RO*** in Dog Plasma by
LC/MS/MS (BA Method
MS-121)
	 	Egan T, Kolis S
	 	6/4/2007
	 	 	18	 	 	method
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1026961

	 	Synthesis of RO***, A
Thyroid Hormone Receptor
Agonist
	 	Shu L, Wang P
	 	11/27/2007
	 	 	18	 	 	method
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1028106

	 	Method for determination
of RO*** in Dog and Rat
Plasma by LC/MS/MS (BA
Method MS-121)
	 	Vidal N, Egan T,

Liang Z, Kolis S
	 	12/11/2007
	 	 	22	 	 	method
	 	Nutley
	 	Pharma
	 	English
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1027730

	 	(Case 24361) PRODRUGS OF

THYROID HORMONE ANALOGS

(RO***)
	 	Haynes N E, Scott N

R, Tilley J W
	 	9/20/2007
	 	 	55	 	 	patent
	 	Nutley
	 	Pharma
	 	English








 




			
	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.






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