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Exhibit 10.2 RESEARCH, DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
This Research, Development and
Commercialization Agreement (" Agreement ") is signed 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:
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.
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1.8 " Dollars " or "
$ " means US dollars. 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 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.
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. 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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ARTICLE 2 GRANT OF LICENSE AND ASSIGNMENTS
2.1 Grants and Assignments .
(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 , under the 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 Roche Know-How for any other purpose.
(c) Subject
to the terms and conditions of this Agreement, Roche hereby assigns
to VIA all of its rights, title and interest in and to the Roche
Patent Rights. VIA shall be solely responsible for preparing and
filing appropriate assignments with the various patent offices in
the Territory.
(d) If
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, then
Roche will not unreasonably deny granting such a direct license
under Roche Know-How, 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. 2.2 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.
2.3 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 (i) practice any Roche Know-How outside
the scope of the licenses granted by Roche in Section 2.1(a)
or (ii) practice any Roche Patent Rights within the scope of
the licenses granted by VIA in Section 2.1(d).
2.4 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. 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 ($***) which shall be
non-refundable, and non-creditable, and payable by VIA within
thirty (30) days after receipt of an invoice from Roche after
the Signing Date. 3.2 Milestone
Payments . VIA shall pay to Roche non-refundable,
non-creditable milestone payments in the amounts specified in
tabular form below (each a "Milestone Payment") no later than
thirty (30) days after the first occurrence of each of the
following events, as they occur:
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Milestones
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Payments (Dollars)
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Commencement of Phase I
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$ ***
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Commencement of Phase II
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$ ***
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Commencement Phase III
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$ ***
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NDA Approval in the USA
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$ ***
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NDA Approval in a Major Market country in Europe
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$ ***
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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.
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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 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
royalty rate of *** percent (***%), subject to reduction as
provided in Sections 4.3, 4.4, 4.5 and 4.6.
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
royalty rate otherwise applicable to any Net Sales of such Licensed
Product under Section 4.1 in such country shall be reduced by
*** percent (***%) of the royalty rate otherwise applicable to such
Net Sales. 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
forward such amount for deduction from subsequent payments to Roche
under Section 4.1.
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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. 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
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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:
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Bank Name:
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Citibank, n.a.
New York, NY
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ABA Routing No.:
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xxxxxxxxx
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Account Name:
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Hoffmann-La Roche Inc.
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Account No.:
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xxxxxxxx
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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,
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
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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 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
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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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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) 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. 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) and
VIA shall reassign the Roche Patent Rights to Roche. 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) and
VIA shall reassign the Roche Patent Rights to Roche with respect to
such sub-territory.
ARTICLE 7 PATENT RIGHTS 7.1
Patent Prosecution and Maintenance .
(a) VIA
shall, at its sole expense, prosecute any and all patent
applications within the Roche Patent Rights and 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 a
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