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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 ($***) which shall be
non-refundable, and non-creditable, and payable by VIA within
thirty (30) days after receipt of an invoice from Roche after
the Signing Date. 3.2 Milestone
Payments . VIA shall pay to Roche non-refundable,
non-creditable milestone payments in the amounts specified in
tabular form below (each a "Milestone Payment") no later than
thirty (30) days after the first occurrence of each of the
following events, as they occur:
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Milestones
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Payments (Dollars)
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Commencement of Phase I
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$
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***
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Commencement of Phase II
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$
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***
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Commencement Phase III
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$
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***
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NDA Approval in the USA
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$
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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. 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.
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Total, Territory-wide Annual Net Sales in a single
calendar year
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Royalty Rate
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Amount of Net Sales up to and including $***
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***
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%
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Amount of Net Sales over $*** and up to and including $***
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***
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%
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Amount of Net Sales over $*** and up to and including $***
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***
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%
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Amount of Net Sales over $***
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***
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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:
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Bank Name:
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Citibank, n.a.
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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,
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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
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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.
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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
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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 Ro
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