EXHIBIT 3.12
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
BIOVATION LIMITED
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (this "Agreement") is made as of the 8th day of
March, 2004 (the "Effective Date") between BIOVATION LIMITED OF ▇▇▇▇▇▇▇ LODGE,
ABERDEEN SCIENCE PARK, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇, ▇▇ (hereinafter
called "Biovation," which expression includes its successors and assigns) of the
one part and VIVENTIA BIOTECH, INC., OF ▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇,
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇ (hereinafter called "Viventia," which
expression includes its successors and permitted assignees) of the other part.
Each of Biovation and Viventia are herein sometimes referred to individually as
a "Party" and collectively as "Parties."
WHEREAS, Biovation Controls certain proprietary Technology related to
the genetic engineering of biological materials, including proteins and the
removal of immunogenic sequences from proteins to produce genetic variants of
such proteins for therapeutic or in vivo diagnostic purposes.
WHEREAS, Biovation and Viventia have entered into that certain Research
Agreement (the "Research Agreement") dated as of September 20, 2002.
WHEREAS, Viventia has exercised its option to obtain an exclusive
license to certain proprietary Technology under Section 3.7 of the Research
Agreement.
NOW, THEREFORE, IT IS HEREBY AGREED as follows:
1. DEFINITIONS.
Throughout this Agreement, where the context so requires, the use of
the singular form of a word shall be construed to include the plural
and the use of the plural shall be construed to include the singular,
and the use of any gender shall include all genders. Any words used but
not otherwise defined herein shall have the meanings ascribed to them
in Section 1 of the Research Agreement. In this Agreement the following
words and expressions shall be construed as follows:
(a) "Affiliate" shall mean any corporation, company, firm,
partnership or other entity that directly or indirectly
controls, is controlled by or is under common control with
either Party to this Agreement. For purposes of this
definition, "control" shall mean the ownership, directly or
indirectly, of fifty percent (50%) or more of the issued share
capital or shares of stock entitled to vote for the election
of directors, in the case of a corporation, or fifty percent
(50%) or more of the equity interests in the case of any other
entity or the legal power to direct or cause the direction of
the general management and policies of the entity in question.
(b) "Biovation Technology" shall mean Technology Controlled by
Biovation as of the Effective Date or developed hereafter
whether or
not in the course of the Research Program, by Biovation or
jointly by Biovation and Viventia or a third party that is
related to the genetic engineering of biological materials,
including proteins and plasmids and the removal of immunogenic
sequences from proteins or plasmids and the generation of
genetic variants thereof, provided that, any Technology
Controlled by Viventia or developed by Viventia that is
related to the Protein shall be deemed to be Viventia
Technology and Viventia shall have exclusive ownership and
control of same.
(c) "BLA" shall mean a Biologics License Application, or similar
application for marketing approval of a Licensed Product for
use in the Field submitted to the FDA, or a foreign equivalent
of the FDA.
(d) "Confidential Information" shall have the meaning set forth in
Section 15 of this Agreement.
(e) "Contract Year" shall mean the period beginning on the
Effective Date and ending on the first anniversary thereof
("Contract Year 1"), and each succeeding twelve (12) month
period thereafter during the term of this Agreement (referred
to herein as "Contract Year ▇," "▇▇▇▇▇▇▇▇ Year 3," etc.).
(f) "Control" or "Controlled" shall mean (i) with respect to any
Technology (other than proprietary materials of a Party)
and/or Patent Rights, the possession by a Party of the ability
to grant a license or sublicense of such Technology and/or
Patent Rights as provided herein without violating the terms
of any agreement or arrangement between such Party and any
third party and (ii) with respect to proprietary materials,
the possession by a Party of the ability to supply such
proprietary materials to the other Party as provided herein
without violating the terms of any agreement or arrangement
between such Party and any third party.
(g) "DeImmunised Proteins" shall mean the DeImmunised genetic
variants of the Protein developed by Biovation under the
Research Agreement identified on Schedule A, attached hereto
and incorporated herein by reference.
(h) "DeImmunised Plasmids" shall mean the genetically engineered
plasmids that encode the DeImmunised Protein identified on
Schedule A, attached hereto and incorporated herein by
reference.
(i) "Effective Date" shall have the meaning set forth above in the
introduction to this Agreement.
(j) "FDA" means the United States Food and Drug Administration or
its successor.
(k) "Field" shall mean the use of the DeImmunised Protein for
therapeutic and in vivo diagnostic purposes in humans.
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(l) "First Commercial Sale" shall mean the date of the first
commercial sale (other than for purposes of obtaining
Regulatory Approval) of a Licensed Product by or on behalf of
Viventia or any sublicensee.
(m) "IND" shall mean Investigational New Drug application filing
in the USA or its equivalent in any country in the European
Union for approval to undertake a controlled and lawful study
in humans of the Licensed Product that is designed to
demonstrate statistically whether such Licensed Product is
safe for use in humans in a manner sufficient to file a BLA or
New Drug Application or its equivalent to obtain regulatory
approval to market and sell that Licensed Product in the
United States or any country in the European Union.
(n) "Joint Patent Rights" shall mean all Patent Rights that claim
Joint Program Technology. Joint Patent Rights as of the
Effective Date are listed in Schedule B, attached hereto and
incorporated herein by reference.
(o) "Joint Program Technology" shall mean any and all Technology
relating to the Protein or any DeImmunised Plasmid or
DeImmunised Protein jointly made, developed conceived and/or
reduced to practice (a) by employees of, or consultants to,
both Parties, or (b) by Viventia through the material use of
Biovation Technology, provided that Joint Program Technology
shall not include Technology relating to (i) the Protein (ii)
the composition, manufacture, or use of antibodies, antibody
fragments (including single chain or single domain
antibodies), or peptide-based antibody mimics, whether by
themselves or conjugated to or associated with an active
molecule, or (iii) fusion proteins..
(p) "Licensed Patent Rights" shall mean all Patent Rights which
are Controlled by Biovation as of the Effective Date
(including Biovation's interest in Joint Patent Rights).
Licensed Patent Rights as of the Effective Date are listed in
Schedule C, attached hereto and incorporated herein by
reference.
(q) "Licensed Product" shall mean any product that (i)
incorporates DeImmunised Protein, (ii) is produced by use of a
DeImmunised Plasmid, or (iii) the manufacture, use, or sale of
which would, absent the license granted to Viventia hereunder,
infringe one or more of the claims included in the Licensed
Patent Rights that has not expired, been revoked or
disclaimed, or found to be invalid or unenforceable in an
unappealed or unappealable decision of a court of competent
jurisdiction.
(r) "Licensed Technology" shall mean all Biovation Technology and
Biovation's interest in Joint Program Technology.
(s) "New Drug Application" shall mean a new drug application (as
defined in Title 21 of the United States Code of Federal
Regulations, as amended from time to time) filed with the FDA
or its foreign
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equivalent seeking regulatory approval to market and sell any
Licensed Product in the United States or any country in the
European Union.
(t) "Net Sales" shall mean gross proceeds measured in Dollars as
of the date of sale resulting from the invoice price less (a)
usual trade and/or cash discounts actually allowed or taken;
(b) forwarding expenses, freight, postage and duties actually
paid or allowed and taxes imposed directly on licensee for
sales, all if separately identified in the invoice; and (c)
credits for goods actually returned. No deductions shall be
made for commissions paid or for the cost of collections. For
Licensed Products sold or otherwise transferred other than for
money, "Net Sales" shall be calculated based upon the "fair
market value" of the Licensed Product determined in an
arm's-length transaction. Net Sales shall be calculated on the
price from Viventia, a licensee, a sublicensee, or their
Affiliates to the first purchaser who is not a licensee, a
sublicensee or Affiliate and not on sales between or among
licensees, sublicensees, or their Affiliates.
(u) "Patent Rights" shall mean the rights and interests in and to
(i) issued patents and pending patent applications without
limitation to any country, including, without limitation, all
provisional applications, substitutions, continuations,
continuations-in-part, divisionals and renewals, all letters
patent granted thereon, if any, and all reissues,
reexaminations and extensions thereof, and supplemental
protection certificates of invention and utility models and
(ii) copyrights with respect to data Controlled by a Party.
(v) "Phase III Clinical Trial" shall mean, as to a particular
Licensed Product for a particular indication, a controlled and
lawful study in humans of the safety and efficacy of such
Licensed Product for such indication, which is prospectively
designed to demonstrate statistically whether such Licensed
Product is safe and effective for use in such indication in a
manner sufficient to file a BLA or New Drug Application or its
equivalent to obtain regulatory approval to market and sell
that Licensed Product in the United States or any country for
the indication under investigation in such study.
(w) "Protein" shall mean the starting protein as specified in
Schedule A hereto.
(x) "Technology" shall mean and include all inventions,
discoveries, improvements, trade secrets and proprietary
methods and materials, whether or not patentable, including,
but not limited to (i) samples of, methods of production or
use of, and structural and functional information pertaining
to, chemical compounds, proteins or other biological
substances and (ii) technical and scientific information
(including any negative results), data, formulations,
techniques and know-how.
(y) For clarity, is is agreed that "Deliverables" (as defined in
the Research Agreement and incorporated in this Agreement)
include deimmunised
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[ ] and the expression
products of the inserts of such plasmids.
2. COMMENCEMENT.
This Agreement shall be deemed to have been made as of the Effective
Date and shall be read and construed accordingly.
3. GRANT OF RIGHTS.
(a) Biovation hereby grants to Viventia an exclusive world-wide,
royalty-bearing license under Licensed Technology and Licensed
Patent Rights solely to develop, have developed, make, have
made, use, sell, distribute for sale, have sold, import and/or
have imported Licensed Products in the Field, together with
the right to grant sublicenses. For clarity, this grant of an
exclusive license to Viventia with respect to Licensed
Products (including Deliverables, Deimmunised Plasmids and
Deimmunised Proteins) shall not prevent Biovation from
granting licenses to others under the Biovation Technology,
Biovation Patent Rights and Biovation's interest in Joint
Program Technology and Joint Patent Rights outside the scope
of the exclusive license granted to Viventia.
(b) Viventia shall notify Biovation of the grant of each
sublicense within thirty (30) days of its effective date, such
notification to include the name and address of the
sublicensee and the general nature and subject matter of the
sublicense. Viventia shall use its best efforts to ensure that
any sublicensee performs its obligations under any such
sublicense and shall remain liable for the performance of
Viventia's obligations hereunder. Biovation will not establish
any contact with the sublicensee in relation to the sublicense
without the prior written consent of Viventia.
4. PAYMENTS.
4.1 General. The Parties acknowledge that the principal value contributed
by Biovation under this Agreement is the Licensed Technology. Viventia
acknowledges and agrees that the value it receives hereunder is in its
access to the Licensed Technology. Accordingly, Viventia has agreed to
pay the license fees and milestones for access to and use of Licensed
Technology as set forth herein even though Biovation may not Control
patent applications or patents covering the manufacture, sale, use or
importation of a particular Licensed Product and, regardless of whether
a Licensed Product is covered by a patent application or patent within
the Licensed Patents.
4.2 Upfront Payment. In consideration for the exclusive license granted
pursuant to Section 3(a) hereof Viventia shall pay to Biovation the sum
of [ ] upon signature of
this Agreement.
4.3 Milestone Payments. Viventia shall pay Biovation the following amounts
upon the achievement of the milestones set forth below:
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(a) [
] upon the commencement of [
] of each and every Licensed Product
for a distinct indication. By way of example, the start of two
such trials would incur two milestones if the same product was
being tested for two indications or if two different products
were being tested for the same indication, but would incur
only one milestone if each was of the same product for the
same indication. Each such milestone payment shall be reduced
to a minimum of [
] according to the following formula if the
event triggering such milestone also triggers a milestone
payment by Viventia to a third party:
Milestone Rate in U.S. dollars = [
]
(b) [
] upon [
] the commencement of which triggered
a milestone under subsection (a) above. Each such milestone
payment shall be reduced to a minimum of [
] according to the
following formula if the event triggering such milestone also
triggers a milestone payment by Viventia to a third party:
Milestone Rate in U.S. dollars = [
]
(c) [
] upon submission of [
] for each and every Licensed Product for each and
every clinical indication. Each such milestone payment shall
be reduced to a minimum of [
] according to the
following formula if the event triggering such milestone also
triggers a milestone payment by Viventia to a third party:
Milestone Rate in U.S. dollars = [
]
(d) [
] upon approval of [ ] the submission of
which triggered a milestone payment under subsection (c)
above. Each such milestone payment shall be reduced to a
minimum of [
] according to the following formula
if the
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event triggering such milestone also triggers a milestone
payment by Viventia to a third party:
Milestone Rate in U.S. dollars = [
]
4.4 Fees.
(a) Viventia shall pay Biovation a sublicense fee of [
] for each and
every sublicense that it grants hereunder.
(b) Viventia shall also pay to Biovation an annual license fee of
[ ] for the
maintenance of the license granted pursuant to Section 3 of
this Agreement for each Contract Year during the term of this
Agreement. Such annual license fees shall be due and payable
to Biovation on the first day of each Contract Year during the
term of this Agreement and are not creditable against amounts
owed by Viventia to Biovation pursuant to Sections 4.3 and
4.5. In the event that Licensee does not receive approval for
an IND by the end of Contract Year 5, then the Licensee shall
make an additional annual payment of [
] in addition to the annual license fee payable
for the relevant Contract Year (each, an "Additional Annual
Payment"). Such Additional Annual Payments shall be due and
payable on the first day of Contract Year 6 and each
subsequent Contract Year until an IND is approved at which
time such Additional Annual Payments will cease. All
Additional Annual Payments to be paid under this Section
4.4(b) shall be creditable against amounts required to be paid
by Viventia to Biovation under Section 4.3 of this Agreement
subsequent to the payment of such Additional Annual Payment.
(c) All of the payments set forth in sections 4.2, 4.3 and 4.4 are
to be understood net, exclusive of Value Added Tax.
4.5 Royalties.
Viventia shall pay Biovation a [ ]% royalty based on aggregate Net
Sales of each Licensed Product sold during the License Term (as defined
in Section 5 below) by Viventia and/or its Affiliates and sublicensees.
The [ ]% royalty rate to be paid to Biovation shall be subject to a
reduction if Viventia's total undiscounted royalty to Biovation and
third parties on aggregate Net Sales of each Licensed Product would
otherwise exceed [ ]%. In such an event, the royalty payable to
Biovation will be discounted based on the following formula: [
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]
4.6 Accounting.
(a) All payments under this Agreement shall be due in the case of
Section 4.3 within thirty (30) days of the occurrence of the
relevant milestone event and, in the case of Section 4.4(a)
within thirty (30) days of the execution of the sublicense, in
each case without the requirement for an invoice from
Biovation. Viventia will promptly notify Biovation of the
achievement of any milestone event for which a payment to
Biovation is required under this Section 4. After the
beginning of commercialization of each Licensed Product, all
payments relating thereto under this Agreement pursuant to
Section 4.5 above shall be due within thirty (30) days
following the end of each calendar quarter.
(b) The Net Sales used for computing the royalties payable
hereunder shall be computed and the royalties shall be paid,
in U.S. Dollars. For purposes of determining the amount of
royalties due from Viventia, the amount of Net Sales in any
foreign currency shall be computed by converting such amount
into dollars at the prevailing commercial rate of exchange for
purchasing dollars with such foreign currency as reported in
The Wall Street Journal as of the last business day of the
relevant quarter.
(c) Viventia agrees to keep true and accurate records and books of
account containing all data necessary for the calculation of
the royalties payable to Biovation under Section 4 of this
Agreement. Such records and books of account shall upon
reasonable notice having been given by Biovation be open
during business hours for inspection by a duly authorised, but
neutral and independent accountant, who shall be acceptable to
both parties without prejudice. Biovation will bear the full
cost of such audit unless such audit discloses an underpayment
of more than five percent (5%) from the amount of total
payments due. In such case, Viventia shall bear the full cost
of such audit. The terms of this Section 4.6(c) shall survive
any termination or expiration of this Agreement for a period
of three (3) years.
(d) Viventia shall prepare a statement in respect of each calendar
quarter of this Agreement which shall show for the calendar
quarter in question Viventia's Net Sales on sales by it, its
Affiliates or sublicensees of the Licensed Products on a
country by country basis, details of the quantities of
Licensed Products manufactured and sold in each country and
the royalty and VAT due, if any, to Biovation thereon pursuant
to Section 4 above. Such statement shall be submitted to
Biovation within thirty (30) days following the end of the
calendar quarter or part thereof to which it relates together
with a remittance for the royalties and VAT due to Biovation,
if any. If Biovation shall give notice to Viventia within
thirty (30) days of the receipt of any such statement that it
does not accept the same such statement shall be
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certified by an independent chartered accountant appointed by
mutual agreement between the parties hereto or, in default of
such an agreement, within fourteen (14) days, by the President
for the time being of the Institute of Chartered Accountants
of England and Wales in London. Viventia shall make available
all books and records required for the purpose of such
certification at reasonable times during normal business hours
and the statement so certified shall be binding between the
parties to this Agreement. The costs of such certification
shall be the responsibility of Biovation if the certification
shows the original statement to have been accurate and
otherwise shall be the responsibility of Viventia. Following
any such certification the Parties shall make any adjustments
necessary in respect of the royalties already paid to
Biovation in relation to the year in question.
(e) Viventia shall pay royalties to Biovation free and clear of
and without deduction or deferment in respect of any demand,
set-off, counterclaim or other dispute and so far as is
legally possible such payment shall be made free and clear of
any taxes imposed by or under the authority of any government
or public authority and in particular but without limitation
where any sums due to be paid to Biovation hereunder are
subject to any withholding or similar tax. Viventia shall pay
such additional amount as shall be required to ensure that the
net amount received by Biovation hereunder will equal the full
amount which would have been received by it had not such tax,
including VAT, been imposed or withheld. Viventia and
Biovation, without prejudice to the foregoing, shall use their
best endeavours to do all such lawful acts and things and to
sign all such lawful deeds and documents as will enable
Viventia to take advantage of any applicable legal provision
or any double taxation treaties with the object of paying the
sums due to Biovation without imposing or withholding any tax.
Sums are expressed in this Agreement as exclusive of value
added tax. Biovation agrees to provide Viventia with a VAT
invoice in respect of every payment affected by VAT.
(f) Where Biovation does not receive payment of any sums due to it
within the period specified hereunder in respect thereof,
interest shall accrue on the sum outstanding at the rate of
one percent (1%) per month calculated on a daily basis without
prejudice to Biovation's right to receive payment on the due
date therefor.
5. LICENSE TERM AND TERMINATION.
(a) Subject to the terms and conditions of this Agreement, the
term of the license (the "License Term") granted pursuant
hereto shall commence upon the Effective Date and continue in
force on a country-by-country and product-by-product basis
until the longer of (a) the expiration of the last to expire
of the Licensed Patent Rights in the country covering the
Licensed Product and (b) ten (10) years from the first
commercial sale in such country of such Licensed Product. Upon
expiration of the Licence Term for each Licensed Product,
Viventia shall have a worldwide, exclusive fully paid up,
royalty-free licence under any and
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all Licensed Technology and/or Licensed Patent Rights covering
the Licensed Product to the extent necessary or useful to
develop, have developed, make, have made, use, sell,
distribute for sale, have sold, import and/or have imported
Licensed Products in the Field.
(b) Viventia may terminate this Agreement and the licenses granted
pursuant hereto by giving to Biovation six (6) months prior
written notice to Biovation of the same. Such termination
shall not prejudice Biovation in its enforcement of the
Licensed Patents in the event of subsequent manufacture of
Licensed Products by Viventia.
(c) Termination of this Agreement or of such licenses shall be
without prejudice to any rights of either Party against the
other which may have accrued up to the date of such
termination and Viventia shall pay to Biovation the
appropriate royalties hereunder on all inventory of Licensed
Products (on which royalties have not already been paid) held
at the date of termination by Viventia or any person engaged
by Viventia to manufacture the Licensed Products and shall
thereafter be free to sell such Licensed Products on which
applicable royalties have been paid to Biovation. Sections
5(a), 9, 11, 14, 15, 16, 19, 20 and 21 shall survive the
expiration or termination of this Agreement.
(d) Neither Party may terminate this Agreement for breach without
first giving the alleged breaching Party written notice of the
acts or omissions alleged to constitute a breach and providing
a reasonable period of time to cure such alleged breach of not
less than sixty (60) days with respect to the payment of money
and not be less than one hundred twenty (120) days for any
other acts.
6. MUTUAL REPRESENTATIONS AND WARRANTIES.
Each Party hereby represents and warrants to the other Party as
follows:
(a) It is duly organized, validly existing and in good standing
under the laws of the jurisdiction in which it is
incorporated, and has full power and authority and the legal
right to own and operate its property and assets and to carry
on its business as it is now being conducted and as
contemplated in this Agreement, including, without limitation,
the right to grant the licenses granted hereunder.
(b) As of the Effective Date, (i) it has the power and authority
and the legal right to enter into this Agreement and perform
its obligations hereunder; (ii) it has taken all necessary
corporate action on its part required to authorize the
execution and delivery of the Agreement and the performance of
its obligations hereunder; and (iii) the Agreement has been
duly executed and delivered on behalf of such Party, and
constitutes a legal, valid and binding obligation of such
Party and is enforceable against it in accordance with its
terms.
(c) As of the Effective Date, it has sufficient legal and/or
beneficial title under its intellectual property rights
necessary to perform activities
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contemplated under this Agreement and to grant the licenses
contained in this Agreement exclusively to Viventia free and
clear of the rightful claim of any third party.
7. LIMITATION ON WARRANTIES.
(a) Nothing in this Agreement or in any licenses granted pursuant
to this Agreement shall be construed as a representation or
warranty that any of the Licensed Patent Rights are valid or
that any manufacture, use, sale or other disposal of the
Licensed Products is not an infringement of any patents or
other rights not vested in Biovation.
(b) BIOVATION MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR
IMPLIED, REGARDING THE LICENSED TECHNOLOGY AND LICENSED PATENT
RIGHTS, DEIMMUNISED PLASMIDS, OR DEIMMUNISED PROTEINS,
INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY
REGARDING VALIDITY, ENFORCEABILITY, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, INCLUDING ANY CLINICAL PURPOSE OR
OTHER USE WITH RESPECT TO HUMANS OR NON-INFRINGEMENT OF THIRD
PARTY RIGHTS. ALL TECHNOLOGY PROVIDED TO VIVENTIA BY BIOVATION
HEREUNDER IS PROVIDED "AS IS."
8. VIVENTIA COVENANTS.
(a) Viventia shall promote the sale of the Licensed Products of
good marketable quality and shall use reasonable endeavours to
meet the market demand therefore.
(b) Viventia will use all Licensed Technology and Licensed Patent
Rights, licensed hereunder, in compliance with all applicable
laws and regulations, including but not limited to, those
relating to animal testing, biotechnological research or the
handling and containment of biohazardous materials.
9. INDEMNIFICATION BY VIVENTIA.
Viventia shall indemnify, defend and hold harmless Biovation, its
Affiliates and their respective directors, officers, employees, and
agents and their respective successors, heirs and assigns (the
"Biovation Indemnitees"), against any liability, damage, loss or
expense (including reasonable attorneys' fees and expenses of
litigation) (collectively, "Losses") incurred by or imposed upon the
Biovation Indemnitees, or any one of them, in connection with any
claims, suits, actions, demands or judgments of third parties,
including without limitation personal injury and product liability
matters and claims of suppliers and Viventia employees (except in cases
where such claims, suits, actions, demands or judgments result from a
material breach of this Agreement, negligence or wilful misconduct on
the part of Biovation) arising out of (a) the breach or alleged breach
of any representation, warranty or covenant of
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Viventia under Sections 6, 7 or 8 hereof, (b) the negligence or
misconduct of Viventia, its Affiliates or their respective employees or
agents; or (c) the development, testing, production, manufacture,
promotion, import, sale or use by any person of any Licensed Product
which is manufactured or sold by Viventia or by an Affiliate,
sublicensee, distributor or agent of Viventia.
10. DILIGENCE.
Viventia agrees to exercise reasonable commercial efforts to seek
regulatory approval to market Licensed Products and develop markets for
and market Licensed Products.
11. OWNERSHIP OF LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS.
(a) Viventia acknowledges and agrees that as between the Parties,
Biovation shall own all Licensed Technology, and Licensed
Patent Rights.
(b) Except as provided in paragraph (c) below, Biovation and its
Affiliates shall have the right, but not the obligation to
prosecute, file and maintain any patent applications or
patents relating to any Licensed Patent Rights. To the extent
that Biovation decides not to prosecute, file, or maintain any
Licensed Patent Rights, it shall notify Viventia of same and
Viventia shall have the right, but not the obligation to
prosecute, file and maintain any patent applications or
patents with respect to Licensed Patent Rights reasonably
related to Licensed Products; Biovation shall reasonably
cooperate with Viventia in such filings.
(c) Viventia shall have the right, but not the obligation, to
prosecute, file and maintain any patent applications or
patents relating to any Licensed Patent Rights that claim or
are otherwise directed to Deliverables, Deimmunised Plasmids
and Deimmunised Proteins (including compositions comprising
same and methods of making or using all of the foregoing. To
the extent that Viventia decides not to prosecute, file or
maintain any such patents or applications, it shall notify
Biovation of same and Biovation shall have the right, but not
the obligation to prosecute, file and maintain them; Vivenia
shall reasonably cooperate with Biovation in such filings.
12. INFRINGEMENT.
(a) Each Party shall notify the other promptly after such Party
becomes aware of any alleged infringement of any Licensed
Patent Rights in any country through the sale of a Licensed
Product.
(b) If any of the Licensed Patent Rights under which Viventia
holds a license is infringed by a third party through the sale
of a Licensed Product, Biovation shall have the right and
option, but not the obligation, to bring an action for
infringement, at its sole expense,
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against such third party in the name of Biovation and/or in
the name of Viventia, and to join Viventia as a plaintiff if
required. Biovation shall promptly notify Viventia of any such
action and shall keep Viventia informed as to the prosecution
of any action for such infringement. Biovation shall have the
full control over the conduct of such litigation including
settlement thereof; provided, however, that Biovation shall
make no decision, including, but not limited to, any
settlement with respect to such infringement which adversely
affects the validity or enforceability or scope of the
Licensed Patent Rights or detracts from the exclusivity of the
license granted to Viventia hereunder without the prior
written consent of Viventia. In the event that Biovation does
not institute an infringement proceeding against an infringing
third party within one hundred twenty (120) days after
becoming aware or receiving notice of any alleged infringement
through the sale of a Licensed Product for which it has a
right and option to bring an action under this Section 12(b),
then Viventia shall have the right and option, but not the
obligation, to institute such an action and to retain any
recovered damages. If by statute or regulation, a delay of one
hundred twenty (120) days would result in a diminshment of
rights, including by way of example but not limitation loss of
the opportunity for a stay of approval of an infringing
product, then the one hundred twenty (120) day period above
shall be shortened to the extent required to end ten (10) days
before the date on which the diminishment of rights would
occur.
(c) In any infringement suit either Party may institute to enforce
any rights pursuant to this Agreement, the other Party hereto
shall, at the request of the Party initiating such suit,
cooperate in all respects and, to the extent reasonably
possible (without adversely affecting the other Party's normal
business operations), have its employees testify when
requested and make available relevant records, papers,
information, samples, specimens, and the like. All reasonable
out-of-pocket costs incurred in connection with rendering
cooperation requested hereunder shall be paid by the Party
requesting cooperation.
(d) The costs and expenses of any action instituted pursuant to
this Section 12 including reasonable fees of attorneys and
other professionals) shall be borne by the Party instituting
the action, or, if the Parties elect to cooperate in
instituting and maintaining such action, such costs and
expenses shall be borne by the Parties in such proportions as
they may agree in writing. Each Party shall execute all
necessary and proper documents and take such actions as shall
be appropriate to allow the other Party to institute and
prosecute such infringement actions (if such other Party has
the right to institute and prosecute such infringement actions
pursuant to this Section 12).
13. INSURANCE.
Viventia shall maintain comprehensive general liability insurance in
the amount of [ ] per
occurrence during the term of this Agreement and Product Liability
Insurance in the amount of
13
[ ] per occurrence for all
periods during which it has a Licensed Product for sale. Viventia shall
list Biovation as an "Additional Insured" under its insurance policies
described above and shall provide a certificate of insurance to
Biovation reflecting the same.
14. NOTICES.
(a) All notices and statements to either Party required under this
Agreement shall be made in writing delivered via certified mail, return
receipt requested, courier, provided that evidence of delivery is made,
or facsimile with confirmation of such transmission addressed to such
Party at the following addresses or faxed to the appropriate numbers
set forth below (with the copies to other parties set forth below) or
to such other address as may be designated from time to time:
To Biovation: With a copy to:
Biovation Limited Mintz, Levin, Cohn, Ferris, Glovsky and
▇▇▇▇▇▇▇ Lodge Popeo PC
Aberdeen Science Park ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Esquire
Scotland Tel: ▇▇▇-▇▇▇-▇▇▇▇
Attention: ▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇
President
Tel: ▇▇ ▇▇▇▇ ▇▇▇▇▇▇
Fax: ▇▇ ▇▇▇▇ ▇▇▇▇▇▇
To Viventia: With a copy to:
Viventia Biotech, Inc. ▇▇▇▇▇▇ & ▇▇▇▇▇▇
▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇ ▇▇▇ Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Esq.
Canada Tel: ▇▇▇-▇▇▇-▇▇▇▇
Attention: ▇▇. ▇▇▇▇ ▇▇▇▇▇▇ Fax: ▇▇▇-▇▇▇-▇▇▇▇
President & CEO
Tel: ▇ ▇▇▇ ▇▇▇ ▇▇▇▇
Fax: ▇ ▇▇▇ ▇▇▇ ▇▇▇▇
(b) All notices and statements provided to a Party hereunder shall
be deemed to have been given as of the date received, or at
the time of delivery of a facsimile to the relevant facsimile
number above.
(c) Each Party hereto may change its address and contact
information set forth above for the purpose of this Agreement
by providing written notice to the other Party of the same
from time to time.
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15. TREATMENT OF CONFIDENTIAL INFORMATION.
For purposes of this Agreement, "Confidential Information" shall mean
with respect to a Party (the "Receiving Party"), all information,
including without limitation, any Technology disclosed by the other
Party (the "Disclosing Party") to the Receiving Party or to any of its
employees, consultants, Affiliates, or sublicensees, whether in
writing, or by oral or visual disclosure or presentation, provided,
however, that "Confidential Information" shall not include information
that:
(a) was known to Receiving Party at the time such Confidential
Information was received by the Receiving Party or its
Affiliates, as shown by written documentation, other than by
virtue of a prior confidential disclosure to such Receiving
Party or its Affiliates; or
(b) was publicly known when received from Disclosing Party or
thereafter becomes publicly known through no fault or omission
of Receiving Party; or
(c) is made known to Receiving Party by a third party who did not
derive it from Disclosing Party and who has a lawful right to
make such disclosure free from any obligation of
confidentiality to the Disclosing Party; or
(d) is independently developed by or for the Receiving Party
without reference to or reliance upon any Confidential
Information; or
(e) is approved for disclosure by prior written consent of
Disclosing Party; or
(f) is required to be disclosed by government authority; provided;
however, that Receiving Party has provided reasonable advance
notice of the impending disclosure to Disclosing Party and
will disclose the Confidential Information to the extent
necessary and to such authority only.
The Receiving Party agrees that it will hold the Confidential
Information received from the Disclosing Party in secrecy and
confidence and will not disclose it to any third party, nor use it for
any purpose other than for the purpose of the performance of this
Agreement (which includes with respect to Viventia the full enjoyment
of the license rights granted to it by Biovation). Each Party further
agrees that it will restrict disclosure of the Confidential Information
within its own organisation and affiliates to those persons having a
need to know it for the purpose of this Agreement, and that such
persons will be advised of the obligation set forth in this Agreement
and obligated in like fashion. The above obligations of the Receiving
Party with respect to its treatment of Confidential Information shall
commence as of the Effective Date and continue through the term of this
Agreement and for a period of five (5) years thereafter. This Agreement
shall not be construed as granting any license rights with respect to
the Confidential Information. Except as otherwise required by
applicable laws and regulations, the Parties hereby
15
agree that any disclosure of the terms and conditions of this Agreement
(including disclosure in connection with potential stock exchange
listings, if any) shall be subject to the other Party's prior written
mutual agreement; provided, however, that each Party may disclose the
terms and conditions of this Agreement to a prospective investor, and
Viventia may disclose the terms of this Agreement to a prospective
sublicensee or marketing partner for a Licensed Product, pursuant to a
written confidentiality agreement.
16. WAIVER.
The waiver by Biovation of any breach, default or omission in the
performance or observance of any of the terms of this Agreement by
Viventia shall not be deemed to be a waiver of any other such breach,
default or omission.
17. FORCE MAJEURE.
If the performance of this Agreement or any obligation hereunder
(except for the payment of money) is prevented, restricted or
interfered with by reason of fire or other casualty or accident,
strikes or labour disputes, inability to procure raw materials, power
or supplies, war, invasion, civil commotion or other violence,
compliance with any order of any governmental authorities or any other
act or conditions whatsoever beyond reasonable control of either Party
hereto, the Party so affected upon giving a prompt notice to the other
Party shall be excused from such performance to the extent of such
prevention, restriction or interference; provided however that the
Party so affected shall use commercially reasonable efforts to avoid or
remove such causes of non-performance and shall continue performance
hereunder with the utmost dispatch whenever such causes are removed, to
the extent commercially reasonable.
18. ASSIGNMENT.
This Agreement shall not be assigned by either Party without the prior
written consent of the other Party, which consent shall not be
unreasonably withheld. Notwithstanding the foregoing, in the event of a
merger, consolidation or similar reorganization of either Party with or
into another party, or in the event of a sale of all or substantially
all of the assets of a Party, or with respect to Viventia in the event
of the sale of the business unit or Licensed Product to which this
Agreement pertains, this Agreement shall be assigned to or become the
obligation and liability of the acquiring entity, subject to the
written notification of such acquisition or merger to the other Party.
Any purported assignment in violation of this Section 18 shall be void.
The terms and conditions of this Agreement shall be binding upon and
inure to the benefit of the permitted successors and assigns of the
Parties.
19. GOVERNING LAW.
This Agreement shall be governed and interpreted in accordance with the
laws of New York without reference to its choice-of-law rules, except
that any issue
16
concerning interpretation, infringement, validity, enforceability,
term, or effect of a patent shall be governed by national law of the
country of such patent.
20. ARBITRATION.
All disputes, differences or controversies arising out of or in
connection with this Agreement, its interpretation, performance, or
termination, which may arise between the Parties arising out of, or
related to, this Agreement shall be amicably settled between the
Parties. In case of failure of amicable settlement between the Parties,
it shall be finally settled by binding arbitration conducted in New
York City in accordance with the Rules of Concilliation and Arbitration
of the International Chamber of Commerce (Paris, France) (the "ICC").
The arbitration panel shall be composed of three arbitrators, one of
whom shall be selected by Biovation, one of whom shall be selected by
Viventia and the third of whom shall be selected by the two so
selected. If both or either of Biovation or Viventia fails to select an
arbitrator or arbitrators within fourteen (14) days after receiving
notice of commencement of arbitration or if the two arbitrators fail to
select a third arbitrator within fourteen (14) days after their
appointment, the ICC shall, in accordance with said rules, upon the
request of both or either of the Parties to the arbitration, appoint
the arbitrator or arbitrators required to complete the panel.
Notwithstanding the terms contained in Section 19 of this Agreement,
U.S. patent law shall govern any disputes with respect to inventorship
under Sections 4.4, 4.5 and 4.6 of this Agreement.
The Parties shall share the costs of the arbitration, including
administrative and arbitrators' fees equally. Each Party shall bear its
own costs and attorneys' and witnesses' fees; provided, however, that
the prevailing Party, as determined by the arbitration panel, shall be
entitled to an award against the other Party in the amount of the
prevailing Party's costs and reasonable attorneys' fees. If judicial
enforcement or review of the arbitrator's decision is sought, the
prevailing Party shall be entitled to costs and reasonable attorneys'
fees in addition to any amount of recovery ordered by the court.
Any dispute between the Parties related to or arising from this
Agreement or the Parties' relationship hereunder that is not
arbitrable, including any action to confirm, enforce, modify, or set
aside an arbitration award, shall be heard exclusively in the state or
federal courts located in New York County, New York, to the exclusion
of all other courts, and the parties consent to the jurisdiction and
venue of such courts for such purpose.
21. MISCELLANEOUS.
21.1 Acknowledgement. Each Party acknowledges that it has negotiated
and entered into this Agreement in good faith.
21.2 Severability. In the event any one of the provisions of this
Agreement is held unenforceable or in conflict with the law of any
jurisdiction, the validity of the remaining provisions shall not be
affected by such holding. The Parties agree to negotiate and amend in
good faith such provision in a manner consistent with the intentions of
the Parties as expressed in the Agreement if
17
any invalid or unenforceable provision affects the consideration of
either Party.
21.3 Interpretation. The Parties acknowledge and agree that: (i) each
Party and its counsel reviewed and negotiated the terms and provisions
of this Agreement and have contributed to its revision; (ii) the rule
of construction to the effect that any ambiguities are resolved against
the drafting Party shall not be employed in the interpretation of this
Agreement; and (c) the terms and provisions of this Agreement shall be
construed fairly as to all Parties hereto and not in favor of or
against any Party, regardless of which Party was generally responsible
for the preparation of this Agreement.
21.4 Entirety of Agreement. This Agreement contains the entire
understanding of the Parties hereto with respect to the subject matter
contained herein. There are no restrictions, promises, covenants or
understandings other than those expressly set forth herein, and no
rights or duties on the part of either Party are to be implied or
inferred beyond those expressly herein provided for. The Parties may,
from time to time during the term of this Agreement, amend, modify,
vary, waive or alter any of the provisions of this Agreement, but only
by a written instrument that makes specific reference to this Agreement
which is duly executed by each Party, or in the case of waiver, by the
Party or Parties waiving compliance.
21.5 Further Assurances. Each Party agrees to duly execute and deliver,
or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further acts and things, including,
without limitation, the filing of such additional assignments,
agreements, documents and instruments, that may be necessary or as the
other Party hereto may at any time and from time to time reasonably
request in connection with this Agreement or to carry out more
effectively the provisions and purposes of, or to better assure and
confirm unto such other Party its rights and remedies under, this
Agreement.
21.6 No Partnership. For the purposes of this Agreement and all
obligations to be performed hereunder, each Party shall be, and shall
be deemed to be, an independent contractor and not an agent, partner,
joint venturer or employee of the other Party. Neither Party shall have
authority to make any statements, representations or commitments of any
kind, or to take any action which shall be binding on the other Party,
except as may be explicitly provided for herein or authorized in
writing.
21.7 Research Agreement. This Agreement supersedes the Research
Agreement with respect to any subject matter addressed herein or any
inconsistency.
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IN WITNESS whereof the Parties have caused this Agreement to be duly
executed in duplicate originals by their respective officers hereunto
duly authorized, of which one original is to be held by each Party.
BIOVATION LIMITED VIVENTIA BIOTECH, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇▇▇
----------------- ------------------
▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, Ph.D.
President President & CEO
19
SCHEDULE A
VIVENTIA'S PROTEIN = [ ]
DEIMMUNISED PROTEIN = [ ]
20
SCHEDULE B
JOINT PATENT RIGHTS
21
SCHEDULE C
LICENSED PATENT RIGHTS
DEIMMUNISATION PATENT FAMILIES
DEIMMUNISATION I
WO 98/52976 (international publication date 26-Nov-98)
Method for the production of non-immunogenic proteins
Regional Applications:
USA US 10/300215
Europe EPO 98922932.3
Japan 550129/98
Canada 2290485
Australia 75393/98
DEIMMUNISATION II
WO 00/34317 (international publication date 15-Jun-00)
Modifying protein immunogenicity
Regional Applications:
USA 09/633516
Europe EPO 99959535.8
Japan 2000-586759
China 99804401.6
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇/▇▇
▇▇▇▇▇▇ 0007746
Canada 2342967
DEIMMUNISATION III
WO 02/069232 (international publication date 6-Sept-02)
Method for identification of T-cell epitopes and use for preparing
molecules with reduced immunogenicity
22