Contract
Exhibit
10.8
CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED
HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS
ARE DESIGNATED AS *. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
PATENT
AND TECHNOLOGY LICENSE AGREEMENT
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This
AGREEMENT (“AGREEMENT”) is
made
on this
2nd
day of February 2005 by and among
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(1)
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UNIVERSITY
COLLEGE CARDIFF CONSULTANTS LIMITED (“LICENSOR”), a company
incorporated under the laws of England and Wales whose address is
00-00
Xxxxxxx
Xxxx, Xxxxxxx, XX00 0XX, Xxxxxx Xxxxxxx and
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(2)
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CONTRAVIR
RESEARCH INCORPORATED a
Delaware
limited liability company having a principal place of business located
at
000 Xxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxx Xxxx 00000
{“LICENSEE”)
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RECITALS
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A.
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LICENSOR
was established, amongst other things, to hold,
to
manage and to
exploit
intellectual property generated by CARDIFF.
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B.
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LICENSOR
and REGA are the joint owners of the PATENT RIGHTS and the TECHNOLOGY
RIGHTS.
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C.
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Pursuant
to the terms of an agreement dated 24 September 1998 as amended by
a
deed
of
variation
dated 23 December 2004 LICENSOR has an irrevocable, exclusive worldwide
right
and licence under the PATENT RIGHTS and the TECHNOLOGY RIGHTS to
manufacture,
use, sell or otherwise deal in or with products utilising the PATENT
RIGHTS
and/or the TECHNOLOGY RIGHTS and/or incorporating the LICENSED SUBJECT
MATTER together with the right to grant sublicenses
thereunder.
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D.
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LICENSOR
desires to have the LICENSED SUBJECT MATTER developed in the LICENSED
FIELD.
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E.
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LICENSEE
wishes to obtain a sublicense from LICENSOR to
practice
LICENSED SUBJECT MATTER in LICENSED TERRITORY in LICENSED
FIELD.
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NOW,
THEREFORE, in consideration of the mutual covenants and promises
herein
contained, the
parties agree as
follows:
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TABLE
OF CONTENTS
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RECITALS
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Page 1
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I.
EFFECTIVE DATE
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Page
3
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II.
DEFINITIONS
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Page
3
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III.
SUBLICENSE
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Page 4
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IV.
CONSIDERATION,
PAYMENTS AND REPORTS
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Page 5
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V.
SPONSORED
RESEARCH
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Page 7
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VI.
PATENTS
AND INVENTIONS
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Page 7
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VII.
INFRINGEMENT
BY THIRD PARTIES
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Page
8
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VIII.
PATENT
MARKING
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Page 9
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IX.
INDEMNIFICATION
AND INSURANCE
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Page
9
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X.
USE
OF NAMES OF LICENSOR, CARDLFF, REGA AND KUL
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Page 10
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XI.
CONFIDENTIAL INFORMATION AND PUBLICATION
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Page 10
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XII.
ASSIGNMENT
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Page 11
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XIII.
TERM AND TERMINATION
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Page
12
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XIV.
WARRANTY:
SUPERIOR-RIGHTS
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Page
14
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XV.
PARENT
COMPANY GUARANTEE
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Page
15
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XVI.
GENERAL
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Page 15
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SIGNATURES
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Page 17
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EXHIBIT
1
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Page
18
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EXHIBIT
II
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Page 20
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I.
EFFECTIVE
DATE
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1
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This AGREEMENT
is
effective as
of the date written
above (“EFFECTIVE
DATE”).
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II.
DEFINITIONS
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As
used
in
this
AGREEMENT, the
following terms have the
meanings
indicated:
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2.1
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AFFILIATE
means any business entity
more
than fifty
percent
(50%) owned by LICENSEE,
any business entity which owns more
than
fifly percent
(50%) of
LICENSEE,
or
any business entity that
is
more than fifty percent (50%)
owned
by a business
entity that owns
more than
fifty percent (50%) of
LICENSEE.
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2.2
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2.3
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KUL
means
Katholieke Universiteit Leuven
which
has
administrative offices
at Xxxx Xxxxx
00, X-0000
Xxxxxx, Xxxxxxx and is
represented
by its technology
transfer
office,
KU
Leuven
Research and
Development
of
Xxxxx Xxxxxxxxxx 00-00, X-0000
Xxxxxx,
Xxxxxxx.
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2.4
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LICENSED
FIELD with
respect
to
LICENSED SUBJECT MATTER shall mean all fields
of
use.
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2.5
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LICENSED
PRODUCTS means
any product
or
service (a)
comprising
or
derived
from
LICENSED
SUBJECT MATTER and that is covered by: (i) a claim
in
a pending patent application
which
claim
has not been finally disallowed without the
possibility
of
appeal
or refiling;
or
(ii) a claim in an issued,
unexpired
patent
that has
not been held
invalid by
a
non-appealed or unappealable decision by a court
or
other appropriate
body
of
competent
jurisdiction; and/or (b)
which
uses
or incorporates
TECHNOLOGY RIGHTS
unless
LICENSEE can demonstrate to LICENSOR's
reasonable satisfaction
that
such
TECHNOLOGY
RIGHTS
as are
used or incorporated are
not
of a
confidential nature and in
assessing
whether
or
not such TECHNOLOGY
RIGHTS
are
of a
confidential nature any
such TECHNOLOGY RIGHTS
that
are in
the public
domain
as
a result of
any
act or omission
by
LICENSEE
(other
than the
inclusion
or reference to
such TECHNOLOGY
RIGHTS
in a
published
application
or issued patent)
shall
be deemed
to be of
a confidential
nature.
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2.6
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LICENSED
SUBJECT MATTER means
inventions and
discoveries covered
by PATENT
RIGHTS or
TECHNOLOGY
RIGHTS.
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2.7
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LICENSED
TERRITORY means
the
whole world.
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2.8
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NET
SALES means,
in the case of
SALES on arm’s length terms, the annual gross revenues
received
from
such SALES
or,
in the
case of
SALES
not
on arm’s length terms, the
annual
gross
revenues
that would
have
been received from such
SALES
had
they been
on arm's
length terms less, in each case, reasonable sales discounts
actually granted, sales
and/or use taxes actually
paid,
import
and/or export duties
actually paid, reasonable outbound
transportation
actually prepaid
or
allowed,
and
reasonable
amounts actually allowed
or credited due to
returns (not exceeding the
original
billing or
invoice
amount).
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2.9
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PARTIES
shall mean LICENSOR and/or LICENSEE as the context requires; and
parties
shall mean LICENSOR and/or
LICENSEE and/or GUARANTOR
as
the context
requires,
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2.10
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PATENT
RIGHTS means LICENSOR and REGA’s rights in any patents,
and/or
patent
applications, whether domestic or
foreign,
and all
divisionals,
continuations, continuations-in-part,
reissues, reexaminations or extensions thereof, including
but
not
limited
to supplementary protection certificates
and
any
letters
patent that issue
thereon as
defined in
Exhibit 1
attached
hereto,
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2.11
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REGA
means Rega Foundation whose address is
Xxxxxxxxxxxxxxxxxxxx
00,
X-0000
Xxxxxx,
Xxxxxxx. Rega Foundation is
a
constituent of
KUL.
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2.12
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SALE
or SOLD means the transfer or disposition of
a LICENSED
PRODUCT by
LICENSEE
or
any
AFFILIATE
for value
to a person, firm, company or
organisation other
than LICENSEE.
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2.13
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TECHNOLOGY
RIGHTS means LICENSOR’s and REGA’s rights
in any
technical
information,
know-how, processes, procedures, compositions, devices, methods,
formulae,
protocols, techniques, or
data
in
existence
at the EFFECTIVE DATE, which
are
not claimed in PATENT RIGHTS
but that
are
necessary
for practicing
PATENT
RIGHTS.
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III.
SUBLICENSE
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3.1
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LICENSOR
hereby grants to
LICENSEE a royalty-bearing,
and,
subject
to the provisions
of
sections 3.5 and 6.2 hereinbelow, exclusive sublicense under PATENT
RIGHTS
and
'TECHNOLOGY
RIGHTS to manufacture, have manufactured, use, import, offer to
sell and/or
sell
LICENSED PRODUCTS within LICENSED TERRITORY for use
within LICENSED
FIELD. This
grant
is subject to Sections 14.2, and
14.3
hereinbelow, the payment by LICENSEE to LICENSOR of all consideration
as
provided herein and the
timely
payment
of all
amounts
due under any
related
sponsored research agreement between
CARDIFF and LICENSEE or between KUL and
LICENSEE
or
between CARDIFF,
KUL and LICENSEE in effect during this
AGREEMENT.
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3.2
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LICENSEE
may grant sublicenses under LICENSED SUBJECT MATTER consistent
with
the terms of this AGREEMENT provided that LICENSEE is responsible
for
such sublicensees,
and for
diligently
collecting all amounts due to
LICENSEE
from such sublicensees.
If
any
such sublicensee becomes bankrupt, insolvent or is placed in the
hands
of a receiver or trustee, LICENSEE, acting
under
applicable law and
in a timely
manner,
agrees to use its best reasonable efforts to collect all
consideration
owed to LICENSEE,
including having the sublicense agreement confirmed or rejected in
a
court
of
proper jurisdiction,
if
commercially
reasonable.
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3.3
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LICENSEE
must deliver to
LICENSOR
a true and correct copy of
each
sublicense
granted
by
LICENSEE
and any modification or
termination
thereof, within thirty (30)
calendar
days after
execution,
modification, or termination.
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3.4
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If
this
AGREEMENT is terminated pursuant to Article XIII-Term and Termination,
LICENSOR
agrees to accept as
successors to
LICENSEE, existing sublicensees in
good standing
at
the date of termination provided that each such sublicensee consents
in
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writing
to be bound by such of the terms and conditions of this AGREEMENT
as
LICENSOR
requires.
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3.5
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Nothing
contained in this AGREEMENT shall be interpreted or construed in
any way
as preventing
LICENSOR from permitting CARDIFF and/or KUL and/or RIGA to undertake
or to Continue with any non-commercial research utilising PATENT
RIGHTS,
TECHNOLOGY RIGHTS and/or LICENSED SUBJECT MATTER.
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IV.
CONSIDERATION, PAYMENTS AND REPORTS
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4.1
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In
consideration of rights granted by LICENSOR to LICENSEE under this
AGREEMENT,
LICENSEE agrees to pay to LICENSOR the
following:
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(a)
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A
license fee in the amount of two hundred and seventy thousand dollars
(US$270,000)
which shall include all out-of-pocket expenses incurred by LICENSOR
prior to
the
EFFECTIVE DATE in filing, prosecuting, enforcing and maintaining
PATENT RIGHTS. This fee will not reduce the amount of any other
payment
provided for in this Article IV. The license fee shall be paid
in
two
(2) installments,
after the LICENSEE has received an invoice for the amount from
LICENSOR
and, in the case of the installment referred to in (ii) below, after
LICENSEE
has received from LICENSOR written documentation confirming that
such
sum has been paid or is owing by LICENSOR, as follows:
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(i)
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one
hundred and five thousand dollars (US$105,000) shall be paid within
thirty
(30) calendar days of the Effective Date; and
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(ii)
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one
hundred and sixty five thousand dollars (US$165,000) shall be paid
within
ninety (90) calendar days of the Effective Date;
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(b)
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A
running royalty equal to * percent (*%)
of NET SALES for NET SALES up
to and including * dollars (US$*), a running royalty
equal to * percent (*%) of NET SALES for NET SALES in excess
of *
dollars (US$*) and up to and including * dollars
(US$*), and a running royalty equal to *
percent (*%) of NET SALES for NET SALES in excess of * dollars
(US$*);
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(c)
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Milestone
payments upon occurrence of the following milestone
events:
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(i)
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upon
initiation of a Phase I clinical trial for a LICENSED PRODUCT,
*
dollars (US$*);
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(ii)
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upon
initiation of a Phase II clinical trial for a LICENSED PRODUCT,
*
dollars (US$*);
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(iii)
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upon
initiation of a Phase III clinical trial for a LICENSED PRODUCT,
*
dollars (US$*):, and
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(iv)
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upon
approval of
the
first
NDA
for any LICENSED PRODUCT, * dollars
(US$*);
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LICENSEE
will notify
LICENSOR within thirty (30)
calendar
days of each and any
such milestone event being reached. LICENSEE
will pay
the above
milestone payments
to
LLCENSOR
in respect of each
and
every LICENSED PRODUCT that
reaches such
milestone
event
to which
such payment relates and irrespective
of
whether
it is LICENSEE or an AFFILLATE that
initiates
or
is responsible
for
achieving
the relevant milestone event PROVIDED THAT
the
milestone payments
required by this section 4.1(c) shall apply
only to (1) the
first LICENSED
PRODUCT reaching each milestone event for a first therapy area
which
relates
to treatment of
VZV
and (2)
the first
LICENSED PRODUCT reaching
each milestone event for a second therapy area which relates to
treatment
of
HCMV; and PROVIDED FURTHER THAT nothing
in
this
section
4. 1(c) shall
oblige
LICENSEE
to make
multiple milestone payments for
the
same milestone
event
for any therapy area
or
upon reaching milestone events
in
more than
two therapy
areas
in total.
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(d)
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For
any sublicense pursuant to
Section 3.2
hereinabove (other than
a sublicense
to an
AFFILIATE), *
percent
(*%)
of
all royalties,
up
front payments,
and milestone payments due to
LICENSEE.
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4.2
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LICENSEE
in furtherance of the objectives of this AGREEMENT agrees to
make
or
to
procure
that
its AFFILIATES
make good faith expenditures towards the clinical development
of
at
least
one
LICENSED PRODUCT, in a minimum amount of
two million
dollars
(US$2,000,000),
such expenditures
to
be
committed within thirty six (36)
months
following the
EFFECTIVE
DATE. Upon written request, LICENSEE shall provide
to
LICENSOR written
documentation
of such expenditures at the conclusion of
such
thirty six
(36) month
period.
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4.3
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During
the term of this
AGREEMENT
and for one year thereafter, LICENSEE agrees to
keep
complete and accurate records of
its
and its
AFFILIATES’
SALES and NET
SALES
and its and its AFFILIATES Section 4.2
expenditures
in sufficient detail to enable
the royalties and other payments due hereunder and LICENSEE's compliance
with
this AGREEMENT to
be determined,
LICENSEE agrees to permit LICENSOR or
its
representatives, at
LICENSOR’s
expense, to
periodically
examine LICENSEE’S and
any
AFFILIATES’
books, ledgers, and
records
during regular business
hours
for the
purpose
of
and
to
the
extent necessary to
verify
any report required under
this
AGREEMENT. If any amounts due to LICENSOR are determined to have
been
underpaid
in
an amount equal to
or
greater than five percent (5%) of
the
total amount due
during
the period
so
examined, then
LICENSEE
will pay the cost of
the
examination plus
accrued
interest at
eight
percent (8%) per annum or the maximum rate allowed by law, whichever
is lower. In the event that
LICENSEE
has overpaid any
payment
due to LICENSOR
in
an
amount equal to or
greater
than five
percent
(5%) of the total, LICENSOR
will return any such
overpayment
to LICENSEE after deduction
of LICENSOR's
reasonable examination expenses.
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4.4
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Within
thirty (30) calendar days following each anniversary of the EFFECTIVE
DATE, LICENSEE
will deliver to LICENSOR a written progress report as to LICENSEE’s and
any
suhlicensee's efforts and accomplishments during the preceding year
in
diligently commercializing
LICENSED SUBJECT MATTER in LICENSED TERRITORY and LICENSEE’s
and sublicensees’ commercialization plans for the upcoming
year.
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4.5
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All
amounts payable hereunder by LICENSEE will be paid in United States
dollars without
set-off, deductions for taxes, assessments, fees, or charges of any
kind.
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4.6
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No
payments due or royalty rates owed under this AGREEMENT will be reduced
as
the result
of co-ownership of LICENSED SUBJECT MATTER by LICENSOR. and another
party,
including, but not limited to, LICENSEE.
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4.7
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LICENSEE
shall not be obligated to pay multiple royalties to LICENSOR for
a single
LICENSED
PRODUCT in the event said LICENSED PRODUCT is covered by more than
one patent application and/or patent that is included in the PATENT
RIGHTS.
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4.8
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LICENSEE
shall not be obliged to pay multiple milestone payments per milestone
event to
LICENSOR for a single LICENSED PRODUCT
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4.9
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Any
and all sums to be paid to LICENSOR pursuant to this Agreement shall
be
paid by LICENSEE
to LICENSOR at six (6) calendar monthly intervals.
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V.
SPONSORED
RESEARCH
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5.1
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If
LICENSEE desires to sponsor research for or related to the LICENSED
SUBJECT MATTER.
and particularly where LICENSEE receives payments for sponsored research
pursuant
to a sublicense granted by LICENSEE under this AGREEMENT, LICENSEE
(a)
will notify CARDIFF and KUL in writing of all opportunities to conduct
this sponsored
research (including clinical trials, if applicable), (b) solicit
research
and/or clinical
proposals from CARDIFF and KUL for this purpose, and (c) will give
good
faith consideration to funding the proposals at CARDIFF and
KUL.
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VI.
PATENTS AND INVENTIONS
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6.1
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After
the EFFECTIVE DATE, LICENSEE will at its sole cost and expense (a)
within
applicable
time limits prosecute and, subject to the provisions of section 6.2
hereinbelow, maintain
in force for the full term thereof all patent applications and patents
comprised within
PATENT RIGHTS together with any patents divided out therefrom, (b)
within
applicable
time limits apply for, prosecute and, subject to the provisions of
section
6.2 hereinbelow,
maintain in force for the full term thereof all and any possible
extensions to
or
continuations of any patents within PATENT RIGHTS including but not
limited to supplementary
patent certificates and (c) within applicable time limits file, prosecute
and maintain
in force any patent applications in respect of any improvements to
PATENT
RIGHTS
developed or acquired by L1CENSEE after the EFFECTIVE DATE and any
patents
granted pursuant thereto or divided out therefrom and LICENSEE will
prepare and file the appropriate patent applications, using an attorney
or
agent of LICENSEE's choosing, and LICENSEE will pay the cost of searching,
preparing, filing, prosecuting and
maintaining same. LICENSEE will promptly provide LICENSOR with a
copy of
any application
filed by or on behalf of LICENSEE, as well as copies of any correspondence
and
documents received or filed by or on behalf of LICENSEE during filing,
prosecution
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and/or
maintenance of any such patent applications and patents including
but not
limited to
all correspondence received from or sent to any patent offices relating
(whether in whole
or in part) to PATENT RIGHTS . LICENSOR agrees to provide copies
of all
information
in its possession (including but not limited to data, reports or
memoranda) necessary
to LICENSEE for the prosecution of any current patent application
comprised in
PATENT RIGHTS.
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6.2
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LICENSEE
shall promptly notify LICENSOR if it does not intend (a) to pursue
any
patent
application comprised within PATENT RIGHTS or relating to any improvements
to
PATENT RIGHTS developed or acquired by LICENSEE after EFFECTIVE DATE;
and/or
(b) to continue to maintain in force any patents within PATENT RIGHTS
or
relating
to any improvements to PATENT RIGHTS. If LICENSEE does not intend
to
pursue
any such patent application or to maintain in force any such patent,
it
will promptly
notify LICENSOR such that LICENSOR, if it so wishes, may take over
the
prosecution of such patent application or the maintenance of such
patent.
LICENSOR may,
at its sole option and discretion, file or prosecute or maintain
such
patent application or
patent at its own expense. In respect of any patent application or
patent
relating to improvements
to PATENT RIGHTS, LICENSEE shall assign to LICENSOR its entire
right,
title and interest in and to the invention which is the subject of
such
patent application
and such patent application, subject to reimbursement of LICENSEE’s
acquisition,
maintenance and transfer costs, if applicable. LICENSEE agrees to
co-operate
with LICENSOR by making available all information in its possession
(including but
not limited to data, reports or memoranda) reasonably necessary to
LICENSOR for the
prosecution of any patent application or for the filing of any patent
application in respect
of any invention assigned by LICENSEE to LICENSOR hereunder. Where
LICENSEE
decides in accordance with this section 6.2 not to prosecute any
patent
application
comprised within PATENT RIGHTS or to maintain in force any patent
comprised
within PATENT RIGHTS LICENSOR shall be entitled, at its option and
in its
sole
discretion, on written notice to LICENSEE either to render the license
granted to LICENSEE
in respect of such patent or patent application non-exclusive or
to
terminate such
licence.
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6.3
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LICENSEE
shall notify LICENSOR in good time, prior to making or attempting
to make
any
change to or restriction of any claim of any patent application or
patent
comprised within
PATENT RIGHTS to afford LICENSOR, at LICENSOR’s own expense, an
opportunity
to suggest an alternative to LICENSEE’s proposal.
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6.4
|
The
PARTIES agree that they share a common legal interest to get valid
enforceable patents
and that LICENSOR and LICENSEE, will keep all privileged information
received
pursuant to this Section VI confidential.
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VII.
INFRINGEMENT BY THIRD PARTIES
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7.1
|
LICENSEE,
at its discretion and expense, may enforce any patent exclusively
licensed
hereunder
against any infringement by third parties and is entitled to retain
recovery from such
enforcement, After reimbursement of LICENSEE’S reasonable legal costs and
expenses
related to such recovery, LICENSEE agrees to pay LICENSOR ten percent
(I0%)
of any recovery (including punitive damages) awarded for patent
infringement. LICENSEE
must notify LICENSOR in writing of any potential infringement within
sixty
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(60)
calendar days of knowledge thereof. If LICENSEE does not file suit
against
a substantial
infringer within six (6) months of knowledge thereof, then LICENSOR
may,
at
its sole discretion and expense, enforce any patent licensed hereunder
on
behalf of itself
and LICENSEE, with LICENSOR retaining all recoveries from such enforcement
and/or
reduce the sublicense granted hereunder to non-exclusive with respect
to
the patent(s)
at issue.
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7.2
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In
any suit or dispute involving an allegation of infringement, the
PARTIES
agree to cooperate
fully with each other. At the request and expense of the party bringing
suit, the other
party will permit reasonable access during regular business hours,
to all
relevant personnel,
records, papers, information, samples, specimens, and the like in
its
possession.
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VIII.
PATENT MARKING
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8.I
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LICENSEE
agrees to permanently and legibly xxxx all packaging containing individual
LICENSED
PRODUCT(S), documentation therefor, and when possible for actual
LICENSED
PRODUCT(S) SOLD by LICENSEE, and/or sublicensees of LICENSEE, LICENSED
PRODUCTS with the number of any applicable patent(s) licensed hereunder
in accordance with the relevant country's patent laws, including
Xxxxx 00,
Xxxxxx
Xxxxxx Code.
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IX.
INDEMNIFICATION AND INSURANCE
|
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9.1
|
LICENSEE
agrees to hold harmless and indemnify LICENSOR, CARDIFF, REGA,
KUL
and their respective officers, employees, students and agents from
and
against any and all claims, demands, causes of action, costs, expenses
(including without limitation costs
of suit and reasonable attorney’s fees), losses, damages and other
liabilities of whatsoever
nature and howsoever arising (including without limitation, any and
all
such things
arising on account of any injury or death of persons or damage to
property) caused by,
or arising out of, or resulting from, the exercise or practice by
LICENSEE, its sublicensees
and/or their respective officers, employees, agents or representatives,
of
the rights
granted hereunder and/or the manufacture, sale, offer for sale, use
and/or
import of LICENSED
PRODUCTS; provided, however, that the following is excluded from
LICENSEE's
obligation to indemnify and hold harmless:
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the
negligence or willful malfeasance by an officer, agent or employee
of
LICENSOR.
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9.2
|
In
no event shall LICENSOR be liable for any:
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(a)
|
loss
of contracts, loss of goodwill, loss of opportunity, loss of profits,
loss
of revenue:
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financial
or economic loss of any nature; or
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indirect,
special, consequential or punitive damages arising out of, or in
connection
with, this AGREEMENT or its subject matter, regardless of whether
LICENSOR
knows or should know of the possibility of such
loss.
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The
total aggregate liability of
LICENSOR for
all
loss
and
damages of
any
kind relating to
this AGREEMENT or
its
subject matter shall not exceed the amounts paid by
LICENSEE
to
LICENSOR
under this AGREEMENT pursuant to section IV during the
one
(1) year period
preceding
the date of the first
event
that gave rise to
such
liability.
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The
foregoing exclusions and limitations shall apply
to all claims and
actions of
any
kind, whether
based on contract, tort
(including,
but not
limited
to, negligence), or any other grounds.
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9.3
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Beginning
at
the
time when any LICENSED SUBJECT MATTER is
being
distributed or
sold
(including for the purpose of obtaining regulatory approvals) by
LICENSEE
or
by
a
sublicensee,
LICENSEE shall, at its sole cost
arid
expense, procure and
maintain
commercial
general liability insurance
in
amounts not less
than
$2,000,000 per incident and
$2,000,000 annual aggregate, and LICENSEE shall use
reasonable
efforts to have the LICENSOR,
CARDIFF, REGA, KUL and their respective officers, employees, students
and
agents named as
additional
insureds. Such commercial general liability insurance shall
provide; (i)
product
liability coverage; (ii)
broad
form contractual liability
coverage
for
LICENSEE’s indemnification under this AGREEMENT; and (iii) coverage
for
litigation
costs.
The minimum amounts of insurance coverage required herein shall not
be
construed
to create a
limit
of
LICENSEE'S liability with respect to its indemnification under
this AGREEMENT.
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9.4
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LICENSEE
shall provide LICENSOR with written evidence of
such
insurance within
thirty
(30)
days of its procurement. Additionally, LICENSEE shall provide LICENSOR
with
written notice of at
least
fifteen (15)
days
prior to the cancellation, non-renewal or
material
change in
such
insurance.
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9.5
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LICENSEE
shall
maintain such commercial general liability insurance beyond the
expiration
or termination of
this
AGREEMENT during:
(i)
the
period that
any LICENSED
PRODUCT is
being
commercially distributed or sold by
LICENSEE
or
by
a
sublicensee
or agent of LICENSEE; and (ii) the five
(5) year
period
immediately
after such
period.
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X.
USE OF NAMES OF LICENSOR,
CARDIFF,
REGA AND KUL
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I0.1
|
LICENSEE
will not use the
name
of (or the name of any
employee
of) LICENSOR or
CARDIFF'
or
REGA or KUL in any advertising, promotional or sales literature,
on
its
Web
site, or for
the
purpose of raising capital without the advance express written
consent
of LICENSOR
or
CARDIFF or
REGA
(as
the case
may be), such consent not to
be
unreasonably withheld.
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XI.
CONFIDENTIAL
INFORMATION AND PUBLICATION
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11.1
|
The
parties
each agree that all
information
contained
in
documents
marked “confidential” and
forwarded to
one
by
the
other (i)
are
to
be
received in strict confidence, (ii)
used
only
for
the purposes
of
this AGREEMENT.
and (iii) not
disclosed
by
the
recipient party (except
as
required
by
law
or court order), its agents or employees without the
prior
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written
consent of the party disclosing the same, except to the extent that
the
recipient party
can establish by competent written proof that such
information:
|
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|
(a)
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was
in the public domain at
the
time
of
disclosure;
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(b)
|
later
became part of the
public
domain through no act or omission of the
recipient
party,
employees,
agents, successors or assigns;
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(c)
|
was
lawfully disclosed to the recipient party by a third party having
the
right to
disclose
it;
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(d)
|
was
already
known by
the
recipient party at the time of disclosure:
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(e)
|
was
independently developed by
the
recipient party without use of an other party’s
confidential information; or
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(f)
|
is
required
by
law
or
regulation
or by the rules
of
any regulatory or
supervisory
body
to which the recipient party is subject or with whose rules it
is
necessary for
the
recipient party to
comply
to be disclosed.
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11.2
|
Each
party’s obligation or
confidence
hereunder will
be
fulfilled by
using
at
least
the same
degree of
care
with the other party’s confidential information as it uses
to
protect its
own
confidential
information, but always at least
a
reasonable degree of care.
The
obligation
of
confidence
shall remain in force throughout the term of this AGREEMENT and
for
a period
of five (5)
years thereafter,
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11.3
|
Any
party may disclose to
the
relevant Patent Office personnel confidential information
of
the
other party, necessary for
the
purpose of advancing the prosecution of patents relating
to the LICENSED SUBJECT MATTER and improvements, provided
however,
that
the disclosing party will inform the non-disclosing party of the
intention
to disclose
and
the
nature of the confidential information to be
disclosed
prior to
making
such
disclosure
and
the non-disclosing party will, to
the
extent possible, be given an opportunity
to
suggest
an alternative to
the
disclosure.
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11.4
|
Notwithstanding
any other provision herein to
the
contrary, LICENSOR shall be free to disclose
confidential information belonging to LICENSEE in confidence to
REGA,
KUL
and
CARDIFF and LICENSOR, CARDIFF, REGA and KUL shall each have the right
to
publish
the general scientific findings from research related to
LICENSED
SUBJECT MATTER,
with due regard to the protection of LICENSEE’S confidential information,
LICENSOR
and/or CARDIFF and/or REGA and/or KUL will submit the manuscript
of
any
proposed publication to
LICENSEE
at
least
thirty 130) calendar days in
advance
of
submission
for publication, and LICENSEE shall have the right to
review
and
comment
upon
the publication in order to
protect
LICENSEE’S confidential information. Upon LICENSEE’S
request, publication may be delayed up
to
ninety (90) additional calendar days
to enable LICENSEE to secure adequate
intellectual
property protection of LICENSEE’S
confidential information that would otherwise be affected by the
publication.
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XII.
ASSIGNMENT
|
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|
12.1
|
This
AGREEMENT may
be transferred or assigned by LICENSEE without the prior written
consent of
LICENSOR
provided
that
(a) no such
transfer
or
assignment
shall be
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effective
until receipt by LICENSOR, in full
and
in
cleared funds,
of all monies due to
LICENSOR
pursuant to Section 4.1(a)
hereinabove
and (b) such transferee
or
assignee agrees
in writing to
be fully
bound by
the
terms and conditions of
this AGREEMENT.
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12.2
|
This
AGREEMENT may be transferred or assigned at any time by LICENSOR
without
the
prior written consent of LICENSEE provided that
such
transferee or assignee agrees in
writing to be fully bound by the terms and conditions of
this AGREEMENT.
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XIII.
TERM AND TERMINATION
|
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|
13.1
|
Subject
to Section 6.2 hereinabove and Sections 13.2, 13.3,
13.4
and 13.5 hereinbelow, the
term
of
this
AGREEMENT
is from EFFECTIVE DATE to
the
date
upon which
the last
of the
last patent or the last continuation (whether in
whole
or in
part),
the last
reissue,
the
last reexamination, the last extension to any patents or the
last
supplementary protection
certificate in
respect
of any patents within PATENT RIGHTS expires.
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13.2
|
Subject
to any rights herein which survive termination, this AGREEMENT will
earlier terminate
in its entirety:
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|
(a)
|
automatically,
if
LICENSEE
becomes bankrupt or
insolvent
and/or if
the
business of
LICENSEE shall be placed in the hands of a
receiver,
assignee, or trustee, whether
by
voluntary
act of
LICENSEE
or
otherwise;
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(b)
|
upon
ninety
(90) calendar days
written
notice from LICENSOR, if
LICENSEE
breaches
or
defaults
on the payment or
report obligations
of Article IV, or use of name
obligations of
Article
X, unless, before the end of
the
such ninety (90)
calendar
day notice period, LICENSEE has cured the default or breach to
LICENSOR’s
reasonable satisfaction, and
so
notifies
LICENSOR,
stating the manner
of the cure;
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(c)
|
upon
thirty (30) calendar days
written
notice from LICENSOR,
if
LICENSEE
fails
to make the good faith
expenditures detailed
in Section 4.2
within
the prescribed
time period;
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(d)
|
upon
ninety (90) calendar days written
notice
from LICENSOR if
LICENSEE
breaches
or defaults on any other obligation under this AGREEMENT, unless,
before
the end of the such ninety (90) calendar-day notice
period, LICENSEE has cured
the default or breach to LICENSOR’s reasonable satisfaction and so
notifies
LICENSOR, stating the manner of the cure:
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(e)
|
at
any
time by
mutual
written agreement between LICENSEE and LICENSOR subject
to
any
terms herein which
survive
termination;
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(f)
|
at
LICENSOR’s
option if
LICENSEE
has defaulted or
been
in excess of
one
(1)
month
late on its
payment
obligations
pursuant
to the terms of this AGREEMENT on
any two (2) occasions
in
a
twelve
(12)
month
period, provided however, that
LICENSEE
shall have fourteen (14) days from receiving written notice from
LICENSOR
of
the
second default or late payment to
cure
the default or late payment
to the reasonable satisfaction of LICENSOR, and so
notifies
LICENSOR,
stating
the manner
of cure;
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(g)
|
upon
one hundred
twenty (120)
calendar
days written
notice
from LICENSEE if
any particular patent or
patents
included in PATENT RIGHTS and which
account
for
at least
thirty (30%) percent of the total royalty to LICENSOR pursuant to
Article
4.1(b), is or are irrevocably adjudicated to be invalid;
or
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(h)
|
upon
ninety (90) calendar days written notice from LICENSEE if LICENSOR
is
in
breach of
Section
11.1 (Confidential Information and Publication) unless, before
the end of the such ninety (90) calendar-day notice period, LICENSOR
has
cured
the default or breach to LICENSEE’s reasonable satisfaction and so
notifies LICENSEE, stating the manner of the cure.
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| 13.3 |
(a)
|
Upon
one hundred twenty (120) calendar days
written notice from LICENSEE, LICENSEE
may terminate its
obligations
to make payments under this
AGREEMENT
solely with respect to a
particular
patent or
patents
included in PATENT
RIGHTS, provided such particular patent or
patents
is or
are
irrevocably
adjudicated to be invalid; such termination of payments shall only
apply
in
respect of SALES in the territory for which such particular patent
or
patents
are invalidated and the definition of
PATENT
RIGHTS shall be deemed to
have been amended by the deletion therefrom of such patent or patents
and
subject
to such amendment this AGREEMENT shall continue in
force.
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(b)
|
LICENSOR
may terminate this AGREEMENT in respect of any patent or
patent
application
comprised within PATENT RIGHTS at any time in accordance with the
provisions of Section 6.2 hereinabove and, where LICENSOR does
so,
the definition
of PATENT RIGHTS shall be deemed to have been amended by the deletion
therefrom of such patent or patent application and subject to
such
amendment
this AGREEMENT shall continue in force.
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13.4
|
Upon
termination
of
this AGREEMENT:
|
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(a)
|
nothing
herein will be construed to release any party of any obligation maturing
prior to the effective date of the termination:
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(b)
|
LICENSEE
covenants and agrees to
be
bound by the provisions of
Articles
IV (Consideration,
Payments and Reports), IX (Indemnification and Insurance), X
(Use
of LICENSOR’s Name), and
XI
(Confidential Information and Publication) of
this AGREEMENT;
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(c)
|
LICENSOR
agrees to
be
bound by Article
XI;
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(d)
|
To
the
extent that termination is caused other than by breach of LICENSEE,
LICENSEE may, after the effective date of the termination, sell all
LICENSED PRODUCTS and parts therefor that
it has
on hand at the date of termination, provided LICENSEE pays the earned
royalty thereon and any other amounts due pursuant
to Article IV of this AGREEMENT.
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(e)
|
Subject
to Section 13.3(d), LICENSEE agrees to cease and desist any use
and
all SALE
of the LICENSED SUBJECT MATTER and LICENSED PRODUCTS upon
termination of this AGREEMENT and to provide to
LICENSOR
within ninety (90) days of the date of termination a written statement
showing all monies due to but not paid to LICENSOR under Section
4
hereinabove
in
respect
of the period up to and including the
date
of termination and LICENSEE AGREES
to
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pay
to
LICENSOR
all
such
monies at the same time as
it
delivers
such statement to
LICENSOR;
and
|
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|
(f)
|
LICENSEE
grants
to
LICENSOR,
CARDIFF, REGA and KUL a nonexclusive royalty bearing license with
the
right to sublicense others with respect to
improvements
made by LICENSEE (including improvements licensed by LICENSEE
from third parties) but
excluding
any
improvements
assigned to
LICENSOR
hereunder. LICENSEE and LICENSOR and CARDIFF and
REGA
and KUL
agree
to
negotiate
in good
faith
the
royalty
rate
for the nonexclusive license.
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(g)
|
To
the extent that
termination
is
caused
other than by
breach
of
LICENSEE,
LICENSEE
shall
provide
LICENSOR with a final statement of NET SALES within
six (6) months following termination, and shall pay any royalties
due
no more
than thirty (30)
calendar
days
thereafter,
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13.5
|
Upon
expiry of this AGREEMENT, LICENSEE shall,
for
a
period
of
five (5)
years
alter the
first (lst)
commercial
SALE of such LICENSED PRODUCT (or such part of
such
period
as
extends
beyond
the expiry date
of this
AGREEMENT), continue to pay royalties,
milestone payments and
other sums
in respect of
such
LICENSED PRODUCT in
accordance
with sections
4.1(b), (c)
and (d)
hereinabove
UNLESS LICENSEE can reasonably
demonstrate that such LICENSED PRODUCT does not use
or
incorporate TECHNOLOGY RIGHTS of a
confidential
nature and in
assessing
whether or not such TECHNOLOGY
RIGHTS are
of
a
confidential
nature any such TECHNOLOGY RIGHTS
that are in the public domain as
a
result
of
any
act or omission by
LICENSEE
(other
than the inclusion of or reference to
such
TECHNOLOGY RIGHTS in a published application
for
a patent or issued patent) shall be
deemed
to be
of a
confidential
nature; and
LICENSEE shall comply with
the provisions of sections
4.3, 4.4, 4.5. 4.6, 4.7 and
4.9
during
such period.
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XIV.
WARRANTY: SUPERIOR-RIGHTS
|
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|
14.1
|
LICENSOR
represents and
warrants
that at EFFECTIVE DATE (a)
it and
REGA are jointly
the owners of
the
entire
right,
title,
and
interest in
and to
PATENT RIGHTS and TECHNOLOGY
RIGHTS, (b)
it
has the sole right to
grant
sublicenses thereunder, (c)
it
has
not
granted sublicenses thereunder to
any
other entity that would restrict rights
granted
hereunder except as stated
herein;
(d)
it
is
not
aware
(not
having made any enquiries
or carried
out
any searches) of
any
belief that any patent comprised within PATENT
RIGHTS is
not
valid or
of
any patent
owned by
LICENSOR
and
not
included in
PATENT
RIGHTS which
would
be infringed by
LICENSEE’s
use of PATENT RIGHTS
in
accordance
with the
terms
of
this
AGREEMENT.
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14.2
|
LICENSEE
understands and agrees
that
LICENSOR, by
this AGREEMENT,
makes no
representation
as
to the
quality, operability or
fitness
for
any
use, safety, efficacy, approvability
by
regulatory
authorities, time
and cost of
development, patentability, and/or
breadth of LICENSED SUBJECT MATTER, PATENT RIGHTS or
TECHNOLOGY
RIGHTS, LICENSOR, by this AGREEMENT, also save as set out
in
section
14.1 hereinabove makes no representation as to
whether
any patent covered by
PATENT
RIGHTS is
valid
or as
to
whether
there are any patents now held, or which
will
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be
held,
by others or by LICENSOR in the. LICENSED FIELD nor does LICENSOR
make
any representation that the inventions contained in PATENT RIGHTS
and/or
LICENSED
SUBJECT MATTER do not
infringe
any
other patents
now held or
that
will be
held
by
others.
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14.3
|
LICENSEE,
by execution hereof, acknowledges, covenants and agrees
that LICENSEE
has
not
been
induced in any way
by
LICENSOR or employees thereof to
enter
into this AGREEMENT,
and further
warrants
and represents
that (a)
LICENSEE has had
the
opportunity
to
conduct sufficient
due diligence
with
respect to all
items and
issues pertaining
to
this AGREEMENT; and
(b) LICENSEE
possesses adequate knowledge
and expertise,
or
has had
the
opportunity to
use knowledgeable
and
expert
consultants,
to adequately
conduct
such due
diligence,
and subject to the representations and warranties provided
by
LICENSOR
in section 14.1, agrees
to
accept all
risks inherent herein; (c)
LICENSEE
is
a corporation
duly
incorporated and
validly
existing under the laws
of the
state
of
Delaware, United
States
of America, with
all
corporate power and
authority to enter
into
this
Agreement
and
to perform
its obligations
hereunder
including
payment of
all
sums due
to the
Licensor hereunder;
(d)
the
execution of this
AGREEMENT
by
LICENSEE
has
been
duly authorised
by all requisite action on the
part of LICENSEE
and
constitutes a valid, binding and
enforceable
obligation of
LICENSEE;
and
(e) LICENSEE
is not a party to
any
agreement (express
or implied
that
may conflict
with its
obligations
hereunder.
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XV.
PARENT COMPANY GUARANTEE
|
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|
15.
|
As
material
inducement for LICENSOR to enter into
and
perform this AGREEMENT, LICENSEE has procured a
guarantor
acceptable
to
LICENSOR, who has
entered
into a guarantee
agreement
in
the
form
set out
in
Exhibit
II
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XVI.
GENERAL
|
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|
16.1
|
This
AGREEMENT
constitutes the entire and only
agreement
between the PARTIES for
LICENSED
SUBJECT MATTER and all other prior negotiations,
representations,
agreements
and understandings are superseded hereby. No
agreements altering or
supplementing
the terms
hereof will be
made except by a written document
signed by both
PARTIES.
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|
16.2
|
Any
notice
required by this
AGREEMENT
shall be in
writing and
served
personally or sent
by registered
or certified mail
(postage
prepaid) or
by
overnight
courier
service or
by facsimile
(and confirmed
by airmail, postage prepaid) and
addressed to the
relevant
party as
follows:
|
|
If
to LICENSOR to:
|
|
|
University
College
Cardiff
Consultants
Limited
00-00
Xxxxxxx
Xxxx
Xxxxxxx
XX00 0XX,
UK ATTENTION: Dr. Xxxx
Xxxxxx |
|
|
Fax:
x00 00 00 00 00 00
|
||
|
If
to LICENSEE to:
|
||
|
ContraVir
Research Incorporated
000
Xxxxxxx Xxxxxx
Xxxxxx
Xxxx
Xxx
Xxxx 00000
ATTENTION:
Xxxxxx X. Xxxxxx, President
Fax:
x0 000 000 0000
|
||
|
or
to such other addresses or facsimile number as may be given from
time to
time under the terms of this notice provision. Any notice served
personally shall be deemed to have been
given upon such service. Any notice sent by mail shall be deemed
to have
been served
five (5) days after the same shall have been posted and any notice
sent by
facsimile
shall be deemed to have been served upon transmission and in providing
such service it shall be sufficient to prove that the letter or facsimile
was properly addressed and
as the case may be posted or transmitted.
|
||
|
16.3
|
LICENSEE
agrees to comply with all applicable federal, state and local laws
and
regulations
in connection with its activities pursuant to this
AGREEMENT.
|
|
|
16.4
|
This
Agreement shall be governed by and construed in all respects in accordance
with the laws
of England and Wales and the PARTIES hereby exclusively submit to
the
jurisdiction
of the courts of England and Wales,
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|
16.5
|
Failure
of LICENSOR to enforce a right under this AGREEMENT will not act
as a
waiver
of right or the ability to later assert that right relative to the
particular situation involved,
|
|
|
I6.6
|
Headings
included herein are for convenience only and will not be used to
construe
this AGREEMENT.
|
|
|
16.7
|
If
any part of this AGREEMENT is for any reason found to be unenforceable,
all other parts
nevertheless will remain enforceable,
|
|
|
16.8
|
Save
in respect of CARDIFF, REGA and KUL who shall each be entitled to
enforce
the provisions
of Sections 15, 5.1, 9.1. 9.3, 10.1, 11.4 and 13.4(f) neither party
intends that any
provision of this AGREEMENT shall be enforceable by any person, firm,
company or organisation who is not a party to this Agreement whether
pursuant to the Contracts (Rights
of Third Parties) Xxx 0000 or
otherwise.
|
|
IN
WITNESS WHEREOF, the parties have caused their duly authorized representatives
to execute
this AGREEMENT.
SIGNED
by
| X. X. XXXXXX | /s/ X. X. Xxxxxx |
| Director |
|
duly
authorised representative
for
and
on behalf of UNIVERSITY
COLLEGE
CARDIFF CONSULTANTS
LIMITED
SIGNED
by
| XXXXXX X. XXXXXX | /s/ Xxxxxx X. Xxxxxx |
| Director |
|
duly
authorised representative
for
and
on
behalf
of
CONTRAVIR
RESEARCH
INCORPORATED
