The Governors of the University of Alberta, a corporation duly organized and existing under the laws of the Province of Alberta and having its principal office at 222, 8625 - 112 Street, Edmonton, Alberta, T6G 2E1, Canada (hereinafter referred to as...
This
license agreement (“AGREEMENT”) made and entered into this first
day of May 2002 (“EFFECTIVE DATE”) by
and
between:
The
Governors of the University of Alberta,
a
corporation duly organized and existing under the
laws
of
the Province of Alberta and having its
principal
office at 222, ▇▇▇▇ - ▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇, ▇▇▇▇▇▇
(hereinafter
referred to as “UA”)
and
Virexx
Research, Inc.,
an
Alberta corporation having its principal officc at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇
(hereinafter
referred to as “VIREXX”)
WHEREAS
UA is the owner of certain PATENT RIGHTS (as later defined in this AGREEMENT)
relating to a technology developed by ▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇▇ ▇▇▇▇, identified
as
UA IP# 94108 and described in the US Patent application No.
08/737,896 “A
Method
for Eliciting a Thl Specific Immune Response”(filed: September 24, 1997), which
is a continuation-in-part of the US Patent application No. 08/480,499 (filed:
June 7, 1995);
AND
WHEREAS one of the inventors of the PATENT RIGHTS, ▇▇▇▇ ▇▇▇▇ is no longer
an
employee of UA;
AND
WHEREAS UA encourages the development and commercialization of the PATENT
RIGHTS
as later defined in this AGREEMENT, and UA desires to transfer this technology
to benefit the public;
AND
WHEREAS VIREXX desires to obtain a license to practice under the PATENT RIGHTS
upon the terms and conditions hereinafter set forth in this
AGREEMENT;
AND
WHEREAS VIREXX has represented to UA, to induce UA to enter into this AGREEMENT,
that VIREXX shall commit itself to a diligent program of exploiting the PATENT
RIGHTS so that public utilization may result therefrom;
AND
WHEREAS UA and VIREXX have agreed that VIREXX shall obtain an exclusive
world-wide license to develop, use, commercialize, manufacture, distribute,
market, sell and sublicense the PATENT RIGHTS in the FIELD OF USE (as later
defined in this AGREEMENT under the terms of this license
agreement;
NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein, the parties hereto agree as follows:
ARTICLE
1- DEFINITIONS
For
the
purposes of this AGREEMENT, the following words and phrases shall have the
following meanings:
1.1 “VIREXX”
shall include Virexx Research Inc. and any related company of Virexx Research
Inc., the voting stock of which is directly or indirectly at least 50%
owned
or
controlled by Virexx Research Inc., an organization which directly or indirectly
controls more than 50%
of
the
voting stock of Virexx Research Inc. and an organization, the majority ownership
of which is directly or indirectly common to the ownership of Virexx Research
Inc.
1.2 “FIELD
OF
USE” means any and all uses of microsphere formulations that infringe one or
more claims contained in the PATENT RIGHTS for the treatment of infectious
disease and cancer caused by chronic viral infection, including but not limited
to hepatoma. (For greater certainty, the FIELD OF USE does not include any
use
of the PATENT RIGHTS in liposomal cancer vaccines.)
1.3 “LICENSED
PRODUCT(S)” means any product or part thereof which infringes in whole or in
part one or more issued and unexpired claims or a pending claim contained
in the
LICENSED TECHNOLOGY.
1.4 “LICENSED
TECHNOLOGY” means PATENT RIGHTS in the FIELD OF USE.
1.5 “NET
SALES” means the aggregate sale prices of LICENSED PRODUCTS sold or provided, as
the case may be, by VIREXX or by its SUBLICENSEE or by both, less the following
items insofar as the same pertain to the sale or provision of such LICENSED
PRODUCTS:
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(a)
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Discounts
allowed in amounts customary in the
trade;
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(b)
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Sales,
tariff duties and/or use taxes directly imposed and with reference
to
particular sales actually paid;
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(c)
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Outbound
transportation prepaid or allowed;
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| (d) |
Amounts
allowed or credited on returns; and
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Import
and/or export duties actually paid.
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No
deductions shall be made for commissions paid to individuals whether they
be
with independent sales agencies or regularly employed by VIREXX and on its
payroll, or for cost of collections.
1.6
“PATENT
RIGHTS” means all of the following UA intellectual
property:
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(a)
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the
US Patent application No. 08/480,499 “A Method for Eliciting a Thl
Specific Immune Response” (filed: June 7,
1995);
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(b)
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the
US Patent application No. 08/737,896 “A Method for Eliciting a Thl
Specific Immune Response” (filed: September 24, 1997), a
continuation-in-part of 1.6 (a) and later issued as US Patent No.
6,168,804 (issued: January 2,
2001);
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(c)
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the
US Patent application No. 09/668,825 “A Method for Eliciting a Thl
Specific Immune Response”, a divisional application of 1.6 (b) (filed:
September 22, 2000);
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(d)
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any
US divisional patent applications covering the invention disclosed
in the
patent application 1.6 (b) above and the resulting
patents;
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(e)
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any
US continuation-in-part application, and the resulting patents,
which are
directed to the invention disclosed in the patent applications
described
in sections 1.6 (b), (c) and (d)
above;
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(f)
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any
Canadian and foreign patent applications, and the resulting patents,
which
are based on the invention disclosed in the patent applications
described
in sections 1.6(e) above; and
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(g)
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any
reissues, extensions and divisions of Canadian and foreign patents
described in sections 1.6 (b), (c), (d), (e) and (f)
above.
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1.7 “SUBLICENSE
REVENUE” means all revenue received by VIREXX from its SUBLICENSEES for
sublicensing the rights to practice the LICENSED TECHNOLOGY, but excluding
any
payments received by VIREXX from third parties specifically to be directed
to
VIREXX’s research and development work on the LICENSED TECHNOLOGY.
1.8 “SUBLICENSEE”
means any third party that sublicenses the rights to practice the LICENSED
TECHNOLOGY that is granted to VIREXX in this AGREEMENT.
1.9 “TERRITORY”
means “world-wide” (unless otherwise determined in accordance with this
AGREEMENT).
1.10 “UA
INVENTOR” means ▇▇. ▇▇▇▇ ▇▇▇▇▇▇.
ARTICLE
2- GRANT AND TERM
2.1 UA
hereby
grants VIREXX an exclusive, royalty-bearing license in the TERRITORY to practice
the LICENSED TECHNOLOGY and to make, develop, use, import, offer to sell,
sell,
market and distribute and have made, developed, used, imported, offered to
sell,
sold, marketed and distributed LICENSED PRODUCT(S), until the end of the
term of
the last registered patent, at which time the license shall become a perpetual,
fully-paid up, royalty-free license, unless this AGREEMENT is sooner terminated
according to the terms defined in article 15 in this AGREEMENT.
2.2 UA
reserves the right to practice under the LICENSED TECHNOLOGY and to use the
LICENSED TECHNOLOGY for its own non-commercial research purposes and in
cooperation with other non-commercial research centers.
2.3 VIREXX
shall have the right to enter into sublicensing agreements for the rights,
privileges and licenses granted in this AGREEMENT but only with the prior
written consent of UA. Such consent by UA shall not be unreasonably withheld.
Upon any termination of this AGREEMENT, SUBLICENSEE’s rights shall also
terminate, subject to section 15.5 in this AGREEMENT.
2.4 Any
sublicenses granted by VIREXX shall be personal to the SUBLICENSEE and shall
not
be assignable or further sublicensed without the prior written consent of
UA.
Such consent by UA shall not be unreasonably withheld. VIREXX further agrees
that any sublicenses granted by it shall provide that the obligations to
UA be
consistent with the terms of this AGREEMENT.
2.5 VIREXX
shall forward to UA a copy of any and all sublicense agreements, amendments
and
novations thereto within 30 days after execution by the parties.
2.6 VIREXX
shall not receive from SUBLICENSEE anything in lieu of cash payments in
consideration for any sublicense under this AGREEMENT without the express
prior
written consent of UA. Such consent by UA shall not be unreasonably withheld,
provided that UA is entitled to such non-cash consideration according to
section
4.1.3 in this AGREEMENT or, at UA’s election that same percentage of the fair
market value of the non-cash consideration. VIREXX shall fully disclose to
UA
anything, including without limitation any share in profits, equity investment,
or any other compensation or benefit, which VIREXX will receive in relation
to
any sublicense. Such disclosure shall include all documents and information
necessary for full disclosure or as reasonably requested by UA. Any dispute
between the parties with respect to whether VIREXX will receive or is receiving
any compensation or benefit not expressly permitted by UA and, correspondingly,
whether UA is receiving fair compensation for such sublicense, or as to the
fair
market value of such non-cash consideration shall be determined by arbitration
as set forth in article 14.
2.7 The
license granted hereunder shall not be construed to confer any rights upon
VIREXX by implication, estoppel or otherwise as to any technology not
specifically set forth in section 1.4, “LICENSED TECHNOLOGY” in this
AGREEMENT.
ARTICLE
3- DUE DILIGENCE
3.1 VIEXX
shall use commercially reasonable efforts to utilize LICENSED TECHNOLOGY
and
develop, promote, market, distribute, and sell LICENSED PRODUCTS and to meet
or
cause to be met the worldwide regulatory requirements and the worldwide market
demand for LICENSED PRODUCTS throughout the term of this AGREEMENT. Failure
to
do so may result in the termination of this AGREEMENT subject to article
15.
VIREXX agrees to adhere to generally accepted pharmaceutical practices in
its
research, promotion, marketing and sales efforts, and that it will use
reasonable commercial efforts to develop LICENSED PRODUCTS.
3.2
In
addition to the covenant contained in section 3.1, VIREXX further agrees
that it
will meet the following milestones with regard to the development of
a LICENSED
PRODUCT:
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(a)
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To
identify an antigen composition to be used with LICENSED TECHNOLOGY
for a
LICENSED PRODUCT within 2 years after the EFFECTIVE
DATE;
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(b)
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To
formulate the antigen composition with LICENSED TECHNOLOGY and
initiate
toxicology studies that are necessary to facilitate the filing
of an IND
for a LICENSED PRODUCT within 3 years after the EFFECTIVE
DATE;
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(c)
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To
initiate clinical trials with a LICENSED PRODUCT within 4 years
after the
EFFECTIVE DATE; and
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(d)
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To
introduce the LICENSED PRODUCT to market within 3 months after
obtaining
marketing approval.
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3.3 VIREXX
shall deliver to UA the following reports:
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(a)
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An
annual progress report, due April 1 of each year, summarizing VIREXX’s
activity towards commercializing the LICENSED TECHNOLOGY starting
from
April 1, 2003 until the first commercial sale of a LICENSED
PRODUCT.
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(b)
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Within
120 days after the first submission of an NDA (New Drug Application)/NDS
(New Drug Submission) or equivalent to the US Food and Drug
Administration, Health Canada, European Medicines Control Agency
or any
other regulatory authority, a report describing VIREXX’s intent with
respect to seeking marketing approval and plans for proceeding
with
commercial sales of the LICENSED PRODUCT in other
countries.
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3.4 UA
acknowledges that VIREXX may perform all or a part of its obligations under
sections 3.1, 3.2 and 3.3 itself or through a SUBLICENSEE, provided that
VIREXX
shall at all times remain committed to UA for the performance of such
obligations, irrespective of any SUBLICENSEE. The failure of Virexx to perform
its obligations under sections 3.1, 3.2 and 3.3 may result in termination
of
this AGREEMENT subject to section 15.1.
ARTICLE
4- ROYALTIES / MILESTONE PAYMENTS
4.1 For
the
rights, privileges and license granted hereunder, VIREXX shall pay royalties
to
UA in the manner herein provided during the term defined in section 2.1 in
this
AGREEMENT or until this AGREEMENT is earlier terminated:
4.1.1
Milestone
Payments:
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(a)
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Milestone
Payment of CDN $100,000, which said Milestone Payment shall be
deemed
earned and due within 30 days after enrollment of the first patient
for a
Phase II clinical trial of a LICENSED
PRODUCT;
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(b)
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Milestone
Payment of CDN$ 150,000, which said Milestone Payment shall be
deemed
earned and due within 30 days after enrollment of the first patient
for a
Phase III clinical trial of a LICENSED
PRODUCT;
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(c)
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Milestone
Payment of CDN$250,000, which said Milestone Payment shall be deemed
earned and due within 30 days after the first marketing approval
for a
LICENSED PRODUCT by the US Food and Drug
Administration.
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4.1.2 Royalties:
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(a)
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1.0%
of NET SALES of LICENSED PRODUCTS sold in the US by VIREXX or SUBLICENSEES
or by both;
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(b)
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0.5%
of NET SALES of LICENSED PRODUCTS sold in countries other than
the US by
VIREXX or SUBLICENSEES or by both.
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4.1.3 Sublicense
Flow-through Payments:
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(a)
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5%
of
all SUBLICENSE REVENUES, excluding royalty payments, received by
VIREXX
from a SUBLICENSEE, if such sublicense is granted in conjunction
with
VIREXX’s proprietary components;
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(b)
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50%
of all SUBLICENSE REVENUES, excluding royalty payments, received
by VIREXX
from a SUBLICENSEE, if such sublicense is granted less than 1 year
after
the EFFECTIVE DATE of this AGREEMENT and such license transaction
does not
include VIREXX’s proprietary
components;
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| (c) |
30%
of all SUBLICENSE REVENUES, excluding royalty payments, received
by VIREXX
from a SUBLICENSEE, if such sublicense transaction does not include
VIREXX’s proprietary components and VIREXX spends at least 1 year but
less
than 2 years after the EFFECTIVE DATE of this AGREEMENT developing
the
LICENSED TECHNOLOGY;
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| (d) |
15%
of
all SUBLICENSE REVENUES, excluding royalty payments, received
by
VIREXX
from a SUBLICENSEE, if such sublicense transaction does not
include
VIREXX’s
proprietary components and VIREXX spends at least 2 years or
longer
after
the EFFECTIVE DATE of this AGREEMENT developing the LICENSED
TECHNOLOGY.
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For
greater certainty, royalty payments for LICENSED PRODUCTS sold by SUBLICENSEE
are defined in sections 4.1.2 (a) and (b).
4.2 All
royalty payments due pursuant to section 4.1.2 shall be paid by VIREXX to
UA
semiannually within 60 days after the end of each pay period commencing with
the
first payment due within 60 days after the end of VIREXX’s first fiscal year in
which the first sale of LICENSED PRODUCTS is made. Sublicense flow-through
payments pursuant to section 4.1.3 shall be paid by VIREXX to UA within 30
days
of any SUBLICENSE REVENUE being received by VIREXX. Payments are due without
deduction of taxes, other than withholding taxes or other fees that may be
imposed by any government and without deduction of any other sums.
4.3 No
multiple royalties shall be payable because of the manufacture, use, lease
or
sale of any LICENSED PRODUCT(S) which are covered by more than one PATENT
RIGHTS
patent application or PATENT RIGHTS patent licensed under this
AGREEMENT.
4.4 VIREXX
shall pay directly to UA all royalties, milestones and any other payments
due to
UA unless otherwise directed by UA. VIREXX shall pay any and all sales taxes
and
value added taxes that may be imposed on the license, this AGREEMENT and
any
payments hereunder to UA.
ARTICLE
5-
REPORTS
AND RECORDS
5.1 VIREXX
shall keep and cause its SUBLICENSEES to keep full, true and accurate books
of
account containing all particulars that may be necessary for the purpose
of
showing the amounts payable to UA hereunder relating to the LICENSED PRODUCT(S)
and LICENSED TECHNOLOGY as defined in this AGREEMENT. VIREXX’s books of account
shall be kept at VIREXX’s principal place of business. Said books and the
supporting data shall be open during reasonable business hours for 5
years
following the end of the calendar year to which they pertain to inspection
by UA
or its agents for the purpose of verifying royalty statements or compliance
with
other respects of this AGREEMENT. Should such inspection of VIREXX’s records
lead to the discovery of a greater than 5%
discrepancy
in reporting to UA’s detriment, VIREXX agrees to pay immediately the full cost
of such inspection and to make payment of any outstanding sums with interest
payable at a per annum rate 5%
above
the
prime rate in effect at the Bank of Montreal, without prejudice to the rights
of
UA to terminate this AGREEMENT subject to article 15. Should such inspection
of
VIREXX’s records lead to the discovery of a 5%
or
less
discrepancy in reporting to UA’s detriment, VIREXX agrees to make payment of any
outstanding sums with interest payable at a per annum rate 5%
above
the
prime rate in effect at the Bank of Montreal, without prejudice to the rights
of
UA to terminate this AGREEMENT subject to article 15.
5.2 Commencing
within 60 days after the end of VIREXX’s fiscal year in which the first
commercial sale of LICENSED PRODUCT(S) occurs, VIREXX shall deliver semiannually
to UA true and accurate reports verified by statutory declaration of an officer
of VIREXX, giving such particulars of the business conducted by VIREXX and
its
SUBLICENSEES during the preceding royalty payment period under this AGREEMENT
as
shall be pertinent to a royalty accounting hereunder. These shall include
at
least the following:
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(a)
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Number
of LICENSED PRODUCT(S) manufactured and sold by VIREXX and all
SUBLICENSEES;
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(b)
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Total
▇▇▇▇▇▇▇▇ for LICENSED PRODUCT(S) sold by VIREXX and all
SUBLICENSEES;
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(c)
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Deductions
applicable as provided in section
1.5;
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(d)
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Royalties,
fees and additional payments from SUBLICENSEE to VIREXX under sections
4.1.2 and 4.1.3;
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(e)
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Total
royalties, fees and additional payments from VIREXX to UA;
and
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(f)
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Names
and addresses of all SUBLICENSEES of
VIREXX.
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5.3 LICENSED
PRODUCTS shall be deemed to have been sold or provided when invoiced, or
if not
invoiced, when paid for. If no royalties shall be due, VIREXX shall so
report.
5.4 The
royalties and milestone payments set forth in this AGREEMENT and any other
amounts due under this AGREEMENT shall, if overdue, bear interest until payment
at a per annum rate of 5% above the prime rate in effect at the Bank of Montreal
on the due date. The payment of such interest shall not prejudice UA in
exercising any other rights it may have as a consequence of the lateness
of any
payment, including termination of this AGREEMENT subject to article
15.
ARTICLE
6- PATENT PROSECUTION
6.1 PATENT
RIGHTS remain the property of UA and, subject to the terms and conditions
hereof, will be licensed to VIREXX under the terms set forth in this
AGREEMENT.
6.2 UA
shall
apply for, seek prompt issuance of and maintain during the term of this
AGREEMENT the essential patent applications and patents included in LICENSED
TECHNOLOGY in the name of UA in the United States of America and, if applicable,
in other countries. The preparation, filing, prosecution and maintenance
of all
patents and patent applications included in LICENSED TECHNOLOGY shall be
the
responsibility of UA and UA shall take all necessary steps to file for,
prosecute and maintain such patent protection. UA shall keep VIREXX fully
informed of such patent prosecution processes. VIREXX agrees that all costs
UA
incurs that are associated with the preparation, filing, prosecution, and
maintenance of such patent protection shall be fully reimbursed by VIREXX
according to 6.4.
6.3 In
the
event VIREXX:
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(a)
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being
required to so do pursuant to the provisions of section 6.2, fails
to
reimburse the costs incurred by UA to file for, prosecute or maintain
patent protection in one or more
countries;
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(b)
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pursuant
to the provisions of section 6.2, elects to discontinue prosecuting
or
maintaining patent protection in one or more countries;
and/or
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(c)
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pursuant
to section 6.2, elects not to file patent protection in one or
more
countries;
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UA
may,
without otherwise waiving any rights it has against VIREXX in the circumstances
described in section 6.3 (a), (b) or (c), at its sole election, file, prosecute
and maintain a patent. In such event the TERRITORY shall without further
action
on the part of either party be amended to exclude the country or countries
and
UA shall be entitled to enter into such other licenses, as it deems appropriate,
in any one or more of the excluded countries for the LICENSED
TECHNOLOGY.
6.4
All
fees and costs incurred by UA after March 1, 2002 relating to the filing,
prosecution, and maintenance of the patent applications and patents included
in
LICENSED TECHNOLOGY in all countries where such filing, prosecution and
maintenance is the responsibility of UA as specified in section 6.2, shall
be
fully reimbursed by VIREXX. Such reimbursement of patent costs shall be due
within 30 days of invoicing by UA commencing on the EFFECTIVE
DATE.
ARTICLE
7-INFRINGEMENT
7.1 VIREXX
and UA shall inform each other promptly in writing of any alleged infringement
of the LICENSED TECHNOLOGY by a third party and of any available evidence
thereof and shall keep each other informed on a timely basis of all
developments.
7.2
In
the event of an alleged infringement of LICENSED TECHNOLOGY or any right
with
respect to the technology, VIREXX may, with the written consent of UA, prosecute
litigation designed to enjoin infringers of LICENSED TECHNOLOGY. UA agrees
to
cooperate to the extent of executing all necessary documents and to vest
in
VIREXX the right to institute any such suit so long as all direct or indirect
costs and expenses of bringing and conducting any such litigation or settlement
shall be borne by VIREXX. In such event recoveries shall belong to VIREXX,
provided that if VIREXX’s recoveries exceed VIREXX’s expenses with respect to
such infringement action, such excess recoveries shall be considered NET
SALES
and subject to the applicable royalty obligations under section 4.1.2. In
the
event VIREXX’s recoveries are realized through a SUBLICENSEE enjoining
infringers of LICENSED TECHNOLOGY, VIREXX’s recoveries shall be subject to the
sublicense fee obligations under section 4.1.3.
7.3 All
costs
and expenses incurred by VIREXX in investigating, resisting, litigating and
settling such a complaint including the payment of any award of damages and/or
costs to any third party, shall be borne by VIREXX.
7.4
No
decision or action concerning or governing any final disposition of the
complaint shall be taken without full consultation with and by UA.
7.5 During
the term of this AGREEMENT, if VIREXX fails to or chooses not to prosecute
infringers, UA shall have the right, but shall not be obligated, to prosecute
at
its own expense all infringements of the LICENSED TECHNOLOGY and, in furtherance
of such right, VIREXX hereby agrees that UA may include VIREXX as a party
plaintiff in any such suit, without expense to VIREXX. The total cost of
any
such infringement action commenced or defended solely by UA shall be borne
by UA
and UA shall keep any recovery or damages for past infringement derived
therefrom.
7.6 In
the
event that a declaratory judgment action alleging invalidity or non-infringement
of any of the LICENSED TECHNOLOGY shall be brought against VIREXX and/or
UA, and
VIREXX fails to or chooses not to defend such action, UA, at its option,
shall
have the right, within thirty (30) days after commencement of such action,
to
intervene and take over the sole defense of the action at its own
expense.
7.7 In
any
infringement suit as either party may institute to enforce the LICENSED
TECHNOLOGY pursuant to this AGREEMENT, the other party hereto shall, at the
request and expense of the party initiating such suit, cooperate in all respects
and, to the extent possible, have its employees testify when requested and
make
available relevant records, papers, information, samples, specimens, and
the
like.
ARTICLE
8- INSURANCE / PRODUCT LIABILITY I
INDEMNITY
8.1 VIREXX
shall indemnify, defend and hold harmless UA, its Board of Governors, trustees,
directors, officers, students, employees and agents and Affiliates and their
respective successors, heirs and assigns (the “INDEMNITEES”) against any
liability, damage, loss or expense (including reasonable solicitor’s fees on a
solicitor and an own client basis and expenses of litigation) incurred by
or
imposed on one or more of the INDEMNITEES in connection with any claim, suit,
action, demand or judgement:
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(a)
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arising
out of the conduct, supervision or participation of any clinical
trial by,
through or on behalf of VIREXX;
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(b)
|
arising
out of design, production, manufacture, sale, use in commerce,
lease or
promotion by VIREXX or any SUBLICENSEE, affiliate, agent or other
person
whose rights arise through VIREXX of any LICENSED PRODUCT(S) or
the
LICENSED TECHNOLOGY.
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8.2
From
and
after the commencement of any clinical trial undertaken by, through or on
behalf
of VIREXX, VIREXX shall at its sole cost and expense, procure and maintain
comprehensive general liability insurance naming the INDEMNITEES as an
additional insured. Such insurance shall provide:
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(a)
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product
liability coverage; and
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(b)
|
broad
form contractual liability coverage for the indemnification contained
in
section 8.1.
|
VIREXX
shall require any SUBLICENSEE to carry insurance of the same type, with the
same
conditions and at least the same named INDEMNITEES as provided in section
8.1.
8.3
Such
insurance shall be written by a reputable insurance company authorized to
do
business in the Province of Alberta. The limits of such insurance in no case
shall be less than the insurance which a reasonable and prudent company carrying
on a similar line of business would acquire. Any cancellation or material
change
in such insurance shall require 30 days written prior notice to be given
to UA
and shall be subject to the approval of UA. VIREXX shall provide UA with
certificates of insurance evidencing the same seven days before commencement
of
the first clinical trial. VIREXX covenants not to start any clinical trial
nor
sell any LICENSED PRODUCTS before such certificate is provided to
UA.
8.4
EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, UA, ITS BOARD OF GOVERNORS,
TRUSTEES, DIRECTORS, OFFICERS, STUDENTS, EMPLOYEES AND AGENT AND AFFILIATES
MAKE
NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, VALIDITY AND SCOPE OF PATENT RIGHTS CLANS, ISSUED
OR
PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT
DISCOVERABLE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION
MADE OR WARRANTY GIVEN BY UA THAT THE PRACTICE BY VIREXX OF THE LICENSE GRANTED
HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO
EVENT
SHALL UA, ITS BOARD OF DIRECTORS, TRUSTEES, DIRECTORS, OFFICERS, STUDENTS,
EMPLOYEES AND AGENTS AN]) AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL
DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND
LOST
PROFITS. REGARDLESS OF WHETHER UA SHALL BE ADVISED, SHALL HAVE OTHER REASON
TO
KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY.
8.5
In
no
event shall UA be liable to VIREXX in excess of the aggregate of the royalties
paid to UA pursuant to this AGREEMENT for any breaches of contract, for tortious
acts or otherwise arising from or in relation to this AGREEMENT or the matters
dealt with herein.
ARTICLE
9- PUBLICATION
9.1
UA
and
the UA INVENTOR shall have the right to present at symposia, professional
meetings, and to publish in journals or other publications, accounts of its
research relating to the LICENSED TECHNOLOGY. UA shall provide VIREXX with
copies of the proposed disclosure relating to the LICENSED TECHNOLOGY by
the UA
INVENTOR at least 30 days in advance of the submission for presentation or
publication, unless otherwise mutually agreed upon by both parties on a
case-by-case basis. VIREXX shall use this 30-day period to evaluate the
disclosures for patentable content and shall notify, UA if it elects to pursue
patent protection on the disclosure relating to the LICENSED TECHNOLOGY.
UA
shall apply for such patent protection pursuant to article 6. VIREXX shall
cooperate in all reasonable respects in order to ensure essential patent
protection. After the 30-day disclosure period has elapsed, UA shall be free
to
submit said disclosures for presentation and/or publication, provided that
the
patent application on the disclosure is complete before the presentation
and/or
publication date.
9.2
VIREXX
shall furnish to UA a copy of press releases relating to the LICENSED TECHNOLOGY
prior to their release.
ARTICLE
10- EXPORT CONTROLS
It
is
understood that UA is subject to Canadian laws and regulations controlling
the
export of technical data, computer software, laboratory prototypes and other
commodities, and that its obligations hereunder are contingent on compliance
with applicable Canadian export laws and regulations. The transfer of certain
technical data and commodities may require a license from the cognizant agency
of the Canadian Government and/or written assurances by VIREXX that VIREXX
shall
not export data or commodities to certain foreign countries without prior
approval of such agency. UA neither represents that a license shall not be
required nor that, if required, it shall be issued.
ARTICLE
11- NON-USE OF NAMES
VIREXX
shall not use the names or trademarks of UA, nor any adaptation thereof,
nor the
names of the inventors, nor the names of any of their employees, in any
advertising, promotional or sales literature without prior written consent
obtained from UA, or said employee or inventor, in each case, except that
VIREXX
may state that the LICENSED TECHNOLOGY is licensed from UA.
ARTICLE
12- ASSIGNMENT
Except
as
provided for in section 2.3 herein, VIREXX will not assign, transfer, mortgage,
charge or otherwise dispose of any or all of the rights, duties or obligations
granted to it under this AGREEMENT without the prior written consent of
UA.
ARTICLE
13- DISPUTE RESOLUTION
13.1
Except
for the right of either party to apply to a court of competent jurisdiction
for
a temporary restraining order, a preliminary injunction, or other equitable
relief to preserve the status quo or prevent irreparable harm and except
for the
right of a party to initiate arbitration in relation to section 2.6, any
and all
claims, disputes or controversies arising under, out of, or in connection
with
this AGREEMENT, which the parties shall be unable to resolve within 60 days
shall be mediated in good faith. The party raising such dispute shall promptly
advise the other party of such claim, dispute or controversy in writing which
describes in reasonable detail the nature of such dispute. By no later than
5
business
days after the recipient has received such notice of dispute, each party
shall
have selected for itself a representative who shall have the authority to
bind
such party, and shall additionally have advised the other party in writing
of
the name and title of such representative. By no later than 10 business days
after the date of such notice of dispute, the party against whom the dispute
shall be raised shall select a mutually agreeable mediator in the Edmonton
area
and such representatives shall schedule a date with such firm for a mediation
hearing. The parties shall enter into good faith mediation and shall share
the
costs equally. If the representatives of the parties have not been able to
resolve the dispute within 15 business days after such mediation hearing,
the
parties shall have the right to pursue any other remedies legally available
to
resolve such dispute in the Courts of the Province of Alberta,
Canada.
13.2 Notwithstanding
the foregoing, nothing in this article 13 shall be construed to waive any
rights
or timely performance of any obligations existing under this
AGREEMENT.
ARTICLE
14- ARBITRATION PROCEDURE
14.1
In
the
event that negotiation fails to resolve any dispute between the parties arising
under section 2.6 of this AGREEMENT or, in the event that the parties agree
to
resolve any other dispute arising under this AGREEMENT by arbitration, such
dispute shall be resolved by arbitration in accordance with the provisions
of
the Arbitration Act of Alberta, except as modified by the following terms
and
conditions:
| (a) |
The
party desiring to refer a dispute for arbitration shall notify
the other
party in writing of the general nature of the dispute, including
sufficient details for
clarification;
|
| (b) |
Within
7 days of receipt of such notice, the opposite party shall by written
notice advise the party so desiring to refer the dispute for arbitration
of any further matters relating to the dispute, including sufficient
details for clarification;
|
|
(c)
|
The
terms of reference for arbitration shall be those areas of dispute
referred to in the initial notice and the responding
notice;
|
|
(d)
|
VIREXX
and UA shall, within 14 days of the establishment of the terms
of
reference referred to in (c) above, appoint an arbitrator on the
agreement
of both parties. Upon failing to agree on the selection of an arbitrator
by both parties within 14 days, both parties or either of them
may apply
to a Justice of the Court of Queen’s Bench to have an arbitrator
appointed;
|
|
(e)
|
Within
30 days of the appointment of an arbitrator, or such further period
as may
be agreed upon by the parties, the arbitrator shall resolve all
matters
and disputes accorded in the terms of
reference;
|
|
(f)
|
The
decision of the arbitrator shall be final and binding upon the
parties
hereto;
|
|
(g)
|
The
costs of the arbitration shall be shared equally between the parties,
unless otherwise determined by the arbitrator and such costs may
exceed
any costs established pursuant to the Arbitration
Act.
|
ARTICLE
15-TERMINATION
15.1
If
VIREXX
fails to remedy any breach or default on its part under this AGREEMENT within
90
days after such notice from UA, UA may upon second written notice to VIREXX
terminate the license granted hereunder, such termination to be in effect
on the
date such second notice is given, except for the causes of termination specified
in section 15.2. This right of termination is without prejudice to or limitation
of any other rights or remedies available to UA at law or in
equity.
15.2
UA
has
the right to terminate the license granted herein by giving written notice
of
termination to VIREXX at any time on or after:
|
(a)
|
the
filing by VIREXX of a petition of bankruptcy or
insolvency;
|
|
(b)
|
any
adjudication that VIREXX is bankrupt or
insolvent;
|
|
(c)
|
the
filing by VIREXX of any petition or answer seeking reorganization,
readjustment or rearrangement of the business of VIREXX under any
law
relating to bankruptcy or insolvency;
and/or
|
|
(d)
|
the
making by VIREXX of any assignment or attempted assignment of this
AGREEMENT for the benefit of
creditors;
|
Such
termination shall be in effect on the date such notice is given. This right
of
termination is without prejudice to or limitation of any other rights or
remedies available to UA at law or in equity.
15.3
VIREXX
shall have the right to terminate the license granted herein at any time
after
90 days notice to UA, and upon payment of all amounts due UA through the
effective date of the termination. Upon the expiry of the 90-day period,
the
license herein granted shall be at an end, and VIREXX shall have no further
obligations under this AGREEMENT, except as otherwise specified in sections
15.4
and 15.6.
15.4
Upon
termination of the license for any reason, nothing herein shall be construed
to
release either party from any obligation that matured prior to the effective
date of such termination; and articles/sections 1, 5,
8,
10,
11, 15.5, 15.6 and
18
shall survive any such termination.
15.5
Upon
termination of the license for any reason, any SUBLICENSEE not then in default
shall have the right to seek a license from UA. UA shall respond to such
requests in good faith.
15.6
VIREXX
shall cease to use LICENSED TECHNOLOGY in any manner whatsoever and shall
cease
to manufacture the LICENSED PRODUCTS on the date that the license granted
herein
is terminated. VIREXX shall deliver to UA full and true accounting records
within 30 days of the termination date. After the date of such termination,
UA
in its sole discretion may permit VIREXX and any SUBLICENSEE thereof to sell
all
LICENSED PRODUCT(S) in stock, and complete the production of LICENSED PRODUCT(S)
in the process of manufacture at the time of such termination and sell the
same
in any or all parts of the world where VIREXX and SUBLICENSEES are permitted
by
law to sell the LICENSED PRODUCT(S) for a time period to be specified by
UA, or
until the unsold LICENSED PRODUCTS(S) have all been sold, whichever is earlier.
VIREXX shall make the payments to UA in the same manner specified in article
4
of this AGREEMENT and shall submit the reports required by article 5 in this
AGREEMENT.
ARTICLE
16- SUCCESSORS
This
AGREEMENT shall be binding upon VIREXX, its successors and permitted
assignees.
ARTICLE
17- PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any
payment, notice or other communication pursuant to this AGREEMENT shall be
sufficiently made or given on the date of delivery, if delivered by hand
during
normal business hours, or on the date of mailing, if sent to such party by
certified first class mail or by courier, postage/fees prepaid, addressed
to it
at its address below or as it shall designate by written notice given to
the
other party:
In
the
case of UA:
Director
Industry
Liaison Office
University
of Alberta
▇▇▇,
▇▇▇▇-▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
In
the
case of VIREXX:
President
and CEO
VIREXX
Research. Inc.
▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
In
the
event of a disruption of postal service, all payments, notices or other
communications shall be delivered by hand.
ARTICLE
18- MISCELLANEOUS PROVISIONS
18.1
This
AGREEMENT shall be construed, governed, interpreted and applied exclusively
by
the courts having jurisdiction in the Province of Alberta and in accordance
with
the laws in force in the Province of Alberta, Canada and any arbitration
shall
be governed by the Laws of the Province of Alberta except that all questions
affecting the construction and effect of any patent shall be determined by
the
law of the country in which the patent was granted.
18.2
The
parties hereto acknowledge that this AGREEMENT sets forth the entire agreement
and understanding of the parties hereto as to the subject matter hereof,
and
shall not be subject to any change or modification except by the execution
of a
written instrument subscribed to by the parties hereto. This AGREEMENT, when
signed, supersedes and replaces the letter of intent (Term Sheet) dated March
1,
2002 between UA and VIREXX.
18.3
The
provisions of this AGREEMENT are severable, and in the event that any provisions
of this AGREEMENT shall be determined to be invalid or unenforceable under
any
controlling body of the law, such invalidity or unenforceability shall not
in
any way affect the validity or enforceability of the remaining provisions
hereof.
18.4
The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this AGREEMENT shall not constitute a waiver
of
that right or excuse a similar subsequent failure to perform any such term
or
condition by the other party.
18.5
Any
delays in performance by any party under this AGREEMENT (other than the payment
of moneys due) shall not be considered a breach of this AGREEMENT if and
to the
extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to, acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
explosion, riots, wars, civil disorder, rebellion or sabotage. The party
suffering such occurrence shall immediately notify the other party and any
time
for performance hereunder shall be extended by the actual time of delay caused
by the occurrence.
18.6
VIREXX
shall use reasonable efforts to develop, make, use, sell and otherwise
commercialize this technology substantially in the Province of Alberta and
will
encourage its SUBLICENSEES to pursue business collaborations with
UA.
18.7
Time
is
of the essence of this AGREEMENT.
18.8
Both
parties shall execute further documents, agreements and instruments as may
be
necessary or advisable from time to time in order to carry out the terms
and
conditions of this AGREEMENT.
IN
WITNESS WHEREOF, the parties have duly executed this AGREEMENT the day and
year
set forth below.
The
Governors of the University of Alberta:
By:
signed
“▇▇▇▇▇
▇▇▇▇▇▇▇▇▇”
▇▇▇▇▇
▇.
▇▇▇▇▇▇▇▇▇
Associate
Vice President (Research & Industry Relations) and
Director,
Research Services Office
November
20,
2002
Date
VIREXX
Research, Inc.:
By:
signed
“▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
▇. ▇▇▇▇▇▇▇ “
President
& CEO
November
20,
2002
Date