EX-10.31
[***Confidential Treatment Requested. Confidential portions of
this agreement have been redacted and have been separately
filed with the Commission]
VIDO TECHNOLOGY
THIS AGREEMENT dated as and from the Effective Date
BETWEEN:
THE UNIVERSITY OF SASKATCHEWAN, a corporation pursuant to an
Act of the Government of Saskatchewan, as represented by the
Veterinary Infectious Disease organization; a division of the
University of Saskatchewan which has its principal offices
located at 000 Xxxxxxxxxx Xxxx, xx the campus of the
University of Saskatchewan, (hereinafter referred to as "the
Licensor")
OF THE FIRST PART
-and -
METAMORPHIX INTERNATIONAL, INC., a corporation incorporated
pursuant to the laws of the State of Delaware with its
registered office located at 0000 Xxxxx Xxxxxxx Xxxx,
Xxxxxxxxx, Xxxxxxxx, Xxxxxx Xxxxxx of America, 21227,
(hereinafter referred to as "the Licensee")
OF THE SECOND PART
WITNESSETH WHEREAS:
A. Biostar Inc. ("Biostar") and the Licensor entered into a
series of license agreements culminating in a consolidated and amended
Pasteurella haemolytica Vaccine and Technology , a Bovine Herpes Virus-1 and
Adjuvant Technology licence agreements, all dated February 29th, 2000
(collectively referred to as the "Original Licenses");
B. The Original Licenses were partially assigned with the consent
of the Licensor in accordance with and as contemplated by the asset purchase
agreement between Biostar and related parties and the Licensee and related
parties dated for reference June 1, 2000 (herein the "Asset Purchase Agreement")
pursuant to the terms of which Asset Purchase Agreement the Licensor agreed to
grant the within license to the Licensee which license effects certain agreed
upon amendments to the Original Licenses partially assigned to the Licensee;
NOW THEREFORE, in consideration of the premises and other good
and valuable consideration, the receipt and sufficiency of which consideration
is hereby acknowledged, the parties agree as follows:
ARTICLE I - INTERPRETATION
1.01 As hereinafter used in this Agreement, terms have the
following meanings:
(a) "Adjuvant Technology" means the adjuvant technology subject of
issued U.S. patent # 5,951,988 or any continuations,
continuations in part, provisional applications, divisions,
patents of additions, re-issues, renewals and extensions of
such patents and patent applications and all non United States
of America patents corresponding to any of the foregoing;
(b) "Bovine Technology" means the bovine herpes virus -1
technology subject of those patents related thereto and listed
on attached Exhibit "A" or any continuations, continuations in
part, provisional applications, divisions, patents of
additions, reissues, renewals and extensions of such patents
and patent applications and all non United States of America
patents corresponding to any of the foregoing;
(c) "Confidential Information" has the meaning given that term by
clause 13.01;
(d) "Effective Date" means the closing date of the Asset Purchase
Agreement;
(e) "External Disclosure" has the meaning given that term by
clause 13.03;
(f) "Improvements" means all discoveries and inventions owned by
the Licensor, whether patentable or not, that consist of an
improvement, addition, extension or enhancement to the subject
matter of the Licensed Patents or to the Licensed Technology
and relating to the within grant of License;
"License" has the meaning given that term by clause 2.01;
"Licensee" includes for the purpose of calculating Net Sales
and Other Consideration any affiliates of the Licensee and any
persons or entities not dealing at arm's length with the
Licensee as that term is employed pursuant to the provisions
of the Income Tax Act (Canada) as of the date hereof provided
that the term "Licensee" does not extend to Minority or
Majority Joint Ventures . For greater particularity, Net Sales
and Other Consideration does not comprise payments and amounts
paid by an entity comprising the Licensee to another entity
comprising the Licensee;
(i) "Licensed Technology" means the Adjuvant Technology and
proteins, peptides, nucleic acids, antibodies and adjuvants
and methods of production and uses described in the Licensed
Patents referenced in Exhibit A including the use of
Pasteurella haemolytica or Bovine Herpes Virus-1 antigens as
immunological carriers, including products based upon
leukotoxin carrier, GnRh or vasoactive intestinal peptide, and
further includes all provisional applications, know-how,
proprietary technical data, information, biological materials
and reagents useful in
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working with the subject matter of the Licensed Patents and
relating to the within grant of license which is in existence
as of the Effective Date;
(j) "Licensed Patents" means any patents that are granted pursuant
to the applications referenced in Exhibit "A" or are granted
pursuant to any patent application subsequently filed that is
based on the Licensed Technology and includes any
continuations, continuations in part, divisions, patents of
additions, re-issues, renewals and extensions of such patents
and patent applications and all non United States of America
patents corresponding to any of the foregoing;
(k) "Majority Joint Venture" means other than a Value Added
Arrangement a partnership or joint venture arrangement between
the Licensee and a third party or parties whose arrangements
with the Licensee permits the use and application of the
Licensed Technology and Licensed Patents for any of the
following species: poultry, swine or cattle, where relative to
such other parties the Licensee has not less than a 50%
interest in the business, assets and profits of the
partnership or joint venture and in respect of which the
Licensee has provided written notice to the Licensor within a
reasonable time after entering into the partnership or joint
venture arrangement. For greater particularity, if the
interest of the Licensee falls below 50% in the business,
assets or profits for two consecutive fiscal periods then as
and from the 1st day of the first of such fiscal periods the
entity shall cease to be a Majority Joint Venture.
(1) "Minority Joint Venture" means a partnership or joint venture
arrangement between the Licensee and a third party or parties
whose arrangements with the Licensee permits the use and
application of the Licensed Technology and Licensed Patents
for any of the following species: poultry, swine or cattle,
but which does not constitute a Majority Joint Venture or a
Value Added Arrangement hereunder.
(m) "Major Species Sublicensee" means a person, partnership, joint
venture or other entity (other than a sublicensee that
constitutes a Majority Joint Venture or a Minority Joint
Venture or a Value Added Arrangement) whose sublicense with
the Licensee permits the use and application of the Licensed
Technology for any of the following species: poultry, swine or
cattle.
(n) "Minor Species Sublicensee" means a person, partnership, joint
venture or other entity (other than sublicensee that
constitutes a Majority Joint Venture or a Minority Joint
Venture or a Value Added Arrangement) whose sublicense with
the Licensee does not extend to the use and application of the
Licensed Technology for poultry, swine or cattle.
(o) "Myostatin Product" means a Product that comprises myostatin
also known as growth differentiating factor 8 (GDF-8) protein,
peptide or nucleic acid.
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(P) "Net Sales" means during any particular period of time the
total revenues or receipts from the sale or disposition of
Products by the Licensee subject to the following inclusions
or exclusions (the intent of the parties in connection with
this 1.01(i) is described in the attached Exhibit "B" which
Exhibit is to be employed as an aid to interpretation of this
provision):
(I) Net Sales revenues or receipts include revenues of
the Licensee from invoiced sales of Product to
distributors, wholesalers or other persons, but
specifically not including Value Added Receipts
(Herein the foregoing referred to as "Conventional
Sales");
Net Sales revenues or receipts include revenues of
the Licensee which are calculated on the basis of
value added benefits realized in connection with
third party commercialization including that by
animal producers, breeders and processors, including
those subject of a sublicense, provided that the
Licensee's revenues from such sublicense are
calculated and periodically payable on the basis of
Licensee's share of the value-added benefits (the
"Value Added Receipts"). During the application of
the applicable Threshold and subject to 1.01(w),
Value Added Receipts include payments and amounts
that are paid to the Licensee in connection with the
arrangements giving rise to the Value Added Receipts
but which are not directly calculated on the basis of
value added benefits . Other than during the
application of the applicable Threshold, Value Added
Receipts do not include payments and amounts that are
paid to the Licensee in connection with the
arrangements giving rise to the Value Added Receipts
but are not directly calculated on the basis of value
added benefits, which payments and amounts are to be
included in Other Consideration. To the extent that
revenues and receipts are included by virtue of them
comprising Value Added Receipts, such revenues and
receipts and such value added benefits on which they
were calculated are not otherwise included in the
calculation of Net Sales or Other Consideration
hereunder;
(III) Other than during the application of the applicable
Threshold, in respect of Majority Joint Ventures that
percentage of the net sales of the Majority Joint
Venture (calculated as if it were the Licensee
hereunder) that the Licensee has in the profits of
such Majority Joint Venture, shall be included in Net
Sales hereunder and the remainder of such net sales
of the Majority Joint Venture shall be excluded in
the calculation of Net Sales or otherwise hereunder;
(IV) During the application of the applicable Threshold,
in respect of Majority Joint Ventures, that
percentage of the net sales of a Majority Joint
Venture that the Licensee has in the profits of such
applicable joint venture, shall be excluded from the
calculation of Net Sales or otherwise hereunder;
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(V) Net Sales do not include any net sales made by or
royalties paid by Minor Species Sublicensees, whether
or not part of a joint venture arrangement, (which
royalties for greater particularity shall constitute
Other Consideration for the purposes of clause
4.06(iii) herein);
(VI) Other than during the application of the applicable
Threshold, Net Sales include the net sales
(calculated as if it were the Licensee hereunder) of
Minority Joint Ventures and Major Species
Sublicensees (other than those constituting Majority
Joint Ventures), but not including sales revenues
that were included for purposes of calculation of
Value Added Receipts which Value Added Receipts were
included in Net Sales;
(VII) During the application of the applicable Threshold,
Net Sales exclude the net sales of Minority Joint
Ventures and Major Species Sublicensees;
(VIII) If Licensee shall have received separate and
identifiable reimbursement or payment for delivery of
Product, including delivery of Product for purposes
of being given away for promotional or similar
purposes, from a Majority or Minority Joint Venture
or a sublicensee or, during the application of the
applicable Threshold, paid to the Licensee in
connection with the arrangements giving rise to the
Value Added Receipts but which are not directly
calculated on the basis of value added benefits, then
to the extent that such reimbursement or payment has
been included in the calculation of Net Sales the
Licensee shall be entitled to deduct from Net Sales
the cost to the Licensee for such Product calculated
on the basis of the aggregate of: third party costs
of manufacture incurred by the Licensee, plus the
Licensee's direct labor cost, plus the Licensee's
direct materials cost plus 40% percent of the direct
labor and materials cost excluding third party costs.
Manufacturing for the purposes of determining direct
material or direct labor or third party costs of
manufacturing under this Agreement includes the
packaging of Product but excludes shipping,
warehousing and distribution.
(IX) Net Sales in respect of included revenues do not
include the following items to the extent that such
items are separately identified on the applicable
invoice:
(i) sales, import, export, value added and
similar taxes including, but without
limitation, the federal goods and services
tax imposed by Part VII of the EXCISE TAX
ACT, R.S.C., 1985, C. E-1, as amended and
similar US or international taxes;
(ii) extraordinary packaging and packing costs
that relate to sales to a particular
customer and which are reimbursed by such
customer;
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(iii) shipping and delivery costs that relate to
sales to a particular customer and which are
reimbursed by such customer;
(iv) credits on returns, allowances or trades
actually allowed and taken; and
(v) freight and insurance charges.
For greater particularity, where Value Added Receipts are
calculated on the basis of value added benefits realized
during the production or growth of products subsequent sales
of the processed Products do not comprise Net Sales hereunder
whether or not the seller is a partner or joint venturer with
the Licensee if the Licensee has no interest in or payment
arising from such sales.
"Other Consideration" shall mean the aggregate of all option
fees, license fees, or other cash payments, equity or other
consideration of any kind that the Licensee receives in
respect of sublicenses, which general definition is more fully
described in clause 4.06 hereof.
(r) "Pasteurella Technology" means the Pasteurella haemolytica
technology subject of those patents related thereto and listed
on attached Exhibit "A" or any continuations, continuations in
part, divisions, patents of additions, re-issues, renewals and
extensions of such patents and patent applications and all non
United States of America patents corresponding to any of the
foregoing;
(s) "Products" means all compositions, processes, methods of use,
or any part or combination thereof, that: (i) infringe any
claim of a Licensed Patent; or (ii) which incorporate, are
made or designed from or with the aid of Licensed Technology;
or both, and "Product" is a singular reference to any one of
the Products;
(t) "Royalty" and "Royalties" has the meaning given those terms by
clauses 4.01, 4.02 and 4.03;
(u) "Term" means the period of time during which the Licensee is
obligated to pay Royalties on Products pursuant to clause
2.03;
(v) "Threshold" means, net of any applicable credits permitted the
Licensee hereunder, the total average cumulative amount of
$1,000,000 US per year for each calendar year from the
commencement of this Agreement received by Licensor (provided
that with respect to 2000 the addition to establish this
amount shall be prorated to reflect such partial year) with
respect to Myostatin Products (the "Myostatin Threshold"); and
the total average cumulative amount of $4,000,000 US per year
for each calendar year from the commencement of this Agreement
received by Licensor
Page 6 of 31
(provided that with respect to 2000 the addition to establish
this amount shall be prorated to reflect such partial year) in
respect to all Products (the Overall Threshold"). "Application
of the applicable Threshold" means the Myostatin Threshold or
the Overall Threshold, as the case may be, has been achieved
and maintained with respect to a particular calendar year and
"during the application of the applicable Threshold" means
during the period and with respect to the calendar year that
the application of the applicable Threshold continues and
"other than during the application of the applicable
Threshold' means any other time.
(w) "Value Added Arrangement" means an arrangement between the
Licensee and one or more third parties which may include a
sublicense, where substantially all of the continuing intended
compensation to the Licensee comprise payments calculated on
the basis of value added benefits. In relation to a Value
Added Arrangement, during the application of the applicable
Threshold, initial license fees or similar up-front payments
and payments made on the basis of achievement of non-sales
related milestones or a singular sales related milestone are
considered payments and amounts that are paid to the Licensee
in connection with the arrangement for the purposes of
1.01(p)(II) and are subject of this Agreement respecting Net
Sales including the provisions of 4.04. However, during the
application of the applicable Threshold, payments to the
Licensee received in connection with a Value Added Arrangement
other than initial license fees or similar up-front payments
and payments made on the achievement of non-sales related
milestones or a singular sales related milestone and payments
calculated on the basis of value added benefits shall be
included as Other Consideration under this Agreement.
(x) "VIDO and/or the Licensor" means for all purposes of this
Agreement, other than the enforcement of this Agreement by the
University of Saskatchewan and the agreements of the
University of Saskatchewan under section 3.02, that separate
and unique division of the University of Saskatchewan known as
the Veterinary Infectious Disease Organization which currently
has its principal offices, facilities and equipment located at
000 Xxxxxxxxxx Xxxx on the campus of the University of
Saskatchewan, has aboard of directors primarily composed of
persons not employed by the Veterinary Infectious Disease
Organization or the University of Saskatchewan and which is
engaged in research and development.
ARTICLE II - GRANT AND TERM OF LICENSE
2.01 In accordance with the provisions of this agreement, the Licensor grants
and the Licensee accepts an exclusive license (the "License") in all
jurisdictions of the world to the Licensed Technology for the purpose of
developing, producing, exploiting, using, selling or otherwise commercially
exploiting, or having developed, produced, used, sold or otherwise commercially
exploited, the Licensed Technology for use in non-humans, and for use in
technology relating to the GDF-8 protein in both humans and non-humans BUT
SPECIFICALLY EXCLUDING use of the Licensed Technology in vaccines to prevent
infectious diseases.
Page 7 of 31
2.02 Subject to the provisions of this Agreement, the Licensor
acknowledges that:
(a) the License is irrevocable during the Term; and
(b) except as herein provided, the License is exclusive to the
extent of the above grant of license in all jurisdictions of
the world during the Term and the Licensor shall not produce,
use, sell, lease or otherwise commercially exploit within the
scope of the above grant of license Products other than for
its own research purposes, nor within the scope of the above
grant license shall the Licensor provide any third party with
Products or the Licensed Patents and Licensed Technology to
any third party, other than for research and educational
purposes. For greater particularity and notwithstanding the
foregoing, this license is non-exclusive as to its use for
diagnostic applications for Pasteurella haemolytica or Bovine
Herpes Virus-1 antibodies.
If within the scope of the above grant of license, the Licensor wishes to
provide a third party with Products for research and educational purposes, or to
license to a third party the Licensed Patents and Licensed Technology for
research and educational purposes, the Licensor shall first obtain the
Licensee's written consent. The granting or withholding of such consent shall be
in the Licensee's sole and absolute discretion and any such consent will be
conditional, at the Licensee's option, upon the beneficiary of such research and
educational license agreeing that the Licensee shall have the right to make use
of any improvements conceived or developed by such beneficiary at no additional
cost to the Licensee.
2.03 Royalty obligations on Products and other payments required
pursuant to Article IV in each jurisdiction of the world shall come to an end
upon the later of:
(a) the expiration or invalidation of the last remaining Licensed
Patents covering the manufacture, use and/or sale of such
Product in such jurisdiction; or
(b) ten (10) years from the date of first marketing such Product
in such jurisdiction.
Following the expiration of the Licensee's royalty obligations in a jurisdiction
pursuant to this clause, the Licensee shall be entitled to continue marketing
Products and using Licensed Technology in such jurisdiction without further
royalty or other payments of any description. This Agreement shall cease to be
exclusive to the Licensee with respect to any jurisdiction upon the expiration
of the Royalty obligations under this Agreement in such jurisdiction. Provided
that prior to such expiration the Licensee may elect by notice in writing to
extend its Royalty obligations at the rate(s) applicable to the circumstance
where a Licensed Patent is not infringed and its other payment obligations for
such period of time as may be specified in such notice and in which event the
Royalty and other payment provisions herein shall be so extended and the license
shall continue for such period to be exclusive to the Licensee.
Page 8 of 31
2.04 The Licensor shall, upon the request of and at the expense of the Licensee,
execute all further documents which may be necessary to give effect to or
register this Agreement and the Licenses granted hereunder in any jurisdiction
of the world.
ARTICLE III - IMPROVEMENTS
3.01 During the Term, the Licensor shall disclose and make available to the
Licensee all Improvements which shall be dealt with in accordance with all the
terms and conditions of this Agreement. If an Improvement is patentable, it
shall be treated as one of the Licensed Patents, and if non-patentable, as part
of the Licensed Technology.
3.02 The Licensee acknowledges that the Licensor's obligations pursuant to
clause 3.01 are conditional upon VIDO's continued existence and operation. For
greater particularity, Improvements made by employees of the University of
Saskatchewan who are not employees of VIDO (the "University Employees") are
exempt from the operation of clause 3.01.
The University of Saskatchewan agrees that in the event that
University Employees effect discoveries and inventions which are owned by the
University of Saskatchewan, whether patentable or not, that consist of an
improvement, addition, extension or enhancement to the subject matter of the
Licensed Patents or, to the extent the same relate to the within grant of
License, the Licensed Technology, the University of Saskatchewan shall provide
the Licensee with the opportunity to obtain entitlements to such discoveries and
inventions for the same purposes as contemplated by this License on terms and
conditions that the University would accept from a third party. If the Licensee
declines to participate in such opportunity (and the License shall be deemed to
have declined in the event that it has not elected to do so within such period
of time as the University may reasonably determine and advise the Licensee), the
University may thereafter without reference to the Licensee provide such
entitlements to third parties on terms no more favorable than those offered the
Licensee. The Licensee expressly acknowledges and agrees that no obligation of
the University to the Licensee arises under this provision where any such
discovery or invention is subject of rights or entitlements in favor of a third
party. The Licensee further acknowledges that any invention or discovery arising
in the course of third party funded research gives rise to an expectation (that
the University views as and the Licensee agrees is an entitlement for purposes
of this provision) to provide such third party with the opportunity to
commercially exploit the discovery or invention. This obligation of the
University shall extend for five (5) years from the Effective Date of this
Agreement.
3.03 The Licensor acknowledges that Licensee may make discoveries or inventions,
whether patentable or not, without the use of the Licensed Technology and which
do not infringe upon the Licensed Patents, which discoveries and inventions
shall be owned by the Licensee and shall be known as "Licensee Improvements,"
for purposes of this Agreement. Licensor also acknowledges that no payment of
royalties shall be due under this Agreement with respect to such Licensee
Improvements.
Page 9 of 31
ARTICLE IV- ROYALTIES
4.01 Subject to 4.02, the Licensee shall pay to the Licensor a royalty on Net
Sales (the "Royalty" or Royalties") during the Term in accordance with the
following subject only to those exclusions provided for in this Agreement and as
such rates may be modified by clause 4.04:
(a) if a Product infringes a claim or claims of a Licensed Patent
related to the Adjuvant Technology, the Royalty shall be ***;
and
(b) if a Product infringes a claim or claims of a Licensed Patent
related to the Bovine Technology, the Royalty shall be *** and
(c) if a Product infringes a claim or claims of a Licensed Patent
related to the Pasteurella Technology, the Royalty shall be
*** and
(d) if 4.01(a) is not applicable and a Product utilizes any part
of the Licensed Technology related to the Adjuvant Technology,
the Royalty shall be *** and
(e) if 4.01(b) is not applicable and a Product utilizes any part
of the Licensed Technology related to the Bovine Technology,
the Royalty shall be *** and
(f) if 4.01(c) is not applicable and a Product utilizes any part
of the Licensed Technology related to the Pasteurella
Technology, the Royalty shall be ***
4.02 Notwithstanding 4.01, other than during the application of the applicable
Threshold, with respect to Net Sales made by a Major Species Sublicensee where
the Licensee is entitled to the receipt of royalties based upon Net Sales of
Products made by such sublicensees (other than Value Added Receipts), the
Licensee shall pay to the Licensor in respect of such Net Sales (other than
Value Added Receipts) the lesser of :
(a) *** of the royalties payable by such sublicensees to the
Licensee in respect of its Net Sales; or
(b) the amount otherwise determined pursuant to 4.01 on the basis
of the Net Sales of the sublicensee.
For greater particularity, this provision 4.02 has no application to Value
Added Receipts.
4.03 Notwithstanding the foregoing, a minimum royalty shall be
payable as follows:
4.03.1 in respect of calender year 2000, *** prorated for such calendar
year as and from the Effective Date;
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4.03.2 in respect of calender year 2001 and 2002, *** and
4.03.3 in respect of calendar years 2003, 2004 and 2005, *** and
4.03.4 in respect of each calendar year thereafter, *** (collectively,
the amounts referred to in 4.03.1 through 4.03.4 are referred to as
"Minimum Annual Royalty").
The Licensee shall be responsible to make the Minimum Annual Royalty payments as
outlined in section 4.03 in four equal quarterly installments within thirty (30)
days of the end of each calendar quarter (other than in respect of the first
year of this Agreement in respect of which the Minimum Royalties shall be made
in two equal installments after the third and fourth calendar quarter).
Notwithstanding any credits against Royalties permitted the Licensee under this
Agreement, no such credits shall apply to reduce Minimum Royalties payable
pursuant to this clause 4.03.
4.04 If the Royalties payable to the Licensor and/or the other
royalties payable for other Product components or associated delivery systems by
the Licensee would exceed seven (7%) percent for a Product, then the Royalty
rates provided for in clause 4.01 shall be reduced to a point that the total
royalties payable by the Licensee to the Licensor and/or such third parties do
not exceed ***. The Licensee shall use reasonable efforts to ensure that any
royalty reduction necessary under this clause is allocated between the Licensor
and such third party in an equitable manner.
With respect to the Net Sales of a Minority Joint Venture or
Major Species Sublicensee, the foregoing reference to Licensee shall be
construed as a reference to the Minority Joint Venture or Major Species
Sublicensee, as the case maybe, and not a reference to the Licensee.
With respect to the Net Sales of a Majority Joint Venture, the
Licensee may elect to have the foregoing reference to Licensee with respect to
the particular Majority Joint Venture be construed as a reference to the
Majority Joint Venture in lieu of the application of this Agreement without such
substitution.
For greater particularity, during application of the
applicable threshold but subject to the provisions of 1.01(w), this provision
4.04 shall apply to payments received by Licensee in connection with
arrangements giving rise to the Value Added Receipts in the manner contemplated
by 1.01 (w).
However, under no circumstances shall the Royalty rates
provided for under clause 4.01 be reduced to less than one-third (1/3) of the
amount otherwise determinable under such clause in respect to Net Sales of
Myostatin Products or one-half (1/2) of the amount otherwise determinable under
such clause in respect of Net Sales of Products other than Myostatin Products.
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4.05 If a third party initiates any legal or administrative proceeding
challenging the validity, scope or enforceability of a Licensed Patent in any
country then the Licensee's royalty obligations pursuant to this Article IV
shall be adjusted as if that particular Product did not infringe the claim or
claims of a Licensed Patent relating to such country. If the enforceability of
the claim in dispute in such proceedings is upheld by a court or other legal or
administrative tribunal from which no appeal is or can be taken, then the
balance of the payment that should have been made during the period of reduction
shall be promptly paid by the Licensee to the Licensor with interest calculated
in accordance with clause 5.05. If the claims of a Licensed Patent which cover
that Product are held to be invalid or otherwise unenforceable by a court or
other legal or administrative tribunal from which no appeal is or can be taken,
then no such payment shall be made. The Licensee acknowledges that the foregoing
constitutes the full extent of the Licensor's liability to the Licensee in the
event of any such suit and is a bar to any proceedings for recovery of any other
damages of any description.
4.06 In addition to the amounts payable under 4.01 or 4.02, the Licensee
shall remit to the Licensor *** (which rate is applicable other than during the
application of the applicable threshold) of Other Consideration and for the
purposes hereof the term "Other Consideration" shall include the following
specific inclusions or exclusions (the intent of the parties in connection with
this 4.06 is described in the attached Exhibit "B" which Exhibit is to be
employed as an aid to interpretation of this provision):
(i) INCLUDE other than during the application of the applicable
Threshold, payments and amounts that are paid to the Licensee
in connection with the arrangements giving rise to Value Added
Receipts which are not directly calculated on the basis of
value added benefits and during the application of the
applicable Threshold the payments and amounts contemplated by
1.01 (w) to be included in Other Consideration PROVIDED that
if other than during the application of the applicable
Threshold, License shall have received separate and
identifiable reimbursement or payment for delivery of Product,
including delivery of Product for purposes of being given away
for promotional or similar purposes, which are paid to the
Licensee in connection with the arrangements giving rise to
the Value Added Receipts but which are not directly calculated
on the basis of value added benefits, then to the extent that
such reimbursement or payment has been included in the
calculation of Other Consideration the Licensee shall be
entitled to deduct from Other Consideration the cost to the
Licensee for such Product calculated on the basis of the
aggregate of: third party costs of manufacture incurred by the
Licensee, plus the Licensee's direct labor cost, plus the
Licensee's direct materials cost plus 40% percent of the
direct labor and materials cost excluding third party costs.
Manufacturing for the purposes of determining direct material
or direct labor or third party costs of manufacturing under
this Agreement includes the packaging of Product but excludes
shipping, warehousing and distribution.
(ii) EXCLUDE Conventional Sales and Value Added Receipts;
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INCLUDE other than receipts that constitute Conventional Sales
or Value Added Receipts all payments of any nature and kind
including royalties on net sales made by Minor Species
Sublicensees;
(iv) In respect of Major Species Sublicensees, Other Consideration
shall:
(A) EXCLUDE, other than during the application of the
applicable Threshold, payments of royalties on net
sales made by Major Species Sublicensees;
(B) INCLUDE during the application of the applicable
Threshold, payments of royalties on net sales made by
Major Species Sublicensees;
(v) In respect of Majority Joint Ventures, Other Consideration
shall:
(A) INCLUDE during the application of the applicable
Threshold, the Licensee's share of profits of
Majority Joint Ventures as of the relevant fiscal
year end of the Majority Joint Venture,
(B) EXCLUDE during the application of the applicable
Threshold, distributions to the Licensee of its
proportionate share of the net operating profits of
Majority Joint Ventures to the extent previously
included in Other Consideration and reflected in the
statements of such Majority Joint Venture as such a
distribution.
(C) EXCLUDE other than during the application of the
applicable Threshold, distributions to the Licensee
of its proportionate share of the net operating
profits of Majority Joint Ventures to the extent
reflected in the statements of such Majority Joint
Venture as such a distribution.
(vi) In respect of Minority Joint Ventures, Other Consideration
shall:
(A) INCLUDE during the application of the applicable
Threshold, the Licensee's share of the profits of
Minority Joint Ventures as of the relevant fiscal
year end of the Minority Joint Venture
(B) EXCLUDE during the application of the applicable
Threshold, distributions to the Licensee of its
proportionate share of net operating profits of
Minority Joint Venturers to the extent previously
included as Other Consideration and reflected in the
statements of such Minority Joint Venture as such a
distribution.
(C) EXCLUDE other than during the application of the
applicable Threshold, distributions to the Licensee
of its proportionate share of the net operating
profits of Minority Joint Ventures to the extent
reflected in the statements of such Minority Joint
Venture as such a distribution.
Page 13 of 31
(vii) Other Consideration shall:
(1) EXCLUDE payments made to the Licensee to fund
research or development, or both, of Product(s) to
the extent that such payments are used for such
purposes; and
(2) EXCLUDE payments made for the purpose of reimbursing
the Licensee for payments made to the Licensor under
this Agreement or for purposes of reimbursing
Licensed Patent related expenses actually incurred by
the Licensee.
The Licensee shall be responsible for demonstrating to the Licensor whether any
payments made to the Licensee falls within an exclusion/deduction to Other
Consideration.
4.07.1 Notwithstanding any other provision to the contrary hereunder, with
respect to any particular calendar year if the Licensee's required payments in
either Royalties or remittances respecting Other Consideration whether in
respect of Myostatin Products or sublicenses or otherwise together with all such
payments in prior years are equal to or in excess of the Myostatin Threshold,
then with respect to such calendar year the applicable percentage for purposes
of calculating the payment under 4.06 for Other Consideration in respect of
Myostatin Sublicenses shall be those applicable percentages under clause 4.01
but not to exceed in aggregate ***, provided that such calculation shall not
permit the payment to the Licensor to fall below the Myostatin Threshold for
such calendar year. For the purposes of this provision, a Myostatin Sublicense
means a sublicense, Majority or Minority Joint Venture or Value Added
Arrangement to the extent that the same is related to Myostatin Products and not
other Products.
4.07.2 Notwithstanding any other provision to the contrary hereunder, if with
respect to any particular calendar year if the Licensee's required payments in
either Royalties or remittances respecting Other Consideration together with all
such payments in prior years are equal to or in excess of the Overall Threshold,
then with respect to such calendar year the applicable percentage for purposes
of calculating the payment under 4.06 for Other Consideration in respect of all
sublicenses shall be those applicable percentages under clause 4.01 but not to
exceed in aggregate ***, provided that such calculation shall not permit the
payment to the Licensor to fall below the Overall Threshold for such calendar
year.
4.08 The Licensee shall pay to the Licensor all applicable goods and
services or value added or similar taxes on its payments hereunder.
ARTICLE V - REPORTS, PAYMENTS AND ACCOUNT
5.01 The Licensee shall make written reports and payments on account of
Royalties to the Licensor within ninety (90) days of the end of each calendar
quarter commencing with the first calendar quarter in which sale of Products
are made in any jurisdiction by the Licensee or its sub licensees. Given the
variable nature of sales revenue, it is difficult to precisely define the
content of written reports to be provided to Licensor. The intent of the
parties is for Licensees to provide Licensor with meaningful data that
accurately summarizes the Net Sales made during the applicable
Page 14 of 31
calendar quarter and the calculation of the payments due to the Licensor
pursuant to Article IV less any credits provided for in this Agreement. All such
written reports shall be certified by a financial officer of the Licensee. The
Licensor acknowledges that the Licensee may integrate its written reports
provided pursuant to this clause 5.01 into and with the written reports that
must be provided to the Licensor pursuant to any other license or similar
agreements in force between the Licensee and the Licensor from time to time. The
Licensee acknowledges that the credits against Royalties otherwise payable
provided by clause 7.03 or otherwise under this Agreement shall not entitle the
Licensee to reduce any payment on account of Royalties to less than fifty (50%)
percent of the amount otherwise due absent any credits and that all payments
previously made on account of Royalties are non-refundable under any
circumstances except as permitted by clause 5.03. In addition to the foregoing
financial reports within ninety days of the end of each calendar year, the
Licensee shall provide the Licensor with an annual report as to the activities
of the Licensee with respect to the development activities and registration of
the Products activities carried on by the Licensee in such twelve month period
and an updated estimate by the Licensee of the date of commencement of sales of
Product.
5.02 The Licensee shall make a final written report and payment within
ninety (90) days of the termination of this Agreement whether by expiration of
time or otherwise.
5.03 The Licensee shall keep at its head office full, clear and accurate
records of the production, sale and disposition of Products in detail sufficient
to allow an audit of payments due under this Agreement for a period of three (3)
years after the delivery of each written report pursuant to clause 5.01. In
addition, the Licensee shall similarly maintain all records provided to it by
its sublicensees and documentation required to establish Net Sales and Other
Consideration hereunder including the nature, status and quantum of sales or
receipts for the relevant period (including the documentation establishing the
relationship of the Licensee with any payor which would constitute a Majority or
Minority Joint Venture or sublicensee or a person with whom arrangements give.
rise to Value Added Receipts). The Licensee shall permit such books and records
to be examined from time to time by an independent accountant from an
international affiliated accounting firm designated by the Licensor, and
reasonably acceptable to the Licensee, for the purpose of conducting an audit of
such written reports. The Licensor shall not conduct more than one (1) audit a
year except as hereinafter set forth. Audits shall be conducted by the Licensor
at its expense unless an audit reveals a discrepancy between the amount of
payments that should have been made, and the amount of payments actually made of
three (3%) percent or greater for any quarterly period. In such event, the
Licensee shall pay the Licensor's audit expenses. The Licensor may thereafter
conduct more than one (1) audit per year, which remedy shall be without
prejudice to any other rights and remedies the Licensor may have as a result of
such breach. In addition, the difference between the amount of Royalties due and
the amount of Royalties actually paid shall be immediately paid to the Licensee
by the Licensor, or to the Licensor by the Licensee, as the case may be, with
interest thereon calculated in accordance with clause 5.05.
5.04 All amounts payable by the Licensee to the Licensor under this
Agreement shall be paid in Canadian dollars. If Products are sold outside of
Canada for a currency other than Canadian dollars, Net Sales shall first be
determined in accordance with the currency in which such Net Sales take place
and then converted into the Canadian dollar equivalent using the rate of
exchange published in the WALL STREET JOURNAL on the last business day of the
applicable calendar quarter. For the purpose of calculating the Thresholds in US
dollars, where revenues are derived in, or financial
Page 15 of 31
data is maintained in, a currency other than US dollars, then the conversion
method used in the prior sentence shall be applied.
5.05 All payments of whatever description owed to either party by the other
under this Agreement shall bear interest at the prime rate published in the WALL
STREET JOURNAL from time to time plus two (2%) percent per annum compounded
monthly, not in advance from and after the due date for payment to the date of
actual payment.
5.06 With respect to the application of clauses 5.04 to the sales of
Products made by sublicensees where the applicable sublicense agreement contains
provisions respecting conversion of funds to Canadian dollars for the purposes
of determining royalties payable to the Licensee, such provisions shall
supersede the provisions of clause 5.04 as regards to calculation and conversion
of Net Sales.
ARTICLE VI - PATENT PROSECUTION
6.01 The Parties acknowledge that Licensor has granted a separate license in
respect of the Licensed Technology and the Licensed Patents for use in vaccines
to prevent infectious disease in non-humans but as more particularly described
in such license dated for reference the 29th day of February, 2000, a copy of
which has been provided to Licensee (herein the "Novartis License"). Pursuant to
the provisions of Article VI and Article VII of the Novartis License, the
licensee thereunder (such license, its successors and assigns herein referred to
as "Novartis") has several entitlements, obligations or responsibilities
including the following:
(a) to file applications, to prosecute and maintain the Licensed
Patents including additions, continuations, divisions and the
like thereto;
(a) to discontinue prosecutions and applications and to
advise and provide Licensor with the option to proceed
with filings, applications and prosecutions;
(a) to regularly apprise Licensor and at Licensor's direction on a
confidential basis Licensor's other licensees of the Licensed
Patents of the status of patent applications and of approved
patents;
(a) to make to Licensor and at Licensor's direction on a
confidential basis to other licensees of the Licensed Patents
who have an interest in an application or registration
respecting a Licensed Patent complete disclosure other than a
disclosure which specifically relates to the license granted
under the Novartis License and which does not affect such
other licensee's interest in the Licensed Patent(s);
(a) to consult with Licensor and at Licensor's direction on a
confidential basis its other licensees of the Licensed Patents
respecting any actions or prosecutions affecting Licensed
Patents and to insure that any actions of Novartis do not
adversely affect such other licensees without the prior
written consent of Licensor; and
Page 16 of 31
(a) to cooperate with Licensor and at Licensor's direction on a
confidential basis Licensor's other licensees of the Licensed
Patents in the application, prosecution and filing of any
continuations, continuations-inpart, divisions, patents of
additions, re-issues, renewals and extensions, further
applications or defense of the Licensed Patents desired by
Licensor or affecting such other licensees provided that the
same is not adverse to the rights of Novartis under the
Licensed Patents. Novartis is entitled to reimbursement by
Licensor of its out of pocket expenditures incurred in
providing such cooperation which is to be reimbursed to
Licensor by the Licensee hereunder.
(g) Within 60 days of execution of this Agreement, Licensor will
direct Novartis to supply Licensee with a copy of all patent
applications and the prosecution histories of the Licensed
Patents or Licensed Technology, as applicable. In addition,
Licensor will direct Novartis to apprise the Licensee of the
status of all patent applications included in the Licensed
Patents or Licensed Technology, as applicable.
6.02 Licensor agrees with Licensee with respect to the scope of the within grant
of license to:
(1) make all directions in favour of Licensee, to Novartis as
directions are contemplated by the provisions of the Novartis
License, and to maintain and not withdraw such directions
without Licensee's consent; and
(2) forthwith apprise Licensee of information in its possession
relating to the status of patent applications, approved
patents, and infringements or suspected infringements except
as restricted by the terms of the Novartis License; and
(3) obtain Licensee's written consent prior to providing any
consent or approval affecting the Licensed Patents as
contemplated or requested pursuant to the Novartis License;
and
(4) to cooperate with Licensee in the application, prosecution and
filing of any continuations, continuations-in-part, divisions,
patents of additions, re-issues, renewals and extensions,
further applications or defense of the Licensed Patents
desired by Licensee (and effecting the applicable directions
contemplated under the Novartis License) and to insure that
Novartis does likewise to the extent to do so pursuant to the
Novartis License, all subject to Licensee's obligation to
reimburse Licensor and Novartis for their respective out of
pocket expenditures incurred in providing such cooperation;
and
(5) to provide Licensee the opportunity to commence or continue
the prosecution and maintenance of patents that Novartis may
determine under its license not to make or pursue for
inclusion under this License; and
Page 17 of 31
(6) not to amend Novartis License in a manner adverse to the
rights and entitlements of Licensee contemplated hereunder
without the Licensee's written consent.
6.03 Intentionally Left Blank
6.04 All patent applications on Licensed Technology or Improvements
undertaken by Licensee in accordance with this Agreement shall be undertaken in
the name and on behalf of the University of Saskatchewan. Licensee shall be
responsible for all costs and expenses associated with the filing and
prosecution of such applications and the maintenance fees, if any, required to
maintain the Licensed Patents in full force and effect except to the extent the
responsibility resides with Novartis, pursuant to the Novartis License. The
selection of the patent agents chosen to prosecute applications pursued
independently by Licensee shall be in the sole discretion of Licensee. Other
than as contemplated by the provisions of 6.05, Licensor shall cooperate with
Licensee in prosecuting such application at no expense to Licensee other than
reimbursement for out-of-pocket expenses that Licensee approves prior to their
being incurred.
6.05 At the request of the Licensee, Licensor shall provide such personnel
as may be available to it for purposes of consultation with and presentations to
governmental authorities in respect of the Licensed Patents and Licensor shall
be entitled to be compensated for such participation of such personnel on the
basis of a commercially reasonable consultation fee.
6.06 With respect to the Licensed Patents which are not subject of the
Novartis License, the following provisions will apply:
(a) All patent applications on Licensed Technology or Improvements
undertaken by the Licensee in accordance with this Agreement
shall be undertaken in the name and on behalf of the
University of Saskatchewan. The Licensee shall be responsible
for all costs and expenses associated with the filing and
prosecution of such applications and the maintenance fees, if
any, required to maintain such applications in fall force and
effect. The selection of the patent agents chosen to prosecute
such applications shall be in the sole discretion of the
Licensee. Other than as contemplated by the provisions of
6.05, Licensor shall cooperate with the Licensee in
prosecuting such applications at no expense to the Licensee
other than reimbursement for out-of-pocket expenses that the
Licensee approves prior to their being incurred. The
Licensee's obligations under this Article VI do not extend to
prosecuting appeals from decisions of the patent office of
various jurisdictions throughout the world nor engaging in
litigation with third parties. The Licensee shall regularly
apprize Licensor and at Licensor's direction on a confidential
basis Licensor's other licensees of the status of patent
applications and of approved patents. The Licensee shall be
entitled to reimbursement of its out of pocket expenditures
incurred in providing such cooperation to other licensees.
(b) Applications for Licensed Patents filed after the date of
execution of this Agreement shall first be filed in the United
States of America and the selection of other jurisdictions of
the world in which any particular application is to be
Page 18 of 31
filed shall be in the sole discretion of the Licensee. The
Licensee shall advise the Licensor of its decision in this
regard within nine (9) months of the filing date of any
particular application in the United States of America. With
respect to applications for Licensed Patents in jurisdictions
where the Licensee chooses not to file, the Licensor may file
and prosecute an application at its own expense. With respect
to any jurisdiction in which the Licensor obtains a patent as
contemplated by this clause, the Licensee shall not have any
rights under this Agreement(.) unless and until it reimburses
the Licensor for the cost of obtaining such patent with
interest as provided for in clause 5.05. Furthermore, the
Licensor may grant a license to any third party for a patent
it obtains under this clause subject to the following right of
first refusal in the Licensee's favour. The Licensor shall not
enter into any such license agreement with any third party
within the scope of the within License without giving the
Licensee at least sixty (60) days written notice which written
notice shall identify the proposed licensee(s) and set forth
the costs incurred by the Licensor in obtaining such patent.
From and after receipt of any such written notice the Licensee
may advise the Licensor in writing that it wishes to have such
patent added to the Licensed Patents. Accompanying such
written notice shall be a cheque in the amount stipulated in
the written notice from the Licensor.
(c) If the Licensee complies with the foregoing, such patent shall
become one of the Licensed Patents and the Licensee shall be
entitled to exercise all of its rights hereunder in such
jurisdiction. If the Licensee fails to deliver such written
notice, or advises the Licensor that it does not intend to
exercise this right of first refusal, the Licensor may enter
into the license agreement described in the written notice to
the Licensee. However, if the Licensor does not enter into
such license agreement for any reason with such proposed
licensee(s), the Licensor shall not enter into any other
license agreements for such patent in such jurisdiction within
the scope of the within License without first again complying
with this right of first refusal in favour of the Licensee.
(d) The Licensee shall have the option of discontinuing the
prosecution of an application for a Licensed Patent or not
filing an application based on the Licensed Technology or any
Improvement in accordance with this clause 6.06. If the
Licensee's patent agents provide a written opinion to the
effect that an application for a Licensed Patent does not
warrant the expense of further prosecution, or that an aspect
of the Licensed Technology or any Improvement (which the
Licensor considers patentable) does not warrant the expense of
an application the Licensee may, in its sole discretion,
refuse to proceed with such prosecution or application. If the
Licensee exercises such option, it shall so advise the
Licensor in writing and provide the Licensor with a copy of
the opinion of the patent agents on which such decision is
based. The Licensor may, in its sole discretion, file and
prosecute, or continue the prosecution, as the case may, of
such an application. If the Licensor is successful in
obtaining such patent or patents, the Licensee must reimburse
the Licensor for the Licensor's costs of obtaining such patent
with interest as provided for in clause 5.05 if the Licensee
desires rights thereunder. Upon payment to the Licensor of its
expenses, such patent or patents, as the case may be, shall
become one of the Licensed Patents.
Page 19 of 31
(e) With respect to any jurisdiction in which the Licensor obtains
a patent as contemplated by this clause and the Licensee
chooses not to reimburse the Licensor for its costs thereof as
set forth above, the Licensor may grant a license to any third
party for such patent within the scope of the within License
subject to the following right of first refusal in the
Licensee's favour. The Licensor shall not enter into any such
license agreement with any third party within the scope of the
within License without giving the Licensee at least sixty (60)
days written notice which written notice shall identify the
proposed licensee(s) and set forth the costs incurred by the
Licensor in obtaining such patent. From and after receipt of
any such written notice, the Licensee may advise the Licensor
in writing that it wishes to have such patent added to the
Licensed Patents. Accompanying such written notice shall be a
cheque in the amount stipulated in the written notice from the
Licensor.
(f) If the Licensee complies with the foregoing, such patents
shall become one of the Licensed Patents and the Licensee
shall be entitled to exercise all of its rights hereunder in
such jurisdiction. If the Licensee fails to deliver such
written notice, or advises the Licensor that it does not
intend to exercise this right of first refusal, the Licensor
may enter into the license agreement described in the written
notice to,the Licensee. However, if the Licensor does not
enter into such license agreement for any reason with the
proposed licensee(s), the Licensor shall not enter into any
other license agreement for such patent in such jurisdiction
within the scope of the within License without first again
complying with this right of first refusal in favor of the
Licensee.
(g) Licensee's patent expenditures for applications covered by
this Section 6.06 shall be credited against payments on
account of Royalties to a maximum of fifty (50%) percent of
any payment otherwise due until Licensee has been reimbursed
in full provided that such credits may not be applied to
reduce Royalties below those amounts of Minimum Royalties
payable pursuant to 4.03.
ARTICLE VII - PATENT PROTECTION AND INFRINGEMENT
7.01 The Licensee and the Licensor shall promptly advise each other of any
infringement or suspected infringement of the Licensed Patents by a third party.
Subject to any subsequent agreement as to the conduct of any such action:
(a) the Licensee, or its sublicensees, or both, may institute a
suit and, subject to the provisions hereinafter appearing,
join the Licensor as a plaintiff in which case the Licensee
and its sublicensees, as the case may be, shall bear the
entire cost of such litigation and shall be entitled to retain
the entire amount of any recovery whether by way of judgement,
award, decree or settlement; or
(b) if the Licensee and its sublicensees choose not to institute a
suit as provided for in subclause (a) above, the Licensor may
institute a suit in which case the Licensor shall bear the
entire cost of such litigation and shall be entitled to retain
the entire amount of any recovery whether by way of judgment,
award, decree or settlement.
Page 20 of 31
If the Licensee and its sublicensees exercise their right to commence a suit,
the Licensor need not consent to being nor shall it be added as a party until
provided with an indemnity agreement from the Licensee and its sublicensees
against all costs, expenses and damages which the Licensor may incur as a result
of such cooperation. Such indemnity agreement shall be in a form satisfactory to
the Licensor's solicitors and be supported by such reasonable assurances in
support of such indemnity as the Licensor considers appropriate in the
circumstances.
7.02 Should the Licensor or the Licensee (which includes for purposes of
this clause the Licensee's sublicensees) commence a suit in accordance with
clause 7.01 and subsequently elect to abandon such suit, the Licensor or the
Licensee, as the case may be, shall first give timely notice to the other, who
may, if it so desires, continue prosecution of such suit provided that an
agreement as to the sharing of expenses and any recoveries is first arrived at.
7.03 If the Licensee institutes a suit in accordance with clause 7.01 it may
deduct fifty (50%) percent of its out-of-pocket expenditures, including legal
fees and disbursements, that are incurred in bringing and prosecuting such
infringement action from Royalties not yet paid to a maximum amount of one-half
of each payment on account of Royalties otherwise due, until such expenditures
are paid in full. If the Licensee recovers profits or damages, or both, from the
alleged infringer, the Licensee shall after reimbursing itself for such
expenditures that it has had to bear, repay the Licensor all Royalties that have
been deducted in accordance with this clause 7.03 and interest as provided for
herein, up to, but not exceeding, the amount of the damages so recovered by the
Licensee. However, if any such infringement suit results in an adverse judgment
and all or some of the Licensed Patents are wholly or partially invalidated,
Royalties shall be adjusted in accordance with clause 4.01.
7.04 Each party shall promptly notify the other in writing of any claim or
action for infringement of the patent rights of any third party based on the
production, use or sale of Products by the Licensee or its sublicensees.
7.05 The entitlements of the Licensee under this Article VII are limited to
third party infringements of the applications subject of this Agreement.
ARTICLE VIII - REPRESENTATIONS AND WARRANTIES
8.01 Subject to Article IX, the Licensor represents and warrants that it:
(a) has obtained and holds title to all such rights in the
Licensed Patents and Licensed Technology as may be necessary
to grant the licenses contemplated by this Agreement subject
to the rights of governmental and other agencies pursuant to
funding agreements that the Licensor has with such agencies;
and
(b) and has full power and authority to enter into this Agreement.
(a)
Page 21 of 31
ARTICLE IX - DISCLAIMER OF WARRANTIES
9.01 The parties acknowledge and agree that nothing in this Agreement is or
shall be construed as being:
(a) a warranty or representation by the Licensor as to whether any
patents based on the Licensed Technology will issue or the
validity or scope of the Licensed Patents once issued; or
(b) a warranty or representation by the Licensor that Products
made, used, sold or otherwise disposed of by the Licensee
are and will be free from infringement of patents,
copyrights, trademarks or other proprietary interests of
any third party; or
(c) an obligation on the Licensor to bring or prosecute actions or
suits against third parties for infringement of the Licensed
Patents or other proprietary rights under any circumstances;
or
(d) the conferring of any rights to use in advertising, publicity
or otherwise any trademark or the name of either the Licensor
or the University of Saskatchewan or any employee, agent or
person otherwise associated with either of those institutions;
or
(e) a grant by implication, estoppel or otherwise of any license
to any patents or other confidential proprietary information
of the Licensor other than the Licensed Patents and Licensed
Technology; or
(f) A REPRESENTATION OR WARRANTY, WHETHER EXPRESS OR IMPLIED, BY
THE LICENSOR OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, NOR A REPRESENTATION OR WARRANTY BY THE LICENSOR THAT
IT SHALL BEAR ANY LIABILITY TO THE LICENSEE WHATSOEVER BY
REASON OF ANY LOSS OR DAMAGE SUSTAINED BY THE LICENSEE, ITS
EMPLOYEES, OR ANY THIRD PARTY ARISING OUT OF THE PRODUCTION,
USE, SALE OR OTHER DISPOSAL OF PRODUCTS OR ARISING DIRECTLY OR
INDIRECTLY OUT OF THE USE BY THE LICENSEE OF THE LICENSED
PATENTS AND LICENSED TECHNOLOGY OR OTHERWISE ARISING OUT OF
THE GRANT OF ANY RIGHTS UNDER THIS AGREEMENT OR OUT OF THE
PROVISION OF ANY INFORMATION IN CONNECTION WITH THIS
AGREEMENT.
ARTICLE X - INDEMNITY
10.01 The Licensee shall indemnify, hold harmless and defend the Licensor and
its officers, employees and agents against any and all claims arising out of the
exercise by the Licensee of any of the rights granted to it under this Agreement
including, without limitation, against any damages, losses or liabilities
whatsoever with respect to death or other personal injury to a person or damage
to property arising from or out of the use of the Licensed Patents and Licensed
Technology by the Licensee, it sublicensees or its customers in any manner
whatsoever or the production, use, sale, or lease of Products by the Licensee,
its sublicensees or its customers in any
Page 22 of 31
manner whatsoever; with the exception of any damage or loss directly resulting
from acts or omissions constituting bad faith, willful misfeasance, gross
negligence or reckless disregard of duties under this Agreement by the Licensor
or its officers, employees or agents acting in such capacity on the behalf of
the Licensor.
ARTICLE XI - SUBLICENSING
11.01 This Agreement has been entered into so that the Licensee may
commercialize the Licensed Patents and Licensed Technology by the development,
production, use and marketing of Products. Accordingly, the Licensee may grant
sublicenses of its rights under this Agreement and enter into contracts to have
Products developed, produced, used or sold provided that all such sublicenses
shall provide, amongst other things, that they come to an end immediately upon
the termination of this Agreement for whatever reason.
ARTICLE XII - TERMINATION
12.01 This Agreement shall terminate at the Licensor's option if the Licensee
is in breach of any material provision hereof and fails to remedy such breach
within ninety (90) days of receipt of written notice from the Licensor of such
breach.
12.02 This Agreement shall further terminate, at the option of the Licensor,
if:
(a) the Licensee files an Assignment in Bankruptcy or is adjudged
a bankrupt or insolvent corporation; or
(b) the Licensee is adjudged a bankrupt or insolvent corporation
as a result of taking advantage of any law or governmental
regulation relating to bankruptcy or insolvency; or
(c) a receiver or receiver-manager for all or substantially all of
the property and assets of the Licensee is appointed; or
(d) the Licensee makes an assignment or attempted assignment for
the benefit of its creditors; or
(e) the Licensee institutes any proceedings for the winding up of
its business; or
(f) a governmental authority exercises its powers in such a way
that the expropriation or confiscation of all or a substantial
part of the property and assets of the Licensee occurs.
12.03 If the Licensor decides to exercise its option to terminate this
Agreement pursuant to either clauses 12.01 or 12.02, it shall so exercise such
option by delivering written notice to the Licensee, which written notice shall
specify the effective date of termination. Termination of this Agreement shall
not prejudice any other rights or remedies, whether in law or in equity, that
the Licensor may have as a result of any actions by the Licensee.
Page 23 of 31
12.04 The Licensee shall be entitled, at its option, to terminate this
Agreement at any time by giving the Licensor a minimum of ninety (90) days
written notice of its intention.
12.05 Upon termination of this Agreement, whether pursuant to clauses 12.01,
12.02 or 12.04, the parties shall return to each other all Confidential
Information with the exception of one (1) copy of each such disclosure which may
be retained for record purposes. The Licensee acknowledges that upon termination
of this Agreement by the Licensor for any reason other than the expiration of
the Term, it shall no longer have any rights to use the Licensed Technology or
infringe the Licensed Patents. Accordingly, the Licensee shall cease production
of Products upon the effective date of termination and return all cell lines,
reagents and other biological material obtained from the Licensor to the
Licensor. With respect to the remaining stock of Products then in the Licensee's
possession, the Licensor shall have the option of purchasing such remaining
stock from the Licensee at and for a price equal to the price that the Licensee
offers such Products to its third party customers less ten (10%) percent, or by
having the Licensee destroy such remaining stock of Products, and providing
proof of such destruction to the Licensor.
12.06 Surviving the termination of this Agreement, whether pursuant to
clauses 12.01 and 12.02 of this Article XII or due to the expiration of time,
are the appropriate provisions of Article II (Licenses), Article III
(Improvements), Article IV (Royalties), Article V (Reports, Payments and
Accounting), Article IX (Disclaimer of Warranties), Article X (Indemnity),
Article XII (Termination) and Article XIII (Confidentiality and Disclosures).
ARTICLE XIII - CONFIDENTIALITY AND DISCLOSURES
13.01 The parties acknowledge that both of them may from time to time
disclose to the other (respectively referred to as the "Discloser" and the
"Recipient", as the case may be) information that is confidential and
proprietary, or both, to the Discloser. Such information may be disclosed
orally, graphically, by way of sample or specimen or otherwise printed or
recorded by any means. Accordingly, all information disclosed pursuant to this
Agreement including, without limitation, all information pertaining to the
Licensed Patents and Licensed Technology, shall be deemed to be confidential
information (hereinafter referred to as "Confidential Information") unless the
Discloser expressly indicates that it is not confidential or it falls into one
of the following categories.:
(a) it is required to be disclosed by reason of judicial action
after all reasonable legal remedies to maintain the
confidentiality of such information have been exhausted; or
(b) it is or becomes part of the public domain through no fault of
the Recipient; or
(c) it is known to the Recipient, or its permitted sublicensees
prior to disclosure by the Discloser; or
(d) it is subsequently legally obtained by the Recipient or its
sublicensees from a third party under circumstances which do
not constitute a breach of this Article XIII; or
Page 24 of 31
(e) it is independently developed by the Recipient outside of this
Agreement and without in any way breaching this Agreement; or
(f) it is approved for public release by the Discloser.
13.02 Each of the parties shall use its reasonable best efforts to preserve
the secrecy of Confidential Information and shall only disclose it to:
(a) employees, or employees of permitted sublicensees who are
required to know the same for performance of their duties and
who have entered into appropriate confidentiality agreements;
and
(b) such Government officials as are required for the purpose of
obtaining all necessary regulatory approvals for the purpose
of commercializing any Product or for the filing of any patent
in any jurisdiction, provided that the parties shall avail
themselves of all available provisions for ensuring that such
disclosures do not become public.
Neither the Licensor nor the Licensee shall submit any manuscript, abstract, or
like document for written or oral publication if it includes data or other
information generated and provided by the other party without first obtaining
the prior written consent of the other, which consent shall not be unreasonably
withheld. The contribution of each party shall be noted in all publications or
presentations by acknowledgment or co-authorship, whichever is appropriate.
13.03 The Licensee recognizes that the Licensor has an obligation to publish
and disseminate scientific knowledge. The Licensor recognizes that the public
release of material pertaining to Licensed Technology may prejudice the
possibility of obtaining letters patent for such Licensed Technology, or result
in Commercially Significant Confidential Information being disclosed to a
competitor of the Licensee's, or both. Therefore, during the Term, the Licensor
shall make all theses, articles and similar publications of any description, and
the contents of all abstracts and poster presentations which relate to the
Licensed Patents or Licensed Technology, or both and Improvements (all
hereinafter referred to as "External Disclosures") available for review by the
Licensee within a reasonable period of time prior to submission for publication
or release, as the case may be, but in any event at least thirty (30) days prior
to such date. The Licensee shall review all External Disclosures to ascertain
whether patentable subject matter or Commercially Significant Confidential
Information is disclosed. The Licensor shall only proceed with an External
Disclosure upon receiving the Licensee's consent, which consent shall be deemed
to have been given if the Licensee does not respond within a period of thirty
(30) days from the date of submission to the Licensee of any particular External
Disclosure. If requested by the Licensee in writing, the Licensor shall:
(a) delay submission for publication or release, as the case may
be, of any particular External Disclosure for the period of
time required for a patent application to be filed, which
period of time shall not exceed six (6) months without the
Licensor's written consent; or
(b) amend such External Disclosure so as to delete those portions
which constitute Commercially Significant Confidential
Information; or both.
Page 25 of 31
As used in clauses 13.03, 13.04 and 13.05, the term "Commercially
Significant Confidential Information" means Confidential Information which, if
disclosed to a commercial competitor of the Licensee's, could allow such
competitor to develop or enhance its position in the market place, or to price a
new product in a more competitive fashion, or to improve the price of an
existing product so as to compete or improve its competitive position with
respect to existing or potential the Licensee Products. Commercially Significant
Confidential Information may include, by way of example and without limitation,
information as to the formulation or composition of a Product, the method of
formulating or combining ingredients for a Product, detailed chemical or
biological structural information for a Product and its ingredients, and the
method or application of a Product.
13.04 The Licensor shall use reasonable efforts to ensure that all scientific
oral presentations which are made by its staff and graduate students do not
contain Commercially Significant Confidential Information.
13.05 The Licensee acknowledges and agrees that clause 13.03 shall not
prohibit the Licensor's personnel from disseminating general information
concerning the Licensed Patents and Licensed Technology to government agencies,
associations of livestock producers, other organizations or groups of whatever
description who provide funding to the Licensor or who derive a direct benefit
from the Licensor's research activities as long as Commercially Significant
Confidential Information is not disclosed.
13.06 The Licensor recognizes that, pursuant to United States laws, the
Licensee may have an obligation, under certain circumstances, to make public
announcements relating to this Agreement or the development, production,
exploitation, use, or sale of Products in connection with this Agreement. The
parties hereby agree to abide by the applicable notice and consent provisions of
Section 13.03 above with respect to proposed disclosures to be made by Licensee.
Licensor acknowledges and agrees that nothing in this Agreement shall prevent
Licensee from making any disclosure to the extent required by law provided that
prior notice of such disclosure is given to Licensor.
ARTICLE XIV - COMMERCIAL DUE DILIGENCE
14.01 The Licensor by written notice to the Licensee may make this License
non- exclusive with respect to a particular Major Jurisdiction if:
(i) the Licensee is not by the expiration of calendar year 2007
selling a Product into such Major Jurisdiction, or
a New Animal Drug Application (NADA or its equivalent) for a
Product has not been submitted to appropriate governmental
authorities prior to the end of calendar year 2004 or if
submitted has not been maintained in effect and diligently
pursued from the end of calendar year 2004, or
(iii) amounts paid hereunder by Licensee to Licensor in each of
calendar years 2005 and 2006 have not exceeded $250,000 US.
Page 26 of 31
For purposes of this Section 14.01, Major Jurisdictions are the United States of
America (which jurisdiction includes other than for registration purposes Canada
and Mexico) and Europe (which is defined as one of the EU member countries).
The Licensor by written notice to the Licensee may make this License
nonexclusive with respect to a particular jurisdiction not constituting a Major
Jurisdiction if:
(iv) the Licensor has the right to render this License
non-exclusive in respect of both Major Jurisdictions, or
(v) amounts paid hereunder by Licensee to Licensor in respect of
2007 or any subsequent calendar year is less than $500,000 and
the Licensor is not selling Product into such jurisdiction.
14.02 In respect of the requirements of 14.01 (ii) to submit a New Animal
Drug Application (NADA or its equivalent) for a Product to appropriate
governmental authorities prior to the end of calendar year 2004, in the event
that such submission has not been so effected the Licensee may obtain an
extension of such date for the purposes of 14.01 of up to 12 months (to the end
of 2005) provided that the Licensee can establish that:
(i) it has substantially made such application and that the
completion of such application within the period of such
extension is probable, and
(ii) the Licensee has used all due diligence in its efforts to
effect the submission within the original time limits but that
circumstances reasonably beyond its control prevented it from
doing so, and that with due diligence on the part of the
Licensee such circumstances will not in all likelihood prevent
the completion of the submission within the period of the
extension.
The Licensee shall be entitled to one further extension of up to 12
months on the time limits pertaining to 14.01 (ii) provided that on such further
extension the Licensee can establish the conditions referred to in (i) and (ii)
above at such time. If the Licensor does not agree that the Licensee has
established the foregoing such determination may be referred to arbitration.
14.03 Wherever commercially feasible to do so, the Licensee shall publicly
acknowledge and shall ensure that its sublicensees publicly acknowledge, the
role of the Licensor or the University of Saskatchewan, or both, in the
development of Products. Prior to providing any such public acknowledgment, the
Licensee shall obtain the approval of the Licensor or the University of
Saskatchewan, as the case maybe. With respect to the University of Saskatchewan,
the Licensee acknowledges that any such approval must be obtained from the Board
of Governors in the manner stipulated by XXX XXXXXXXXXX XX XXXXXXXXXXXX XXX,
0000, Statutes of Saskatchewan.
Page 27 of 31
ARTICLE XV - MISCELLANEOUS
15.01 ASSIGNMENT
This Agreement shall not be assigned by the Licensee in whole or in
part without the prior written consent of the Licensor which consent may be
unreasonably withheld provided, however, that the Licensee may, without
obtaining such consent, assign, transfer, or part with any of its rights,
duties, or obligations under this Agreement to any parent or subsidiary
corporation of the Licensee or an affiliate of the Licensee as those terms are
defined in THE BUSINESS CORPORATIONS Act (Canada), if such proposed assignee
promptly executes and delivers an agreement in favour of the Licensor pursuant
to which the assignee agrees to be bound by all of the terms and conditions
contained in this Agreement. Furthermore, such assignee must covenant to remain
during the continuance of this Agreement, a parent, subsidiary or affiliate of
the Licensee, as the case may be. The Licensee acknowledges that no such
assignment shall in any way affect its liabilities and responsibilities under
this Agreement.
15.02 GOVERNING LAW
This Agreement shall be construed, interpreted and applied in
accordance with the laws of the Province of Saskatchewan and Canada, and the
parties hereby attorn to the jurisdiction of the Courts of the Province of
Saskatchewan.
15.03 NOTICES
All notices, demands or other writings required or permitted to be
given hereunder by either party hereto to the other, may be effectively given by
letter, mailed by registered mail, postage prepared, addressed to:
(a) to the Licensor:
VIDO
000 Xxxxxxxxxx Xxxx
Xxxxxxxxxx xx Xxxxxxxxxxxx
Xxxxxxxxx, Xxxxxxxxxxxx
X0X OWO
Attention: Director
With a copy to:
McKercher, McKercher and Xxxxxxxx,
000 0xx Xxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxx
X0X 0X0
Attention: X.X. Xxxx Xxxxxx
(b) to the Licensee:
MetaMorphix-International , Inc.
0000 Xxxxx Xxxxxxx Xxxx, Xxxxxxxxx,
Xxxxxxxx, Xxxxxx Xxxxxx of America, 21227
Attention: President
Page 28 of 31
With a copy to:
Xxxxxxx and Xxxxxxx,
Twentieth Floor, 00 Xxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxx, 00000-0000
Attention: Xxxxxxx X. Xxxxxxx
or hand delivered to the above addresses or sent by electronic means. If mailed
as aforesaid, any such notice shall be deemed to have been given by the seventh
(7th) business day following the date of posting, and if delivered personally or
by electronic means, on the date or delivery, provided that such date is a
business day. Either party to this Agreement may change its address for service
from time to time by giving notice in writing in accordance with the foregoing.
15.04 WAIVER
The parties covenant and agree that if either party hereto fails or
neglects, for any reason, to take advantage of any of the terms herein provided
for its benefit, any such failure or neglect by such party shall not be, nor be
deemed to be construed as waiver of any of the terms, covenants or conditions of
this Agreement or the performance thereof.
15.05 NO AGENCY OR JOINT VENTURE
This is a contract between separate legal entities and neither party is
the agent of the other for any purposes whatsoever, and nothing in this
Agreement does or shall directly or indirectly constitute either party to be the
agent of the other.
15.06 SUCCESSORS AND PERMITTED ASSIGNS
This Agreement shall enure to the benefit of and be binding upon the
parties hereto and their respective successors and any permitted assigns.
15.07 FORCE MAJEURE
Neither party to this Agreement shall be liable to the other for
failure or delay in the performance of their obligations under this Agreement,
by Acts of God, regulations, or laws of any government, war, civic commotion,
strike, lock-out, or labour disturbances, destruction of facilities and any
materials and equipment by fire, earthquake, storm, failure of public utilities
or common carriers, and any cause beyond the control of that party for the
period of time that the foregoing prevents performance. The Licensee
acknowledges and agrees that the foregoing does not operate so as to excuse it
from prompt payment of any and all sums due by it to the Licensor pursuant to
the terms and conditions of this Agreement.
15.08 ARBITRATION
With the exception of:
(a) a dispute arising from any breach or alleged breach of the
party's obligations with respect to confidentiality; or
Page 29 of 31
(b) a failure by the Licensee to make any payments when due; or
(c) the exercise by the Licensor of its right to terminate this
Agreement pursuant to Article XII,
the parties shall submit all disputes arising under this Agreement to
arbitration. The party desiring to initiate arbitration shall serve a written
request on the other party.
The party receiving such written request shall designate the locale
within which arbitration is to take place. Within thirty (30) days of receipt of
such written request, each party shall appoint an umpire. The arbitration shall
take place in accordance with the provisions of THE ARBITRATION ACT, 1992
Statutes of Saskatchewan, or its successor legislation-in force from time to
time.
15.09 This Agreement constitutes the entire agreement between the parties
pertaining to the subject matter. No representative of the Licensee or the
Licensor has been authorized to make any representation, warranty or promise not
contained herein. This Agreement may not be amended or modified in any manner
except by written agreement executed by both of the parties.
Page 30 of 31
15.10 The headings contained in this Agreement are for reference purposes
only and shall in no way affect the meaning or interpretation of any section of
this Agreement.
IN WITNESS WHEREOF VIDO has hereunto affixed its corporate seal as
evidence of its approval of this Agreement by the hands of its duly authorized
officers in that behalf on the day and year first above written.
THE VETERINARY INFECTIOUS DISEASE
ORGANIZATION
PER: /s/ Xxxxx Xxxxxx
PER: /s/ Xxxxxx
IN WITNESS WHEREOF the Board of Governors University of Saskatchewan
has hereunto affixed its corporate by the hands of its duly authorized officers
in that behalf day and year first above written.
BOARD OF GOVERNORS OF THE
UNIVERSITY OF SASKATCHEWAN
PER: /s/ X.Xxxxxxx
PER: /s/ J.Finwirth
IN WITNESS WHEREOF MetaMorphix International, Inc. has hereunto affixed
its corporate seal by the hands of its duly authorized officers in that behalf
on the day and year first above written.
METAMORPHIX INTERNATIONAL , INC.
PER: /s/ Xxxxx Xxxxxxxxxxx
PER: /s/ Xxxx Xxxxxx
Page 31 of 31
EXHIBIT "A"
ATTACHED TO AND FORMING PART OF THE VIDO TECHNOLOGY LICENSE
MADE BETWEEN
THE UNIVERSITY OF SASKATCHEWAN
- AND -
METAMORPHIX-INTERNATIONAL INC.
PLEASE SEE ATTACHED
SCHEDULE "A"
VIDO TECHNOLOGY
Includes all patents and patent applications arising from U.S.A. patent
application numbers 07/779/171 and 07/335,018, as listed in Robins and
Associates patent series 9001-0006 and 90010016. The symbol (alpha) indicates
patents for which Novartis is charged with the maintenance and prosecution under
the provisions of the EXCLUSIVE LICENSE - - NOVARTIS TO BIOSTAR DATED FEBRUARY
29, 2000, and the symbol (beta) indicates patents for which MIMI is charged with
the maintenance and prosecution under the provisions of this License.
X. XXXXXX AND ASSOCIATES PATENT SERIES 9001-0006
"COMPOSITIONS AND TREATMENTS FOR PNEUMONIA IN ANIMALS"
o Issued U.S. Patent No. 5,849,531 (alpha)
"LEUKOTOXIN VACCINE COMPOSITIONS AND USES THEREOF"
o Issued U.S. Patent No. 5,871,750 (alpha)
"PASTEURELLA HAEMOLYTICA LEUKOTOXIN COMPOSITIONS AND USES THEREOF"
o Issued U.S. Patent No. 5,476,657 (alpha)
X. XXXXXX AND ASSOCIATES PATENT SERIES 9001-0016
"ENHANCED IMMUNOGENICITY USING LEUKOTOXIN CHIMERAS"
o U.S. Application 08/976,566 (alpha)
o U.S. Patent 5,708,155 (alpha)
o U.S. Patent 5,422,110 (alpha)
"GNRH LEUKOTOXIN CHIMERAS"
o U.S. Application 09/383,912 (alpha)
o U.S. Patent 5,969,126
o U.S. Patent 5,723,129
o U.S. Patent 5,837,268 (alpha)
o U.S. Patent 6,022,960 (alpha)
VIDO
BIOSTAR
Patent Report by Invention Printed: 01/06/2000
Reference Number: 9001-0006
COMPOSITIONS AND TREATMENTS FOR PNEUMONIA IN ANIMALS
----------------------------------------------------------------------------------------------------------------------------
COUNTRY REFERENCE TYPE FILED SERIAL # ISSUED PATENT# STATUS
# -
----------------------------------------------------------------------------------------------------------------------------
AUSTRALIA 9001-0006.43 CEQ 05/25/1990 5662190 03/07/1994 642650 ISSUED
----------------------------------------------------------------------------------------------------------------------------
BELGIUM 9001-0006.48 DCA 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
CANADA 9001-0006.40 CEQ 04/06/1990 2014033 02/09/1993 2014033 ISSUED
----------------------------------------------------------------------------------------------------------------------------
SWITZERLAND 9001-0006.49 DCA 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
GERMANY 9001-0006.50 DCA 05/25/1990 909068314 0527724 ISSUED
----------------------------------------------------------------------------------------------------------------------------
EUROPEAN PATENT CO 9001-0006.44 CEQ 05/25/1990 909068314 08/27/1997 0527724 ISSUED
----------------------------------------------------------------------------------------------------------------------------
SPAIN 9001-0006.51 DCA 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
FINLAND 9001-0006.45 CEQ 05/25/1990 924457 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
FRANCE 9001-0006.52 DCA 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXXX 0000-0000.00 XXX 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
ITALY 9001-0006.54 DCA 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
JAPAN 9001-0006.46 CEQ 05/25/1990 2507689 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
NETHERLANDS 9001-0006.55 DCA 05/25/1990 909068314 08/27/1997 0527724 PENDING
----------------------------------------------------------------------------------------------------------------------------
NORWAY 9001-0006.47 CEQ 05/25/1990 P923827 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000 NEW 04/07/1989 07/335,0 18 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CIP 04/05/1990 07/504,850 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.01 CON 02/09/1993 08/015,537 12/19/1995 5,476,657 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CON 12/14/1994 08/355,919 02/16/1999 5,871,750 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 DIV 05/31/1995 08/455,510 12/15/1998 5,849,531 ISSUED
----------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0006.41 CEQ 04/06/1990 PCT/US9O ABANDONED
/01884
----------------------------------------------------------------------------------------------------------------------------
WIPO 900 1-0006.42 CEQ 05/25/1990 PCT/CA9O /00 NAT PHASE
170
----------------------------------------------------------------------------------------------------------------------------
Patent Report by Invention
Reference Number: 9001-0016
GnRH-LEUKOTOXIN CHIMERAS
----------------------------------------------------------------------------------------------------------------------------
COUNTRY REFERENCE TYPE FILED SERIAL # ISSUED PATENT # STATUS
#
----------------------------------------------------------------------------------------------------------------------------
AUSTRALIA 9001-0016.64 DCA 01/24/1996 4477796 PENDING
----------------------------------------------------------------------------------------------------------------------------
AUSTRALIA 9001-0016.84 DCA 08/08/1997 3843797 PENDING
----------------------------------------------------------------------------------------------------------------------------
AUSTRALIA 9001-0016.52 DIV PROPOSED
----------------------------------------------------------------------------------------------------------------------------
BRAZIL 9001-0016.65 DCA 01/24/1996 P196075260 PENDING
----------------------------------------------------------------------------------------------------------------------------
BRAZIL 9001-0016.85 DCA 08/08/1997 P197111236 PENDING
----------------------------------------------------------------------------------------------------------------------------
CANADA 9001-0016.66 DCA 01/24/1996 2212054 PENDING
----------------------------------------------------------------------------------------------------------------------------
CANADA 9001-0016.86 DCA 08/08/1997 2262524 PENDING
----------------------------------------------------------------------------------------------------------------------------
CHINA 9001-0016.67 DCA 01/24/1996 961926805 PUBLISHED
----------------------------------------------------------------------------------------------------------------------------
CHINA 9001-0016.87 DCA 08/08/1997 97197617 PENDING
----------------------------------------------------------------------------------------------------------------------------
EUROPEAN PATENT CO 9001-0016.75 DCA 01/24/1996 969007962 PUBLISHED
----------------------------------------------------------------------------------------------------------------------------
EUROPEAN XXXXXX XX 0000-0000.0 1 DCA 08/08/1997 979353950 PENDING
----------------------------------------------------------------------------------------------------------------------------
HUNGARY 9001-0016.68 DCA 01/24/1996 2544797 PENDING
----------------------------------------------------------------------------------------------------------------------------
HUNGARY 9001-0016.88 DCA 08/08/1997 519499 PENDING
----------------------------------------------------------------------------------------------------------------------------
ISRAEL 9001-0016.89 DCA 08/08/1997 128123 PENDING
----------------------------------------------------------------------------------------------------------------------------
IINDIA 9001-0016.81 CEQ 08/07/1997 2204DEL97 PENDING
----------------------------------------------------------------------------------------------------------------------------
JAPAN 9001-0016.69 DCA 01/24/1996 8523847 PENDING
----------------------------------------------------------------------------------------------------------------------------
JAPAN 9001-0016.90 DCA 08/08/1997 10509192 PENDING
----------------------------------------------------------------------------------------------------------------------------
NORTH KORLA 9001-0016.91 DCA 08/08/1997 PCT/CA97/
00559 PENDING
----------------------------------------------------------------------------------------------------------------------------
SOUTH KOREA 9001-0016.70 DCA 01/24/1996 70551397 PENDING
----------------------------------------------------------------------------------------------------------------------------
XXXXX XXXXX 0000-0000.00 XXX 08/08/1997 700109799 PENDING
----------------------------------------------------------------------------------------------------------------------------
MEXICO 9001-0016.71 DCA 01/24/1996 976009 PENDING
----------------------------------------------------------------------------------------------------------------------------
MEXICO 9001-0016.93 DCA 08/08i'1997 PCT/CA97/
00559 PENDING
----------------------------------------------------------------------------------------------------------------------------
NORWAY 9001-0016.94 DCA 08/08/1997 19990533 PENDING
----------------------------------------------------------------------------------------------------------------------------
XXX XXXXXXX 0000-0000.00 XXX 01/24/1996 300125 04/29/1999 300125 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXX XXXXXXX 0000-0000.00 XXX 08/08/1997 333999 PENDING
----------------------------------------------------------------------------------------------------------------------------
PHILIPPINES 9001-0016.61 CEQ 02/09/1996 52321 PENDING
----------------------------------------------------------------------------------------------------------------------------
PHILIPPINES 9001.0016.82 CEQ 08/08/1997 57547 PENDING
----------------------------------------------------------------------------------------------------------------------------
POLAND 9001-0016.73 DCA 01/24/1996 P321704 PENDING
----------------------------------------------------------------------------------------------------------------------------
POLAND 9001-0016.96 DCA 08/08/1997 P331537 PENDING
----------------------------------------------------------------------------------------------------------------------------
FEDERATION OF RUSSIA 9001-0016.74 DCA 01/24/1996 97115447 PENDING
----------------------------------------------------------------------------------------------------------------------------
FEDERATION OF RUSSIA 9001-0016.97 DCA 08/08/1997 99104772 PENDING
----------------------------------------------------------------------------------------------------------------------------
SINGAPORE 9001-0016.98 DCA 08/08/1997 99004533 PENDING
----------------------------------------------------------------------------------------------------------------------------
THAILAND 9001-0016.63 CEQ 02/08/1996 029979 PUBLISHED
----------------------------------------------------------------------------------------------------------------------------
TURKEY 9001-0016.99 DCA 08/08/1997 199900267 PENDING
----------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------
TAIWAN 9001-0016.41 NEW 11/24/1992 81109431 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
TAIWAN 9001-0016.62 CEQ ABANDONED
----------------------------------------------------------------------------------------------------------------------------
TAIWAN 9001-0016.83 CEQ ABANDONED
----------------------------------------------------------------------------------------------------------------------------
UKRAINE 9001-0016.50 DCA 08/08/1997 99031259 PENDING
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000 NEW 10/16/1991 07/779,171 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CIP 10/14/1992 07/960,932 06/06/1995 5,422,110 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CIP 02/10/1995 08/387,156 03/03/1998 5,723,129 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 DIV 05/31/1995 08/455,970 01/13/1998 5,708,155 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CIP 08/09/1996 08/694,865 11/17/1998 5,837,268 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 DIV 06/19/1997 08/878,748 10/19/1999 5,969,126 ISSUED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CON 11/24/1997 08/976,566 PENDING
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 DIV 07/29/1998 09/124,49 1 PENDING
----------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.02 CON 08/26/1999 09/383,912 PENDING
----------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0016.40 CEQ 10/15/1992 PCT/CA92/ ABANDONED
00449
----------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0016.60 CEQ 01/24/1996 PCT/CA96/ NAT PHASE
00049
----------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0016.80 CEQ 08/08/1997 PCT/CA97/ NAT PHASE
00559
----------------------------------------------------------------------------------------------------------------------------
BOVINE HERPES VIRUS-I TECHNOLOGY
"BOVINE HERPESVIRUS TYPE 1 POLYPEPTIDES AND VACCINES"
o Issued U.S. Patent No. 5,151,267
"NUCLEOTIDE SEQUENCES ENCODING RECOMBINANT BOVINE HERPESVIRUS TYPE 1, GI, XXXX,
GIV POLYPEPTIDES
o Issued U.S. Patent No. 5,585,264
Non-U.S.A. counterparts to the above are listed on the attached page.
--------------------------------------------------------------------------------
BOVINE HERPESVIRUS TYPE 1 POLYPEPTIDES AND VACCINES
--------------------------------------------------------------------------------
REF NO.(1) COUNTRY PATENT/APPI. NO. STATUS
--------------------------------------------------------------------------------
5.40 Canada 1,338,069 Granted (expires 2/20/13)
--------------------------------------------------------------------------------
5.41 Canada 2,057,387 Pending (awaiting examination)
--------------------------------------------------------------------------------
5.42 PCT PCT/CA92/00537 National Phase
--------------------------------------------------------------------------------
5.43 EP 0618814 Granted
--------------------------------------------------------------------------------
5.44 EP 98108774.5 Pending: div. of 5.43 (awaiting exam)
--------------------------------------------------------------------------------
5.45 Belgium 0618 814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.46 France 0618 814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.47 Germany P69228944.5-08 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.48 Ireland 0618814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.49 Italy 0618 814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.50 Netherlands 0618 814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.51 Spain 2,130,184 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.52 Gr. Britain 0618 814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
5.53 Switzerland 0618 814 Granted (expires 12/11/12)
--------------------------------------------------------------------------------
--------------------------------
Xxxxxxxx and Xxxxxxxx reference number in patent series 9310-0005.
ADJUVANT TECHNOLOGY
"ADJUVANT FORMULATION WITH ENHANCED IMMUNOGENIC ACTIVITY, AND RELATED
COMPOSITIONS AND METHODS"
o Issued U.S. Patent No. 5,951,988
Patent Report by Invention Printed: 02/17/2000
Reference Number: 9001-0023
ADJUVANT FORMULATION WITH ENHANCED IMMUNOGENIC ACTIVITY, AND RELATED
COMPOSITIONS AND METHODS
----------------------------------------------------------------------------------------------------------------------------
COUNTRY REFERENCE# TYPE FILED SERIAL # ISSUED PATENT# STATUS
TABLE>
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000 NEW 03/30/1983 08/039,990 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 R82 03/04/1986 08/610,694 ABANDONED
----------------------------------------------------------------------------------------------------------------------------
XXXXXX XXXXXX 0000-0000.00 CON 05/03/1995 08/463,837 09/14/1999 5,951,988 ISSUED
----------------------------------------------------------------------------------------------------------------------------
EXHIBIT "B"
ATTACHED TO AND FORMING PART OF THE VIDO TECHNOLOGY LICENSE
MADE BETWEEN
THE UNIVERSITY OF SASKATCHEWAN
- and -
METAMORPHIX-INTERNATIONAL INC.
Please see attached
---------------------------------------------------------------------------------------------------------
EXHIBIT B PRE-THRESHOLD
MANNER OF EXPLOITATION
OF TECHNOLOGY BY
LICENSEE ---------------------------------------------------------------------
DEFINITION OF "NET SALES" DEFINITION OF "OTHER
August 15, 2000 1.01(I) CONSIDERATION" ***
4.06
---------------------------------
"Conventional Sales" Stacked Royalty applies. Not Applicable
Conventional Sales Include
Defined 1.01(p) (I) Product delivery to Majority
JVs, Minority JVs and
sublicensees by Licensee
butr qualify for cost of
manufacturing deduction.
1.01 (p)(I)(VIII); 4.04 4.06 (ii)
---------------------------------------------------------------------------------------------------------
"VALUE ADDED RECEIPTS" Stacked Royalty applies Other Consideration
and "Value Added includes all payments
Arrangements" Payments based on sharing in connection with
of 'valued added benefits' arrangements giving
included, however, payments rise to Value Added
not caluclated on the basis of Receipts not
value added benefits calculated on basis
excluded of valude added
benefits, however in
respect of Product
delivery qualify for cost
of manufacturing
deduction
4.06 (I); 1.01(p)(II)
---------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------
POST-THRESHOLD
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DEFINITION OF "NET SALES" DEFINITION OF "OTHER
1.01(i) CONSIDERATION" MAXIMUM
Stacked Royalty applies. OF *** 4.07
Conventional Sales Not Applicable
include Product delivery
to Majority JVs,
Minority JVs and
sublicensees by Licensee
but qualify for cost of
manufacturing deduction
1.01(p) (I)((VIII); 4.04 4.06(i)
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Stacked Royalty applies Not Applicable
Payments based on sharing Certain payments
of value added benefits (payments other than
included. Certain payments initial license fees or
(initial license fees or similar upfronnt payments
similar upfront payments and and pyaments made on
made on the basis of the achievement of non-
achievement of non-sales sales related milestone
related milestones and a or a singular sales related
singular sales related mile- milestone) not calculated
stone) not calculated on on basis of sharing of
basis of value added benefits "value added benefits' are
are also included. included, however, in
respect of Product
delivery qualify for cost of
manufacturing deduction.
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EXHIBIT B PRE-THRESHOLD
MANNER OF EXPLOITATION
OF TECHNOLOGY BY
LICENSEE
August 15, 2000
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Defined 1.01 (p) (II); 1.01 (p) (II); 4.04
1.01 (w)
---------------------------------
"MAJORITY JOINT Inclusion in Net Sales of Licensee receipt of
VENTURE" (50%+) Licensee % share of Other Consideration
Has to extend by Majority JV Net Sales applies, however Other
arrangement (whether Consideration does not
or not sublicense) to Royalty is the lower of Stated include distributions of
Major Species - specifi- royalty or Stacked Royalty Licensee's share of
cally excludes Value by reference to Joint Venture accounting income
Added Arrangements royalty load
Defined 1.01(k); 1.01(w) 1.01(p)(III); 4.04 4.06(v)C
---------------------------------
A majority interest in a Same as Other Sublicense Same as Other
JV (50%+) in a Minor Minor Species Sublicnse - Minor
Species is not accorded Species
special consideration
and falls into Minor
Species Sublicense
category
---------------------------------
"MINORITY JOINT VENTURE" Stacked Royalty to be paid Other Consideration
(-50%) on Minority JV Net Sales applies: however,
Has to extend by Other Consideration
arrangement (whether does not include
or not sublicense) to Licensee share of
Major Species - profit as earned from
specifically excludes JV or distributions of
Value Added Licensee shares of
Arrangements accounting income.
Defined 1.01(1) 1.01(p)(VI); 4.04 4.06 (vi) C
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POST-THRESHOLD
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1.01(w); 4.04; 1.01(w); 4.06 (I)
1.01(p)(II), (VIII)
-----------------------------------------
Joint Venture Net Sales Stated Royalty applies
attract no payment obligation -
Applies only Pre-Threshold Other Consideration receipt
includes Licensee share of
profit as earned from
Majority JV, and that income
when distributed is
excluded
4.06(v)(A); 4.06 (v) (B).
Xxxxx as Other Sublicense - Same as Other Sublicense -
Minor Species Minor Species
Joint Venture Net Sales Stated Royalty applies
attract no payment obligation -
Applies only Pre-threshold
only Pre-Threshold Other
Consideration receipt
includes Licensee share of
profit as earned from
Majority JV, and that income
when distributed is excluded
4.06 (vi)(A); 4.06(vi)(B)
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EXHIBIT B PRE-THRESHOLD
MANNER OF EXPLOITATION
OF TECHNOLOGY BY
LICENSEE
August 15, 2000
---------------------------------------------------------------------------------------------------------
A minority JV (-50%) in Xxxxx as Other Sublicense- Same as Other
Minor Species is not Minor Species Sublicense - Minor
accorded special Species
consideration and falls
into Minor Species
Sublicense category
---------------------------------
"MAJOR SPECIES Required payment is the Other Consideration
SUBLICENSE" - LESSER OF: applies: provided
specifically excludes *** of Licensee's royalty payments made
Majority and Minority JV entitlements, or, (ii) Stacked by Major Species
and Value Added Royalty, on Major Species Sublicense are
Arrangements Sublicensee's Net Sales EXCLUDED from
other Consideration
Defined 1.01 (m) 4.02; 4.04 4.06 (iv) (A)
---------------------------------
"MINOR SPECIES No payment obligation All receipts are Other
SUBLICENSE" Consideration and
- not a Majority or include royalties paid
Minority Joint venture or by Minor Species
Major Species Sublicensee.
Sublicensee or Value
Added Arrangements
1.01 (n) 4.06 (iii)
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POST-THRESHOLD
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Same as Other Sublicense - Same as Other Sublicense -
Minor Species Minor Species
Sublicensee Net Sales attract Stated Royalty applies
no payment obligation -
Applies only Pre-Threshold Other Consideration receipt
includes royalty payments
made by Major Species
1.01(p)(VII) 4.06 (iv) (B)
No payment obligation All receipts re Other
Consideration and include
royalties paid by Minor
Species Sublicensee
1.01 (p) (V) 4.06 (iii)
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COMMENTS:
Stated Royalty = aggregate of individual Technology royalties set out in
4.01, SUBJECT TO 4.07
Stacked Royalty = Stated Royalties as affected by the provisions of 4.04
Other Consideration = as defined 1.01 (w) (option fees, license fees, other
cash payments, equity or other consideration of any kind,
if received from sublicensee) as modified by the specific
provisions of 4.06; 1.01(p)(II); 1.01(w)
Agreement references noted