Exhibit 4.2
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "Agreement"), effective the 11th day of
October__, 2000, is entered into
-BY-
YORK MEDICAL INC.
a corporation incorporated under the
laws of Ontario, having its principal place of business at
5045 Orbitor Drive, Building 11, Suite 400,
Mississauga, Ontario, L4W 4Y4, Canada
-AND-
BIOSTAR INC.
a corporation pursuant to the laws of the Dominion of Canada,
with its principal place of business located at
405-15 Innovation Blvd.
Saskatoon, SK, S7N 2X8, Canada
1. BACKGROUND
1.1 The Veterinary Infectious Disease Organization ("VIDO") a division of the
University of Saskatchewan, has developed and owns, amongst other things,
methods of producing and using proteins derived from Pasteurella
haemolytica which developments are the subject matter of an application
for a patent in the United States of America filed on or about April 7,
1989 bearing serial No. 07/335,018 entitled "Compositions and Treatments
for Pneumonia in Animals" and a continuation in part of such patent
application bearing serial No. 504,850 and filed on or about April 5, 1990
and an application for a patent filed in the United States of America on
or about October 16, 1991 bearing serial No. 07/779,171 entitled "Enhanced
Immunoreactivity Using Pasteurella Haemolytica Leukotoxin Chimeras" and a
continuation in part of such patent application filed on or about October
13, 1992 bearing serial No. 07/960,932, and patents and patent
applications originating therefrom all as more particularly described in
Exhibit "A" attached hereto (the "VIDO Assets");
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1.2 By a series of agreements culminating in an agreement entitled Pasteurella
Haemolytica Technology - Human Applications, effective August 15, 2000,
between VIDO and Biostar, attached hereto as Exhibit "C", (the
"VIDO/Biostar Agreement"), VIDO licensed the VIDO Assets to Biostar.
1.3 Pursuant to its licence of the VIDO Assets, Biostar has developed the VIDO
Assets and know-how in the field of GnRH vaccines and immunological
carriers based on Pasteurella haemolytica for humans by, amongst other
activities, performing preclinical investigations and a clinical
investigation of a certain product, Norelin (the "Biostar Assets").
1.4 York is a biopharmaceutical licensing and development company, with a
management group experienced in developing human pharmaceuticals in the
clinical fields of oncology and anti-infectives. In addition, the
management group has experience in partnering with multinational
pharmaceutical companies and other related business development and
commercialization activities.
1.5 Biostar has revealed to York certain information relating to the Biostar
Assets under terms of a confidentiality agreement dated April 12, 2000
(the "Confidentiality Agreement").
1.6 York and Biostar now wish to set forth the terms and conditions of an
agreement through which York shall acquire an exclusive worldwide license
to exploit certain of the Biostar Assets (the "Assets" as herein further
defined) for specific applications in the field of human medicine.
NOW THEREFORE, in consideration of the foregoing premises, the mutual covenants
and obligations hereinafter contained, and other good and valuable consideration
which is hereby acknowledged, Biostar and York agree as follows:
2. DEFINITIONS
As used herein, the following terms shall have the meanings set forth below:
2.1 "Affiliate" means any Company that is Controlled directly or indirectly by
a party hereto or any Company that directly or indirectly Controls a party
hereto, so that Affiliate shall include any parent or subsidiary of a
party hereto, or any directly or indirectly held subsidiary of a party
hereto.
2.2 "Assets" shall consist of Biostar's entitlements to the VIDO Assets
licensed to Biostar under the VIDO/Biostar Agreement and the Biostar
Assets existing and arising, including Norelin, IPS-21, Information,
Material and Patents, or related to Norelin, IPS-21 and immunological
carriers based on Pasteurella haemolytica that are or become owned or
controlled by Biostar and are useful to York for the purpose herein
licensed. For greater clarity, certain Assets includes, without limitation
those items listed in Exhibit "D".
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2.3 "Biostar" shall mean Biostar Inc., a corporation incorporated under the
federal laws of Canada, with its principal place of business located at
405-15 Innovation Blvd., Saskatoon, SK, S7N 2X8, Canada, and its
assignees.
2.4 "Company" means a corporation or other juridical entity.
2.5 "Control" or "Controlled" means the ownership, directly or indirectly, of
more than 50 % of voting rights attached to the issued and outstanding
voting shares of a Company.
2.6 "Effective Date" shall be the date first written above.
2.7 "Information" means information relating to the Assets made available to
York in accordance with this Agreement and the Confidentiality Agreement,
and includes but is not limited to, confidential information and know-how,
particularly but not exclusively including information relating to
production & manufacturing and to preclinical and clinical protocols and
results, IND applications, results and approvals.
2.8 "IPS-21" means the GnRH-carrier fusion protein [as defined by sequence in
Patents]
2.9 "Improvements" means products or processes the manufacture, use or sale of
which would infringe a Valid Claim.
2.10 "Licensed Territory" means all countries of the world.
2.11 "Licensed Field" means, and is limited to, the exploitation of the Assets
in respect of Licensed Products for use in humans, comprising
Gonadotrophin Hormone Releasing Hormone (GnRH), Pasteurella haemolytica
proteins or peptides combined with GnRH or Epidermal Growth Factor
Receptors or Epidermal Growth Factor Receptor Ligands as defined in
Exhibit "B" hereto, and for clarity excludes all products comprising GDF-8
or Myostatin, and further excludes applications of the Assets and the
Patents relating to the diagnosis, treatment, or prevention of infectious
diseases.
2.12 "Licensed Product" means all compositions, processes, methods of use, or
any part or combination thereof, that incorporates, is made or designed
from or with the aid of the Assets.
2.13 "Material" means the Pasteurella haemolytica proteins and peptides, and
the GnRH technology, and methods of producing and using them as described
in the Patents referenced in Exhibit "A" and further includes all
technical data and information and biological materials and reagents
useful in working with the subject matter of the Patents relating to the
within grant of license and which is in existence and owned by Biostar as
of the Effective Date;
2.14 "Net Sales" shall mean the total Net Sales Price of Licensed Product sold
by York, and any sub-licensees.
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2.15 "Net Sales Price" means during any period of time the total sales of
Licensed Product made by York or its Sub-licensees to third party
customers (who are not Sub-licensees) less discounts, rebates, samples and
freight charges, and taxes separately listed on such invoices, and less
the amount of any credits or refunds actually given by York or its
Sub-licensees for defective or returned Licensed Products. Net Sales Price
shall not include any consideration received by York or its Sub-licensees
for the sale, use or other disposition of Licensed Product prior to the
receipt of all regulatory approvals required to commence full commercial
sales of the Licensed Product in a given country, which are similar to
sales under a "treatment IND", "named patient sales", "compassionate use
sales", and the sale, use or other disposition of Licensed Product in the
course of clinical trials.
2.16 "Norelin" means IPS-21 in a form covered by a Valid Claim.
2.17 "Patents" means:
(a) the patents and applications summarized in Exhibit "A" and the
patents that issue from those applications;
(b) the patents and applications directed to Improvements;
(c) the patents granted pursuant to any patent application subsequently
filed that is based on the Assets;
(d) all divisions, continuations in whole and in part, reissues,
re-examinations, substitutes, extensions and foreign and
international counterparts of (1) and patents that mature therefrom;
(e) patents and patent applications that become owned or controlled by
Biostar related to Norelin and IPS-21 and which is included in the
definition of Assets; and
(f) patents and patent applications licensed to Biostar that Biostar is
permitted to sub-license related to Norelin and IPS-21 and which is
included in the definition of Assets.
For greater certainty, Patents includes the patents and applications
listed on the attached Exhibit "A", which may be updated from time to time
during the term of this Agreement.
2.18 "Sub-licensee" means a person or entity to whom York has sub-licensed all
or part of the rights granted to York by Biostar by this Agreement.
2.19 "Sub-Licensing Revenue" shall, unless otherwise agreed upon in writing,
mean the aggregate of all option fees, license fees, or other cash
payments, equity or other consideration of any kind that York receives in
respect of sub-licenses for or an assignment of any of the rights granted
to York under this Agreement.
2.20 "Valid Claim" means a granted claim for the Patents so long as such claim
shall not have been disclaimed or abandoned by the patentee or shall not
have been disallowed by a Patent Office, expired under the patent laws of
a country, or held invalid in a final decision rendered by a court,
government or tribunal of competent jurisdiction from which no appeal has
been, or can be, taken.
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2.21 "York" shall mean York Medical Inc., a corporation incorporated under the
laws of Ontario, having its principal place of business at 5045 Orbitor
Drive, Building 11, Suite 400, Mississauga, Ontario, L4W 4Y4, Canada, its
affiliates and assignees.
2.22 "York Medical Unit" means one common York Medical share and one warrant to
purchase one half of one common York Medical share. Two warrants shall
entitle the holder to purchase one common share at a share price that
either is CAD$ 9.00 per share, or is the share price used in the first of
any financing that is closed within 12 months from the execution of this
agreement, whichever share price is lower. The warrant shall be valid for
four years from the date of issue.
3. LICENSE GRANT
3.1 Biostar hereby grants to York for the Licensed Field and in the Licensed
Territory, a worldwide exclusive license to exploit the Assets,
particularly including but not limited to the Patents, to develop and have
developed, to make and have made (including contract production by a toll
manufacturer), to use and have used, and to sell or have sold, and
otherwise dispose of, Licensed Product.
3.2 The license granted pursuant to section 3.1 hereof shall be exclusive.
Notwithstanding the foregoing, the license is non-exclusive as to
diagnostic applications for Pasteurella haemolytica antibodies.
4. LICENSING CONSIDERATION AND MINIMUM REMUNERATIONS
4.1 In consideration of the rights granted by Biostar to York under this
Agreement, and upon delivery of the Assets listed in Exhibit "D", York
shall pay Biostar the consideration set out in this Section 4.
4.2 York shall pay to Biostar a license fee in the form of 50,000 York Medical
Units.
4.3 York shall further pay Biostar a milestone payment of 25,000 York Medical
Units on a date which is the earlier of (1) the date on which a human
first receives Licensed Product in a clinical trial directed by or for
York, and (2) the first anniversary of the Effective Date.
4.4 York shall pay to Biostar a royalty calculated on the Net Sales Price (the
"Royalty" or "Royalties") during the Term in accordance with the
following, subject only to those withholdings provided for in this
Agreement:
(a) if a Licensed Product infringes a Valid Claim, the Royalty shall be
four (4%) percent of the Net Sales Price; and
(b) if subsection 4.4(a) is not applicable, the Royalty shall be two
(2%) percent of the Net Sales Price.
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4.5 Notwithstanding section 4.4, with respect to sales made by Sub-licensees
(not including Affiliates or other Sub-licensees not at arm's length with
York) where York is in receipt of royalties based on sales or other
commercial dispositions of Licensed Products made by such Sub-licensees,
York shall pay to Biostar the lesser of:
(a) ten (10%) percent of the net royalties payable to York by such
sub-licensees; and
(b) the amount otherwise due to Biostar pursuant to clause 4.4.
As used in section 4.5(a) above, "net royalties" means the gross amount of
royalties recoverable by York from such Sub-licensees after deduction of
applicable withholdings or similar taxes less any royalties or similar
payments that York has to make to any party other than Biostar in
connection with sales of Licensed Products. Furthermore, in jurisdictions
which restrict or prohibit the payment of funds out of the jurisdiction,
York shall have no obligation to make any payments to Biostar except from
and after Biostar electing to receive payment in such jurisdiction. If
Biostar makes such election in regards to any such jurisdiction, York's
obligation in respect of royalties in such jurisdiction shall not exceed
fifty (50%) percent of its royalty entitlements net of applicable taxes in
such jurisdiction.
4.6 In addition to the amounts payable under section 4.5, York shall remit to
Biostar ten (10%) percent of all Sub-Licensing Revenue.
5. COMMERCIALIZATION AND FURTHER RESEARCH
5.1 Upon execution of this Agreement, York, either acting for itself or
through a sub-licensee, shall ensure that reasonable commercial efforts
are used to commercialise the Licensed Product in the Licensed Field in
the Licensed Territory, in accordance with section 14.01 of the
VIDO/Biostar Agreement.
5.2 During the term of this Agreement, Biostar shall disclose as soon as
possible, and make available to York all Improvements owned or controlled
by Biostar or VIDO and other Information and Material relating to the
Assets which shall be dealt with in accordance with the terms and
conditions of this Agreement.
5.3 Biostar shall disclose and provide to York, and York shall be entitled to
exploit the Assets so as to enable York to perform its obligations and
enjoy the rights granted under this Agreement. Biostar shall provide to
York, at York's request and expense, all further assistance reasonably
available from Biostar to enable York or its sub-licensee to commercialize
the Licensed Product for a period of one (1) year following the Effective
Date.
5.4 Information, Material, as well as Patents and further Improvements owned
or controlled by Biostar or VIDO, that are available from Biostar and
arise during the term of this Agreement are hereby licensed exclusively to
York under the terms and conditions stipulated in this Agreement.
5.5 Any Information, Material, Improvements, inventions or any patents that
are generated or invented solely and independently by York during the term
of this Agreement shall belong solely to York.
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5.6 Any Information, Material, Improvements, and Patents therefor, that are
generated and/or invented jointly by Biostar and York or their employees
or consultants during the term of this Agreement shall be owned jointly by
Biostar and York and constitute an Asset. Biostar's interest in this Asset
shall be hereby licensed exclusively to York under the terms and
conditions stipulated herein.
5.7 For the purpose of this Agreement, determination of inventorship shall be
made in accordance with patent laws in force in the United States of
America from time to time.
5.8 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 or
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 Assets,
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;
(b) it is or becomes part of the public domain through no fault of the
Recipient;
(c) it is known to the Recipient or its permitted sub-licensees, prior
to disclosure by the Discloser;
(d) it is subsequently legally obtained by the Recipient or its
sub-licensees from a third party under circumstances which do not
constitute a breach of this clause; or
(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.
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5.9 Each of the parties shall use its reasonable best efforts to preserve
the secrecy of Confidential Information and shall only disclose it to:
(a) employee or employees of any licensor of the Assets or of permitted
Sub-licensees of the Assets, who are required to know the same for
performance of their duties and who have entered into appropriate
confidentiality agreements;
(b) such Government officials as are required for the purpose of
obtaining all necessary regulatory approvals for the purpose of
commercializing any Licensed 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; and
(c) to a person or entity strictly for bona fide business purposes
including for negotiation of a bona fide financing of York or for
the purpose of Sub-Licensing by York, so long as the person or
entity to whom the Confidential Information is disclosed executes an
agreement to keep such information confidential.
Neither Biostar nor York shall submit any manuscript, abstract, or like
document for written or oral publication if it includes data or other
information generated or provided by the other party or by VIDO without
first obtaining the prior express written consent of the party generating
or providing the data or other information, which consent shall not be
unreasonably withheld. The contribution of the contributor shall be noted
in all publications or presentations by acknowledgment or co-authorship,
whichever is appropriate.
6. SUB-LICENSING AND ASSIGNMENT
6.1 York shall have the right to grant sub-licenses of its rights and
obligations contained in this Agreement. Such sub-licenses shall be on
fair and reasonable terms and conditions consistent with the terms and
conditions set out in this Agreement. The sub-licenses may, at York's sole
election, be either exclusive or non-exclusive. At all times York shall
protect the rights of Biostar in any such sub-licenses as set forth in
this Agreement.
6.2 Subject to the other party's prior written consent, either party shall
have the right to assign, in whole or in part, this Agreement together
with the rights and obligations herein. Such consent shall not be
unreasonably withheld or delayed. Notwithstanding the foregoing, York is
entitled to assign its rights and obligations to an Affiliate without the
consent of Biostar so long as the organization remains an Affiliate of
York. In the event assignment is made to an Affiliate entity, and
subsequent to such assignment the status of the entity changes such that
the entity is no longer an Affiliate of York, York agrees to seek the
consent of Biostar for the continued operation of a subject sub-license.
In the event Biostar does not provide such consent, York agrees to cancel
any sub-license with the former Affiliate.
Notwithstanding any of the foregoing, the parties agree that no assignment
proposed by an assignor to an assignee shall be valid unless the assignor
acquires from the assignee an executed written acknowledgment in favour of
the non-assigning party to be bound by the terms and conditions of this
Agreement.
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6.3 York agrees to apprise Biostar of any material discussions in which York
is engaged respecting sub-licensing, assignment or disposal of its rights
under this Agreement, and shall provide Biostar with a copy of all
agreements regarding sub-licensing, assignment or disposal of rights
granted York under this Agreement.
7. PAYMENTS
7.1 Within ninety (90) days of the end of each calendar quarter commencing
with the first calendar quarter in which sale of Licensed Products is made
in any jurisdiction by York, its assignees or its sub-licensees, Biostar
shall be furnished a written statement of milestones achieved, and of all
Net Sales and Sub-licensing Revenues received, if any, for the calendar
quarter, and shall be paid all amounts due. If no Net Sales or
Sub-licensing Revenues are received by York, its assignees or its
sub-licensees during the calendar quarter, a written statement to that
effect shall be furnished.
7.2 If this Agreement is terminated for any reason before all of the payments
herein provided for have been made, York shall submit a final report and
pay any remaining unpaid balance which has accrued as soon as all revenue
reporting is available and in any event no later than 90 days after
termination.
7.3 Payment provided for in this Agreement, when overdue, shall bear interest
at a rate per annum equal to five percent (5 %) in excess of the prime
rate at the Canadian Imperial Bank of Commerce (CIBC), as may be in effect
from time to time.
8. PATENT RIGHTS AND PATENT INFRINGEMENT
8.1 The Parties acknowledge that VIDO has granted a license to Novartis in
respect of the Material and the Patents including a license granted 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").
8.2 The Parties also acknowledge that VIDO has granted a further license to
MMI in respect of the Material and the Patents for use in
immunopharmaceutical products based upon leukotoxin carrier, GnRH, or VIP
for use in non-humans (other than for use in vaccines for the prevention
of infectious diseases in animals) and technology relating to the GDF-8
protein, but as more particularly described in such license dated as and
from August 15, 2000, a copy of which has been provided to Licensee
(herein the "MMI License").
8.3 Pursuant to the provisions of Article VI and Article VII of the Novartis
License and of the MMI License, respectively, the licensee thereunder
(such licensees, successors and assigns herein referred to as "Novartis"
and "MMI" respectively) has several entitlements, obligations or
responsibilities including the following:
(a) to file applications, to prosecute and maintain the Patents
including additions, continuations, divisions and the like thereto;
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(b) to discontinue prosecutions and applications and to advise and
provide VIDO with the option to proceed with filings, applications
and prosecutions;
(c) to regularly apprise VIDO and, at VIDO's direction on a confidential
basis, VIDO's other licensees of the Patents of the status of patent
applications and of approved patents;
(d) to make to VIDO and, at VIDO's direction on a confidential basis, to
other licensees of the Patents who have an interest in an
application or registration respecting a Patent complete disclosure
other than a disclosure which specifically relates to the license
granted under the Novartis License or under the MMI License and
which does not affect such other licensee's interest in the Patents;
(e) to consult with VIDO and, at VIDO's direction on a confidential
basis, its other licensees of the Patents respecting any actions or
prosecutions affecting Patents and to insure that any actions of
Novartis or of MMI do not adversely affect such other licensees
without the prior written consent of Licensor; and
(f) to cooperate with VIDO and, at VIDO's direction on a confidential
basis, VIDO's other licensees of the Patents in the application,
prosecution and filing of any continuations, continuations-in-part,
divisions, patents of additions, re-issues, renewals and extensions,
further applications or defence of the Patents desired by VIDO or
affecting such other licensees provided that the same is not adverse
to the rights of Novartis or of MMI under the Patents. Novartis and
MMI are entitled to reimbursement by Licensor of their out of pocket
expenditures incurred in providing such cooperation which is to be
reimbursed to Licensor by a licensee hereunder.
8.4 Pursuant to Article 6.02 of the VIDO/Biostar Agreement, VIDO agreed with
Biostar, in respect of the licence granted thereunder, to:
(a) make all directions in favour of Biostar to Novartis as directions
are contemplated by the provisions of the Novartis License, and to
MMI as directions are contemplated by the provisions of the MMI
License, and to maintain and not withdraw such directions without
Biostar's consent; and
(b) obtain Biostar's written consent prior to providing any consent or
approval affecting the Patents as contemplated or requested pursuant
to the Novartis License or the MMI License; and
(c) to cooperate with Biostar in the application, prosecution and filing
of any continuations, continuations-in-part, divisions, patents of
additions, re-issues, renewals and extensions, further applications
or defence of the Patents desired by Biostar (and effecting the
applicable directions contemplated under the Novartis License and
the MMI License) and to insure that Novartis and MMI do likewise to
the extent possible pursuant to the Novartis License and the MMI
License, all subject to Biostar's obligation to reimburse VIDO,
Novartis, and MMI for their respective out of pocket expenditures
incurred in providing such cooperation; and
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(d) to provide Biostar the opportunity to commence or continue the
prosecution and maintenance of patents that Novartis or MMI may
determine under its license not to make or pursue, for inclusion
under the VIDO/Biostar Agreement; and
(e) not to amend the Novartis License or the MMI License in a manner
adverse to the rights and entitlements of Licensee contemplated
hereunder without the Biostar's written consent.
8.5 Biostar hereby agrees with York, with respect to the scope of the within
grant of license to:
(a) make all directions in favour of York to VIDO as directions are
contemplated by the provisions of the Novartis License and the MMI
License, and to maintain and not withdraw such directions without
York's consent; and
(b) obtain York's written consent prior to providing any consent or
approval affecting the Patents as contemplated or requested pursuant
to the Novartis License or the MMI License; and
(c) to cooperate with York in the application, prosecution and filing of
any continuations, continuations-in-part, divisions, patents of
additions, re-issues, renewals and extensions, further applications
or defence of the Patents desired by York (and effecting the
applicable directions contemplated under the Novartis License and
the MMI License) and to insure that VIDO instructs Novartis and MMI
to do likewise to the extent possible pursuant to the Novartis
License and the MMI License, all subject to York's obligation to
reimburse Biostar, VIDO, Novartis, and MMI for their respective out
of pocket expenditures incurred in providing such cooperation; and
(d) to provide York the opportunity to commence or continue the
prosecution and maintenance of patents that Biostar, Novartis or MMI
may determine under its license not to make or pursue, for inclusion
under this Agreement;
(e) not to provide its consent to VIDO's amendment of the Novartis
License or the MMI License in a manner adverse to the rights and
entitlements of York contemplated hereunder without York's express
written consent.
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8.6 All patent applications undertaken by York in accordance with this
Agreement shall be undertaken in the name and on behalf of the University
of Saskatchewan. York 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 Patents in full force
and effect except to the extent the responsibility resides with Novartis
or MMI, pursuant to the Novartis License or the MMI License. The selection
of the patent agents chosen to prosecute applications pursued
independently by York shall be in the sole discretion of York. Other than
as contemplated by 8.7, Biostar shall cooperate with York in prosecuting
such application at no expense to York other than reimbursement for
out-of-pocket expenses that York approves prior to their being incurred.
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8.7 At the request of York, Biostar shall obtain from VIDO such personnel as
may be available to it for purposes of consultation with and presentations
to governmental authorities in respect of the Patents and York shall
reimburse Biostar for any compensation invoiced by VIDO for such
participation of such personnel.
8.8 With respect to the Patents which are not the subject of the Novartis
License or the MMI License, the following provisions will apply:
(a) All patent applications undertaken by York in accordance with this
Agreement shall be undertaken in the name and on behalf of the
University of Saskatchewan. York 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 full force and effect. The selection of the
patent agents chosen to prosecute such applications shall be in the
sole discretion of the York. Biostar shall cooperate with, and shall
seek VIDO's co-operation with York in prosecuting such applications
at no expense to York other than reimbursement for out-of-pocket
expenses that York approves prior to their being incurred. York's
obligations under this section 8.8 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.
York shall regularly apprise Biostar, and, at Biostar's direction on
a confidential basis, VIDO of the status of patent applications and
of approved patents. York shall be entitled to reimbursement of its
out of pocket expenditures incurred in providing such cooperation to
VIDO.
(b) Applications for 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 filed shall be in the sole
discretion of the York. York shall advise Biostar 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 Patents in jurisdictions where York chooses not
to file, Biostar may file and prosecute an application at its own
expense. With respect to any jurisdiction in which Biostar obtains a
patent as contemplated by this clause, York shall not have any
rights under this Agreement provided this does not adversely affect
the ability of York to exercise its rights granted hereunder with
respect to the other jurisdictions to which this Agreement applies.
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(c) York shall have the option of discontinuing the prosecution of an
application for a Patent or not filing an application based on the
Material or any Improvement in accordance with this section 8.8. If
York's patent agents provide a written opinion to the effect that an
application for a Patent does not warrant the expense of further
prosecution, or that an aspect of the Material or any Improvement
(which Biostar considers patentable) does not warrant the expense of
an application York may, in its sole discretion, refuse to proceed
with such prosecution or application. If York exercises such option,
it shall so advise Biostar in writing and provide Biostar with a
copy of the opinion of the patent agents on which such decision is
based. Biostar may, in its sole discretion, file and prosecute, or
continue the prosecution, as the case may be, of such an
application, and any patents so obtained shall not be the subject of
this license.
9. PATENT PROTECTION AND INFRINGEMENT
9.1 York and Biostar shall promptly advise each other of any infringement or
suspected infringement of the Patents by a third party. Subject to any
subsequent agreement as to the conduct of any such action:
(a) York, or its Sub-licensees, or both, may institute a suit and,
subject to the provisions hereinafter appearing, join Biostar as a
plaintiff in which case York and its Sub-licensees, 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 York and its Sub-licensees choose not to institute a suit as
provided for in subsection 9.1(a) above, Biostar may institute a
suit in which case Biostar 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.
If York and its Sub-licensees exercise their right to commence a suit,
Biostar shall not be added as a party until its consent to being added as
a party is obtained and until Biostar is provided with an indemnity
agreement from York and its Sub- Licensees against all costs, expenses and
damages which Biostar may incur as a result of such cooperation. Such
indemnity agreement shall be in a form satisfactory to Biostar's
solicitors and be supported by such reasonable assurances in support of
such indemnity as Biostar considers appropriate in the circumstances.
9.2 Should Biostar or York (which includes for purposes of this section York's
Sub-licensees) commence a suit in accordance with section 9.1 and
subsequently elect to abandon such suit, Biostar or York, 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.
9.3 If York or its Sub-licensees recover profits or damages, or both, from the
alleged infringer, by settlement or otherwise, such profits or damages
shall be applied for the following purposes and in the following order:
(a) against legal and other expenses of the suit;
(b) against liabilities of York or Biostar resulting from the suit; and
14
(c) to Biostar in accordance with section 4.6, wherein such money shall
be considered Sub-Licensing Revenue.
However, if any such infringement suit results in an adverse judgment and
all of the Patents are wholly invalidated, Royalties shall be adjusted in
accordance with section 4.4(b) as and from the date of judgment.
9.4 If the royalties payable to Biostar and other third parties would exceed
eight (8%) percent of Net Sales for a Licensed Product that infringes a
Valid Claim or claims of the Patents (the "Patent Royalty Ceiling") then
the Royalty rate provided for in clause 4.4(a) shall be reduced by
one-half of the collective royalties in excess of the Patent Royalty
Ceiling otherwise payable by York to Biostar and other third parties. York
shall use reasonable efforts to ensure that any royalty reduction
necessary under this clause is allocated between the Biostar and such
third party in an equitable manner. However, notwithstanding the
foregoing, under no circumstances shall the Royalty rates provided for
under clause 4.4(a) be reduced to less than one-half (1/2) of the amount
otherwise determinable under that clause.
9.5 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 Licensed Products by York or its
Sub-licensees.
9.6 The entitlements of York under this section 9 are limited to third party
infringements of the applications which are the subject of this Agreement.
10. REPRESENTATIONS AND WARRANTIES
10.1 Biostar represents and warrants:
(a) to its knowledge that VIDO is the sole owner of the Patents and of
the inventions claimed therein and that VIDO has licensed the rights
to such invention to Biostar as documented in Exhibit "C";
(b) that it has not entered into any agreement regarding the Licensed
Product, whether in writing or verbally, with any other person that
is inconsistent with the terms of this Agreement; and
(c) that Biostar has the capacity and authority to enter into this
Agreement.
10.2 York represents and warrants:
(a) that it has the capacity and authority to enter into this Agreement;
(b) that it has obtained any approvals required under its Articles of
Incorporation so as to permit Biostar to transfer to VIDO, in
accordance with the VIDO/Biostar Agreement, York Medical Units; and
16
(c) that Biostar's transfer to VIDO of York Medical Units pursuant to
the VIDO/Biostar Agreement will not be precluded by the provisions
of article 9(a) of York's Articles of Incorporation, or any clause
of similar effect.
10.3 Biostar shall not have any liability whatsoever to York or any other
person for or on account of any injury, loss, or damage, or any kind or
nature, sustained by, or any damage assessed or asserted against, or any
other liability incurred by or imposed upon York or any other person,
arising out of or in connection with or resulting from (1) the
manufacture, use, or sale of any Licensed Product; or (2) any advertising
or other promotional activities with respect to any of the foregoing.
10.4 York, at its own expense and at all times during the term of this
Agreement, will carry and maintain in full force and effect comprehensive
general liability insurance, including product liability provisions, in a
form and with a carrier acceptable in the pharmaceutical industry. The
limits of such policy shall be sufficient at all times for York's then
current activities under this Agreement, and customary for York's business
within the industry.
11. DISCLAIMER OF WARRANTIES
11.1 The parties acknowledge and agree that nothing in this Agreement is or
shall be construed as being:
(a) a warranty or representation by Biostar as to whether any Patents
based on the Material will issue or the validity or scope of the
Patents once issued;
(b) a warranty or representation by Biostar that Licensed Products made,
used, sold or otherwise disposed of by York are and will be free
from infringement of patents, copyrights, trademarks or other
proprietary interests of any third party;
(c) an obligation on Biostar to bring or prosecute actions or suits
against third parties for infringement of the Patents or other
proprietary rights under any circumstances;
(d) the conferring of any rights to use in advertising, publicity or
otherwise any trademark or the name of Biostar, VIDO, or of the
University of Saskatchewan or any employee, agent or person
otherwise associated with any of these institutions;
(e) a grant by implication, estoppel or otherwise of any license to any
patents or other confidential proprietary information of Biostar
other than the Patents and Material; or
17
(f) a representation or warranty, whether express or implied, by Biostar
of merchantability or fitness for a particular purpose, nor a
representation or warranty by Biostar that it shall bear any
liability to York whatsoever by reason of any loss or damage
sustained by York, its employees, or any third party arising out of
the production, use, sale or other disposal of licensed products or
arising directly or indirectly out of the use by York of the patents
and material 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.
12. INDEMNITY
12.1 York shall indemnify, hold harmless and defend Biostar and its officers,
employees and agents against any and all claims arising out of the
exercise by York 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 Patents and
Material by York, it Sub-licensees or its customers in any manner
whatsoever or the production, use, sale, or lease of Licensed Products by
York, its sub-licensees or its customers in any manner whatsoever, with
the general exception of any damage or loss directly resulting from acts
or omissions constituting bad faith, wilful misfeasance, gross negligence
or reckless disregard of duties under this Agreement by Biostar or its
officers, employees or agents acting in such capacity on behalf of
Biostar.
12.2 Biostar shall indemnify, hold harmless and defend York and its officers,
employees and agents against any and all claims arising out of a breach of
any representations or warranties made by Biostar in this Agreement, and
the breach by Biostar of any of its obligations in this Agreement.
13. TERM AND TERMINATION
13.1 This Agreement shall commence on the Effective Date and, unless terminated
sooner, in accordance with the terms hereof, shall remain in force as long
as any Patent contains a Valid Claim in any part of the Licensed
Territory.
13.2 In the event either party shall be in default in the performance of any of
its material obligations hereunder, including, but not limited to, breach
of representation or warranty, and if the default has not been remedied
within ninety (90) days following the date of receipt of a notice in
writing from the other party specifying such default and its claim of a
right to terminate, the other party may terminate this Agreement by
written notice to the defaulting party in addition to any other remedies
available to it by law or equity.
It is understood that termination pursuant to this section 13.2 shall be a
remedy of last resort, and the arbitrators may enter an award terminating
only where the default of either party cannot be reasonably remedied by
the payment of money damages.
18
13.3 Either party shall have the right to terminate this Agreement with
immediate effect if the other party should enter into liquidation, either
voluntary or compulsory, or become insolvent, or institutes any
proceedings for the winding up of its business, or if execution be levied
on any goods and effects of the other party, or the other party should
enter into receivership or bankruptcy.
13.4 York may voluntarily terminate this Agreement, without cause, at any time
on ninety (90) days written notice. Termination will take effect
immediately at the end of the notice period.
13.5 Upon the termination of this Agreement for any reason York shall make no
further use of the Assets or derivatives therefrom. York shall discontinue
to use and exploit the Assets or other derivatives therefrom and shall
promptly return all paper, data, drawings, manuals, specifications,
descriptions and material of any kind supplied to it hereunder. York
shall, when transmitting such material, acknowledge in writing that the
documentation thus transmitted is complete and that York does not retain
any copies thereof.
13.6 This section 13.6 and the following rights and obligations shall survive
any termination of this Agreement to the degree necessary to permit their
complete fulfilment or discharge;
(a) York's obligation to supply a final report as specified in section
7.2 of this Agreement.
(b) Biostar's right to receive or recover and York's obligation to pay
amounts pursuant to section 4 and section 7.3 of this Agreement,
accrued up to and including the date of termination.
(c) York's obligation to maintain records and make them available under
section 14 of this Agreement.
(d) The representations, warranties and indemnities under section 10 of
this Agreement.
13.7 The parties agree that termination of this Agreement by Biostar shall not
affect the rights of any Sub-licensee which at the time of termination is
in good standing under its sub-licensing agreement with York. In the event
of such termination, Biostar shall step in to the sub-licensing agreement
which shall continue, mutatis mutandis, so that all rights and obligations
of the Sub-licensee are retained in accordance with that sub-licensing
agreement.
13.8 Notwithstanding section 13.7, in the event that Biostar terminates this
Agreement as a result of the termination of the VIDO/Biostar Agreement,
Biostar shall have no obligations to any Sub-licensee,. York agrees that
in case of termination of this Agreement by Biostar resulting from the
termination of the VIDO/Biostar Agreement, it shall terminate all
sub-licenses then in effect for the rights granted to York under this
Agreement.
13.9 The obligations of confidentiality as provided in this Agreement will
survive termination of this Agreement for a period of ten (10) years post
termination.
19
13.10 Termination of this Agreement by either party shall not take effect while
any dispute is being arbitrated pursuant to section 18.
13.11 Biostar agrees that while this Agreement is in force it shall maintain a
corporate existence, and shall not institute any proceeding for the
winding up of its business.
14. RECORDS
14.1 York shall keep accurate records relating to all matters relevant to this
Agreement (including payments due hereunder) and shall permit Biostar or
its duly authorized representative to inspect all such records and to make
copies of or extracts from such records during regular business hours and
on reasonable notice throughout the term of this Agreement and for a
period of six (6) years thereafter. York shall fully co-operate at such
inspection and shall give any explanations that may be requested. If any
such inspection discloses any underpayment of royalties, York shall
promptly pay the amount of any shortfall at the rate determined in
accordance with section 4 and section 7.3 hereof from the date such
payment was due until the date that York pays this shortfall.
14.2 York shall at each time of payment of royalties render a report to Biostar
including copies of the Sub-licensee reports to York, giving an accurate
account of total manufacture and sale of Licensed Product and
Sub-Licensing Revenues during the preceding quarter.
15. SEVERABILITY
15.1 The parties agree that if any part, term, or provision of this Agreement
shall be found illegal or in conflict with any applicable law, the
validity of the remaining provisions shall not be affected thereby.
16. USE OF LICENSOR'S NAME
16.1 Neither York nor Biostar shall use the other party's name or trademark,
nor the name of any employee or agent, in any advertising or promotional
material or publicity release relating to the Assets or the Licensed
Products without prior written consent from the other party, which consent
shall not be unreasonably withheld.
17. WAIVER, INTEGRATION, ALTERATION
17.1 The waiver of a breach hereunder may be effected only by a written
document signed by the waiving party and shall not constitute a waiver of
any other breach.
17.2 A provision of this Agreement may be altered only by a written document
signed by both the parties, except as provided in section 15.
20
18. DISPUTE RESOLUTION
18.1 If the parties are unable to resolve any dispute arising under this
Agreement, such matter shall first be referred for resolution to the
Presidents of Biostar and York. In the event that no resolution is reached
within 10 business days following such referral, or such further period as
the Presidents may mutually agree, resolution of the dispute shall be
determined by arbitration to be held in the English language in Saskatoon,
Saskatchewan, in accordance with The Arbitration Act, 1992, Statutes of
Saskatchewan, or its successor legislation, as may be in force from time
to time.
19. APPLICABLE LAW
19.1 This Agreement shall be governed and construed in accordance with the laws
of Saskatchewan, and any federal laws applicable therein, and the parties
hereby attorn to the jurisdiction of the Courts of the Province of
Saskatchewan.
20. NOTICES UNDER THE AGREEMENT
20.1 All written communications and notices between the parties shall be
delivered personally or by courier, sent by prepaid mail, registered mail
or facsimile transmission to the attention of the party at the addresses
provided below, or any other addresses of which either party shall notify
the other party in writing. Any notice, if delivered personally or by
courier, will be deemed to have been given when actually received; if
transmitted by fax before 3:00 p.m. on a business day, will be deemed to
have been given on that business day; and if transmitted by fax after 3:00
p.m. on a business day, will be deemed to have been given on the first
business day following the date of transmission.
If to York: The President
York Medical Inc.
5045 Orbitor Drive, Building 11, Suite 400
Mississauga, Ontario L4W 4Y4, Canada
Facsimile: (905) 629-4959
If to Biostar: The President
Biostar Inc.
405-15 Innovation Blvd.
Saskatoon, Saskatchewan, S7N 2X8, Canada
Facsimile: (306) 651-1931
21. EXTENDED MEANING
21.1 The use of the singular in this Agreement shall include the plural and
vice versa.
21
22. FORCE MAJEURE
22.1 The parties shall be relieved from liability for a failure to perform any
obligation under this Agreement during such period and to the extent that
the due performance thereof by either of the parties is prevented by
reason of any circumstance beyond the control of the parties, such as war,
warlike hostilities, mobilization or general military call-up, civil war,
fire, flood or other circumstances of similar importance.
22.2 The party desiring to invoke an event of force majeure shall give
immediate notice to the other party of the commencement and the cessation
of such event of force majeure, failing which the party shall not be
discharged from liability for any non-performance caused by such event of
force majeure.
22.3 Both parties shall make all reasonable efforts to prevent and reduce the
effect of any non-performance of this Agreement caused by an event of
force majeure.
23. CURRENCY
23.1 All amounts due under this Agreement shall be paid in Canadian currency
and shall be calculated into Canadian currency using the exchange rate
published in the Wall Street Journal on the date that the payment is due.
24. COUNTERPARTS AND FACSIMILE
24.1 This Agreement and any amendment, supplement, restatement or termination
of any provision of this Agreement may be executed and delivered in any
number of counterparts, each of which when delivered is an original and
all of which taken together constitute one and the same instrument. A
party's transmission by facsimile of a copy of this Agreement duly
executed by that party shall constitute effective delivery by that party
of an executed copy of this Agreement to the party receiving the
transmission. A party that has received this Agreement by facsimile shall
forthwith deliver an originally executed copy to the other party.
25. ENTIRE AGREEMENT
25.1 This Agreement represents the entire understanding between the parties,
and supersedes all other agreements, express or implied, between the
parties concerning ASSETS.
IN WITNESS WHEREOF the parties have caused this Agreement to be executed by
their duly authorized officers on the respective dates and at the respective
places hereinafter set forth.
22
Mississauga / 2000 Saskatoon / 2000
YORK MEDICAL INC. BIOSTAR INC.
"David G.P. Allan" "Brad Munro"
--------------------------- --------------------------
By: Mr. David G.P. Allan By: Brad Munro
Title: Chairman and Chief Executive Title: President and Chief
Officer Executive Officer
At: Mississauga, Ontario At: Saskatoon, Saskatchewan
"Niclas Stiernholm" "Todd L Lahti"
--------------------------- --------------------------
By: Dr. Niclas Stiernholm By: Todd L Lahti
Title: Director, Science & Technology Title: Treasurer
At: Mississauga, Ontario At: Saskatoon, Saskatchewan
23
EXHIBIT "A"
PATENTS AND PATENT APPLICATIONS
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 9001-0016. The symbol [x] indicates
patents for which Novartis is charged with the maintenance and prosecution under
the provisions of the Novartis License, and the symbol [x] indicates patents for
which MMI is charged with the maintenance and prosecution under the provisions
of the MMI License.
1. Robins and Associates Patent Series 9001-0006
"COMPOSITIONS AND TREATMENTS FOR PNEUMONIA IN ANIMALS"
o Issued U.S. Patent No. 5,849,531 [x]
"LEUKOTOXIN VACCINE COMPOSITIONS AND USES THEREOF"
o Issued U.S. Patent No. 5,871,750 [x]
"PASTEURELLA HAEMOLYTICA LEUKOTOXIN COMPOSITIONS AND USES THEREOF"
o Issued U.S. Patent No. 5,476,657 [x]
(continued on next page)
24
2. Robins and Associates Patent Series 9001-0016
"ENHANCED IMMUNOGENICITY USING LEUKOTOXIN CHIMERAS"
o U.S. Application 08/976,566 [x]
o U.S. Patent 5,708,155 [x]
o U.S. Patent 5,422,110 [x]
"GNRH LEUKOTOXIN CHIMERAS"
o U.S. Application 09/383,912 [x]
o U.S. Patent 5,969,126 [x]
o U.S. Patent 5,723,129 [x]
o U.S. Patent 5,837,268 [x]
o U.S. Patent 6,022,960 [x]
25
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
- --------------------------------------------------------------------------------------------------------------------------------
UNITED KINGDOM 9001-0006.53 DCA 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
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006 NEW 04/07/1989 07/335,018 ABANDONED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.20 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
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.02 CON 12/14/1994 08/355,919 02/16/1999 5,871,750 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.10 DIV 05/31/1995 08/455,510 12/15/1998 5,849,531 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0006.41 CEQ 04/06/1990 PCT/US90/01884 ABANDONED
- --------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0006.42 CEQ 05/25/1990 PCT/CA90/00170 NAT PHASE
- --------------------------------------------------------------------------------------------------------------------------------
Patent Report by Invention
Reference Number: 9001-0016
ENHANCED IMMUNOGENICITY USING LEUKOTOXIN CHIMERAS AND
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 PATENT CO 9001-0016.51 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
- --------------------------------------------------------------------------------------------------------------------------------
INDIA 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 KOREA 9001-0016.91 DCA 08/08/1997 PCT/CA97/00559 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
SOUTH KOREA 9001-0016.70 DCA 01/24/1996 70551397 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
SOUTH KOREA 9001-0016.92 DCA 08/08/1997 700109799 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
MEXICO 9001-0016.71 DCA 01/24/1996 976009 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
MEXICO 9001-0016.93 DCA 08/08/1997 PCT/CA97/00559 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
NORWAY 9001-0016.94 DCA 08/08/1997 19990533 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
NEW ZEALAND 9001-0016.72 DCA 01/24/1996 300125 04/29/1999 300125 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
NEW ZEALAND 9001-0016.95 DCA 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
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016 NEW 10/16/1991 07/779,171 ABANDONED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.20 CIP 10/14/1992 07/960,932 06/06/1995 5,422,110 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.21 CIP 02/10/1995 08/387,156 03/03/1998 5,723,129 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.10 DIV 05/31/1995 08/455,970 01/13/1998 5,708,155 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.22 CIP 08/09/1996 08/694,865 11/17/1998 5,837,268 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.11 DIV 06/19/1997 08/878,748 10/19/1999 5,969,126 ISSUED
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.01 CON 11/24/1997 08/976,566 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.12 DIV 07/29/1998 09/124,491 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.02 CON 08/26/1999 09/383,912 PENDING
- --------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0016.40 CEQ 10/15/1992 PCT/CA92/00449 ABANDONED
- --------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0016.60 CEQ 01/24/1996 PCT/CA96/00049 NAT PHASE
- --------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0016.80 CEQ 08/08/1997 PCT/CA97/00559 NAT PHASE
- --------------------------------------------------------------------------------------------------------------------------------
EXHIBIT "B"
Epidermal Growth Factor Receptors include:
HER1 (EGFR or ErbB1)
HER2 (neu or ErbB2)
HER3 (ErbB3)
HER4 (ErbB4)
Epidermal Growth Factor Receptors Ligands include:
Epidermal Growth Factor (EGF)
Transforming Growth Factor alpha (TGF--)
Amphiregulin
Heparin Binding Epidermal Growth Factor (HB-EGF)
Betacellulin
EXHIBIT C
PASTEURELLA HAEMOLYTICA TECHNOLOGY
HUMAN APPLICATIONS
THIS AGREEMENT made with effect as and from the Closing Date of an Asset
Purchase Agreement (as hereinafter defined) (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 120 Veterinary Road, on the campus of the
University of Saskatchewan, (hereinafter referred to as "Licensor" )
OF THE FIRST PART
- -and -
BIOSTAR INC., a corporation pursuant to the laws of the Dominion of Canada, with
is principal place of business located at #343 -111 Research Drive, Saskatoon,
Saskatchewan,
(hereinafter referred to as "Licensee")
OF THE SECOND PART
WI TNESSETH WHEREAS:
A. The Licensee and the Licensor entered into a series of license
agreements culminating in a consolidated and amended Pasteurella haemolytica
Vaccine and Technology license agreement dated February 29th, 2000 (the
"Original License");
B. Licensor has developed and owns, amongst other things, methods of
producing and using proteins derived from Pasteurella haemolytica which
developments are the subject matter of an application for a patent in the United
States of America filed on or about April 7, 1989 bearing serial No. 07/335,018
entitled "Compositions and Treatments for Pneumonia in Animals" and a
continuation in part of such patent application bearing serial No. 504,850 and
filed on or about April 5, 1990 and an application for a patent filed in the
United States of America on or about October 16, 1991 bearing serial No.
07/779,171 entitled "Enhanced Immunoreactivity Using Pasteurella Haemolytica
Leukotoxin Chimeras" and a continuation in part of such patent application filed
on or about October 13, 1992 bearing serial No. 07/960,932, and patents and
patent applications originating therefrom all as more particularly described in
Exhibit "A" attached;
C. The Original License was partially assigned with the consent of the
Licensor and as contemplated by the asset purchase agreement between the
Licensee and related parties and Metamorphix-Canada, Inc and related parties
dated for reference June 1, 2000 (herein the "Asset Purchase Agreement");
D. Pursuant to the terms of a VIDO Biostar Closing Agreement the Licensor
agreed to grant the within license to the Licensee which license effects a
license of certain human related technology in the form of the within license;
NOW THEREFORE, in consideration of the premises, 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) "Confidential Information" has the meaning given that term by clause
13.01;
(b) "Effective Date" means the date set forth on the face page of this
Agreement;
(c) "External Disclosure" has the meaning given that term by clause 13.03
(d) "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 for use in Products subject of the License granted herein.
(e) "License" has the meaning given that term by clause 2.01;
(f) "Licensed Technology" means the Pasteurella haemolytica proteins and
peptides, and the GnRH technology, and methods of producing and using them as
described in the Licensed Patents referenced in Exhibit "A" and further includes
all technical data and information and biological materials and reagents useful
in working with the subject matter of the Licensed Patents relating to the
within grant of license and which is in existence as of the Effective Date;
(g) "Licensed Patents" means any patents granted pursuant to the
applications referenced in Exhibit "A" or 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;
(h) "Net Sales" means during any period of time the total sales of
Products made by Licensee or Licensee's sublicensees to third party customers
(who are not sublicensees) less only 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-l, as amended;
2
(ii) extraordinary packaging and packing costs that relate to sales
to a particular customer and which are reimbursed by such customer;
(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 insurance;
Notwithstanding the foregoing, Net Sales for purposes of calculating royalties
on sales by sublicensees shall be as provided for in the applicable agreement
with such sublicensees including any allocations of the selling price of
Products as between Components and Licensed Technology or Licensed Patents, as
the case may be.
(i) This clause intentionally left blank.
(j) "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 anyone of the Products;
(k) "Royalty" and "Royalties" has the meaning given those terms by clauses
4.01 and 4.02;
(l) "Term" means the period of time during which Licensee is obligated to
pay Royalties on Products pursuant to clause 2.03;
(m) "Licensor" means for all purposes of this Agreement, other than the
enforcement of this Agreement by the University of Saskatchewan, 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 120 Veterinary Road on the campus of the
University of Saskatchewan, has a board of directors primarily composed of
persons not employed by Licensor 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 a license (the "License") in all jurisdictions of the
world to the Licensed Patents and Licensed Technology for the purpose of
developing, producing, exploiting, using, selling or otherwise commercially
3
exploiting or having developed, produced, used, sold or otherwise commercially
exploited Products for use in humans comprising Gonadotrophin Hormone Releasing
Hormone (GnRH), Pasteurella haemolytica proteins or peptides combined with GnRH
or Epidermal Growth Factor Receptors or Epidermal Growth Factor Receptor Ligands
as defined in Schedule "B", and for clarity excluding products comprising GDF-8
or myostatin, and further excluding applications of the Licensed Patents and
Licensed Technology relating to the diagnosis, treatment or prevention of
infectious disease.
2.02 Subject to the provisions of this Agreement, Licensor acknowledges that:
(a) the License is irrevocable during the Term; and
(b) the License is exclusive in all jurisdictions of the world during the
Term to the extent of the above grant and Licensor shall not produce, use, sell,
lease or otherwise commercially exploit within the scope of this License
Products other than for its own research purposes, nor shall, within the scope
of the above grant 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, the license is non-exclusive as to diagnostic applications for
Pasteurella haemolytica antibodies.
If, within the scope of the above grant, the Licensor wishes to provide a third
party with Products for research and educational purposes, or to license to a
third party within the scope of the above grant the Licensed Patents and
Licensed Technology for research and educational purposes, Licensor shall first
obtain Licensee's written consent. The granting or withholding of such consent
shall be in Licensee's sole and absolute discretion and any such consent will be
conditional, at Licensee's option, upon the beneficiary of such research and
educational license agreeing that Licensee shall have the right to make use of
any improvements conceived or developed by such beneficiary at no additional
cost to 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 and other payment obligations for such period as may be
specified in such notice 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.
4
2.04 Licensor shall, upon the request of and at the expense of 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.
2.05 Licensor shall, if it has not already done so, disclose the Licensed
Technology to Licensee within a reasonable period of time after the Effective
Date, and Licensor's personnel shall provide Licensee's personnel with
reasonable assistance in understanding and applying the Licensed Technology, for
reimbursement at Licensor's direct costs.
ARTICLE III
IMPROVEMENTS
3.01 During the Term, Licensor shall disclose and make available to 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 Licensee acknowledges that Licensor's obligations pursuant to clause 3.01
are conditional upon Licensor's continued existence. Improvements made by
employees of the University of Saskatchewan who are not employees of Licensor
are exempt from the operation of clause 3.01. In addition, Licensee acknowledges
that Licensor's ability to disclose and transfer Improvements may be limited by
Licensor's contractual obligations from time to time to third parties who
provide funding to support Licensor's various research and development programs.
Licensor shall, however, use all reasonable efforts to arrange its contractual
and funding obligations so as to be able to comply with clause 3.01.
ARTICLE IV
ROYALTIES
4.01 Licensee shall pay to Licensor a royalty on Net Sales (the "Royalty" or
Royalties") during the Term in accordance with the following subject only to
those withholdings 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, the
Royalty shall be four (4%) percent of Net Sales; and
(b) if 4.01(a) is not applicable, the Royalty shall be two (2%) percent of
Net Sales.
4.02 Notwithstanding Clause 4.01, with respect to sales made by sublicensees
where Licensee is in receipt of royalties based on sales or other commercial
dispositions of Products made by such sublicensees, Licensee shall pay to
Licensor the lesser of:
(a) twenty-five (25%) percent of the net royalties payable to Licensee by
such sublicensees; and
(b) the amount otherwise due to Licensor pursuant to Clause 4.01.
As used in subclause 4.02 (a) above, "net royalties" means the gross amount of
royalties recoverable by Licensee from such sublicensees after deduction of
5
applicable withholdings or similar taxes less any royalties or similar payments
that Licensee has to make to any party other than Licensor in connection with
sales of Products. Furthermore, in jurisdictions which restrict or prohibit the
payment of funds out of the jurisdiction, Licensee shall have no obligation to
make any payments to Licensor except from and after Licensor electing to receive
payment in such jurisdiction. If Licensor makes such election in regards to any
such jurisdiction, Licensee's obligation in respect of royalties in such
jurisdiction shall not exceed fifty (50%) percent of its royalty entitlements
net of applicable taxes in such jurisdiction.
4.03 This clause left intentionally blank.
4.04 If the Royalties payable to the Licensor and/or other third parties would
exceed seven (7%) percent of Net Sales for a Product that infringes a claim or
claims of the Licensed Patents or three and one-half percent (3 1/2 %) for a
Product that does not, 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 7%. 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. However, under no circumstances shall the Royalty rates provided for
under clause 4.01(a) and (b) be reduced to less than one-third (1/3) of the
amount otherwise determinable under such clauses.
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 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 Licensee to 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. Licensee acknowledges that the foregoing
constitutes the full extent of Licensor's liability to 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 clause 4.02, Licensee shall remit
to Licensor twenty-five (25%) percent of all option fees, license fees, or other
cash payments, equity or other consideration of any kind that Licensee receives
from Sublicensees, pursuant to sublicenses Licensee enters into as contemplated
by Article XI, other than payments that fall into the following categories:
(a) payments made on account of royalties pursuant to such sublicense;
(b) payments made to Licensee to fund research or development, or both, of
Product(s) to the extent that such payments are used for such purposes;
6
(c) payments made to reimburse Licensee for expenses incurred in the
research or development, or both, of Product(s); and
(d) payments made to reimburse Licensee for payments made to Licensor
under this Agreement.
Licensee shall be responsible for demonstrating to Licensor whether any payments
made to Licensee by a sublicensee fall into categories (a) through (d) above.
ARTICLE V
REPORTS, PAYMENTS AND ACCOUNT
5.01 Licensee shall make written reports and payments on account of Royalties to
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 Licensee or its sublicensees. Such written reports shall be
certified by a financial officer of Licensee and shall state the number of doses
sold and Net Sales made during the applicable calendar quarter and the
calculation of the payments due to Licensor pursuant to Article IV less any
credits provided for in this Agreement. Licensor acknowledges that Licensee may
integrate its written reports provided pursuant to this clause 5.01 into and
with the written reports that must be provided to Licensor pursuant to any other
license or similar agreements in force between Licensee and Licensor from time
to time. Licensee acknowledges that the credits against Royalties otherwise
payable provided by clause 7.03 or otherwise hereunder shall not entitle
Licensee to reduce any payment on account of Royalties to less than fifty (50%)
percent of the amount actually due 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, the
Licensee shall provide the Licensor with a report semi-annually as to the
activities of the Licensee with respect to the development and registration of
the Products carried on by the Licensee in such six month period and an updated
estimate by the Licensee of the date of commencement of sales of Product.
5.02 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 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,
Licensee shall similarly maintain all records provided to it by its
sublicensees. Licensee shall permit such books and records to be examined from
time to time by a chartered accountant designated by Licensor, and reasonably
acceptable to Licensee, for the purpose of conducting an audit of such written
reports. Licensor shall not conduct more than one (1) audit a year except as
hereinafter set forth. Audits shall be conducted by 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, Licensee shall pay
Licensor's audit expenses. Licensor may thereafter conduct more than one (1)
audit per year, which remedy shall be without prejudice to any other rights and
remedies Licensor may have as a result of such breach. In addition, the
7
difference between the amount of Royalties due and the amount of Royalties
actually paid shall be immediately paid to Licensee by Licensor, or to Licensor
by Licensee, as the case may be, with interest thereon calculated in accordance
with clause 5.05.
5.04 All amounts payable by Licensee to 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 posted by Licensee's bank
on the last day of the applicable calendar quarter.
5.05 All payments of whatever description owed to either party by the other
under this Agreement shall bear interest at the prime rate charged by Licensee's
bank 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 clause 5.04 to the sales of Products
made by sublicensees where the applicable sublicense agreement contains
provisions respecting conversion of funds to Canadian dollars, 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 separate licenses in
respect of the Licensed Technology and the Licensed Patents including a license
granted 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"). The Parties also acknowledge that Licensor has granted a
further licenses in respect of the Licensed Technology and the Licensed Patents
for use in immunopharmaceutical products based upon leukotoxin carrier, GnRH, or
VIP for use in non-humans (other than for use in vaccines for the prevention of
infectious diseases in animals) and technology relating to the GDF-8 protein,
but as more particularly described in such license dated as an from of the
Effective Date (as such terms are defined therein) a copy of which has been
provided to Licensee (herein the "MMI License"). Pursuant to the provisions of
Article VI and Article VII of both the Novartis License and the MMI License, the
licensee thereunder (such licensees, successors and assigns herein referred to
as "Novartis" and "MMI" respectively) 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;
B. to discontinue prosecutions and applications and to advise and provide
Licensor with the option to proceed with filings, applications and prosecutions;
C. 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;
8
D. 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 or the MMI License and which does not affect such other
licensee's interest in the Licensed Patent(s);
E. 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 or MMI do not adversely affect such other licensees without the prior
written consent of Licensor; and
F. 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-in-part,
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 or MMI under the Licensed Patents. Novartis and MMI are entitled to
reimbursement by Licensor of their out of pocket expenditures incurred in
providing such cooperation which is to be reimbursed to Licensor by the Licensee
hereunder.
6.02 Licensor agrees with Licensee with respect to the scope of the within grant
of license to:
A. make all directions in favour of Licensee, to Novartis as directions
are contemplated by the provisions of the Novartis License, and to MMI as
directions are contemplated by the provisions of the MMI License, and to
maintain and not withdraw such directions without Licensee's consent; and
B. 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 or the MMI License; and
C. 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 the MMI License) and to insure that
Novartis and MMI do likewise to the extent to do so pursuant to the Novartis
License and the MMI License, all subject to Licensee's obligation to reimburse
Licensor, Novartis, and MMI for their respective out of pocket expenditures
incurred in providing such cooperation; and
D. to provide Licensee the opportunity to commence or continue the
prosecution and maintenance of patents that Novartis or MMI may determine under
its license not to make or pursue for inclusion under this License; and
E. not to amend the Novartis License or the MMI License in a manner
adverse to the rights and entitlements of Licensee contemplated hereunder
without the Licensee's written consent.
9
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 or MMI, pursuant to the Novartis License and the MMI 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 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 full force and effect. The selection of the patent
agents chosen to prosecute such applications shall be in the sole discretion of
the Licensee. The 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 apprise 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 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.
10
(c) 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 be, of such an application, and any patents so obtained shall not be
the subject of this License and the Licensor may grant licenses for such patents
to any third party.
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.
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%) of its out-of-pocket expenditures, including legal fees and
disbursements, that are incurred in bringing and prosecuting such infringement
11
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, 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 Licensor has with such agencies;
and
(b) and has full power and authority to enter into this Agreement.
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 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 Licensor that Products made, used,
sold or otherwise disposed of by 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 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
12
(d) the conferring of any rights to use in advertising, publicity or
otherwise any trademark or the name of either 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 Licensor other than the
Licensed Patents and Licensed Technology; or
(1) A REPRESENTATION OR WARRANTY, WHETHER EXPRESS OR IMPLIED, BY LICENSOR OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NOR A REPRESENTATION OR
WARRANTY BY LICENSOR THAT IT SHALL BEAR ANY LIABILITY TO LICENSEE WHATSOEVER BY
REASON OF ANY LOSS OR DAMAGE SUSTAINED BY 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 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 Licensee shall indemnify, hold harmless and defend Licensor and its
officers, employees and agents against any and all claims arising out of the
exercise by 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 Licensee, it sublicensees or its customers in any manner
whatsoever or the production, use, sale, or lease of Products by Licensee, its
sublicensees or its customers in any manner whatsoever.
ARTICLE XI
SUBLICENSING
11.01 This Agreement has been entered into so that Licensee may commercialize
the Licensed Patents and Licensed Technology by the development, production, use
and marketing of Products. Accordingly, 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 Licensor's option if 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 Licensor of such breach.
13
12.02 This Agreement shall further terminate, at the option of Licensor, if:
(a) Licensee files an Assignment in Bankruptcy or is adjudged a bankrupt
or insolvent corporation; or
(b) 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 Licensee is appointed; or
(d) Licensee makes an assignment or attempted assignment for the benefit
of its creditors;
or
(e) 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 Licensee occurs.
12.03 If 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 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 Licensor may
have as a result of any actions by Licensee.
12.04 Licensee shall be entitled, at its option, to terminate this Agreement at
any time by giving 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. Licensee acknowledges that upon termination of
this Agreement by 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, Licensee shall cease production of Products
upon the effective date of termination and return all cell lines, reagents and
other biological material obtained from Licensor to Licensor. With respect to
the remaining stock of Products then in Licensee's possession, Licensor shall
have the option of purchasing such remaining stock from Licensee at and for a
price equal to the price that Licensee offers such Products to its third party
customers less ten (10%) percent, or by having Licensee destroy such remaining
stock of Products, and providing proof of such destruction to 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).
14
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 XIll; or
(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 Licensor nor 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 hot be unreasonably
withheld. The contribution of each party shall be noted in all publications or
presentations by acknowledgement or co-authorship, whichever is appropriate.
15
13.03 Licensee recognizes that Licensor has an obligation to publish and
disseminate scientific knowledge. 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
Licensee's, or both. Therefore, during the Term, 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 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. Licensee
shall review all External Disclosures to ascertain whether patentable subject
matter or commercially significant Confidential Information is disclosed.
Licensor shall only proceed with an External Disclosure upon receiving
Licensee's consent, which consent shall be deemed to have been given if Licensee
does not respond within a period of thirty (30) days from the date of submission
to Licensee of any particular External Disclosure. If requested by Licensee in
writing, 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 Licensor's written consent; or
(b) amend such External Disclosure so as to delete those portions which
constitute commercially significant Confidential Information; or both.
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 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 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 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 Licensee acknowledges and agrees that clause 13.03 shall not prohibit
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 Licensor or who derive a direct benefit from Licensor's
research activities as long as commercially significant Confidential Information
is not disclosed.
16
ARTICLE XIV
COMMERCIAL DUE DILIGENCE
14.01 Licensee shall make diligent efforts to introduce Products subject of the
License granted herein as soon and in as wide a market as is practicable and
consistent with sound and reasonable business practice and judgment. Licensor
shall have the right to terminate this Agreement on a jurisdiction by
jurisdiction basis, at any time after the Effective Date if, in Licensor's
reasonable judgment, Licensee has failed to meet such obligations in a
particular jurisdiction. If Licensee disagrees with Licensor's decision to
terminate this Agreement, such dispute shall be referred to arbitration in
accordance with clause 15.08 and the decision of the arbitrator once rendered
shall be final and binding upon the parties.
14.02 Wherever commercially feasible to do so, Licensee shall publicly
acknowledge and shall ensure that its sublicensees publicly acknowledge, the
role of Licensor or the University of Saskatchewan, or both, in the deveiopment
of Products. Prior to providing any such public acknowledgement, Licensee shall
obtain the approval of Licensor or the University of Saskatchewan, as the case
may be. With respect to the University of Saskatchewan, Licensee acknowledges
that any such approval must be obtained from the Board of Governors in the
manner stipulated by the University of Saskatchewan Act, Statutes of
Saskatchewan.
ARTICLE XV
MISCELLANEOUS
15.01 This Agreement may be assigned by Licensee in whole or in part without the
prior written consent of Licensor with the provision of written notice of such
assignment to Licensor. As a condition precedent to assignment, the proposed
assignee shall promptly execute and deliver an agreement in favour of Licensor
pursuant to which the assignee agrees to be bound by all of the terms and
conditions contained in this Agreement. Licensee acknowledges that no such
assignment shall in any way affect its liabilities and responsibilities under
this Agreement.
15.02 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 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 Licensor: VIDO
120 Veterinary Road
University of Saskatchewan
Saskatoon, Saskatchewan S7N OWO
Attention: Director
(b) to Licensee: Biostar Inc.
#343-111 Research Drive
Saskatoon, Saskatchewan S7N OWO
Attention: President
17
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 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 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 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 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. 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 Licensor pursuant to the terms and conditions of this
Agreement.
15.08 With the exception of:
(a) a dispute arising from any breach or alleged breach of the party's
obligations with respect to confidentiality; or
(b) a failure by Licensee to make any payments when due; or
(c) the exercise by 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, Statute 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 Licensee or Licensor has
been authorized to make any representation, warranty or promise not contained
18
herein. This Agreement may not be amended or modified in any manner except by
written agreement executed by both of the parties.
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:
-----------------------------------------
PER:
-----------------------------------------
19
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
UNIVERSITY OF SASKATCHEWAN
PER:
-----------------------------------------
PER:
-----------------------------------------
IN WITNESS WHEREOF Biostar 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.
BIOSTAR INC.
PER:
-----------------------------------------
PER:
-----------------------------------------
A-1
SCHEDULE "A"
Pasteurella haemolytica Vaccine and 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 9001- 0016. The symbol "a" indicates
patents for which Novartis is charged with the maintenance and prosecution under
the provisions of the Novartis License, and the symbol "a" indicates patents for
which MMI is charged with the maintenance and prosecution under the provisions
of the MMI License.
2 A. Robins and Associates Patent Series 9001-0006
"Compositions and Treatments for Pneumonia in Animals"
Issued U.S. Patent No. 5,849,531 a
"Leukotoxin Vaccine Compositions and Uses Thereof"
Issued U.S. Patent No. 5,871,750 a
"Pasteurella haemolytica Leukotoxin Compositions and Uses Thereof"
Issued U.S. Patent No. 5,476,657 a
B. Robins and Associates Patent Series 9001-0016
"Enhanced Immunogenicity Using Leukotoxin Chimeras"
U.S. Application 08/976,566 a
U.S. Patent 5,708,155 a
U.S. Patent 5,422,110 a
"GnRH Leukotoxin Chimeras"
U.S. Application 09/383,912 a
U.S. Patent 5,969,126 a
U.S. Patent 5,723,129 a
U.S. Patent 5,837,268 a
U.S. Patent 6,022,960 a
A-1
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 9001-0006.44 CEQ 05/25/1990 909068314 08/27/1997 0527724 ISSUED
CO
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED KINGDOM 9001-0006.53 DCA 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
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006 NEW 04/07/1989 07/335,018 ABANDONED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.20 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
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.02 CON 12/14/1994 08/355,919 02/16/1999 5,871,750 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0006.10 DIV 05/31/1995 08/455,510 12/15/1998 5,849,531 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0006.41 CEQ 04/06/1990 PCT/US90 ABANDONED
/01884
- -----------------------------------------------------------------------------------------------------------------------------------
WIPO 9001-0006.42 CEQ 05/25/1990 PCT/CA90 NAT PHASE
/00170
- -----------------------------------------------------------------------------------------------------------------------------------
A-2
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 9001-0016.75 DCA 01/24/1996 969007962 PUBLISHED
CO
- -----------------------------------------------------------------------------------------------------------------------------------
EUROPEAN PATENT 9001-0016.51 DCA 08/08/1997 979353950 _ PENDING
CO
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
INDIA 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 KOREA 9001-0016.91 DCA 08/08/1997 PCT/CA97/ PENDING
00559
- -----------------------------------------------------------------------------------------------------------------------------------
SOUTH KOREA 9001-0016.70 DCA 01/24/1996 70551397 PENDING
- -----------------------------------------------------------------------------------------------------------------------------------
SOUTH KOREA 9001-0016.92 DCA 08/08/1997 700109799 PENDING
- -----------------------------------------------------------------------------------------------------------------------------------
MEXICO 9001-0016.71 DCA 01/24/1996 976009 PENDING
- -----------------------------------------------------------------------------------------------------------------------------------
MEXICO 9001-0016.93 DCA 08/08/1997 PCT/CA97/ PENDING
00559
- -----------------------------------------------------------------------------------------------------------------------------------
NORWAY 9001-0016.94 DCA 08/08/1997 19990533 PENDING
- -----------------------------------------------------------------------------------------------------------------------------------
NEW ZEALAND 9001-0016.72 DCA 01/24/1996 300125 04/29/1999 300125 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
NEW ZEALAND 9001-0016.95 DCA 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
- -----------------------------------------------------------------------------------------------------------------------------------
A-3
- -----------------------------------------------------------------------------------------------------------------------------------
COUNTRY REFERENCE TYPE FILED SERIAL ISSUED PATENT STATUS
# # #
- -----------------------------------------------------------------------------------------------------------------------------------
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
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016 NEW 10/16/1991 07/779,171 ABANDONED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.20 CIP - 10/14/1992 07/960,932 06/06/1995 5,422,110 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.21 CIP 02/10/1995 08/387,156 03/03/1998 5,723,129 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.10 DIV 05/31/1995 08/455,970 01/13/1998 5,708,155 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES - 9001-0016.22 CIP 08/09/1996 08/694,865 11/17/1998 5,837,268 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.11 DIV 06/19/1997 08/878,748 10/19/1999 5,969,126 ISSUED
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.01 CON 11/24/1997 08/976,566 PENDING
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.12 DIV 07/29/1998 09/124,491 PENDING
- -----------------------------------------------------------------------------------------------------------------------------------
UNITED STATES 9001-0016.02 CON 08/26/1999 69/383,912 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
- -----------------------------------------------------------------------------------------------------------------------------------
A-4
SCHEDULE B
Epidemlal Growth Factor Receptors include:
HERl (EGFR or ErbBl)
HER2 (neu or ErbB2)
HER3 (ErbB3)
HER4 (ErbB4)
Epidemlal Growth Factor Receptors Ligands include:
Epidemlal Growth Factor (EGF)
Transforming Growth Factor alpha (TGF-Ct)
Amphiregulin
Heparin Binding Epidemlal Growth Factor (HB-EGF)
Betacellulin
B-1
EXHIBIT "D"
List of Certain Assets:
1) Patents and patent applications
2) Hard copies and electronic versions of complete INDs filed in the US and
Canada
3) Preclinical reports, including but not limited to, toxicology, safety,
efficacy and ADME studies
4) Clinical reports
5) Documentation containing information about the manufacturing process
6) Research reagents, including but not limited to, reagents such as
expression constructs, cell lines, monoclonal antibodies
7) Assays for detection of GnRH antibodies, including but not limited to,
experimental protocols and reagents
8) Documentation related to market analyses, competitive intelligence,
projected sales
9) Limited rights to use carrier protein with oncology products involving the
EGF receptor family and its ligands.
D-1
EXHIBIT D
LIST OF CERTAIN ASSETS:
1) Patents and patent applications
2) Hard copies and electronic versions of complete INDs filed in the US and
Canada
3) Preclinical reports, including but not limited to, toxicology, safety,
efficacy and ADME studies
4) Clinical reports
5) Documentation containing information about the manufacturing process
6) Research reagents, including but not limited to, reagents such as
expression constructs, cell lines, monoclonal antibodies
7) Assays for detection of GnRH antibodies, including but not limited to,
experimental protocols and reagents
8) Documentation related to market analyses, competitive intelligence,
projected sales
9) Limited rights to use carrier protein with oncology products involving the
EGF receptor family and its ligands