TECHNOLOGY LICENSE AGREEMENT CONFIDENTIAL TREATMENT REQUESTED
Exhibit 4.3
CONFIDENTIAL TREATMENT
REQUESTED
INFORMATION
FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND IS IDENTIFIED
BY THREE ASTERISKS, AS FOLLOWS “* * *”, AN UNREDACTED VERSION OF THIS DOCUMENT
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
BETWEEN
:
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NATIONAL RESEARCH COUNCIL OF
CANADA, whose head office address is:
1200
Montreal Road
Ottawa,
Ontario KIA 0R6
(through
its Institute, whose name and address are:
Institute
for Biological Sciences 0000 Xxxxxxxx Xxxx, Xxxxxxxx X-00 Xxxxxx, Xxxxxxx
X0X 0X0
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(called
“NRC”)
(called
the “Institute”)
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AND
:
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HELIX
BIOPHARMA CORPORATION
a
corporation under the laws of Ontario, Canada whose head office address
is:
0-000
Xxxxxxxxxx Xxxxxxx Xxxxx,
Xxxxxx
XX Xxxxxx X0X 0X0
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(called
the “Licensee”)
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WHEREAS
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(a)
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NRC
owns or controls certain technology which is subject to intellectual
property rights, including without limitation inventions (which may be
protected by patents), copyright, trade secrets, know-how, and information
that is confidential.
|
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(b)
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NRC
and the Licensee desire to enter into a licence agreement that will permit
the technology to be used for commercial
purposes.
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IN CONSIDERATION of the
following terms, conditions, promises, and payments, the parties agree as
follows:
1.0 DEFINITIONS IN THIS
AGREEMENT
For all
purposes of this Agreement the following terms, in singular or plural form as
appropriate to the context, are defined as follows:
1.1
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“NRC Technology” means
the inventions (not necessarily patentable), trade secrets, know-how,
Software, designs, written works, samples, biological materials, and
technical information (confidential or not) relating to the “*** Antibody
patent application” (NRC case # ***) tentatively
entitled:
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“An Antibody Fragment, and
Derivatives Thereof, for the Detection and Treatment of Lung
Adenocarcinoma”,
***
1.2
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“Licensee Technology’
means the inventions (not necessarily patentable), patent(s), trade
secrets, know-how, software, designs, written works, samples, biological
materials, and technical information (confidential or not) relating to
Helix Biopharma Proprietary Compound named “DOS47” and related compounds
as described by US application # 20040115186 including any improvements,
continuation, divisional applications derived from
it.
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1.3
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“Foreground Technology”
means the inventions (not necessarily patentable), patent(s),
including any improvements, continuation, divisional applications derived
from such patent(s), trade secrets, know-how, software, designs, written
works, samples, biological materials, and technical information
(confidential or not) relating to novel molecules resulting from the
combination of the NRC Technology and the Licensee Technology. Such
Foreground Technology is proprietary to
NRC.
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1.4
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“Patents” means the
following patents and patent applications, plus any divisions,
continuations, continuations-in-part, re-issues, and extensions of these
patents and patent applications plus any other patents and patent
applications in countries within the Territory, covering essentially the
same inventions or claiming priority of patenting rights from any other
patent application within the Patent
entitled:
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An Antibody Fragment, and
Derivatives Thereof, for the Detection and Treatment of Lung
Adenocarcinoma”,
***.
NRC
currently holds no other patents or patent applications in relation to the NRC
Technology. If NRC does apply for such Patents, the licence granted by this
Agreement covers these patents, specifically.
1.5
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“NRC Intellectual
Property Rights” means Patents and other exclusionary rights in respect of
the NRC Technology, and rights in respect of Confidential information
included in the NRC Technology.
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1.6
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“NRC’s Internal Purposes”
means research and development within NRC’s laboratories and the
provision of services to NRC’s customers, conducted in such a way as to
avoid the disclosure of either confidential information of the Licensee or
confidential information of NRC which is deliverable under this Agreement
and whose disclosure would deprive the Licensee of some significant
advantage intended by this
Agreement.
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1.7
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“Licensee’s Internal
Purposes” means research and development within Licensee’s
laboratories conducted in such a way as to avoid the disclosure of
Confidential information of NRC whose disclosure would deprive NRC of some
significant advantage intended by this
Agreement.
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1.8
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“Product” means any
thing (including equipment, system, device, component, chemical, molecule,
database, or software) that incorporates or embodies or is derived from
any part of the Foreground Technology (including all modifications made by
the Licensee or NRC), or that results from practicing or using the
Foreground Technology, and also any document that relates to the
Foreground Technology.
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1.9
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Service” means any
service to third parties, not provided free, that is provided by using any
part of the Foreground Technology (including all modifications made by the
Licensee or NRC), or by using a Product, or that relates to a Product,
including (without limiting the generality of the foregoing)
customization, maintenance, installation, training, consulting, testing,
operating, dissemination of advertising or publicity, production,
packaging and distribution.
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1.10
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“Sale” means every
disposition of a Product, including selling, renting, leasing, licensing,
lending, and bartering of a Product. It also means every
instance of providing Service. It is considered to occur when a Product or
Service is delivered or an invoice is issued, whichever occurs first. A
Sale exists irrespective of the collection of any debt (regardless of any
accounting principle), but not if money received is refunded. “Sell”, and
“Sold” have corresponding meanings.
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1.11
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“Sales Revenue” means
the gross price billed by the Licensee or sub-licensee to a purchaser on
account of every Sale of a Product or Service, including recurring and
deferred payments when received, less the following
deductions:
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(a)
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rebates
granted and taken, except rebates granted wholly or partially in
consideration of a third party’s agreement to purchase anything that is
not a Product or Service as defined in this
Agreement;
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(b)
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trade,
promotional, quantity or cash discounts actually allowed and taken, not
exceeding amounts that are customary in the
trade;
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(c)
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amounts
repaid or credited by reason of rejections or returns of Products, or as
retroactive price reductions;
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(d)
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custom
duties, excise taxes, sales taxes, value-added taxes and any compulsory
payments made to government authorities, if separately stated on an
invoice with the intention that costs incurred by the Licensee will be
recovered from the invoiced person,
and
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(e)
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actual
shipping and insurance costs in transporting Products to third parties if
separately stated on an invoice with the intention that costs incurred by
the Licensee will be recovered from the invoiced
person.
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If
Products or Services are bartered for goods or services, or are disposed of
through a transaction that is not at Arm’s Length, the Sales Revenue shall be
calculated as above, using the average of gross prices billed in typical recent
Sales of equivalent Products or Services, and if there are no such Sales, then
it shall be deemed to be the fair market value (having regard to the Licensee’s
advertised prices and prices of near equivalents in the market).
If a
Product is incorporated as part of another article, the Licensee shall price the
Product separately on an invoice. When a distinct price for a Product is not
invoiced, or when the price stated is not a reasonable price, the Sales Revenue
shall be calculated as above, using the average of net prices billed in typical
recent Sales of equivalent Products, and if there are no such Sales, then the
Sales Revenue for the Product shall be deemed to be the Sales Revenue for the
article multiplied by the ratio of the manufacturing cost of the Product to the
manufacturing cost of the article. The Licensee shall be responsible for
providing satisfactory evidence of manufacturing costs. This paragraph does not
apply to Services, and no adjustment is allowed to the net price billed for a
Service.
1.12
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“Other Revenue” means
all payments, and the value of other consideration, which the Licensee
receives in relation to sub-licences, other than royalties from Sales of
Products or Services by the sub-licensee. This includes,
without limitation, initial fees, milestone payments, bonuses, periodic
fees, fees for consulting, fees for upgrades, dividends, and the value of
equity.
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1.13
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“Reporting Date(s)” is
(are) the date(s) in every year up to which royalties since the last
Reporting Date are calculated as follows: January 31 and July
31.
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1.14
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“Affiliate” is a
corporation of which more than 20% of the voting shares are owned by the
Licensee, or which owns more than 20% of the voting shares of the
Licensee, or of which more than 50% of the voting shares are owned by
another Affiliate or if it owns more than 50% of another
Affiliate.
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1.15
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“Arm’s length” has the
meaning as used for purposes of the Income Tax Act of
Canada, and is not limited to the same meaning as being an
Affiliate.
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1.16
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“Territory means
worldwide.
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2.0
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GRANT OF
LICENCE
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2.1
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Grant: NRC
grants to the Licensee a licence of NRC’s Intellectual Property Rights and
the Patents, for the Licensee’s Internal Purposes. NRC also
grants to the Licensee a licence of the Foreground Technology effective
throughout the Territory:
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(a)
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to
reproduce, make, use, import and Sell any Product and export any Product
to any place within the Territory;
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(b)
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to
engage contractors to reproduce or make any Product to be used or sold by
the Licensee;
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(c)
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to
Sell any Service.
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2.2
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Field of
Use: The Licensee shall not deaf in any manner with
Product, Services or Foreground Technology except as authorized under this
Agreement for applications within the Territory and within the authorized
field of use, which is: therapeutic and diagnostic applications for
humans.
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2.3
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Exclusivity: The
rights granted to the Licensee by way of licence under this Agreement
are:
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(a)
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non-exclusive,
for Licensee’s Internal Purposes, with respect to NRC Technology and the
Patents;
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(b)
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exclusive,
with respect to Foreground Technology and to any patent relying on
Foreground Technology.
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2.4
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Sub-licensing: The
Licensee may sub-license the rights granted by this Agreement with respect
to Foreground Technology to:
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(a)
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purchasers
of a Product, as needed to permit normal use of a Product by an end- user
and such sub-licences survive termination of this
Agreement;
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(b)
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any
other person, on terms approved by NRC in writing in
advance.
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2.5
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Canadian
Content: The Licensee shall perform all manufacturing of
Products in Canada, and shall use Canadian-made materials in Products to
the extent that they are reasonably available. Canadian-based
sub-licensees shall be subject to the same
requirement. Foreign-based sub-licensees are not so restricted,
but they shall not be permitted to sell Products that will be imported
into Canada.
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2.6
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Delivery: NRC
shall give the Licensee a copy of all of NRC’s
relevant:
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(a)
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Patents,
including the latest draft of any applications that have not matured into
patents;
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(b)
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documentation
that is reasonably necessary for an understanding of the NRC Technology,
to the extent that it exists;
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(c)
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samples,
in reasonable quantities, of materials illustrating the NRC
Technology.
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The
Licensee shall be conclusively deemed to have received all necessary delivery
under this paragraph if the Licensee has not notified NRC, within 60 days after
the effective date of this Agreement that delivery is lacking.
3.0
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FEES AND
ROYALTIES
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3.1
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Licence
Fee: As consideration for the grant of the licence,
immediately upon receiving a fully signed original of this Agreement the
Licensee shall pay NRC the sum of *** plus applicable
taxes.
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3.2
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Licensee’s
Royalty: The Licensee shall pay to NRC royalties for all
Sales of Products and Services as follows: three percent (3%) of Sales
Revenue.
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The
Parties shall mutually agree on an approach to establish a reduced royalty rate
if a Licensed Product uses one or more additional technologies licensed from a
third and unrelated party, based on the material contribution of the NRC
technology to the composition of the final, licensed product (so-called ‘Royalties stacking
provision’).
Under
such circumstances, however, the reduced royalty rate for such Licensed Product
shall not be less than *** of Sales Revenue.
3.3
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Milestone
payments:
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For the development of the first
Licensed Product:
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–
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A
milestone payment of twenty five thousand dollars (CAN $25,000) upon
successful completion of Phase I clinical trials as confirmed by a
regulatory authority (e.g.: United States Food and Drug
Administration).
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–
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A
milestone payment of fifty thousand dollars (CAN $50,000) upon successful
completion of Phase Ilb clinical trials as confirmed by a regulatory
authority.
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–
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A
milestone payment of one hundred and twenty five thousand dollars (CAN
$125,000) upon successful completion of Phase Ill clinical trials as
confirmed by a regulatory
authority.
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–
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A
milestone payment of two hundred thousand dollars (CAN $200,000) upon
receipt of market approval by a regulatory
authority.
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For
the development of each subsequent Licensed Products
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–
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A
milestone payment of two hundred thousand dollars (CAN $200,000) upon
receipt of market approval by a regulatory
authority.
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3.4
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Royalty for Unauthorized
Sales: Without implying any waiver of NRC’s rights to
enforce limitations in this Agreement or to seek damages for breach of
this Agreement, the Licensee shall pay to NRC, without further demand by
NRC, royalties on Sales of Products or Services which are not authorized
with respect to Territory or Field of
Use.
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3.5
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Other
Revenue: The Licensee shall pay to NRC *** of Other
Revenue.
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3.6
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Minimum Annual
Royalty: The Licensee shall pay NRC a Minimum Annual
Royalty (“MAR”) according to the following schedule (with tax to be
added), regardless of whether
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NRC
issues an invoice for the MAR. The MAR becomes overdue, and subject
to interest on overdue payments, on the date stated here, regardless of whether
that is a Reporting Date and regardless of when the next royalty payment and
statement are due. MAR payments shall be credited against royalties and shares
of Other Revenue, payable to NRC for the same period by the Licensee and by any
sub-licensee.
The
Minimum Annual Royalty is: CA$10,000 (Ten thousand Dollars Canadian) per
calendar year, owed if no research collaboration agreement is in place between
Collaborator and NRC in a given calendar year, when the license is in full
force. Royalties owed in a given calendar year are to be applied against this
Minimum Annual Royalty.
3.7
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Sub-Licensee’s
Royalty: the Licensee shall be responsible for paying
NRC the same royalties that would be payable if Sales by the sub-licensee
were Sales by the Licensee.
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(a)
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Licensee
shall require the sub-licensee to pay directly to NRC royalties for all
Sales of Products and Services by the sub-licence royalties as if Sales of
Products and Services by the sub-licensee were Sales of Products and
Services by the Licensee;
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(b)
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Licensee
guarantees the payments required from the
sub-licensee.
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3.8
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Tax: The
Goods and Services Tax, or Harmonized Sales Tax, or Quebec Sales Tax, is
applicable to payments required by this Agreement, depending on the
residence of the Licensee or sub-licensee, while none of those taxes
normally applies to foreign-based payers. It is the responsibility of the
payer, whether Licensee or sub-licensee, to determine tax status and to
pay the applicable tax. NRC’s GST and HST registration number
is 121 491 807. NRC’s QST registration number is 1006 178
088.
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3.9
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Interest: In
lieu of the regulation that requires NRC to charge interest on overdue
amounts at a rate based on variable central-bank rates, interest at one
percent (1%) per month compounded monthly (annual rate of 12.68%) must be
paid on overdue amounts from the date when payment is due until the date
it is received by NRC. NRC may revise that rate upon two (2)
months’ notice. An administrative charge of $25 will be invoiced for any
cheque, which is refused payment by the financial institution on which it
is drawn.
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3.10
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Delinquent
Accounts: NRC may use a collection agency to collect any
debt arising under this Agreement, and NRC may obtain a set-off of the
debt against any other money payable by the Government of Canada to the
Licensee. The costs and fees of collection agencies shall be
added to the debt payable to NRC.
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3.11
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Statements: The
Licensee must deliver royalty statements to NRC within sixty (60) days
after each Reporting Date, even if no Products or Services were
Sold. NRC may provide a form for royalty statements, which the
Licensee must use. Royalty statements must be certified
accurate and correct by the Chief Financial Officer or some other senior
officer of the Licensee, and must include the following information for
the period up to the Reporting Date or since the last Reporting
Date:
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(a)
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the
quantity of Products made by or for the
Licensee;
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(b)
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the
quantity, and the Sales Revenue, for Products Sold at Arm’s
Length;
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(c)
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the
quantity of Products disposed of at other than Arm’s Length or by barter,
the persons to whom disposed, and the basis for the
royalties;
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(d)
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Sales
Revenue from Services Sold;
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(e)
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a
calculation of the royalties due to
NRC;
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(f)
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a
projection of Sales of Products and Services for the periods to be covered
in the next two royalty statements;
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(g)
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where
applicable, identical information as in (a) to (f) from the
sub-licensee.
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3.12
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Currency
Translation: Sales Revenue and Other Revenue, and any
fixed payment to NRC required by this Agreement, when required to be
converted to Canadian dollars, shall be converted using the Bank of Canada
monthly exchange rate for the last month of the reporting
period. This currency information is available at the Bank of
Canada website:
xxxx://xxxx-xxxxxx-xxxxxx.xx/xxxxxxx/xxxxx/xxx. If payments to
NRC are required to be made in U.S. dollars, the conversion shall be the
rate of exchange in a major financial market, as published (errors
excluded) in a widely distributed Canadian or U.S. newspaper on the last
date of the reporting period, or within the seven preceding
days. The basis of all conversions shall be stated in the
royalty statement submitted to NRC, accompanied by a printed copy of the
published basis of that conversion.
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3.13
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Remittances: Royalty
statements must be accompanied by a remittance of the royalties due, in
Canadian or U.S. funds payable at par at Xxxxxx, Xxxxxxx, Xxxxxx.
Remittances can be made either by a bank transfer to an account which NRC
will designate if asked, or by a cheque payable to: “Receiver General -
National Research Council”, indicating on the cheque the reference number
(if any) appearing on the first page of this
Agreement.
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Cheques
must be addressed to:
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- NRC -
Accounts Receivable, at the NRC head office address stated above
(on page 1);
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A copy of
the royalty
statement must be sent to:
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- NRC -
Intellectual Property Services, at the NRC head office address
stated above (on page 1);
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and
to:
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- the Institute,
at its address stated above (on page
1).
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3.14
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Records: The
Licensee shall, and shall require sub-licensees
to:
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(a)
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keep
accurate, detailed and complete records in accordance with generally
accepted accounting principles, at its expense, which shall be retained
and available at its principal place of business in respect of Products
and Services, and the basis of any Other Revenue which may require a
payment to NRC;
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(b)
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provide
NRC, upon request and without charge, with annual Financial Statements
(prepared by an external auditor, if available) that will verify the Sales
Revenue derived from Products and
Services;
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(c)
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keep
all the records intact for a period of not less than three (3)
years.
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3.15
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NRC’s
Audits: The Licensee shall make all relevant records
available at its premises during normal business hours, upon reasonable
notice, and permit NRC and its authorized representatives to audit,
inspect, and copy the records. In such circumstances, the
Licensee shall afford all facilities and collaboration to NRC and its
authorized representatives, and furnish all information necessary to the
understanding of the records. If NRC’s audit reveals that
payments made by the Licensee are less than eight-tenths (80%) of the
amount that should have been paid, the Licensee shall reimburse NRC’s cost
of the audit which becomes a debt due immediately to NRC, along with a
debt of the shortfall in royalties and share of Other Revenue with
interest from the date on which the payments should have been
made. If the Licensee presents obstacles to the audit, such
that a Chartered Accountant makes an affidavit that the audit is
impossible or impractical, the Licensee shall be deemed by this clause to
have agreed that NRC may estimate a fair value of the royalties and share
of Other Revenue payable, based on the best information available, and the
Licensee shall pay that amount to NRC immediately together with interest
from the date on which the payments should have been
made.
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3.16
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Licensee’s
Audits: At its option, NRC shall be entitled to an audit
of Other Revenue and of the Sales Revenue from the Sale of Products and
Services as part of the Licensee’s regular audit, at no cost to
NRC. When NRC gives reasonable advance notice of requiring that
audit, the Licensee will provide NRC with an audited statement prepared by
an external auditor that will verify Other Revenue and the Sales Revenue
derived from the Sales of Products and Services in any year for which an
audit has not been completed at the time NRC gives notice. If
the audit reveals a shortfall in what was paid to NRC, the Licensee shall
pay the shortfall amount to NRC immediately, with interest from the date
on which the payments should have been made. If the audit
reveals that payments made by the Licensee are not less than eight-tenths
(80%) of the amount that should have been paid, NRC shall reimburse the
Licensee for any incremental costs of the additional part of the
audit.
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3.17
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Continuing
Rights: The rights granted in the preceding three (3)
paragraphs shall survive the termination of this Agreement for a period of
three (3) years.
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3.18
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Allocation To
Technology: If requested, the Licensee shall cooperate
with NRC in providing information about a reasonable allocation of the
Licensee’s Sales Revenue and Other Revenue, and therefore of royalties,
amongst the various elements of the Products or Services, which is
information that NRC requires for allocating shares of royalties amongst
the creators pursuant to NRC’s Awards
Policy.
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4.0
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INTELLECTUAL
PROPERTY
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4.1
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Patenting
Responsibility: NRC shall bear the responsibility and
pay the cost to obtain and maintain Patents in the countries that NRC
chooses to file an application directly or through the national phase of a
PCT application. NRC shall use reasonable efforts to obtain
those Patents and shall not allow those Patents to lapse for failure to
comply with maintenance obligations. If applications (including
the national phase of a PCT application) could be filed in countries,
which NRC has not chosen, they may be requested by the Licensee and shall
be filed by NRC if the Licensee bears all expenses including without
limitation the cost of maintaining those
Patents.
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4.2
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Sharing Patent
Costs: The Licensee shall reimburse NRC, promptly on the
receipt of an invoice for twenty five per cent (25%) of NRC’s internal
costs (to the extent reasonable) and disbursements related to obtaining
and maintaining the Patents. This includes costs and
disbursements incurred before this Agreement was in
effect.
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5.0
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TECHNICAL
ASSISTANCE
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5.1
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No
Assistance: NRC is not obliged to provide the Licensee
with technical assistance relating to the NRC Technology or the
Product. NRC may, at its sole discretion, supply technical
assistance under separate contracts, in accordance with NRC’s customary
terms and standard rates.
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5.2
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NRC’s
Improvements: In the event that NRC produces additions
or changes to the NRC Technology or to the Foreground Technology, which by
their nature could not be used without some use of the NRC Technology or
the Foreground Technology, NRC shall inform the Licensee and, the
additions or changes shall be regarded as part of the NRC Technology or
the Foreground Technology for all purposes of this
Agreement.
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5.3
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Licensee’s Improvements or
Additions: In the event that the Licensee produces
additions or changes to the NRC Technology or the Foreground Technology,
which by their nature could not be made or used without some use of the
NRC Technology or the Foreground Technology, the Licensee shall provide
NRC, within ninety (90) days from the time the additions or changes have
been made, with all available technical information concerning them,
including source code if software is involved, and shall be deemed to
license NRC to use them for NRC’s Internal Research Purposes at no cost to
NRC.
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5.4
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Grant
Back: Upon Termination of this Agreement, the Licensee
shall be deemed to have granted to NRC, and shall execute any documents
reasonably required by NRC as additional evidence of this, a
non-exclusive, unconditional, irrevocable, perpetual royalty- free
licence, including the right to sub-license, to make, use or sell articles
incorporating any additions and changes made by the Licensee which were
required by the preceding paragraph to be reported to NRC, whether
patentable or unpatentable, without any obligation to account to the
Licensee.
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6.0
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CONFIDENTIALITY
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6.1
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What
is Confidential: The NRC Technology and the Foreground
Technology are confidential to NRC except for published elements and
elements which NRC states in writing to be not confidential. Software
source code is confidential to NRC. The Licensee’s derivative
software is confidential to the Licensee, unless the Licensee states
otherwise in writing. Any documents of either party, marked
‘Confidential”, “Protected’’, “Proprietary”, or similar words, are
confidential to that party.
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6.2
|
Obligations of
Confidentiality: Except to the extent expressly
authorized in this Agreement, each party shall, until five years after the
expiration date defined in paragraph 11.1, protect the other party’s
confidential information with some degree of care as it uses to protect
its own confidential information, but not less than a reasonable degree of
care, and shall not use such information for purposes other than those
contemplated by this Agreement. Disclosure of information by a
receiving party is permitted to the extent that it can be proved to
be:
|
(a)
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independently
developed by the receiving party without reference to or use of the
confidential information of the other
party;
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(b)
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received
from the third party without breach of any obligation of
confidentiality;
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(c)
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in
the public domain at the time of its disclosure or that later becomes
publicly available without breach of this
Agreement;
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(d)
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required
to be disclosed by law, including in the case of NRC, the Access to Information Act,
provided that the receiving first provides the disclosing party
with notice of such requirements and of its intent to disclose the
information; or
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(e)
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required
in order to comply with applicable rules and regulations of any stock
exchange on which the Licensee’s shares are
listed.
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6.3
|
If Confidentiality
Lost: This Agreement remains in effect regardless of any
loss of confidentiality of the NRC Technology or the Foreground Technology
at any time for
any reason, although each party retains the right to terminate this
Agreement for a breach by the other
party.
|
7.0
|
DILIGENT
EXPLOITATION
|
7.1
|
Requiring
Diligence: The licence granted by this Agreement is
conditional upon diligent exploitation of the rights granted to the
Licensee, in a manner likely to satisfy the demand for the Products and
Services in relation to all reasonable applications, and to adequately
serve the Licensee’s customers, throughout the Territory. If
NRC suspects a lack of diligence, NRC will give written notice to the
Licensee, inviting the Licensee to explain to the satisfaction of NRC, in
writing within six (6) months, why the level of exploitation should be
considered satisfactory. Diligence will be judged without regard to
royalties or minimum royalties paid. NRC reserves the right to
find a lack of diligence after the six-months’ notice and after having
studied any response made by the Licensee, and this decision shall be
conclusive, subject only to the dispute resolution provisions of this
Agreement.
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7.2
|
Consequences of Lack of
Diligence: On a country-by-country basis, or in all
countries at the same time, when NRC finds a lack of diligence in
accordance with the preceding paragraph, NRC has the right
to:
|
(a)
|
convert
any exclusivity to non-exclusivity in a
country,
|
(b)
|
terminate
the licence entirely in respect of a country,
or
|
(c)
|
modify
the field of use.
|
NRC shall
not exercise those rights before six (6) years or the date of entry into Phase 1
clinical trials in humans as formally evidenced by a national regulatory
authority having jurisdiction on such matters, but NRC’s demand for
justification can be made earlier.
7.3
|
Multiple
Occurrences: The procedure for challenging diligence,
and the consequences, may be invoked more than
once.
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8.0
|
USE OF NRC’S
NAME
|
8.1
|
Control of
Use: NRC reserves the right, in its sole discretion, to
control any unauthorized use of its name and may notify the Licensee that
it must immediately cease using the name, including any abbreviations,
words, or images that imply an association with NRC. Upon
receipt of such notification, the Licensee must use its best efforts to
withdraw from circulation any written material that represents an
unauthorized use.
|
8.2
|
Authorized
Use: Notwithstanding any other provision of this
Agreement, NRC hereby authorizes the Licensee, and the Licensee agrees to
take all reasonable opportunities, such as in sales literature or press
releases, to acknowledge NRC as the source of the NRC Technology, but not
so as to imply, in any such acknowledgment, that NRC endorses or approves
any Product or Service offered for Sale by the
Licensee.
|
9.0
|
WARRANTIFS,
DISCLAIMERS AND INDEMNITIES
|
9.1
|
Warranty of Licensing
Rights: NRC warrants that it has not previously granted
any rights that would conflict with the rights granted by this
Agreement. NRC warrants that it is either the owner or the
licensee (with power to sub-license) of Patents licensed by this
Agreement.
|
9.2
|
No Implied
Warranties: Except for representations, warranties or
conditions expressly made in this Agreement, the NRC Technology and the
Foreground Technology are supplied and licensed on an as is” basis, and
there are no representations, warranties or conditions, express or implied
by statute, including without limitation any with respect
to:
|
(a) | market readiness, merchantability, or fitness for any use or purpose; |
(b)
|
operational
state, character, quality, or freedom from
defects;
|
(c)
|
non-infringement
of rights of third parties under present or future
patents.
|
9.3
|
No Contestation of
Validity: The Licensee acknowledges the validity of the
Patents and copyright licensed hereunder and agrees not to contest such
validity during the life of this Agreement, either directly or indirectly
by assisting other parties. This clause is not operational
under U.S. law.
|
9.4
|
Limited
Damages: NRC shall not be liable, in any event, for
consequential or incidental damages, or loss of income, arising from the
possession or use of anything licensed or conveyed pursuant to this
Agreement.
|
9.5
|
Indemnity: NRC
rejects all liability and responsibility relating to the consequences of
using the Products or providing Services. The Licensee shall
indemnify and save harmless NRC, its employees and agents from and
against, and be responsible for:
|
(a)
|
all
claims, demands, losses, damages, costs including solicitor and client
costs, actions, suits or proceedings brought by any third party, that are
in any manner based upon, arising out of, related to, occasioned by, or
attributable to:
|
(b)
|
the
manufacturing, distribution, shipment, offering for Sale, Sale, or use of
Products, Services or the Foreground Technology;
and
|
(c)
|
product
liability and infringement of intellectual property rights other than
copyright;
|
(d)
|
other
costs, including extra-judicial costs, of NRC defending any such action or
proceeding, which NRC shall have the right to defend with counsel of its
choice.
|
This
clause shall survive expiration or termination of this Agreement.
10.0
|
INFRINGFMENT
LITIGATION
|
10.1
|
Initial
Consultation: If the Licensee receives or become aware
of any claim or assertion by a third party that any activities by the
Licensee under this Agreement constitute an infringement or other
violation of a third party’s patents or other intellectual property, the
Licensee shall notify NRC and shall provide NRC with all details relating
to the allegation. The parties shall promptly enter into
discussions with the third party to determine the extent and validity of
the infringement and the parties mutually agreed course of action. Each
party will absorb its own costs of the
discussions.
|
10.2
|
Negotiation: The
parties may negotiate with a third party to obtain any additional rights
required, such as may arise if a third party’s patent
emerges. Each party will absorb its own costs of
negotiation. If those additional rights require payment, the
parties will negotiate for a reduction in royalties payable to NRC, and
failing agreement within sixty (60) days, either party may invoke the
arbitration procedure in this Agreement to settle the amount of the
reduction of the royalty.
|
10.3
|
Legal
Action: The parties may agree to jointly defend or
pursue litigation, but neither party shall bind or commit the other party
to any course of action which involves liability for legal costs, expenses
or damages. If the parties fail to agree, within a reasonable
time having regard to the normal progress of litigation, as to any course
of action which might be jointly taken, either party may take or defend
proceedings alone, if legally entitled to act alone, and shall be entitled
to retain any amount awarded to it by a court, or paid to it as a
settlement by the third party, and the excess of that amount over costs
|
reasonably incurred by
both parties for the settlement or litigation, shall be regarded as Sales
Revenue of a sub-licensee for the purpose of calculating
royalties. If one party wishes to act alone but formalities require
participation of the other party, the other party shall join in the proceeding
to the extent necessary for formalities. Each party will cooperate
with the other in making available all necessary documents and witnesses for any
legal proceeding, without fees. A party proceeding alone (or with one
party as a formality) shall indemnify the other party for reasonable legal costs
for representation that is reasonably necessary, and for any court-ordered
payments.
10.4
|
Damages for
Infringement: If the parties (and not with one party
participating only as a formality) have jointly pursued an infringer by
litigation and the Licensee obtains money from the infringer as a
settlement or by court order, the excess of that money above the
Licensee’s costs that were reasonably incurred for the settlement or
litigation, shall be regarded as Other Revenue in relation to a
sub-licence.
|
11.0
|
DURATION AND
TERMINATION
|
11.1
|
Expiration: This
Agreement shall become effective when it has been signed by both parties.
Unless terminated earlier, this Agreement shall terminate when the last
patent right related to the Foreground Technology expires, on a
country-by-country basis.
|
11.2
|
Termination by Either Party for
Default or Breach: In the event that one party defaults
or breaches any of the provisions of this agreement, the other party shall
have the right to terminate this Agreement by giving written notice to the
defaulting party, but this act shall not prejudice the right of NRC to
recover any fee due at the time of such termination and shall not
prejudice any cause of action or claim of NRC accrued or to accrue on
account of any breach or default by the Licensee. However, if
the defaulting party cures the breach within sixty (60) days after the
notice is given, this Agreement shall continue in full force and
effect.
|
11.3
|
Termination by
NRC: This Agreement, at the option of NRC, may be
terminated forthwith by NRC if the Licensee becomes bankrupt, or
insolvent, or has a receiver appointed to continue its operations, or
passes a resolution for winding up, or takes the benefit of any statute
relating to bankrupt or insolvent debtors or the orderly payment of
debts.
|
11.4
|
Procedure on
Termination: Upon termination the Licensee
shall:
|
(a)
|
deliver
a detailed statement to NRC of the inventory of all Products then existing
and not Sold by the Licensee as at that
date;
|
(b)
|
retain
the right to Sell Products then existing and shall pay royalties (but not
MAR) to NRC as Products are Sold for a period of one year provided that
any remaining inventory of Products shall be destroyed by the License at
the end of that year;
|
(c)
|
retain
the right to deliver Services for which a contractual commitment has been
made before the Termination, for a period of one year, subject to the
continued obligation to pay Royalties on the Sales Revenue for those
services; and
|
(d)
|
cease
any other use of the NRC Technology and the Foreground Technology unless
the NRC Technology and the Foreground Technology, in total, has then
become part of the public domain other than through any act or omission
of the
Licensee.
|
11.5
|
Accrued
Obligations: Termination does not release a party from
any obligations, which accrued while this Agreement was in force or upon
its termination.
|
12.0
|
LAW AND
DISPUTES
|
12.1
|
Choice of
Law: This Agreement shall be interpreted according to
the laws of the Province of Ontario and the laws of Canada in force
there.
|
12.2
|
Courts: Any
litigation concerning this Agreement, including litigation arising from
arbitration, shall be brought only in a court which has ordinary
jurisdiction over the defendant on the basis of residence, and the
residence of NRC for this purpose shall be regarded as the location of the
Institute.
|
12.3
|
Dispute
Resolution: Both parties will use reasonable efforts to
reach an amicable negotiated settlement of any dispute concerning the
interpretation or operation of this Agreement. Disputes
concerning this Agreement shall not be litigated. If
negotiation fails to resolve a dispute within sixty (60) days, either
party can require non-binding mediation, whereupon the parties shall
jointly appoint one impartial expert mediator to mediate according to
mutually agreed procedures. If a party refuses to effectively
participate in mediation, or if mediation continues for more than sixty
(60) days, either party can require binding arbitration under the Commercial Arbitration Act
of Canada, whereupon the parties shall attempt to jointly appoint
one impartial expert arbitrator. If the parties cannot agree
within thirty (30) days on the choice of an arbitrator, each party shall
appoint its own arbitrator and those arbitrators shall jointly appoint a
chairperson of an arbitral tribunal. An arbitral award shall
not include punitive damages, or interim measures. Each party
shall pay its own costs and an equal share of all other costs of mediation
and arbitration, except for the exceptional circumstance in which an
arbitral award may require the payment of all costs by a party who has
brought a plainly frivolous dispute. Unless otherwise agreed by
the parties when the occasion arises, mediation and arbitration shall be
held in the city where the Institute is located. This provision
survives the Termination of this
Agreement.
|
13.0
|
GENERAL TERMS AND
CONDITIONS
|
13.1
|
Entire
Agreement: This Agreement represents the entire
understanding between the parties as of the effective date hereof, and
supersedes all prior communications, negotiations and agreements, written
or oral, concerning the NRC Technology and the Foreground
Technology.
|
13.2
|
Limits of
Agreement: For greater certainty, the parties agree that
this is not an assignment of ownership of copyright or of patent rights,
but merely a licence. This Agreement shall not be construed as
creating the relationship of principal and agent, employer and employee,
partnership, or joint venture.
|
13.3
|
Amendments: This
Agreement may only be amended by an agreement in writing, signed by the
parties, expressly referring to this
Agreement.
|
13.4
|
Severance: If
any provision in this Agreement is found, by a court or arbitration, to be
wholly or partly invalid, illegal or unenforceable in any respect, the
remainder of this Agreement shall remain enforceable and this Agreement
shall be construed as if that provision had never existed. The
request to initial each page is not a condition of this
Agreement.
|
13.5
|
Waiver: Failure
by either party to assert rights arising from any breach or default of
this Agreement, or acceptance of payments, shall not be regarded as a
waiver of rights. No failure to assert rights, no waiver, and
no toleration implies any continuing or future waiver of
rights.
|
13.6
|
Assignment: This
Agreement is personal to the parties, so that neither its assignment, nor
its assumption by a corporation formed by amalgamation with a party is
valid without the other party’s written
consent.
|
13.7
|
Force
Majeure: Neither party shall be responsible or liable to
the other for failure or delay in the performance of this Agreement due to
war, fire, accident or other casualty, labour disturbance, act of the
public enemy, act of God, or any other contingency beyond that party’s
reasonable control. In the event of applicability of this
paragraph, the party affected by such force majeure shall use its best
efforts to eliminate, cure and overcome any such causes and resume
performance of its obligations as soon as
possible.
|
13.8
|
Notices: Any
notice contemplated by this Agreement, unless a different address is
subsequently notified by one Party to the other in writing, must be sent
to the address stated at the beginning of this Agreement where the Parties
are identified, by:
|
(a)
|
registered
mail, and then it is deemed to be an effective notice five (5) days after
it is sent,
|
(b)
|
courier,
and then it is an effective notice only when acknowledged by an official
receipt, or
|
(c)
|
by
personal delivery to the office of the chief executive officer of the
Party, and then it is an effective notice only when acknowledged by a
signature of either that person or a person with apparent authority to
receive messages.
|
SIGNED by the Licensee
in duplicate at
Aurora,
Canada ,
Canada:
|
|
HELIX
BIOPHARMA CORPORATION
|
|
Date April 27,
2005
|
Per: /s/ Xxxxxx
Xxxxx
|
Name and title: Xxxxxx
Xxxxx, President
|
|
SIGNED by NRC in
duplicate at Ottawa, Canada:
|
|
NATIONAL
RESEARCH COUNCIL OF CANADA
|
|
Date April 28,
2005
|
Per: /s/ Xx. Xxxxxxxxx
Xxxxx
|
Name and title: Xx.
Xxxxxxxxx Xxxxx
Director General NRC-Institute for Biological
Sciences
|