EXHIBIT 10.4
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement") dated as of December 4, 2007
(the "Effective Date"), is entered into between INVERNESS MEDICAL SWITZERLAND
GmbH, a Swiss corporation ("Inverness"), having a place of business at
Xxxxxxxxxxxxxx 00, XX-0000 Xxx, Xxxxxxxxxxx and Whispering Oaks International,
Inc. d.b.a. BioCurex, Inc., a Texas corporation having a place of business at
000-0000 Xxxxx Xxxx, Xxxxxxxx XX, Xxxxxx ("BioCurex").
WHEREAS, BioCurex owns or has rights in certain technology regarding a new
cancer marker named RECAFTM.
WHEREAS, Inverness desires to obtain a semi-exclusive worldwide license
under BioCurex's rights in such technology to develop and commercialize the
Products (as defined below).
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the parties hereby agree as follows:
1. DEFINITIONS
For purposes of this Agreement, the terms defined in this Section 1 shall
have the respective meanings set forth below:
1.1 "Affiliate" shall mean, with respect to any Person, any other Person
which directly or indirectly controls, is controlled by, or is under common
control with, such Person. A Person shall be regarded as in control of another
Person if it owns, or directly or indirectly controls, at least fifty percent
(50%) of the voting stock or other ownership interest of the other Person, or if
it directly or indirectly possesses the power to direct or cause the direction
of the management and policies of the other Person by any means whatsoever.
1.2 "Annual Minimum Royalty" shall mean the applicable amount set forth in
Section 0.
1.3 "Annual Minimum Royalty Term" shall mean the period commencing on the
Effective Date and, unless earlier terminated as provided herein, continuing
until the last to occur of (i) expiration of the last to expire of the patents
included in the Patent Rights, or (ii) Inverness ceases manufacture and
distribution of all Products that incorporate BioCurex Antibodies.
1.4 "Average Net Sales Price" for a product in each country means
Inverness's, or any Inverness affiliate's, actual Net Sales for such product in
such country during a calendar quarter divided by the total number of units of
such product sold in such country during such calendar quarter.
1.5 "BioCurex Marks" means the trademark "RECAF(TM)", or "Serum-RECAF(TM)"
or "BioCurex(TM)" and their respective logos.
* Confidential treatment requested. Confidential portion has been omitted and
filed separately with the Securities and Exchange Commission.
1.6 "BioCurex Antibody" means any antibody to RECAF (or any fragment
thereof) delivered by BioCurex to Inverness under this Agreement, together with
all progeny thereof. Any peptide sequence provided or disclosed by BioCurex to
Inverness that binds to the same antigen and epitope on RECAF recognized by a
BioCurex Antibody shall be considered, for the purpose of this Agreement, as a
BioCurex Antibody.
1.7 "Field" shall mean all in vitro diagnostic applications, except:
-----
(a) any immunohistochemistry, immunocytochemistry application, or
any other procedures that detect RECAF in prepared and excised human tissue
sections;
(b) any immunoradiometric assay application (also known as
radioimmunoassay or RIA), including such applications designed to detect or
measure RECAF;
(c) any non-automatic RECAF microplate assays designed to detect or
measure RECAF;
(d) any type of flow cytometry assay application designed to detect
or measure RECAF;
(e) any imaging of tumors in any form;
(f) any non-immunometric assay designed to detect or measure RECAF
utilizing nucleic acids, including (i) all forms of synthetic or natural
ribonucleic acid (RNA), (ii) all forms of synthetic or natural deoxyribonucleic
acid (DNA), including complementary DNA and (iii) all modifications of said
nucleic acids that in their natural form are related to the synthesis of RECAF;
(g) any non-immunometric assay designed to detect or measure RECAF
utilizing nucleic acid amplification technology (e.g., PCR), including (i) all
forms of synthetic or natural ribonucleic acid (RNA), (ii) all forms of
synthetic or natural deoxyribonucleic acid (DNA), including complementary DNA
and (iii) all modifications of said nucleic acids that in their natural form are
related to the synthesis of RECAF;
(h) any therapeutic application, including therapeutic applications
relating to cleansing bone marrow specimens, or pregnancy, the pregnant mother,
the fetus or the embryo;
(i) any vaccination against cancer or pregnancy; or
(j) any use in animals for any veterinary medicine application
including, but not limited to cancer diagnostics, screening and treatment
monitoring.
1.8 "First Commercial Sale" shall mean the first sale in any country of a
Product by Inverness or its Affiliate to customers who are not Affiliates after
all applicable marketing and pricing approvals (if any) have been granted by the
applicable governing health authority of such country.
2
1.9 "Inverness Antibody" means any antibody to RECAF (or any fragment
thereof) developed by Inverness or its Affiliates using antigen, antiserum,
cells or other materials supplied by BioCurex hereunder or any progeny thereof.
1.10 "Licensed Know-How" shall mean all information and data, which is not
generally known including, but not limited to, formulae, procedures, protocols,
techniques and results of experimentation and testing, which are necessary or
useful for Inverness to make, use, develop, sell or seek regulatory approval to
market a composition based on RECAF, or to practice any method or process, in
which BioCurex has an ownership or licensable interest.
1.11 "Licensed Materials and Technology" shall mean, collectively, the
Licensed Patent Rights, Licensed Know-How and Materials provided by BioCurex
under this Agreement and future patent rights, know how and materials related to
the Field that BioCurex might make available to Inverness.
1.12 "Licensed Patent Rights" shall mean (a) all patent applications
heretofore or hereafter filed or having legal force in any country that are
applicable in the Field that claim (i) RECAF, any antibody or other molecule
that is directed towards RECAF, or any fragment of the foregoing (or any
nucleotide sequence that encodes, or amino acid sequences or glycan sequence of
the foregoing), or (ii) any process of manufacture or use of any of the
foregoing; (b) all patents that have issued or in the future issue from such
patent applications, including utility, model and design patents and
certificates of invention; and (c) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions or additions to any such
patent applications and patents; in each case in which BioCurex has an ownership
or licensable interest.
1.13 "Materials" shall mean all antigen, antibodies, antiserum, cells and
other materials delivered by BioCurex to Inverness under this Agreement,
together will all progeny thereof, and all substances produced by such cells,
micro-organisms or vectors supplied by BioCurex hereunder (even if produced by
Inverness or a Third Party) other than Inverness Antibodies.
1.14 "Minimum Royalty Value" shall mean, with respect to each Product:
(a) in each country where there is a Valid Claim, the sum of * per
Test Sold.
(b) in each country where there is a Pending Claim but no Valid
Claim, the sum of * per Test Sold, whether or not the Product uses one or more
BioCurex Antibodies.
(c) in each country where there is neither a Pending Claim nor a
Valid Claim and the Product uses one or more BioCurex Antibodies, the sum of *
per Test Sold.
(d) in each country where there is neither a Pending Claim nor a
Valid Claim and the Product does not use a BioCurex Antibody, the sum of * per
Test Sold, provided, however, that if in said country any other company sells a
competing Product, with the exception of BioCurex's licensees, their
sublicensees and their corresponding affiliates, then the Minimum Royalty Value
3
in such country shall be zero. Inverness shall have the responsibility to notify
BioCurex of the existence of such competitor as set forth in Section 0.
1.15 "Net Sales" shall mean, with respect to any product, the gross sales
price of such product invoiced by a Party or its Affiliate to customers who are
not Affiliates (or are Affiliates but are the end users of such product) less,
to the extent actually paid or accrued by such Party or its Affiliate (as
applicable), (a) credits, allowances, discounts and rebates to, and chargebacks
from the account of, such customers for spoiled, damaged, out-dated and returned
product; (b) freight and insurance costs incurred by such Party or its Affiliate
(as applicable) in transporting such product in final form to such customers;
(c) cash, quantity and trade discounts, rebates and other price reductions for
such product given to such customers under price reduction programs that are
consistent with industry practices and price reductions given for similar
products by such Party or its Affiliate (as applicable); (d) sales, use,
value-added and other direct taxes incurred on the sale of such product in final
form to such customers; and (e) customs duties, surcharges and other
governmental charges incurred in exporting or importing such product in final
form to such customers. Notwithstanding anything to the contrary in this
Agreement, if any reusable instrument (that is itself a Product) is used in
combination with a separate diagnostic reagent-containing device (that is itself
a Product) to detect or measure one or more analytes from a patient sample on or
in such device, then for purposes of calculating Net Sales, such device shall
constitute a Product, but such instrument shall not constitute a Product.
1.16 "New Patent" shall have the meaning set forth in Section 0.
----------
1.17 "Party" shall mean Inverness or its Affiliate(s), or BioCurex or its
Affiliate(s), and "Parties" shall mean Inverness or any of its Affiliates, and
BioCurex or any of its Affiliates.
1.18 "Pending Claim" shall mean any claim of a pending patent application
included within the Licensed Patent Rights, which claim was filed in good faith
and has not been abandoned or finally disallowed without the possibility of
appeal or refilling of such application.
1.19 "Person" shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.
1.20 "Product(s)" shall mean any product for use in the Field that if
made, used, sold, gifted, offered for sale or imported would infringe a Valid
Claim or Pending Claim, or which incorporates a BioCurex Antibody or a Inverness
Antibody.
1.21 "RECAF" (an acronym for "receptor of alpha-fetoprotein") shall mean
any synthetic or natural molecule, or portion of such molecule, or molecule
derivative from another molecule, that in its natural state shows specific
binding to any of the following: (a) natural or synthetic alpha-fetoprotein
("AFP"); (b) a fragment of AFP; (c) a modification of AFP; (d) a modification of
a fragment of AFP; (e) native or synthetic AFP or AFP produced by genetic
engineering, bound or not to fatty acids or other molecules; or (f) a fragment
of AFP bound to other fatty acids or other molecules (g) any derivatives, parts
4
or polymorphisms (including without limitation splice variants) of RECAF, (h)
any nucleotide sequences with homology to the RECAF gene or RECAFs'
translational sequences, (together with any derivatives, parts or splice
variants of the corresponding nucleotide sequences), (i) amino acid sequences
and proteins encoded by each such nucleotide sequences (together with any
derivatives or parts of such amino acid sequences and proteins) and (j) glycans
and sequences of sugars that specifically bind AFP. "Specific binding" as used
in this Section, means an interaction between two (2) molecules that: (x)
becomes saturated as the concentration of one (1) of the molecules is increased
with respect to the other; and (y) can be competed with the other molecule or an
excess of the same molecule unlabeled. In the event (i) RECAF is known as
another molecule known in the public domain, and (ii) Inverness does not have a
product for sale or a technology already licensed to others based on said
molecule as of the Effective Date, and (iii) Inverness decides to develop and
commercialize a product or a technology based on said molecule specifically
pertaining to the Field, then such product or technology shall be deemed a
Product subject to the terms and conditions of this Agreement.
1.22 "Royalty Term" shall mean, with respect to each country, the period
commencing on the Effective Date and, unless earlier terminated as provided
herein, continuing until the last to occur of (i) expiration of the last to
expire of the patents included in the Patent Rights in such country, (ii)
Inverness ceases manufacture and distribution of all Products that incorporate
BioCurex Antibodies in such country, or (iii) ten (10) years after the First
Commercial Sale of the first Product Sold in such country.
1.23 "Sold" shall mean sold or transferred by Inverness or its Affiliate
to a customer who is not an Affiliate (or is an Affiliate but is the end user of
such Product).
1.24 "Territory" shall mean all the countries, regions and territories of
the world.
1.25 "Test" shall mean a unit of a Product comprising one determination of
RECAF in serum, blood, plasma or urine belonging to one human being.
1.26 "Third Party" shall mean any Person other than BioCurex, Inverness
and their respective Affiliates.
1.27 "Valid Claim" shall mean any claim of an issued and unexpired patent
included within Licensed Patent Rights that has not been held unenforceable,
unpatentable or invalid by a decision of a court or governmental agency of
competent jurisdiction, unappealable or unappealed within the time allowed for
appeal or which has not been admitted by the holder of the patent to be invalid
or unenforceable through reissue, disclaimer or otherwise. In the event a patent
has been held to be invalid or unenforceable and an appeal is pending, such
claims shall not be considered a Valid Claim until reinstated by a final
decision of a court or governmental agency of competent jurisdiction.
1.28 All values in dollars represent USA dollars (USD or US$).
5
2. REPRESENTATIONS AND WARRANTIES
Each party hereby represents and warrants to the other party as follows:
2.1 Corporate Existence. Such party is a corporation duly organized,
validly existing and in good standing under the laws of the state in which it is
incorporated.
2.2 Authorization and Enforcement of Obligations. Such party (a) has the
corporate power and authority and the legal right to enter into this Agreement
and to perform its obligations hereunder, and (b) has taken all necessary
corporate action on its part to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such party, and constitutes a
legal, valid, binding obligation, enforceable against such party in accordance
with its terms.
2.3 No Consents. All necessary consents, approvals and authorizations of
all governmental authorities and other Persons required to be obtained by such
party in connection with this Agreement have been obtained.
2.4 No Conflict. The execution and delivery of this Agreement and the
performance of such party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations, and (b) do not
conflict with, or constitute a default under, any contractual obligation of it.
2.5 Licensed Materials and Technology. BioCurex (a) is the sole owner of
the Licensed Materials and Technology, except for Xxxxxx Laboratories, Inc.
("Xxxxxx Labs")which has a semi-exclusive License to the Licensed Materials and
Technology in the Field; (b) is not aware of any Third Party patent, patent
application or other intellectual property rights that would be infringed (i) by
practicing any process or method or by making, using or selling any composition
which is claimed or disclosed in the Licensed Patent Rights or which constitutes
Licensed Know-How, or (ii) by making, using or selling Products; and (c) is not
aware of any infringement or misappropriation by a Third Party of the Licensed
Materials and Technology.
2.6 Other Licensees. Inverness is aware and understands that BioCurex has
already signed an agreement with Xxxxxx Labs (the "Abbot Labs Agreement") which
(a) limits to three (3) the number of licensees for manufacturing RECAF tests to
be used in the Field and (b) grants Xxxxxx Labs the exclusive right to
sublicense certain Licensed Materials and Technology. The licensing agreement
with Xxxxxx Labs includes the field of lateral flow chromatography (also known
as rapid tests) on a non-exclusive basis, that is, the limitation in the number
of licensees in the Field does not apply to lateral flow chromatography. If
Xxxxxx Labs ceases to be a BioCurex licensee, then, subject to the limitations
in Section 0 below, BioCurex shall have the right to replace such licensee. In
addition, if Xxxxxx Labs ceases to be a BioCurex licensee, then it is understood
that Xxxxxx Labs will assign to BioCurex all of Xxxxxx Labs' rights and
obligations contained in each sublicense agreement between it and its
sublicensees, provided that the applicable sublicensee provides its consent
thereto.
6
3. LICENSE GRANT
3.1 Licensed Materials and Technology. BioCurex hereby grants to Inverness
and its Affiliates a semi-exclusive license of the Licensed Materials and
Technology in the Territory with the right to conduct research and to develop,
make, have made, use, offer for sale, sell and import Products anywhere in the
Territory for use in the Field. As used in this Agreement, "have made" shall
mean that Inverness shall have the right to utilize a Third Party to develop,
test, manufacture and import (but not offer for sale or sell) Products.
3.1.1 For purposes of this Section, "semi-exclusive" shall mean that
there is a limitation to a total number of three (3) Parties, including
BioCurex, permitted to use the Licensed Materials and Technology in the Field
and in the Territory at any given time; provided, however that such limitation
on the number of licensees shall not apply with respect to (i) any lateral flow
immunochromatography application; or (ii) any sublicensee of Xxxxxx Labs
described in Section 2.6 above, or (iii) to any sublicensee of Xxxxxx Labs
described in Section 2.6 above that becomes a direct licensee of BioCurex as
described in the last sentence of such Section or is or becomes a sublicensee of
any party to whom Xxxxxx Labs transfers or assigns the Xxxxxx Labs Agreement.
3.1.2 For clarity purposes, BioCurex has the right to license the
Licensed Materials and Technology to Inverness, and two more parties, one of
which is currently Xxxxxx Labs. One of these three parties may be BioCurex
itself without permission from Inverness. Should BioCurex be one of the
licensees, BioCurex or its Affiliates retain the right to conduct research,
develop, make, have made, use, offer for sale, sell and import Products anywhere
in the Territory for use in the Field. Should a licensing agreement between
BioCurex and one of its licensees be terminated, BioCurex shall have the right
to license the Licensed Materials and Technology to another licensee or to
develop, test, manufacture, import, sell or offer for sale Products without
permission from Inverness. Notwithstanding the foregoing, BioCurex shall not
license or grant the use of the Licensed Materials and Technology in the Field
to any Third Party after the Effective Date on terms with minimum annual
royalties, as described in Section 4.3 below, less than those so described.
3.1.3 BioCurex shall retain the right to license, conduct research,
develop, make, have made, use, offer for sale, sell and import competing RECAF
tests not included in the Field.
3.1.4 BioCurex shall retain the right to develop, manufacture, sell
and license the Licensed Materials and Technology for use outside of the Field
in the Territory.
3.2 Availability of the Licensed Materials and Technology.
-----------------------------------------------------
3.2.1 Delivery. Within ninety (90) days of the Effective Date of
this Agreement, BioCurex shall deliver the RECAF Materials in the designated
amounts set forth below:
(a) 500 micrograms of pure RECAF antigen;
7
(b) 3 x vials (frozen) of cells for producing monoclonal antibodies
designated as 1-4G11;
(c) 3 x vials (frozen) of cells for producing RECAF antigen;
(d) 20 milligrams of purified monoclonal antibody designated as
1-4G11;
The RECAF Materials will be sent to Inverness care of Biosite Incorporated at
0000 Xxxxxxx Xxxxx Xxxx, Xxx Xxxxx, XX 00000. BioCurex shall place any
appropriate temperature, pressure, and/or shock indicators in any shipment of
RECAF Material to insure the common carrier's conformance with shipping
instructions and restrictions, such as temperature or handling.
3.2.2 Successful RECAF Material Transfer. Successful transfer of the
RECAF Material pursuant to the previous Section shall be determined by
independent establishment of RECAF Material at Inverness in accordance with the
following criteria:
(a) RECAF Material is viable, as determined by stabilization and
production of RECAF monoclonal antibody for at least ten doublings; and
(b) RECAF Material produces monoclonal antibodies that bind
specifically to RECAF consistent with monoclonal antibodies produced by such
RECAF Material.
3.2.3 Unsuccessful Transfer. If establishment of the RECAF Material
delivered to Inverness under this Article is unsuccessful, as determined solely
by Inverness using the criteria of the previous Section, BioCurex hereby agrees
to use commercially reasonable efforts to provide additional quantities of RECAF
Material in such amounts as Inverness may reasonably request until such time
that Inverness is able to produce RECAF Material in sufficient quantities to
support its Research and Development and other commercialization efforts.
3.2.4 Additional Transfers of RECAF Technology. Within thirty (30)
days of the Effective Date, BioCurex shall use commercially reasonable efforts
to deliver to Inverness additional reference reagents, assay kits, monoclonal
antibody and antigen for RECAF in such sufficient quantities as Inverness may
reasonably request until such time that Inverness is able to produce RECAF
Material in sufficient quantities to support its Research and Development and
other commercialization efforts.
3.2.5 Assistance By BioCurex. With respect to all transfers and
establishment procedures of RECAF Material and RECAF Technology pursuant to this
Article, BioCurex shall make available to Inverness: (a) any relevant and useful
documents and other technical information; (b) any necessary protocols
associated with the RECAF Materials and other Licensed Materials and Technology;
and (c) any consultation services and other assistance that Inverness may
reasonably request.
8
3.2.6 Notification by Inverness of Successful Transfer. Upon each
successful transfer of RECAF Material in accordance with this Article, Inverness
shall promptly provide BioCurex with written notification thereof.
4. FINANCIAL CONSIDERATIONS
4.1 License fee. As consideration for the license granted by this
Agreement, and for BioCurex's agreement to the other terms and conditions
hereof, Inverness shall pay to BioCurex a fee of *. Any such fees submitted
pursuant to this Section 4.1 shall be non-refundable and non-creditable toward
future royalty obligations.
4.2 Royalties.
4.2.1 Royalty Rate.
(a) Subject to the provisions of this Section 0, in consideration
for the licenses granted to Inverness herein, Inverness shall pay to BioCurex a
royalty on each Test Sold during the applicable Royalty Term equal to the
Minimum Royalty Value for such Test in the country of sale plus * of the amount
by which the Average Net Sales Price for such Product in such country exceeds *.
By way of example, if Inverness's Average Net Sales Price of a Product in a
given country in any calendar quarter during the Royalty Term for such country
is less than *, then the royalty payable for each such Product Sold during such
calendar quarter would be equal to the Minimum Royalty Value for such Product in
such country. If Inverness's Average Net Sales Price for that Product in that
country during any calendar quarter during the Royalty Term for such country is
*, then the royalty payable for each such Product Sold during such calendar
quarter would be equal to the Minimum Royalty Value for such Product in such
country plus *.
(b) If Inverness offers combination Products that assay targets
other than RECAF, then, for purposes of calculating royalties hereunder,
"Average Net Sales Price" of such Product shall be equal to the Average Net
Sales Price of Tests sold individually by Inverness or its Affiliate, provided
that the number of Tests sold individually is equal or greater than 25% of the
number of Tests sold in combination with other products. If the number of Tests
sold individually is less than 25% of the number of Tests sold in combination
with other products, then, for purposes of calculating royalties hereunder, "Net
Sales" of such Product shall be equal to Net Sales calculated in accordance with
Section 0 divided by the total number of different antibodies contained in such
Product that bind to and are directed against known, non-antibody targets that
do no represent experimental controls.
(c) If Inverness offers free Tests to a Third Party as a promotion
that includes other Inverness products, then such Tests shall generate royalties
in accordance with this Section 0 unless BioCurex agrees, in writing, to lower
or forfeit the royalty for that particular promotion or promotional campaign.
9
4.2.2 In the following cases Inverness is exempted from paying
royalties to BioCurex:
(a) Tests provided at no cost to generate data to present to
regulatory agencies such as the FDA, or for validation studies to be performed
by independent companies or institutions.
(b) Tests sold to BioCurex or its Affiliate(s).
(c) Tests sold in any country in which (i) there is neither a
Pending Claim nor a Valid Claim, (ii) the Product does not incorporate a
BioCurex Antibody, and (iii) there exists a company (other than Inverness,
BioCurex, BioCurex's licensees and their respective Affiliates) that sells a
competing product. Inverness shall have the responsibility to notify BioCurex of
the existence of such competitor and any change in royalties payable on account
thereof shall be made effective from the time of the notification. BioCurex
shall then have a period of 90 days from the time of the notification to dispute
Inverness's claim. If the dispute is resolved in BioCurex's favor, then
Inverness shall pay all royalties due with respect to such Product, including
royalties accruing from the time of the notification to the time of the
resolution of the dispute.
4.3 Annual Minimum Royalties.
(a) During the Annual Minimum Royalty Term, Inverness shall pay
minimum annual royalties to BioCurex as follows: Commencing on the second
anniversary of the Effective Date and ending on the anniversary of the Effective
Date that follows the First Commercial Sale of a Product to a Third Party,
Inverness shall pay BioCurex a minimum royalty of $150,000 per year. For the two
years of the Annual Minimum Royalty Term following such period, Inverness shall
pay BioCurex an Annual Minimum Royalty of *. Thereafter, for the remainder of
the Annual Minimum Royalty Term, Inverness shall pay BioCurex an Annual Minimum
Royalty of *.
(b) Notwithstanding the foregoing, if during any year there exists
more than three (3) Persons having a license or sublicense under the Licensed
Materials and Technology (in whole or in part) for use in the Field, then for
such year the Annual Minimum Royalties set forth above shall be reduced by
multiplying the Annual Minimum Royalty set forth above for the applicable year
times the fraction (1- (n-3)/n), where n is the total number of such Persons.
For example, if there are four (4) persons having such a license or sublicense
and the Annual Minimum Royalty for three (3) persons or less was * for a given
year, then the reduced Annual Minimum Royalty for such year would be *
multiplied by *, or *.
(c) Notwithstanding the foregoing, if during any year there are no
Valid Claims or Pending Claims in the European Union, then for such year the
Annual Minimum Royalties set forth in subsection (a) above, as modified by
subsection (b), if applicable, shall be further reduced by fifty (50%).
(d) All royalties paid pursuant to Section 0 shall be credited
against the Annual Minimum Royalty for the applicable year. Should royalties
paid fall short of the stipulated Annual Minimum Royalty for a given year
counted from the Effective Date, Inverness shall have thirty (30) days after the
10
end of such year to pay the difference. Should Inverness default in its payment
of the Annual Minimum Royalty and fail to cure such default, then BioCurex may
terminate this Agreement for cause in accordance with Section 0.
5. ROYALTY REPORTS AND ACCOUNTING
5.1 Royalty Reports. During the term of this Agreement following the First
Commercial Sale of a Product, Inverness shall furnish to BioCurex a quarterly
written report showing in reasonably specific detail (a) the gross sales of
Product sold by Inverness or its Affiliates during such calendar quarter and the
calculation of Net Sales from such gross sales; (b) the calculation of the
royalties, if any, that shall have accrued based upon such Net Sales; (c) the
withholding taxes applicable to Biocurex, if any, required by law to be deducted
with respect to such sales; and (d) the exchange rates, if any, used in
determining the amount of United States dollars. With respect to sales of
Products invoiced in United States dollars, the gross sales, Net Sales and
royalties payable shall be expressed in United States dollars. With respect to
sales of Products invoiced in a currency other than United States dollars, the
gross sales, Net Sales and royalties payable shall be expressed in the domestic
currency of the party making the sale together with the United States dollar
equivalent of the royalty payable, calculated using the average closing buying
rate for such currency quoted in the continental terms method of quoting
exchange rates (local currency per US$1) by Bank of America NT&SA in London,
England on each of the last business day of each month in the quarter prior to
the date of payment. Reports shall be due on the ninetieth (90th) day following
the close of each quarter. Inverness shall keep complete and accurate records in
sufficient detail to properly reflect all gross sales and Net Sales and to
enable the royalties payable hereunder to be determined.
5.2 Audits.
5.2.1 Upon the written request of BioCurex and not more than once in
each calendar year, Inverness shall permit an independent certified public
accounting firm of nationally recognized standing selected by BioCurex and
reasonably acceptable to Inverness, at BioCurex's expense, to have access during
normal business hours to such of the records of Inverness as may be reasonably
necessary to verify the accuracy of the payment reports hereunder for the eight
(8) calendar quarters immediately prior to the date of such request (other than
records for which BioCurex has already conducted an audit under this Section.
5.2.2 If such accounting firm concludes that additional amounts were
owed during the audited period, Inverness shall pay such additional amounts
within thirty (30) days of the date BioCurex delivers to Inverness such
accounting firm's written report so concluding. The fees charged by such
accounting firm shall be paid by BioCurex; provided, however, if the audit
discloses that the royalties payable by Inverness for such period are more than
one hundred ten percent (110%) of the royalties actually paid for such period,
then Inverness shall pay the reasonable fees and expenses charged by such
accounting firm.
5.2.3 BioCurex shall cause its accounting firm to retain all
financial information subject to review under this Section in strict confidence;
provided, however, that Inverness shall have the right to require that such
accounting firm, prior to conducting such audit, enter into an appropriate
non-disclosure agreement with Inverness regarding such financial information.
11
The accounting firm shall disclose to BioCurex whether the reports are correct
or not and the amount of any discrepancy. In case of discrepancy, if Inverness
fails to remedy such discrepancy within sixty (60) days after written notice
thereof, then the accounting firm will provide BioCurex with all the information
in its possession related to the discrepancy.
6. PAYMENTS
Royalties shown to have accrued by each royalty report shall be due on the
date such royalty report is due. Payment of royalties in whole or in part may be
made in advance of such due date.
7. RESEARCH AND DEVELOPMENT OBLIGATIONS AND RESTRICTIONS
7.1 Research and Development Efforts. Inverness agrees to use its
commercially reasonable efforts to conduct such research, development and
preclinical and human clinical trials as Inverness determines are necessary or
desirable to obtain regulatory approval to manufacture and market one or more
Products and shall use its commercially reasonable efforts to obtain regulatory
approval to market, and upon approval to commence marketing and market one or
more Products in the Territory.
7.2 Records. Inverness shall maintain records, in sufficient detail and in
good scientific manner, which shall reflect all work done and results achieved
in the performance of its research and development regarding the Licensed
Materials and Technology and the Products (including all data in the form
required under all applicable laws and regulations).
7.3 Reports. Within ninety (90) days following the end of each quarter
during the term of this Agreement, Inverness shall prepare and deliver to
BioCurex a written summary report which shall describe (a) the research
performed to date employing the Licensed Materials and Technology, (b) the
progress of the development, and testing of Products in clinical trials, and (c)
the status of obtaining regulatory approvals to market Products.
8. CONFIDENTIALITY
8.1 Confidential Information. During the term of this Agreement, and for a
period of three (3) years following the expiration or earlier termination
hereof, each party shall maintain in confidence all information of the other
party disclosed by the other party and identified as, or acknowledged to be,
confidential (the "Confidential Information"), and shall not use, disclose or
grant the use of the Confidential Information except on a need-to-know basis to
its and its Affiliates' directors, officers, employees, permitted licensees,
permitted assignees and agents, consultants, clinical investigators or
contractors, to the extent such disclosure is reasonably necessary in connection
with such party's activities as expressly authorized by this Agreement. To the
extent that disclosure is authorized by this Agreement, prior to disclosure,
each party hereto shall obtain agreement of any such Person to hold in
confidence and not make use of the Confidential Information for any purpose
other than those permitted by this Agreement. Each party shall notify the other
promptly upon discovery of any unauthorized use or disclosure of the other
party's Confidential Information.
12
8.2 Permitted Disclosures.
8.2.1 The confidentiality obligations contained in the previous
Sections shall not apply to the extent that (a) any receiving party (the
"Recipient") is required (i) to disclose information by law, order or regulation
of a governmental agency or a court of competent jurisdiction, or (ii) to
disclose information to any governmental agency for purposes of obtaining
approval to test or market a product, provided in either case that the Recipient
shall provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof; or (b) the Recipient can demonstrate that (i) the disclosed
information was public knowledge at the time of such disclosure to the
Recipient, or thereafter became public knowledge, other than as a result of
actions of the Recipient in violation hereof; (ii) the disclosed information was
rightfully known by the Recipient (as shown by its written records) prior to the
date of disclosure to the Recipient by the other party hereunder; (iii) the
disclosed information was disclosed to the Recipient on an unrestricted basis
from a source unrelated to any party to this Agreement and not under a duty of
confidentiality to the other party; or (iv) the disclosed information was
independently developed by the Recipient without use of the Confidential
Information disclosed by the other party. Notwithstanding any other provision of
this Agreement, Inverness may disclose Confidential Information of BioCurex
relating to information developed pursuant to this Agreement to any Person with
whom Inverness has, or is proposing to enter into, a business relationship, as
long as such Person has entered into a confidentiality agreement with Inverness.
Conversely, BioCurex may disclose Confidential Information of Inverness relating
to information developed pursuant to this Agreement to any Person with whom
BioCurex has, or is proposing to enter into, a business relationship, as long as
such Person has entered into a confidentiality agreement with BioCurex.
8.2.2 BioCurex shall be permitted to utilize or disclose to a
prospective Third Party licensee (in the course of negotiating the license
agreement between it and such prospective Third Party licensee) Confidential
Information specifically pertaining and limited to (i) the semi-exclusive nature
of this Agreement, (ii) a description of the Licensed Materials and Technology,
the Field and the Territory and (iii) the Minimum Royalty Value to other
licensees and prospective licensees, provided that such prospective licensee
agrees to maintain the confidentiality of such Confidential Information to the
same extent required by parties under this Article.
8.3 Terms of this Agreement. Except as otherwise provided in the preceding
Sections, BioCurex and Inverness shall not disclose any terms or conditions of
this Agreement to any Third Party without the prior consent of the other party.
Notwithstanding the foregoing, prior to execution of this Agreement, Inverness
and BioCurex shall agree upon the substance of information that can be used to
describe the terms of this transaction, and Inverness and BioCurex may disclose
such information, as modified by mutual agreement from time to time, without the
other party's consent.
9. NEW INVENTIONS AND MATERIALS
9.1 Ownership. All right, title and interest in any patentable invention,
discovery, composition, or enhancement conceived and reduced to practice by
employees or others on behalf of Inverness, BioCurex or both through use of the
13
Licensed Materials and Technology during the term of the Agreement, together
with all patent rights and other intellectual property rights therein, (a)
conceived and reduced to practice solely by employees or others acting on behalf
of Inverness shall be owned solely by Inverness, (b) conceived and reduced to
practice solely by employees or others acting on behalf of BioCurex shall be
owned solely by BioCurex, and (c) conceived and reduced to practice jointly by
employees or others acting on behalf of Inverness and by employees or others
acting on behalf of BioCurex (a "Joint Invention") shall be owned jointly by
Inverness and BioCurex.
9.2 Joint Inventions.
9.2.1 The Parties shall jointly determine which Party will control
the procurement and maintenance of any patent application or patent claiming a
Joint Invention (a "New Patent"). Unless otherwise agreed upon in writing,
procurement and maintenance costs of any New Patent shall be equally paid by
BioCurex and Inverness.
9.2.2 Each Party may use any Joint Invention for research purposes
without payment of royalties or duty to account to the other Party. If either
Party commercializes any product (other than a Product), the use, manufacture or
sale of which is claimed by an unexpired claim of a New Patent (which claim has
not been abandoned, finally disallowed or declared invalid or unenforceable),
then such Party shall pay to the other Party a royalty of 5% of Net Sales of
such product, payable quarterly in U.S. dollars. All such payments shall be
accompanied by a royalty report showing the basis for calculating royalties
payable under this Section, with no less detail than the reports required under
Section 0 hereof.
9.2.3 Except as otherwise set forth herein, neither Party shall
transfer, license or encumber its rights in any Joint Invention (or the patent
and other intellectual property rights therein) without the written consent of
the other party. Neither Party shall withhold or fail to give its consent to
license any Joint Invention (a) in order to renegotiate the terms set forth in
this Agreement, or (b) other than in good faith, and any Party withholding or
failing to give such consent shall provide the other Party with the reasons, in
writing, for the denial. Should a Party find those reasons insufficient, it
shall have the right to seek resolution of the dispute in accordance with the
terms of this Agreement.
9.2.4 BioCurex and Inverness shall have the right to forfeit
ownership of each Joint Invention by written notice to the other Party, in which
case such Joint Invention shall be assigned to the other Party within thirty
days after the date of such notice, and costs incurred with respect to such
Joint Invention following such assignment shall be borne solely by the assignee.
9.2.5 Each party shall cause all employees and other Persons acting
on its behalf in performing its obligations hereunder to be obligated under a
binding written agreement to assign to it, or as it shall direct, all Joint
Inventions made or conceived by such employees or other Persons.
14
9.3 Inverness Antibodies.
9.3.1 Prior to including a Inverness Antibody in a Product offered
for sale in any country, Inverness shall provide BioCurex with data
demonstrating that (a) both the Inverness Antibody and a BioCurex Antibody
detect the same band(s) on a nitrocellulose transfer (also known as a Western
blot) of a poly-acrylamide gel electrophoresis (PAGE) of an extract of MCF-7
cells, (b) said Inverness Antibody competes for binding to RECAF by at least 75%
against a BioCurex Antibody and conversely, that the same BioCurex Antibody
competes for binding to RECAF by at least 75% against said Inverness Antibody
and (c) that either (i) the statistic regression coefficient (r) of a comparison
between the RECAF values obtained with said Inverness Antibody and a BioCurex
Antibody on at least 50 (fifty) serum samples obtained half of them from healthy
individual and the other half from cancer patients be equal or higher than 90%
(0.9) or (ii) the Inverness Antibody performs better than or as well as the best
BioCurex Antibody in discriminating between cancer and normal samples taken at
random, in a blind study controlled by a reputable third party. BioCurex shall
have sixty (60) days to contest the accuracy or validity of such data.
9.3.2 During the term of this Agreement, upon request by BioCurex,
Inverness will provide BioCurex with samples of Inverness Antibodies at
Inverness's fully burdened cost, solely for use by BioCurex and its Affiliates
to conduct research. BioCurex shall not transfer the Inverness Antibodies or any
progeny or derivative thereof to any Third Party without the prior written
consent of Inverness.
10. PATENTS
10.1 Licensed Patent Procurement and Maintenance. BioCurex shall secure
and maintain the Licensed Patent Rights in such countries and in such manner as
BioCurex shall elect after reasonable consideration of the views of Inverness
and BioCurex's other licensees. BioCurex shall pay all costs associated with the
filing, prosecution and maintenance of the Licensed Patent Rights. BioCurex
shall notify Inverness of any change in the status of any patent and/or patent
application, including any abandonment, lapse, invalidity, unenforceability,
nullification or revocation thereof, and of the filing of any patent
applications within the scope of the Licensed Patent Rights within sixty (60)
days. In the event any of the Licensed Patent Rights shall become involved in an
opposition or interference proceeding, BioCurex shall manage the proceeding, at
its own expense, and shall keep Inverness informed and shall take Inverness's
views into account in setting BioCurex's strategy in the proceeding. If BioCurex
wishes to abandon an existing issued patent or any pending patent application
within the Licensed Patent Rights, it shall notify Inverness within a time
sufficient for Inverness to familiarize itself with the case and make a decision
before abandoning or failing to pursue the Licensed Patent Rights. Inverness
shall have thirty (30) days from the date of such notice within which it may
notify BioCurex that Inverness wishes to assume the costs of prosecuting or
maintaining any such patent or patent application.
10.2 Notification of Infringement. Each party shall notify the other party
of any infringement in the Territory known to such party of any Licensed Patent
Rights and shall provide the other party with the available evidence, if any, of
such infringement.
15
10.3 Enforcement of Licensed Patent Rights. BioCurex, at its sole expense,
shall have the right to determine the appropriate course of action to enforce
Licensed Patent Rights or otherwise xxxxx the infringement thereof, to take (or
refrain from taking) appropriate action to enforce Licensed Patent Rights, to
defend any declaratory judgments seeking to invalidate or hold the Licensed
Patent Rights unenforceable, to control any litigation or other enforcement
action and to enter into, or permit, the settlement of any such litigation,
declaratory judgments or other enforcement action with respect to Licensed
Patent Rights, and shall consider, in good faith, the interests of Inverness in
so doing. If BioCurex does not, within one hundred twenty (120) days of receipt
of notice from Inverness, xxxxx the infringement or file suit to enforce the
Licensed Patent Rights against at least one infringing party in the Territory,
Inverness shall have the right to take whatever action it deems appropriate to
enforce the Licensed Patent Rights; provided, however, that, within thirty (30)
days after receipt of notice of Inverness's intent to file such suit, BioCurex
shall have the right to jointly prosecute such suit and to fund up to one-half
(1/2) the costs of such suit. The party controlling any such enforcement action
shall not settle the action or otherwise consent to an adverse judgment in such
action that diminishes the rights or interests of the non-controlling party
without the prior written consent of the other party. All monies recovered upon
the final judgment or settlement of any such suit to enforce the Licensed Patent
Rights shall be shared, after reimbursement of expenses, by BioCurex and
Inverness pro rata according to the respective percentages of costs borne by
each in such suit. Notwithstanding the foregoing, BioCurex and Inverness shall
fully cooperate with each other in the planning and execution of any action to
enforce the Licensed Patent Rights, including, if necessary, joining in such
action.
10.4 BioCurex shall have no liability to Inverness for any losses,
liabilities, damages and expenses (including attorneys' fees and costs) incurred
by Inverness or its Affiliates, should, for any reason, the Licensed Patent
Rights not be enforceable for any reason, including final rejections by patent
offices or disputes from other parties claiming rights to the patents licensed
under this Agreement.
10.5 BioCurex shall remain neutral and shall have no obligation to defend,
indemnify and hold harmless Inverness and its Affiliates in any legal action
between Inverness and another BioCurex's licensee relating to the Licensed
Materials and Technology; provided that BioCurex shall have the right to become
involved in any such legal action to the extent required by any court or other
government order.
10.6 BioCurex shall have no obligation, in accordance with this Section,
to defend, indemnify and hold harmless Inverness and its Affiliates from any
judgment, damage, liability, loss, cost or other expense (including reasonable
attorneys' fees and court costs) resulting from any claim, suit or proceeding so
far and to the extent that such claim, suit or proceeding is based upon an
assertion that a Inverness modification of the Licensed Materials and Technology
constitutes an infringement of any modification of the Licensed Materials and
Technology developed solely by another BioCurex's licensee.
10.7 Inverness Opposition to Patent Rights. BioCurex shall have the right
to terminate this Agreement if Inverness, after the Effective Date, institutes a
suit, nullity action, opposition to grant, or other legal action seeking to
invalidate the claims of any patent in the Patent Rights in the Territory, or
16
actively participates (other than by legal compulsion) in any of the foregoing.
11. TERM AND TERMINATION
11.1 Term. The term of this Agreement shall commence on the Effective Date
and shall continue until terminated as provided herein.
11.2 Termination by Inverness. Inverness may terminate this Agreement, in
its sole discretion, upon thirty (30) days prior written notice to BioCurex.
Should Inverness terminate this Agreement without cause after the First
Commercial Sale and before the end of the Annual Minimum Royalty Term, then
Inverness shall pay BioCurex upon such termination a termination fee equivalent
to the higher value of (a) the royalties generated during the 12 months prior to
the termination or (b) the sum of * (the "Termination Fee").
11.3 Termination for Cause. Except as otherwise provided in other Sections
of this Agreement, either party may terminate this Agreement upon or after the
breach of any material provision of this Agreement by the other party if the
other party has not cured such breach within ninety (90) days after notice
thereof by the non-breaching party; provided, however, if any default is not
capable of being cured within such ninety (90) day period and the other party is
diligently undertaking to cure such default as soon as commercially feasible
thereafter under the circumstances, the non-breaching party shall have no right
to terminate this Agreement. Should the cause for termination be a default in
Inverness's obligations under this Agreement, then Inverness shall lose any and
all licensing rights as specified in this Agreement.
11.4 Effect of Termination after End of Annual Minimum Royalty Term. If
this Agreement is terminated after the end of the Annual Minimum Royalty Term by
either Party, (i) Inverness shall have a non-exclusive license under the
Licensed Know-How to make, have made, use and sell Products in the Territory for
use in the Field; (ii) all royalties due under Section 4.2 shall continue to be
due and payable with respect to each Test Sold from and after the date of such
termination, and (iii) the annual minimum royalties under Section 4.3 shall no
longer be paid.
11.5 General Effect of Termination. Upon any termination of this Agreement
under this Section 11, the parties shall have no further rights or obligations
hereunder except as specifically provided in Sections 11.2 and 11.4; provided,
however, that (i) such termination shall not relieve the parties of any
obligation accruing prior to such termination, and any debt, due royalties or
due payments incurred before the date of termination of this Agreement shall
survive such termination; (ii) such termination shall not relieve Inverness of
its obligation to pay the license fee set forth in Section 0, and (iii) the
provisions of Sections 0, 0 and 13 shall survive the termination of this
Agreement.
12. TRADEMARKS.
12.1 License Grant for BioCurex Marks. During the term of this Agreement,
BioCurex hereby grants to Inverness, its Affiliates and its distributors
hereunder a license to use the BioCurex Marks for Inverness's marketing, sale,
promotion, advertising, testing and/or distribution of the Product in the
Territory. For the term of this Agreement, BioCurex shall own all rights, title,
17
and interests in and to the BioCurex Marks. Further, Inverness shall use the
trade xxxx RECAFTM to describe the substance being detected by the Tests and it
shall insert "Sold Under License from BioCurexTM Inc." or substantially similar
language identifying BioCurex or its successors or its appointees as the
licensor on Inverness's marketing and promotional materials, and packaging
materials, related to Product, provided that such insertion is permitted by
applicable Regulatory Authorities. After the expiration of this Agreement,
Inverness shall have the right to continue using the trade xxxx RECAFTM to
describe the substance being detected by the Tests.
12.2 Inverness Trademarks. Inverness and its Affiliates may develop and
use any Inverness Trademarks for its marketing, sale, promotion, advertising,
testing and/or distribution of the Product in the Territory. All costs related
to the selection and maintenance of the Inverness Trademarks shall be borne by
Inverness, and Inverness shall, at all times, own all rights, title, and
interests in and to such Inverness Trademarks.
12.3 Termination of Use of BioCurex Marks. Upon termination of this
Agreement, Inverness, its Affiliates and its distributors hereunder shall cease
and desist from all further use of the BioCurex Marks, except that Inverness,
its Affiliates and its distributors hereunder may continue to use the BioCurex
Marks consistent with the terms and conditions of this Agreement in connection
with any remaining inventory of the Product. Should Inverness wish to continue
using BioCurex's marks after the termination of this Agreement, a royalty for
use of such marks shall be negotiated in good faith between the two parties.
13. INDEMNIFICATION
13.1 Indemnification. Inverness shall defend, indemnify and hold BioCurex
harmless from all losses, liabilities, damages and expenses (including
attorneys' fees and costs) incurred as a result of any claim, demand, action or
proceeding by a Third Party arising out of or relating to manufacturing,
marketing or selling the Products or any breach of this Agreement by Inverness,
or the negligence or willful misconduct of Inverness in the performance of its
obligations under this Agreement.
13.2 Procedure. BioCurex promptly shall notify Inverness of any liability
or action in respect of which BioCurex intends to claim such indemnification,
and Inverness shall have the right to participate in, and, to the extent
Inverness so desires, jointly with any other indemnitor similarly noticed, to
assume the defense thereof with counsel selected by Inverness; provided,
however, that BioCurex shall have the right to retain its own counsel, at its
sole expense, if representation of BioCurex by the counsel retained by Inverness
would be inappropriate due to actual or potential differing interests between
BioCurex and any other party represented by such counsel in such proceedings.
The indemnity agreement in this Section shall not apply to amounts paid in
settlement of any loss, claim, damage, liability or action if such settlement is
effected without the consent of Inverness, which consent shall not be withheld
unreasonably. The failure to deliver notice to Inverness within a reasonable
time after the commencement of any such action, if prejudicial to its ability to
defend such action, shall relieve Inverness of any liability to BioCurex under
this Section, but the omission so to deliver notice to Inverness will not
relieve it of any liability that it may have to BioCurex otherwise than under
this Section. BioCurex under this Section, its employees and agents, shall
18
cooperate fully with Inverness and its legal representatives in the
investigation and defense of any action, claim or liability covered by this
indemnification.
13.3 Insurance. Inverness shall maintain product liability insurance with
respect to the research, development, manufacture and sales of Products by
Inverness in such amount as Inverness customarily maintains with respect to the
research, development, manufacture and sales of its similar products. Inverness
shall maintain such insurance for so long as it continues to research, develop,
manufacture or sell any Products, and thereafter for so long as Inverness
customarily maintains insurance covering the research, development, manufacture
or sale of its similar products. The insurance shall also cover any potential
costs and damages resulting from BioCurex being included in any legal action
against Inverness.
13.4 LIMITATION OF LIABILITY. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY HEREUNDER FOR ANY
CONSEQUENTIAL, INCIDENTAL, SPECIAL OR INDIRECT DAMAGES WHATSOEVER, INCLUDING
LOST PROFITS.
14. FORCE MAJEURE
Neither party shall be held liable or responsible to the other party nor
be deemed to have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement to the extent, and
for so long as, such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party including but not limited to fire,
floods, embargoes, war, acts of war (whether war be declared or not), acts of
terrorism, insurrections, riots, civil commotions, strikes, lockouts or other
labor disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party.
15. MISCELLANEOUS
15.1 Notices. Any consent, notice or report required or permitted to be
given or made under this Agreement by one of the parties hereto to the other
party shall be in writing, delivered by any lawful means to such other party at
its address indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor and (except as otherwise
provided in this Agreement) shall be effective upon receipt by the addressee.
If to BioCurex: BioCurex, Inc.
000-0000 Xxxxx Xxxx
Xxxxxxxx, X.X. X0X 0X0, Xxxxxx
Attention: Xx. Xxxxxxx Xxxx
with a copy to: Xxxx & Trinen L.L.P., Attorneys at Law
0000 Xxxxxxxxxx Xxxxxx, Xxxxxx, XX, 00000
Attention: Mr. Xxxxxxx Xxxx
19
If to Inverness: Inverness Medical Switzerland GmbH
c/o Inverness Medical Innovations, Inc.
00 Xxxxxx Xxxx, Xxxxx 000
Xxxxxxx XX 00000
Attention: General Counsel
With copy to:
Biosite Incorporated
0000 Xxxxxxx Xxxxx Xxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
With a copy to: Legal Affairs
15.2 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the Province of British Columbia, Canada, without
regard to the conflicts of law principles thereof.
15.3 CONSENT TO JURISIDICTION. INVERNESS IRREVOCABLY SUBMITS, FOR ITSELF
AND IN RESPECT OF ITS PROPERTY, GENERALLY AND UNCONDITIONALLY, TO THE
NON-EXCLUSIVE JURISDICTION AND VENUE OF ANY COURT OF GENERAL JURISDICTION IN
VANCOUVER, BRITISH COLUMBIA AND/OR ANY FEDERAL COURT SITTING IN SAID STATE IN
ANY SUIT, ACTION, OR PROCEEDING ARISING OUT OF, RELATING TO OR MENTIONING THIS
AGREEMENT. INVERNESS IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW,
ANY OBJECTION WHICH IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF THE VENUE OF
ANY SUCH SUIT, ACTION, OR PROCEEDING BROUGHT IN SUCH A COURT AND ANY CLAIM THAT
ANY SUCH SUIT, ACTION, OR PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM.
NOTHING CONTAINED HEREIN SHALL LIMIT THE RIGHT OF BIOCUREX TO XXX INVERNESS OR
TO ENFORCE ANY JUDGMENT IN ANY JURISDICTION. WHERE INVERNESS OR ITS ASSETS ARE
LOCATED.
15.4 Assignment. Inverness shall not assign its rights or obligations
under this Agreement without the prior written consent of BioCurex; provided,
however, that Inverness may, without such consent, assign this Agreement and its
rights and obligations hereunder in connection with the transfer or sale of all
or substantially all of its business to which this Agreement relates, or in the
event of its merger, consolidation, change in control or similar transaction.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement.
15.5 Waivers and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions herein
contained, shall be valid unless made in writing and signed by duly authorized
representatives of the parties hereto.
15.6 Entire Agreement. This Agreement embodies the entire agreement
between the parties and supersedes any prior representations, understandings and
agreements between the parties regarding the subject matter hereof. There are no
20
representations, understandings or agreements, oral or written, between the
parties regarding the subject matter hereof that are not fully expressed herein.
15.7 Severability. Any of the provisions of this Agreement which are
determined to be invalid or unenforceable in any jurisdiction shall be
ineffective to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the remaining
provisions hereof and without affecting the validity or enforceability of any of
the terms of this Agreement in any other jurisdiction.
15.8 Waiver. The waiver by either party hereto of any right hereunder or
the failure to perform or of a breach by the other party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
15.9 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement effective as
of the Effective Date.
INVERNESS MEDICAL SWITZERLAND GmbH
By Xxx Xxxxxxxxx
---------------------------------
Title Chief Executive Officer
-----------------------
BIOCUREX, INC.
By Xx. Xxxxxxx Xxxx
---------------------------------
Title President
-----------------------------
