<PAGE>
EXHIBIT 10.52
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 240.24B-2
LICENSE, DEVELOPMENT AND COOPERATION AGREEMENT
THIS LICENSE, DEVELOPMENT, AND COOPERATION AGREEMENT (this
"AGREEMENT"), dated as of November 19, 2003
(the "EFFECTIVE DATE"), is entered
into between GEN-PROBE INCORPORATED, a
Delaware corporation ("GEN-PROBE") with
its principal place of business at 10210
Genetic Center Drive, San Diego
California 92121, U.S.A., and DIAGNOCURE
INC., a company organized under the
laws of the Province of Quebec, Canada
("DIAGNOCURE") with its head office at
2050, Rene-Levesque Blvd. W., 6th floor,
Sainte-Foy QC G1V 2K8, Canada.
WHEREAS, DiagnoCure owns or has intellectual property rights
with
respect to the PCA3(DD3) gene (as defined
below) and certain related technology.
WHEREAS, Gen-Probe desires to obtain an exclusive worldwide license
of
DiagnoCure's rights in the PCA3(DD3) gene,
DiagnoCure Technology (as defined
below), and certain related technology in
order to develop and commercialize
products for use in the Field (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 entity,
any other entity which directly or
indirectly controls, is controlled by, or is
under common control with, such entity. An
entity shall be regarded as in
control of another entity if it owns, or
directly or indirectly controls at
least fifty percent (50%) of the voting
stock or other ownership interest of the
other entity, or if it directly or
indirectly possesses the power to direct or
cause the direction of the management and
policies of the other entity by any
means whatsoever.
1.2 "APTIMA(R)
TECHNOLOGY" shall mean all technology
reasonably necessary to make or use
Gen-Probe's APTIMA generation of amplified
nucleic acid assays, including Target
Capture (TC), Transcription-Mediated
Amplification (TMA), Hybridization
Protection Assay (HPA) and Dual Kinetic Assay
(DKA) technologies, each to the extent in
each case that Gen-Probe has a right
to license or sublicense (and subject to
the provisions of Section 3.3).
1.3
"CHANGE-IN-CEO" shall mean the replacement of Henry
L. Nordhoff as Chief Executive Officer of
Gen-Probe; provided, however that (a)
no Change-in-CEO will occur if the
successor to Mr. Nordhoff has been an
employee of Gen-Probe for at least the
one-year period preceding the date on
which he or she is appointed CEO and (b) no
Change-in-CEO will occur if Mr.
Nordhoff remains as Chairman of Gen-Probe.
In the event that Mr. Nordhoff does
not remain as Chairman, and his successor
as President and CEO has not been an
employee of Gen-Probe for at least one year
before the later of Mr. Nordhoff's
termination as (i) President and CEO or
(ii) Chairman, then DiagnoCure shall
have the option for a period of six months
to terminate the right of the
President and CEO of Gen-Probe, pursuant to
Section 6.5.2, to make the final
decision in order to resolve a Program
Dispute.
1.
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1.4
"CHANGE-IN-CONTROL" shall mean, with respect to
Gen-Probe, (a) the acquisition of Gen-Probe
by another entity by means of any
transaction or series of related
transactions (including, without limitation,
any reorganization, merger or
consolidation, but excluding any merger effected
exclusively for the purpose of changing the
domicile of Gen-Probe); (b) the
sale, transfer or other disposition of all
or substantially all of the assets of
Gen-Probe (including without limitation all
of its assets relating to this
Agreement); or (c) the sale of all or
substantially all of the capital stock of
Gen-Probe; unless in each of clauses (a)
through (c) above, Gen-Probe's
stockholders of record immediately prior to
such acquisition or sale hold (by
virtue of the securities issued in
consideration for Gen-Probe's acquisition or
sale or otherwise) greater than fifty
percent (50%) of the total voting power of
the surviving or acquiring entity.
1.5
"CONFIDENTIAL INFORMATION" shall mean, with respect
to a party, all information of any kind
whatsoever (including without
limitation, data, compilations, formulae
models, patent disclosures, procedures,
processes, projections, protocols, results
of experimentation and testing,
specifications, strategies and techniques),
and all tangible and intangible
embodiments thereof of any kind whatsoever
(including without limitation,
apparatus, compositions, documents,
drawings, machinery, patent applications,
records, reports), (i) which is disclosed
by such party to the other party under
this Agreement and is marked, identified as
or otherwise acknowledged to be
confidential at the time of disclosure to
the other party and (ii) which was
disclosed by such party to the other party
under the Confidential Disclosure
Agreement between the parties dated
November 15, 2002. Notwithstanding the
foregoing, Confidential Information of a
party shall not include information
which the other party can establish by
written documentation (a) to have been
publicly known prior to disclosure of such
information by the disclosing party
to the other party, (b) to have become
publicly known without fault on the part
of the other party, subsequent to
disclosure of such information by the
disclosing party to the other party, (c) to
have been received by the other
party at any time from a source, other than
the disclosing party, rightfully
having possession of and the right to
disclose such information, (d) to have
been otherwise known by the other party
prior to disclosure of such information
by the disclosing party to the other party,
or (e) to have been independently
developed by employees or agents of the
other party without access to or use of
such information disclosed by the
disclosing party to the other party.
1.6 "CONTRACT
DEVELOPMENT" shall mean the funded work as
more particularly described in Section
6.3.
1.7
"DIAGNOCURE KNOW-HOW RIGHTS" shall mean all of
DiagnoCure's rights in and to Know-How that
directly relates to the DiagnoCure
Technology (other than University Know-How
Rights) and is reasonably necessary
for the purposes of this Agreement.
1.8
"DIAGNOCURE PATENT RIGHTS" shall mean all Patent
Rights owned or licensed by DiagnoCure that
claim any discovery or invention
directly related to the DiagnoCure
Technology (other than University Patent
Rights), including but not limited to those
patents and patent applications (and
patents issued thereon) listed in Schedule
1 attached hereto and made a part
hereof, together with any divisions,
continuations, extensions, renewals,
reissues reexamination certificates and
continuations of such patents and the
foreign equivalents of any of the
foregoing.
2.
<PAGE>
1.9
"DIAGNOCURE PRODUCT" shall mean the [...***...] for
the detection of PCA3(DD3) that are being
sold by DiagnoCure prior to the date
that Gen-Probe provides the notice under
Section 10.1.1 that a Licensed Product
is ready for commercial launch.
1.10
"DIAGNOCURE TECHNOLOGY" shall mean all technology
relating to PCA3(DD3) or the use,
measurement or detection thereof, within the
Field.
1.11
"DISPUTE" shall mean any dispute, disagreement,
controversy, stalemate or claim arising out
of or relating to this Agreement, or
the breach, termination or validity
thereof.
1.12
"END USER" shall mean, with respect to a Licensed
Product, a Third Party that uses such
Licensed Product to generate data and
report the results of such data.
1.13
"EXCHANGE RATE" shall mean, with respect to any
amount to be converted from a foreign
currency to U.S. dollars hereunder, the
exchange from the foreign currency to the
U.S. dollars currency 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 relevant date.
1.14
"FDA" shall mean the United States Food and Drug
Administration, or the successor
thereto.
1.15
"FIELD" shall mean the detection and/or measurement
of PCA3(DD3) as:
(a) a marker
for the diagnosis, monitoring,
prognosis, or drug susceptibility of
prostate cancer; and/or
(b) a marker
for cancer (without limitation),
[...***...].
The "FIELD" shall not include the use of any assay in drug
discovery.
1.16
"FIRST COMMERCIAL SALE" shall mean, with respect to
any Licensed Product, the first commercial
sale of such Licensed Product by
Gen-Probe, its Affiliates, distributors or
(sub)licensees to customers in any
country who are not Affiliates.
1.17
"FULLY-BURDENED COST" shall mean the fully-burdened
cost to a party (expressed on a per unit
basis) of manufacturing or having
manufactured such product, together with
the packaging thereof, including the
following specified costs of
manufacturing:
1.17.1 direct manufacturing and quality control costs
(i.e., those costs which vary with
production), including, without limitation,
direct labor and benefit expenses for
manufacturing and quality control
personnel, actual cost of raw materials,
components, consumable bulk, costs
associated with scrap and other production
materials incorporated into a
product; plus
*CONFIDENTIAL TREATMENT REQUESTED
3.
<PAGE>
1.17.2 fixed manufacturing overhead costs allocable
to the product based on actual utilization
for manufacturing work directly
related to such product conducted at the
relevant manufacturing facility,
including, but not limited to, direct
benefit and labor expenses for technical
services and support services,
depreciation, maintenance and repairs and
insurance costs associated with such
utilization of the manufacturing facility;
plus
1.17.3 any and all royalties payable for rights used
in the manufacture of the product, in each
case in accordance with GAAP and
consistent with the cost structures used by
the party for the same or similar
materials, components or products in its
business operations outside the scope
of this Agreement.
The fully-burdened manufacturing cost shall be subject to the right
of
audit.
1.18
"GEN-PROBE IP RIGHTS" shall mean, collectively, the
Gen-Probe Patent Rights and the Gen-Probe
Know-How Rights.
1.19
"GEN-PROBE KNOW-HOW RIGHTS" shall mean all of
Gen-Probe's rights in and to Know-How that
directly relates to the APTIMA
Technology and is reasonably necessary for
the purposes of this Agreement.
1.20
"GEN-PROBE PATENT RIGHTS" shall mean all Patent
Rights owned or controlled by Gen-Probe
that claim any discovery or invention
directly related to and reasonably
necessary for practicing the APTIMA
Technology, including those identified in
Schedule 2, in each case that
Gen-Probe has a right to license or
sublicense (and subject to the provisions of
Section 3.3).
1.21
"IUO KIT" shall mean a kit to measure the expression
of PCA3(DD3) intended and technically
sufficient to be used for FDA (or similar
governmental authority) mandated clinical
trials.
1.22
"JOINT ADVISORY COMMITTEE" shall mean the committee
established pursuant to Section 6.
1.23
"JOINT WORKING TEAM" shall mean the team established
pursuant to Section 5.4.
1.24
"KNOW-HOW" shall mean all information and data, which
is not generally known including, but not
limited to, formulae, procedures,
protocols, techniques, market research,
copies of regulatory filings, and
results of experimentation and testing.
1.25
"LICENSE AGREEMENT" shall mean that certain License
Agreement between the University of
Nijmegen and DiagnoCure dated May 1, 2000
and any amendments thereto.
1.26
"LICENSED KNOW-HOW RIGHTS" means the DiagnoCure
Know-How Rights and the University Know-How
Rights.
4.
<PAGE>
1.27
"LICENSED METHOD" shall mean any method or process
used in the Field which if used absent the
license granted hereunder would
infringe a Valid Claim of the Licensed
Patent Rights, or which otherwise uses
the Licensed Know-How Rights.
1.28
"LICENSED PATENT RIGHTS" means the DiagnoCure Patent
Rights and the University Patent
Rights.
1.29
"LICENSED PRODUCT" shall mean any product for use in
the Field, which if made, used, sold,
offered for sale or imported absent the
license granted hereunder would infringe a
Valid Claim of the Licensed Patent
Rights, or which otherwise uses or
incorporates the Licensed Know-How Rights.
1.30
"LICENSED IP RIGHTS" shall mean, collectively, the
Licensed Patent Rights and the Licensed
Know-How Rights.
1.31
"NET SALES" shall mean the aggregate amount of
revenue in U.S. Dollars (converted as
necessary for sales made in a currency
other than U.S. Dollars into U.S. Dollars
at the applicable Exchange Rate)
realized by Gen-Probe or its Affiliates,
sublicensees, or distributors from End
Users for any Licensed Product sold or
otherwise disposed of for consideration
(for any such Licensed Product sold or
otherwise disposed of for consideration
other than cash, the revenue from each such
Licensed Product shall be deemed to
be the average price charged for identical
or similar (after reasonable
adjustments) Licensed Products sold or
Licensed Methods practiced by Gen-Probe
or its Affiliates during the same royalty
period in "arms-length" transactions),
less only the following:
(a) customary
credits and allowances granted by
Gen-Probe and its Affiliates (if any) for
such Licensed Products on account of
refunds, price reductions, price discounts
or rebates, whether arising out of
recalls, rejections, returns or otherwise
relating to Licensed Products sold
during or prior to such royalty period (and
for which royalties were previously
paid hereunder);
(b) excise
taxes, sales taxes, value added
taxes, consumption taxes, customs duties
and other taxes or duties (excluding
income taxes or franchise taxes) imposed
with respect to such Licensed Products;
and
(c)
transportation charges (including packing,
insurance, and freight costs) actually
incurred in connection with the sales of
such Licensed Products
1.32
"PATENT RIGHTS" shall mean (a) all patent
applications heretofore or hereafter filed
or having legal force in any country
worldwide; (b) all patents, including
utility, model and design patents and
certificates of invention; and (c) all
divisionals, continuations,
continuations-in-part, reissues, renewals,
extensions or additions to the
foregoing.
1.33
"PCA3(DD3") shall mean the PCA3(DD3) gene more
particularly described in the patents
included within the DiagnoCure Patent
Rights and the University Patent Rights,
together with and any derivative,
polymorphism, progeny, splice variant, or
part thereof (including introns and
exons).
5.
<PAGE>
1.34
"PROGRAM" shall mean the collaborative program
described in Section 5.
1.35
"PROGRAM DISPUTE" shall mean any and all disputes,
disagreements, or stalemates between the
parties arising from or relating to the
design, modification, or execution of the
Program or any activity thereunder,
including but not limited to issues arising
in connection with Third Party
patent infringement claims as referred to
in Section 11.4.
1.36
"PROGRAM INVENTION" shall mean any invention,
discovery, composition technology,
enhancement, data or information (whether or
not patentable), made or conceived by
employees or others on behalf of
Gen-Probe, DiagnoCure or both in the
performance of the Program during the term
of the Program.
1.37
"PROGRAM PATENT RIGHTS" shall mean all Patent Rights
which claim any Program Invention.
1.38
"ROYALTY TERM" shall mean, with respect to each
Licensed Product in each country, if the
manufacture, use or sale of such
Licensed Product in such country was at the
time of the First Commercial Sale in
such country covered by a Valid Claim of
the Licensed Patent Rights, the term
for which such Valid Claim remains in
effect and would be infringed but for the
license granted by this Agreement. For each
country in which no Valid Claim has
ever existed because DiagnoCure has not
filed a patent application in that
country, the parties agree that the Royalty
Term shall be determined by
reference to the status of a Valid Claim in
the United States.
1.39
"THIRD PARTY" shall mean any person or entity other
than Gen-Probe or DiagnoCure or any of
their Affiliates.
1.40
"THIRD PARTY MARKER" shall mean a biomarker (a)
detected by a Licensed Product (other than
for control purposes) that is not
covered by the Licensed Patent Rights and
(b) for which Gen-Probe owes a royalty
to a Third Party for the making, using or
selling of such Licensed Product that
detects such marker.
1.41
"UNIVERSITY KNOW-HOW RIGHTS" means all rights in and
to Know-How licensed from the University of
Nijmegen to DiagnoCure or otherwise
provided by the University of Nijmegen to
DiagnoCure, in each case to the extent
that directly related to the DiagnoCure
Technology and reasonably necessary for
the purposes of this Agreement.
1.42
"UNIVERSITY PATENT RIGHTS" means all Patent Rights
licensed from the University of Nijmegen to
DiagnoCure directly related to the
DiagnoCure Technology.
1.43
"VALID CLAIM" shall mean, in the case of an issued
and unexpired patent within the Licensed
Patent Rights, a claim of an issued and
unexpired patent which has not been held
permanently revoked, unenforceable or
invalid by a decision of a court or other
governmental agency of competent
jurisdiction, unappealable or unappealed
within the time allowed for appeal, and
which has not been admitted to be invalid
or unenforceable through reissue or
disclaimer or otherwise, and in the case of
a United States or foreign patent
application, a claim that has not been
cancelled, withdrawn, or abandoned
without being refiled
6.
<PAGE>
in another application or that has not been
finally rejected by an
administrative agency action from which no
appeal can be taken.
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 or
jurisdiction 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 CONSENTS.
All necessary consents, approvals and
authorizations of all governmental
authorities and other entities required to be
obtained by DiagnoCure in connection with
this Agreement have been obtained. All
necessary consents, approvals and
authorizations of all governmental authorities
and other entities required to be obtained
by Gen-Probe 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 LICENSE
NEGOTIATIONS WITH [...***...]. Gen-Probe
represents, warrants, and agrees that,
without the prior written consent of
DiagnoCure, Gen-Probe shall not at any time
after the Effective Date seek to
acquire, for itself or any Third Party,
rights under any patent or patent
application owned or controlled by
[...***...] to make, use or sell a product or
service that measures or detects PCA3(DD3)
in order to reduce any financial
obligation of Gen-Probe to DiagnoCure under
this Agreement. For the avoidance of
doubt, nothing herein shall restrict
Gen-Probe's right to negotiate with
[...***...], subject to the terms of this
Agreement and, particularly, in
compliance with the terms of Sections 5 and
6, if the Licensed Patent Rights are
insufficient to provide freedom-to-operate
as to PCA3(DD3) as a marker for
prostate cancer.
2.6 LICENSED
IP RIGHTS.
2.6.1 As
of the Effective Date, DiagnoCure
represents, warrants and covenants to
Gen-Probe that, except as DiagnoCure has
expressly informed Gen-Probe in writing
prior to the Effective Date, (a)
DiagnoCure is the sole owner or exclusive
licensee of the Licensed IP Rights,
and has not granted to any Third Party any
license or other interest in the
Licensed IP Rights; (b) to the best of
DiagnoCure's knowledge, there are not and
will not be any Third Party Patent Rights
related to PCA3(DD3) that are or will
be infringed by (i) the making, using,
selling or importing of Licensed Products
incorporating the Licensed IP Rights in
the
*CONFIDENTIAL TREATMENT REQUESTED
7.
<PAGE>
Field, or (ii) practicing a method of
detecting, measuring, monitoring or
diagnosing prostate cancer utilizing
PCA3(DD3) in the Field; (c) to the best of
DiagnoCure's knowledge, DiagnoCure is not
aware of any infringement or
misappropriation by a Third Party of the
Licensed IP Rights; and (d) the License
Agreement (i) is in full force and effect,
(ii) is not in a state of breach, and
(iii) except as DiagnoCure has expressly
provided to Gen-Probe, has not been
amended in any manner.
2.6.2 As
of the Effective Date, Gen-Probe
represents, warrants and covenants to
DiagnoCure that, except as Gen-Probe has
expressly informed DiagnoCure in writing
prior to the Effective Date, (a)
Gen-Probe is the owner or licensee of the
Gen-Probe IP Rights; (b) to the best
of Gen-Probe's knowledge, there are not and
will not be any Third Party Patent
Rights related to APTIMA technology that
are or will be infringed by (i) the
making, using, selling or importing of
Licensed Products incorporating the
APTIMA Technology in the Field; and (c) to
the best of Gen-Probe's knowledge,
Gen-Probe is not aware of any infringement
or misappropriation by a Third Party
of the Gen-Probe Patent Rights and
Gen-Probe Know-How Rights.
3.
LICENSE GRANT
3.1 LICENSED
IP RIGHTS. Subject to the terms of this
Agreement, DiagnoCure hereby grants to
Gen-Probe a worldwide, exclusive license
and sublicense (including the right to
grant sublicenses) in the Field under the
Licensed IP Rights to research, develop,
make, have made, use, offer for sale,
sell and import Licensed Products, and
practice Licensed Methods, in each case
for the detection and/or measurement of
PCA3(DD3) as a marker for the diagnosis
monitoring, prognosis, or drug
susceptibility of prostate cancer. Subject to the
terms of this Agreement, DiagnoCure hereby
grants to Gen-Probe a worldwide,
co-exclusive license (co-exclusive with
DiagnoCure and its future sublicensees)
and sublicense (including the right to
grant sublicenses) in the Field under the
Licensed IP Rights to research, develop,
make, have made, use, offer for sale,
sell and import Licensed Products, and
practice Licensed Methods, in each case
for the detection and/or measurement of
PCA3(DD3) as a marker for cancer
(without limitation) [...***...]. For the
avoidance of doubt, nothing contained
herein shall constitute a license to
Gen-Probe for the use of any assay in drug
discovery.
3.2 DIAGNOCURE
RIGHTS. Notwithstanding the exclusive
license granted to Gen-Probe under Section
3.1, subject to the terms of this
Agreement DiagnoCure shall have the
following worldwide rights under the
Licensed IP Rights:
3.2.1
pursuant to Sections 3.3 and 3.4, to
research and develop (but not to offer for
sale or sell) assays solely for
non-commercial, research applications.
3.2.2
until Gen-Probe provides written notice to
DiagnoCure that a Licensed Product is ready
for commercial launch pursuant to
Section 10.1.1., to make, have made, use,
offer for sale, sell and import the
DiagnoCure Product;
*CONFIDENTIAL TREATMENT REQUESTED
8.
<PAGE>
3.2.3
after Gen-Probe provides such notice, to
sell its then-current inventory of
DiagnoCure Product until the earlier of the
date (i) DiagnoCure has sold off such
inventory, or (ii) [...***...] after
Gen-Probe has provided such notice; and
3.2.4
subject to the oversight and governance of
the Joint Advisory Committee, to co-promote
the DiagnoCure Technology as used in
Licensed Products, but not to co-market or
to sell the Licensed Products.
3.3 LICENSE TO
DIAGNOCURE. Subject to supervision of the
Joint Advisory Committee and subject to the
terms of this Agreement, Gen-Probe
hereby grants to DiagnoCure under the
Gen-Probe Know-How Rights and Gen-Probe
Patent Rights a non-exclusive, royalty-free
license to research and develop
assays using the APTIMA Technology in the
Field in conjunction with the
DiagnoCure Technology for non-commercial
applications, including research. With
respect to technology that Gen-Probe uses
in connection with the APTIMA
Technology, but that is not APTIMA
Technology and/or not owned by Gen-Probe, and
that is reasonably necessary, as determined
by the Joint Advisory Committee, for
DiagnoCure to practice its license above,
Gen-Probe shall use best efforts to
obtain rights for DiagnoCure to practice
such technology.
3.4 ADDITIONAL
APPLICATIONS WITHIN THE FIELD. If, at any
time during the term of this Agreement,
DiagnoCure becomes aware of any
additional PCA3(DD3) application within the
Field (the "ADDITIONAL
APPLICATION"), which application is then
not the subject of a Licensed Product
that is planned for development, in
development, or being sold pursuant to this
Agreement (an "EXISTING APPLICATION"), then
DiagnoCure shall have the right to
present such Additional Application, with
reasonable supporting documentation
and/or data, to the Joint Advisory
Committee for review. For the period of
[...***...] following such presentation
Gen-Probe shall have the following
options:
(a) Committing
to develop and commercialize such
Additional Application in accordance with a
schedule to be mutually agreed by
both parties; or
(b) Electing
to license such Additional
Application to a Third Party licensee, in
accordance with a schedule to be
mutually agreed by both parties, on terms
that shall provide that DiagnoCure
shall receive [...***...] of any
consideration received from such licensee for
such license and Gen-Probe shall receive
[...***...] of such consideration.
Gen-Probe shall exercise its option by delivering written notice
to
DiagnoCure. If Gen-Probe does not elect
either of the options set forth above
within the time allowed, and if the
proposed Additional Application will not
substantially compete with an Existing
Application, then DiagnoCure may elect to
license such Additional Application to a
Third Party licensee on terms that
shall provide that DiagnoCure shall receive
[...***...] of any consideration
received from such licensee for such
license and Gen-Probe shall receive
[...***...] of such consideration. For
purposes of this section, an Additional
Application will be deemed to
"substantially compete" with an Existing
Application if the Additional Application
is reasonably expected to erode more
than [...***...] of the market for the
Existing Application.
*CONFIDENTIAL TREATMENT REQUESTED
9.
<PAGE>
3.5 ADDITIONAL
UTILITY OUTSIDE THE FIELD. If, at any time
during the term of this Agreement,
DiagnoCure becomes aware of any PCA3(DD3)
utility outside the Field, DiagnoCure shall
notify Gen-Probe in writing and,
upon Gen-Probe's written request
[...***...] of such written notification,
DiagnoCure shall enter into good faith
negotiations with Gen-Probe concerning
the possible expansion, on commercially
reasonable terms to be negotiated by the
parties in good faith, of the license
rights granted hereunder to encompass the
additional utility of PCA3(DD3) outside the
Field. If such good faith
negotiations do not result in a
mutually-acceptable agreement [...***...] from
the date of Gen-Probe's written request,
then Gen-Probe's right of first
negotiation hereunder shall terminate and
DiagnoCure shall have no further
obligation to Gen-Probe with under this
section.
4.
FINANCIAL TERMS
4.1 FEES. In
consideration of this Agreement and subject
to the terms hereof including in particular
Gen-Probe's rights of termination
under Section 12, Gen-Probe shall pay to
DiagnoCure non-refundable fees of Nine
Million Dollars ($9,000,000) to be paid as
follows:
4.1.1
Gen-Probe shall pay to DiagnoCure upon
execution of this Agreement the sum of
three million dollars ($3,000,000).
4.1.2
Gen-Probe shall pay to DiagnoCure within
[...***...] following the Effective Date
the additional sum of one million
dollars ($1,000,000).
4.1.3
Gen-Probe shall pay to DiagnoCure within
[...***...] following the Effective Date
the additional sum of three million
dollars ($3,000,000).
4.1.4
Gen-Probe shall pay to DiagnoCure within
[...***...] following the Effective Date
the additional sum of two million
dollars ($2,000,000).
4.1.5
Notwithstanding the foregoing, the parties
acknowledge and agree that if, on the date
any license fee payment is due to
DiagnoCure under this Section 6.1, at least
one (1) Third Party has acquired
rights under a Valid Claim of a patent or
patent application owned or controlled
by [...***...] to make, use or sell a
product or service that measures or
detects PCA3(DD3) and competes with a
Licensed Product and the Third Party has
sold such competing product or service
prior to the date the license fee payment
is due, then each such license fee payment
when due shall be reduced by
[...***...].
4.2
ROYALTIES
(a) As
additional consideration for licenses
granted to Gen-Probe hereunder, following
the First Commercial Sale of a
Licensed Product, Gen-Probe shall pay to
DiagnoCure during the Royalty Term
annual royalties equal to (i) eight percent
(8%) of Net Sales of Licensed
Products by Gen-Probe its Affiliates or
sublicensees up to fifty million dollars
($50,000,000) in cumulative Net Sales, and
(ii) sixteen percent (16%) of Net
Sales of Licensed Products by Gen-Probe its
Affiliates or sublicensees in excess
of fifty million dollars ($50,000,000) in
cumulative Net Sales.
*CONFIDENTIAL TREATMENT REQUESTED
10.
<PAGE>
(b)
Notwithstanding the foregoing, the parties
acknowledge and agree that, on a
country-by-country basis, if, at the time a
royalty is due under this Section 4.2(a)
for a Licensed Product sold in such
country, Gen-Probe does not have worldwide
exclusive rights under Section 3.1 in
the Field because a Third Party has
acquired rights under a Valid Claim of a
patent or patent application owned or
controlled by [...***...] to make, use and
sell a product OR service that measures or
detects PCA3(DD3) and competes with a
Licensed Product, then
(i) for so
long as [...***...] in such
country is selling a product or service
that measures or detects PCA3(DD3) in
the Field and such product or service
would, if made, used or sold in the United
States, infringe a Valid Claim of the
Licensed Patent Rights, then the
applicable royalty rate set forth in (a)
above shall be reduced to the
[...***...] of the stated royalty rate in
such country; and
(ii)
for so long as [...***...] in such
country are selling products or services
that measure or detect PCA3(DD3) in the
Field and such products OR services would,
if made, used or sold in the United
States, infringe a Valid Claim of the
Licensed Patent Rights, then the
applicable royalty rate set forth in (a)
above shall be reduced to the
[...***...] of the stated royalty rate in
such country.
(c) In the
event a Licensed Product detects or
measures a Third Party Marker, as
determined by the Joint Advisory Committee,
then the Net Sales of such Licensed
Product, for purposes of royalty payments on
such Licensed Product, shall be calculated
by multiplying the Net Sales of that
Licensed Product by the quotient of (a)
[...***...] (b) [...***...]. In no event
shall the Net Sales on such Licensed
Product be reduced under this Section
4.2(c) to less than [...***...] of the
amount of Net Sales of such Licensed
Product before giving effect to the
application of this Section 4.2(c).
(d) For the
avoidance of doubt, the financial
obligation of Gen-Probe to DiagnoCure in
connection with sales of Licensed
Products under this Agreement shall be
solely the royalty obligations set forth
in this Section 4.2.
4.3 CONTRACT
DEVELOPMENT. In consideration for the
research and development to be conducted by
DiagnoCure pursuant to Schedule 3,
Gen-Probe shall, commencing on January 1,
2004, pay to DiagnoCure seven hundred
and fifty thousand dollars ($750,000) per
year for two (2) consecutive years
thereafter, each such yearly funding
payable in twelve (12) equal monthly
installments. The Contract Development
periods may be extended at Gen-Probe's
option on an annual basis at a rate to be
mutually-agreed upon, by the delivery
of written notice not later than ninety
(90) days prior to the expiration of the
then-existing period. Gen-Probe shall
provide to DiagnoCure, at Gen-Probe's
cost, the instruments and reagents more
particularly described in Schedule 3 for
DiagnoCure's internal non-commercial
purposes, including research. Except as
expressly set forth in this Section 4.3,
any additional research and development
funding by Gen-Probe shall be negotiated in
good faith by the parties and
subject in each case to written approval by
the Joint Advisory Committee.
DiagnoCure shall have the right to request
during the term of this Agreement,
that Gen-Probe supply instruments and
reagents to
*CONFIDENTIAL TREATMENT REQUESTED
11.
<PAGE>
a Third Party for non-commercial research
and development conducted by such
Third Party for the benefit of DiagnoCure.
Subject to approval of any such
request by the Joint Advisory Committee and
subject to such Third Party entering
into an agreement acceptable to Gen-Probe
regarding intellectual property
ownership, non-disclosure and restrictions
on further transfer of such
instruments and reagents, Gen-Probe shall
provide such instruments and reagents
to such Third Party at a cost no greater
than [...***...] of the Fully-Burdened
Costs of such instruments and reagents.
4.4
INSTRUMENTS, ETC. [...***...] instruments, analyzers
or similar equipment, [...***...].
5. THE
PROGRAM
5.1
PROGRAM.
5.1.1
Following the Effective Date, the parties
shall work together in a timely manner to
conduct the Program to research,
develop, and commercialize Licensed
Products, to identify applications related
to the DiagnoCure Technology, to manage the
intellectual property related to
PCA3(DD3), and to coordinate marketing of
the DiagnoCure Product. During the
term of the Program, DiagnoCure shall use
its best efforts to provide to
Gen-Probe, for no additional consideration
other than that described in Section
4, all information and assistance of
DiagnoCure as is reasonably necessary to
Gen-Probe under the Program in the
following areas:
(a) assay
development capabilities including
providing research and prototype
development assistance;
(b) network of tissue
banks (including without
limitation providing access to all
specimens included within DiagnoCure's
network of tissue banks as of the Effective
Date);
(c) input and
assistance so that the Product
Requirements Document ("PRD") may be
approved within six weeks following the
Effective Date, and expertise and
assistance for the technical aspects of
clinical trial and regulatory
authorizations;
(d) access to
experts and market development
expertise in the fields of urology and
oncology (to the best of DiagnoCure's
ability and subject to Gen-Probe bearing
its own costs and any costs of third
parties in connection therewith); and
(e) all
Know-How available to DiagnoCure
regarding the DiagnoCure Technology which
is reasonably necessary to the
performance of this Agreement.
5.1.2
During the term of the Program, and subject
to the supervision of and approval of the
Joint Advisory Committee, Gen-Probe
shall use reasonable commercial efforts to
provide to DiagnoCure, at Gen-Probe's
cost, introductions to Gen-Probe customers
who may be potential purchasers of
the DiagnoCure Product. During the term of
the Program, and subject to the
approval of, and supervision by, the Joint
Advisory Committee, Gen-Probe
*CONFIDENTIAL TREATMENT REQUESTED
12.
<PAGE>
shall provide to DiagnoCure for its
internal use only, at no charge to
DiagnoCure, such instruments and reagents
as mutually agreed upon by the parties
and reasonably necessary for DiagnoCure to
conduct research and development
activities under the Program using the
APTIMA Technology pursuant and subject to
the license grant set forth in Section 3.3.
Gen-Probe shall provide commercially
reasonable training to DiagnoCure with
respect to the instruments and reagents
and Gen-Probe know-how, as reasonably
necessary in connection with DiagnoCure's
activities under the Program. Each Party
shall bear its own costs in connection
with such training. DiagnoCure shall have
the right to request during the term
of this Agreement that Gen-Probe supply
instruments and reagents to a Third
Party for noncommercial research and
development conducted by such Third Party
for the benefit of DiagnoCure under the
Program. Subject to approval of any such
request by the Joint Advisory Committee and
subject to such Third Party entering
into an agreement acceptable to Gen-Probe
regarding intellectual property
ownership, non disclosure and restrictions
on further transfer of such
instruments and reagents, Gen-Probe shall
provide such instruments and reagents
to such Third Party at a cost no greater
than [...***...] of the Fully-Burdened
Cost of such instruments and reagents.
5.2 CONDUCT OF
PROGRAM. Each party shall conduct the
Program in a manner consistent with good
scientific practice, and in compliance
in all material respects with all
requirements of applicable laws and
regulations to attempt to achieve the
Program's objectives efficiently and
expeditiously. Each party shall proceed
diligently with its responsibilities
under the Program, and shall allocate such
personnel, equipment, facilities and
other resources as reasonably necessary to
conduct its obligations under the
Program and to accomplish the objectives
thereof.
5.3
RESULTS.
5.3.1
REPORTS. Within [...***...] following the
end of [...***...] during the term of the
Program and within [...***...]
following the expiration or termination of
the Program, each party shall
prepare, and provide to the other party, a
reasonably detailed written report
which shall describe the work performed by
such party, and the results achieved,
to date under the Program, together with
copies of all data resulting from the
tests and evaluation performed by such
party to date under the Program.
5.3.2
RECORDS. Each party shall maintain records,
in sufficient detail and in a manner
consistent with good scientific practice
and appropriate for patent purposes, which
shall be complete and accurate and
shall fully and properly reflect all work
done and results achieved in the
performance of the Program.
5.3.3
INSPECTION OF RECORDS. Each party shall have
the right, during normal business hours and
on reasonable notice, to inspect and
copy such records of the other party
regarding the work done and results
achieved in the performance of the Program,
to the extent permitted by
applicable government regulations and
reasonably necessary to enable such party
to conduct its obligations under the
Program or to exercise its rights
hereunder. Each party shall maintain such
records of the other party (together
with the information contained therein) in
confidence in accordance with Section
9 below and shall not use such records (or
information) except to the extent
otherwise permitted by this Agreement.
*CONFIDENTIAL TREATMENT REQUESTED
13.
<PAGE>
5.4 JOINT
WORKING TEAM.
5.4.1 No
later than fifteen (15) days following
the Effective Date, Gen-Probe and
DiagnoCure shall form the Joint Working Team
which shall comprise three (3) named
representatives of Gen-Probe and three (3)
named representatives of DiagnoCure.
Gen-Probe and DiagnoCure each shall appoint
its representatives to the Joint Working
Team from time to time, and may
substitute one or more of its
representatives, in its sole discretion, effective
upon written notice to the other of such
change. Each party shall designate one
of its representatives to the Joint Working
Team as its senior representative.
The senior Gen-Probe representat