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 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx
Xxxxxxxxxx 00000, U.S.A., and DIAGNOCURE INC., a company organized under the
laws of the Province of Quebec, Canada ("DIAGNOCURE") with its head office at
0000, Xxxx-Xxxxxxxx Xxxx. W., 0xx xxxxx, Xxxxxx-Xxx XX X0X 0X0, Xxxxxx.
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 Xxxxx
X. Xxxxxxxx as Chief Executive Officer of Gen-Probe; provided, however that (a)
no Change-in-CEO will occur if the successor to Xx. Xxxxxxxx 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 Xx.
Xxxxxxxx remains as Chairman of Gen-Probe. In the event that Xx. Xxxxxxxx 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 Xx. Xxxxxxxx'x
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
(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.
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.
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.
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 representative shall be the chairman of the Joint Working
Team and shall be responsible for coordination and planning of meetings and
communications, reasonably consulting with the DiagnoCure's senior
representative. For the avoidance of doubt, the chairman of the Joint Working
Team shall not have any special or deciding vote to resolve impasses.
5.4.2 The Joint Working Team shall meet on such
dates and at such times as agreed to by the parties. As of the Effective Date of
this Agreement, the parties anticipate that meetings will initially take place
twice each month, subject to being held more or less frequently at the
discretion of the parties. Unless expressly agreed to by the parties, all such
meetings shall be conducted by telephone or videoconference. The agenda for such
meetings shall be determined by DiagnoCure and Gen-Probe in good faith. Each
party may permit visitors other than the member of the Joint Working Team to
meetings of the Joint Working Team as the parties mutually agree in writing
prior to such meetings. Each party shall be responsible for its own costs in
connection with the meetings of the Joint Working Team.
5.4.3 The Joint Working Team shall be responsible
for overseeing the management of all aspects of the Program. Any approval,
determination or other action agreed to by all of the members of the Joint
Working Team present at the relevant Joint Working Team meeting shall be the
approval, determination or other action of the Joint Working Team; provided,
however, that at least two (2) representatives of each party shall be present at
such meeting.
5.4.4 Within seven (7) days following each Joint
Working Team meeting, a representative of the parties to the Joint Working Team,
on an alternating basis, shall prepare and provide to each party a copy of the
minutes of such meeting which shall set forth, in reasonably specific detail,
any approval, determination or other action agreed to by all of the members of
the Joint Working Team, provided that such minutes are reasonably acceptable to
both parties.
5.5 SUBCONTRACTS. Either party may subcontract portions
of the Program to be performed by it in the normal course of its business
without the prior consent of the other party; provided, however, that (a) such
subcontracting shall not involve the transfer of Confidential Information of the
other party to any Third Party; (b) the subcontracted party shall enter into a
confidentiality agreement with the subcontracting party in accordance with
Section 9 below; (c) the subcontracting party shall supervise such subcontract
work; and (d) the subcontracted party shall be in compliance in all material
respects with all requirements of applicable laws and regulations.
14.
5.6 PROGRAM EXPENSES. Except as expressly set forth in
this Agreement, each party shall conduct its respective obligations under the
Program at its own cost and expense and each party shall be liable for its own
expenses under this Agreement.
5.7 TERM OF PROGRAM. Unless this Agreement is terminated
earlier under Section 12 below, the term of the Program shall commence on the
date of this Agreement and shall continue for the term of this Agreement.
5.8 PROGRAM INVENTIONS. All right, title and interest in
all Program Invention (whether or not patentable and whether or not made by
Gen-Probe), together with all patent rights and other intellectual property
rights therein, shall be owned by Gen-Probe, and included within the Gen-Probe
Patent Rights for purposes of this Agreement, if such Program Invention
constitutes an improvement primarily to, or relates primarily to, the APTIMA
Technology. All right, title and interest in all Program Invention (whether or
not patentable and whether or not made by DiagnoCure), together with all patent
rights and other intellectual property rights therein, shall be owned by
DiagnoCure, and included within the Licensed Patent Rights for purposes of this
Agreement, if such Program Invention constitutes an improvement primarily to, or
relates primarily to, the DiagnoCure Technology. If a Program Invention
constitutes an improvement to or relates equally to both the DiagnoCure
Technology and the APTIMA Technology, such Program Invention shall be jointly
owned by the parties and included within the Gen-Probe Patent Rights and the
Licensed Patent Rights for purposes of this Agreement. Ownership of all other
Program Inventions shall be determined by the laws of inventorship of the United
States. All Program Inventions shall be included within the intellectual
property rights licensed by each party to the other party pursuant to this
Agreement, for use within the scope of this Agreement. Neither party shall use
or license any Program Invention in connection with any product that competes
with or would compete with a Licensed Product under this Agreement. Each party
hereby represents and warrants that all employees and other persons acting on
its behalf in performing its obligations under the Program shall be obligated
under a binding written agreement to assign to it, or as it shall direct, all
Program Inventions made or conceived by such employees or other persons.
6. JOINT ADVISORY COMMITTEE
6.1 COMPOSITION OF THE COMMITTEE. No later than fifteen
(15) days following the Effective Date, Gen-Probe and DiagnoCure shall form the
Joint Advisory Committee 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 Advisory
Committee 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 Advisory Committee as its senior representative. The senior Gen-Probe
representative shall be the initial chairman of the Joint Advisory Committee
responsible for coordination and planning of meetings and communications,
reasonably consulting with the DiagnoCure's senior representative. The position
of chairman of the Joint Advisory Committee shall rotate between the parties on
each anniversary of the Effective Date. For the avoidance of doubt, the chairman
of the Joint Advisory Committee shall not have any special or deciding vote to
resolve impasses.
15.
6.2 MEETINGS. The Joint Advisory Committee shall meet on
such dates and at such times as agreed to by the parties. As of the Effective
Date of this Agreement, the parties anticipate that meetings will initially take
place twice each month, subject to being held more or less frequently at the
discretion of the parties. Unless otherwise agreed to by the parties, all such
meeting shall be conducted by telephone or videoconference. The agenda for such
meetings shall be determined by DiagnoCure and Gen-Probe in good faith. Each
party may permit visitors other than the member of the Joint Advisory Committee
to meetings of the Joint Advisory Committee as the parties mutually agree in
writing prior to such meetings. Each party shall be responsible for its own
costs in connection with the meetings of the Joint Advisory Committee.
6.3 PURPOSE OF COMMITTEE. The Joint Advisory Committee
shall be responsible for providing oversight and direction to the Joint Working
Team, providing supervision and authorizations as specified in this Agreement
and to resolve any Program Dispute. The Joint Advisory Committee shall determine
when to publish information concerning Licensed Products and the Program. Any
approval, determination or other action agreed to by all of the members of the
Joint Advisory Committee present at the relevant Joint Advisory Committee
meeting shall be the approval, determination or other action of the Joint
Advisory Committee; provided, however, that at least two (2) representatives of
each party shall be present at such meeting.
6.4 MINUTES. Within seven (7) days following each Joint
Advisory Committee meeting, a representative of the parties to the Joint
Advisory Committee, on an alternating basis, shall prepare and provide to each
party a copy of the minutes of such meeting which shall set forth, in reasonably
specific detail, any approval, determination or other action agreed to by all of
the members of the Joint Advisory Committee, provided that such minutes are
reasonably acceptable to both parties.
6.5 PROGRAM DISPUTES.
6.5.1 Any Program Dispute shall be subject to
Executive Mediation in accordance with Section 16.1 of this Agreement
("EXECUTIVE MEDIATION").
6.5.2 If the Program Dispute cannot be resolved in
accordance with Section 6.5.1 of this Agreement, then Gen-Probe's President and
Chief Executive Officer (or Gen-Probe's chairman if Xxxxx X. Xxxxxxxx is
Chairman, but not President and CEO) shall have the right to make a final
decision in order to resolve the Program Dispute, in the exercise of reasonable
commercial judgment after considering in good faith the views of DiagnoCure.
This right shall apply only to Disputes that are Program Disputes as defined in
this Agreement, and Gen-Probe's President and Chief Executive Officer shall not
have the right to unilaterally decide any other Disputes; provided, however,
that the right hereby granted to Gen-Probe's President and Chief Executive
Officer shall terminate immediately upon any Change in Control or any Change in
CEO, and thereafter Program Disputes that cannot be resolved pursuant to Section
6.5.1 or Section 16.1 shall be resolved by final and binding arbitration before
a single arbitrator in accordance with the rules of Arbitration of the
International Chamber of Commerce as then in effect (the "ICC RULES").
Arbitration shall be held in New York, New York within 90 days of the demand for
arbitration and the arbitrator shall have full power to decide the Program
Dispute. Upon the submission of any Program Dispute to Arbitration, Gen-Probe's
16.
senior representative shall immediately become the Chairman of the Joint
Advisory Committee and remain the chairman until the next anniversary of the
Effective Date following resolution of the arbitration.
7. ROYALTY REPORTS AND ACCOUNTING
7.1 ROYALTY REPORTS. During the term of this Agreement
following the First Commercial Sale of a Licensed Product, Gen-Probe shall
furnish to DiagnoCure a written report showing in reasonably specific detail (a)
the gross sales of each Licensed Product sold by Gen-Probe, its Affiliates,
distributors and sublicensees during the reporting period and the calculation of
Net Sales from such gross sales; (b) the royalties payable, if any, which shall
have accrued hereunder based upon Net Sales of each Licensed Product (including
written evidence of required royalty reductions under Section 8.3); and (c)
withholding taxes, if any, required by law to be deducted in respect of such
sales. With respect to sales of Licensed 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 Licensed 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 at the Exchange Rate. Reports shall be due on the
[...***...] day following the close of each quarter for sales made by Gen-Probe
or its Affiliates and reports shall be due on the [...***...] day following the
close of each quarter for sales made by Third Party distributors. Gen-Probe
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.
7.2 AUDITS.
7.2.1 Upon the written request of DiagnoCure and
not more than once in each calendar year, Gen-Probe shall permit an independent
certified public accounting firm of nationally recognized standing selected by
DiagnoCure and reasonably acceptable to Gen-Probe, at DiagnoCure's expense, to
have access during normal business hours to such of the records of Gen-Probe as
may be reasonably necessary to verify the accuracy of the royalty reports
hereunder for any year ending not more than thirty six (36) months prior to the
date of such request. The accounting firm shall disclose to DiagnoCure only
whether the reports are correct or not and the specific details concerning any
discrepancies. No other information shall be shared.
7.2.2 If such accounting firm concludes that
additional royalties were owed during such period, Gen-Probe shall pay the
additional royalties within [...***...] of the date DiagnoCure delivers to
Gen-Probe such accounting firm's written report so concluding. The fees charged
by such accounting firm shall be paid by DiagnoCure; provided, however, if the
audit correctly discloses that the royalties payable by Gen-Probe for the
audited period are more than [...***...] of the royalties actually paid for such
period, then Gen-Probe shall pay the reasonable fees and expenses charged by
such accounting firm. Additionally, DiagnoCure shall then have the right to
verify the accuracy of any and all past royalty reports provided to DiagnoCure
hereunder, subject to the terms of the Section 7.2. For the avoidance of doubt,
the fees for any such further audit shall be paid by DiagnoCure provided,
*CONFIDENTIAL TREATMENT REQUESTED
17.
however, if the further audit discloses that the royalties payable by Gen-Probe
for the additional period of such further audit are more than [...***...] of the
royalties actually paid for that period, then Gen-Probe shall pay the reasonable
fees and expenses charged for such further audit by such accounting firm.
7.3 CONFIDENTIAL FINANCIAL INFORMATION. DiagnoCure shall
treat all financial information subject to review under this Section 7 as
confidential, and shall cause its accounting firm to retain all such financial
information in confidence under Section 9 below.
7.4 GEN-PROBE AUDIT OF DISTRIBUTORS. Gen-Probe shall
reasonably audit its authorized distributors of Licensed Products, if any, in
order to monitor reporting of end user sale prices of Licensed Products. In its
agreements with authorized distributors, Gen-Probe will use its best efforts to
obtain such a right of audit and shall use its best efforts to ensure that such
information may be provided to DiagnoCure.
8. PAYMENTS
8.1 PAYMENT TERMS. Royalties shown to have accrued by
each royalty report provided for under Section 7.1 above shall be due on the
date such royalty report is due and, subject to Section 8.3, shall be payable in
United States dollars. Payment of royalties in whole or in part may be made in
advance of such due date.
8.2 LATE PAYMENT. If royalties are not paid by Gen-Probe
when due, interest shall accrued and be paid to DiagnoCure on the unpaid
royalties at the rate of [...***...] per annum calculated from the date on which
each respective payment should have been paid until the date of the applicable
actual payment.
8.3 EXCHANGE CONTROL. If at any time legal restrictions
prevent the prompt remittance of part or all royalties with respect to any
country where a Licensed Product is sold, Gen-Probe shall have the right, in its
sole discretion, to make such payments by depositing the amount thereof in local
currency to DiagnoCure's account in a bank or other depository institution in
such country.
8.4 WITHHOLDING TAXES. Gen-Probe shall be entitled to
deduct the amount of any withholding taxes, value added taxes or other taxes,
levies or charges with respect to such amounts, other than United States taxes,
payable by Gen-Probe, its Affiliates or sublicensees, or any taxes required to
be withheld by Gen-Probe, its Affiliates or sublicensees, to the extent
Gen-Probe, its Affiliates or sublicensees pay to the appropriate governmental
authority on behalf of DiagnoCure such taxes, levies or charges. Gen-Probe shall
use reasonable efforts to minimize any such taxes, levies or charges required to
be withheld on behalf of DiagnoCure by Gen-Probe, its Affiliates or sublicensees
and will provide reasonable assistance to DiagnoCure, including providing
DiagnoCure with the appropriate Form W-8, if necessary, in order to avoid or
reduce withholding income taxes. Gen-Probe shall also provide reasonable
assistance to DiagnoCure at DiagnoCure's written request to recover any such
withheld taxes, levies or charges. Gen-Probe promptly shall deliver to
DiagnoCure proof of payment of all such taxes, levies and other charges,
together with copies of all communications from or with such governmental
authority with respect thereto.
*CONFIDENTIAL TREATMENT REQUESTED
18.
9. CONFIDENTIALITY
9.1 CONFIDENTIAL INFORMATION. During the term of this
Agreement, and for a period of [...***...] following the expiration or earlier
termination hereof, each party shall maintain in confidence all Confidential
Information disclosed by the other party, and shall not use, disclose or grant
the use of the Confidential Information except on a need to know basis to those
directors, officers, employees, consultants, clinical investigators,
contractors, licensors, licensees, distributors or permitted assignees, 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 and shall remain liable for any breach of this Section
9.1 as provided herein.
9.2 TERMS OF THIS AGREEMENT. Except as otherwise provided
in Section 9.1 above, neither party shall 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, the parties
shall agree upon the substance of information that can be used to describe the
terms of this transaction, and each party may disclose such information, as
modified by mutual agreement from time to time, without the other party's
consent.
9.3 PERMITTED DISCLOSURES. The confidentiality
obligations contained in this Section 9 shall not apply to the extent that the
receiving party is required (a) to disclose information by law, order or
regulation of a governmental agency or a court of competent jurisdiction, or (b)
to disclose information to any governmental agency for purposes of obtaining
approval to test or market a Licensed Product, provided in either case that such
receiving party shall provide written notice thereof to the other party and
sufficient opportunity to object to any such disclosure or to request
confidential treatment thereof.
9.4 TAX TREATMENT. Notwithstanding anything in this
Agreement or in any other written or oral understanding or agreement to which
the parties hereto are parties or by which they are bound, each party (and its
representatives, agents and employees) may consult any tax advisor regarding the
tax treatment and tax structure of the transaction contemplated by this
Agreement and may at any time disclose to any person without limitation of any
kind, the tax treatment and tax structure of such transaction and all materials
(including opinions or other tax analyses) that are provided relating to such
treatment or structure. The preceding sentence is intended to satisfy the
requirements for the transaction contemplated herein to avoid classification as
a "confidential transaction" in accordance with Treasury Regulations Section
1.6011-4(b)(3) and shall be interpreted consistent with such intent. This
authorization is not intended to permit disclosure of any other information
relating to the transaction contemplated by this Agreement, including (without
limitation) (i) any portion of any materials to the extent not related to the
tax treatment or tax structure of the transaction, (ii) the identities of
participants or potential participants in the transaction, (iii) the existence
or status of any negotiations, (iv) any pricing or financial information (except
to the extent such pricing or
*CONFIDENTIAL TREATMENT REQUESTED
19.
financial information is related to the tax treatment or tax structure of the
transaction), or (v) any other term or detail not relevant to the tax treatment
or the tax structure of the transaction.
10. COMMERCIALIZATION AND DILIGENCE OBLIGATIONS
10.1 DIAGNOCURE COMMERCIALIZATION OBLIGATION.
10.1.1 Immediately following written notification
by Gen-Probe to DiagnoCure that a Licensed Product has received appropriate
regulatory approval or clearance (or, if regulatory approval or clearance is not
required for sales of such Licensed Product, has met the criteria established in
the Product Requirements Document) and is therefore ready for commercial launch,
DiagnoCure shall use its best efforts to inform its then current customer base
for the DiagnoCure Product of the availability of such Licensed Product, and
shall provide assistance to Gen-Probe and such customers, as Gen-Probe or such
customer reasonably requests, in its promotional and marketing plan to switch
such customers from the use of the DiagnoCure Product to the use of such
Licensed Product. Subject to the oversight of the Joint Advisory Committee,
DiagnoCure shall give Gen-Probe the right to co-promote the DiagnoCure Product
and the transition from the DiagnoCure Product to the Licensed Product,
including, as to both, by participating in customer calls with DiagnoCure sales
representatives. Gen-Probe's participation in co-promotion activities shall be
at its own expense.
10.1.2 During the term of this Agreement,
DiagnoCure shall take all steps necessary to ensure that the License Agreement
remains in full force and effect. DiagnoCure shall not enter into any amendment
to the License Agreement without Gen-Probe's express written consent in each
instance.
10.2 GEN-PROBE DILIGENCE OBLIGATIONS. Subject to
DiagnoCure providing the information and assistance described in Section 5.1.1,
Gen-Probe shall, at its own cost:
10.2.1 complete [...***...] and [...***...] within
[...***...] following the Effective Date.
10.2.2 file a 510(k) application or pre market
approval application with the FDA in the United States for a Licensed Product,
that the Joint Advisory Committee has determined is suitable for
commercialization, within [...***...] following commencement of clinical trials
for such Licensed Product; and
10.2.3 on a country-by-country basis, sell a
Licensed Product in such country within [...***...] after receipt by Gen-Probe
of all required regulatory, marketing, and/or pricing approvals required by such
country for the sale of such Licensed Product in such country.
10.2.4 if the Joint Working Team determines, with
the Joint Advisory Committee's approval, that a Licensed Product design requires
the targeting, in whole or in part, of one or more PCA3(DD3) transcripts that
are not targeted in the DiagnoCure Product, then the time period set forth in
Section 10.2.1 shall be extended by [...***...], for a total of [...***...]
following the Effective Date, without additional compensation due to DiagnoCure.
*CONFIDENTIAL TREATMENT REQUESTED
20.
10.2.5 In addition to the extension in Section
10.2.4, if Gen-Probe fails to meet any of the diligence obligations set forth in
this Section 10.2.1, then for the first such diligence obligation that Gen-Probe
fails to meet, Gen-Probe shall automatically receive a [...***...] grace period
(the "FREE GRACE PERIOD"). If Gen-Probe fulfills its diligence obligation during
such a grace period, for purposes of this Section 10.2.1 Gen-Probe shall be
deemed to have satisfied its diligence obligation.
10.2.6 If, with respect to the diligence obligation
set forth in Section 10.2.1, Gen-Probe fails to meet such diligence obligation
during the associated time period and extensions described in Sections 10.2.1,
10.2.4, and 10.2.5 (collectively the "FIRST DILIGENCE PERIOD"), Gen-Probe shall
have the right to obtain up to [...***...] additional [...***...] extensions of
the First Diligence Period by paying to DiagnoCure a fee of [...***...] for each
such [...***...] extension. For each such [...***...] payment by Gen-Probe to
DiagnoCure to extend the First Diligence Period, the First Diligence Period
shall be extended by [...***...]. If Gen-Probe fails to meet such diligence
obligation during the First Diligence Period (including any extensions thereto),
AS DiagnoCure's sole and exclusive remedy therefor, then, subject to the terms
of this Agreement, Gen-Probe's license under Section 3.1 shall [...***...]. IF
Gen-Probe extends the First Diligence Period by [...***...] by making
[...***...] such payments, Gen-Probe shall have the right, at no additional
cost, to apply the Free Grace Period to the time period set forth in Section
10.2.2.
10.2.7 If, with respect to the diligence obligation
set forth in Section 10.2.2, Gen-Probe fails to meet such diligence obligation
during the associated time period described in Section 10.2.2 and the Free Grace
Period, if available (collectively the "SECOND DILIGENCE PERIOD"), Gen-Probe
shall have the right to obtain up to [...***...] additional [...***...]
extensions of the Second Diligence Period by paying to DiagnoCure a fee of
[...***...] for each such [...***...] extension. For each such [...***...]
payment by Gen-Probe to DiagnoCure to extend the Second Diligence Period, the
Second Diligence Period shall be extended by [...***...]. If Gen-Probe fails to
meet such diligence obligation during the Second Diligence Period (including any
extensions thereto), then, AS DiagnoCure's sole and exclusive remedy therefore
and subject to the terms of this Agreement, Gen-Probe's license under Section
3.1 shall be co-exclusive (with DiagnoCure) in the United States.
11. PATENTS
11.1 PATENT PROSECUTION AND MAINTENANCE. During the term
of this Agreement, Gen-Probe shall provide reasonable guidance to DiagnoCure, at
Gen-Probe's expense, to assist DiagnoCure in strengthening DiagnoCure's present
and future patent portfolio concerning PCA3(DD3) in the Field. Gen-Probe shall
be responsible for and shall control the preparation, filing, prosecution and
maintenance of patent applications and patents for the Program Patent Rights,
subject to a right of DiagnoCure to elect in writing to file, prosecute and
maintain patent applications and patents for Program Patent Rights that are
Licensed Patent Rights and owned by DiagnoCure. The parties shall equally share
all such preparation, filing, prosecution and maintenance expenses for the
Program Patent Rights. Gen-Probe shall give
*CONFIDENTIAL TREATMENT REQUESTED
21.
DiagnoCure a reasonable opportunity to review and comment on the text of each
patent application subject to this Section 11.1 before filing, and shall supply
DiagnoCure with a copy of such patent application as filed, together with notice
of its filing date and serial number. DiagnoCure shall reasonably cooperate with
Gen-Probe, execute all lawful papers and instruments and make all rightful oaths
and declarations as may be necessary in the preparation, prosecution and
maintenance of all patents and other filings referred to in this Section 11.1.
11.2 NOTIFICATION OF INFRINGEMENT. Each party shall notify
the other party of any infringement worldwide known to such party of any
Licensed Patent Rights in the Field, Gen-Probe Patent Rights in the Field, or
Program Patent Rights and shall provide the other party with the available
evidence, if any, of such infringement.
11.3 ENFORCEMENT OF PATENT RIGHTS. Gen-Probe shall have
the right to determine the appropriate course of action to enforce the Licensed
Patent Rights (in the case of the University Patent Rights to the maximum extent
allowed under the License Agreement) and the Program Patent Rights or otherwise
xxxxx the infringement thereof, to take (or refrain from taking) appropriate
action to the Licensed Patent Rights and Program Patent Rights, to control any
litigation or other enforcement action and to enter into, or permit, the
settlement of any such litigation or other enforcement action with respect to
Licensed Patent Rights and Program Patent Rights, and DiagnoCure shall fully
cooperate with Gen-Probe in the planning and execution of any action to enforce
the Licensed Patent Rights and Program Patent Rights. Gen-Probe shall pay
[...***...] of the expense of all such actions and DiagnoCure shall pay
[...***...] of the expense of all such actions; provided, however, that
DiagnoCure shall be solely responsible for all expenses incurred in connection
with such actions that may be brought against any party to whom DiagnoCure has
granted any rights with respect to the DiagnoCure Product or the DiagnoCure
Technology prior to the Effective Date. All monies recovered upon the final
judgment or settlement of any such suit to enforce the Licensed Patent Rights
and Program Patent Rights shall be first paid to reimburse each party for its
actual costs incurred to investigate and pursue the claims against the
infringement, and second [...***...] of the remainder shall be paid to Gen-Probe
and [...***...] shall be paid to DiagnoCure.
11.4 PATENT INFRINGEMENT CLAIMS. If either party receives
a claim by a Third Party that any Licensed Product or component thereof
infringes a patent or misappropriates any other right of the Third Party, then
such party shall notify the other party promptly in writing within thirty (30)
days of receipt of such claim and the parties shall provide each other with all
reasonable information available to them for the defense of such claim. The
claim of infringement shall be referred to the Joint Advisory Committee for
determination pursuant to the provisions of Section 6 ("PROGRAM") and the
parties will reasonably cooperate in connection with such claim, subject to the
supervision of the Joint Advisory Committee. If the claim of infringement
relates primarily to the Gen-Probe Patent Rights, Gen-Probe shall be responsible
for responding to such notice and for any litigation that may result. If the
claim relates primarily to the Licensed Patent Rights, the parties shall be
jointly responsible for responding to such notice and for any litigation that
may result, and Gen-Probe shall pay [...***...] of the expense of any litigation
and any damages awarded and DiagnoCure shall pay [...***...] of the expense of
any litigation and any damages awarded.
*CONFIDENTIAL TREATMENT REQUESTED
22.
12. TERMINATION
12.1 EXPIRATION. Subject to the provisions of Sections
12.2 and 12.3 below, this Agreement shall expire, on a country-by-country basis,
on the expiration of Gen-Probe's obligation to pay royalties to DiagnoCure under
Section 4.2 above. Following such expiration, Gen-Probe shall receive a
worldwide, perpetual, royalty free, non exclusive (sub)license (including the
right to grant sublicenses) under the Licensed IP Rights to research, develop,
make, have made, use, offer for sale, sell and import the compositions, and to
practice the processes and methods, that are claimed in the Licensed Patent
Rights or that constitute Licensed Know-How Rights for use in the Field.
12.2 TERMINATION BY GEN-PROBE.
12.2.1 Gen-Probe may terminate this Agreement for
any reason or no reason, in its sole discretion, upon thirty (30) days prior
written notice to DiagnoCure.
12.2.2 Gen-Probe may terminate this Agreement upon
thirty (30) days prior written notice to DiagnoCure if a Licensed Product fails
in any clinical trial of [...***...] to produce a [...***...] and a [...***...]
in a patient population with (a) a prostate cancer prevalence of [...***...];
(b) an initial PSA result of [...***...]; and (c) a prior [...***...] for
prostate cancer.
12.3 TERMINATION FOR CAUSE. 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
one hundred eighty (180) days after notice thereof by the non breaching party;
provided, however, if any default is not capable of being cured within such one
hundred eighty (180) 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.
12.4 EFFECT OF EXPIRATION OR TERMINATION.
12.4.1 Upon termination of this Agreement by
Gen-Probe under Section 12.2.1 or Section 12.2.2 after (a) Gen-Probe has
notified DiagnoCure pursuant to Section 10.1.1 that a Licensed Product is ready
for commercial launch, and (b) the parties have commenced the substantial
transfer of DiagnoCure's customer base for the DiagnoCure Product to such
Licensed Product, then Gen-Probe shall grant to DiagnoCure under the Gen-Probe
IP Rights a worldwide, non exclusive license to research, develop, make, use,
offer for sale, sell and import such Licensed Product in the Field for the life
of such Gen-Probe IP Rights. Such right to offer for sale and sell shall extend
to DiagnoCure's bona fide distributors. The foregoing grant shall include the
right to research, develop, make, use, offer for sale, sell and import any
upgrades or modifications to such Licensed Product as reasonably necessary to
adapt such Licensed Product to future versions of Gen-Probe's Tigris
instrumentation platform or other Gen-Probe instrument platform for use with
assays incorporating APTIMA Technology. In consideration for such license grant,
DiagnoCure shall pay to Gen-Probe annual royalties equal to [...***...] of Net
Sales of such Licensed Product by DiagnoCure, its Affiliates and sublicensees.
The provisions of Sections 7 and 8 shall apply to DiagnoCure pari passu. Gen-
*CONFIDENTIAL TREATMENT REQUESTED
23.
Probe shall, upon DiagnoCure's written request promptly transfer all Know-How in
Gen-Probe's possession specifically regarding such Licensed Product and shall
provide to DiagnoCure, reasonably necessary training on the use of such Licensed
Product.
12.4.2 Upon termination of this Agreement by
DiagnoCure under Section 12.3 after (a) Gen-Probe has notified DiagnoCure
pursuant to Section 10.1.1 that a Licensed Product is ready for commercial
launch, and (b) the parties have effected the substantial transfer of
DiagnoCure's customer base for the DiagnoCure Product to such Licensed Product,
then Gen-Probe shall grant to DiagnoCure under the Gen-Probe IP Rights a
worldwide, non-exclusive license to research, develop, make, use, offer for
sale, sell and import such Licensed Product in the Field for the life of such
Gen-Probe IP Rights. Such right to offer for sale and sell shall extend to
DiagnoCure's bona fide distributors. The foregoing grant shall include the right
to research, develop, make, use, offer for sale, sell and import any upgrades or
modifications to such Product as reasonably necessary to adapt such Licensed
Product to future versions of Gen-Probe's Tigris instrumentation platform or
other Gen-Probe instrument platform for use with assays incorporating APTIMA
Technology. In consideration for such license grant, DiagnoCure shall pay to
Gen-Probe annual royalties equal to [...***...] of Net Sales of such Licensed
Product by DiagnoCure its Affiliates and sublicensees. The provisions of
Sections 7 and 8 shall apply to DiagnoCure pari passu. Gen-Probe shall, upon
DiagnoCure's written request, promptly transfer all Know-How in Gen-Probe's
possession specifically regarding such Licensed Product and shall provide to
DiagnoCure reasonably necessary training on the use of such Licensed Product.
12.4.3 If, as a result of the sale of the Licensed
Products by DiagnoCure pursuant to Sections 12.4.1 or 12.4.2 above, DiagnoCure
is able to place a Tigris instrument platform, or other Gen-Probe instrument
platform for use with assays incorporating APTIMA Technology, with a Third Party
that is not a customer of Gen-Probe or a new Tigris instrument platform with an
existing customer of Gen-Probe solely as a result of DiagnoCure's efforts,
Gen-Probe shall, upon written notice from DiagnoCure, provide such instrument to
such Third Party for (a) an amount no greater than [...***...] of Gen-probe's
Fully-Burdened Costs of such instrument and (b) the execution of a standard
service agreement between Gen-Probe and such Third Party that Gen-Probe
customarily enters into with its other Tigris instrument customers. In the event
that subsequent to such a placement Gen-Probe desired to place additional tests
on such Tigris instrument sold to such Third Party, the parties will negotiate
in good faith and agree on mutually acceptable terms and conditions (including
without limitation compensation to DiagnoCure) for placement of such additional
tests.
12.4.4 In the event that Gen-Probe develops and
distributes a new version of the Tigris instrument that directly results in a
necessary modification to a Licensed Product then being sold by DiagnoCure
pursuant to Sections 12.4.1 or 12.4.2 above:
(a) subject to the limitations set forth below,
the parties shall enter into an agreement governing the licensing and transfer
of technology with respect to such new version of the Tigris instrument to the
extent reasonably necessary for DiagnoCure to manufacture such modified Licensed
Product, and the royalties payable to Gen-Probe therefore, on terms and
conditions which, taken as a whole (including without limitation royalty rate,
license fees or prices) are, as determined by Gen-Probe in good faith, no less
favorable to
*CONFIDENTIAL TREATMENT REQUESTED
24.
DiagnoCure than the terms and conditions Gen-Probe has agreed to with any Third
Party licensee for rights under the Gen-Probe IP Rights of the same type and
scope as the license to be granted to DiagnoCure (e.g., geographic scope, field
of use, same licensed rights, etc.). Notwithstanding the foregoing, nothing in
Section 12.4.4(a) shall be deemed to include and Gen-Probe shall have no
obligation under this Section for or in connection with (i) forgiveness by
Gen-Probe for past infringements of the Gen-Probe IP Rights by third parties to
reach settlement of a lawsuit or dispute between Gen-Probe and third parties
with respect to the Program Patent Rights; (ii) rights arising out of
governmental rights or sponsorship; (iii) any implied license which Gen-Probe
may be deemed to have granted a Third Party, including without limitation a
Third Party who infringed Gen-Probe rights under the Gen-Probe IP Rights; (iv)
any agreement with any wholly or partially owned subsidiary, joint venture or
other entity or with any Affiliate of Gen-Probe; (v) a cross license agreement
or (vi) any agreement where the licensee under the agreement is not in
competition with Gen-Probe; and
(b) Gen-Probe shall provide to DiagnoCure, at an
amount no greater than [...***...] of Gen-Probe's Fully-Burdened Costs,
instruments and reagents reasonably necessary for DiagnoCure to manufacture such
modified Licensed Product to the extent such instruments and reagents are
reasonably necessary for such modifications.
12.4.5 Upon termination of this Agreement by
Gen-Probe under Section 12.3, then (a) the license grant under Section 3.1 shall
be perpetual, irrevocable and royalty-free, (b) DiagnoCure shall, upon
Gen-Probe's written request, promptly transfer all Know-How in DiagnoCure's
possession (not previously provided to Gen-Probe) specifically regarding the
DiagnoCure Technology, and (c) the sublicense to Gen-Probe under the University
Patent Rights and University Know-How Rights pursuant to the License Agreement
shall continue in full force and effect provided that Gen-Probe shall be
obligated to pay all applicable royalties and milestone payments under the
License Agreement. DiagnoCure shall provide to Gen-Probe reasonably necessary
training concerning the use of the Know-How.
12.4.6 Expiration or termination of this Agreement
shall not relieve the parties of any obligation accruing prior to such
expiration or termination, and the provisions of Section 5.8, 7, 8, 9, 11, 12,
13, 14, 16, and 17 shall survive the expiration or termination of this
Agreement. Except as expressly set forth in this Agreement, upon such expiration
or termination neither party shall retain any rights under intellectual property
rights of the other party pursuant to this Agreement.
12.4.7 For avoidance of doubt, any termination by
Gen-Probe pursuant to Sections 12.2.1 or 12.2.2 and any termination by
DiagnoCure pursuant to 12.3 due to breach by Gen-Probe shall each result in the
cancellation of any and all licenses granted to Gen-Probe under this Agreement
and all Licensed IP Rights shall revert back to DiagnoCure. For avoidance of
doubt, any termination by Gen-Probe pursuant to Section 12.3 due to breach by
DiagnoCure shall result in the cancellation of any and all licenses granted to
DiagnoCure under this Agreement and all Gen-Probe IP Rights shall revert back to
Gen-Probe.
*CONFIDENTIAL TREATMENT REQUESTED
25.
13. INDEMNIFICATION
13.1 INDEMNIFICATION. Each party shall defend, indemnify
and hold the other party harmless from all losses, liabilities, damages and
expenses (including attorneys' fees and costs) incurred as a result of any
claim, demand, action or proceeding arising out of or relating to any breach of
any representation, warranty or covenant contained within this Agreement by such
party, or the gross negligence or willful misconduct of the party in the
performance of its obligations under this Agreement; provided, however, that
nothing contained in this Section 13 shall modify the Limitations of Liability
and Disclaimers of Warranties set forth in Section 14.
13.2 PROCEDURE. A party intending to claim indemnification
under this Section 13 (the "INDEMNITEE") promptly shall notify the other party
(the "INDEMNITOR") of any liability or action in respect of which the Indemnitee
intends to claim such indemnification, and the Indemnitor shall have the right
to participate in, and, to the extent the Indemnitor so desires, jointly with
any other indemnitor similarly noticed, to assume the defense thereof with
counsel selected by the Indemnitor; provided, however, that the Indemnitee shall
have the right to retain its own counsel, at its sole expense, if representation
of the Indemnitee by the counsel retained by the Indemnitor would be
inappropriate due to actual or potential differing interests between the
Indemnitee and any other party represented by such counsel in such proceedings.
The indemnity agreement in this Section 13 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 the Indemnitor, which consent shall not be
withheld unreasonably. The failure to deliver notice to the Indemnitor within a
reasonable time after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve the Indemnitor of any liability to
the Indemnitee under this Section 13, but the omission so to deliver notice to
the Indemnitor will not relieve it of any liability that it may have to the
Indemnitee otherwise than under this Section 13. The Indemnitee under this
Section 13, its employees and agents, shall cooperate fully with the Indemnitor
and its legal representatives in the investigation and defense of any action,
claim or liability covered by this indemnification.
13.3 INSURANCE. Each party shall maintain product
liability insurance with respect to the research, development, manufacture and
sales of Licensed Products in such amount as such party customarily maintains
with respect to the research, development, manufacture and sales of its similar
products. Each party shall maintain such insurance for so long as it continues
to research, develop, manufacture or sell any Licensed Products, and thereafter
for so long as such party customarily maintains insurance covering the research,
development, manufacture or sale of its similar products.
14. LIMITATION OF LIABILITY; DISCLAIMER OF WARRANTIES
14.1 LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER
PARTY BE LIABLE TO THE OTHER PARTY FOR ANY LOSS OF PROFITS OR INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES DIRECTLY OR INDIRECTLY ARISING OUT OF THIS
AGREEMENT OR THE RESEARCH, DEVELOPMENT, MANUFACTURE OR SALE OF THE PRODUCTS.
26.
14.2 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET
FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR
IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING WITHOUT LIMITATION, ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
15. FORCE MAJEURE. Except as to obligation solely for the payment
of money, 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.
16. DISPUTE RESOLUTION
16.1 EXECUTIVE MEDIATION. If a Dispute arises, the parties
hereto shall first attempt to settle such Dispute by good faith negotiation any
Dispute. Within ten (10) business days of receipt by a party of written notice
of a Dispute (the "NOTICE OF DISPUTE"), the senior representatives of each party
on the Joint Advisory Committee shall meet in person and attempt, in good faith,
to resolve the Dispute. If the Dispute has not been resolved by the senior Joint
Advisory Committee representatives within twenty (20) business days of receipt
of the Notice of Dispute, then on the written demand ("DEMAND FOR EXECUTIVE
MEETING") of either party the Dispute shall be submitted to the President and
CEO of Gen-Probe and to the President and CEO of DiagnoCure for resolution.
Within ten (10) business days of receipt by a party of a Demand for Executive
Meeting, the President and CEO of Gen-Probe and the President and CEO of
DiagnoCure shall meet in person and attempt, in good faith, to resolve the
Dispute. (The requirement for an in person meeting may be waived only by mutual
agreement of the parties.)
16.2 ARBITRATION. If no resolution is reached within
fifteen (15) days following submission of a Dispute to Executive Mediation by
the Presidents and CEO's as provided above, the Dispute (other than a Program
Dispute, which shall be subject to the terms set forth in Section 6.5), either
Party may commence arbitration of such Dispute pursuant to this section. Any
controversy or claim relating to, arising out of, or in any way connected to any
provision of this Agreement shall be finally resolved by final and binding
arbitration in accordance with this Section by a single arbitrator in accordance
with the rules of Arbitration of the International Chamber of Commerce as then
in effect (the "ICC RULES"). Arbitration shall be held in New York, New York
within 90 days of the demand for arbitration and the arbitrator shall have full
power to decide the Program Dispute. The arbitrator may order a change of venue
upon a showing of good cause. Discovery shall be permitted in accordance with
the civil rules and procedures of the forum state unless otherwise limited by
the parties or ordered by the arbitrator for good cause shown. The arbitrator
shall have the power to grant equitable relief where applicable under the law.
The arbitrator shall issue a written opinion setting forth his or her decision
and the reasons therefor within thirty (30) days after the arbitration
proceeding is concluded. The obligation of the parties to submit any dispute
arising under or related to this
27.
Agreement to arbitration as provided in this Section shall survive the
expiration or earlier termination of this Agreement.
17. MISCELLANEOUS
17.1 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 DiagnoCure: DiagnoCure Inc.
0000, Xxxx Xxxxxxxx Xxxx.
W., 6th floor
Sainte-Xxx QC G1V 2K8, Canada
Attention: President and CEO
If to Gen-Probe: Gen-Probe Incorporated
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx Xxxxxxxxxx 00000, U.S.A.
Attention: President and CEO
17.2 GOVERNING LAW. This Agreement shall be governed by
and construed in accordance with the laws of the State of New York, without
regard to the conflicts of law principles thereof.
17.3 ASSIGNMENT. Neither party shall assign its rights or
obligations under this Agreement without the prior written consent of the other
party; provided, however, that either party 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 related to this
Agreement, 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.
17.4 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.
17.5 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, other than the Confidential Disclosure Agreement between the parties
dated November 15, 2002. The parties agree that the November 15, 2002
Confidential Disclosure Agreement shall terminate prospectively upon execution
of this Agreement. There are no representations, understandings or agreements,
oral or written, between the parties regarding the subject matter of this
Agreement that are not fully expressed herein.
17.6 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
28.
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.
17.7 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.
17.8 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 as of the
date first set forth above.
GEN-PROBE INCORPORATED
By: /s/ Xxxxx X. Xxxxxxxx
----------------------------------------
Xxxxx X. Xxxxxxxx
President and Chief Executive Officer
Signed at San Diego, California, USA
DIAGNOCURE, INC.
By: /s/ Xxxxxx Xxxx
----------------------------------------
Xxxxxx Xxxx
President and Chief Executive Officer
Signed at Xxxxxx Xxxx, Xxxxxx
November 19th/03
29.
SCHEDULE 1
DIAGNOCURE PATENT RIGHTS
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
S1-1.
SCHEDULE 2
GEN-PROBE PATENT RIGHTS
The Gen-Probe patent rights include the following patents, together
with any divisions, continuations, extensions, renewals, reissues, reexamination
certificates and continuations of such patents and the foreign equivalents of
any of the foregoing.
TMA PATENTS
United States patent no. 5,399,491
United States patent no. 5,480,784
United States patent no. 5,824,518
United States patent no. 5,888,779
TARGET CAPTURE PATENTS
United States patent no. 6,110,678
United States patent no. 6,280,952
United States patent no. 6,534,273
HOMOGENEOUS PROTECTION ASSAY
United States patent no. 5,283,174
United States patent no. 5,639,604
DUAL KINETIC ASSAY
United States patent no. 5,656,207
United States patent no. 5,658,737
United States patent no. 5,756,011
United States patent no. 5,756,709
S2-1.
SCHEDULE 2.1
TEKNIKA PATENT RIGHTS
Gen-Probe has entered into a non-assertion agreement with Organon
Teknika with respect to intellectual property rights related to Organon
Teknika's NASBA method of nucleic acid amplification and Gen-Probe's TMA method
nucleic acid amplification.
The Organon Teknika non assertion agreement sets forth the following
terms and conditions relating to rights of Gen-Probe's Licensees should a breach
by Gen-Probe terminate its rights under the Teknika Agreement:
10.3 Upon termination of this Agreement, as permitted by
Section 10.2, the non-breaching party shall grant direct immunity from
legal action to Licensees of the breaching party, under the terms and
conditions set forth in this Agreement, provided that:
(a) the non-breaching party shall have received
express written notice of the license granted to such Licensee prior to
the effective termination date of this Agreement;
(b) the Licensee expressly agreed in writing on
or before the ninetieth (90th) day prior to the effective termination
date of this Agreement to be bound by the terms and conditions of this
Agreement.
The Organon Teknika non assertion agreement sets forth the following
definitions with respect to each party's right to practice its version of
nucleic acid amplification:
TRANSCRIPTION BASED AMPLIFICATION VERSIONS
"GEN-PROBE VERSION" shall mean transcription based nucleic acid
amplification using [...***...]
"TEKNIKA VERSION" shall mean transcription based nucleic acid
amplification using [...***...]
*CONFIDENTIAL TREATMENT REQUESTED
S2.1-2.
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
S2.1-3.
SCHEDULE 2.2
STANFORD PATENT RIGHTS
Gen-Probe has entered into a license agreement with Stanford University
with respect to intellectual property rights related to nucleic acid
amplification.
The Stanford Agreement sets forth the following terms and conditions
relating to the continuation of sublicenses following termination of the
Stanford Agreement:
4.3.2 Any such sublicense shall also expressly include the
provisions of Articles 7, 8, and 9 for the benefit of STANFORD.
4.3.3 Upon termination of this Agreement for any cause, any
sublicense granted hereunder shall continue with Stanford provided the
sublicensee agrees to thereafter assume the obligations of Gen-Probe insofar as
they correspond to the scope of the sublicense.
7. REPORTS, PAYMENTS, AND ACCOUNTING
7.1 QUARTERLY ROYALTY PAYMENT AND REPORT. GEN-PROBE shall
make written reports and royalty payments to STANFORD within ninety (90) days
after the end of each calendar quarter. This report shall state the number,
description, and aggregate Net Sales of Licensed Product(s) during such
completed calendar quarter, and resulting calculation pursuant to Paragraph 6.2
of earned royalty payment due STANFORD for such completed calendar quarter.
Concurrent with the making of each such report, GEN-PROBE shall include payment
due STANFORD of royalties for the calendar quarter covered by such report.
7.2 ACCOUNTING. GEN-PROBE agrees to keep records for a
period of three (3) years showing the manufacturing, sales, use, and other
disposition of products sold or otherwise disposed of under the license herein
granted in sufficient detail to enable the royalties payable hereunder by
GEN-PROBE to be determined, and further agrees to permit its books and records
to be examined to the extent necessary to verify reports provided for in
Paragraph 7.1 by an independent certified public accountant, provided that such
audits occur no more than one (1) time per calendar year and provided further
that accountant shall report to STANFORD only errors regarding calculation of
royalties. Such examination is to be made by STANFORD, at the expense of
STANFORD, except in the event that the results of the audit reveal a discrepancy
in GEN-PROBE'S favor of ten percent (10%) or more, then the audit fees shall be
paid by GEN-PROBE.
8. WARRANTY AND NEGATION OF WARRANTIES
8.1 Nothing in this Agreement is or shall be construed
as:
(a) A warranty or representation by STANFORD as
to the validity or scope of any Licensed Patent(s);
S2.2-1.
(b) A warranty or representation that anything
made, used, sold, or otherwise disposed of under any license granted in this
Agreement is or will be free from of patents, copyrights, and other rights of
third parties;
(c) An obligation to bring or prosecute actions
or suits against third parties for infringement, except to the extent and in the
circumstances described in Article 12; or
(d) Granting by implication, estoppel, or
otherwise any licenses under patents of STANFORD or other persons other than
Licensed Patent(s), regardless of whether such patents are dominant or
subordinate to any Licensed Patent(s).
8.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, STANFORD
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE LICENSED PRODUCT(S)
WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD
PARTIES.
9. INDEMNITY
9.1 GEN-PROBE agrees to indemnify, hold harmless, and
defend STANFORD and its trustees, officers, employees, students, and agents
against any and all claims for death, illness, personal injury, property damage,
and improper business practices arising out of the manufacture, use, sale, or
other disposition of Invention, Licensed Patent(s), or Licensed Product(s) by
GEN-PROBE, its sublicenses or their customers.
9.2 GEN-PROBE shall at all times comply, through
insurance or self-insurance, with all statutory workers, compensation and
employers, liability requirements covering any and all employees with respect to
activities performed under this Agreement.
9.3 GEN-PROBE shall maintain, beginning on the first day
GEN-PROBE or any GEN-PROBE sublicensee ships a therapeutics product manufactured
by the licensed process, commercial general liability insurance, including
products liability insurance, with minimum limits of liability of $5 million
with reputable and financially secure insurance carrier(s) to cover the
activities of GEN-PROBE and its sublicensee(s). Any and all such policies of
insurance described in the previous sentence shall include as additional named
insureds STANFORD, Stanford Health Services, their trustees, directors,
officers, employees, students and agents, and shall provide that such policies
may not, without 30 days prior written notice to STANFORD, be canceled or
changed to materially adversely affect any such additional named insured's
coverage. Such insurance shall be written to cover liability of such additional
named insureds incurred beginning on the first day GEN-PROBE or any GEN-PROBE
sublicensee ships a therapeutics product.
S2.2-2.
SCHEDULE 3
RESEARCH AND DEVELOPMENT BY DIAGNOCURE
PCA3 GENE EXPRESSION PROGRAM [...***...]
- Qualitative and quantitative characterization of the PCA3 gene
expression:
- Qualitative study:
In-Situ Hybridization experiments to define the expression
profile of PCA3 gene on tissues: prostate cancer with
different Xxxxxxx Grades, BPH, PIN, PIA, ASAP, and normal cell
phenotype. (These results will be an important part in the
regulatory FDA filing of the section description of the target
gene.)
- Quantitative analysis:
[...***...]
INCREMENTAL PRE CLINICAL AND CLINICAL STUDIES (EXAMPLES ONLY, TBD)
[...***...]
BIOLOGICAL SAMPLE ACCESS (DEVELOPMENT, PRE CLINICAL AND CLINICAL): [...***...]
ARCHIVING
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
S3-4.
