***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
And 240.24b-2
EXHIBIT 10.66
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement") dated as of December 30, 2004
(the "Effective Date"), is entered into between AdnaGen AG, ("AdnaGen"), having
a place of business at Xxxxxxxxxx 0 X-00000, Xxxxxxxxxxx, Xxxxxxx and Gen-Probe
Incorporated ("Gen-Probe"), having a place of business at 00000 Xxxxxxx Xxxxxx
Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000 (collectively, the "parties" and each a
"party").
RECITALS
WHEREAS, AdnaGen owns or has rights in certain technology concerning the
qualitative and quantitative detection of cells which may be useful in
connection with nucleic acid diagnostic assays.
WHEREAS, Gen-Probe desires to obtain an exclusive worldwide license in
such technology to develop and commercialize Licensed Products and Services (as
defined below).
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the parties agree as follows:
1. DEFINITIONS
1.1 "ADDITIONAL LICENSED PRODUCT" shall mean any Product within the
Group 1 Additional Products or within the Group 2 Additional Products if and
when the licenses granted to Gen-Probe under this Agreement have been expanded
to include such Product in accordance with Section 3.4 or Section 3.5.
1.2 "AFFILIATE" shall mean, with respect to any Person, any other
Person which directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in control of
another Person if it owns, or directly or indirectly controls, at least fifty
percent (50%) of the voting stock or other ownership interest of the other
Person, or if it directly or indirectly possesses the power to direct or cause
the direction of the management and policies of the other Person by any means
whatsoever.
1.3 "CONFIDENTIAL INFORMATION" shall mean, with respect to a party,
all information of any kind whatsoever, and all tangible and intangible
embodiments thereof of any kind whatsoever, which is disclosed by such party to
the other party and is marked, identified as or otherwise acknowledged to be
confidential at the time of disclosure to the other party. 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.
1.4 "EXISTING DISTRIBUTION AGREEMENTS" shall mean those existing
distribution agreements made between AdnaGen and MoBiTec GmbH and AdnaGen and
Genzyme Virotech GmbH for the distribution of AdnaGen's existing diagnostic
tests for breast cancer and colon cancer.
1.5 "FIRST COMMERCIAL SALE" shall mean, with respect to any Licensed
Product, the first sale of such Licensed Product for use by a third party in any
country in the Territory or the first commercial use by Gen-Probe or any of its
Affiliates of such Licensed Product in exchange for payment by a third party.
1.6 "GROUP 1 ADDITIONAL PRODUCTS" shall mean in-vitro diagnostic
assays to isolate, detect, identify or quantify, or test for drug susceptibility
of, one or more proteins or nucleic acid sequences as diagnostic indicators for
the presence of KIDNEY CANCER, CERVICAL CANCER, AND/OR OVARIAN CANCER, for the
purpose of research, diagnosis or medical care, the manufacture, use, sale offer
for sale or importation of which would, but for the license herein granted by
AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent
Rights.
1.7 "GROUP 2 ADDITIONAL PRODUCTS" shall mean in-vitro diagnostic
assays to isolate, detect, identify or quantify, or test for drug susceptibility
of, one or more proteins or nucleic acid sequences as diagnostic indicators for
the presence of LUNG CANCER, COLON CANCER, AND/OR BREAST CANCER, for the purpose
of research, diagnosis or medical care, the manufacture, use, sale offer for
sale or importation of which would, but for the license herein granted by
AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent
Rights.
1.8 "LICENSED IP RIGHTS" shall mean, collectively, the Licensed
Patent Rights and the Licensed Know-How Rights.
1.9 "LICENSED KNOW-HOW RIGHTS" shall mean all trade secret and other
know-how rights in all information and data that is not generally known
(including, but not limited to, information and data regarding formulae,
procedures, protocols, techniques and results of experimentation and testing) in
AdnaGen's possession as of the Effective Date of this Agreement, which is
reasonably useful or necessary for Gen-Probe to make, use, develop, sell or seek
regulatory approval to market a composition, or to practice any method or
process, constituting Licensed Products or Services at any time claimed or
disclosed in any issued patent or pending patent application within the Licensed
Patent Rights.
1.10 "LICENSED PATENT RIGHTS" shall mean (a) those certain patent
applications and patents listed on Exhibit A hereto; (b) all patents that have
issued or in the future issue from such foregoing patent applications, including
utility, model and design patents and certificates of invention; (c) all patents
that have issued or in the future issue from any patent application that
2
claims priority from, or common priority with, any of the foregoing patent
applications, including utility, model and design patents and certificates of
invention; and (d) all divisionals, continuations, continuations-in-part,
reissues, renewals, extensions or additions to any such foregoing patent
applications and patents.
1.11 "LICENSED PRODUCTS" shall mean [...***...] to [...***...],
[...***...], [...***...], or [...***...] for [...***...] of, one or more
proteins or nucleic acid sequences as diagnostic indicators for the presence of
PROSTATE CANCER AND/OR BLADDER CANCER, for the purpose of [...***...],
[...***...] or [...***...], the [...***...], [...***...], [...***...] or
[...***...] of which would, but for the license herein granted by AdnaGen to
Gen-Probe, infringe one or more Valid Claims of the AdnaGen Patent Rights.
1.12 "NET SALES" shall mean, with respect to any Licensed Product or
Services, the gross amount invoiced for such Licensed Product or Services billed
by Gen-Probe, its Affiliates or their respective sublicensees to independent
customers who are not Affiliates or sublicensees, less the following deductions,
to the extent that they are actually incurred: (a) [...***...], [...***...] and
[...***...], and [...***...] from the account of, such independent customers for
[...***...], [...***...], [...***...], [...***...] or [...***...] Licensed
Product, to the extent these deductions are normal and customary; (b)
[...***...] and [...***...] incurred in transporting such Licensed Product to
such customers, each only to the extent separately invoiced and reasonably
allocated among all goods subject to the shipment; (c) [...***...], [...***...]
and [...***...] and other [...***...]; (d) [...***...], [...***...], [...***...]
and [...***...] incurred, but excluding [...***...] imposed on [...***...]; and
(e) [...***...], [...***...] and other [...***...] incurred in connection with
the exportation or importation of such Licensed Product.
1.12.1 For the avoidance of doubt, Net Sales shall not include
products transferred for purposes of a clinical trial by Gen-Probe and the use
of such products for clinical trials will not be royalty bearing.
1.12.2 In the event that a Licensed Product is sold pursuant
to a "reagent/rental" program or comparable sale or lease program, that portion
of the invoiced price of such Licensed Product reasonably allocable to recovery
of the cost of the instrumentation shall also be deducted in determining the Net
Sales of such Licensed Product; provided that Gen-Probe shall not market
Licensed Products and instrumentation in such a manner as to distort the
relative profitability of the Licensed Products when considered in light of
Gen-Probe's standard accounting practices and standard marketing practices
within the clinical diagnostic industry.
1.13 "PERSON" shall mean an individual, corporation, partnership,
limited liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.
1.14 "ROYALTY TERM" shall mean (a) with respect to each Licensed
Product in each country of the Territory, considered on a country-by-country
basis, if the manufacture, use or sale of such Licensed Product in such country
is at the time of the First Commercial Sale in such country covered by a Valid
Claim, the period beginning upon the First Commercial Sale of a Licensed Product
and extending for so long as a Valid Claim remains in effect and would, if in
***CONFIDENTIAL TREATMENT REQUESTED
3
an issued patent, be infringed but for the license granted by this Agreement
provided that in any country where the manufacture, use or sale of such Licensed
Product in such country is at the time of the First Commercial Sale in such
country not covered by a Valid Claim, "Royalty Term" in respect of that Licensed
Product shall mean the period determined by reference to the foregoing
applicable to such Licensed Product in the United States of America, and (b)
with respect to each Service in each country of the Territory, considered on a
country-by-country basis, if the provision of such Services in such country is
at the time of the first provision of such Service in such country covered by a
Valid Claim, the period beginning upon the first provision of a Service and
extending for so long as a Valid Claim remains in effect and would, if in an
issued patent, be infringed but for the license granted by this Agreement
provided that in any country where the provision of such Services in such
country is at the time of the first provision in such country not covered by a
Valid Claim, "Royalty Term" in respect of that Service shall mean the period
determined by reference to the foregoing applicable to such Service in the
United States of America.
1.15 "SERVICES" shall mean services using Licensed Products or
Additional Licensed Products, which services are chargeable to a Third Party.
1.16 "TERRITORY" shall mean the world.
1.17 "THIRD PARTY" shall mean any Person other than AdnaGen,
Gen-Probe and their respective Affiliates.
1.18 "VALID CLAIM" shall mean a claim of an issued and unexpired
patent within the Licensed Patent Rights 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 determined by a court of competent
jurisdiction 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
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
2.1 MUTUAL REPRESENTATIONS AND WARRANTIES. Each party hereby
represents and warrants to the other party as follows:
2.1.1 Corporate Existence. Such party is a corporation duly
organized, validly existing and in good standing under the laws of the
jurisdiction wherein it is incorporated.
2.1.2 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.
4
2.1.3 No Other Consents Required. All necessary consents,
approvals and authorizations of all governmental authorities and other Persons
required to be obtained by such party in connection with this Agreement have
been obtained.
2.1.4 No Conflict. The execution and delivery of this
Agreement and the performance of such party's obligations hereunder, except as
expressly described in Exhibit B, (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.
2.2 LICENSED IP RIGHTS. AdnaGen represents and warrants to Gen-Probe
that as at the Effective Date (a) except as expressly described in Exhibit B,
AdnaGen has not granted to any Third Party any license or other interest in the
Licensed IP Rights in respect of Licensed Products; (b) AdnaGen has included in
the Licensed Patent Rights all patent applications and patents owned or
controlled by AdnaGen that in AdnaGen's reasonable judgment are necessary for
Gen-Probe to practice the technology in respect of Licensed Products as covered,
described or claimed by the Licensed Patent Rights; (c) AdnaGen has no actual
knowledge of any Third Party patent, patent application or other intellectual
property rights that would be infringed (i) by practicing any process or method
or by making, using or selling any composition which is claimed or disclosed in
the Licensed Patent Rights or which constitutes Licensed Know-How Rights, or
(ii) by making, using or selling Licensed Products in respect of Licensed
Products; and (d) AdnaGen has no actual knowledge of any infringement or
misappropriation by a Third Party of the Licensed IP Rights in respect of
Licensed Products. If, during the term of this Agreement, AdnaGen obtains or
becomes aware of any information relevant to (a) - (d) above, AdnaGen
immediately shall, subject to any obligation of confidence owed to a Third
Party, provide to Gen-Probe a written notice describing in reasonable detail
such information.
2.3 DISCLAIMER. SAVE AS PROVIDED IN SECTION 2.2, ALL RIGHTS AND
ITEMS LICENSED HEREUNDER ARE PROVIDED "AS IS" AND WITHOUT WARRANTY OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THE
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES OR WARRANTIES ARISING FROM A
COURSE OF DEALING, USAGE OR TRADE PRACTICES. IN NO EVENT WILL ADNAGEN BE LIABLE
FOR ANY INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTAL OR OTHER SIMILAR DAMAGES
RESULTING FROM THE EXERCISE OF THE RIGHTS LICENSED HEREUNDER.
3. LICENSE GRANT
3.1 LICENSED IP RIGHTS. AdnaGen hereby grants to Gen-Probe an
exclusive license (including the right to grant sublicenses) under the Licensed
Patent Rights to conduct research and to develop, make, use, offer for sale,
sell and import Licensed Products and to provide Services in the Territory. To
the extent required to enable AdnaGen to perform its existing obligations under
the Existing Distribution Agreements, the foregoing license shall be sole.
Further, AdnaGen hereby grants to Gen-Probe a non-exclusive license (including
the right to grant sublicenses) under the Licensed Know-How Rights to conduct
research and to develop, make, use, offer for sale, sell and import Licensed
Products and to provide Services in the
5
Territory. The right to sell Licensed Products granted in this Paragraph 3.1
shall extend to distributors of Gen-Probe that are not Affiliates of Gen-Probe
relative to their distribution of Licensed Products from Gen-Probe with no
additional obligation by such distributors to pay royalties.
3.2 SUBLICENSES. Gen-Probe shall give AdnaGen prompt written notice
of each sublicense under this Agreement along with a copy of the sublicense
agreements. Each sublicense shall be subject to the terms and conditions of this
Agreement and Gen-Probe shall be responsible for the compliance of the terms and
conditions of this Agreement by each of its sublicensees.
3.3 AVAILABILITY OF THE LICENSED IP RIGHTS. AdnaGen has or shall
provide Gen-Probe, at Gen-Probe's expense, with all information available to
AdnaGen regarding the Licensed IP Rights that is reasonably necessary to
practice under the license granted herein.
3.4 OPTION TO EXPAND LICENSE TO INCLUDE GROUP 1 ADDITIONAL PRODUCTS.
Subject to the terms and conditions of this Agreement, AdnaGen hereby grants to
Gen-Probe and its Affiliates, and Gen-Probe (on behalf of itself and its
Affiliates) hereby accepts, an option (the "OPTION") for a period of [ *** ]
months following the Effective Date (the "Option Period") to expand the license
granted by this Agreement to include one or more of the Group 1 Additional
Products. Unless this Agreement is earlier terminated as provided in Section 9,
Gen-Probe may exercise the Option as to any one or more of the Group 1
Additional Products at any time during the Option Period by sending written
notice ("EXERCISE NOTICE") to AdnaGen of Gen-Probe's intent to exercise the
Option. Gen-Probe shall pay AdnaGen a one-time option exercise payment of two
hundred fifty thousand dollars ($250,000) for each Group 1 Additional Product as
to which Gen-Probe exercises the Option. Gen-Probe may exercise the Option on
one or more occasions and as to one or more of the Group 1 Additional Products.
If on any occasion Gen-Probe exercises the Option for less than all of the Group
1 Additional Products, the remaining Group 1 Additional Products shall continue
to be subject to the Option for the balance of the Option Period.
3.5 RIGHTS OF FIRST NEGOTIATION FOR GROUP 2 ADDITIONAL PRODUCTS. In
the event that AdnaGen proposes to grant to any Third Party (or discuss or
negotiate with any Third Party the grant of) any right or license under the
AdnaGen IP Rights to make, have made, use, offer for sale, sell, have sold or
import any Group 2 Additional Product during the period commencing upon the
Effective Date and ending upon the third (3rd) anniversary of the Effective Date
(the "RIGHT OF NEGOTIATION PERIOD"), then AdnaGen shall provide Gen-Probe with
prompt written notice thereof and Gen-Probe, at its option, will have the right
to negotiate to expand Gen-Probe's license hereunder to include such Group 2
Additional Product provided that Gen-Probe exercises such right by written
notice to AdnaGen within [...***...] of receipt of AdnaGen's notice. In
addition, Gen-Probe may, at any time during the Right of Negotiation Period,
provide AdnaGen with written notice that Gen-Probe wishes to negotiate to expand
the License to include one or more Group 2 Additional Products. In such event,
the parties shall negotiate in good faith for up to [...***...] regarding the
terms pursuant to which Gen-Probe would obtains such an expansion of the rights
granted pursuant to Section 3.1. Gen-Probe may exercise its rights under this
Section 3.5 on a target-by-target basis, and Gen-Probe's waiver of its rights
hereunder with respect to any particular Group 2 Additional Product shall not
constitute
***CONFIDENTIAL TREATMENT REQUESTED
6
a waiver of such rights with respect to any other Group 2 Additional Product.
AdnaGen shall not grant any Third Party a license of the AdnaGen IP Rights for a
Group 2 Additional Product prior to the end of such 90-day negotiation period.
AdnaGen shall not grant any Third Party a license of the AdnaGen IP Rights for a
Group 2 Additional Product on terms which, when considered in the aggregate, are
more favorable than terms offered to Gen-Probe during the Right of Negotiation
Period.
3.6 TRANSFER OF TECHNOLOGY. Promptly following the Effective Date,
AdnaGen shall provide Gen-Probe with all information comprising the Licensed
Know-How Rights that may be reasonably useful to Gen-Probe in connection with
this Agreement. AdnaGen shall record the cost of such services in a manner
consistent with its standard accounting practices and where any cost is incurred
in a currency other than US dollars, such cost shall be converted into US
dollars at the exchange rate prevailing on the date on which the cost is
recorded in AdnaGen's accounts (as published in The Wall Street Journal, Western
Edition, under the heading "Currency Trading") in accordance with its standard
accounting practices. Gen-Probe shall reimburse AdnaGen for the cost of
AdnaGen's services to the extent, if any, that such cost exceeds [...***...].
All technology transfer activities shall be preapproved by Gen-Probe. All
technology transfer expenses incurred by AdnaGen shall be at reasonably
commercial levels and the labor component of all technology transfer shall be at
an annual salary rate of no more than [...***...] per individual.
3.7 REASONABLE COMMERCIAL EFFORTS. Gen-Probe shall at its own cost
and expense use its reasonable commercial efforts to develop, to obtain all
necessary and desirable regulatory and other approvals from all relevant
competent authorities (including the US Food and Drug Administration) in respect
of, and to maximize the use, sales and market penetration of, at least one (1)
Licensed Product throughout the Territory including in the United States of
America. Gen-Probe shall, within thirty (30) days of each anniversary of the
Effective Date, provide AdnaGen with a written report of the steps taken by
Gen-Probe, its Affiliates and any permitted sublicensees to comply with the
foregoing performance obligations and shall notify AdnaGen immediately upon
achievement of each milestone described in Section 4.2. The parties acknowledge
that all commercial decisions relating to the development and commercialization
of Licensed Products and Services shall be taken at the sole discretion of
Gen-Probe.
4. ROYALTIES AND MILESTONES
4.1 ROYALTIES. In consideration for the licenses granted to
Gen-Probe herein, during the Royalty Term, Gen-Probe shall pay royalties to
AdnaGen equal to [...***...] of Net Sales of Licensed Products or Services by
Gen-Probe, its Affiliates and sublicensees in the Territory.
4.2 MILESTONES. As additional consideration for the licenses granted
to Gen-Probe herein, Gen-Probe shall pay to AdnaGen the following milestone
payments upon the occurrence of each event set forth below:
4.2.1 One million dollars ($1,000,000) within thirty (30) days
of the Effective Date.
***CONFIDENTIAL TREATMENT REQUESTED
7
4.2.2 Seven hundred fifty thousand dollars ($750,000) on the
later of February 1, 2006 or the issue of a patent containing valid claims that
cover a Licensed Product or an Additional Licensed Product. For the purposes of
this Section 4.2.2 only "valid claim" shall mean a claim of an issued and
unexpired patent within the Licensed Patent Rights 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 determined by a court of
competent jurisdiction to be invalid or unenforceable through reissue or
disclaimer or otherwise.
4.2.3 [...***...] within thirty (30) days following initiation
by Gen-Probe, its Affiliates or sublicensees of the first clinical trial in the
United States for the first Licensed Product or the first Additional Licensed
Product.
4.2.4 [...***...] within thirty (30) days following the first
submission by Gen-Probe, its Affiliates or sublicensees to the United States FDA
for acceptance or approval of the first Licensed Product or the first Additional
Licensed Product.
4.2.5 [...***...] within thirty (30) days following the First
Commercial Sale by Gen-Probe, its Affiliates or sublicensees of the first
Licensed Product or the first Additional Licensed Product.
ROYALTY REPORTS AND ACCOUNTING
4.3 ROYALTY REPORTS. During the Royalty Term, Gen-Probe shall
furnish to AdnaGen, within [...***...] days of 31 March, 30 June, 30 September
and 31 December in each year during the term of this Agreement, a written report
showing in reasonably specific detail the calculation of royalties owing for the
reporting period. Each quarterly report shall set forth all sales of Licensed
Products or Services, as applicable, details of the quantities of each type of
Licensed Products sold or Services performed in the respective territories and
the country of manufacture, if different, gross revenues from such sales, other
allowances and discounts allowed and taken, Net Sales (and the calculation
thereof) and the royalties due to the payee thereon. Concurrently with providing
each such report, Gen-Probe shall pay AdnaGen all amounts payable for the period
covered by such report. With respect to sales of Licensed Products or Services
invoiced in United States dollars, all amounts shall be expressed in United
States dollars. With respect to sales of Licensed Products or Services invoiced
in a currency other than United States dollars, all amounts shall be expressed
in the domestic currency of the party making the sale together with the United
States dollar equivalent. The United States dollar equivalent shall be
calculated using the exchange rate (local currency per US$1) published in The
Wall Street Journal, Western Edition, under the heading "Currency Trading" on
the last business day of each calendar quarter. 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 enable the
royalties payable hereunder to be determined.
***CONFIDENTIAL TREATMENT REQUESTED
8
4.4 AUDITS.
4.4.1 Upon the written request of AdnaGen, 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 AdnaGen and
reasonably acceptable to Gen-Probe, at AdnaGen'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 for any year ending not
more than [...***...] prior to the date of each such request. The accounting
firm shall disclose to AdnaGen only whether or not the reports are correct and
the amount of any discrepancies.
4.4.2 If such accounting firm concludes that additional
royalties were owed during such period, Gen-Probe shall pay the additional
royalties within thirty (30) days of the date AdnaGen delivers to Gen-Probe such
accounting firm's written report so concluding. The fees charged by such
accounting firm shall be paid by AdnaGen; provided, however, if the audit
discloses discrepancies of greater than [...***...], then Gen-Probe shall pay
the reasonable fees and expenses charged by such accounting firm.
4.4.3 AdnaGen shall treat all financial information subject to
review under this Section 5.2 as confidential, and shall cause its accounting
firm to retain all such financial information in confidence under Section 5.2
below.
5. PAYMENTS
5.1 PAYMENT TERMS. Royalties shown to have accrued by each royalty
report provided for under Section 4.3 above shall be due on the date such
royalty report is due. Payment of royalties in whole or in part may be made in
advance of such due date.
5.2 EXCHANGE CONTROL. If at any time legal restrictions prevent the
prompt remittance of part or all royalties with respect to any country in the
Territory where the Licensed Product is sold, Gen-Probe shall have the right,
and as directed by AdnaGen, to make such payments by depositing the amount
thereof in local currency to AdnaGen's account in a bank or other depository
institution in such country or, if permitted by applicable law, any other
country designated by AdnaGen. If the royalty rate specified in this Agreement
should exceed the permissible rate established in any country, the royalty rate
for sales in such country shall be adjusted to the highest legally permissible
or government-approved rate.
5.3 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 AdnaGen 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 AdnaGen by Gen-Probe, its Affiliates or sublicensees. Gen-Probe
promptly shall deliver to AdnaGen 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
9
6. CONFIDENTIALITY
6.1 CONFIDENTIAL INFORMATION. During the term of this Agreement, and
for a period of [ *** ] years 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, under
confidentiality, to those directors, officers, employees, consultants, clinical
investigators, contractors, (sub)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 or entity 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.
6.2 TERMS OF THIS AGREEMENT. Except as otherwise provided in Section
6.1 above, neither party shall disclose any terms or conditions of this
Agreement to any third party without the prior consent of the other party;
provided, however, that each party shall have the right to disclose the terms
and conditions of this Agreement to any potential investor, investment banker,
attorney, consultant, and permitted assignee if such person has agreed in
writing, or is otherwise legally obliged, to preserve the confidentiality of
that information and to make no further distribution of the information.
Notwithstanding the foregoing, prior to execution of this Agreement, the parties
have agreed 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. 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 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.
6.3 PERMITTED DISCLOSURES. The confidentiality obligations contained
in this Section 7.3 shall not apply to the extent that the receiving party (the
"Recipient") 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 the
***CONFIDENTIAL TREATMENT REQUESTED
10
Recipient shall provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof, and the Recipient agrees to cooperate fully with the other
party in all reasonable respects relating thereto. Additionally, either party
may request specific written permission to disclose particular Confidential
Information of the other party to a Third Party; however, the other party shall
have the absolute right to refuse such request in the good faith exercise of its
own business judgment.
7. PATENTS
7.1 PROSECUTION AND MAINTENANCE. AdnaGen shall have the right and
obligation at its sole expense and in its sole discretion to control the
preparation, filing, prosecution and maintenance of the Licensed Patent Rights.
If AdnaGen reasonably decides to abandon any pending application or issued
patent in any country within the Licensed Patent Rights, AdnaGen shall provide
written notice to Gen-Probe and give Gen-Probe the opportunity to assume control
of the preparation, filing, prosecution, maintenance and enforcement of such
patent application or patent at Gen-Probe's expense.
7.2 ENFORCEMENT. AdnaGen shall have the right at its sole expense
and in its sole discretion to control the enforcement of the Licensed Patent
Rights against infringers. If, within six (6) months of receipt of written
notice from Gen-Probe of the infringement of the Licensed Patent Rights by third
party products which are directed to the same cancers or markers as any Licensed
Product, AdnaGen fails to xxxxx the infringement or file suit to enforce such
Licensed Patent Rights against the infringing party, then Gen-Probe shall have
the right to take whatever action it deems appropriate in its own name or, if
required by law, in the name of AdnaGen to enforce such Licensed Patent Rights
and AdnaGen shall take all necessary actions to permit Gen-Probe to take such
action, provided Gen-Probe indemnifies AdnaGen and its representatives from any
costs, claims or damages associated with such enforcement actions. The party
controlling any such enforcement action may not settle, or otherwise consent to
an adverse judgment in, such action that diminishes the rights or interests of
the non-controlling party without the prior express written consent of the
non-controlling party. All monies recovered upon the final judgment or
settlement of such action shall be used first to reimburse each party for its
actual costs incurred to investigate and pursue the claims against the
infringement, and second to split the remaining amount equally between the
parties.
8. TERMINATION
8.1 EXPIRATION. This Agreement shall expire on the expiration of
Gen-Probe's obligation to pay royalties to AdnaGen under Section 4.1 above.
8.2 TERMINATION BY GEN-PROBE. Gen-Probe may terminate this
Agreement, in its sole discretion, upon [...***...] days prior written notice to
AdnaGen, provided Gen-Probe pays AdnaGen all monies owed AdnaGen as of the
effective date of such termination and without prejudice to AdnaGen's rights
under this Agreement that accrued prior to such termination.
8.3 TERMINATION FOR CAUSE. A party may terminate this Agreement by
written notice (a) upon or after the material breach of this Agreement by the
other party if the other party has not cured such material breach within
[...***...] days after written notice thereof by the non-
***CONFIDENTIAL TREATMENT REQUESTED
11
breaching party, or (b) if the other party is unable to pay its debts or enters
into compulsory or voluntary liquidation (other than for the purpose of
effecting a reconstruction or amalgamation in such a manner that the company
resulting from such reconstruction or amalgamation if a different legal entity
shall agree to be bound by and assume the obligations of such party under this
Agreement) or compounds with or convenes a meeting of its creditors or has an
administrative receiver or administrator appointed over all or part of its
assets or takes or suffers any similar action in consequence of a debt or ceases
for any reason to carry on business.
8.4 EFFECT OF EXPIRATION OR TERMINATION. Upon expiration of this
Agreement under Section 9.1, Gen-Probe shall have a paid-up, non-exclusive
license under the Licensed Know-How Rights in the Territory in respect of
Licensed Products and Services. Upon termination of this Agreement under Section
9.2 or 9.3, Gen-Probe shall, and shall procure that its Affiliates and
sublicensees shall, return to AdnaGen or destroy, as AdnaGen may direct, all
documents (in whatever form whether electronic, printed or otherwise) and
biological materials which embody the Licensed IP Rights (to the extent that
these do not solely disclose information already in the public domain) and make
no further use of the same for any reason whatsoever. 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 Sections 7, 10, and 11
shall survive the expiration or termination of this Agreement.
9. INDEMNIFICATION
9.1 INDEMNIFICATION. Gen-Probe shall defend, indemnify and hold
AdnaGen, its affiliates and/or all directors, officers, employees, owners,
agents and representatives of AdnaGen and its affiliates (the "AdnaGen Parties")
harmless from any and all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) resulting from any claims, demands,
actions and other proceedings to the extent related to or resulting from the
manufacture, sale or use of Licensed Products or Additional Licensed Products,
or Gen-Probe's use of the Licensed IP Rights under this Agreement, made against
incurred or sustained by any of the AdnaGen Parties, including product liability
claims (whether as a result of Gen-Probe's negligence or otherwise) and breach
by Gen-Probe of any of the representations, warranties, covenants or agreement
set forth herein.
9.2 PROCEDURE. AdnaGen shall promptly notify Gen-Probe of any claim,
demand, action or other proceeding for which AdnaGen Parties intend to claim
indemnification. Gen-Probe shall have the right to participate in, and to the
extent Gen-Probe so desires jointly with any other indemnitor similarly noticed,
to assume the defense thereof with counsel selected by Gen-Probe; provided,
however, that AdnaGen shall have the right to retain its own counsel, with the
fees and expenses to be paid by Gen-Probe, if representation of a AdnaGen Party
by the counsel retained by Gen-Probe would be inappropriate due to actual or
potential differing interests between AdnaGen Party and any other party
represented by such counsel in such proceedings. The indemnity obligations under
this Section 9 shall not apply to amounts paid in settlement of any claim,
demand, action or other proceeding if such settlement is effected without the
prior express written consent of Gen-Probe, which consent shall not be
unreasonably withheld or delayed. The failure by AdnaGen to deliver notice to
Gen-Probe within a reasonable time after notice of any such claim or demand, or
the commencement of any such action or other proceeding, shall relieve such
Indemnitor of any liability to AdnaGen under this Section 9 to the
12
extent Gen-Probe is actually prejudiced thereby, but the failure or omission so
to deliver notice to Gen-Probe shall not relieve it of any other liability that
it may have to AdnaGen. Gen-Probe may not settle or otherwise consent to an
adverse judgment in any such claim, demand, action or other proceeding, without
the prior express written consent of AdnaGen, which consent shall not be
unreasonably withheld or delayed. AdnaGen, its employees and agents, shall
reasonably cooperate with Gen-Probe and its legal representatives at Gen-Probe's
expense in the investigation of any claim, demand, action or other proceeding
covered by this Section 9.
10. MISCELLANEOUS
10.1 CURRENCY. All references to dollar amounts in this Agreement
are to United States dollars.
10.2 NOTICES. Any consent, notice or report required or permitted to
be given or made under this Agreement by one of the parties to the other shall
be in writing and addressed 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 shall be effective upon receipt by the addressee.
If to AdnaGen: AdnaGen XX
Xxxxxxxxxx 0
X-00000 Xxxxxxxxxxx,
Xxxxxxx
Attention: Xxxxxxxx Xxxxxx
If to Gen-Probe: Gen-Probe Incorporated
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
10.3 ASSIGNMENT. Except as otherwise expressly provided under this
Agreement neither this Agreement nor any right or obligation hereunder may be
assigned or otherwise transferred (whether voluntarily, by operation of law or
otherwise), without the prior express written consent of the other party, which
consent shall not be unreasonably withheld; 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, or in the event of its merger, consolidation, change in control or
similar transaction. Any permitted assignee shall assume all obligations in
writing of its assignor under this Agreement. Any purported assignment or
transfer in violation of this Section 10.3 shall be void.
10.4 APPLICABLE 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.
10.5 ENTIRE AGREEMENT. This Agreement contains the entire
understanding of the parties with respect to the subject matter hereof. All
express or implied representations,
13
agreements and understandings, either oral or written, heretofore made are
expressly superseded by this Agreement.
10.6 INDEPENDENT CONTRACTORS. Each party hereby acknowledges that
the parties shall be independent contractors and that the relationship between
the parties shall not constitute a partnership, joint venture or agency. Neither
party shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other party, without the prior consent of the other party to do so.
10.7 WAIVER. The waiver by a party of any right hereunder, or of any
failure to perform or breach by the other party hereunder, shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by the
other party hereunder whether of a similar nature or otherwise.
10.8 FORCE MAJEURE. Neither party shall be held liable or
responsible to the other party nor be deemed to have defaulted under or breached
this Agreement for failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay is caused by
or results from causes beyond the reasonable control of the affected party
including but not limited to fire, floods, embargoes, war, acts of war (whether
war be declared or not), 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.
10.9 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
10.10 DISPUTE RESOLUTION. Any question, difference or dispute which
may arise concerning the construction meaning or effect of this Agreement or
concerning the rights and liabilities of the parties hereunder or any other
matter arising out of or in connection with this Agreement shall be determined
by arbitration in accordance with the International Arbitration Rules of the
American Arbitration Association (the "RULES"). The arbitrator shall have no
authority to award punitive or other damages not measured by the prevailing
party's actual damage. Any party initiating arbitration shall give written
notice of arbitration to the other party. There shall be a single arbitrator
appointed by the President for the time being of the American Arbitration
Association. The arbitration shall take place in London, England. The decision
and award rendered by the arbitrator shall be final and binding upon the
parties. The costs and expenses, including the parties' attorney's fees,
incurred in connection with the arbitration shall be assessed in accordance with
Article 31 of the Rules. Judgment upon the award may be entered in any court
having jurisdiction thereof. Notwithstanding the foregoing, any party may seek
immediate injunctive or other interim relief from any court of competent
jurisdiction with respect to any matter for which monetary damages would not
adequately protect such party's interests or otherwise to enforce and protect
intellectual property rights owned or licensed to such party.
14
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
Effective Date.
ADNAGEN AG
By /s/ Xxxx Xxxxxxx
----------------------------------
Xxxx Xxxxxxx
Chief Financial Officer
GEN-PROBE INCORPORATED
By /s/ Xxxxx X. Xxxxxxxx
----------------------------------
Xxxxx X. Xxxxxxxx
President and Chief Executive Officer
15
EXHIBIT A
LICENSED PATENT RIGHTS
[ *** ]
[ *** ]
***CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
EXISTING DISTRIBUTION AGREEMENTS
MoBiTec GmbH
Agreement to supply diagnostic kits and research reagents relating to proteins
or nucleic acid sequences as diagnostic indicators for the presence of breast
cancer and/or colon cancer embodying technology falling within the
subject-matter of the Licensed Patent Rights. This agreement was originally
entered into on an oral basis.
Genzyme Virotech GmbH
Agreement (dated October 2004) to supply diagnostic kits and research reagents
relating to proteins or nucleic acid sequences as diagnostic indicators for the
presence of breast cancer and/or colon cancer embodying technology falling
within the subject-matter of the Licensed Patent Rights. This agreement is
non-exclusive and covers the European Union as at 1 May 2004 together with
Norway and Switzerland, with an initial termination date of 31 December 2005.
