EXHIBIT 10.11
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
AMENDED AND RESTATED
ANAIS
LICENSE, DEVELOPMENT AND COOPERATION AGREEMENT
BY AND BETWEEN
GEN-PROBE INCORPORATED
AND
BIOMERIEUX, INC.
AMENDED AND RESTATED
ANAIS LICENSE, DEVELOPMENT AND COOPERATION AGREEMENT
This Amended and Restated ANAIS License, Development and Cooperation
agreement (the "Agreement") is entered into as of August 4, 2000 (the "Effective
Date") by and between Gen-Probe Incorporated, a Delaware corporation having its
principal place of business at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx
00000-0000 (hereinafter "GP"), and bioMerieux, Inc. ("BMX"), a Missouri
corporation having its principal place of business at 000 Xxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxx 00000-0000.
RECITALS
WHEREAS, BMX and its Affiliates are engaged in the development of an
advanced, fully-automated diagnostic instrument to be called "ANAIS"; and
WHEREAS, BMX possesses technology, knowledge, know-how and proprietary
rights pertaining to instrument systems, related microbiological know-how,
identification and susceptibility testing of microorganisms, multiple analyte
detection technologies, culture collections and specific probe and target
sequences and related intellectual property; and
WHEREAS, GP possesses technology, knowledge, know-how and proprietary
rights pertaining to nucleic acid hybridization and amplification technologies,
detection and identification technologies (including specific probes targeting
ribosomal RNA and specific target sequences and regions), microbiological
culture collections, Probe Assay formats, specimen collection and processing,
multiple analyte detection technologies and related intellectual property; and
WHEREAS, BMX and GP are Parties to that certain ANAIS License, Development
and Cooperation Agreement (the "ANAIS Agreement"), by and between BMX and GP and
dated as of May 2, 1997 pursuant to which they, among other things, established
a joint research and development collaboration for the development of certain
Probe Assays to be processed and interpreted upon ANAIS instrumentation; and
WHEREAS, BMX and GP desire to amend and restate the ANAIS Agreement in
order to bring to a conclusion the collaborations referred to and to provide
for, among other things, replacement of the profit-sharing arrangements set
forth in the ANAIS Agreement with a royalty arrangement and the licensing of
certain intellectual property on the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the covenants and
premises contained in this Agreement, the Parties agree as follows:
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1. DEFINITIONS
As used in this Agreement and the accompanying Exhibits, the following
terms have the following meanings:
1.1 "AFFILIATE" shall mean any corporation or other business entity
controlled by, controlling, or under common control with a Party hereto. For
purposes of this definition, "control" shall mean direct or indirect ownership
of more than fifty percent (50%) of the voting interest or income interest in a
corporation or entity or such relationship as, in fact, constitutes actual
control. An Affiliate shall lose its status as such, prospectively, upon a
Change in Control of such Affiliate which causes the Party's direct or indirect
ownership interest to become fifty percent (50%) or less.
1.2 "ANAIS AGREEMENT" shall mean that certain ANAIS License, Development
and Cooperation Agreement by and between BMX and GP dated as of May 2, 1997.
1.3 "ANAIS FIELD" shall mean:
A. the detection, identification, quantification, and/or
susceptibility testing of organisms or agents causing human
clinical infectious diseases, as present in the human body,
solely for the purpose of diagnosis and medical care of the
persons from whom the tested samples were taken;
B. testing for sequences encoding [***];
C. testing for microorganisms or agents, including [***] in quality
control processes of water, food products, and/or previously
developed pharmaceutical or cosmetic products; and/or
D. testing for the purposes of identifying [***] foodstuffs or
identifying [***] in foodstuffs.
The ANAIS Field specifically does not include testing for infectious agents in
blood and blood products intended for transfusion, or the testing for infectious
agents in blood in connection with organ transplants, or the testing of
specimens from non-human animals or environmental sources except as specifically
provided above, even if such testing is for the purpose of detecting or
identifying organisms which are associated with infectious diseases in man.
1.4 "ANAIS INSTRUMENTATION" shall mean only that diagnostic instrument to
be developed by BMX, which instrument is described in Exhibit C to this
Agreement. ANAIS Instrumentation shall also include a semi-automated component
system based on the [***] Instrument System, as specifically described in
Exhibit D to this Agreement, to be used for the early market introduction of the
instrument concept described in Exhibit C. "ANAIS Instrumentation" shall exclude
all ANAIS Products to be run on such instrumentation. The Parties agree that
notwithstanding any other provision of this Agreement, ANAIS Instrumentation may
perform Probe Assays other than ANAIS
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Products as defined herein (provided that nothing contained in this sentence
shall expand the scope of the rights licensed by GP to BMX pursuant to Section
3.1).
1.5 "ANAIS PRODUCTS" shall mean the following Probe Assays, in each case
made, used, or sold under the license granted by GP herein and solely and
exclusively for use on ANAIS Instrumentation:
A. Probe Assays for the detection, identification, quantification,
and/or susceptibility testing for panels of microorganisms or agents (but
specifically excluding single organisms) in specimens taken from humans,
solely for the purpose of diagnosis and medical care of the persons from
whom the tested samples were taken. A panel shall test for [***] distinct
species of organisms or agents in the following groups of microorganisms
or agents:
(i) [***]
(ii) [***]
(iii) [***]
(iv) [***]
The panels shall be medically relevant.
B. Probe Assays for the detection, identification, quantification,
and/or susceptibility testing for an individual organism (together with
its subtypes, phenotypes, or genotypes), drawn only from the groups or
families listed below, in specimens taken from humans, solely for the
purpose of diagnosis and medical care of the persons from whom the tested
samples were taken:
(i) [***]
(ii) [***]
(iii) [***]
(iv) [***]
(v) [***]
(vi) [***]
(vii) [***]
(viii) [***]
(ix) [***].
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omitted portions.
C. Probe Assays for testing of sequences encoding [***] in specimens
taken from humans: and/or
D. Probe Assays to detect and /or precisely identify microorganisms
or agents including [***] for use in quality control processes of water,
food products, and/or previously developed pharmaceutical or cosmetic
products, and/or [***].
Nothing contained in this definition of ANAIS Products shall in any way modify
the definition of ANAIS Instrumentation set forth in this Agreement and each of
the ANAIS Products shall be developed and sold exclusively for use on such ANAIS
Instrumentation. ANAIS Products shall not include multiplex screens (or other
methods for differentiation or identification of organisms) so as to permit
independent use of the detection and/or quantification capability of the ANAIS
instrument.
1.6 "ASSAY" shall mean a diagnostic process or procedure applied to a
sample, or a portion of a sample, whereby a particular chemical compound, or a
collection of compounds, or a portion of a chemical compound, is detected and
optionally quantified.
1.7 "BMX TECHNOLOGY" shall mean:
A. the patents and patent applications in existence as of May 2,
1997 and which BMX owned or which were licensed to BMX (with right to
sublicense or otherwise transfer) as of May 2, 1997, together with any
divisionals, continuations, continuations-in-part, reissues, renewals,
substitute applications and inventors' certificates which issue from
applications filed after May 2, 1997 with respect to any of the foregoing
patents or patent applications and claim priority therefrom, and any
counterparts of any of the foregoing filed in any other jurisdiction.
(Pursuant to the ANAIS Agreement, BMX provided a list of the foregoing in
a confidential annex furnished under a confidentiality agreement dated
April 30, 1997 between GP and BMX.);
B. the ideas, inventions, Confidential Information, devices, trade
secrets, procedures, methods, data, studies, reports, processes, rights,
manufacturing information, and other information that is generally not
known that affords BMX a competitive advantage with respect to its
business ("Know-How"), each to the extent it is useful in practicing the
patents and patent applications referred to in subparagraph (a) above and
each to the extent that it existed as of May 2, 1997;
C. any technology which existed prior to the Effective Date hereof
and constituted BMX Core-Related Collaboration Technology or BMX
Collaboration Technology under the definitions of the ANAIS Agreement; and
D. Any Derivative Invention made by BMX after the Effective Date
hereof.
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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1.8 "CALENDAR QUARTER" shall mean, for each Calendar Year, the quarter
beginning on each January 1, April 1, July 1 or October 1 of such year, without
regard to whether such dates are otherwise business days.
1.9 "CALENDAR YEAR" shall mean any calendar year commencing on January 1
and ending on December 31.
1.10 "CHANGE IN CONTROL" shall mean, with respect to a Party, (a) the
acquisition of such Party 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 such Party); (b) the
sale, transfer or other disposition of all or substantially all of the assets of
such Party (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
such Party; unless in each of clauses (a) through (c) above, such Party's
stockholders of record immediately prior to such acquisition or sale hold (by
virtue of the securities issued in consideration for such Party's acquisition or
sale or otherwise) greater than fifty percent (50%) of the total voting power of
the surviving or acquiring entity.
1.11 "COMMERICALLY REASONABLE EFFORTS" shall mean that level of effort
which would be devoted by an independent entity reasonably seeking to pursue a
profit-making business, in light of all of the relevant circumstances actually
faced by the Party charged with the duty to use such efforts.
1.12 "CONFIDENTIAL INFORMATION" shall mean all information and materials,
patentable or otherwise, of a Party which are not generally known or available,
are treated as private and confidential by the disclosing Party and are
disclosed by or on behalf of such Party to the other Party pursuant to this
Agreement, including, but not limited to, formulations, techniques, methodology,
equipment, data, reports, Know-How, preclinical and clinical trials and the
results thereof, sources of supply, patent positioning and business plans,
including any negative developments, whether or not related to ANAIS Products
and ANAIS Instrumentation.
1.13 "DERIVATIVE INVENTION" shall have the meaning ascribed in Section
7.3.
1.14 "FDA" shall mean the United States Food and Drug Administration.
1.15 "FIRST COMMERCIAL SALE" of an ANAIS Product shall mean the first sale
for use or consumption of such ANAIS Product to a Third Party after Regulatory
Approval (if required by law) has been granted by the governing health
regulatory authority of the country or political subdivision in which such sale
occurs. Sale to an Affiliate shall not constitute a First Commercial Sale unless
the Affiliate is the end user of the ANAIS Product.
1.16 "FORCE MAJEURE" shall have the meaning ascribed in Section 16.3.
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1.17 "FTE" shall mean the equivalent of a full-time researcher's or
program manager's work time expended on activities pursuant to approved Work
Plans over a 12- month period (including normal vacations, sick days and
holidays).
1.18 "FULLY-ABSORBED MANUFACTURING COST" shall mean, with respect to any
KBCs manufactured by GP pursuant to Article 8 of this Agreement:
A. the price paid or other cost incurred for any product, component
or raw material acquired for incorporation into such KBCs; and
B. the following specified costs of manufacturing or incorporating
such products, components or raw materials into the relevant KBC in
applicable form: (i) direct manufacturing and quality control costs
related to an individual KBC (i.e., those costs which vary with
production), including, without limitation, direct labor and benefit
expenses for manufacturing personnel, actual cost of raw materials,
components, consumable bulk, costs associated with scrap and other
production materials incorporated into such KBC, plus (ii) fixed
manufacturing overhead costs allocable to the KBC based on actual
utilization for manufacturing work directly related to such KBC 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 (iii)
any and all royalties payable for rights used in the manufacture of a KBC
sold by GP (provided that as to all such royalties known to GP on the
Effective Date, such royalties shall have been disclosed in writing to
BMX), in each case in accordance with GAAP and consistent with applicable
Exhibits to the ANAIS Agreement, and subject to verification on audit by
BMX pursuant to Section 8.1(d).
Manufacturing overhead of GP hereunder shall be based upon substantially the
same cost structures as are used for the same or similar materials, components
or products, which are used by GP in its business operations outside the scope
of this Agreement.
1.19 "GAAP" shall mean United States Generally Accepted Accounting
Principles, consistently applied.
1.20 "GP RNA TECHNOLOGY" shall mean the technology claimed in the patents
and patent applications identified on Exhibit A, together with any divisionals,
continuations, continuations-in-part, reissues, renewals, substitute
applications and inventors' certificates which claim priority therefrom, and any
counterparts of any of the foregoing filed in any other jurisdiction. For the
avoidance of doubt, GP RNA Technology shall include any method for testing,
detection, identification, quantification, and/or susceptibility testing of
non-viral organisms using RNA sequencing methods, including resequencing, with
High Density DNA Probe Arrays (as defined in Exhibit C).
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1.21 "GP TECHNOLOGY" shall mean:
A. the patents and patent applications in existence as of May 2,
1997 and which GP owned or which were licensed to GP (with right to
sublicense or otherwise transfer) as of May 2, 1997, together with any
divisionals, continuations, continuations-in-part, reissues, renewals,
substitute applications and inventors' certificates which issue from
applications filed after May 2, 1997 with respect to any of the foregoing
patents or patent applications and claim priority therefrom, and any
counterparts of any of the foregoing filed in any other jurisdiction.
(Pursuant to the ANAIS Agreement, GP provided a list of the foregoing in a
confidential annex furnished under a confidentiality agreement dated April
30, 1997 between GP and BMX.) For the avoidance of doubt, GP Technology
shall include the GP RNA Technology and the GP TMA Technology;
B. the ideas, inventions, Confidential Information, devices, trade
secrets, procedures, methods, data, studies, reports, processes, rights,
manufacturing information, and other information that is generally not
known that affords GP a competitive advantage with respect to its business
("Know-How"), each to the extent it is useful in practicing the patents
and patent applications referred to in subparagraph (a) above and each to
the extent that it existed as of May 2, 1997;
C. any technology which existed prior to the Effective Date hereof
and constituted GP Core-Related Collaboration Technology or GP
Collaboration Technology under the definitions of the ANAIS Agreement; and
D. any Derivative Invention made by GP after the Effective Date
hereof.
For the avoidance of doubt, GP and BMX agree that BMX shall have the right under
this Agreement to purchase from GP, pursuant to Article 8 (and in particular
Section 8.2(e)), hybridization protection assays ("HPA") using acridinium ester
labeling technologies, which shall be used by BMX solely for product development
of ANAIS Products and quality control of ANAIS Products (in a manner consistent
with the prior use of such technologies for such product development and quality
control purposes by GP in connection with the ANAIS Agreement). Nothing
contained herein shall permit BMX to include HPA or acridinium ester labeling
technologies in ANAIS Products.
1.22 "GP TMA TECHNOLOGY" shall mean the technology claimed in the patents
and patent applications identified on Exhibit B, together with any divisionals,
continuations, continuations-in-part, reissues, renewals, substitute
applications and inventors' certificates which claim priority therefrom, and any
counterparts of any of the foregoing filed in any other jurisdiction.
1.23 "KEY BIOCHEMISTRY COMPONENTS" or "KBCS" shall mean: (a) the lysing
tubes, enzymes, nucleic acids and other biochemical compounds and reagents
identified on Exhibit E hereto.
1.24 "NET SALES" shall mean the gross amount invoiced to Third Party end
users by BMX, its Affiliates, and distributors for all ANAIS Products sold
(except to the extent an
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Affiliate is the end user of such ANAIS Products, in which case the gross amount
invoiced therefor shall be deemed to be the amount that would be invoiced to a
Third Party in an arms length transaction) after deduction for the following
items (i) trade, quantity and cash discounts or rebates actually allowed, paid
or taken; (ii) credits, rebates, charge-back rebates or reimbursements actually
granted or given to wholesalers and other distributors, buying groups, health
care insurance carriers, governmental agencies and other institutions;
(iii) credits or allowances actually granted or given for rejection or return
of such ANAIS Products previously sold; (iv) any tax, tariff, duty or other
governmental charge (other than an income tax) levied on the sale,
transportation or delivery of ANAIS Products and actually and finally borne by
the seller thereof; and (v) any charge for freight or insurance actually and
finally borne by the seller thereof. [***].
1.25 "PARTY" shall mean BMX or GP; "PARTIES" shall mean BMX and GP.
1.26 "PROBE ASSAY" shall mean an Assay using a nucleic acid as a necessary
and active reagent or which detects a set of nucleic acid sequences or a
specific nucleic acid sequence, as a means of obtaining useful information
relevant to the sample being assayed.
1.27 "PRODUCT LIABILITY CLAIMS" shall have the meaning ascribed in Section
8.6(b).
1.28 "REGULATORY APPROVAL" shall mean all approvals (including price and
reimbursement approvals), licenses, registrations or authorizations of any
country, federal, state or local regulatory agency, department, bureau or other
government entity that are necessary for the use, storage, import, transport
and/or sale of an ANAIS Product in a country or other political subdivision.
1.29 "ROYALTY TERM" shall mean, in the case of sales of any ANAIS Product
in any country, the period of time commencing on the First Commercial Sale of
any ANAIS Product and ending upon the later of:
(a) ten (10) years;
(b) the date on which all of the Patents registered in the United
States, Japan, France, Italy, or Germany and covering any portion of
the GP RNA Technology and/or the GP TMA Technology used in the
Product for which a royalty is to be computed have expired; and
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(c) the date on which all of the Patents registered in the country
of sale (without considering the patents for the GP RNA Technology
and the GP TMA Technology), and used in the Product for which a
royalty is to be computed, have expired.
Notwithstanding the foregoing, the sale of an ANAIS Product for use on the semi-
automated component instrument shall not constitute a First Commercial Sale of
an ANAIS Product for purposes of the 10 year expiration provision of this
section 1.29; provided, however, that any such sale shall commence BMX's
obligation to pay royalties and further provided that any calendar year for
which BMX pays GP a total annual royalty of not less than [***], for ANAIS
Products to be used on the semi-automated component instrument, shall reduce the
10-year period by one year.
1.30 "THIRD PARTY" shall mean any person or entity other than BMX or GP or
any of their Affiliates.
1.31 "TRANSITION PERIOD" shall mean the period beginning on the Effective
Date and ending December 30, 2000 (unless extended pursuant to the terms of this
Agreement).
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2. TERMINATION OF PRIOR RELATIONSHIP
It is the Parties' intention by the adoption of this Agreement to
prospectively terminate, as of the Effective Date, the collaborative
relationships established by the ANAIS Agreement and to substitute in its place
the new relationships provided for in this Agreement. The ANAIS Agreement shall
not apply to the activities of the Parties occurring after the Effective Date,
except as specifically stated in this Agreement, and the terms of this Agreement
shall prospectively supersede the terms of all prior related understandings and
agreements between the parties (including, without limitation, the ANAIS
Agreement) as of the Effective Date, except where the terms of such prior
related understandings or agreements are expressly and specifically incorporated
by reference into this Agreement. For the avoidance of doubt, and
notwithstanding any other provision of this Agreement, nothing contained herein
shall negate or diminish any obligation of a Party to preserve the
confidentiality of any confidential information obtained by that Party from the
other Party pursuant to a prior agreement between the Parties.
2.1 TERMINATION OF ANAIS DEVELOPMENT PROGRAMS. The joint development
programs described in Article II of the ANAIS Agreement are hereby terminated,
except to the extent specifically set forth herein.
2.2 TERMINATION OF ANAIS FUNDING OBLIGATIONS. The funding obligations
described in Article III of the ANAIS Agreement are hereby terminated, except to
the extent specifically set forth herein.
2.3 TERMINATION OF THREE-WAY BMX-GP-AFFX AGREEMENT. BMX, GP, and
Affymetrix, Inc. ("AFFX") entered into a three-way agreement dated September 21,
1998 concerning the ANAIS Instrumentation, hereafter referred to as the
Three-Way Agreement. BMX and GP agree that the provisions of this Agreement
shall be effective to terminate -- pursuant to, inter alia, section 3.5 of the
Three-Way Agreement -- all GP Permitted Uses and all GP Development Uses
established by the Three-Way Agreement. BMX and GP agree that the provisions of
this Agreement shall be effective to terminate -- pursuant to, inter alia,
section 3.5 of the Three-Way Agreement -- all AFFX Permitted Uses and all AFFX
Development Uses established by the Three-Way Agreement. All obligations to make
available any technology pursuant to Section 3.1 of the Three-Way Agreement are
hereby terminated. Nothing contained in this Agreement shall constitute a waiver
by any Party of any rights established by Three-Way Agreement in connection with
technology previously disclosed pursuant to section 3.1 of the Three-Way
Agreement. Nothing contained in this Agreement shall constitute agreement by GP
and/or BMX to an alteration of the ANAIS System for any purpose(s) of the
Three-Way Agreement. BMX and GP shall use their best efforts to obtain AFFX's
acknowledgment of the termination of rights and obligations under the Three-Way
Agreement, as expressly set forth herein, promptly following GP's and BMX's
execution of this Agreement.
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3. RIGHTS, LICENSES, AND RESTRICTIONS
3.1 LICENSE GRANTS BY GP. Subject to the terms and conditions of this
Agreement, GP hereby grants to BMX a non-exclusive, non-transferable (except to
Affiliates), royalty-bearing (as set forth in Article 4) worldwide license in
the ANAIS Field to use the GP Technology to develop, make and have made, use,
sell, offer for sale, have sold, and import the ANAIS Products, solely and
exclusively for use on the ANAIS Instrumentation.
3.2 LICENSE GRANTS BY BMX.
A. BMX hereby grants to GP a non-exclusive, non-transferable,
fully-paid license under the BMX Technology to the extent necessary or
appropriate to permit GP to perform its limited obligations pursuant to
Article 6 ("Product Development Transition").
B. Subject only to the provisions of section 7.6(a) of this
Agreement, below, BMX hereby grants to GP a non-exclusive,
non-transferable (except to Affiliates), fully-paid and royalty-free
license to develop, make and have made, use, sell, offer for sale, have
sold and import products which would otherwise infringe a claim of any
patent which issues from U.S. patent applications [***] (and any patent
which issues from any divisionals, continuations, continuations-in-part,
reissues, renewals, substitute applications which claim priority from such
applications and/or any patent which issues from any foreign counterparts
to any of the foregoing). The license hereby granted shall extend to and
include any product (a "Collaboration Product") that is developed by
Gen-Probe in active collaboration with a third party, if -- and only if --
both GP and such third party (a "Gen-Probe Active Collaborator") each make
a substantial contribution of funds and effort toward developing such
Collaboration Product to the point where it can be commercially marketed.
Upon cessation of such active collaboration, the limited license to the
Gen-Probe Active Collaborator for the Collaboration Product shall
immediately terminate. No license whatsoever is granted by this Agreement
to the Gen-Probe Active Collaborator except for Collaboration Products.
The license grant set forth in this paragraph shall be subject only to the
provisions of Sections 7.2, 7.3 and 7.6 (a) of this Agreement, and shall
not be conditioned upon or subject to any other terms of the Agreement.
The license grant set forth in this paragraph shall survive termination of
the Agreement.
3.3 DISCLOSURE OF TECHNOLOGY. Subject to the confidentiality requirements
of Article 12 and the express limitations of Article 8, promptly following the
Effective Date and from time to time as necessary, GP shall disclose to BMX such
GP Technology as is licensed to BMX hereunder and GP shall promptly provide to
BMX all information resulting from GP's work in the collaboration under the
ANAIS Agreement that may be necessary or useful for BMX to carry on the
development, manufacture, and sale of the ANAIS Products. Subject to the
confidentiality requirements of Article 12, promptly following the Effective
Date and from time to time as necessary, BMX shall disclose to GP such BMX
Technology as is licensed to GP hereunder. For the avoidance of doubt, nothing
contained in this Section shall be construed to require GP to disclose to BMX
GP's hybridization
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protection assay ("HPA") and/or acridinium ester labeling technologies.
3.4 PATENT MARKING. BMX agrees that it will duly xxxx all ANAIS Products
made, used, offered for sale, sold, or imported under the terms of this
Agreement with the patent number or numbers of any applicable GP Patents
practiced thereby, in a manner reasonably intended to comply with the
requirements for providing constructive notice under applicable patent laws.
3.5 NO OTHER TECHNOLOGY RIGHTS. Except as otherwise expressly provided in
this Agreement, under no circumstances shall a Party, as a result of this
Agreement, obtain any ownership interest or other right in any discovery,
invention or other technology, data or information (or any patent, copyright,
trademark, or other intellectual property rights therein) of the other Party,
including items that may be transferred by the other Party to such Party at any
time pursuant to this Agreement. Except as expressly provided in this Agreement,
neither Party shall be under any obligation to grant to the other Party any
rights in any patent, copyright, trademark, or other intellectual property nor
under any restriction with respect thereto; provided, however, that if use of
any GP trademark is required for sale of any ANAIS Product by reason of the
inclusion in such Product of any GP Technology or component, the same shall be
authorized by GP.
3.6 LIMITATION ON REVERSE ENGINEERING. Nothing in this Agreement shall be
interpreted as giving a Party the right to analyze, dissect, or disassemble any
instrument, reagent, component, object, software or other property of the other
Party provided under the terms of this Agreement, and which is not properly
available from other sources which have the right to transfer such property and
authorize such activity, in order to circumvent the need for a license of the
technology reflected therein. The licenses granted hereunder do not include a
license for research and development activities which are intended to identify
means by which the need for the license can be avoided.
3.7 NO RESTRICTION ON COLLABORATION WITH THIRD PARTIES. Neither BMX nor GP
shall be restricted from entering into any collaboration with any Third Party in
the Field or outside the Field (or any portion thereof). Nothing contained in
this Section shall independently permit assignment of any rights and/or
obligations of this Agreement by any Party in connection with any collaboration.
3.8 RESERVATION OF RIGHTS TO GP TECHNOLOGY. Except for the licenses
expressly granted by GP to BMX under section 3.1, no right, title, or interest
in or to the GP Technology shall pass from GP to BMX under this Agreement or
otherwise vest in or become the property of BMX. Except as expressly set forth
in section 7.6, GP shall retain the unrestricted right to use and/or license for
use the GP Technology for any purpose whatsoever, inside or outside the ANAIS
Field.
3.9 RESERVATION OF RIGHTS TO BMX TECHNOLOGY. Except for the licenses
expressly granted by BMX to GP under section 3.2, no right, title, or interest
in or to the GP Technology shall pass from BMX to GP under this Agreement or
otherwise vest in or become the property of GP. BMX shall retain the
unrestricted right to use and/or license for use the BMX Technology for any
purpose whatsoever, inside or outside the ANAIS Field.
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3.10 RECOGNITION OF STANFORD AND ORGANON TEKNIKA AGREEMENTS. The rights
granted to BMX by GP hereunder are subject to the following:
X. XXXXXXXX AGREEMENT. The patent rights designated as "Selective
Amplification", U.S. Patent No. 5,537,990 are sublicensed to BMX by GP
under the terms of a co-exclusive license agreement (the "Stanford
Agreement") effective April 27, 1997 between Gen-Probe and The Board of
Trustees of the Xxxxxx Xxxxxxxx Junior University, Palo Alto, California
("Stanford"). Under the terms of the Stanford Agreement, certain
provisions as set forth in Schedule H, attached hereto, are incorporated
into this Agreement by reference.
B. TEKNIKA AGREEMENT. GP is a party to a non-assertion agreement
effective February 7, 1997 (the "Teknika Agreement") with Organon Teknika
B.V., having a place of business at Xxxxxxx 00, 0000 XX Xxxxxx, Xxx
Xxxxxxxxxxx ("Teknika"), which agreement grants certain rights and imposes
certain conditions with respect to the transcription-based amplification
patent rights owned or licensed by GP. BMX agrees, at the request of
Teknika, to permit and to cooperate fully with an annual review of its
manufacturing records (and such other records as may be required) by an
impartial, technically qualified third party to verify compliance with the
provisions of Section 3.3 of the Teknika Agreement. Selection of such
third party shall be subject to the approval of BMX, such approval to be
not unreasonably withheld. The results of such a review as provided to
Teknika will consist solely of a finding of compliance or non-compliance.
The cost of such review shall be born by Teknika and shall not be
unreasonably burdensome for BMX.
C. CONTINUATION OF RIGHTS. In the event the Stanford Agreement or
Teknika Agreement is terminated for any reason, the rights under such
agreements which are granted by GP to BMX under this Agreement, as
applicable, may be continued with Stanford and/or Teknika, as applicable,
provided that certain conditions precedent, as set forth in Exhibit H,
shall have been fulfilled.
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4. FEES AND PAYMENTS
4.1 EARNED ROYALTIES. In exchange for the rights granted BMX by this
Agreement, shall pay to GP an earned royalty on worldwide annual Net Sales of
ANAIS Products as follows:
A. [***] of worldwide annual Net Sales for any ANAIS Product which
is covered by any part of both of the GP TMA Technology and the GP RNA
Technology.
B. [***] of worldwide annual Net Sales for any ANAIS Product which
is covered by any part of one but not both of the GP TMA Technology and
the GP RNA Technology.
C. [***] of worldwide annual Net Sales for any ANAIS Product which
is not covered by any part of either the GP TMA Technology or the GP RNA
Technology but which is covered by other GP Technology; provided that the
royalty for any such ANAIS product shall be reduced to [***] of worldwide
annual Net Sales on the following terms:
(i) For any calendar year in which BMX has previously
commercialized at least four (4) ANAIS Products, each
of which is covered by the GP TMA Technology and/or
the GP RNA Technology, and for which BMX pays GP a
total annual royalty of not less than [***],
reasonably adjusted for inflation following the
Effective Date, then the royalty payable on any ANAIS
Product which is not covered by any part of either the
GP TMA Technology or the GP RNA Technology but which
is covered by other GP Technology shall be reduced to
[***] of worldwide annual Net Sales for that year. Any
reduction to [***] pursuant hereto shall be made at
the end of the applicable year and GP shall make the
appropriate repayment of royalties to BMX, if
necessary, within thirty days of BMX's royalty report
for the fourth calendar quarter.
(ii) When BMX has made cumulative royalty payments to GP
for ANAIS Products of [***], adjusted for inflation
following the Effective Date, then the royalty payable
on any ANAIS Product which is not covered by any part
of either the GP TMA Technology or the GP RNA
Technology but which is covered by other GP Technology
shall be permanently reduced to [***] of worldwide
annual Net Sales for all calendar quarters after the
quarter for which the qualifying payment is made by
BMX.
(iii) The provisions of subparagraphs (C) (i) and (C) (ii)
shall be cumulative in favor of BMX.
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*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
D. ROYALTY TERM. Earned Royalties for sales of any ANAIS Product in
a given country shall be paid for a period equal to the Royalty Term for
such product in such country.
4.2 MINIMUM ANNUAL ROYALTY. Beginning January 1, 2006, BMX shall pay to GP
a minimum annual royalty as follows:
2006............................................................ [***]
2007............................................................ [***]
2008............................................................ [***]
2009............................................................ [***]
2010............................................................ [***]
2011............................................................ [***]
The minimum annual royalty for each year shall accrue as of January 1 in that
year. To the extent that earned royalties paid for such year are not equal to or
more than the minimum royalty for that year, then at the time of BMX's report
and payment for the fourth Calendar Quarter BMX shall pay to GP the amount
necessary to make the total royalty payments equal the minimum annual royalty.
If BMX terminates this Agreement pursuant to Xxxxxxx 00.0, XXX shall not have
any obligation or liability with respect to any minimum annual royalty which had
not accrued as of the termination date. Each minimum annual royalty shall be
creditable against earned royalties that accrue under this Agreement in any
calendar year.
4.3 THIRD PARTY ROYALTIES. BMX shall be solely responsible for payment of
all royalties due to Third Parties from either GP or BMX in connection with the
development, manufacture, use or sale of ANAIS Products.
4.4 COMPLETION OF ROYALTY TERM. Upon the conclusion of the Royalty Term,
BMX's license hereunder shall be deemed to be fully paid-up.
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5. PAYMENTS; RECORDS; AUDITS
5.1 PAYMENTS; REPORTS. Royalty payments and reports for the sale of ANAIS
Products shall be calculated and reported for each Calendar Quarter by each of
BMX and its Affiliates. All royalty payments due to a Party under this Agreement
shall be paid within sixty (60) days of the end of each Calendar Quarter, unless
otherwise specifically provided herein. Each payment of royalties shall be
accompanied by a report of Net Sales of ANAIS Products, on a country-by-country
basis, showing for each country the breakdown among BMX and its Affiliates, in
sufficient detail to permit confirmation of the accuracy of the royalty payment
made, including, without limitation, the number of ANAIS Products sold, the
gross sales and Net Sales of ANAIS Products, the amount of each category of
deduction from Net Sales specified in the definition thereof in Article 1, the
royalties, in U.S. dollars, payable, the method used to calculate the royalty
and the exchange rates used. The report provided pursuant to this paragraph
shall be treated as Confidential Information under this Agreement and shall only
be used or made available to GP employees for purposes of verifying that proper
Royalty payments have been made by BMX.
5.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments hereunder
shall be payable in U.S. dollars. With respect to each Calendar Quarter, for
countries other than the United States, royalties shall first be calculated in
the currency of the country in which such royalties are earned and whenever
conversion of payments from any foreign currency shall be required, such
conversion shall be made in accordance with the internal, accounting principles
and practices of BMX and its applicable Affiliates as of the Effective Date, as
described in Exhibit F hereto. All payments due from BMX hereunder shall be made
by wire transfer of immediately available funds in U.S. Dollars to such bank
account in the United States as GP may from time to time designate.
5.3 RECORDS AND AUDITS. BMX shall keep, and shall cause its Affiliates to
keep, for a period of not less than three (3) years after each Calendar Year,
complete, true and accurate books of account and other records containing all
information and data which may be necessary to ascertain and verify the amount
of royalties payable hereunder for such Calendar Year. During the Term of this
Agreement and for a period of three (3) years thereafter, GP shall have the
right from time to time (not to exceed twice during each Calendar Year) to
inspect, in confidence, and audit all such books and records of BMX. At its
option and expense, GP shall have the right to cause its independent public
accountants to conduct such review and audit. If any such audit results in a
determination that royalties payable for any Calendar Year have been underpaid
by five percent (5%) or more, BMX shall bear all costs of the inspection. In any
event, any royalty payment underpayment shall be paid within thirty (30) days
after the discovery of such underpayment, and, during the period from the
original date on which such amount should have been paid hereunder until the
date paid, shall bear interest at an annual rate of two percentage points above
the prime rate from time to time quoted by Bank of America at its principal
office in San Francisco, California, with changes in such prime rate to be
effective as of the date of each such change.
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5.4 WITHHOLDING OF TAXES. Any and all taxes imposed or levied on account
of royalties and revenue participation payments payable under this Agreement
which are required to be withheld by BMX or its Affiliates shall be withheld by
BMX and its Affiliates, as the case may be, and shall be paid to the proper
taxing authority. Proof of payment reasonably satisfactory to GP shall be
secured by BMX and submitted to GP as evidence of such payment. Such taxes shall
be deducted from the royalty or revenue participation payment amounts that would
otherwise be payable by BMX and its Affiliates hereunder.
5.5 NO ROYALTIES PAYABLE BY GP. All of the rights and licenses granted by
BMX to GP under this Agreement are royalty free, and nothing contained in this
Agreement obligates, or shall be deemed to obligate, GP to make any royalty
payments to BMX.
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6. PRODUCT DEVELOPMENT
Pursuant to the ANAIS Agreement, and prior to the Effective Date of this
Agreement, the Parties have been involved in collaborative efforts to jointly
develop assays for the ANAIS Instrumentation. Such collaborative efforts shall
be terminated in accordance with the following provisions:
6.1 DEVELOPMENT TRANSITION. The Parties shall cooperate in the Development
Transition described herein and in the transfer of any information and Know-How
necessary for BMX to assume the development of the ANAIS Products. The parties
have agreed upon a work plan which will provide for the transition of product
development activities (hereafter the "Development Transition") from GP to BMX.
It is the Parties' intent that the Development Transition work plan, a copy of
which is attached as Exhibit I and incorporated herein by reference, shall
provide for the transfer from GP to BMX of any knowledge, records, procedures,
work instructions, formulations, and Know-How, necessary for the development of
the ANAIS Products or in carrying out the tasks as previously performed by GP
under the working relationship established between BMX and GP under the ANAIS
Agreement. Know-How and other information regarding such activities disclosed by
GP to BMX pursuant hereto may be used only in accordance with the rights granted
under this Agreement. It is the Parties' intent that the Development Transition
work plan shall also provide for the reasonable availability of GP personnel and
support by GP in the event needed to ensure compliance with regulatory
requirements or the orderly transfer of any development work to BMX, to the
extent that such support can only reasonably be provided by GP within the
time-frame contemplated in the Development Transition work plan. Except as
otherwise stated herein, it is the Parties' intent that GP's obligations in
connection with the Development Transition shall terminate as of December 30,
2000 and the work plan shall reflect such termination date. Neither GP nor BMX
shall have any responsibility with respect to the development of the ANAIS
Products except as set forth in this Agreement and in the Development Transition
work plan. GP shall be compensated by BMX for GP's activities during the
Development Transition pursuant to the work plan, as set forth in Section 6.3,
below.
6.2 COORDINATION OF DEVELOPMENT TRANSITION. The BMX-GP representatives
referred to under the ANAIS Agreement as the ANAIS Committee, as applicable,
will serve to coordinate the execution of the Development Transition work plan
(and any mutually- agreed modifications thereof). Both parties shall use
commercially reasonable and diligent efforts to perform their respective
responsibilities under the Development Transition work plan and this section and
shall make reasonably available any key personnel identified in the Development
Transition work plan to perform the work contemplated therein. During the
Transition Period, either Party shall have the right to propose modifications to
the Development Transition work plan by providing the other Party with a revised
work plan. The proposed modified work plan shall be subject to the other Party's
written approval. Within fifteen (15) days following the other Party's receipt
of any proposed modified work plan hereunder, that other Party shall either (i)
indicate its acceptance of the terms of such work plan by countersigning such
work plan and returning it to the proposing Party or (ii) communicate to the
proposing Party in writing any good faith objections to the terms of such Work
Plan, in which case the Parties shall discuss in good faith appropriate
revisions
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to the work plan. Upon execution by both Parties, a modified work plan shall be
deemed incorporated into and become a part of this Agreement. Consent to a
proposed modification of a work plan shall not be withheld if that modification
is consistent with the original intent of this Agreement as stated in Section
6.1. Except as set forth in the preceding sentence, nothing contained in this
Section 6.2 shall impose any obligation on either party to agree to any
modification of the initial Development Transition work plan.
6.3 COMPENSATION OF GP. GP shall commit the number(s) of appropriately
qualified FTEs to the performance of GP's responsibilities under the Development
Transition work plan. In return for the obligations of GP pursuant to the ANAIS
Agreement and/or the Development Transition, GP shall be compensated for any and
all work performed by GP after December 31, 1999 at the rate of [***].
6.4 REPORTS. GP shall provide BMX with monthly written reports during the
Transition Period presenting a meaningful summary of GP's progress under the
Development Transition work plan. In addition, on reasonable request by BMX, GP
will make presentations of its activities under the Development Transition work
plan to inform BMX of the details of the work done under this Agreement.
Know-How and other information regarding such activities disclosed by GP to BMX
pursuant hereto may be used only in accordance with the rights granted under
this Agreement. GP will also make available to BMX such information of materials
concerning the ANAIS Products as may be reasonably requested by BMX for use in
seeking FDA and other regulatory approval of the ANAIS Products, or to otherwise
comply with regulatory requirements and such obligation shall survive the
termination of the Development Transition.
6.5 DEVELOPMENT TRANSITION PERIOD. The Development Transition shall be
deemed to have commenced as of January 1, 2000 and shall be completed by
December 30, 2000 (the "Transition Period") . If Gen-Probe has failed, solely
due to its own fault, to accomplish any action required by the initial work
plans referred to above, the Transition Period shall be extended until such
action has been accomplished by Gen-Probe. After the Transition Period, all
development work for the ANAIS Products shall be the sole responsibility of
BMX. After the termination of the Transition Period and until December 31, 2001,
BMX may request that GP perform additional work in connection with the
development of the ANAIS Products, which work shall be limited in scope to
specific "troubleshooting"-type assignments. GP will promptly thereafter inform
BMX whether it has resources reasonably available for the proposed work and, if
so, GP will provide a quote for the charges which would be incurred by BMX
(which shall not be limited to the FTE charges otherwise set forth in this
Article.)
6.6 SUPPLY OF KEY BIOCHEMISTRY COMPONENTS FOR DEVELOPMENT WORK. Pursuant
to the provisions of Article 8, GP shall supply to BMX Key Biochemistry
Components which are not product-specific (e.g., "generic") and which GP has
developed prior to December 30, 2000, in order to facilitate BMX's development
of the ANAIS Products.
6.7 MILESTONE PAYMENT UPON COMPLETION OF DEVELOPMENT TRANSITION PERIOD.
Upon the completion of the Development Transition in accordance with the
operative mutually-agree work plan, BMX shall make a milestone payment to GP.
GP agrees to
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accept, as and for this milestone payment, a payment equal in amount to the sum
paid to GP by BMX under the ANAIS Agreement and characterized thereunder as
prepaid royalties. Therefore, upon the completion of the Development Transition
in accordance with the operative mutually-agree work plan, all of BMX's right
and interest in the prepaid royalties shall be waived, and BMX's prior payment
to GP shall not be credited against any royalty payment due from BMX to GP on
any ANAIS Product pursuant to this Agreement.
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7. INTELLECTUAL PROPERTY
7.1 ANAIS AGREEMENT. The classification of any invention conceived prior
to the Effective Date, and ownership thereof, shall be determined in accordance
with the categories and other terms and provisions of the ANAIS Agreement. To
the extent that any invention (including a Joint Collaboration Technology
invention)is subject to the terms of the ANAIS Agreement and categorized
thereunder, such invention shall become, as of the Effective Date, subject to
the provisions of this Agreement. If any invention is ever categorized by the
Parties as Joint Collaboration Technology under the ANAIS Agreement, that
categorization shall always apply thereafter for purposes of the Parties' access
to and use of and such technology under this Agreement, notwithstanding any
subsequent change to such categorization for other purposes.
7.2 OWNERSHIP OF INVENTIONS. Ownership of any inventions (whether or not
patentable) that are first conceived after the Effective Date, including,
without limitation, any improvements to BMX Technology or GP Technology, shall
be determined in accordance with United States laws of inventorship (including,
where applicable, laws concerning contractual modification of the standard rules
of inventorship).
7.3 DERIVATIVE INVENTIONS. The parties acknowledge and agree that,
notwithstanding that only limited rights have been granted hereunder, certain
new technology may be discovered, invented or created solely by BMX through
BMX's use of the GP Technology within the uses and in the manner contemplated by
this Agreement. The Parties also acknowledge and agree that, notwithstanding
that only limited rights have been granted hereunder, certain new technology may
be discovered, invented or created solely by GP through GP's use of the BMX
Technology within the uses and in the manner contemplated by this Agreement. Any
discovery or invention that is made by one Party as a result of access to the
other Party's Confidential Information, or through the use of, the other Party's
Technology as licensed under the ANAIS Agreement or this Agreement and which is
closely and fundamentally related to such other Party's Technology, shall be
referred to herein as a "Derivative Invention". A Party which makes a Derivative
Invention shall be referred to for purposes of this Section 7.3 as an "Inventing
Party."
A. When an Inventing Party recognizes that it has made a Derivative
Invention subject to this Section 7.3, it shall promptly disclose that
fact to the other Party.
B. Any Derivative Invention shall be considered to be within the
Technology of the Inventing Party and to be included within the license
grants of the Inventing Party to the other Party under this Agreement.
C. The Inventing Party may use such Derivative Invention, together
with the other Party's Technology licensed hereunder, for those uses and
purposes which do not require any further license of the Technology of the
other Party other than that granted herein (it being the agreement of the
Parties that there are no implied license rights created by this
Agreement).
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D. Each Inventing Party agrees not to assert its rights in a
Derivative Invention in such a manner as would block or diminish the other
Party's rights to practice, independently of the Derivative Invention
itself, the technology of such other Party directly related to the
technology with which the Derivative Invention was made.
E. Upon request, the Inventing Party shall grant a nonexclusive
license to the other Party to enable such other Party to make, use, sell,
offer for sale, and import products which use or include the Derivative
Invention. If a Derivative Invention is not separately patentable, or if
the Derivative Invention does not have any substantial commercial use
other than uses which would infringe the Technology of the other Party
which is the subject of this Agreement, then the nonexclusive license to
be granted hereunder shall be royalty-free. If a Derivative Invention is
patentable and has a substantial commercial use which would not infringe
the Technology of the other Party, then the nonexclusive license to be
granted hereunder shall include commercially reasonable terms to be
negotiated. The "commercially reasonable terms" referred to above shall
give full recognition, in favor of the other Party, to the value of the
Technology of such other Party with which the Derivative Invention was
made. The commercially reasonable terms" shall also give full recognition,
in favor of the Inventing Party, to the value of the inventive application
of such Technology. Nothing contained herein shall require the Inventing
Party to license to the other Party any technology other than the
Derivative Invention itself.
7.4 OWNERSHIP OF BMX TECHNOLOGY. Subject to the grant of intellectual
property rights to GP under the licenses granted under Article 3, BMX shall own
all rights to the BMX Technology. The filing, prosecution and maintenance of
patent rights and other proprietary rights directed at the protection of all
rights to the BMX Technology shall be the responsibility of, and at the
discretion of, BMX.
7.5 OWNERSHIP OF GP TECHNOLOGY. Subject to the grant of intellectual
property rights to BMX under the licenses granted under Article 3, GP shall own
all rights to the GP Technology. The filing, prosecution and maintenance of
patent rights and other proprietary rights directed at the protection of all
rights to the GP Technology shall be the responsibility of, and at the
discretion of, GP.
7.6 NO RESTRICTION ON USE OF TECHNOLOGY. Subject to the licenses granted
under Article 3, neither BMX nor GP shall be restricted from using, or
authorizing the use of, its own technology (including technology which
constituted such Party's Core-Related Collaboration Technology or Collaboration
Technology, or constituted Joint Collaboration Technology, under the ANAIS
Agreement) whether in the Field or outside the Field (or any portion thereof),
except as expressly set forth below in this section. Without limiting the
foregoing or any other provision of this Agreement, each Party hereby agrees
that this Section supersedes Sections 4.9, 4.10 and 4.11(d) of the ANAIS
Agreement in their entirety.
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A. LIMITATION ON USE OF TECHNOLOGY BY GP -- ANAIS INSTRUMENTATION.
As to any technology which (i) existed prior to the Effective Date hereof
and which, under the ANAIS Agreement, constituted GP Core-Related
Collaboration Technology, GP Collaboration Technology, or Joint
Collaboration Technology, or (ii) constitutes an Improvement made by GP
(separately or jointly with employees or consultants of BMX) in the course
of performing work funded by BMX during the Transition Period, during the
Royalty Term GP shall not use, or license the use by a Third Party of,
such technology in the ANAIS Field with any probe assay instrumentation
system which comprises a fully-automated laboratory instrument for
performing nucleic acid hybridization assays utilizing arrays of
oligonucleotide probes having a density of equal to or greater than [***],
said probes having been immobilized on a solid support, with each probe
having a predefined position in the array. This restriction shall
terminate upon the earlier of:
(i) BMX's commencement of regulatory trials, application
for regulatory approval, or BMX's commercial
introduction, of any probe assay instrumentation
system, other than [***], which has performance
characteristics substantially [***];
(ii) December 31, 2005, unless BMX has by that date
accomplished the commercial introduction in at least
one of the following countries: [***]; provided,
however, that the expiration date shall be extended,
once only, for an additional two years, if BMX
demonstrates that it has consistently exercised
reasonable diligence in connection with the development
and commercial introduction of such ANAIS
Instrumentation described on Exhibit C;
(iii) The date, if any, as of which GP declares in writing
that BMX's licenses hereunder shall be fully paid up
and thereafter royalty-free (e.g., GP may, in its sole
discretion, expedite the expiration of the Royalty Term
and the expiration of the limitation set forth in the
main paragraph of this Section 7.6(a)).
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7.7 PATENT PROSECUTION OF INVENTIONS.
A. SOLELY-OWNED INVENTIONS. Subject to the terms of the Invention
Classification Agreement executed by the Parties concurrently with this
Agreement, BMX shall be responsible for the filing, prosecution and
maintenance of all patents and patent applications claiming BMX Technology
and all patent applications and patents covering any BMX Derivative
Inventions at BMX's sole expense. Subject to the terms of the Invention
Classification Agreement executed by the Parties concurrently with this
Agreement, GP shall be responsible for the filing, prosecution and
maintenance of all patent applications and patents claiming GP Technology
and all patent applications and patents covering any GP Derivative
Inventions at GP's sole expense. The inventing Party shall keep the other
Party informed of progress with regard to the filing, prosecution,
maintenance, enforcement and defense of patents applications and patents
claiming any Derivative Invention. No Party shall include any Confidential
Information of the other Party in any patent application without the
express written consent of the other Party.
B. JOINT INVENTIONS. Subject to the terms of the Invention
Classification Agreement executed by the Parties concurrently with this
Agreement, the Parties shall negotiate reasonably and in good faith with
respect to preparing, filing and prosecuting any patent applications or
other appropriate filings with respect any invention that is owned jointly
by the Parties and maintaining any patents, copyrights or other similar
rights issued thereon, using patent counsel reasonably acceptable to the
other Party. The Parties may select one Party to be responsible for such
activities with respect to any specific invention and may allocate between
them the out-of-pocket expenses for patent preparation, filing,
prosecution and maintenance. If the responsible Party with respect to any
joint invention decides to abandon or not to pursue prosecution of any
patent right which claims such joint invention, it shall give prior notice
to other Party and permit the other Party, at its option and expense, to
undertake such obligations. Each Party shall fully cooperate with the
other Party in connection with any joint invention.
7.8 INFRINGEMENT BY THIRD PARTIES.
A. Each Party shall notify the other of any suit which such Party
proposes to commence with respect to any jointly-owned patent. The Party
proposing to commence suit shall give the other Party reasonable advance
notice of its intention to commence such suit, the reasons for commencing
such suit and the evidence supporting its claims, and a reasonable
opportunity to make comments and suggestions regarding the advisability of
commencing such suit and the litigation strategies therefor. Subject to
confidentiality requirements as may be reasonably necessary to maintain
privilege or fulfill obligations imposed by Third Party agreements or
court order, the Party bringing the suit shall keep the other Party
promptly informed, and shall consult with the other Party on a periodic
basis and provide the other Party with copies of all court filings made in
such suit, including all pleadings and other assertions therein. The Party
bringing suit shall select counsel reasonably acceptable to the other
Party. Except as otherwise provided in this Agreement, the Party bringing
suit shall pay all expenses of the suit, including
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without limitation attorneys' fees and court costs, and shall be entitled
to all damages, royalties, awards, judgments, settlement amounts, costs or
other payments recovered in such suit.
B. In the event a Party brings a suit relating to jointly-owned
patents, the other Party, at its sole discretion, may elect within sixty
(60) days after the commencement of such suit, to contribute a fixed
percentage of up to fifty (50%) of the costs incurred by the suing Party
in connection with such suit. In the event of any such election, all
damages, royalties, awards, judgments, settlement amounts, costs or other
payments recovered in such suit shall be shared by the Parties on a pro
rata basis in accordance with their respective cost contributions.
C. In the event a Party brings a suit relating to jointly-owned
patents and the other Party does not voluntarily elect to participate in
such suit pursuant to subparagraph (b) above or otherwise, such other
Party shall, upon request, reasonably cooperate with the Party bringing
suit by providing any documents or information relevant to the suit. The
Party bringing suit shall ensure that the confidential information of the
other Party provided pursuant to this section shall be adequately
protected and, upon request, shall reasonably compensate the other Party
for its efforts in cooperating in the manner described herein.
7.9 INFRINGEMENT OF THIRD PARTY RIGHTS.
A. In the event that any Third Party makes a written claim or
demand, or brings an action, suit or proceeding, against either Party (or
any of its Affiliates), alleging infringement, unauthorized use or
misappropriation of such Third Party's Technology or Confidential
Information, arising out of, in connection with or relating to any ANAIS
Products or any of the activities of the Parties directly related to this
Agreement, such Party shall promptly notify the other Party in writing,
and provide copies of all materials or papers received by or served on
such Party from or by such Third Party. Each Party agrees to make
available to the other Party, without charge, its advice and assessment
with respect to the technical merits of any matter which is the subject of
any such claim, demand, action, suit or proceeding.
B. It is the intention of the Parties that the Party against whom
such action is brought shall assume the defense of such action; provided,
however, that such Party shall keep the other Party reasonably informed of
developments in such action. Notwithstanding the foregoing, if both
Parties are named as defendants in such action, the Parties shall jointly
assume the defense of such action. To the extent that GP incurs any costs
or suffers any damages or awards in connection with any such action, BMX
shall be obligated to contribute thereto to the extent provided in Section
7.10 below.
C. Notwithstanding anything to the contrary in the foregoing, if any
such action involves claims which in any way challenge or call into
question the Technology of either Party, such Party shall have the right
to review and approve
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all assertions regarding the construction, scope or validity of Patent
claims included in the relevant Technology and in doing so shall act
reasonably and in good faith in defense of such Technology. All such
assertions shall be submitted to such Party for its review and approval
before being presented by the other Party in any such action by way of
pleading, oral argument or otherwise.
7.10 BMX CONTRIBUTION OBLIGATIONS.
A. Subject to the amount limitations set forth in Section 7.10(b)
below, BMX shall contribute to and reimburse GP, upon GP's request, for
[***] of all costs and expenses, (such costs and expenses to include,
without limitation, reasonable attorneys' fees and any reasonable lump sum
cash amount paid by GP upon settlement of litigation prior to and in lieu
of any verdict or award of damages (but not any verdict or award of
damages nor any payment upon any compromise of any verdict or award nor
any payments in kind or assumption of obligations upon settlement),
incurred by GP in (i) defending against any pending or future claims,
suits, actions, proceedings or arbitrations which in any way challenge or
call into question the validity of any patent within the GP Core
Technology (as defined in the ANAIS Agreement), (ii) enforcing rights in
an action commenced under Section 7.8 or (iii) defending against claims
under Section 7.9; provided, however, that BMX shall have the right to
elect not to pay its share of the aforesaid costs and expenses for any
Technology which is not then being used by BMX in the ANAIS
Instrumentation or any ANAIS Product and which is not considered by BMX to
be of material importance to BMX. If BMX makes the election set forth in
the preceding sentence, it shall forthwith lose all license rights granted
to it hereunder with respect to such Technology. The Parties agree that
BMX's obligations under this paragraph (a) shall remain in force during
all periods in which any GP Core Technology (as defined in the ANAIS
Agreement) is being exploited by BMX or its Affiliates under the licenses
granted hereby. The obligation of BMX to reimburse GP for its expenses
hereunder shall be separate and distinct from, and cumulative to, any
obligation of BMX under any other Agreement (including the VIDAS Agreement
and any amendment thereto). Notwithstanding any other provision of this
Section 7.10A, the obligation of BMX under the VIDAS Agreement, the ANAIS
agreement, and any amendments thereto, combined, in connection claims
asserted against GP by Enzo Biochem, Inc. in the lawsuit entitled Enzo
Biochem, Inc. v. Gen-Probe Incorporated, case no. 99 Civ. 4548 (AKH),
United States District Court for the Southern District of New York, shall
be [***] of all costs and expenses incurred by GP before or after the
Effective Date. For the avoidance of doubt, Sections 7.10B through E shall
apply to the reimbursement obligation for the Enzo litigation.
B. The maximum combined aggregate amount of any contribution and
reimbursement paid by BMX to GP in any one Calendar Year under this
Section 7.10, the ANAIS Agreement, the VIDAS Agreement, and any amendment
to the VIDAS Agreement, combined, shall not exceed [***] and the total
maximum combined aggregate amount of all such reimbursements by BMX to GP
under this Section 7.10 shall not exceed [***] (which maximum amount shall
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include all contributions previously made by BMX to GP under the VIDAS
Agreement and ANAIS Agreement); provided, however, that GP shall have used
under the ANAIS Agreement and shall use under this Agreement reasonable
efforts to obtain similar reimbursement and contribution commitments in
any other agreements licensing GP Technology and, to the extent that GP
has been or is able in the future to obtain similar burden sharing from
any other Party, then BMX's share and respective maximum will be reduced
in proportion to the share and the respective maximum of the burden
assumed by such other Party or Parties, in such manner that any such
contributions actually required to be made by any such licensees of GP in
any Calendar Year shall reduce BMX's obligation under this Section 7.10
with respect to such Calendar Year on a dollar for dollar basis for such
Calendar Year and shall reduce the total maximum aggregate amount of BMX's
financial commitment under this Section 7.10 on a dollar for dollar basis
during the Term of this Agreement. Any costs and expenses incurred by GP
which are not subject to reimbursement by BMX in a particular year due to
BMX having previously paid the annual limit of [***] for that year may
be carried over into the following year by GP and reimbursement may be
sought by GP in the following year (subject to the continuing annual and
cumulative maximum limits); provided, however, that in no event shall any
expense be carried over into any calendar year which begins more than one
year after the termination of the litigation which gave rise to the
expense.
C. In the event any damages, awards or other amounts are received by
or awarded to GP in connection with any action or proceeding in which BMX
has contributed to GP's costs under this Section 7.10, BMX shall be
entitled to receive a proportionate share thereof based upon the
percentage of costs reimbursed by it in connection with such action.
D. Within sixty (60) days after the end of each Calendar Quarter, GP
shall submit to BMX a statement of the contribution and reimbursement
amount payable by BMX to GP under this Section 7.10 for such Calendar
Quarter, with appropriate supporting documentation. Subject to reasonable
requests for backup detail, BMX shall pay the contribution and
reimbursement amount to GP within thirty (30) days after receiving such
statement from BMX. Interest shall accrue and be payable on all amounts
which are not timely paid at the prime rate referred to in Section 5.3
above.
E. With respect to any litigation subject to BMX's contribution
obligation, BMX shall have the same rights to be informed by and consult
with GP and to receive copies of all court filings as was provided in the
ANAIS Agreement and BMX's contribution obligation hereunder shall be
conditional on GP's fulfillment on a timely and ongoing basis of such
future obligations hereunder.
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8. MANUFACTURING AND SUPPLY OBLIGATIONS
GP shall supply to BMX the Key Biochemistry Components ("KBCs") to be
incorporated into ANAIS Products on the terms set forth below. Nothing contained
in this Article 8 shall be deemed to constitute a requirements contract.
8.1 KEY BIOCHEMISTRY COMPONENTS.
A. During the period from the Effective Date to January 1, 2003, or
for any extended period pursuant to section 8.2(c), those KBCs to be
incorporated into ANAIS Products which GP has developed prior to the
Effective Date shall be manufactured by GP in accordance with terms of
this Agreement, except as otherwise provided herein or agreed by the
Parties. All Key Biochemistry Components manufactured by GP hereunder
shall be transferred and sold to BMX in accordance with the standard GP
purchase order form attached as Exhibit G hereto, subject to the
warranties, exclusions and limitations set forth therein. GP's right and
obligation to manufacture shall be limited to those non-product specific
(e.g., "generic") KBCs which GP has developed prior to December 30, 2000
and which are to be incorporated into, or used for development of, ANAIS
Products.
B. All KBCs manufactured hereunder, other than those referred to in
subparagraph (c) below, shall be sold to BMX at [***] of GP's
Fully-Absorbed Manufacturing Cost, plus (i) an incremental amount (the
"Margin") equal to [***] of GP's Fully Absorbed Manufacturing Cost and
(ii) shipping, handling and related costs associated with the delivery of
KBCs to BMX; provided, however, that in no case shall the Margin with
respect to all KBC's in a product exceed a ceiling amount of [***] of the
Net Sales price per unit of the ANAIS Product into which such KBCs are to
be incorporated except that in no case shall the Margin be less than a
floor amount of [***] of such Manufacturing Cost. Repayment of any excess
payment to GP shall be offset from any royalty payments (with appropriate
disclosure in the quarterly reports described in Section 5.1) or otherwise
reimbursed to BMX in such manner as the Parties may agree.
C. All Key Biochemistry Components manufactured hereunder which BMX
specifically designates as for product development purposes (and which are
in fact used for development purposes) shall be sold to BMX at [***] of
GP's Fully-Absorbed Manufacturing Cost, plus (i) shipping, handling and
related costs associated with the delivery of Key Biochemistry Components
to BMX and (ii) an incremental amount (the "Margin") equal to [***] of
GP's Fully Absorbed Manufacturing Cost, except that such Manufacturing
Costs shall not include costs which BMX has funded by paying GP's FTE cost
pursuant to an approved work plan adopted in accordance with Article 6.
Upon request by GP, BMX shall provide reasonable evidence that KBCs
designated for product development purposes were used for such purposes.
D. Attached hereto as Exhibit J are GP's estimates as of the
Effective Date of GP's Fully-Absorbed Manufacturing Cost for the KBCs
relevant to the ANAIS Products. GP shall use its best efforts to provide
BMX with updated
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estimates of such Fully-Absorbed Manufacturing Cost on at least an annual
basis. To the extent that GP incorporates efficiencies into the
manufacturing of KBCs to be sold to BMX hereunder, GP agrees to pass on
any concomitant cost savings to BMX.
E. GP shall keep, and shall cause its Affiliates to keep, for a
period of not less than three (3) years after each Calendar Year,
complete, true and accurate books of account and other records containing
all information and data which may be necessary to ascertain and verify
GP's Fully-Absorbed Manufacturing Cost of KBCs during such Calendar Year
or any part thereof. During the Term of this Agreement and for a period of
three (3) years thereafter, BMX shall have the right from time to time
(not to exceed twice during each Calendar Year) to inspect, in confidence,
and all audit all such book and records of GP. GP shall refund to BMX any
overpayment for KBCs within thirty (30) days after the discovery of such
overpayment.
F. Not less than three (3) months prior to the First Commercial Sale
of any ANAIS Product and, thereafter, not less than three (3) months prior
to the commencement of each Calendar Year during which BMX reasonably
anticipates that GP will manufacture KBCs pursuant to this Agreement, BMX
shall provide GP with a reasonable forecast of its projected requirements
for Key Biochemistry Components during the next Calendar Year, broken down
by Calendar Quarter. BMX shall update such annual forecast, for a rolling
twelve month period, as frequently as practicable but in any event not
less frequently than quarterly. BMX shall submit written purchase orders
to GP for Key Biochemistry Components at least sixty (60) days prior to
the requested delivery date therefor, which shall be for not less than
[***] of the most recent quarterly forecast. GP shall promptly confirm
receipt of such purchase orders from BMX. If BMX submits orders during any
Calendar Quarter which exceed BMX's most recent quarterly forecast for
such quarter by more than [***], GP shall have the right to defer delivery
of any such excess orders until the next Calendar Quarter. Subject to the
foregoing and the remaining provisions of this Article 8, GP will produce
and ship to BMX, and BMX shall purchase, all of such confirmed purchase
order amounts.
G. GP shall invoice BMX for KBCs delivered under this section upon
shipment of each order. Payment shall be made by BMX within thirty (30)
days of its receipt of each invoice.
H. The Parties shall consult regularly as to the manner of
performance hereunder and to assure reliability and continuity of KBCs. If
at any time either Party is reasonably of the view that GP may not be able
to meet future purchase orders from BMX, such Party shall notify the other
Party in writing and the Parties shall in good faith cooperate and
endeavor to make appropriate arrangements for a continuous and adequate
supply of KBCs to BMX. In the event that GP becomes aware of any
occurrences or developments that could reasonably be anticipated to create
problems or impediments to supply KBCs to BMX, or to interrupt supply of
such KBCs, GP shall give BMX reasonable advance notice thereof and the
Parties shall consult as to the resolution of the matter.
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I. In the event that GP fails to supply BMX, for any reason other
than an event of Force Majeure, with at least [***] of any KBC on the
delivery date set forth in a valid purchase order pursuant to subsection
(f) above for any three months in any nine-month period, or, after
receipt of a valid purchase order GP fails to supply at least [***] of
BMX's purchase order for any KBC within thirty days after the requested
delivery date for such KBC, then BMX shall have the right, after
consultation with Gen-Probe and at BMX's option, to either: (i) procure
any such KBC from alternative sources or (ii) manufacture, or have
manufactured, BMX's requirements for such KBC to be incorporated into
the ANAIS Products. In the event BMX so elects to manufacture, GP shall
use its best efforts to provide BMX with assistance necessary to enable
BMX to manufacture such KBC. Such assistance shall include, but not be
limited to delivering to BMX any necessary records, procedures, work
instructions, formulations, raw materials and personnel support to allow
BMX to manufacture such KBC to be incorporated into the ANAIS Products.
BMX's rights under this paragraph with respect to any failure by GP to
supply BMX shall be BMX's sole and exclusive remedy.
J. GP shall promptly notify BMX in the event it is considering
implementing any material changes to the KBC's or to their manufacturing
processes and shall not undertake any such changes without BMX's prior
written approval, which shall not be unreasonably withheld. GP shall
provide BMX with any records and information that may be necessary in
order for BMX to review any proposed change. In the event BMX reasonably
withholds consent to any change proposed by GP, then GP shall continue to
supply BMX with the KBC in question as originally specified, unless such
supply is impossible or impracticable due to the unavailability of key raw
materials or regulatory restrictions, in which case the Parties agree to
make a good faith effort to implement a mutually satisfactory alternative
(e.g. purchase of large stock of raw material or finished KBC). In the
event GP implements a change to a KBC or its manufacturing processes with
the approval of BMX, which change requires a regulatory submission, GP
shall at the request of BMX continue to supply BMX with such original KBC
until such time as BMX receives approval of the regulatory agency for such
changed material.
K. Notwithstanding the foregoing, in the event BMX, due to a lot
loss or other unforeseeable event, determines that it is suffering a
shortage, or will suffer a shortage, of any KBC(s), BMX shall provide GP
with written notice of such shortage together with a firm order for the
amount of such KBC as BMX needs to eliminate the shortage. GP shall upon
such notice use commercially reasonable efforts to fill all of BMX's order
for such KBC on an expedited basis (regardless of the forecasted amount
for such KBC).
8.2 TRANSITION OF MANUFACTURING CAPABILITY. GP and BMX agree that
responsibility for manufacturing KBCs shall be transferred to BMX as follows:
A. Following the Effective Date, the Parties shall develop and agree
upon a work plan which will provide for completion of the transfer of KBC
manufacturing know-how from GP to BMX in order to allow the orderly
transfer of manufacturing responsibility for all KBC's to BMX on or before
January 1, 2003, giving due
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consideration to the need for any required regulatory approval(s),
including all procedures, work instructions, formulations, and necessary
and unique materials necessary for such manufacturing. The work plan shall
provide for access to any needed suppliers of KBC's or sub-components and
shall seek to obtain for BMX similar terms to existing GP terms for such
materials from such suppliers. The work plan shall also provide for
transfer of specifications and QC procedures as conveyed to suppliers or
used internally at GP for final and in-process QC of KBC's or
sub-components. The work plan shall also provide for the transfer of
work-in- progress and raw materials and shall provide adequate time to
allow the performance of any preparatory work, including procurement of
plant and equipment, calibrations, validation studies and the running of
test lots, that may be necessary before the actual manufacture of KBCs is
performed by BMX. The work plan shall provide reasonable compensation to
GP for the FTE's required for the transfer of manufacturing and for any
raw materials and work-in-progress transferred.
B. In the event BMX provides written notice to GP prior to January
1, 2003, that it is capable of manufacturing a particular KBC, GP shall be
permitted, but shall not be required, to provide written notice to BMX
that it will no longer manufacture and supply such KBC under this
Agreement. Notwithstanding the foregoing, BMX shall be permitted to
manufacture validation lots of KBCs and limited production lots (which
shall not exceed [***] of BMX's forecasted need for the subsequent
quarter) for purposes of ensuring BMX's ability to manufacture its
requirements of KBCs at the end of the Transition Period.
C. GP and BMX shall each have the option, upon six months notice
given after January 1, 2003, to elect and require that manufacturing of
KBC's shall be transferred from GP to BMX after July 1, 2003. The six
month period for transition shall be extended to the extent necessary for
any required regulatory approval(s) which may be delayed, without fault of
BMX, beyond such six-month period.
D. The parties shall reasonably cooperate in carrying out the work
plan adopted pursuant to subparagraph (a). Upon the election of either
Party to transfer manufacturing pursuant to this section, the Parties
shall reasonably update the work plan and cooperate in completing the
transfer of manufacturing know-how unique to the ANAIS Products and the
transfer of raw materials and work-in-progress pursuant to the updated
work plan.
E. EXCEPTIONS. Notwithstanding the provisions of any other Section
of this Agreement, unless G-P fails to supply BMX (within the meaning of
Section 8.1(i)) with any item listed below G-P shall at all times have the
exclusive right and obligation to make, or have made by a Third Party, the
following items: [***]. Notwithstanding any other provision of this
Agreement, BMX shall at all times have the right to purchase such items
from GP in reasonable commercial quantities to be used by BMX for the
purposes of this Agreement.
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(i) Notwithstanding any other provision of this Agreement,
G-P shall have no obligation to make any disclosure to
BMX concerning the manufacture of the above-listed
items unless GP fails to supply BMX with such item, as
set forth in Section 8.1 (i).
(ii) Notwithstanding any other provision of this Agreement,
BMX shall at all times have the right to purchase any
or all of the above-listed items from a Third Party or
to manufacture such items itself; provided, however,
that nothing contained herein shall require GP to make
any disclosure of Confidential Information to BMX or
to such Third Party in connection with BMX's purchase
of such items from the Third Party. Notwithstanding
any other provision of this Agreement, BMX shall at
all times have the right to purchase, in reasonable
commercial quantities to be used by BMX for the
purposes of this Agreement, any or all of the above
items directly from any entity which supplies such
items to GP in the same form as purchased by GP;
provided, however, that nothing contained herein shall
require GP to make any disclosure of Confidential
Information to BMX, or require GP to permit such
disclosure to BMX by such Third Party, in connection
with BMX's purchase of such items from the Third
Party.
(iii) Immediately following execution of this Agreement, GP
shall use its best efforts to arrange for a Third
Party supplier to [***] to be used by BMX in
accordance with the rights granted by this Agreement.
Upon completion of arrangements with a Third Party
supplier, any requests by BMX for [***] to be used in
accordance with the rights granted by this Agreement
shall be made to GP and GP shall direct such requests
to the Third Party supplier. BMX shall have the right
to disclose any Confidential Information concerning
such [***] only to the Third Party supplier and to
decline to disclose such Confidential Information to
GP.
(iv) If GP makes improvements to any of the above-listed
items, it shall make such improvements reasonably
available to BMX pursuant to this Agreement.
(v) GP shall at all times after July 1, 2002 have the
right on written notice to BMX to require BMX to
assume responsibility for manufacturing any or all of
the items listed above. Promptly after GP delivers any
such notice, the Parties shall meet to agree,
reasonably and in good faith, upon a plan for
transition
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of manufacuring from GP to BMX. As part of any such
transition, GP shall make any and all disclosures
necessary to permit BMX to make or have made such
items.
(vi) BMX shall not have any right to analyze, dissect, or
disassemble any such item which is not properly
available from sources other than GP in order to
circumvent the need to acquire such item from GP or
GP's supplier.
8.3 BMX MANUFACTURING RESPONSIBILITIES.
A. Unless otherwise agreed by BMX and except as otherwise expressly
set forth herein, BMX shall be solely responsible for the manufacture,
assembly marketing, sale, and delivery of ANAIS Products and ANAIS
Instrumentation.
B. BMX shall not grant or extend to customers any specific product
warranties regarding Key Biochemistry Components manufactured by GP
without GP's prior written consent.
8.4 MANUFACTURING ACTIVITIES.
A. The Parties shall reasonably consult on all matters relating to
the manufacture of the Key Biochemistry Components and Sample Collection
Kits.
B. Manufacturing activities shall be conducted in compliance with
all applicable legal and regulatory requirements in each relevant
jurisdiction, including, without limitation, the requirements of the
United States Food and Drug Administration (the "FDA"). GP shall perform
all of its manufacturing obligations under this Agreement in accordance
with all FDA requirements including the Quality Systems Regulations as set
forth in 21 C.F.R. 820, "good laboratory practices," and "good clinical
practices" to the extent applicable, and GP's own standard operating and
quality control standards and applicable industry-wide standards for
proper laboratory procedures and practices.
C. GP will allow BMX to audit GP's records and facilities used in
the manufacture of KBCs and Sample Collection Kits at least once a year or
more frequently if necessary. GP agrees to respond to any comments or
observations of potential non-compliance arising from these audits with
proposed corrective actions that are acceptable to both Parties and to
implement these actions in a reasonable time. BMX shall reasonably
compensate GP for employee time and any expenses incurred in connection
with such audits, as well as for the cost of any action requested by BMX
as a result of such audits. All information obtained in the course of any
such audit by BMX shall be considered Confidential Information hereunder,
but may be disclosed by BMX to regulatory agencies when and as necessary.
D. In connection with GP's manufacture of KBCs and Sample Collection
Kits, GP will provide reasonable assistance, information and documentation
to BMX
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in the investigation of complaints, MDR reportable events, recalls and
other quality issues and will be reasonably available in responding to
questions posed by the FDA or other authorities (the topics of such
questions may include submissions, recalls and inquiries following
inspections).
E. GP will manufacture, store, package and ship KBCs in conformance
with applicable specifications in order to ensure the suitability, quality
and stability of the materials. GP will maintain necessary systems and
associated records to ascertain conformance to these specified
requirements including environmental, monitoring and calibration systems.
GP shall reasonably cooperate in resolving any KBC quality problems
identified by BMX upon receipt of shipment of KBCs from GP (including
replacement of such KBCs as the Parties agree fail to meet applicable BMX
quality standards). Following delivery of KBCs from GP, BMX will store
KBCs in conformance with applicable specifications in order to ensure the
suitability, quality and stability of the materials. BMX will maintain
adequate records to ascertain conformance to these specified requirements
including environmental, monitoring and calibration systems.
8.5 PRODUCT LIABILITY.
A. GP shall be responsible for, and shall assume the defense of and
indemnify and hold harmless BMX and its Affiliates from and against, all
Product Liability Claims (as defined below) arising out of or related to
any Key Biochemistry Components supplied by GP hereunder which are
incorporated into ANAIS Products and sold or distributed by BMX or its
Affiliates hereunder. BMX shall be responsible for, and shall assume the
defense of and indemnify and hold harmless GP and its Affiliates from and
against, all Product Liability Claims arising out of or related to any and
all ANAIS Products and ANAIS Instrumentation which are manufactured, sold
and distributed by BMX hereunder, except to the extent that such Product
Liability Claim relates to or arises out of any Key Biochemistry
Components incorporated into such ANAIS Product or for which GP shall have
responsibility under this Section 8.6(a), unless the condition or
performance of such Key Biochemistry Component has been adversely affected
by any act or omission on the part of BMX.
B. For purposes of this Agreement, the term "Product Liability
Claims" shall mean any and all claims asserted against either Party or its
Affiliates, or their respective directors, officers and agents, arising
out of or relating to any ANAIS Products, ANAIS Instrumentation and Key
Biochemistry Components manufactured sold or distributed by the Parties
hereunder, including, but not limited to, claims based on strict liability
in tort, negligence or breach of express or implied warranty and claims
for exemplary and consequential damages, in cases in which it is alleged
that personal injury, death or property damage was caused by a defect in
design, material or manufacture.
C. If either Party receives information indicating that a Product
Liability Claim exists or has been asserted, such Party shall immediately
notify the other Party in writing of such claim; provided, however, that
no such notice need be given
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if, in the reasonable opinion of counsel to such Party, the giving of such
notice would result in the loss of the ability of such Party to claim any
applicable legal privileges.
D. The Parties shall reasonably cooperate with each other, and shall
cause their Affiliates to reasonably cooperate with each other, in the
investigation and defense of any Product Liability Claim. Subject to any
applicable legal privileges, each Party shall provide, when reasonably
requested by the Party which is obligated to defend a Product Liability
Claim hereunder, to provide records, information and employees of such
Party to assist the indemnifying Party or its Affiliates in the
investigation and defense of such claim or suit; provided, however, that
such indemnifying Party and its Affiliates shall reimburse the other Party
for the reasonable out-of-pocket costs incurred in providing such
assistance.
8.6 INDEMNIFICATION FOR PRODUCT WARRANTIES. BMX shall assume the defense
of, and shall indemnify and hold harmless GP and its Affiliates from and
against, any and all claims that may be asserted against GP or its Affiliates in
connection with any express product warranties concerning the ANAIS Products and
ANAIS Instrumentation which are extended by BMX or its Affiliates in favor of
Third Parties. GP shall assume the defense of, and shall indemnify and hold
harmless BMX and its Affiliates from and against, any and all claims that may be
asserted against BMX or its Affiliates in connection with any express product
warranties concerning the KBCs which are extended by GP or its Affiliates in
favor of Third Parties.
8.7 PATENT INFRINGEMENT CLAIMS. If either Party receives a claim by a
Third Party that any KBC 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 fifteen (15) 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. GP shall promptly suspend
manufacture of any KBC for BMX after receipt of notice of an infringement claim,
unless BMX (i) expressly instructs GP to continue to manufacture such KBC and
(ii) agrees to indemnfy, protect, and hold harmless GP as to the subject matter
of the infringement claim with respect to the continuing manufacture of such
KBC.
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9. MARKETING
9.1 BMX shall have the sole responsibility for marketing and sales of
ANAIS Products and ANAIS Instrumentation throughout the world (including but not
limited to the selection of accounts, advertising, promotion, and distribution
of the ANAIS Products). BMX shall use Commercially Reasonable efforts to market
and sell the ANAIS Products and ANAIS Instrumentation.
9.2 Subject to applicable regulatory requirements, the packaging and
labeling for all ANAIS Products shall not bear GP's name other than in patent
markings, unless BMX has obtained GP's prior written approval to use the same;
provided, however, that to the extent reasonably requested by either Party, such
packaging and labeling shall include appropriate references to any Patents (or
pending Patent applications) to which such products are subject.
9.3 BMX shall have sole discretion in establishing prices to individual
customers based upon prevailing market conditions, competitive factors and other
commercial considerations it reasonably deems relevant. Royalties payable on
ANAIS Products shall not be reduced through sale of ANAIS Products in such a
manner as to serve as a "loss leader" nor through marketing of ANAIS Products,
instrumentation, or other products and services in such a manner as to distort
the relative value of the ANAIS Products in relation to the cost or value of the
instrument or other products and services, when considered in light of the
primary marketing practices within the clinical diagnostic industry (or other
relevant industry, if applicable).
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10. RELEASES
10.1 In consideration of the promises and agreements set forth herein, the
sufficiency and receipt of all such consideration being hereby acknowledged,
upon execution of this Agreement, GP and all of its respective directors,
officers, affiliates, subsidiaries, parent companies, controlling entities,
stockholders, partners, joint ventures, employees, successors, attorneys,
agents, assigns, legal representatives, and other representatives, hereby
release, relieve, and forever discharge BMX, and its directors, officers,
affiliates, subsidiaries, parent companies, controlling entities, stockholders,
partners, joint ventures, employees, successors, attorneys, agents, assigns,
legal representatives, other representatives, and others acting in association
with them (collectively the "BMX Releasees"), in each case whether past,
present, or future, from any and all manner of claims, demands, obligations,
injunctions, actions, causes of action, suits, rights, damages, expenses,
requests for statutory or common law sanctions, or potential requests for
compensation or payment of any nature whatsoever, in law or in equity, by reason
of any matter, act or action, omission, cause, happening or thing whatsoever
that occurred, arose, or began prior to and including the date of this
Agreement, against any of the BMX Releasees, to the extent that any facts
supporting any such claims are known to the GP Releasors as of the date of this
Agreement, including, without limitation, any claims arising out of or related
to the filing or prosecution of any known patent application by BMX on or after
May 2, 1997. This release shall include all known claims under the ANAIS
Agreement, except that nothing contained in this paragraph shall (a) terminate
any ownership claim, interest, or right of GP in any property, (including
patents, inventions, and proprietary information) and/or (b) terminate any claim
by GP to enforce an express contractual obligation of BMX solely for the payment
for money pursuant to the ANAIS Agreement.
10.2 In consideration of the promises and agreements set forth herein, the
sufficiency and receipt of all such consideration being hereby acknowledged,
upon execution of this Agreement, BMX and its respective directors, officers,
affiliates, subsidiaries, parent companies, controlling entities, stockholders,
partners, joint ventures, employees, successors, attorneys, agents, assigns,
legal representatives, and other representatives (collectively the "BMX
Releasors") hereby release, relieve, and forever discharge GP and each of its
respective directors, officers, affiliates, subsidiaries, parent companies,
controlling entities, stockholders, partners, joint ventures, employees,
successors, attorneys, agents, assigns, legal representatives, and other
representatives, in each case whether past, present, or future, from any and all
manner of claims, demands, obligations, injunctions, actions, causes of action,
suits, rights, damages, expenses, requests for statutory or common law
sanctions, or potential requests for compensation or payment of any nature
whatsoever, in law or in equity, by reason of any matter, act or action,
omission, cause, happening or thing whatsoever that occurred, arose, or began
prior to and including the date of this Agreement, against any of the GP
Releasees, and to the extent that any facts supporting any such claims are known
to the BMX Releasors as of the date of this Agreement, including, without
limitation, any claim arising out of the (i) GP's having obtained license rights
for BMX under the Xxxxxxx [***] patents for BMX in connection with the [***] and
(ii) GP's execution of an agreement with Chiron Corp. with respect to blood
screening and clinical
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-37-
diagnostic products. This release shall include all known claims under the ANAIS
Agreement, except that nothing contained in this paragraph shall (a) terminate
any ownership claim, interest, or right of BMX in any property, (including
patents, inventions, and proprietary information) and/or (b) terminate any claim
by BMX to enforce an express contractual obligation of GP solely for the payment
for money pursuant to the ANAIS Agreement.
-38-
11. REPRESENTATIONS AND WARRANTIES
11.1 REPRESENTATIONS AND WARRANTIES OF GP. GP represents to BMX that:
A. POWER AND AUTHORITY. The execution and delivery of this Agreement
and the performance of the transactions contemplated hereby have been duly
authorized by all appropriate corporate action, and GP has all requisite
power and authority to enter into this Agreement and to perform its
obligations hereunder, and this Agreement constitutes a valid and binding
obligation of GP, enforceable against GP in accordance with its terms.
B. NO BREACH. The performance by GP of any of the terms and
conditions of this Agreement on its part to be performed does not and will
not constitute a breach of any other agreement or understanding, whether
written or oral, to which it or any of its Affiliates is a Party.
C. RIGHTS TO INTELLECTUAL PROPERTY. To the best of GP's knowledge,
GP has good and valid title to or has the right to use, and has the right
to license hereunder pursuant to license, sublicense, agreement or
permission, the GP Technology. GP is not aware of any claims for
royalties, and has not contracted for payment of any royalties, with
respect to the GP Technology other than have previously been disclosed in
writing to BMX.
D. CONSENTS AND APPROVALS. No consent, approval, authorization,
license, order or permit of, or declaration, filing or registration with,
any governmental entity, or any other person or entity, is required to be
made or obtained by GP or any Affiliate of GP in connection with the
execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby.
11.2 REPRESENTATIONS AND WARRANTIES OF BMX. BMX represents to GP that:
A. POWER AND AUTHORITY. The execution and delivery of this Agreement
and the performance of the transactions contemplated hereby have been duly
authorized by all appropriate corporate action, and BMX has all requisite
power and authority to enter into this Agreement and to perform its
obligations hereunder, and this Agreement constitutes a valid and binding
obligation of BMX, enforceable against BMX in accordance with its terms.
B. NO BREACH. The performance by BMX of any of the terms and
conditions of this Agreement on its part to be performed does not and will
not constitute a breach of any other agreement or understanding, whether
written or oral, to which it or any of its Affiliates is a Party.
C. RIGHTS TO INTELLECTUAL PROPERTY. To the best of BMX's knowledge,
BMX has good and valid title to or rights in, and has the right to license
hereunder pursuant to license, sublicense, agreement or permission, the
BMX Technology.
-39-
D. CONSENTS AND APPROVALS. No consent, approval, authorization,
license, order or permit of, or declaration, filing or registration with,
any governmental entity, or any other person or entity, is required to be
made or obtained by BMX or any Affiliate of BMX in connection with the
execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby.
11.3 INDEMNIFICATION. Each Party shall indemnify and hold harmless the
other Party and each of its Affiliates, their respective directors, officers,
employees and agents from and against any and all losses, liabilities, damages,
judgments, awards or costs (including, without limitation, reasonable attorneys'
fees and expenses) arising out of or resulting from (i) any breach or other
default by the indemnifying Party of any of the representations, warranties or
undertakings made by such Party in this Article 11, and (ii) any failure by such
indemnifying Party or its Affiliates to perform or discharge any of the
covenants or agreements contained in this Agreement.
11.4 WARRANTY DISCLAIMER; LIMITATIONS. NOTWITHSTANDING ANY OTHER PROVISION
HEREIN TO THE CONTRARY, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF
ANY KIND, EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY AS
TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE
LICENSES GRANTED HEREUNDER OR ANY OF THE PRODUCTS OR TRANSACTIONS CONTEMPLATED
HEREBY. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY LOST PROFITS OR
OTHER SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM THE GRANT OR
EXERCISE OF LICENSES HEREUNDER OR THE TRANSACTIONS CONTEMPLATED HEREBY. NEITHER
BMX NOR GP MAKES ANY REPRESENTATION THAT THE LICENSED PRODUCTS WILL NOT INFRINGE
ANY PATENT OR OTHER PROPRIETARY RIGHT WHICH IS NOT THE SUBJECT OF THE LICENSE
RIGHTS GRANTED HEREUNDER OR OTHERWISE OBTAINED.
-40-
12. CONFIDENTIALITY; PUBLICATION
12.1 CONFIDENTIALITY. Each Party hereto shall maintain the Confidential
Information of the other Party in confidence, and shall not disclose, divulge or
otherwise communicate such Confidential Information to any Third Party, or use
it for any purpose, except that such Party shall have the right to disclose
Confidential Information to its Affiliates and to its employees who have a need
to know such information in order to fulfill the objectives of this Agreement.
Each Party hereby agrees to exercise its best efforts precautions to prevent and
restrain the unauthorized disclosure of such Confidential Information by any of
its directors, officers, employees, consultants, subcontractors, agents,
collaborators, and Affiliates, which shall include obtaining appropriate secrecy
or confidentiality undertakings from such persons. Each Party shall be
responsible for any breach of any such undertakings by its employees, agents or
representatives. Each Party shall also take all steps necessary to insure that
no employees or other agents of such Party who are not directly involved in the
activities contemplated by this Agreement do not have access to any Confidential
Information of the other Party. Without limiting the foregoing, each Party
agrees to use its best efforts to maintain in confidence the Know-How and other
trade secrets licensed to the other Party.
12.2 AUTHORIZED DISCLOSURE. The provisions of Section 12.1 shall not apply
to any Confidential Information disclosed hereunder which:
A. was known or used by the receiving Party or its Affiliates prior
to its date of disclosure to the receiving Party, as evidenced by the
prior written records of the receiving Party or its Affiliates; or
B. either before or after the date of the disclosure to the
receiving Party is lawfully disclosed without restriction on disclosure to
the receiving Party or its Affiliates by an independent, unaffiliated
Third Party rightfully in possession of the Confidential Information; or
C. either before or after the date of the disclosure to the
receiving Party becomes published or generally known to the public through
no fault or omission on the part of the receiving Party or its Affiliates;
or
D. is required to be disclosed by the receiving Party to comply with
applicable laws or to comply with governmental regulations or the order of
a court of law, provided that the receiving Party provides prior written
notice of such disclosure to the other Party and takes reasonable and
lawful actions to avoid and/or minimize the degree of such disclosure,
which shall include, without limitation, seeking appropriate protective
orders, providing such information under seal or in camera or similar
protective devices.
-41-
12.3 PUBLICATIONS. The following restrictions shall apply with respect to
the disclosure in scientific journals or publications by any Party or any of its
Affiliates or any employee or consultant of any Party or any of its Affiliates
of Confidential Information of the other Party:
A. Each Party shall retain all publishing/presentation rights for
its Confidential Information (regardless of medium, including, without
limitation, paper, graphic, electronic, optical and multimedia).
B. The Parties will jointly have publication/presentation rights for
all Confidential Information that is jointly-owned hereunder; provided,
however, that proper and reasonable attributions to the other Party are
made, if applicable, and subject to the prior approval requirements of
Section 12.3(c).
C. Each Party will furnish to the other accurate and complete copies
of any proposed publication or transcript of any proposed presentation at
least thirty (30) days prior to the date of proposed presentation or
submission of a manuscript for publication, in each case either because
there is patentable subject matter which requires protection and/or there
is Confidential Information of a Party contained in the proposed
publication or presentation. Any Confidential Information of a Party
identified by such Party will be deleted from the proposed publication or
presentation unless such Party consents to its inclusion.Neither Party
shall enter into any agreements or other commitments, with any employees,
agents or other Third Parties which conflict with or otherwise interfere
with the provisions of this Section.
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13. TERMINATION
13.1 TERMINATION BY MUTUAL AGREEMENT. The Parties may at any time
terminate this Agreement by written agreement executed by both BMX and GP.
13.2 TERMINATION BY BMX. This Agreement (and all license and rights
granted herein, except for the license set forth in section 3.2 (b)) may be
terminated by BMX upon written notice of termination to GP. Thereafter, this
Agreement (including all licenses and rights granted herein, except for the
license set forth in section 3.2 (b)) shall terminate automatically on the
effective date of the notice of termination.
13.3 TERMINATION FOR MATERIAL BREACH. Each Party shall have the right, in
addition to and not in limitation of any other right and remedies it may have at
law or in equity, to terminate this Agreement after sixty (60) days prior
written notice to the other upon the occurrence of any of the following:
A. Upon or after the bankruptcy, insolvency, dissolution or winding
up of the other Party (other than a dissolution or winding up for the
purpose of reconstruction or amalgamation); or
B. Upon or after the breach of any material provision of this
Agreement by the other Party if the breaching Party has not cured such
breach within the sixty (60) day period following written notice of
termination by the non-breaching Party.
If BMX is the non-breaching Party, all licenses granted to BMX under Section
3.1(a)of this Agreement which are in effect at the time of termination shall
survive such termination for so long as BMX is not in breach of its obligations
to GP under this Agreement, which survive such termination so long as such
licenses remain in effect. Without limiting the foregoing, the Agreement is
terminated due to BMX being the breaching Party, BMX shall immediately cease and
desist from manufacturing, developing, upgrading, selling and distributing ANAIS
Products (but without prejudice to BMX's right to conduct independent research
and development activities with the BMX Technology).
Notwithstanding any other provision of this Agreement, a Party receiving a
written notice of termination pursuant to subparagraph (b) above shall have the
right to dispute the existence of a default or material breach or the adequacy
or remedy thereof, the alleged breaching Party may require that the right to
terminate this Agreement be determined by arbitration pursuant to Section 15.2
and in the event the arbitrator(s) determine that there were reasonable grounds
for the alleged breaching party so charged to dispute termination and that the
alleged breaching party acted in good faith, the arbitrator(s) may afford
reasonable opportunity to cure upon such terms as they may direct. The
Termination Date in the event of termination for breach shall be the date duly
fixed in any valid notice of termination by the non-breaching Party (consistent
with the aforesaid cure periods), except that in the case of any arbitration as
to such breach, the arbitrators may determine the Termination Date.
13.4 SURVIVING OBLIGATIONS. Promptly after termination of this Agreement,
each Party shall return or dispose of any Know-How and Confidential Information
of the other
-43-
in the accordance with the instructions of the other, including without
limitation any compounds, assays or other biological or chemical materials;
provided that this requirement shall not apply to a Party so long as it retains
a license pursuant hereto. Notwithstanding any other provision of this
Agreement, Articles 1, 2, 7 (except -- if termination results from any breach by
GP -- section 7.10), 10, 11, 12, and 15 hereof shall survive the expiration or
termination of this Agreement. Section 3.2(b) and section 5.3 shall also survive
termination. Termination shall not affect any obligation of BMX under Article 4
of this Agreement which accrued prior to the date of termination.
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14. EXPORT
14.1 ACKNOWLEDGMENT. The Parties acknowledge that the export of technical
data, materials or products is subject to the exporting Party receiving all
necessary export licenses and that the Parties cannot be responsible for any
delays attributable to export controls which are beyond the reasonable control
of either Party. Each Party covenants and agrees to comply with all applicable
treaties, laws, statutes, rules and regulations of any federal, state, local or
foreign governmental entity or instrumentality, including, without limitation,
the provisions of the United States Export Administration Act of 1969, as
amended, and all other applicable export laws, restrictions and regulations of
the Department of Commerce and the FDA. The receiving Party shall provide the
exporting Party with any information, materials, certifications or other
documents which may be reasonably required in connection with such export laws,
restrictions and regulations.
14.2 WRITTEN ASSURANCES. Without limitation of the foregoing, and in
support of maintaining a general license for the export of technical data under
this Agreement, a Party receiving an export agrees to not knowingly export or
reexport any technical data or materials furnished to such Party under this
Agreement, any part thereof or any direct product thereof, directly or
indirectly, without first obtaining permission to do so (if required) from the
United States Department of Commerce, the FDA and/or other appropriate United
States governmental agencies, into any country to which restrictions apply.
-45-
15. GOVERNING LAW; DISPUTE RESOLUTION
15.1 GOVERNING LAW. This Agreement shall be governed by and interpreted in
accordance with the laws of New York (without regard to its or any other
jurisdiction's choice of law principles), except that any arbitration hereunder
shall be subject to the federal law applicable to arbitration.
15.2 ARBITRATION. In the event of any controversy or claim relating to,
arising out of or in any way connected to any provision of this Agreement or any
of the Interrelated Agreements ("Dispute"), the Parties shall seek to settle
their differences amicably between themselves, including entering into
non-binding mediation. Any unresolved Dispute shall be finally resolved by final
and binding arbitration in accordance with this Section 15.2. Whenever a Party
shall decide to institute arbitration proceedings, it shall give written notice
to that effect to the other Party. The Party giving such notice shall refrain
from instituting the arbitration proceedings for a period of ten (10) days
following such notice to allow the Parties to attempt to resolve the Dispute
between themselves. If the Parties are still unable to resolve the dispute, the
Party giving notice may institute the arbitration proceeding under the rules of
Conciliation and Arbitration of the International Chamber of Commerce as then in
effect ("ICC Rules"). Arbitration shall be held in New York, New York. The
arbitration shall be conducted before three arbitrators, with each Party to
select one arbitrator and with the third arbitrator to be appointed in
accordance with ICC Rules. The arbitrators shall undertake in writing as a
condition of service to conduct proceedings in a speedy and efficient manner to
render the award promptly after the final arbitration hearing, and further shall
confirm in writing to the President of the Court of Arbitration of the
International Chamber of Commerce that such undertaking is being or has been
fulfilled, or shall report the reasons for any failure of fulfillment, as a
condition for any application for fees. If so requested by either Party,
preparation of any Terms of Reference referred to in ICC Rules shall be waived
and the matters at issue in the Dispute shall be determined by the arbitrators
based on the timely submissions of the Parties, the arbitrators shall not have
the power to award punitive damages or any award of multiple damages under this
Agreement and such awards are expressly prohibited. Any arbitral award shall be
by majority vote and shall be final and binding on the Parties. Judgment on the
award may be entered in any court having jurisdiction. Except to the extent
entry of judgment and any subsequent enforcement may require disclosure, all
matters relating to the arbitration, including the award, shall be held in
confidence by the Parties. Nothing contained in this Section 15.2 shall prevent
either Party from seeking temporary restraining orders, injunctions or such
other relief in any court of competent jurisdiction.
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16. GENERAL PROVISIONS
16.1 PUBLICITY. Neither Party, nor any of its Affiliates, shall originate
any publicity, news release or other public announcement, written or oral,
relating to this Agreement or the existence of an arrangement between the
Parties, without the prior written approval of the other Party, which approval
shall not be unreasonably withheld, except as otherwise required by law.
16.2 NOTICES. All notices required or permitted to be given under this
Agreement shall be in writing and shall be mailed by registered or certified
mail, Federal Express or DHL, addressed to the signatory to whom such notice is
required or permitted to be given and transmitted by facsimile to the number
indicated below. All notices shall be deemed to have been given when mailed, as
evidenced by the postmark at the point of mailing, or faxed.
All notices to BMX shall be addressed as follows:
bioMerieux, Inc.
000 Xxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
Attention: President
Facsimile: (000) 000-0000
All notices to GP shall be addressed as follows:
Gen-Probe Incorporated
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000-0000
Attention: President
Facsimile: (000) 000-0000
Any Party may, by written notice to the other, designate a new address or
fax number to which notices to the Party giving the notice shall thereafter be
mailed or faxed.
16.3 FORCE MAJEURE. In the event that either Party is prevented from
performing or is unable to perform any of its obligations under this Agreement
(other than the obligation to pay money) due to any act of God; fire; casualty;
flood; war; strike; lockout; failure of public utilities; injunction or any act,
exercise, assertion or requirement of governmental authority; epidemic;
destruction of production facilities; riots; insurrection; inability to procure
or use materials, labor, equipment, transportation or energy; or any other cause
beyond the reasonable control of the Party invoking this Section 16.3 if such
Party shall have used its best efforts to avoid such occurrence ("Force
Majeure"), such Party shall give notice to the other Party in writing promptly,
and thereupon the affected Party's performance shall be excused and the time for
performance shall be extended for the period of delay or inability to perform
due to such occurrence.
-47-
16.4 CALENDAR AND BUSINESS DAYS. Unless otherwise expressly stated to be
business days, all references to days shall mean calendar days; provided,
however, that if the last date or the deadline for the giving of notice or
performance of any other act or fulfillment or satisfaction of any condition set
forth in this Agreement shall fall on a day which is not a business day, then
the time for the giving of such notice or performance of such act or fulfillment
or satisfaction of such condition shall be extended to the next business day. As
used herein, the term "business days" shall mean all days other than Saturdays,
Sundays or state or federal holidays.
16.5 ENTIRETY OF AGREEMENT; EFFECT ON ANAIS AGREEMENT. This Agreement and
the Exhibits and Schedules hereto (which Exhibits and Schedules are deemed to be
a part of this Agreement for all purposes) contain the full understanding of the
Parties with respect to the subject matter hereof and prospectively supersede
all prior understandings and writings relating thereto (including, without
limitation, the ANAIS Agreement, except as interpretation of the same may be
necessitated hereby or otherwise required for determination of the rights of the
Parties prior to or as of the Effective Date hereof) and shall be deemed a
single, integrated agreement. Nothing contained in this section shall affect the
rights of the Parties with respect to the ownership of any invention pursuant to
the terms of the ANAIS Agreement. Nothing contained in this section shall affect
other agreements between the parties which are not directly related to the
subject matter of this agreement (including the Parties' VIDAS Agreement of May
2, 1997). No waiver, alteration, consent or modification of any of the
provisions hereof shall be binding unless made in writing and signed by the
Parties by their respective officers thereunto duly authorized.
16.6 NON-WAIVER. The waiver by either Party of a breach or a default of
any provision of this Agreement by the other Party shall not be construed as a
waiver of any succeeding breach of the same or any other provision, nor shall
any delay or omission on the part of either Party to exercise or avail itself of
any right, power or privilege that it has or may have hereunder operate as a
waiver of any right, power or privilege by such Party.
16.7 NO PARTNERSHIP OR AGENCY. Nothing herein shall be deemed to
constitute either Party as the agent or representative of the other Party, or
both Parties as joint venturers or partners for any purpose. Each Party shall be
an independent contractor, not an employee or partner, of the other Party, and
the manner in which a Party renders its services under this Agreement shall be
within such Party's sole discretion. Neither Party shall be responsible for the
acts or omissions of the other Party, and neither Party will have authority to
speak for, represent or obligate the other Party in any way without prior
written authority from the other Party.
16.8 SEVERABILITY. In the event that any provision of this Agreement is
held by a court of competent jurisdiction to be unenforceable because it is
invalid or in conflict with any law of any relevant jurisdiction, the validity
of the remaining provisions shall not be affected, and the rights and
obligations of the Parties shall be construed and enforced as if the Agreement
did not contain the particular provisions held to be unenforceable.
-48-
16.9 ASSIGNMENT.
A. Except as otherwise provided in this Agreement, neither this
Agreement nor any of the rights or obligations hereunder may be directly
or indirectly transferred or assigned by either Party without the prior
written consent of the other Party, which shall not be unreasonably
withheld; provided, however, that either Party may assign without the
consent of the other Party to an Affiliate.
B. Upon any assignment or other transfer of any rights under this
Agreement by BMX ( including a transfer resulting from a merger,
consolidation, or other Change in Control) to [***] (or any Affiliate of
any of these companies), then:
(i) BMX shall pay to GP the sum of [***]; and
(ii) Each and every one of the royalty rates set forth in
section 4.1 of this Agreement shall be increased by
[***].
C. Any purported assignment or transfer in violation of this section
shall be void.
D. Any permitted assignee or transferee shall assume all obligations
of its assignor or transferor under this Agreement, provided that the
assigning or transferring Party shall remain liable on all obligations
which accrued prior to assignment or transfer.
16.10 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their permitted successors and
permitted assigns.
16.11 HEADINGS. The headings contained in this Agreement are for
convenience of reference only and shall not be considered in construing this
Agreement.
16.12 DRAFTING PARTY. The provisions of this Agreement, and the documents
referred to in the Agreement, have been prepared, examined, negotiated and
revised by each Party to this Agreement and their respective counsel, and no
implication will be drawn and no provision will be construed against either
Party to this Agreement by virtue of the purported identity of the drafter of
this Agreement, or any portion of this Agreement.
16.13 ENGLISH LANGUAGE. This Agreement may be translated into one or more
languages for the convenience of the Parties, provided that the English language
version shall be controlling for all purposes hereunder. All reports, data,
information, notices, schedules, plans, records and other information required
to be provided pursuant to this Agreement by any Party to this Agreement will be
in the English language.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
-49-
16.14 LIMITATION OF LIABILITY. No Party shall be liable to another for
indirect, incidental, consequential or special damages, including but not
limited to lost profits, arising from or relating to any breach of this
Agreement, regardless of any notice of the possibility of such damages. Nothing
in this Section is intended to limit or restrict the indemnification rights or
obligations of any Party.
16.15 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
16.16 NO THIRD-PARTY BENEFICIARIES. Nothing in this Agreement, express or
implied, is intended to confer on any person other than the Parties hereto, or
their respective permitted successors and assigns, any benefits, rights or
remedies.
16.17 PUBLIC ANNOUNCEMENTS. Neither Party shall issue any press release,
statement or other announcement to the general public or to the general or trade
press relating to this Agreement or the transactions contemplated hereby, with
the agreement of the other Party, such agreement not to be unreasonably
withheld.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their properly and duly authorized officers or representatives as of
the date first above written.
GEN-PROBE INCORPORATED BIOMERIEUX, INC.
By: /s/ Xxxxx X. Xxxxxxxx By: /s/ Xxxxxx X. Xxxxxxx
---------------------------------- --------------------------
Xxxxx X. Xxxxxxxx Xxxxxx X. Xxxxxxx
President and Chief Executive Officer President
-50-
-51-
EXHIBIT A
GP RNA TECHNOLOGY
-52-
EXHIBIT A
TITLE OF INVENTION PATENT NO. ISSUE DATE INVENTORS PRIORITY
[***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
EXHIBIT B
GP TMA TECHNOLOGY
-1-
Issue/Pub.
Title of Invention Issue/Xxx.Xx Date Priority Date
------------------ ------------ ---------- -------------
[***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
EXHIBIT C
ANAIS INSTRUMENTATION
1. The ANAIS Instrument shall be an automated laboratory instrument for
performing nucleic acid assays utilizing High Density DNA Probe Arrays. For
purposes of this Exhibit C and the definitions of ANAIS Instrumentation and GP
RNA Technology, "High Density DNA Probe Array" means an array of oligonucleotide
probes containing [***].
2. The ANAIS Instrument shall be a single, integrated laboratory
instrument except to the extent specifically set forth herein.
3. The ANAIS Instrument shall provide a step of operation for High
Resolution Analysis of the target nucleic acid(s) using a High Density DNA Probe
Array. For purposes of this Exhibit C and the definition of the ANAIS
Instrumentation, "High- Resolution Analysis" means:
A. For ANAIS Probe Assays for individual organisms, the detection
of specific genetic sequences in order to: [***] for purposes of
optimizing patient health.
B. For ANAIS Probe Assays for panels of organisms, the detection
of specific genetic sequences in order to: [***].
C. For ANAIS Products not involving agents or organisms, such
other [***] as reasonably may be required for testing of human leukocyte
antigens and/or for identifying the source of genetically-modified
foodstuffs.
4. The ANAIS Instrument may also provide, as a first step of operation,
the capability to [***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-1-
5. [***]
6. [***]
7. The ANAIS Instrument shall perform nucleic acid hybridization of up to
[***] samples per 8 hour shift. The time to first result should not exceed
[***]. Time to first result does not include pre-enrichment, if needed, or
manual nucleic acid extraction outside the ANAIS Instrument.
8. The ANAIS Instrument shall accept a majority of clinical samples and/or
organisms isolated from culture. Sample volumes shall be at a level sufficient
to achieve clinically acceptable sensitivity. The ANAIS Instrument shall also
accept industrial samples of raw materials, environmental materials, and
processed materials coming from the following sample types: water; food
products; cosmetic products; and/or previously developed pharmaceutical
products.
9. The sample handling protocol for the ANAIS Instrument shall provide for
sample identification to be linked from specimen collection to final result.
Certain types of samples that vary widely in volumes, viscosity, or
heterogeneities may be processed manually before being placed into the
instrument and/or a "smart module" system, e.g., a separate, automated sample
preparation device, may be used for such purpose.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-2-
EXHIBIT D
SEMI-AUTOMATED COMPONENT
EARLY MARKET INTRODUCTION INSTRUMENT
The semi-automated component system will be used for the early market
introduction of the instrument concept described in Exhibit C. The component
system shall be substantially similar [***] and will include all of the
following: sample preparation, amplification, a fluidics station, and a [***]
reader [***], all for use with [***] DNA Probe Arrays. For purposes of this
Exhibit D, "[***] DNA Probe Array" means [***] consisting of an array of not
less than [***] probes, each probe having a distinct sequence and the array
having a density of equal to or greater than [***] probes per square centimeter
(Probes/cm(2)), said probes having been immobilized on a solid support with each
probe having a predefined position in the array.
The component system shall not provide a detection and/or quantification
capability independent of the high resolution analysis capability of the system.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-1-
EXHIBIT E
KEY BIOCHEMISTRY COMPONENTS
All enzymes used in transcription-based amplification (including TMA and
variations and improvements to TMA) for use in ANAIS Assays.
All biochemical components used for amplification of amplicon of target
with TMA.
All probes, primers, and oligonucleotides used in ANAIS Assays.
Nucleic acids used for positive and negative controls, standards,
calibrators, and for quality control of ANAIS Assay components.
This exhibit is subect to all limitations of section 8.1(a) of the
foregoing agreement, i.e., that GP's right and obligation to manufacture KBC's
for ANAIS Products are limited to those non-product specific ("Generic") KBCs
which GP has developed prior to December 30, 2000 and which are to be
incorporated into, or used for development of, ANAIS Products.
-1-
EXHIBIT F
BMX ACCOUNTING PRINCIPLES AND PRACTICES
FOR CURRENCY CONVERSION
-1-
Currency Exchange
The currency exchange rates used to convert amounts stated in currencies
other than U.S. Dollars to U.S. dollars by Affiliates of BMX shall be as
follows.
1. Amounts initially stated in French francs shall be converted into
U.S. dollars on a monthly basis, using a separate currency rate of exchange for
each of the three months in the quarter. With respect to each such month, a
"monthly average" of the reported conversion franc to dollar conversion rate,
the conversion rate entitled the "Cours Indicatif de la Banque de France", for
each Wednesday in such month, as published in La Tribune, shall be calculated,
and applicable amounts converted using such conversion rate. The report
pursuant to Section 5.6 shall state the relevant dollar figures for the
applicable quarter in U.S. dollars as so calculated, and shall state the
conversion rates applicable for each month in such quarter.
2. Amounts initially stated neither in French Francs nor in U.S. dollars
shall be converted to French francs on a monthly basis, using a separate
currency rate of exchange for each of the three months in the quarter, and such
amounts, as stated in French francs, shall then be converted to U.S. dollars in
the manner set forth in paragraph 1. The report pursuant to Section 5.6 shall
state the aggregate relevant dollar figures for the applicable quarter in U.S.
dollars as so calculated, and shall state the conversion rates applied in each
month to calculate the conversion to French francs and the conversion to U.S.
dollars. The conversion rate applied to calculate the conversion of such
currencies to French francs shall be the "monthly average" of the reported
applicable currency to French franc conversion rate, for each Wednesday in such
month, as published in La Tribune, which rate shall be the "Cours Indicatif de
la Banque de France", if available, or otherwise the "Cours du Fixage de la
B.F.C.E." or another applicable rate.
EXHIBIT G
STANDARD GP PURCHASE ORDER FORM
-1-
[GEN-PROBE LOGO]
00000 XXXXXXX XXXXXX XXXXX
Xxx Xxxxx, XX 00000-0000 REQUISITION DATE DATE REQUIRED P.O. NUMBER
PURCHASE REQUISITION
[]SERVICE []EXPENSE []CONSULTANT []STANDING ORDER []CHECK REQUEST []CHANGE ORDER
________________________________________________________________________________
REQUESTOR MAIL STATION EXTENSION APPROVAL SIGNATURE
(Please Write Legibly)
________________________________________________________________________________
DELIVER TO MAIL STATION EXTENSION APPROVAL SIGNATURE
(Please Write Legibly)
________________________________________________________________________________
SHIP TO: []GENETIC CENTER []OTHER: ACCOUNT
NUMBER []-[][]-[][]-[][][][][]
________________________________________________________________________________
RECOMMENDED SOURCE SUPPLIER
________________________________________________________________________________
NAME NAME
________________________________________________________________________________
ADDRESS ADDRESS
________________________________________________________________________________
CITY, STATE, ZIP CITY, STATE, ZIP
________________________________________________________________________________
PHONE FAX PHONE FAX
________________________________________________________________________________
CONTACT VENDOR CODE CUSTOMER ACCT.# VENDOR CODE
________________________________________________________________________________
SHIP VIA ORDER DATE CONFIRM TO SALES
ESTIMATED ORDER NO.
FREIGHT CHARGE
________________________________________________________________________________
F P.O. TYPE BUYER TERMS
O [] FACTORY _________________________
B [] DESTINATION [] PREPAID [] COLLECT
________________________________________________________________________________
ITEM QTY UOM PART NUMBER DESCRIPTION EST. QUOTED EXT. DEL.
PRICE PRICE PRICE DATE
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
SPECIAL INSTRUCTIONS TOTAL COST
[] THIS REQUISITION MAY AFFECT THE QUALITY OF GEN-PROBE PRODUCTS
WHITE-PURCHASING YELLOW-REQUESTOR PINK-INTERNAL
THIS PURCHASE ORDER IS SUBJECT TO AND INCLUDES
THE FOLLOWING TERMS AND CONDITIONS
1. AGREEMENT: This Purchase Order becomes the exclusive agreement between the
parties for the goods, subject to the terms and conditions hereof, when accepted
by acknowledgment or commencement of performance by Vendor. Additional or
different terms proposed by Vendor shall not apply, and no change in,
modification of or revision to this Purchase Order shall be valid unless
accepted in writing by Buyer. Acceptance of goods delivered under this Purchase
Order shall be made subject to the terms herein, and mere acceptance of
delivered goods shall in no way be considered to be an acceptance of any
additional, different, changed, modified or revised terms. Buyer must be
notified in accordance with Section 27 of any change in delivery date. If this
Purchase Order is for services, the term "goods" as used herein shall mean
"services".
2. CHANGES/CANCELLATION: This order or any contract made pursuant hereto may be
changed or cancelled by the Buyer at his option by written notice at any time.
Any result in contract price differential shall be equitably adjusted in
writing. In the event of cancellation, reimbursement for labor and materials
already used on this order will be made and the materials so paid for will be
shipped to Buyer.
3. PAYMENT: All taxes imposed upon the sale of the goods, whether by federal,
state or municipal government, shall be paid by Vendor unless otherwise
indicated on this Purchase Order. Any adjustment to Vendor's invoices due to
shortages, late deliveries, rejection or other failure to comply with the
requirements of this Purchase Order may, at Buyer's option, be made by Buyer
before payment. Failure to so adjust shall not deprive buyer of the right to do
so thereafter. Payment of invoices may be withheld pending final acceptance.
Payment, with or without delivery, for all or part of the goods covered hereby
does not constitute acceptance. Except as otherwise noted in this Purchase
Order, Buyer shall not have any liability for payment of extras or Vendor's
expenses unless such expenses or extras have been authorized in writing in
advance by Buyer.
4. INDEPENDENT CONTRACTOR: Services provided hereunder shall be performed by
Vendor solely as an independent contractor. All personnel furnished by Vendor
to provide services to Buyer shall at all times be the employees of Vendor and
shall not be deemed to be the employees or agents of Buyer.
5. MATERIALS FURNISHED BY BUYER: If Buyer furnishes any material for
fabrication of the goods, Vendor (1) shall not substitute any other material in
such fabrication without Buyer's written consent, and (2) agrees that title to
such material shall not be affected by incorporation in or attachment to any
other property. Vendor shall use any designs, tools, patterns, drawings,
information and equipment furnished by Buyer only in the performance of this
Purchase Order. Upon completion or termination of this Purchase Order, all items
furnished by Buyer shall be returned to Buyer or disposed of pursuant to
instructions issued by Buyer. Vendor shall be liable for any loss or damage to
property furnished by Buyer while such property is in Vendor's possession.
6. ASSIGNMENT: Vendor shall not assign or delegate this Purchase Order or any
interest under it without the prior written consent of Buyer, and any
unauthorized assignment or delegation shall be void and ineffective for all
purposes.
7. TITLE ON TERMINATION: In the event of termination, Buyer may give notice
concurrent with or subsequent to the notice effecting termination that all right
of possession, title and interest in or to all or any portion of the materials,
tooling, work in process or completed goods covered by this Purchase Order
shall pass to Buyer effective upon Vendor's receipt of such notice.
8. PACKING AND SHIPPING: Vendor shall ship only as specified in this Purchase
Order or as subsequently directed in writing by Buyer. All extra charges of any
kind, including but not limited to insurance, packing, crating, excess
transportation costs, storage, etc. will be borne by Vendor.
9. CONFIDENTIALITY AND RETURN OF PROPRIETARY MATERIALS: Vendor agrees that
Vendor will not, during the course of providing goods or services under this
Purchase Order and for a period of five (5) years thereafter, disclose directly
or indirectly to any person or entity, or copy, reproduce or use, any
information designated as confidential Information, trade secret or information
treated as confidential by Buyer ("Confidential Information") known, learned or
acquired by Vendor during the period of Vendor's engagement by Buyer. Vendor
agrees that any copies or reproductions of any Confidential Information made or
caused to be made by Vendor are the property of Buyer. Vendor agrees to deliver
promptly to Buyer on termination of this Purchase Order, whatever the reason, or
at any time Buyer may so request, all documents, records, Artwork, designs,
data, drawings, flowcharts, listings, models, sketches, apparatus, notebooks,
notes and similar repositories of Confidential Information and any other
documents of a confidential nature belonging to Buyer, including all copies,
summaries, records, descriptions, modifications, drawings or adaptations of such
materials which Vendor may the possess or have under its control.
10. INDEMNIFICATION: Vendor agrees to indemnify and protect Buyer against all
claims, actions, demands losses and liabilities of any kind resulting from: (a)
Vendor's breach of this agreement; (b) infringement of any U.S. or foreign
patent, trademark or intellectual property claims (c) personal injury or
property damage during work on Buyer's premises. Without limiting the foregoing,
Vendor shall maintain public liability and property damage insurance in
reasonable amounts covering the obligations set forth above and required
xxxxxxx'x compensation insurance covering all employees performing this Purchase
Order.
11. WARRANTY: In addition to all warranties established by statute or common
law or set forth elsewhere in this order, Vendor expressly warrants that all
material or services covered herein shall conform to all specifications,
drawings, samples and descriptions furnished or adopted by Buyer, and shall be
of best quality and fit and sufficient for the purpose for which purchased if
specified hereon, merchantable, of good material and workmanship, free from any
liens and encumbrances, and free from all patent and patent defects. Buyer's
failure to give notice to Vendor of any breach of warranty shall not discharge
Vendor's liability therefor. Without limiting the generality of the foregoing,
Vendor agrees to supply Buyer with copies of operating manuals, drawings,
schematics, diagrams and other information needed for proper maintenance and
repair of applicable purchased material upon Buyer's request therefore, and
Vendor further agrees to be responsible for all defects in design, workmanship
and materials which may become apparent within twelve (12) months of beneficial
occupancy and/or use by the Buyer. These warranties shall run to the Buyer, its
successors, assigns, customers and the users of its products. Buyer's normal
maintenance and repair of applicable purchased material after receipt from
Vendor shall not affect Vendor's warranties and representations stated above.
EXHIBIT H
EXCERPTS OF STANFORD AND TEKNIKA AGREEMENTS
-1-
ADDITIONAL CLAUSES RELATING TO THE STANFORD AGREEMENT
AND THE TEKNIKA AGREEMENT
STANFORD LICENSE
The Stanford Agreement sets forth the following terms and conditions
relating to required provisions in any sublicense and 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.
1
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);
(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
2
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.
TEKNIKA AGREEMENT
The Teknika Agreement sets forth the following 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.
3
EXHIBIT E
TRANSCRIPTION-BASED AMPLIFICATION VERSIONS
"GEN-PROBE Version" shall mean transcription-based nucleic acid
amplification using reverse transcriptase, RNA polymerase and [***] wherein
(a) the reverse transcriptase and RNase H activities are provided by
a [***];
(b) said protein has a minimal reverse transcriptase activity of
[***] (where the unit definition and assay conditions are equivalent to those
set forth below); and
(c) the amplification reaction is performed at [***]
"TEKNIKA Version" shall mean transcription-based nucleic acid
amplification using reverse transcriptase, RNA polymerase and [***],
wherein
(a) [***]
(b) [***] and
(c) the amplification reaction is performed at [***]
ENZYME ASSAYS
[***]
[***]
[***]
[***]
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
1
[***]
Equivalent unit definitions and assay conditions may be substituted as long as
they produce results that may be quantitatively converted by established valid
procedures (e.g., multiplication by a conversion factor or by reference to a
standard curve) to the assay conditions and unit definitions set forth above.
For example, [***]
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
2
[***]
Data supporting equivalence of any substitutions must be made available for
inspection as set forth in Section 3.3 of this Agreement.
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
3
EXHIBIT I
ANAIS DEVELOPMENT TRANSITION WORK PLAN
-1-
ANAIS DEVELOPMENT TRANSITION WORK PLAN
GEN-PROBE/BMX
CONFIDENTIAL
This work plan describes the obligations of GP and BMX with respect to the
Development Transition which the Parties believe are necessary to accomplish the
Development Transition as described in the accompanying ANAIS
License,
Development and Cooperation Agreement. It is not the intention of this work plan
to address or provide for the transfer of manufacturing capability from GP to
BMX or to address issues concerning supply of key biochemistry components
("KBC's"). Each of these subjects is addressed by the accompanying ANAIS
License, Development and Cooperation Agreement and may be further addressed by
the parties in supplemental work plans or supplemental agreements as provided in
such Agreement.
This work plan is subject to and controlled by the terms of the ANAIS
License,
Development and Cooperation Agreement.
GP EMPLOYEE SUPPORT
In order to support the development transition activities required of it, GP
shall make available such personnel as shall be reasonably necessary to allow
the Development Transition as described in the ANAIS Agreement. During the
Development Transition Period, GP shall make the following GP employees
reasonably available for consultation with BMX on the development transition
matters described below:
1. Amp research X. Xxxxxxxx
2. Screening X. Xxxxxxxxxxx
3. HIV assay X. Xxxx
4. Myco assay X. Xxxxxx
5. Management X. Xxxxxxxx, X. Xxxxxxxxxxx
In the event either Party during the Transition Period believes that the
activities identified in this Work Plan will not be completed before December
30, 2000, such Party shall immediately inform the other Party. Upon such notice,
the Parties shall promptly attempt to identify the cause of the delay and shall
dedicate such resources as shall be reasonably necessary to rectify the problem,
subject always
ANAIS PROBE WORKPLAN 2000
GEN-PROBE/BMX
Confidential
to GP's right to limit the number of GP personnel assigned to the Development
Transition in accordance with the staffing levels set forth above.
As set forth in the ANAIS Agreement, the Development Transition period and
related GP Dedicated Transition activities will terminate as of December 30,
2000 unless GP has failed, solely due to its own fault, to accomplish any action
required by Development Transition work plan at which time the Development
Transition period will be extended until such action has be accomplished by
Gen-Probe.
GENERAL DESCRIPTION OF BMX DEVELOPMENT TRANSITION ACTIVITIES
Prior to the date of the accompanying ANAIS
License, Development And Cooperation
Agreement, BMX has assumed lead responsibility for development of all ANAIS
Probe Assays. BMX shall be primarily responsible for all development activities
after the effective date of the ANAIS
License, Development and Cooperation
Agreement.
BMX SUPPORT
In order to support the development transition activities required of it, BMX
shall make available such personnel and facilities as may be reasonably required
to accomplish BMX's Development Transition activities.
GP ACTIVITIES
As part of the Development Transition, GP shall transfer from GP to BMX
knowledge, records, procedures, work instructions, formulations, and Know-How
which is reasonably necessary for the development of the ANAIS Products or in
carrying out the tasks as previously performed by GP under the ANAIS Agreement.
GP will undertake the following specific activities with the intent to complete
all work by December 30, 2000, subject always to GP's right to limit the number
of GP personnel assigned to the development transition in accordance with the
staffing levels set forth above.
2
ANAIS PROBE WORKPLAN 2000
GEN-PROBE/BMX
Confidential
1. AMP RESEARCH
BIOMERIEUX LEAD : F. Beseme
1. Transfer TMA and Amp research knowledge and expertise. Provide the
following to MaV:
1.1 [***]
1.2 [***]
1.3 [***]
1.4 [***]
1.5 [***]
1.6 [***]
1.7 [***]
2. SCREENING
BIOMERIEUX LEAD : A. Laayoun
1. [***]
2. [***]
[***]
3. [***]
BIOMERIEUX LEAD : X. Xxxxxxxx and X. Xxxxxx
Transfer relevant specific knowledge and expertise of Gen-Probe. Provide the
following information to bioMerieux/Moulin-a-Vent, if not already available at
bioMerieux/Rockland:
3.1. GENERAL CONSIDERATIONS
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
3
ANAIS PROBE WORKPLAN 2000
GEN-PROBE/BMX
Confidential
- For all chemicals : specific requirements, specifications, grades,
suppliers which have been tested and approved.
- Requirements on water quality.
- [***]
3.2. SPECIFIC REQUIREMENTS
Capture reagents.
- [***]
Amplification reagents.
[***]
Magenta: Specifications, maintenance procedures.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
4
TOOLS
[***]
R&D tools:
[***]
Statistical tools:
- Statistical tools well suited for Amplification optimization.
Lab/Environment control:
- bio-burden
- control of PIPS/SRI and of amplicons spread (swab tests).
- Cleaning procedures, preventive procedures.
Amplification Inhibition problem:
- theory of PIPS and SRI
- Analytical tools to control PIPS and SRI.
*** Certain information on this page has been omitted and file separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
5
EXHIBIT J
ESTIMATED KBC COSTS
Specific ANAIS products are not in development as of the Effective Date of
the foregoing agreement. GP's estimated KBC costs for VIDAS Products, including
the cost of non-product specific KBC's, is attached to this exhibit. The cost of
non-product specific KBC's for ANAIS Products and for ANAIS development work
will be the same as the costs of such KBC's for VIDAS Products.
-1-
Summary of Per Test Cost Estimates
for BMX MT, CT, AND NG AMP Reagents
MT REAGENT KIT TOTAL
COMPONENT COST
-------------- -----
[***] [***]
--------
TOTAL COST FOR MT [***]
CT REAGENT KIT TOTAL
COMPONENT COST
----------------- -------
[***] [***]
-------
TOTAL COST FOR CT [***]
NG REAGENT KIT TOTAL
COMPONENT COST
----------------- -------
[***] [***]
-------
TOTAL COST FOR NG [***]
Notes:
Costs are based on current lot sizes.
These costs are exclusive of the oligonucleotides for Internal Controls and
Probe Reagents.
Theses costs do not include the transfer price margin.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
