Exhibit 99.3
IMPROVEMENTS LICENSE AGREEMENT
THIS IMPROVEMENTS LICENSE AGREEMENT (the "Agreement") is made
as of the 24th day of July, 2003, by and between Roche Diagnostics GmbH
("ROCHE"), a German limited liability company having a principal place of
business at Xxxxxxxxx Xxxxxxx 000, X-00000 Xxxxxxxx, Xxxxxxx, and IGEN
International, Inc. ("IGEN"), a Delaware corporation having a principal place of
business at 00000 Xxxxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxx 00000, Xxxxxx Xxxxxx
of America:
NOW, THEREFORE, in consideration of the foregoing and the
mutual covenants and promises set forth below, and in consideration for the
granting of intellectual property rights to ROCHE and its Affiliates from IGEN
pursuant to agreements between ROCHE and IGEN (the "Parties") and their
respective Affiliates, the Parties hereby agree as follows:
1. Definitions. As used in this Agreement, capitalized terms
shall have the respective meanings set forth below:
1.1 Affiliate. "Affiliate" of any person means another
person that directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with, such first person.
The term "person" means any individual, firm, corporation, partnership, company,
limited liability company, trust, joint venture, association, Governmental
Entity or other entity. The term "Government Entity" means any domestic or
foreign (whether a national, Federal, state, provincial, local or otherwise)
government or any court of competent jurisdiction, agency or commission or other
governmental authority or instrumentality, domestic or foreign. Neither
Genentech Inc., 0 XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000-0000, XXX, nor
Chugai Pharmaceutical Co., Ltd, 1-9 Kyobashi 2-chome, Xxxx-xx, Xxxxx, 000-0000,
Xxxxx, shall be deemed an Affiliate of ROCHE for purposes of this Agreement.
Neither Meso Scale Diagnostics, LLC., 0000 Xxxxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxx,
XXX 00000 ("MSD") nor Meso Scale Technologies, LLC., 0000 Xxxxxxx Xxxx,
Xxxxxxxxxxxx, Xxxxxxxx, XXX 00000 ("MST") shall be deemed an Affiliate of IGEN
for purposes of this Agreement.
1.2 Assays. "Assays" means any and all methods, and the
labels and reagents used therein, that use ECL Technology for detection and/or
quantification.
1.3 Copycat Instrument.
"Instrument" shall mean an Instrument based on ECL Technology
that:
(1) weighs 70 kg or more and has a volume of 251,000
cubic centimeters or more and has a footprint of 3,900 square centimeters or
more; and
(2) (a) uses the same software code as an ECL
Instrument (as defined in the License Agreement) manufactured by, for or on
behalf of Roche or any of
its Affiliates (as long as such software code is proprietary to Roche, any of
its Affiliates, or an Authorized Third Party (and such software is not licensed
to IGEN by such Authorized Third Party)); or (b) would literally infringe (i)
any of the claims of: US Patent No. 6,042,786 (Oonuma et al.); US Patent No.
5,772,962 (Uchida et al.); US Patent No. 5,628,962 (Kanbara et al.); or claims
3, 5, 6, 7, 8, 9, 10, 11, 12 or 13 of US Patent No. 5,639,425 (Komiyama et al.)
if sold in the United States or (ii) any of the English language claims which
grant from EP 1 275 966 A1 (Sugiyama et al.) if sold in the corresponding
jurisdictions.
1.4 ECL Technology. "ECL Technology" shall mean detection
methods and detection systems, which employ electrochemiluminescence in
detection and/or quantification, including but not limited to ECL reagents, ECL
assays and/or immunodiagnostic detection methods by which light generation
occurs when a molecular compound (such as a ruthenium metal chelate) is
electrically stimulated by applying a voltage to an electrode which triggers a
chemical reaction to emit photons.
1.5 Field. "Field" means:
(a) the analyzing of specimens taken from a
human body, including without limitation, blood, bodily fluid or tissue, for the
purpose of testing, with respect to that human being, for a physiological or
pathological state, a congenital abnormality, safety and compatibility of a
treatment or to monitor therapeutic measures.
(b) Notwithstanding anything contained in
subsection 1.5(a), above, to the contrary, the Field shall not include analyzing
for (A) life science research and/or development, including at any
pharmaceutical company or biotechnology company, (B) patient self testing use,
(C) drug discovery and/or drug development (including at any pharmaceutical
company or biotechnology company), including clinical research or determinations
in or for clinical trials or in the regulatory approval process for a drug or
therapy, or (D) veterinary, food, water, or environmental testing or use.
1.6 Hitachi.
"Hitachi" means Hitachi High Technologies Corporation and its
Affiliates.
1.7 Hitachi Intellectual Property Rights."Hitachi
Intellectual Property Rights" means the Hitachi patents, patent rights, patent
applications, unpublished patent applications and technical information that is
used by Hitachi in the development and manufacture of the Elecsys Model 2010 and
the ECL Module of the E-170 Instrument, and that has been licensed to ROCHE for
sublicense to IGEN and its sublicensees. The Hitachi Intellectual Property
Rights include the patents and patent applications disclosed in Exhibit F
(Hitachi patents and patent applications) other than those patents and patent
applications denoted on Exhibit F as "jointly owned."
1.8 Instruments. "Instruments" means instruments that use
ECL Technology for detection and/or quantification.
1.9 Judgment.
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"Judgment" means the final order of judgment issued by the U.S.
District Court for the District of Maryland on February 15, 2002 in the matter
IGEN International, Inc. x. Xxxxx Diagnostics GmbH, Case No. PJM 97-3461.
1.10 Licensed Product(s).
"Licensed Product(s)" shall mean all Product(s) manufactured, used,
sold or otherwise commercialized under the licenses and sublicenses granted by
ROCHE hereunder.
1.11 Molecsys Program.
"Molecsys Program" shall mean the research and development program,
commenced and terminated by ROCHE predecessor Boehringer Mannheim GmbH prior to
its acquisition by the ROCHE Group, for ECL-based DNA probes.
1.12 Non-Exclusive.
"Non-Exclusive" as to the grant of a license right means that the
licensor may during the Term of this Agreement exercise the licensed rights
itself in the licensee's field or grant Non-Exclusive licenses in the licensee's
field to a third party, or retain for itself any non-exclusive license rights.
1.13 Open System.
"Open System" means an ECL Instrument (as defined in the License
Agreement) manufactured by, for or on behalf of LLC or any of its Affiliate
Sublicensees (as defined in the License Agreement), which is designed or
modified by, for or on behalf of LLC or its Affiliate Sublicensees to accept,
and is capable of operating with, reagents manufactured by, for or on behalf of
third parties without permission, authorization or license by LLC or its
Affiliate Sublicensees (as defined in the License Agreement).
1.14 PCR Technology. "PCR Technology" shall mean the
technology that is covered by claims of the patents, and the claims from the
patents which issue from the patent applications, listed in Exhibit E hereto.
1.15 Prior Agreement.
"Prior Agreement" means the License and Technology Development
Agreement between ROCHE (t/k/a Boehringer Mannheim GmbH) and IGEN (t/k/a IGEN
Incorporated), dated September 23, 1992.
1.16 Product(s). "Product(s)" means all products and
services that are based on (i.e. uses or incorporates) ECL Technology including,
but not limited to Instruments (including, without limitation, specially
developed consumables and related software, i.e., tips and cups used with
Instruments), service for Instruments and spare parts; Assays (including,
without limitation, reagents, calibrators, controls cleaning solutions,
diluents, and substrate); and peripheral equipment that uses ECL Technology.
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1.17 ROCHE Improvements. The term "ROCHE Improvements"
shall mean the following in the form existing at the Effective Time:
(a) The entire Elecsys 1010 instrument;
(b) The entire Elecsys 2010 instrument;
(c) All aspects of the ECL assays that ROCHE or
any of its Affiliates developed prior to the Effective Time;
(d) All aspects of the instruments or assays
that arose out of the Molecsys Program;
(e) The PCR Technology;
(f) The method of ROCHE or any of its Affiliates
for coating magnetic beads;
(g) The ECL module of the E-170 instrument; and
(h) All aspects of the ECL Technology and
Robotics that prior to the Effective Time Roche or any of its Affiliates used or
developed to be used in performing ECL testing; provided, however, that this
part (h) shall not include specific antibodies, antigens or other
analyte-specific reagents.
1.18 Robotics.
The term "Robotics" shall mean the components/features that are used in
ECL Instruments (as defined in the License Agreement) being sold by ROCHE or any
of its Affiliates at or prior to the Effective Time and that are described in
Exhibit B of the Covenants Not to Xxx, of even date herewith executed by NEWCO,
MSD, MST, ROCHE and Roche Holding Ltd (the "Covenants Not to Xxx").
1.19 ROCHE Licensed Patent Rights. The term "ROCHE
Licensed Patent Rights" shall mean rights arising out of or resulting from (i)
any and all U.S. and foreign patent applications and patents owned by Roche (or
its Affiliates), covering ROCHE Improvements; (ii) any other patent applications
or patents owned by ROCHE (or its Affiliates) relating to ECL Technology that
claim their earliest priority from a patent application filed on or before the
Effective Time; (iii) any other patents or patent applications that claim
priority to one or more of the patents or patent applications listed in Exhibit
D including corresponding foreign applications or patents; and any patents or
patent applications that claim priority to a priority application of one or more
of the patents and patent applications listed in Exhibit D including
corresponding foreign applications or patents; and (iv) any substitutions,
divisions, continuations, continuations in part, renewals, reissues,
confirmations or registrations of the patent applications and patents rights
described in Sections 1.19(i), (ii) and (iii) above listed and extensions of the
foregoing, now existing or hereafter filed. The ROCHE Licensed Patent Rights
include the patents and patent applications disclosed in Exhibit D (ROCHE
Patents and Patent
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Applications), the patents and patent applications identified as "jointly owned"
in Exhibit F and the PCR Technology.
1.20 ROCHE Licensed Technology. The term "ROCHE Licensed
Technology" shall mean so much of the technology, including without limitation,
patents, patent applications, techniques, designs, specifications, instruments,
compounds, devices, ideas, technical information, processes, schematics,
inventions, discoveries, methods, know-how, show-how, hardware and software
(including object codes and source codes) based on the ROCHE Improvements as is
proprietary to ROCHE (or its Affiliates) or licensed to ROCHE or its Affiliates
with the right to grant the license under Section 2.2(a) hereof (excluding
Hitachi Intellectual Property Rights), whether or not the same is eligible for
protection under the patent laws of the United States or elsewhere, and whether
or not any such processes and technology, or information related thereto, would
be enforceable as a trade secret or the copying of which would be enjoined or
restrained by a court as constituting unfair competition.
1.21 ROCHE Licensors. The term "ROCHE Licensors" shall
mean Hitachi and Affiliates of ROCHE that license ROCHE Licensed Patent Rights
or ROCHE Licensed Technology to ROCHE with right to sublicense to IGEN.
1.22 Term. The "Term" of this Agreement shall mean the
entire period of time this Agreement is in full force and effect and shall begin
at the Effective Time and terminate automatically upon the later of the (a)
expiration of the last-to-expire of any patent issued for ROCHE Licensed Patent
Rights or Hitachi Intellectual Property Rights, that is not earlier invalidated,
or its enforcement enjoined, by a final decision of a court of competent
jurisdiction from which no further appeal may be taken; and (b) complete loss of
confidential and proprietary status for all ROCHE Licensed Technology. The term
"Effective Time" shall have the meaning ascribed to that term in that certain
Merger Agreement of even date herewith by and among, inter alia, IGEN and Roche
Holding Ltd (the "Merger Agreement").
2. Grant and Scope of License.
2.1 Prior Agreement Superceded. The Parties agree that
this Agreement and the LLC License Agreement supercede in their entirety as of
the Effective Time the Prior Agreement and the License for Improvements dated
May 28, 2002, granted to IGEN by ROCHE pursuant to the Judgment.
2.2 Licenses.
(a) During the Term of this Agreement, and subject to the terms
and conditions of this Agreement, ROCHE and its Affiliates grant to IGEN an
irrevocable, perpetual, Non-Exclusive, worldwide, fully-paid, royalty-free right
and license (with the right to sublicense) under ROCHE Licensed Patent Rights
and ROCHE Licensed Technology, to develop, have developed, prepare derivative
works based on, reproduce, use, manufacture, have manufactured, distribute, have
distributed, display, perform,
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modify, import, sell, have sold, offer for sale, lease and otherwise
commercially exploit Products in all fields, including the Field. No license,
express or implied, is granted hereunder for use of the ROCHE Licensed Patent
Rights or ROCHE Licensed Technology for any products not using or incorporating
the ECL Technology.
(b) During the Term of this Agreement, and subject to the terms
and conditions of this Agreement, ROCHE and its Affiliates grant to IGEN an
irrevocable, perpetual, Non-Exclusive, worldwide, fully-paid, royalty-free right
and sublicense (with the right to sublicense) under Hitachi Intellectual
Property Rights, to develop, have developed, prepare derivative works based on,
reproduce, use, manufacture, have manufactured, distribute, have distributed,
display, perform, modify, import, sell, have sold, offer for sale, lease and
otherwise commercially exploit Products in all fields other than the Field. No
license, express or implied, is granted hereunder for use of the Hitachi
Intellectual Property Rights for (i) any products not using or incorporating the
ECL Technology or (ii) in any part of the Field.
2.3 Included/Excluded Rights.
(a) The rights and licenses granted in Section 2.2 hereof include:
(i) the right of IGEN to grant to its distributors, contract manufacturers, toll
manufacturers, component suppliers, leasing agents and other third parties
engaged by IGEN to assist IGEN in commercializing the intellectual property
rights licensed hereunder (the "Authorized Third Parties") immunity from suit
under the licensed intellectual property rights for use of the ECL Technology,
and (ii) the right of IGEN to grant immunity from suit under the licensed
intellectual property rights to IGEN's customers for use or subsequent sale of
the Licensed Products, in each case only as permitted within the limitations of
this Agreement. IGEN shall: (i) assure that the Authorized Third Parties' use of
the intellectual property rights licensed hereunder to IGEN is utilized by such
Authorized Third Parties only as permitted by this Agreement; and (ii) cause
each Authorized Third Party to assign to IGEN any and all intellectual property
rights to Roche Licensed Patent Rights, Roche Licensed Technology or Hitachi
Intellectual Property Rights which such Authorized Third Party may develop or
create. IGEN shall indemnify ROCHE and its Affiliates (and their respective
officers, directors, shareholders, representatives, employees, consultants and
agents and each of the heirs, executors, successors and assigns of the
foregoing) against any loss, cost, damage or liability (including reasonable
attorneys' fees) arising from IGEN's failure to perform its obligations under
the preceding sentence. In addition, any Authorized Third Party which does not
comply with (ii) above shall not benefit from the immunity from suit described
in this Section if such Authorized Third Party sues ROCHE or any of its
Affiliates or sublicensees to the extent such suit by such Authorized Third
Party is based on those intellectual property rights which should have been
assigned to IGEN in accordance with (ii) above.
(b) IGEN shall have no right to develop, use, manufacture, have
manufactured or sell assays that contain barcodes (or other labeling) which make
them useable on (i) ECL Instruments manufactured, sold or placed by ROCHE or its
licensees (excluding IGEN, its Affiliates, Sublicensees or Authorized Third
Parties) or resellers in the Field
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(unless such ECL Instrument is an Open System) or (ii) Copycat Instruments
manufactured by IGEN, its Affiliates, Sublicensees or Authorized Third Parties
which are used in the Field.
(c) No rights are licensed or deemed licensed to IGEN hereunder or
in connection herewith, other than those rights specifically licensed to IGEN in
Section 2.2 above and this Section 2.3.
2.4 Out-of-Field Licenses. Nothing contained in this
Agreement shall be construed to limit or restrict, in any way or manner, any
right of IGEN or its Affiliates or Sublicensees to use, license, transfer or
sell its owned or licensed intellectual property rights (excluding the rights
licensed to IGEN hereunder) anywhere in the world and/or for any purpose,
whether inside or outside the Field.
2.5 Sublicenses. IGEN shall have the right to grant
sublicenses to (i) any Affiliate of IGEN and (ii) other entities not being IGEN
Affiliates (such other entities being the "Sublicensees") on condition that the
sublicense is in writing and binds the IGEN Affiliate or Sublicensee to the
conditions applicable to IGEN under this Agreement and to the conditions
applicable for IGEN Affiliates and Sublicensees stated in this Agreement. IGEN's
Affiliates and Sublicensees shall have no right to sublicense to any third
party. IGEN shall cause each Affiliate or Sublicensee to assign to IGEN any and
all intellectual property rights to Roche Licensed Patent Rights, Roche Licensed
Technology or Hitachi Intellectual Property Rights which such Affiliate or
Sublicensee may develop or create. IGEN shall indemnify ROCHE and its Affiliates
(and their respective officers, directors, shareholders, representatives,
employees, consultants and agents and each of the heirs, executors, successors
and assigns of the foregoing) against any loss, cost, damage or liability
(including reasonable attorneys' fees) arising from IGEN's failure to perform
its obligations under the preceding sentence. IGEN shall provide ROCHE with a
copy of each sublicense granted by IGEN hereunder with respect to Hitachi
Intellectual Property Rights or PCR Technology within ten (10) days following
execution of such sublicenses. ROCHE may deliver copies of such sublicenses with
respect to Hitachi Intellectual Property Rights or PCR Technology to ROCHE
Licensors. IGEN shall ensure and be liable for full compliance therewith for its
permitted sublicensees. On a semi-annual basis, IGEN shall provide to each of
its Affiliates and Sublicensees, with a contemporaneous copy to ROCHE, a written
description of IGEN's obligations under this Agreement and the steps to be taken
by IGEN and its Affiliates and Sublicensees to ensure compliance with those
obligations. Contemporaneously with the delivery of such description, IGEN shall
notify ROCHE in writing of all sublicenses with Affiliates or Sublicensees.
2.6 Unauthorized Sales.
(a) The licenses to IGEN set forth in this
Agreement shall not include the right to manufacture, have manufactured, sell,
have sold, distribute, have distributed or otherwise commercialize any Copycat
Instrument in the Field ("Field Limitation"). ROCHE and IGEN will, within ninety
(90) days prior to the end of each calendar year, jointly engage a mutually
acceptable independent, neutral third party to
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monitor IGEN's compliance with the Field Limitation of its licenses granted
hereunder (the "Field Monitor"). The expense of the Field Monitor will be shared
equally by IGEN and ROCHE. IGEN will give the Field Monitor full access to such
records as are necessary for the Field Monitor to review placements and sales of
Copycat Instruments by IGEN and its affiliates, sublicensees, distributors and
agents to confirm whether the Parties are adhering to the Field Limitation
applicable to IGEN. Such examination shall be confidential and information
disclosed or reviewed shall not be disclosed to ROCHE except as is necessary for
the Field Monitor to report the results of the examination process. The Field
Monitor will be instructed to prepare and deliver a report to ROCHE and IGEN
within 90 days following the end of each calendar year. Such report will
identify all sales or placements of Copycat Instruments within the Field and
Products (e.g. assays) used on such Copycat Instruments in the Field
("Unauthorized Sales"). For purposes of this Section 2.6, references to IGEN,
either by name or as a "party" or "seller," shall include IGEN's affiliates,
sublicensees, Authorized Third Parties, distributors and agents that sell
Copycat Instruments and Products (e.g. assays) used on such Copycat Instruments
under the license granted hereunder.
(b) In the event of Unauthorized Sales, IGEN may
continue to sell such Copycat Instruments and Products until ROCHE notifies IGEN
in writing that it is prohibited from making any further such sales. In
addition, IGEN will pay to ROCHE within thirty (30) days after receiving the
Field Monitor's report 65% of all undisputed revenues earned through
Unauthorized Sales for the prior year. Except as provided below in Section 5.1,
the payment provisions of this Section 2.6(b) shall be the exclusive remedy of
ROCHE for Unauthorized Sales by IGEN under this Agreement. ROCHE shall have no
right to terminate this Agreement for Unauthorized Sales by IGEN, or its
affiliates or sublicensees.
2.7 Covenants. IGEN hereby covenants that it will not,
under any circumstances, actively advertise or market Copycat Instruments in the
Field.
3. Ownership.
3.1 ROCHE Retains Ownership. IGEN (for itself and its
Affiliates and Sublicensees) acknowledges and agrees that IGEN has no rights in
or to the intellectual property rights licensed to IGEN, other than the license
rights specifically granted herein. Nothing in this Agreement shall obligate
ROCHE or its Affiliates to obtain ownership of or sublicensing rights to
intellectual property rights obtained from or licensed from third parties.
4. [RESERVED].
5. Books Of Account.
5.1 Business Records. IGEN shall keep, and cause its
Affiliates and Sublicensees to keep complete and accurate sales and accounting
records and accounts of all uses of the PCR Technology and the Hitachi
Intellectual Property Rights in sufficient detail to enable ROCHE to confirm
that the use of the PCR Technology and the Hitachi
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Intellectual Property Rights by IGEN and its affiliates, sublicensees,
distributors and agents complies with the terms of this Agreement. Once each
year during the Term of this Agreement, ROCHE may designate an independent
certified public accountant reasonably acceptable to IGEN to conduct, during
normal business hours, an examination of the records referenced above. Such
examination shall be confidential, and the information disclosed shall not be
communicated to ROCHE except as is necessary for the accountant to report the
results of the examination process. Such accountants shall execute a
confidentiality agreement reasonably acceptable to IGEN. All records necessary
to confirm the extent of IGEN's Unauthorized Sales, if any, shall be made
available in Gaithersburg, Maryland upon request and reasonable advance notice.
If any audit conducted on behalf of ROCHE shows that IGEN, or any of its
affiliates, sublicensees, distributors or agents, underpaid amounts due to ROCHE
for Unauthorized Sales under Section 2.6, then IGEN shall immediately pay to
ROCHE any deficiency, with interest thereon calculated in accordance with
Section 5.3.
5.2 Retention. Records required to be maintained
hereunder shall be retained for not less than three (3) years.
5.3 Interest. All payments due hereunder from IGEN that
are not paid to ROCHE when due and payable as specified herein shall bear
interest, compounded monthly, at an annual rate equal to two percent (2%) above
the U.S. dollar reference rate ("prime rate") charged from time to time by
Citibank, N.A. (or a successor bank that is the largest bank headquartered in
New York City) from the date due until paid or at such lower rate as shall be
the maximum rate permitted by law.
6. Dispute Resolution; Venue And Choice Of Law.
6.1 Good Faith Resolution. In the event that at any time
during the Term of this Agreement a disagreement, dispute, controversy or claim
should arise out of or relating to the interpretation of this Agreement, or
performance by a Party under this Agreement, or a breach of this Agreement by a
Party, or any claim by a Party that any provision of this Agreement is invalid
(a "Dispute" or collectively "Disputes"), one Party shall give written notice to
the other Party that a dispute exists and the Parties will then attempt in good
faith to resolve their differences before resorting to arbitration provided in
Section 6.2. If the Parties cannot resolve the disputed matter within thirty
(30) days after such notice, then either Party shall be free to submit the
disputed matter to binding arbitration in accordance with Section 6.2 hereof.
For purposes of this Article 6, the terms "Party" and "Parties" shall include
each of the signatories to this Agreement and/or any one or more of their
respective Affiliates, whether the reference is to a Party as a claimant or a
Party against which a claim is made.
6.2 Arbitration.
(a) The Parties intend Section 6.2 hereof to be
enforceable in accordance with the Federal Arbitration Act (9 U.S.C. Section 1,
et seq.), including any amendments to that Act which are subsequently adopted,
notwithstanding any other choice of law provision set forth in this Agreement.
In the event that either Party refuses
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to submit to arbitration as required herein, the other Party may request a
United States District Court to compel arbitration in accordance with the
Federal Arbitration Act.
(b) Any dispute or other matter in question
between LLC and IGEN arising out of or relating to the formation,
interpretation, performance, or breach of this Agreement, whether such dispute
or matter arises before or after termination of this Agreement, shall be
resolved solely by arbitration if the Parties are unable to resolve the dispute
through negotiation pursuant to Section 6.1 hereof. Arbitration shall be
initiated by the delivery of a written notice of demand for arbitration by one
Party to the other. The date on which the other Party receives such written
notice shall be hereinafter referred to as the "Arbitration Notice Date."
(c) Each Party shall appoint an individual as
arbitrator and the two so appointed shall then appoint a third arbitrator. If
either Party refuses or neglects to appoint an arbitrator within thirty (30)
days after the Arbitration Notice Date, then the arbitration shall be conducted
by a single arbitrator appointed by the American Arbitration Association. If two
arbitrators are appointed but do not agree on the third arbitrator within sixty
(60) days after the Arbitration Notice Date, each of the arbitrators shall
nominate within sixty-seven (67) days after the Arbitration Notice Date three
individuals. Each arbitrator shall then within seventy-two (72) days after the
Arbitration Notice Date decline two of the nominations presented by the other
arbitrator. The third arbitrator shall then be chosen from the remaining two
nominations by drawing lots. Notwithstanding anything contained herein to the
contrary, if the third arbitrator is not chosen with seventy-two (72) days after
the Arbitration Notice Date, then the American Arbitration Association shall
appoint the third arbitrator within seventy-seven (77) days after the
Arbitration Notice Date. The arbitrators shall not be or have been affiliated
with, or have any personal, financial or business relationship with, either of
the Parties or any Affiliate of either Party; the arbitrators shall not have a
personal or financial interest in the result of the arbitration.
(d) The arbitration hearings shall be held in
Borough of Manhattan, State of New York or such other place as may be mutually
agreed by the Parties, shall be conducted in the English language and shall be
conducted as confidential proceedings (except to the extent necessary to enforce
the award resulting therefrom). Unless the Parties agree otherwise, the
arbitrators shall commence the arbitration hearing within thirty (30) days after
the selection of the third arbitrator. The arbitrators shall issue orders to
protect the confidentiality of proprietary information, trade secrets and other
sensitive information disclosed. Pending the arbitration hearing, at the request
of a Party, the arbitrators may issue temporary injunctive or other equitable
relief to address any violation or threatened violation of this Agreement. All
awards shall be made based on a majority vote of the arbitrators, shall be in
writing, shall not be considered confidential information of either Party, shall
be issued within sixty (60) days after hearings before the arbitrators are
completed, and shall state the reasoning on which the award rests unless the
Parties agree otherwise. In addition to any relief at law which may be available
to an aggrieved Party for such breach, such Party shall be entitled to
injunctive and other equitable relief as the arbitration panel may grant. The
arbitrators shall deliver a copy of the award to each Party personally or by
registered mail. Any
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party may request within ten (10) days after receiving the decision that, for
good cause, the arbitrators reconsider and modify such decision. The arbitrators
shall have thirty (30) days after such request to modify their decision, if they
consider it appropriate. Thereafter, the decision of the arbitrators shall be
final, binding and nonappealable, except to the extent appeals are permitted by
the Federal Arbitration Act, with respect to all persons, including (without
limitation) persons who have failed or refused to participate in the arbitration
process. Judgment upon the award rendered may be entered in any court having
jurisdiction thereof.
(e) Each Party shall bear its own costs in
connection with any such arbitration including, without limitation, (i) all
legal, accounting, and any other professional fees and expenses, (ii) the fees
and expenses of its own arbitrator, and (iii) all other costs and expenses each
Party incurs to prepare for such arbitration. Other than set forth above, each
side shall pay, (iv) one-half of the fee and expenses of the third arbitrator,
and (v) one-half of the other expenses that the Parties jointly incur directly
related to the arbitration proceeding.
(f) Except as provided above, arbitration shall
be based upon the Commercial Arbitration Rules of the American Arbitration
Association. Discovery shall be limited at the discretion of the arbitrators, so
that the timing and extent of such discovery shall not interfere with the normal
business operations of the Parties. The arbitrators may proceed to an award
notwithstanding the failure of either Party to participate in the proceedings.
(g) In the event of subsequent actions or
proceedings to confirm the award or to enforce the judgment entered thereon or
any other rights flowing therefrom, the prevailing Party shall be entitled to
recover its reasonable attorney's fees incurred in such actions or proceedings.
(h) The fact that the dispute resolution
procedures specified in this Article 6 shall have been or may be invoked shall
not excuse any Party from performing its obligations under this Agreement, and
during the pendency of any such procedure the Parties shall continue to perform
their respective obligations in good faith.
6.3 Limited Recourse to Courts. This Article 6 shall be
the exclusive dispute resolution procedure for Disputes under this Agreement and
no Party shall bring Disputes before any court, except as appeals to arbitration
awards are permitted by Section 6.2. Except as permitted by Section 6.2, the
Parties hereby waive any right to appeal an arbitration award to any court. The
provisions of Section 6.2 may be enforced, and judgment on the award (including
without limitation equitable remedies) granted in any arbitration hereunder may
be entered, in any court of competent jurisdiction. The Parties hereby submit to
the non-exclusive in personam jurisdiction of the federal courts in New York for
such purposes. THE PARTIES HEREBY WAIVE ANY AND ALL RIGHTS TO TRIAL BY JURY FOR
MATTERS RELATED TO DISPUTES SUBMITTED TO ANY COURT.
11
6.4 Governing Law. This Agreement is made in accordance
with and shall be governed and construed under the laws of the State of New
York, U.S.A., without regard to its conflicts of laws rules.
7. Term And Termination.
7.1 Term. This Agreement shall remain in full force and
effect for the Term.
7.2 No Termination for Cause. In the event IGEN breaches
any of its obligations hereunder, then ROCHE shall be entitled to seek and
obtain monetary damages, specific performance of this Agreement and/or
injunctive or other equitable relief, but ROCHE shall not be entitled to seek or
obtain a termination of this Agreement.
7.3 Effect of Expiration. Upon expiration of this
Agreement at the end of its Term, all licensed rights under Section 2 of this
Agreement shall cease. Notwithstanding any expiration, the provisions of
Sections 3, 5, 6, 7.3, 8, 9, 10, 11, 12, 13 and 14 shall survive.
7.4 Bankruptcy. IGEN shall retain the rights granted to
it as a licensee under Section 365(n) of the United States Bankruptcy Code in
case of the bankruptcy, insolvency or winding-up of ROCHE.
8. No Patent Warranty; Technology Exchange; Noninterference.
8.1 No Patent Warranty. ROCHE specifically excludes any
representation or warranty, express or implied, that ROCHE will successfully
obtain any patent.
8.2 Technology Exchange. IGEN and ROCHE agree and
acknowledge that the patents, patent applications, information and consulting
regarding the technology licensed hereunder heretofore delivered or provided to
IGEN through the Effective Time satisfies ROCHE's obligations to deliver such
material and provide such assistance as contemplated hereby or as required by
the Judgment. IGEN and ROCHE further acknowledge that ROCHE has no other
obligations to deliver such material or provide such assistance to IGEN.
8.3 Noninterference. In the event that any of the
Improvements is subject to contractual restrictions by third parties that limit
or prohibit IGEN from using such Improvements, ROCHE agrees not to interfere
with, but shall have no affirmative obligation to assist in, IGEN's efforts to
obtain a waiver of such contractual restrictions. Other than its seeking such
waiver, IGEN shall not interfere with ROCHE's relationship/contractual
arrangements with such third parties in IGEN's efforts to obtain such waiver. In
addition, in the event that ROCHE or any of its Affiliates has an exclusive
supplier or vendor, on IGEN's written request, ROCHE agrees to waive such
exclusivity with respect to IGEN and its Affiliates for the commercialization of
Products by IGEN and its Affiliates pursuant to this Agreement, but ROCHE shall
not be required to waive such exclusivity with respect to other parties. The
provisions of the foregoing
12
sentence shall not apply to require ROCHE to waive its exclusive supply
arrangement with Hitachi for ECL Instruments (as defined in the License
Agreement).
9. Indemnification, Liability, Infringement.
9.1 Defense of Third Party Infringement Actions. If the
manufacture, production, sale, or use of any Licensed Product results in a
claim, suit or proceeding brought by a third party (each, an "Action") alleging
patent infringement against ROCHE or IGEN (or any of their respective
Affiliates), such Party shall promptly notify in writing the other Party. The
Party subject to such Action (the "Controlling Party") shall have the exclusive
right and obligation to defend and control the defense of any such Action using
counsel of its own choice; provided that the Controlling Party shall not enter
into any settlement of such Action without the written consent of the other
Party, which consent may be withheld in the unfettered discretion of the other
Party if such settlement admits the invalidity or unenforceability of any patent
rights of the other Party, and otherwise may not be unreasonably withheld. The
Controlling Party agrees to keep the other Party reasonably informed of all
material developments in connection with any Action.
9.2 Suits for Infringement by Others. In the event either
Party becomes aware of any actual or threatened infringement of any intellectual
property rights licensed under this Agreement by any third party, that Party
shall promptly notify the other Party, and the Parties shall discuss the most
appropriate action to take. ROCHE shall have the sole right to bring, at its own
expense, an infringement action against the third party infringer and shall be
entitled to keep any awards made in such proceeding. IGEN may elect to appear as
a Party to the suit and shall, at Roche's request, assist Roche without expense
to Roche.
13
9.3 Product Liability Indemnity. IGEN expressly and
unequivocally agrees to and hereby does indemnify, release, defend and hold
ROCHE (and its Affiliates, sublicensees and licensors and their respective
officers, directors, shareholders, representatives, employees, consultants and
agents and each of the heirs, executors, successors and assigns of the
foregoing) harmless from and against all claims, damages, losses, costs and
expenses, including reasonable attorneys' fees, arising in favor of any person,
firm or corporation resulting from or arising out of liability in any way
relating to the Licensed Products sold, placed or otherwise commercialized by
IGEN, or its Affiliates, Sublicensees or Authorized Third Parties, including
without limitation, the manufacture, packaging, use, sale or other distribution
of Licensed Products by IGEN or its Affiliates or sublicensees, or any
representation made or warranty given by IGEN with respect to any Licensed
Product provided that ROCHE (a) gives IGEN notice of such claim, (b) cooperates
with IGEN, at IGEN's expense, in the defense of such claim, and (c) gives IGEN
the right to control the defense and settlement of any such claim, except that
IGEN shall not enter into any settlement that affects ROCHE's rights or interest
without ROCHE's prior written approval. ROCHE shall have no authority to settle
any claim on behalf of IGEN. IGEN also agrees to maintain proper product
liability insurance policies, reasonably acceptable to ROCHE everywhere it sells
Licensed Products and to furnish satisfactory evidence of same upon request by
ROCHE from time to time.
9.4 Waiver of Claims. IGEN shall not assert, and IGEN
shall ensure that its Affiliates and Sublicensees do not assert, any claims
against ROCHE and its licensors (including ROCHE Licensors) for any matter for
which IGEN has provided indemnity to ROCHE under Sections 9.3 and 9.5 hereof.
IGEN shall indemnify, hold harmless and defend ROCHE and its licensors
(including ROCHE Licensors) against any such claims.
9.5 Breach by Affiliate, Sublicensee or Authorized Third
Party. Failure of an Affiliate, Sublicensee or Authorized Third Party to adopt
and satisfy a condition stated in this Agreement applicable to IGEN, an
Affiliate, Sublicensee or Authorized Third Party, as the case may be, shall be
considered a breach of this Agreement by IGEN. IGEN and such Affiliate or
Sublicensee shall be jointly and severally responsible for and indemnify ROCHE
and its Affiliates (and their respective officers, directors, shareholders,
representatives, employees, consultants and agents and each of the heirs,
executors, successors and assigns of the foregoing) against any loss, cost,
damage or liability (including reasonable attorneys' fees) arising from the
breach by such Affiliate or Sublicensee of this Agreement. IGEN shall indemnify
ROCHE and its Affiliates (and their respective officers, directors,
shareholders, representatives, employees, consultants and agents and each of the
heirs, executors, successors and assigns of the foregoing) against any loss,
cost, damage or liability (including reasonable attorneys' fees) arising from
the failure by an Authorized Third Party to adopt and satisfy a condition stated
in this Agreement applicable to Authorized Third Parties.
9.6 Title and Authority. ROCHE hereby represents and
warrants to IGEN that: (i) ROCHE has the requisite corporate power and authority
to enter into this Agreement and to grant the license to IGEN under ROCHE
Licensed Patent Rights,
14
ROCHE Licensed Technology and Hitachi Intellectual Property Rights hereunder and
fully perform its obligations hereunder, and that the grant of the rights and
licenses, and the performance of its obligations hereunder, will not conflict
with its charter documents or any agreement, contract or other arrangement to
which it is a party or by which it is bound; (ii) ROCHE has title to or license
rights in such licensed intellectual property rights sufficient to grant such
license rights to IGEN and its Affiliates; (iii) ROCHE has not assigned,
transferred, licensed or otherwise disposed of such licensed intellectual
property rights in any manner that limits or restricts IGEN's or its Affiliates'
exploitation of the license granted by ROCHE hereunder; (iv) no consent, notice,
approval, authorization, waiver, or permit, to or from any person, including,
but not limited to, any Governmental Entity or third party holder of
intellectual property rights, is required to be obtained or made by ROCHE in
connection with its execution, delivery and performance of this Agreement; and
(v) Exhibit F includes all Hitachi patents and patent applications which ROCHE
has the right to sublicense to IGEN, and that ROCHE has no other rights to
Hitachi patents and patent applications which ROCHE has the right to sublicense
to IGEN.
9.7 Completeness of Exhibit X. XXXXX hereby represents
and warrants to IGEN that the Exhibit D includes all patents and patent
applications which: (a) exist at or prior to the Effective Time; (b) are owned
and/or controlled by ROCHE and/or any Affiliate thereof; and (c) satisfy the
definition of ROCHE Improvements (other than PCR Technology or Hitachi
Intellectual Property Rights). If, after the Effective Time, it is discovered
that ROCHE has breached any of its representations and warranties under this
Section 9.7 and additional patents or patent applications should have been or
should be included in the patents and patent applications set forth in the
Exhibit D, then (i) such additional patent and patent applications shall be
deemed automatically included in Exhibit D, as of the Effective Time, without
any amendment of this Agreement or other further action required of the Parties,
and (ii) IGEN shall hold a license to such additional patents and patent
applications under and in accordance with the terms of this Agreement, as of the
Effective Time. The foregoing shall be IGEN's exclusive remedy for a breach by
ROCHE of the representations and warranties in this Section 9.7.
9.8 Indemnity. ROCHE hereby agrees to indemnify and hold
harmless IGEN, its Affiliates and any sublicensee (and their respective
directors, officers, employees, consultants and agents and each of their heirs,
executors, successors and assigns of the foregoing) (collectively the
"Indemnitees") against all losses, claims, damages, liabilities, fees and
expenses (including reasonable attorneys' fees), judgments, fines and amounts
paid in settlement (in the case of settlements with the approval of IGEN (which
approval shall not be unreasonably withheld)) incurred by or imposed upon the
Indemnitees (or any one of them), as a result of a breach by ROCHE of any of
ROCHE's representations and warranties in Section 9.6; provided, that IGEN: (a)
gives ROCHE notice of such claim, (b) cooperates with ROCHE, at ROCHE's expense,
in the defense of such claim, and (c) gives ROCHE the right to control the
defense and settlement of any such claim, except that ROCHE shall not enter into
any settlement that affects IGEN's rights or interest without IGEN's prior
written approval. IGEN shall have no authority to settle any claim on behalf of
ROCHE.
15
10. Disclaimer Of Warranties; Further Action.
10.1 Disclaimer. EXCEPT AS OTHERWISE PROVIDED HEREIN (E.G.
SECTIONS 9.6, 9.7 and 9.8 REPRESENTATIONS, WARRANTIES AND INDEMNIFICATIONS) The
INTELLECTUAL PROPERTY Rights LICENSED HEREUNDER are provided BY ROCHE "as is
where is" and ROCHE MAKES NO, AND DISCLAIMS ALL WARRANTIES AND REPRESENTATIONS,
EXPRESS OR IMPLIED, CONCERNING: (a) LICENSED INTELLECTUAL PROPERTY RIGHTS
COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED
WARRANTY OF DESIGN, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO
LICENSED INTELLECTUAL PROPERTY RIGHTS OR ANY PRODUCT; (b) THE COMMERCIAL SUCCESS
OF ANY PRODUCT; (c) THE EXISTENCE, VALIDITY OR SCOPE OF LICENSED INTELLECTUAL
PROPERTY RIGHTS; (d) ANY PRODUCT BEING FREE FROM AN INFRINGEMENT ON PATENTS OR
OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES; (e) WHETHER ANY THIRD
PARTIES ARE IN ANY WAY INFRINGING LICENSED INTELLECTUAL PROPERTY RIGHTS COVERED
BY THIS AGREEMENT; OR (f) THE ACCURACY, UTILITY OR SUFFICIENCY OF ANY TECHNICAL
INFORMATION TRANSFERRED TO IGEN HEREUNDER. THE PARTIES SPECIFICALLY AGREE THAT
NEITHER PARTY SHALL BE SUBJECT TO AND THAT EACH DISCLAIMS: (A) ANY OTHER
OBLIGATIONS OR LIABILITIES ARISING OUT OF BREACH OF WARRANTY, AND (B) ALL
CONSEQUENTIAL, INCIDENTAL, CONTINGENT, PUNITIVE AND EXEMPLARY DAMAGES WHATSOEVER
WITH RESPECT TO (i) ANY DISPUTES BETWEEN THE PARTIES UNDER THIS AGREEMENT OR
(ii) CLAIMS MADE BY ONE PARTY AGAINST ANOTHER PARTY ARISING FROM THE COURSE OF
CONDUCT WITHIN THE RELATIONSHIP OF THE PARTIES UNDER THIS AGREEMENT (WHETHER
SUCH CLAIMS ARISE UNDER CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE), EVEN
THOUGH A PARTY MAY HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE
LIMITATION OF DAMAGES IN CLAUSE (B) ABOVE SHALL NOT APPLY TO DAMAGES PAID TO
UNRELATED THIRD PARTIES (WHETHER PURSUANT TO JUDGMENT OR SETTLEMENT) FOR WHICH A
PARTY HAS AN OBLIGATION TO INDEMNIFY THE OTHER PARTY HEREUNDER.
10.2 Export Control. IGEN agrees, and shall cause its
Affiliates and Sublicensees to agree, to abide by all laws and regulations of
the United States Government, or the government having jurisdiction therefor,
governing the export or re-export of any Licensed Products. IGEN shall inform
itself as to the details of such laws and regulations and their amendments.
10.3 Additional Documents. Each Party agrees to execute
such further papers or agreements as may be necessary to effect the purposes of
this Agreement.
10.4 Governmental Approvals and Marketing of Licensed
Products. IGEN shall be responsible for obtaining all necessary governmental
approvals for the development, production, distribution, sale and use of any
Licensed Product, at IGEN's
16
expense, including, without limitation, any safety studies. IGEN shall have sole
responsibility for any warning labels, packaging and instructions as to the use
of Licensed Products and for the quality control for any Licensed Product.
10.5 Patent Marking and Labeling. IGEN shall xxxx all
Licensed Products, or their containers, in accordance with the applicable patent
marking laws. IGEN shall xxxx/label conspicuously all Licensed Products
utilizing or intended for use with the PCR Technology made by or for it for use
in the diagnostic field or the research field, and shall cause each of its
Affiliates and Sublicensees to xxxx conspicuously all such Licensed Products,
with a label license bearing one of the following legends, as the case may be
depending on whether the Licensed Product is sold for use in the diagnostic
field or the research field:
LEGEND FOR USE ON LICENSED PRODUCTS DESIGNED AND SOLD FOR USE IN
DIAGNOSTIC FIELD.
NOTICE TO PURCHASER: LIMITED LICENSE
The purchase of this product allows the purchaser to use it solely for
amplification by PCR of nucleic acid sequences and detection by ECL
Technology for diagnostic uses. No general patent or other license of
any kind other than this specific right of use from purchase is granted
hereby.
LEGEND FOR USE ON LICENSED PRODUCTS DESIGNED AND SOLD FOR USE IN
RESEARCH FIELD.
NOTICE TO PURCHASER: LIMITED LICENSE
A license under U.S. Patents 4,683,202, 4,683,195 and 4,965,188 or
their foreign counterparts, owned by ROCHE Molecular Systems, Inc. and
X. Xxxxxxxx-Xx XXXXX Ltd ("XXXXX"), has an up-front fee component and a
running-royalty component. The purchase price of this product includes
limited, nontransferable rights under the running-royalty component to
use only this amount of the product to practice the Polymerase Chain
Reaction ("PCR") and related processes described in said patents solely
for the research and development activities of the purchaser when this
product is used in conjunction with a thermal cycler whose use is
covered by the up-front fee component and a detection system based on
ECL Technology. Rights to the up-front fee component must be obtained
by the end user in order to have a complete license. These rights under
the up-front fee component may be purchased from Applied Biosystems or
obtained by purchasing an Authorized Thermal Cycler. No right to
perform or offer commercial services of any kind using PCR, including
without limitation reporting the results of purchaser's activities for
a fee or other commercial consideration, is hereby granted by
implication or estoppel.
17
10.6 No Use of Names. Except as required by Section 10.5
hereof, neither IGEN nor any of its Affiliates or Sublicensees shall have the
right to use any of the names "ROCHE," "ROCHE DIAGNOSTICS," "HITACHI," "ELECSYS"
or any variation thereof, or any other corporate name, trade name, trademark,
service name, service xxxx or brand name proprietary to ROCHE or any ROCHE
Licensor or any of their respective Affiliates, in connection with the
advertising, sale, lease or use of Licensed Products.
11. Confidentiality. ROCHE and IGEN agree for themselves and their
Affiliates, and on behalf of their respective officers, employees and agents,
that until the later of (i) 10 years from the Effective Time hereof or (ii) 5
years after the expiration date of this Agreement (in perpetuity as to
confidential and proprietary information of Hitachi, or such shorter period as
Hitachi agrees with IGEN in writing or to which ROCHE is subject), each will
treat as confidential, using the same degree of care as it uses for its own
confidential and proprietary information, but in no event less than reasonable
care, and shall not disclose to any third party, and shall not use for its own
benefit or the benefit of any third party (except as permitted hereunder,
including disclosures to IGEN Affiliates and permitted sublicensees or
subcontractors to the extent necessary to have Products manufactured and subject
to confidentiality obligations at least as restrictive as those contained
herein) the ROCHE Licensed Patent Rights, ROCHE Licensed Technology or Hitachi
Intellectual Property Rights (and any other information marked as confidential,
and reports generated by the Field Monitor or accountant pursuant to Sections
2.6 and 5.1) furnished to it by the other Party unless the furnishing party
("Discloser") otherwise agrees in writing or unless such information clearly and
convincingly falls within the following exceptions:
(a) Such confidential information was known to the
receiving party ("Recipient") prior to the time of disclosure by the Discloser
or was in the public domain at the time of disclosure by Discloser as can be
documented by written records; or
(b) Such confidential information is or becomes publicly
known after disclosure by Discloser through no fault or omission attributable to
Recipient; or
(c) Such confidential information is given to Recipient
from sources independent of Discloser who have the right to disclose it; or
(d) Such confidential information is independently
developed by employees of Recipient that did not have access to it as can be
documented by written records; or
(e) Recipient is required to disclose such confidential
information to a court of law or to appropriate governmental agencies to enable
Recipient to carry out the evaluation of a Product or to secure a governmental
approval, or as otherwise required by law; provided, however, that (1) Recipient
gives the Discloser prompt written notice of such required disclosure and
reasonably assists the Discloser in
18
its efforts to prevent or limit such disclosure; and (2) any confidential
information disclosed pursuant to this Section 11(e) shall otherwise remain
confidential information for the purposes of this Agreement.
For purposes of this License, ROCHE's confidential information
shall include (subject to the exclusions in (a)-(e) above) all information
relating to the ROCHE Licensed Patent Rights, ROCHE Licensed Technology and
Hitachi Intellectual Property Rights whether such information is owned by ROCHE
or ROCHE Licensors and whether disclosed to IGEN by ROCHE or any ROCHE Licensor
before or after the Effective Time. Furthermore, each Party's confidential
information hereunder shall include all confidential information of such Party
disclosed to the other Party under the Prior Agreement or the Judgment. Access
to such confidential information must be restricted to the Recipient's,
sublicensee's, or subcontractor's employees or agents with a need to have
access. The Recipient acknowledges that by virtue of this Agreement it acquires
only such rights as set forth under the terms and conditions of this Agreement
and only so long as it is in effect and does not acquire any rights of ownership
or title in the Discloser's confidential information. In addition, each of the
Parties agrees to execute appropriate confidentiality agreements with third
party collaborators of such Party prior to disclosing the other party's
confidential information to such third party collaborator. Upon expiration of
this Agreement, each Party, its sublicensees, subcontractors and their employees
and agents shall immediately discontinue use of the other's confidential
information, except as otherwise permitted under the provisions hereof. The
Parties agree that this Section 11 sets out in its entirety the Parties'
confidentiality obligations with respect to the subject matter of this
Agreement, and that this Section 11 shall supercede in its entirety as of the
Effective Time all prior confidentiality agreements or arrangements with respect
to the subject matter of this Agreement between or among the Parties and their
Affiliates (including confidentiality agreements or arrangements between IGEN
and Roche Diagnostics GmbH and its Affiliates).
12. License Registration. IGEN shall pay all costs and legal fees
connected with registration of this Agreement in those countries where it (or
its Affiliates, Sublicensees, distributors and/or agents) sells Licensed
Products, where required, and shall otherwise ensure that the laws of all the
countries where sales of its Licensed Products occur are fully satisfied. None
of such amounts shall be deductible against amounts payable to ROCHE hereunder.
ROCHE shall provide reasonable assistance to IGEN in effecting such
registrations if IGEN reimburses any out-of-pocket expenses incurred in
providing such assistance.
13. Interests in Intellectual Property Rights.
13.1 Preservation of Title. IGEN acknowledges that ROCHE,
its Affiliates and ROCHE Licensors, where applicable, shall retain full
ownership and title to the intellectual property rights it licenses to IGEN
hereunder and that IGEN has no rights in or to such intellectual property rights
other than the express license rights specifically confirmed herein. Neither
IGEN nor any of IGEN's employees, Affiliates and Sublicensees, or any of their
respective employees, have rights under this Agreement to practice or use the
ROCHE Licensed Patent Rights, ROCHE Licensed Technology or
19
Hitachi Intellectual Property Rights to develop, manufacture, sell or otherwise
commercialize products not based on the ECL Technology or, with respect to the
Hitachi Intellectual Property Rights, to copy, make, have made, use and/or sell
Products in the Field.
13.2 Hitachi Interest. Hitachi, as subcontractor for
ROCHE, owns the Hitachi Intellectual Property Rights that have been licensed to
ROCHE for sublicense to IGEN.
13.3 Reservation of Rights. ROCHE reserves the right to
use for any purpose (commercial or noncommercial), anywhere in the world, and
the right to allow other parties to use for any purpose, anywhere in the world,
any ROCHE Licensed Patent Rights and ROCHE Licensed Technology licensed
hereunder, without ROCHE or such other parties being obligated to pay IGEN any
royalties or other compensation. Without limiting the generality of the
foregoing, ROCHE reserves the right to license any Party to use the ROCHE
Improvements in non-ECL Technology applications and in any fields, including
without limitation all fields outside the Field.
14. Miscellaneous.
14.1 Waiver. No delay or omission on the part of either
Party to this Agreement in requiring performance by the other Party or in
exercising any right hereunder shall operate as a waiver of any provision hereof
or of any right or rights hereunder; and the waiver, omission or delay in
requiring performance or exercising any right hereunder on any one occasion
shall not be construed as a bar to or waiver of such performance or right, or of
any right or remedy under this Agreement, on any future occasion. Any agreement
on the part of either Party to any such extension or waiver shall be valid only
if set forth in an instrument in writing signed on behalf of such Party.
14.2 Assignment. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their permitted successors and
assigns; provided, however, that: (a) neither Party shall assign any of its
rights and obligations hereunder except as consented to by the other Party,
which consent shall not be unreasonably withheld, and (b) such consent shall not
be required with respect to an assignment of (i) any or all of its rights and
obligations hereunder to an Affiliate of such assigning party; or (ii) all (but
not less than all) of its rights and obligations hereunder to an acquirer of all
or substantially all of the assets or business of the assigning party related to
such party's use of ECL Technology, whether as incident to a merger,
consolidation, reorganization, acquisition or otherwise. In addition, IGEN may
assign, without Roche's consent, all of its rights under this Agreement to IGEN
Integrated Healthcare, LLC ("NEWCO") as a part of the transactions contemplated
by the Merger Agreement. Whenever there has been an assignment or a sublicense
by IGEN or ROCHE, as the case may be, as permitted by this Agreement, the term
"IGEN" or "ROCHE" as used in this Agreement shall also include and refer to, if
appropriate, such assignee or sublicensee.
14.3 Notices. Any notice or other communication required
or permitted to be given to either Party hereto shall be in writing and shall be
deemed to have been
20
properly given and to be effective on the date of delivery if delivered in
person or by facsimile (with electronic confirmation of receipt and with a
confirmation copy sent by internationally-recognized air courier service), to
such Party at the following address:
In the case of IGEN:
IGEN International, Inc.
00000 Xxxxxxxxxx Xxxxx
Xxxxxxxxxxxx, Xxxxxxxx 00000
Xxxxxx Xxxxxx of America
Attention: President
Fax No.: 0-000-000-0000
With a copy to IGEN's designated legal counsel.
In the case of ROCHE:
ROCHE Diagnostics GmbH
Xxxxxxxxx Xxxxxxx 000
X-00000 Xxxxxxxx
Xxxxxxx Xxxxxxxx of Germany
Attention: Legal Department
Fax No.: 000-00-000-000-0000
With a copy to Roche's designated legal counsel.
Either Party may change its address for communications by a
notice to the other Party in accordance with this Section.
14.4 Headings. The headings of the several sections are
inserted for convenience of reference only and are not intended to be a part of
or to affect the meaning or interpretation of this Agreement.
14.5 Force Majeure. Any delays in performance by any Party
under this Agreement (other than a Party's failure to make payments hereunder)
shall not be considered a breach of this Agreement if and to the extent caused
by occurrences beyond the reasonable control of the Party affected, including
but not limited to acts of God, embargoes, governmental restrictions, strikes or
other concerted acts of workers, fire, flood, explosion, riots, wars, civil
disorder, rebellion or sabotage. The Party suffering such occurrence shall
immediately notify the other Party and any time for performance hereunder shall
be extended by the actual time of delay caused by the occurrence.
14.6 Independent Contractors. In granting, performing or
exercising rights under this Agreement, ROCHE and IGEN act and shall act at all
times as independent contractors and nothing contained in this Agreement shall
be construed or implied to create an agency, partnership or employer and
employee relationship between
21
IGEN and ROCHE. At no time shall one Party make commitments or incur any charges
or expenses for or in the name of the other Party.
14.7 Severability. If, under applicable law, any term,
condition or provision of this Agreement is held invalid or unenforceable, or
otherwise directly or indirectly affects the validity of any other material
provision(s) of this Agreement (the "Severed Clause"), then this Agreement shall
remain in full force and effect, except for the Severed Clause. The Parties
agree to renegotiate in good faith the Severed Clause and be bound by the
mutually agreed substitute provision.
14.8 Interpretation. The official text of this Agreement
shall be English. For purposes of this Agreement, except as otherwise expressly
provided or unless the context otherwise requires:
(a) the terms of this Agreement do not amend or
supersede, and shall not be used to interpret, the
terms of the License Agreement, as of the date
hereof, by and between IGEN and IGEN LS LLC, the
Covenants Not to Xxx, the License Agreement (Human
IVD, Veterinary IVD, HLA Typing, Paternity, DNA
Manufacturing and Plasma Testing), dated as of the
date hereof, by and among NEWCO, X. Xxxxxxxx-Xx Xxxxx
Ltd ("Roche/Basle"), ROCHE and Roche Molecular
Systems, Inc. ("Roche/USA"), or the License Agreement
(Human IVD Services and Animal Diagnostic Services),
dated as of the date hereof, by and among NEWCO,
Roche/Basle, ROCHE and Roche/USA;
(b) the terms defined in this Agreement have the
meanings assigned to them in this Agreement and
include the plural as well as the singular, and the
use of any gender herein shall be deemed to include
the other gender;
(c) references herein to "Sections,"
"Subsections," "Paragraphs," and other subdivisions
without reference to a document are to designated
Sections, Subsections, Paragraphs and other
subdivisions of this Agreement;
(d) a reference to a Subsection without further
reference to a Section is a reference to such
Subsection as contained in the same Section in which
the reference appears, and this rule shall also apply
to Paragraphs and other subdivisions;
(e) the words "herein," "hereof," "hereunder,"
and other words of similar import refer to this
Agreement as a whole and not to any particular
provision;
(f) the term "include" or "including" shall mean
"including without limitation";
22
(g) the term "to the extent" shall mean the
degree to which a subject or other thing extends, and
such phrase shall not mean simply "if";
(h) the term "or" is not exclusive; and
(i) the Exhibits, Appendices and Annexes to this
Agreement are hereby incorporated and made a part
hereof and are an integral part of this Agreement.
14.9 Cumulative Rights. The rights, powers and remedies
hereunder shall be in addition to, and not in limitation of, all rights, powers
and remedies provided at law or in equity. All of such rights, powers and
remedies shall be cumulative, and may be exercised successively or cumulatively.
14.10 Entire Agreement; Amendment. This Agreement and any
and all Schedules and Appendices referred to herein, together with the other
agreements referenced herein and the Transactions Agreements (as defined in the
Merger Agreement), embody the entire understanding of the Parties with respect
to the subject matter hereof and shall supersede all previous communications,
representations or understandings, either oral or written, between the Parties
relating to the subject matter hereof. This Agreement shall not be amended,
altered or changed except by a written agreement signed by all of the Parties
hereto.
14.11 No Third Party Beneficiary Rights. Except for the
provisions of Section 2.3(a) relating to immunity from suit and Article 9
relating to Indemnitees, nothing contained in this Agreement is intended to
confer upon any person other than the Parties hereto and their respective
successors and permitted assigns, any benefit, right or remedy under or by
reason of this Agreement.
14.12 Counterparts. This Agreement may be executed in one
or more counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
[Remainder of Page Intentionally Left Blank]
23
IN WITNESS WHEREOF, both ROCHE and IGEN have executed this
Agreement, in duplicate originals, by their respective officer hereunto duly
authorized, as of the day and year hereinabove written.
ROCHE DIAGNOSTICS GMBH IGEN INTERNATIONAL, INC.
By: /s/ X.X. Xxxxxxx By: /s/ Xxxxxxx X. Xxxxxx
(Signature) (Signature)
Claus-Xxxxx Xxxxxxx Xxxxxxx X. Xxxxxx
(Printed Name) (Printed Name)
General Counsel President and Chief Operating
Officer
(Title) (Title)
7/24/2003 7/24/2003
(Date) (Date)
And
By: /s/ Xxxxx Von Prondzynski
(Signature)
Xxxxx Von Prondzynski
(Printed Name)
Authorized Signatory
(Title)
7/24/2003
(Date)
[Signature Page to Improvements License Agreement]
24
EXHIBIT D
(Refer to Section 1.19)
Disclosure of ROCHE Patents and Patent Applications
[Attached]
ROCHE covenants and agrees that this Exhibit D shall be deemed to include
patents, patent applications and patent rights, to the extent it is subsequently
determined that such patents, patent applications and patent rights are within
the term "Roche Licensed Patent Rights."
EXHIBIT E
(Refer to Section 1.14)
Disclosure of PCR Patent and Patent Applications
[Attached]
EXHIBIT F
(Refer to Section 1.7)
Disclosure of Hitachi Patents and Patent Applications
[Attached]
