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Exhibit 10.21
REDACTED FOR
CONFIDENTIALITY
Execution Copy
CONFIDENTIAL TREATMENT
REQUESTED
The asterisked portions of this document have been
omitted and are filed separately with the Securities and
Exchange Commission
AMENDMENT NO. 3 TO COLLABORATION AND LICENSE AGREEMENT
This amendment (the "Amendment") is made this 28 day of July, 1999,
among SmithKline Xxxxxxx Corporation, a Pennsylvania corporation with offices
at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, XXX (hereunder "SB
Corporation"): SmithKline Xxxxxxx plc. an English corporation with offices at
Xxx Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxxx (hereinafter "SB
plc"). Quest Diagnostics Incorporated, a Delaware corporation with offices at
Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 (hereinafter "Quest Diagnostics"),
diaDexus LLC, a Delaware limited liability company with offices at 0000
Xxxxxxxx Xxxxx, Xxxxx Xxxxx, XX 00000 (hereinafter "diaDexus") and Incyte
Pharmaceuticals, Inc, a Delaware corporation with offices at 0000 Xxxxxx Xxxxx,
Xxxx Xxxx, XX 00000 (hereinafter "Incyte").
WITNESSETH:
WHEREAS, SB Corporation, SB plc, diaDexus and Incyte are parties to that
certain Collaboration and License Agreement dated September 2, 1997, as amended
(the "Collaboration Agreement");
WHEREAS, pursuant to the terms of the Collaboration Agreement, diaDexus
and Incyte granted SB Corporation and SB plc certain beneficial rights (the
"diaDexus Rights") that relate to the conduct of the business of SmithKline
Beechan Clinical Laboratories ("SBCL");
WHEREAS, SB Corporation and SB plc have entered into that certain Stock
and Asset Purchase Agreement dated February 9, 1999 (hereinafter the "Stock and
Asset Purchase Agreement") pursuant to which SB plc has agreed to sell its
interest in SBCL to Quest;
WHEREAS, in connection with the Stock and Asset Purchase Agreement, SB plc
has agreed to use its reasonable best efforts to assign the diaDexus Rights to
Quest; and
WHEREAS, SB Corporation, SB plc, Incyte, diaDexus and Quest desire to
assign the diaDexus Rights to Quest and otherwise amend the Collaboration
Agreement in accordance with the terms and conditions of this Amendment.
NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein and other good and valuable consideration, the receipt and
adequacy of which is hereby acknowledged, the parties as follows:
1. DEFINITIONS.
1.1 All capitalized words used herein shall have the meaning set forth in
the Collaboration Agreement, except as expressly otherwise defined herein.
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1.2 The definition of "Affiliate" is hereby deleted in its entirety and
replaced with the following:
"Affiliate(s)": shall mean individually and collectively
Incyte Affiliates, DiaDexus Affiliates, SB Affiliates and
Quest Affiliates, as the case may be. For the purposes of
this Agreement, DiaDexus shall not be an Affiliate of
either SB or Incyte.
1.3 "Quest" shall mean Quest Diagnostics and any Quest Affiliates to
which any rights or obligations shall be assigned and/or delegated pursuant to
the Collaboration Agreement.
1.4 "Quest Affiliate": shall mean (i) each of those entities listed on
Appendix A hereto for so long as each such entity continues to be owned by
Quest in at least the amounts set forth on Appendix A and (ii) any corporation,
firm, partnership or other legal entity, which is directly or indirectly owned,
by Quest to the extent of which the common stock or other equity ownership
thereof is one hundred percent (100%) owned by Quest; provided however that
where local laws require a minimum percentage of local ownership, the status of
a Quest Affiliate will be established if Quest directly or indirectly owns or
controls one hundred percent (100%) of the maximum ownership percentage that
may, under such local laws, be owned or controlled by foreign interests.
1.5 "Clinical Laboratory Services": shall mean clinical laboratory,
anatomic pathology or other diagnostics testing services (including, without
limitation, routine and esoteric clinical laboratory services (including
genetics testing), clinical laboratory services involved with clinical trials,
point-of-care testing, clinical laboratory services involving corporate
healthcare and services involved with managing hospital laboratories)
or providing to any unaffiliated person, in any manner, directly or
indirectly, data or information products or services which substantially
consists of laboratory data.
1.6 The definition of "Clinical Diagnostic(s)" is hereby deleted in its
entirety and replaced with the following:
"Clinical Diagnostic(s)" ("cDx"): shall mean test(s)
performed on a human tissue or other human biological
sample, the results of which are provided to payors,
providers, or patients for use in the clinical management of
individual patients, which become part of such patient's
health record; provided, however, that Clinical Diagnostics
shall expressly exclude test(s) performed on human tissue or
other human biological sample in the course of Phase I, II,
III or IV clinical trials for an ethical pharmaceutical.
1.7 The definition of "Homebrew Territory," as it related to Quest, shall
mean the countries and territories that would be considered Quest's Homebrew
Territory if
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Quest was a Party to the Collaboration Agreement (i.e., reading all references
to "a Party" to include "Quest" in such definition).
1.8 The definition of "Research Diagnostics" is hereby deleted in its
entirety and replaced by the following:
"Research Diagnostic(s)" ("rDx"): shall mean test(s)
performed on a commercial basis on a tissue or other
biological sample, the results of which are provided to any
party for any purpose, excluding use as Clinical Diagnostic.
For purposes of clarity, rDx includes test(s) performed on
human tissue or other human biological sample in the course
of Phase I, II, III or IV clinical trials for an ethical
pharmaceutical.
1.9 "Quest Closing" shall mean the date of the closing of the
transactions contemplated by Stock and Asset Purchase Agreement between SB and
Quest relating to the sale of SBCL to Quest.
2. SPECIFIC PROVISIONS.
2.1 Paragraph 3.1.3 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
3.1.3 Notwithstanding anything else to the contrary,
Incyte does not xxxxx XX or Quest any rights pursuant to
this Agreement under Incyte IP, Incyte Technology IP, or
Incyte Diagnostic IP.
2.2 Paragraph 3.5 of the Collaboration Agreement is hereby deleted in its
entirety.
2.3 Paragraph 3.8 of the Collaboration Agreement is hereby deleted in its
entirety and replaced with the following:
3.8 Other: Incyte agrees to negotiate with Quest in good
faith for access to Incyte Technology IP which is required
for the commercially reasonable conduct of cDx Homebrews
licensed to Quest by DiaDexus pursuant to Section 5.
2.4 Paragraph 4.1.5 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
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4.1.5 Notwithstanding anything else to the contrary, SB
does not grant Incyte or Quest any rights pursuant to this
Agreement under SB IP, SB Technology IP, or SB Diagnostic
IP.
2.5 Paragraph 4.6.5 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
4.6.5 DiaDexus hereby acknowledges that Incyte has
ongoing research and development programs involving material
investment by Incyte to produce and develop Incyte IP
independent of that which would constitute Incyte Diagnostic
IP, including Incyte IP which is or shall be provided to
third parties on a non-exclusive commercial basis as Incyte
database product(s), including Ix Product(s). Incyte shall
provide SB and DiaDexus with access on commercial terms to
those Ix Product(s), or other Incyte database products which
are made generally available by Incyte to other Third
Parties on a non-exclusive basis. Incyte shall not refuse to
negotiate in good faith with Quest with respect to access on
commercial terms to those Ix Product(s), or other Incyte
database products which are made generally available by
Incyte to other Third Parties on a non-exclusive basis.
2.6 Paragraph 5.1.3 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
5.1.3 DiaDexus retains all rights under DiaDexus IP
unless expressly granted to SB, Incyte and/or Quest pursuant
to the terms and conditions of this Agreement.
2.7 Paragraph 5.1.4 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
5.1.4 All rights and licenses granted by DiaDexus to
Quest and/or Incyte pursuant to Paragraphs 5.2, 5.3, and
5.4, shall include a non-exclusive sublicense or exclusive
sublicense, as the case may be, by DiaDexus to any SB
Diagnostic IP and/or Incyte Diagnostic IP each only as may be
necessary to exercise such right or license. Such license
shall only be granted exclusively hereunder to Incyte if
Incyte had granted the license exclusively to DiaDexus in
Section 3, and if not, such sublicense shall only be granted
by DiaDexus to Incyte pursuant to this Paragraph,
non-exclusively. Such license shall only be granted
exclusively hereunder to Quest if SB had granted the license
exclusively to DiaDexus in Section 4,
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and if not, such sublicense shall only be granted by DiaDexus to
Quest pursuant to this Paragraph non-exclusively.
2.8 Paragraph 5.2, 5.2.1 and 5.2.2 of the Collaboration Agreement are
hereby deleted in their entirety and replaced with the following:
5.2 DiaDexus Class I Dx Test(s) Grants: Subject to all the terms and
conditions of this Agreement, DiaDexus hereby grants the following
rights to Quest in the field of Class I Dx Test(s):
5.2.1 cDx Homebrew(s)
(a) DiaDexus grants Quest a first right to negotiate with DiaDexus
to obtain an exclusive license (with the right to sublicense) under
DiaDexus IP, generated during the Extended License Period to Make,
Have Made, Use, and Sell cDx Homebrew(s) in the field of Class I Dx
Test(s) in the Homebrew Territory. Such license, if agreed to, would
include a royalty and license fee as specified in Paragraph 6.3 and
other terms and conditions mutually acceptable to Quest and DiaDexus
and customary in such licenses, however, no additional payments
beyond such royalty and license fee shall be required for such
license.
(b) DiaDexus agrees to notify Quest in writing of the commencement
of such first right. Quest and DiaDexus shall have a three (3) month
period in which to negotiate and execute such license for such cDx
Homebrew if Quest and DiaDexus mutually agree thereto. Quest shall
within thirty (30) days after receipt of such notice either accept
in writing or decline such first right (no notice to DiaDexus within
such thirty (30) day period shall constitute a waiver of such first
right with respect to such cDx Homebrew). If Quest accepts such first
right in writing, Quest and DiaDexus agree to negotiate exclusively
with each other in good faith effort to reach mutually acceptable
agreement and to execute such agreement within such three (3) month
period. In the event a license agreement is not entered into during
such three (3) month period or a mutually agreed extension thereof,
Quest shall have no further right with respect to such cDx Homebrew
leaving DiaDexus free to pursue agreements with Third Parties or
Incyte at its own discretion for such cDx Homebrew.
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Execution Copy
5.2.2 rDx Services(s)
(a) DiaDexus grants Quest a first right to negotiate with DiaDexus
to obtain a non-exclusive or exclusive (as negotiated), world-wide
license (with the right to sublicense) under DiaDexus IP generated
during the Extended License Period to Make, Have Made, Use, and Sell
rDx Service(s) in the field of Class I Dx Test(s).
(b) DiaDexus agrees to notify Quest in writing of the commencement
of such first right. Quest and DiaDexus shall have a six (6) month
period in which to negotiate and execute such license for such rDx
Service, if Quest and DiaDexus mutually agree thereto. Quest shall
within thirty (30) days after receipt of such notice either accept in
writing or decline such first right (no notice to DiaDexus within such
thirty (30) day period shall constitute a waiver of such first right
with respect to such rDx Service). If Quest accepts such first right
in writing, Quest and DiaDexus agree to negotiate exclusively with
each other in good faith effort to reach mutually acceptable agreement
and to execute such agreement within such six (6) month period. In the
event a license agreement is not entered into during such six (6)
month period or a mutually agreed extension thereof, Quest shall have
no further right with respect to such rDx Service leaving DiaDexus
free to pursue agreements with Third Parties or Incyte at its own
discretion for such rDx Service.
2.9 Paragraphs 5.3, 5.3.1 and 5.3.2 of the Collaboration Agreement are
hereby deleted in their entirety and replaced with the following:
5.3 DiaDexus Class II Dx Test(s) Grants. Subject to all the terms
and conditions of this Agreement, DiaDexus hereby grants the following
rights to Quest and/or Incyte in the field of Class II Dx Test(s):
5.3.1 cDx Homebrews
(a) DiaDexus grants Quest a first right to negotiate with DiaDexus
to obtain an exclusive license under DiaDexus IP generated during the
Extended License Period, with the right to sublicense only to Incyte,
to Make, Have Made, Use, and Sell cDx Homebrews in the field of Class
II Dx Test(s) in the Homebrew Territory.
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(b) DiaDexus agrees to notify Quest in writing of the commencement
of such first right. Quest and DiaDexus shall have a six (6) month
period in which to negotiate and execute such license for such cDx
Homebrew if Quest and DiaDexus mutually agree thereto. Quest shall
within thirty (30) days after receipt of such notice either accept in
writing or decline such first right (no notice to DiaDexus within
such thirty (30) day period shall constitute a waiver of such first
right with respect to such cDx Homebrew). If Quest accepts such first
right in writing, Quest and DiaDexus agree to negotiate exclusively
with each other in good faith effort to reach mutually acceptable
agreement and to execute such agreement within such six (6) month
period. In the event a license agreement is not entered into during
such six (6) month period or a mutually agreed extension thereof,
Quest shall have no further right with respect to such cDx Homebrew.
(c) In the event Quest declines such first right with respect to a
cDx Homebrew, or fails to reach agreement with DiaDexus within the
six (6) month period, DiaDexus grants Incyte the right to negotiate
with DiaDexus to obtain an exclusive license under DiaDexus IP, with
the right to sublicense only to Quest, to Make, Have Made, Use, And
Sell such cDx Homebrew in the field of Class II Dx Test(s) in the
Homebrew Territory.
(d) DiaDexus agrees to notify Incyte in writing of the commencement
of such right promptly after the earlier of when Quest declines such
first right or the expiration of the six (6) month period in which no
agreement was reached with Quest. Incyte and DiaDexus shall have a
six (6) month period in which to negotiate and execute such license
for such cDx Homebrew if Incyte and Quest mutually agree thereto.
Incyte shall within thirty (30) days after receipt of such notice
either accept in writing or decline such right (no notice to DiaDexus
within such thirty (30) day period shall constitute a waiver of such
right with respect to such cDx Homebrew). If Incyte accepts such
right in writing, Incyte and DiaDexus agree to negotiate exclusively
with each other in good faith effort to reach mutually acceptable
agreement and to execute such agreement within such six (6) month
period. In the event a license agreement is not entered into during
such six (6) month period or a mutually agreed extension thereof,
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Incyte relinquishes any such right with respect to such cDx Homebrew
and DiaDexus is free to enter into a license with respect to such cDx
Homebrew with Third Parties.
5.3.2 rDx Service(s)
(a) DiaDexus grants Quest and Incyte a first right to negotiate with
DiaDexus to obtain a co-exclusive, world-wide license under DiaDexus
IP generated during the Extended License Period, each without the
right to sublicense, to Make, Have Made, Use, and Sell rDx Service(s)
in the field of Class II Dx Test(s).
(b) DiaDexus agrees to notify Quest and Incyte in writing of the
commencement of such first right. Each of Quest and Incyte shall have
a six (6) month period in which to negotiate with DiaDexus and execute
a license for such rDx Service if Quest and/or Incyte, as the case may
be, and DiaDexus mutually agree thereto. Quest and Incyte shall each
within thirty (30) days after receipt of such notice either accept in
writing or decline such first right (no notice to DiaDexus within such
thirty (30) day period shall constitute a waiver of such first right
with respect to such rDx Service with respect to the company failing
to provide notice). If Quest and/or Incyte accept such first right in
writing, Quest and DiaDexus and/or Incyte and DiaDexus, each agree to
negotiate exclusively with each other in good faith effort to reach
mutually acceptable agreement and to execute such agreement within
such six (6) month period. In the event a license agreement is not
entered into during such six (6) month period or mutually agreed
extension(s) thereof, Quest or Incyte, as the case may be, shall have
no further right with respect to such rDx Service.
2.10 Paragraphs 5.4, 5.4.1 and 5.4.2 of the Collaboration Agreement are
hereby deleted in their entirety and replaced with the following:
5.4 DiaDexus Class III Dx Test(s) Grants: Subject to all the
terms and conditions of this Agreement, DiaDexus hereby grants the
following rights to Quest and/or Incyte in the field of Class III Dx
Tests(s):
5.4.1 cDx Homebrew(s)
(a) DiaDexus grants Quest a first right to negotiate with
DiaDexus to obtain an exclusive, world-wide license under
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DiaDexus IP, generated during the Extended License Period, with the
right to sublicense only to Incyte, to Make, Have Made, Use, and Sell
cDx Homebrew in the field of Class III Dx Test(s) in the Homebrew
Territory.
(b) DiaDexus agrees to notify Quest in writing of the commencement of
such first right. Quest and DiaDexus shall have a six (6) month period
in which to negotiate and execute such license for such cDx Homebrew if
Quest and DiaDexus mutually agree thereto. Quest shall within thirty
(30) days after receipt of such notice either accept in writing or
decline such first right (no notice to DiaDexus within such thirty (30)
day period shall constitute a waiver of such first right with respect to
such cDx Homebrew). If Quest accepts such first in writing, Quest and
DiaDexus agree to negotiate exclusively with each other in good faith
effort to reach mutually acceptable agreement and to execute such
agreement within such six (6) month period. In the event a license
agreement is not entered into during such six (6) month period or a
mutually agreed extension thereof, Quest shall have no further right
with respect to such cDx Homebrew.
(c) In the event Quest declines such first right with respect to a cDx
Homebrew or fails to reach agreement with DiaDexus within a six (6)
month period, DiaDexus grants Incyte the right to an exclusive license
under DiaDexus IP, with the right to sublicense only to Quest, to Make,
Have Made, Use, and Sell Clinical Dx Homebrew(s) in the field of Class
III Dx Test(s) in the Homebrew Territory.
(d) DiaDexus agrees to notify Incyte in writing of the commencement of
such right promptly after the earlier of when Quest declines such right
or the expiration of the six (6) month period in which no agreement was
reached with Quest. Incyte and DiaDexus shall have a six (6) month
period in which to negotiate and execute such license for such cDx
Homebrew if Incyte and DiaDexus mutually agree thereto. Incyte shall
within thirty (30) days after receipt of such notice either accept in
writing or decline such right (no notice to DiaDexus within such thirty
(30) day period shall constitute a waiver of such right with respect to
such cDx Homebrew). If Incyte accepts such right in writing, Incyte and
DiaDexus agree to negotiate exclusively with each other in good faith
effort to execute
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such agreement within such six (6) month period. In the event a
license agreement is not entered into during such six (6) month
period or a mutually agreed extension thereof. Incyte shall have no
further right with respect to such cDx Homebrew and DiaDexus is free
to enter into a license with respect to such cDx Homebrew with Third
Parties.
5.4.2 rDx Service(s)
(a) DiaDexus grants Quest and Incyte a first right to negotiate with
DiaDexus to obtain a co-exclusive, world-wide license under DiaDexus
IP generated during the Extended License Period, each without the
right to sublicense, to Make, Have Made, Use, and Sell rDx Service(s)
in the field of Class III Dx Test(s).
(b) DiaDexus agrees to notify Quest and Incyte in writing of the
commencement of such first right. Each of Quest and Incyte shall have
a six (6) month period in which to negotiate with DiaDexus and
execute a license for such rDx Service if Quest and/or Incyte, as the
case may be, and DiaDexus mutually agree thereto. Quest and Incyte
shall each within thirty (30) days after receipt of such notice
either accept in writing or decline such first right (no notice to
DiaDexus within such thirty (30) day period shall constitute a waiver
of such first right with respect to such rDx Service with respect to
the company failing to provide notice). If Quest and/or Incyte accept
such first right in writing, Quest and DiaDexus and/or Incyte and
DiaDexus, each agree to negotiate exclusively with each other in good
faith effort to reach mutually acceptable agreement and to execute
such agreement within such six (6) month period. In the event a
license agreement is not entered into during such six (6) month
period or mutually agreed extension(s) thereof, Quest or Incyte, as
the case may be, shall have no further right with respect to such rDx
Service.
2.11 A New Paragraph 5.6.1(c) is hereby added to the Collaboration
Agreement, as follows:
(c) Notwithstanding anything else to the contrary, DiaDexus grants
to Quest a non-exclusive, paid-up, non-cancellable, royalty-free,
license in the field of Clinical Laboratory Services under DiaDexus
IP which is an improvement to SB Technology IP (to the extent and only
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to the extent such improvement was conceived and reduced to practice
as of the Quest Closing). However, diaDexus represents and warrants
that, as of the Quest Closing, there is no such diaDexus IP which is
an improvement to SB Technology IP.
2.12 Paragraph 5.6.4 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
5.6.4 Research
DiaDexus hereby grants to each of SB and Quest a non-exclusive license
under DiaDexus IP which is Clinical Non-genomic DiaDexus Data
generated by or on behalf of DiaDexus during the Extended License
Period, to use for its own respective internal research purposes.
2.13 Paragraph 5.6.5(a) of the Collaboration Agreement is hereby deleted
in its entirety and replaced with the following:
(a)(1) For all Tests to which DiaDexus has lost its licenses to SB
Diagnostic IP (to the extent such SB Diagnostic IP was conceived and
reduced to practice as of the Quest Closing) pursuant to Paragraph
13.5, DiaDexus grants Quest an exclusive, royalty-free,
non-cancellable, world-wide license under DiaDexus IP, with the right
to sublicense, to the extent necessary to Make, Have Made, Use, and
Sell such Tests.
(a)(2) For all Tests to which DiaDexus has lost its licenses to SB
Diagnostic IP (to the extent such SB Diagnostic IP was conceived and
reduced to practice after the Quest Closing) pursuant to Paragraph
13.5, DiaDexus grants an exclusive, royalty-free, non-cancellable,
world-wide license to SB under DiaDexus IP, with the right to
sublicense, to the extent necessary to Make, Have Made, Use, and Sell
such Tests.
(a)(3) For all Tests to which DiaDexus has lost its licenses to
Incyte Diagnostic IP pursuant to Paragraph 13.5, DiaDexus grants an
exclusive, royalty-free, non-cancellable, world-wide license to
Incyte under DiaDexus IP, with the right to sublicense, to the
extent necessary to Make, Have Made, Use, and Sell such Tests.
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2.14 Paragraph 5.6.5(c) of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
(c) During the Extended License Period and for each cDx Kit
manufactured by DiaDexus, DiaDexus grants Quest most favored
nation pricing with respect to the price of such cDx Kit sold to
Third Parties.
2.15 Paragraph 6.3 of the Collaboration Agreement is hereby deleted in its
entirety and replaced with the following:
6.3 Tests Field of Use: Payments and Royalties to DiaDexus by Quest.
Contingent on the following events, and subject to Paragraph 6.5 and
6.6, the following payments and royalties shall be paid by Quest to
DiaDexus for Tests under the licenses granted under Paragraph 5.2.1 to
Quest as applicable:
(a) Royalties on Net Sales: A royalty will be paid on Net Sales by
Quest for any Test under the following schedule:
Test subject to Paragraph 6.5(a) 6.5(b)
cDx Homebrew (Class I) ****** ******
(b) License Fee: Promptly upon the execution of each license agreement
between Quest and DiaDexus for each cDx Homebrew entered into pursuant
to Paragraph 5.2.1, Quest shall pay to DiaDexus a license fee of
between ****** Such license fee is fully creditable against future
royalties for such cDx Homebrew.
(c) Applicable Royalty Rate/License Fee: The applicable royalty rate
for each such cDx Homebrew within such range specified in Paragraphs
(a) shall be calculated as follows:
(i) If the Quest profit margin is ******
(ii) If the Quest profit margin is ******
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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(iii) For profit margins in excess of ******
(iv) For profit margins in excess of ******
(d) Other Terms: All other terms of such license agreement entered
into pursuant to Paragraph 5.2.1 for such cDx Homebrew to be
negotiated pursuant to the relevant agreement between Quest and
DiaDexus with respect to such cDx Homebrew.
(e) Other Tests: Quest and/or Incyte shall pay royalties to DiaDexus
on Net Sales of Tests to which Quest and/or Incyte has obtained rights
from DiaDexus pursuant to this Agreement. Such royalty and other
terms shall be negotiated pursuant to the relevant agreement
negotiated between Quest and/or Incyte and DiaDexus with respect to
such Test.
2.16 Paragraph 6.5 of the Collaboration Agreement is hereby deleted in its
entirety and replaced with the following:
6.5 Payment Obligation. The foregoing payment obligations of SB,
Quest and Incyte to DiaDexus under Sections 6.1 and 6.3 will accrue or
become due or payable only with respect to Rx Products and Tests:
(a) which but for the patent licenses granted herein would otherwise
infringe a Valid Claim(s) of a DiaDexus Patent(s); or
(b) are covered by a pending claim of a DiaDexus Patent(s) but not a
Valid Claim(s) of a DiaDexus Patent(s).
2.17 Paragraph 6.6.2 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
6.6.2 Upon termination of the royalty payment obligation, DiaDexus,
SB, Quest and Incyte, as the case may be, shall thereafter
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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have in perpetuity a royalty-free license to make, use and sell such
Product in the specified field(s) of use.
2.18 Paragraph 9.3.2 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
9.3.2
(a) During the Extended License Period, DiaDexus shall use reasonable
and ongoing efforts to disclose and supply to SB, DiaDexus IP which
are improvements to SB Technology IP which are reasonably available
and transferable.
(b) During the Extended License Period, DiaDexus shall use reasonable
and ongoing efforts to disclose and supply to Quest, DiaDexus IP which
are improvements to SB Technology IP (to the extent and only to the
extent such improvements are conceived and reduced to practice as of
the Quest Closing) which are reasonably available and transferable.
2.19 Paragraph 9.3.3 of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
9.3.3 cDx Homebrew(s)
During the Extended License Term and to the extent Quest and/or Incyte
have a right to a license, DiaDexus shall promptly notify Quest and/or
Incyte, as the case may be, in writing of any DiaDexus IP which is
potentially useful as a specific cDx Homebrew and shall specify any
prior Third Party obligations with respect to such DiaDexus IP.
2.20 Paragraph 9.3.4(a) of the Collaboration Agreement is hereby deleted in
its entirety and replaced with the following:
(a) During the Extended License Term and to the extent Quest has a
right to a license, DiaDexus shall promptly notify Quest in writing of
any DiaDexus IP which is potentially useful as a rDx Service in the
field of Class I, Class II, or Class III Dx Test(s) and shall specify
any prior Third Party obligations with respect to such DiaDexus IP.
2.21 Paragraphs 9.3.9(a) and (b) of the Collaboration Agreement are hereby
deleted in their entirety and replaced with the following:
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(a) During the Extended License Period and with respect to DiaDexus
IP which is the subject of any license granted to SB, Quest or Incyte
under Section 5, DiaDexus shall use reasonable and ongoing efforts to
disclose and supply to SB, Quest or Incyte, as the case may be, with
that certain DiaDexus IP which is reasonably available and
transferable and the subject of such license.
(b) Notwithstanding anything else to the contrary, DiaDexus IP which
is based on the use of or derived by the use of HGS derived SB
Diagnostic IP as provided to DiaDexus pursuant to Paragraph 9.1 shall
only be disclosed to SB.
3. QUEST OBLIGATIONS.
3.1 Quest hereby assumes all liabilities and agrees to perform all
obligations arising out of or in connection with the exercise by Quest of the
rights granted to it under this Amendment, including, but only to the extent
applicable, the royalty and other payment obligations set forth in Article 6 of
the Collaboration and License Agreement, the diligence obligations set forth in
Article 13 of the Collaboration and License Agreement, the requirements set
forth Paragraph 14.5 of the Collaboration and License Agreement, the reporting
obligations set forth in Article 15 of the Collaboration and License Agreement,
the termination provision set forth in Paragraph 16.2.2 of the Collaboration and
License Agreement, the representation and warranty set forth in Paragraph 17.2
of the Collaboration and License Agreement, and all other obligations due with
respect to the sale by Quest or any of its Affiliates of any Test licensed by
Quest pursuant to the terms of the Collaboration Agreement.
3.2 Quest acknowledges that in connection with its activities under this
Amendment it may receive Confidential Information of SB, Incyte and/or
DiaDexus. Quest agrees to be subject to the provisions of Article 12 of the
Collaboration Agreement, as if Quest was a Party to the Collaboration
Agreement. In addition, SB, Incyte and DiaDexus acknowledge that each of them
may receive confidential information from Quest in connection with their
respective activities under this Amendment and each agrees to treat such
confidential information as Confidential Information belonging to Quest under
Article 12 of the Collaboration and License Agreement.
3.3 Quest agrees that with respect to the sale by Quest or any of its
Affiliates of any Test licensed by Quest under this Amendment, it will
undertake the indemnification obligations set forth in Article 18 of the
Collaboration Agreement, as if Quest was a Party to the Collaboration Agreement.
4. RESEARCH COMMITTEE.
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The Parties agree that during the Extended License Period Quest shall have
reasonable access to the Research Committee or other multiparty research
governance organizations that are or may be established under the Collaboration
Agreement on a non-voting observer basis, provided, however, that such
participation shall be limited to discussion concerning research projects,
their status, and the conveyance of rights to Quest related thereto, all as
limited to such projects that are subject to the rights and licenses granted to
Quest hereunder.
5. NO OTHER RIGHTS OR OBLIGATIONS.
Except with respect to the rights and obligations specifically granted to Quest
in this Amendment, Quest shall have no rights or obligations as a Party to the
Collaboration Agreement, including, without limitation, the right to approve
an amendment to the Collaboration Agreement or the right to enforce any rights
or obligations of the Parties to the Agreement.
6. MISCELLANEOUS.
6.1 Quest shall be deemed a Party to the Collaboration Agreement with
respect to Paragraphs 16.3, 19.1, 19.3, 19.5, 19.6, 19.7, 19.14, and 19.15 of
the Collaboration Agreement; provided, however, that Quest shall be deemed a
Party to the extent, and only to the extent, such Paragraphs are applicable to
the rights and obligations granted to Quest pursuant to this Amendment.
6.2 Paragraphs 14.6.1 (subject to the sublicensing restrictions set forth
in Paragraphs 5.3.2 and 5.4.2), 17.3, 19.4, 19.8, 19.9, 19.11, 19.16, and 19.17
are hereby incorporated by reference into this Amendment.
6.3 The rights and obligations set forth in this Amendment shall be
binding upon and inure to the benefit of the successors in interest of the
respective parties. The rights and obligations set forth in this Amendment
shall not be directly or indirectly assigned or transferred (whether
voluntarily, by operation of law or otherwise) by Quest without the prior
express written consent of the other parties; provided, however, that Quest may
assign or transfer this Amendment or any of its rights or obligations hereunder
(i) to any Quest Affiliate, or (ii) to any Third Party with which it may merge
or consolidate, or to which it may transfer all or substantially all of its
assets in each case without obtaining the consent of the other parties, and if
in any such event (including any merger involving Quest), (i)(A) Quest remains
liable under this Amendment, and (ii)(B) the relevant Quest Affiliate, Third
Party assignee or surviving entity assumes in writing all of Quest's
obligations under this Agreement. Any purported assignment or transfer by Quest
in violation of this Paragraph shall be void.
6.4 Notices and deliveries to Quest shall be governed by Paragraph 19.10.
If sent to Quest, addressed to:
Quest Diagnostics Incorporated
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Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Vice President, Business Development
6.5 This Amendment shall become effective upon the Quest Closing. In the
event the Quest Closing does not occur on or prior to September 30, 1999, this
Amendment shall terminate and be of no further force or effect.
6.6 The parties acknowledge that the Amendment to the Collaborative
LifeSeq Agreement and the Amendment to the Collaborative PathoSeq Agreement,
both between Incyte and diaDexus and of even date herewith, are supportive of
and constitute partial consideration for this Amendment. Accordingly, during
the Initial License Period, Incyte and diaDexus agree not to subsequently
amend, only with respect to diaDexus rights in Class I rDx Kits and Class I rDx
Services, either the Collaborative LifeSeq Agreement or the Collaborative
PathoSeq Agreement without the prior approval of Quest, which approval shall
not be unreasonably withheld.
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IN WITNESS WHEREOF, the parties, through their authorized officers, have
executed this Assignment Agreement as of the date first written above.
SMITHKLINE XXXXXXX CORPORATION
By: /s/ XXXXXX X. XXXXXX
--------------------------
Its: Secretary
-------------------------
SMITHKLINE XXXXXXX PLC
By: /s/ XXXXXX XXXXXX
--------------------------
Its: Attorney-in-Fact
-------------------------
QUEST DIAGNOSTICS INCORPORATED
By: /s/ [SIGNATURE ILLEGIBLE]
--------------------------
Its: Vice President, Business Development
-------------------------
[INITIAL]
PATENT DEPT
28/7/99
DIADEXUS LLC
By: /s/ [SIGNATURE ILLEGIBLE]
--------------------------
Its: COO
-------------------------
INCYTE PHARMACEUTICALS, INC.
By: /s/ [SIGNATURE ILLEGIBLE]
--------------------------
Its: President
-------------------------
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APPENDIX A
LIST OF QUEST AFFILIATES
100% SBCL, INC. (DE)(1)
100% SmithKline Xxxxxxx Clinical Laboratories, Inc. (DE)(2)
(33-1/3%) Compunet Clinical Laboratories (OH)
(44%) Mid America Clinical Laboratories (IN)
(49%) Diagnostic Laboratory of Oklahoma (OK)
50% Corporacion MSB, S.A. de C.V. (Mexico)
100% Quest Holdings Incorporated (DE)
51% Quest Diagnostics of Missouri LLC (MO)
100% Quest Holdings Incorporated (MD)
100% Quest Diagnostics Incorporated (MD)
100% Diagnostic Reference Services Inc. (MD)
50% Pathology Building Partnership (MD)(gnl pshp)(1)
100% Quest Holdings Incorporated (MI)
100% Quest Diagnostics Incorporated (CA)
100% Quest Diagnostics LLC (IL)
100% Quest Diagnostics Incorporated (MI)
100% Laboratory Holdings Incorporated (MA)
100% Quest Diagnostics Incorporated (CT)
100% Quest Diagnostics Incorporated (MA)
100% Quest Diagnostics of Pennsylvania Inc. (DE)
100% Quest Diagnostics Incorporated (OH)
100% Medical Management Systems, Inc. (PA)
51% Quest Diagnostics Venture LLC (PA)
53.5% Associated Clinical Laboratories (PA)(gen pshp)
50% Surgical Eye Enterprise L.P. (PA)(ltd pshp)
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(1) Will become a subsidiary on the Effective Date and the name will be
changed to Quest Diagnostics Holdings Inc.
(2) Will become a subsidiary on the Effective Date and the name will be
changed to Quest Diagnostics Clinical Laboratories, Inc.
(1) Other 50% interest held by Quest Diagnostics Incorporated (MD)
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50% Surgical Eye Institute L.P. (PA)(ltd pshp)
100% Quest Diagnostics of Arizona Incorporated (DE)
49% Sonora Quest Laboratories LLC (AZ)
100% Quest Diagnostics Investments Incorporated (DE)
100% Quest Diagnostics Finance Incorporated (DE)
100% Damon Investment Holdings, Inc. (DE)
100% DPD Holdings, Inc. (DE)
100% MetWest Inc. (DE)
100% Quest MRL Inc. (DE)
100% Xxxxxxx Institute Diagnostics (CA)
100% Xxxxxxx Institute Sales Corporation (U.S.V.I.)
100% Xxxxxxx Institute Diagnostics Limited (U.K.)
100% Xxxxxxx Institute Diagnostics Trading S.A. (Switzerland)
100% Xxxxxxx Institute Diagnostica GMBH (Germany)
100% Xxxxxxx Institute Diagnostica GMBH (Austria)
100% Xxxxxxx Institute International Holding B.V. (Netherlands)
100% Xxxxxxx Institute Diagnostics B.V. (Netherlands)
100% Xxxxxxx Institute Diagnostics SARL (France)
100% Quest Diagnostics do Brasil Ltda. S.C. (Brazil)
100% Quest Diagnostics Limited (UK)
100% Nomad-Massachusetts, Inc. (MA)
100% Quest Laboratorios Clinicos, S.A. de C.V. (Mexico)
100% Analisis, S.A. (Mexico)
100% Laboratorios Clinicos de Mexico, S.A. de C.V. (Mexico)
100% Servicios de Laboratorio, S.A. de C.V. (Mexico)
100% Laboratorios de Frontera Xxxxxxx, X.X. de C.V. (Mexico)
100% Laboratorios de Analisis Biomedicos, S.A. (Mexico)
100% New England Medical Laboratory Inc.*
100% Stat Toxicology Service of Boston, Inc.*
100% MetPath Europe Limited (U.K.)*
100% TransUnited Casualty and Indemnity Insurance Company
(Cayman Islands)*
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* In process of dissolution
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