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Exhibit 10.1
AMENDMENT NO. 1 TO
RESEARCH AND LICENSE AGREEMENT
This Amendment No. 1, dated as of September 30, 1998 is between
ArQule, Inc. ("ArQule") a Delaware Corporation and Roche Bioscience, a
division of Syntex (U.S.A.) Inc. ("Roche Bioscience"), a Delaware
Corporation.
WHEREAS, ArQule and Roche Bioscience entered into a Research and
License Agreement dated September 13, 1996 (the "Agreement") under which,
among other things, ArQule performs certain research and compound
optimization activities for Roche Bioscience in exchange for payment by
Roche Bioscience of research funds, milestone payments and royalties;
WHEREAS, Roche Bioscience notified ArQule by letter dated March 31,
1993 that Roche Bioscience was exercising its right to terminate the
Directed Array Program of the Agreement effective September 30, 1998 (the
"Termination Notice") but are willing to continue the collaboration in a
different form;
WHEREAS, Roche Bioscience and ArQule have agreed to meet to discuss
the possibility of a broader collaboration between ArQule and the Roche
Group, of which Roche Bioscience is a member;
WHEREAS, Roche Bioscience; has decided to withdraw the Termination
Notice and desires instead to amend the Agreement as provided herein; and,
WHEREAS, ArQule is willing to amend certain provisions of the
Agreement as set forth herein;
NOW, THEREFORE, in consideration of the mutual covenants set forth
in this Amendment No. 1, the parties hereby agree as follows:
1. Except as specifically amended by the terms hereof, the remaining terms
and provisions of the Agreement shall not be affected by this Amendment No. 1
and shall remain in full force and effect.
2. Capitalized terms utilized and not otherwise defined herein shall have
the meanings ascribed to such terms in the Agreement.
3. Roche Bioscience hereby withdraws the Termination Notice.
4. Section 1.36 of the Agreement is hereby deleted and replaced with the
following:
1.36 "Research Period" shall mean the period commencing on the
Effective Date and ending on March 31, 1999, unless extended by
mutual agreement of the parties or terminated early in accordance
with Article 11.
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5. Section 1.46 of the Agreement is hereby re-designated Section 1.50 and
the following sections are hereby added to the Agreement:
1.46 "Production Plan" means a plan developed by the parties for
the production of Proprietary Screening Array Sets by ArQule for
Roche Bioscience under the Proprietary Screening Array Program. If
necessary, the Research Committee will periodically update the
Production Plan during the performance of the Proprietary Screening
Array Program. The initial Production Plan is attached as Exhibit A
to this Amendment.
1.47 "Proprietary Screening Array Compound" means a compound that
ArQule has produced for Roche Bioscience and delivered to Roche
Bioscience under a Proprietary Screening Array Program as described
in Section 3.5 of the Agreement.
1.48 "Proprietary Screening Array Program" means a research program
in which ArQule produces Proprietary Screening Array Sets pursuant
to the Production Plan and delivers the Proprietary Screening Array
Compounds to Roche Bioscience, as further described in Section 3.5
of the Agreement.
1.49 "Proprietary Screening Array Set" means an Array synthesized
by ArQule for Roche Bioscience under the Proprietary Screening
Array Program, as described in Section 3.5 of the Agreement.
6. The following sentence is hereby added to the end of Section 2.2 of the
Agreement:
The Research Committee shall direct and administer the Proprietary
Screening, Array Program in accordance with Section 3.5.
7. The parties agree that the obligations of ArQule and Roche Bioscience
pursuant to Sections 3.1, 3.2 and 3.3 of the Agreement shall be satisfied upon
the completion by ArQule, subject to Section 3.6, of the [*] and, if requested
by Roche Bioscience, a small amount of exploratory array support for the [*].
ArQule acknowledges the payment by Roche Bioscience of the funds set forth in
Section 3.6 of the Agreement.
8. Section 3.4 of the Agreement is hereby deleted and replaced with:
3.4 TERMINATION OF DIRECTED ARRAY PROGRAM. The Directed Array
Program shall commence on the Effective Date of the Agreement and
continue until March 31, 1999, unless earlier terminated as
provided in Article 11.
9. The following sections are hereby added to the Agreement:
3.5 PROPRIETARY SCREENING ARRAY PROGRAMS.
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*Confidential treatment has been requested for the marked portion.
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3.5.1 DESCRIPTION OF PROPRIETARY SCREENING ARRAY PROGRAM. Subject
to Section 3.6, ArQule shall produce and deliver to Roche
Bioscience the Proprietary Screening Array Set(s) set forth in the
Production Plan. Roche Bioscience shall provide the molecular cores
as specified by the Production Plan. ArQule shall produce the
Proprietary Screening Array Compounds in its AMAP(TM) parallel
synthesis system, perform quality analysis, register the
Proprietary Screening Array Compounds, and deliver the completed
Proprietary Screening Array Set(s) to Roche Bioscience as further
described in Section 3.5.3 below.
3.5.2 CONDUCT OF PROPRIETARY SCREENING ARRAY PROGRAM. Subject to
Section 3.6, ArQule shall commence and perform the Proprietary
Screening Array Program as directed by the Research Committee in
accordance with the Production Plan. With respect to each
Proprietary Screening Array Set, the Production Plan will contain
the following: (i) the constant molecular core for the Proprietary
Screening Array Set; (ii) the variable diversity elements that will
be used in the Proprietary Screening Array Set; (iii) the
appropriate number and types of compounds that each Proprietary
Screening Array Set should contain; (iv) the appropriate amount and
purity of the compounds in each Proprietary Screening Array Set;
and (v) completion criteria for a satisfactory Proprietary
Screening Array Set. ArQule reserves the right to exclude from the
Proprietary Screening Array Program any molecular cores, diversity
elements, and compounds that, prior to the time that the compound
was proposed by Roche Bioscience, was already included in a program
with a third party or an internal ArQule program. In such event,
ArQule shall notify the Research Committee as soon as possible
after Roche Bioscience proposes the compound. At the request of the
Research Committee, ArQule shall conduct limited probing reactions
to determine chemical feasibility with respect to no more than [*]
chemical cores as part of the planning process. The Production Plan
may also include an expected production and delivery schedule of
Proprietary Screening Array Set(s) by ArQule and any other issues
or items that the Research Committee determines would facilitate
the Proprietary Screening Array Program. The Proprietary Screening
Array Sets shall not include proprietary chemistries that ArQule
has licensed from third parties.
3.5.3 PROGRAM PERFORMANCE. ArQule shall have primary responsibility
for conducting the Proprietary Screening Array Program, with the
cooperation and assistance of Roche Bioscience as further specified
in the Production Plan. Roche Bioscience shall provide the
molecular cores as specified by the Production Plan. Subject to the
authority of the Research Committee, ArQule will use commercially
reasonable efforts to produce the Proprietary Screening Array
Set(s) in accordance with the Production Plan. After ArQule
synthesizes a Proprietary Screening Array Set, ArQule will analyze
selected compounds in the Proprietary Screening Array Set to
determine overall compound purity, with the results furnished to
the Research
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*Confidential treatment has been requested for the marked portion.
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Committee. ArQule will deliver the Proprietary Screening Array
Compounds to Roche Bioscience formatted in 96-well microtiter
plates with both a paper and electronic copy of the chemical
structures and spatial address of each compound in the Proprietary
Screening Array Set. The parties anticipate that each Proprietary
Screening Array Set produced in the Proprietary Screening Array
Program will include approximately twenty (20) milligrams of each
Proprietary Screening Array Compound (subject to availability of
the component compounds provided by Roche Bioscience). However, the
Research Committee will determine the actual specifics for
implementation of the Proprietary Screening Array Program.
ArQule shall continue efforts to produce each Proprietary Screening
Array Set, as set forth in this Section 3.5.3 and subject to
Section 3.6, until the earliest to occur of (i) the Research
Committee determines that ArQule has delivered a satisfactory
Proprietary Screening Array Set in accordance with the completion
criteria in the Production Plan; (ii) the Research Committee
determines that further work is unlikely to result in production of
a Proprietary Screening Array Set that will meet the completion
criteria in the Production Plan; (iii) the end of the Research
Period; or (iv) expiration or termination of this Agreement in
accordance with Article 11.
3.5.4 RIGHTS IN PROPRIETARY SCREENING ARRAY COMPOUNDS. Roche
Bioscience shall own all right, title and interest in the
Proprietary Screening Array Compounds delivered by ArQule to Roche
Bioscience under this Article. ArQule hereby assigns, transfers and
conveys to Roche Bioscience all right, title and interest in these
Proprietary Screening Array Compounds and any intellectual property
rights therein. ArQule reserves the right to exclude from the
delivered Proprietary Screening Array Sets any compounds that were
licensed, reserved or otherwise committed to a third party or an
internal ArQule program prior to shipment to Roche Bioscience
("Committed Compounds"). ArQule will use its best efforts to
identify such Committed Compounds before they are incorporated into
the Production Plan, but in any event ArQule will identify such
Committed Compounds during the registration process before the
Committed Compounds are delivered to Roche Bioscience.
ArQule shall not use any proprietary chemical components provided
by Roche Bioscience except in the Proprietary Screening Array
Program as directed by the Research Committee. ArQule shall not
transfer such proprietary chemical components to any third party
and shall return any unused amounts to Roche Bioscience when the
Proprietary Screening Array Program is completed. Roche Bioscience
agrees that the above restrictions on proprietary chemical
components shall not apply to components that are in the public
domain or provided to ArQule by a third party that is not under
similar restrictions to Roche Bioscience.
3.6 FINAL PAYMENT FOR DIRECTED ARRAY PROGRAM AND PROPRIETARY
SCREENING ARRAY PROGRAM. In consideration of the completion of
performance by ArQule of the
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Directed Array Program and the performance of the Proprietary
Screening Array Program, Roche Bioscience has paid ArQule [*], and
ArQule hereby acknowledges such payment, which amount shall support
FTEs as set forth below and shall be allocated between the Directed
Array Program and the Proprietary Screening Array Program as
directed by the Research Committee. It is anticipated by the
parties that such funding will support approximately [*].
10. In Section 6.1.3 (with the heading "Roche Bioscience Patent Rights") of
the Agreement, the words "or covering a Proprietary Screening Array Compound"
are hereby added after the words "Roche Bioscience Derivative Compounds."
11. In Section 8.4 (with the heading "Publications") of the Agreement, the
words "Proprietary Screening Array Compounds" are hereby added after the words
"ArQule Derivative Compounds."
12. This Amendment No. 1 shall be governed by and construed in accordance
with the laws of the State of New York.
IN WITNESS WHEREOF, the undersigned have duly executed and
delivered this Amendment No. 1 as a sealed instrument effective as of the
date first above written.
ROCHE BIOSCIENCE, a division of ARQULE, INC.
SYNTEX (U.S.A.) INC.
By: /s/ X.X. Xxxxxxx By: /s/ Xxxx Xxxxxx
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Name: X.X. Xxxxxxx Name: Xxxx Xxxxxx
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Title: SVP, Head, Neurobiology Title: President and CEO
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*Confidential treatment has been requested for the marked portion.
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Exhibit A
Research Plan: Proprietary Screening Arrays.*
*[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE MARKED PORTION.]
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