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EXHIBIT 10.17
CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4), 200.83
AND 230.406 * INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST THAT IS FILED SEPARATELY WITH THE COMMISSION
RESEARCH AGREEMENT
THIS RESEARCH AGREEMENT, effective the 17th day of June, 1996
(the "Effective Date"), is entered into by and between ALANEX CORPORATION, a
California Corporation (hereinafter "Sponsor") and the MOUNT SINAI SCHOOL OF
MEDICINE OF THE CITY UNIVERSITY OF NEW YORK, a New York corporation (hereinafter
"Mount Sinai").
RECITALS:
WHEREAS, Sponsor desires to obtain the services of Dr. Stuart Sealfon
(the "PRINCIPAL INVESTIGATOR"), a Mount Sinai researcher, and the members of his
laboratory at Mount Sinai to conduct research relating to the human GnRH
receptor;
WHEREAS, Sponsor is willing to fund such research and Mount Sinai is
willing to perform such research under the terms set forth in this Agreement and
an Exclusive License Agreement between the parties of even date herewith (the
"EXCLUSIVE LICENSE AGREEMENT"); and
WHEREAS, Under the Exclusive License Agreement, Mount Sinai grants to
Sponsor certain rights to technology developed in the course of the Research
Program;
NOW, THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereto agree to the following:
1. DEFINITIONS
(A) "FIELD" shall mean the research and development of novel ligands to
the GnRH receptor, using the GnRH receptor, for the diagnosis, prevention or
treatment of human diseases and disorders.
(B) "RESEARCH PROGRAM" shall mean the research program described in
Exhibit A hereto, as established under Articles 2 through 4 of this Agreement.
(C) "RESEARCHER OR RESEARCHERS" shall mean individually and
collectively the Principal Investigator and such postdocs, graduate students,
technicians and other Mount Sinai personnel as the Principal Investigator may
designate pursuant to Section 2(b) to conduct work under the Research Program.
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*CONFIDENTIAL TREATMENT REQUESTED
2. CONDUCT OF THE RESEARCH PROGRAM
(A) Sponsor hereby engages the services of Mount Sinai as an
independent contractor to conduct the Research Program in accordance with the
terms of this Agreement. Mount Sinai will use its best efforts to conduct the
Research Program. During the term of this Agreement, the Principal Investigator
will collaborate with Sponsor in the Field on an exclusive basis; he will not
consult, perform work or otherwise engage in activities in the Field with any
other for-profit entity. This provision shall not restrict in any manner the
Researchers' rights to engage in academic, non-commercial scientific discourse
regarding the Field, including applying to the federal government for grants.
(B) The Principal Investigator shall exercise technical direction of
the Research Program. Sponsor shall have the right to consult with the Principal
Investigator at times reasonably agreed upon and to comment on the performance
of the Research Program. If Dr. Stuart Sealfon becomes unavailable to direct the
Research Program for any reason, and if the parties are unable to agree on a
suitable replacement within thirty (30) days of notice from Sponsor, Sponsor may
terminate this Agreement immediately upon notice.
(C) Unless Sponsor agrees otherwise in advance, the Principal
Investigator shall assign work under the Research Program only to those
Researchers who are bound to assign any inventions made by such Researcher in
the course of the Research Program (alone or jointly with others) to Mount
Sinai. The Principal Investigator shall not disclose to any Researcher any
Confidential Information (as defined in Section 7) of Sponsor relating to the
structure of ligands to the GnRH receptor (or the activity of such ligands on
the GnRH receptor or mutants of such receptor), unless such Researcher agrees in
writing not to disclose such Confidential Information to any third party except
in accordance with this Agreement or use such information for any purpose other
than the Research Program.
3. PHASE I FUNDING
Within ten (10) days of the Effective Date, Sponsor shall pay Mount
Sinai ******** to fund Phase I of the Research Program. The parties agree that
******* of such amount shall be used directly in the Research Program and the
remainder constitutes institutional overhead at the rate of ******************
*****. Promptly upon receipt
of such funding, Mount Sinai shall commence Phase I of the Research Program as
described on Exhibit A.
4. PHASE II FUNDING
(A) Provided that at least one stable transfected cell line described
under Phase I on the attached Exhibit A is delivered to Sponsor within six
months of the Effective Date, Sponsor shall pay Mount Sinai ******* to fund
Phase II of the Research Program. Such
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*CONFIDENTIAL TREATMENT REQUESTED
payment shall be due on or before the date six (6) months from the Effective
Date. The parties agree that ******* of such amount shall be used directly in
the Research Program and the remainder constitutes institutional overhead at the
rate of ************************. Promptly upon receipt of such funding, Mount
Sinai will commence Phase II of the Research Program as described on Exhibit A.
If the above milestone is not achieved and Sponsor elects not to make the
******* payment, this Agreement shall expire on the date six (6) months from the
Effective Date.
(B) During Phase II of the Research Program, the Principal Investigator
shall make himself available to provide reasonable assistance to Sponsor in the
preparation of an application for an SBIR grant of approximately ********
relating to further research in the Field.
5. SPONSOR'S PROGRAM; PHASE III
Concurrently with the Research Program, Sponsor intends to perform
chemical synthesis and pharmacological testing of compounds to initiate studies
to discover novel small molecule GnRH receptor agonists or antagonists, using
cells transfected with DNA coding for the human GnRH receptor provided by Mount
Sinai. If Sponsor identifies a lead drug candidate, the parties anticipate that
they may wish to provide for further research to be carried out at Mount Sinai.
The parties currently envision that such research might require up to ********
in research funding for up to two years. Prior to the conclusion of the Research
Program established under this Agreement, the parties shall meet to discuss the
progress of the parties' efforts in this area and the need for further research
at Mount Sinai.
6. REPORTS AND CONFERENCES
(A) Mount Sinai agrees to keep complete and accurate scientific records
of the work conducted under the Research Program and to provide Sponsor, upon
request, with access to such records for review during normal business hours
upon reasonable notice and subject to confidentiality restrictions. During the
Research Program, Mount Sinai will provide Sponsor with informal reports (which
may be oral) as reasonably requested by Sponsor. A final written report shall be
submitted by Mount Sinai to Sponsor within forty-five (45) days after the
completion of the Research Program.
(B) During the term of this Agreement, the Principal Investigator shall
be available to meet with representatives of Sponsor at time and places mutually
agreed upon to discuss the Research Program.
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7. CONFIDENTIAL INFORMATION; PUBLICATION
(A) All knowledge, know-how, practices, processes or other information
disclosed by one party to the other (the "RECEIVING PARTY") hereunder and which
is designated in writing as Confidential Information or, if disclosed orally, is
reduced to writing within thirty (30) days of disclosure and designated as
Confidential Information ("CONFIDENTIAL INFORMATION"), shall be received and
maintained by such party in strict confidence and shall not be disclosed to any
third party except in accordance with Section 7(b). The Receiving Party shall
not use said Confidential Information for any purpose other than those purposes
specified in this Agreement. The Receiving Party may disclose Confidential
Information for the purposes of this Agreement to affiliates, employees or
consultants who are obliged to comply with this confidentiality provision.
Sponsor may disclose Confidential Information to potential sublicensees,
collaborators, investors or other third parties in connection with commercial
transactions, provided that such third parties are required to not disclose such
Confidential Information further. This Section 7(a) shall survive for a period
of three (3) years from expiration or termination of this Agreement. The
nondisclosure obligations of this Section 7(a) shall not apply to Confidential
Information which the Receiving Party can establish by competent evidence (i) is
in the public domain prior or subsequent to disclosure without breach by the
Receiving Party, (ii) was in the Receiving Party's possession at the time of
disclosure, (iii) is received by Receiving Party from a third party who has the
lawful right to disclose it, (iv) is disclosed as required by law or regulation
or with the written consent of the other party or (v) is independently developed
by the Receiving Party without the aid or use of such Confidential Information.
(B) Sponsor recognizes that the publication of papers, including oral
presentations and abstracts, regarding the results of the Research Program,
subject to reasonable controls to protect Sponsor's Confidential Information, is
part of Mount Sinai's academic mission. Accordingly, Mount Sinai shall have the
right to disclose the results of the Research Program as follows. At least ten
(10) days before any paper is submitted for publication or any presentation or
other disclosure made, a complete version of the substance of such disclosure
shall be given to Sponsor. Sponsor shall have ten (10) days to review such paper
or presentation in order to identify Confidential Information provided by
Sponsor relating to the structure of ligands to the GnRH receptor (or the
activity of such ligands on the GnRH receptor or mutants of such receptor) to be
deleted from such paper, and/or to require delay of disclosure for up to ninety
(90) days in order to file for patent protection.
8. OWNERSHIP OF INVENTIONS
All right and title to inventions made by Mount Sinai personnel in the
course of the Research Program shall belong to Mount Sinai and shall be subject
to the terms and
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conditions of the Exclusive License Agreement. All right and title to inventions
made by Sponsor personnel during the term of this Agreement shall belong to
Sponsor. All right and title to inventions made jointly by Sponsor and Mount
Sinai shall be owned jointly by Sponsor and Mount Sinai and shall be subject to
the terms and conditions of the Exclusive License Agreement. Inventorship shall
be determined in accordance with U.S. patent laws.
9. TERM AND TERMINATION
(A) This Agreement shall become effective upon the date first written
above and shall continue until the final written report described in Section
6(a) is delivered to Sponsor, unless it expires early pursuant to Section 4(a).
(B) Sponsor may terminate this Agreement as provided in Section 2(b).
In such event, Mount Sinai shall reimburse to Sponsor all funds provided
hereunder except to the extent such funds have already been expended or
committed (without the ability to cancel) in performing the Research Program.
(C) Either party may terminate this Agreement for material breach by
the other party upon thirty (30) days written notice to the breaching party;
provided that such termination shall not be effective if such breach is cured
during such thirty (30) day period. In the event of termination by Sponsor
pursuant to this subsection (c), Mount Sinai shall reimburse to Sponsor all
funds provided hereunder except to the extent such funds have already been
expended or committed (without the ability to cancel) in performing the Research
Program.
(D) Upon any expiration or termination of this Agreement, Section 7 and
all accrued rights and obligations shall survive.
10. USE OF NAME
Sponsor agrees that it will not use the name, trademark or any other
identifier of Mount Sinai in any advertising or promotion without the prior
approval of Mount Sinai, except to disclose the existence of this Agreement and
as otherwise required by law.
11. INDEMNIFICATION AND INSURANCE
Alanex agrees to indemnify, hold harmless and defend Mount Sinai, its
trustees, officers, medical and professional staff, the Principal Investigator,
employees, students and agents, and their respective successors and assigns (the
"Indemnitees"), against any liability, damage, loss or expense (including
reasonable attorneys fees and expenses of litigation) incurred or imposed upon
Indemnitees in connection with any claims, suits, actions, demands or judgments
resulting or arising out of the Research Program. Alanex
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or its sublicensees agree to carry and keep in force commercial general
liability insurance of not less than $1 million per occurrence and $2 million in
aggregate to cover liability for damages on account of bodily or personal injury
or death to any person or damage to property of any person. In addition, Alanex
or its sublicensees shall keep in force product liability insurance of not less
than $2 million per occurrence and $4 million in aggregate prior to any
commercial distribution of any products arising out of the Research Program;
provided, however, such limits shall be increased in Mount Sinai can demonstrate
that higher amounts are customary for businesses the size of Alanex or engaged
in the businesses in which Alanex is engaged. Mount Sinai will be named as an
additional insured on any such insurance and such insurance shall not be
canceled without at least thirty (30) days notice to Mount Sinai. Alanex shall
provide a certificate of insurance evidencing that all required coverage is in
effect stating the limits of such coverage. Such insurance shall be written to
include coverage for any claims incurred in connection with Alanex's activities
under the Research Program, regardless of when such claims are brought. Mount
Sinai shall promptly notify Alanex of any claim for which Mount Sinai may seek
indemnification under this Section 11. Alanex shall have the right to control
the defense of such claim and may enter into any settlement that does not
adversely affect the rights of Mount Sinai. Mount Sinai shall fully cooperate
with Alanex in the defense of such claim, with out-of-pocket costs reimbursed by
Alanex as part of the indemnification.
12. NOTICES
All notices or communications to either party by the other party shall
be delivered personally or sent by first-class or express mail, postage prepaid,
addressed to such party at the following addresses for each and shall be deemed
given on the date so delivered.
If to Mount Sinai,
Mount Sinai School of Medicine of
the City University of New York
One Gustave L. Levy Place
New York, New York 10029-6574
Attn: Director, Office of Science
and Technology Development
If to Sponsor,
Alanex Corporation
3550 General Atomics Court
San Diego, CA 92121
Attn: Chief Executive Officer
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13. ASSIGNMENT
Neither party to this Agreement may assign or transfer any rights or
obligations arising from this Agreement without the prior written consent of the
other party, not to be unreasonably withheld; provided, however, that Sponsor
may assign all of its rights and obligations under this Agreement in connection
with a merger, sale of assets or other transaction involving a change of control
of the line of Sponsor's business to which this Agreement relates.
14. ENTIRE AGREEMENT; AMENDMENTS
The Agreement sets forth all the promises, conditions, understandings
and agreements between the parties relative to the subject matter hereof, and
there are no promises, conditions, understandings or agreements, oral or
written, between the parties relative to the subject matter hereof other than as
set forth herein. This Agreement may only be modified or amended by a written
agreement signed by both parties.
15. CHOICE OF LAW; COUNTERPARTS
The Agreement shall be governed by and construed in accordance with the laws of
the State of California, as applied to contracts entered into between California
residents and performed entirely within California. This Agreement may be
executed in two or more counterparts, all of which together shall constitute one
original.
MOUNT SINAI SCHOOL OF MEDICINE
OF THE CITY UNIVERSITY OF NEW YORK ALANEX CORPORATION
By: /s/ ILLEGIBLE By: /s/ MARVIN R. BROWN
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Title: Dean Title: President
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Date: May 24, 1996 Date: 6/14/96
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Acknowledged by:
/s/ STUART SEALFON
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DR. STUART SEALFON
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*CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT A
RESEARCH PROGRAM
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