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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-Q/A
(Mark one)
X Quarterly report pursuant to Section 13 or 15(d) of the Securities
- --------- Exchange Act of 1934. For the quarterly period ended June 30, 1996.
or
Transition report pursuant to Section 13 or 15(d) of the Securities
- --------- Exchange Act of 1934. For the transition period from ___________ to
___________.
Commission File Number:
0-24814
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SUGEN, Inc.
(Exact name of registrant as specified in its charter)
Delaware 13-3629196
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
515 Galveston Drive, Redwood City, California 94063
(address of principal executive offices)
(415) 306-7700
(Registrant's telephone number, including area code)
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Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to filing requirements
for the past 90 days. Yes X No
----- -----
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date. Common Stock $.01 par value;
10,543,057 shares outstanding at July 31, 1996.
This report on form 10-Q/A, including all exhibits, contains ___ pages. The
exhibit index is located on page 14 of this report.
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EXPLANATORY NOTE
This Form 10-Q/A is being filed solely for the purpose of amending Exhibit 10.51
to the Quarterly Report on Form 10-Q for the quarterly period ending June 30,
1996.
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SUGEN, Inc.
INDEX
PAGE NO.
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PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K 4
Signatures 5
Exhibit Index 6
Exhibit
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PART II. OTHER INFORMATION
Item 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
Exhibit Number Description
10.51* Cooperative Research and Development Agreement between the
Registrant and the National Cancer Institute, dated April
12, 1996.
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* The Registrant has requested confidential treatment with
respect to portions of this Exhibit.
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the quarter ended June 30,
1996.
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SUGEN, Inc.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Date: October 24, 1996 SUGEN, Inc.
By: /s/ Christine E. Gray-Smith By: /s/ Christine E. Gray-Smith
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Christine E. Gray-Smith Christine E. Gray-Smith
Senior Director of Finance Senior Director of Finance
(Principal Financial and (Principal Financial and
Accounting Officer) Accounting Officer)
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SUGEN, Inc.
EXHIBIT INDEX
Exhibit No. Description Page in Form 10-Q/A
10.51* Cooperative Research and Development Agreement
between the Registrant and the National Cancer
Institute, dated April 12, 1996.
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* The Registrant has requested confidential treatment with respect
to portions of this Exhibit.
6
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
EXHIBIT 10.51
Cooperative Research and
Development Agreement
(CACR-0345)
Characterization of the NCI Cancer Screening Panel Regarding RTK/TK and
Phosphatase Expression Status and Profiling of NCI and SUGEN Leads
Dr. George Johnson
DTP
DCTDC
Dr. Peter Hirth
SUGEN, Inc.
Prepared by
Office of Technology Development
National Cancer Institute
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PUBLIC HEALTH SERVICE
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
This Cooperative Research and Development Agreement, hereinafter referred to as
the "CRADA," consists of this Cover Page, an attached Agreement, a Signature
Page and various Appendices referenced in the Agreement. This Cover Page serves
to identify the Parties to this CRADA:
(1) the following Bureau(s), Institute(s), Center(s) or Division(s) of
the National Institutes of Health ("NIH"), the Food and Drug Administration
("FDA"), and the Centers for Disease Control and Prevention ("CDC"): National
Cancer Institute, hereinafter singly or collectively referred to as the Public
Health Service ("PHS"); and
(2) SUGEN, Inc., which has offices at 515 Galveston Drive, Redwood
City, CA 94063, hereinafter referred to as the "Collaborator."
Although drafted for two Parties, the attached CRADA also may be used for any
number. This Cover Page, however, should be modified by repeating block (2) to
identify other Parties to the CRADA. All non-PHS Parties are hereinafter
collectively referred to as the "Collaborator." Use of the terms "Collaborator,"
"Party," and "Parties" should be construed as appropriate for the actual number
of CRADA participants.
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COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Article 1. Introduction
This Cooperative Research and Development Agreement (CRADA) between PHS and the
Collaborator will be effective when signed by all Parties. The research and
development activities which will be undertaken by each of the Parties in the
course of this CRADA are detailed in the Research Plan (RP) which is attached as
Appendix A. The funding and staffing commitments of the Parties are set forth in
Appendix B. Any exceptions or changes to the CRADA are set forth in Appendix C.
Article 2. Definitions
As used in this CRADA, the following terms shall have the indicated meanings:
2.1 "Cooperative Research and Development Agreement" or "CRADA" means this
Agreement, entered into by PHS pursuant to the Federal Technology
Transfer Act of 1986, as amended, 15 U.S.C. 3710a et seq. and Executive
Order 12591 of October 10, 1987.
2.2 "Government" means the Government of the United States as represented
through the PHS agency that is a Party to this agreement.
2.3 "Invention" means any invention or discovery which is or may be
patentable or otherwise protected under title 35, United States Code,
or any novel variety or plant which is or may be protectable under the
Plant Variety Protection Act (7 U.S.C. 2321 et seq.).
2.4 "Principal Investigator(s)" or "PIs" means the persons designated
respectively by the Parties to this CRADA who will be responsible for
the scientific and technical conduct of the RP.
2.5 "Proprietary/Confidential Information" means confidential scientific,
business, or financial information provided that such information does
not include:
2.5.1 information that is publicly known or available from other
sources who are not under a confidentiality obligation to the
source of the information;
2.5.2 information which has been made available by its owners to
others without a confidentiality obligation;
2.5.3 information which is already known by or available to the
receiving Party without a confidentiality obligation; or
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CONFIDENTIAL TREATMENT REQUESTED
2.5.4 information which relates to potential hazards or cautionary
warnings associated with the production, handling or use of
the subject matter of the Research Plan of this CRADA.
2.6 "Research License" shall mean a nontransferable, nonexclusive license
under any IP license to make and use a licensed invention for purposes
of research and not for purposes of commercial manufacture or
distribution or in lieu of purchase.
2.7 "Research Materials" means all tangible materials other than Subject
Data first produced in the performance of this CRADA.
2.8 "Research Plan" or "RP" means the statement in Appendix A of the
respective research and development commitments of the Parties to this
CRADA.
2.9 "Subject Invention" means any Invention of the Parties, conceived or
first actually reduced to practice in the performance of the Research
Plan of this CRADA.
2.10 "Subject Data" means all recorded information first produced in the
performance of this CRADA by the Parties.
Article 3. Cooperative Research
3.1 Principal Investigators. PHS research work under this CRADA will be
performed by the PHS laboratory identified in the RP, and the PHS
Principal Investigator (PI) designated in the RP will be responsible
for the scientific and technical conduct of this project on behalf of
PHS. Also designated in the RP is the Collaborator PI who will be
responsible for the scientific and technical conduct of this project on
behalf of the Collaborator.
3.2 Research Plan Change. The RP may be modified by mutual written consent
of the Principal Investigators. Substantial changes in the scope of the
RP will be treated as amendments under Article 13.6.
Article 4. Reports
4.1 Interim Reports. The Parties shall exchange formal written interim
progress reports on a schedule agreed to by the PIs, but at least
within [REDACTED] after this CRADA becomes effective and at least
within every [REDACTED] thereafter. Such reports shall set forth the
technical progress made, identifying such problems as may have been
encountered and establishing goals and objectives requiring further
effort, any modifications to the Research Plan pursuant to Article 3.2,
and all CRADA- related patent applications filed.
4.2 Final Reports. The Parties shall exchange formal reports of their
results within [REDACTED] after completing the projects described in
the RP or after the expiration or termination of this CRADA.
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CONFIDENTIAL TREATMENT REQUESTED
Article 5. Financial and Staffing Obligations
5.1 PHS and Collaborator Contributions. The contributions of the Parties,
including payment schedules, if applicable, are set forth in Appendix
B. PHS shall not be obligated to perform any of the research specified
herein or to take any other action required by this CRADA if the
funding is not provided as set forth in Appendix B. PHS shall return
excess funds to the Collaborator when it sends its final fiscal report
pursuant to Article 5.2, except for staffing support pursuant to
Article 10.3. Collaborator acknowledges that the U.S. Government will
have the authority to retain and expend any excess funds for up to
[REDACTED] subsequent to the expiration or termination of the CRADA to
cover any costs incurred during the term of the CRADA in undertaking
the work set forth in the RP.
5.2 Accounting Records. PHS shall maintain separate and distinct current
accounts, records, and other evidence supporting all its obligations
under this CRADA, and shall provide the Collaborator a final fiscal
report pursuant to Article 4.2.
5.3 Capital Equipment. Equipment purchased by PHS with funds provided by
the Collaborator shall be the property of PHS. All capital equipment
provided under this CRADA by one party for the use of another Party
remains the property of the providing Party unless other disposition is
mutually agreed upon by in writing by the Parties. If title to this
equipment remains with the providing Party, that Party is responsible
for maintenance of the equipment and the costs of its transportation to
and from the site where it will be used.
Article 6. Intellectual Property Rights and Patent Applications
6.1 Reporting. The Parties shall promptly report to each other in writing
each Subject Invention resulting from the research conducted under this
CRADA that is reported to them by their respective employees. Each
Party shall report all Subject Inventions to the other Party in
sufficient detail to determine inventorship. Such reports shall be
treated as Proprietary/Confidential Information in accordance with
Article 8.4.
6.2 Collaborator Employee Inventions. If the Collaborator does not elect to
retain its IP rights, the Collaborator shall offer to assign these IP
rights to the Subject Invention to PHS pursuant to Article 6.5. If PHS
declines such assignment, the Collaborator may release its IP rights as
it may determine.
6.3 PHS Employee Inventions. PHS on behalf of the U.S. Government may elect
to retain IP rights to each. Subject Invention made solely by PHS
employees. If PHS does not elect to retain IP rights, PHS shall offer
to assign these IP rights to such Subject Invention to the Collaborator
pursuant to Article 6.5. If the Collaborator declines such assignment,
PHS may release IP rights in such Subject Invention to its employee
inventors pursuant to Article 6.6.
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6.4 Joint Inventions. Each Subject Invention made jointly by PHS and
Collaborator employees shall be jointly owned by PHS and the
Collaborator. The Collaborator may elect to file the joint patent or
other IP application(s) thereon and shall notify PHS promptly upon
making this election. If the Collaborator decides to file such
applications, it shall do so in a timely manner and at its own expense.
If the Collaborator does not elect to file such application(s), PHS on
behalf of the U.S. Government shall have the right to file the joint
application(s) in a timely manner and at its own expense. If either
Party decides not to retain its IP rights to a jointly owned Subject
Invention, it shall offer to assign such rights to the other Party
pursuant to Article 6.5. If the other Party declines such assignment,
the offering Party may release its IP rights as provided in Articles
6.2, 6.3, and 6.6.
6.5 Filing of Patent Applications. With respect to Subject Inventions made
by the Collaborator as described in Article 6.2, or by PHS as described
in Article 6.3, a Party exercising its right to elect to retain IP
rights to a Subject Invention agrees to file patent or other IP
applications in a timely manner and at its own expense and after
consultation with the other Party. The Party shall notify the other
Party of its decision regarding filing in countries other than the
United States in a timely manner. The Party may elect not to file a
patent or other IP application thereon in any particular country or
countries provided it so advises the other Party ninety (90) days prior
to the expiration of any applicable filing deadline, priority period or
statutory bar date, and hereby agrees to assign its IP right, title and
interest in such country or countries to the Subject Invention to the
other Party and to cooperate in the preparation and filing of a patent
or other IP applications. In any countries in which title to patent or
other IP rights is transferred to the Collaborator, the Collaborator
agrees that PHS inventors will share in any royalty distribution that
the Collaborator pays to its own inventors.
6.6 Release to Inventors. In the event neither of the Parties to this CRADA
elects to file a patent or other IP application on a Subject Invention,
either or both (if a joint invention) may retain or release their IP
rights in accordance with their respective policies and procedures.
However, the Government shall retain a nonexclusive, non-transferrable,
irrevocable, royalty-free license to practice any such Subject
Invention or have it practiced throughout the world.
6.7 Patent Expenses. The expenses attendant to the filing of patent or
other IP applications generally shall be paid by the Party filing such
application. If an exclusive license to any Subject Invention is
granted to the Collaborator, the Collaborator shall be responsible for
all past and future out-of-pocket expenses in connection with the
preparation, filing, prosecution and maintenance of any applications
claiming such exclusively-licensed inventions and any patents or other
IP grants that may issue on such applications. The Collaborator may
waive its exclusive license rights on any application, patent or other
IP grant at any time, and incur no subsequent compensation obligation
for that application, patent or IP grant.
6.8 Prosecution of Intellectual Property Applications. Within one month of
receipt or filing, each Party shall provide the other Party with copies
of the applications and all
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CONFIDENTIAL TREATMENT REQUESTED
documents received from or filed with the relevant patent or other IP
office in connection with the prosecution of such applications. Each
Party shall also provide the other Party with the power to inspect and
make copies of all documents retained in the patent or other IP
application files by the applicable patent or other IP office. Where
licensing is contemplated by Collaborator, the Parties agree to consult
with each other with respect to the prosecution of applications for PHS
Subject Inventions described in Article 6.3 and joint Subject
Inventions described in Article 6.4. If the Collaborator elects to file
and prosecute IP applications on joint Subject Inventions pursuant to
Article 6.4, PHS will be granted an associate power of attorney (or its
equivalent) on such IP applications.
Article 7. Licensing
7.1 Option for Commercialization License. With respect to Government IP
rights to any Subject Invention not made solely by the Collaborator's
employees for which a patent or other IP application is filed, PHS
hereby grants to the Collaborator an option to elect an exclusive or
nonexclusive commercialization license, which is substantially in the
form of the appropriate model PHS license agreement. This option does
not apply to Subject Inventions conceived prior to the effective date
of this CRADA if PHS has filed a patent application on the invention
and has licensed it or offered to license it to a third party. The
terms of the license will fairly reflect the nature of the invention,
the relative contributions of the Parties to the invention and the
CRADA, the risks incurred by the Collaborator and the costs of
subsequent research and development needed to bring the invention to
the marketplace.
7.2 Exercise of License Option. The option of Article 7.1 must be exercised
by written notice mailed within [REDACTED] after collaborator receives
written notice that the patent or other IP application is filed.
Exercise of this option by the Collaborator initiates a negotiation
period that expires [REDACTED] after the patent or other IP application
filing date. If the last proposal by the Collaborator has not been
responded to in writing by PHS within this [REDACTED] period, the
negotiation period shall be extended to expire [REDACTED] after PHS so
responds, during [REDACTED] the Collaborator may accept in writing the
final license proposal of PHS. In the absence of such acceptance, PHS
will be free to license such IP rights to others. In the event that the
Collaborator elects the option for an exclusive license, but no such
license is executed during the negotiation period, PHS agrees not to
make an offer for an exclusive license on more favorable terms to a
third party for a period of [REDACTED] without first offering
Collaborator [REDACTED.]
7.3 Government Intellectual Property Rights. For inventions developed
wholly by PHS investigators or jointly with a Collaborator, under this
CRADA, pursuant to Articles 6.3 and 6.4, PHS retains, pursuant to the
Federal Technology Transfer Act of 1986, as amended, 15 U.S.C. ss.
3710a(b)(2), a nonexclusive, irrevocable, paid-up license to practice
the invention or to have the invention practiced throughout the world
by or on behalf of the U.S. Government. The PHS also reserves the right
under any exclusive IP license to require Collaborator to grant on
reasonable terms a Research License to third parties.
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CONFIDENTIAL TREATMENT REQUESTED
7.4 Research Licenses. For inventions developed wholly by Collaborator
under this CRADA, pursuant to Article 6.2, the Collaborator agrees to
grant the Government a Research License, as defined in Article 2.6,
which shall be [REDACTED.]
7.5 Joint Inventions Not Exclusively Licensed. In the event that the
Collaborator does not acquire an exclusive commercialization license to
IP rights in all fields in joint Subject Inventions described in
Article 6.4, then each Party shall have the right to use the joint
Subject Invention and to license its use to others in all fields not
exclusively licensed to Collaborator. The Parties may agree to a joint
licensing approach for such IP rights.
Article 8. Proprietary Rights and Publication
8.1 Right of Access. PHS and the Collaborator agree to exchange all Subject
Data produced in the course of research under this CRADA, whether
developed solely by PHS or jointly with the Collaborator. Research
Materials will be shared equally by the Parties to the CRADA unless
other disposition is agreed to by the Parties. All Parties to this
CRADA will be free to utilize Subject Data and Research Materials for
their own purposes, consistent with their obligations under this CRADA.
8.2 Ownership of Subject Data and Research Materials. Subject to the
sharing requirements of Paragraph 8.1 and the regulatory filing
requirements of Paragraph 8.3, the producing Party will retain
ownership of and title to all Subject Inventions, all Subject Data and
all Research Materials produced solely by their investigators. Jointly
developed Subject Inventions, Subject Data and Research Materials will
be jointly owned.
8.3 Dissemination of Subject Data and Research Materials. To the extent
allowed under law, the Collaborator and PHS agree to use reasonable
efforts to keep Subject Data and Research Materials confidential until
published or until corresponding patent applications are filed. Any
information that would identify human subjects of research or patients
will always be maintained confidentially. Collaborator shall have the
exclusive right to use any and all CRADA Subject Data in and for any
regulatory filing by or on behalf of Collaborator, except that PHS
shall have the exclusive right to use Subject Data for that purpose,
and authorize others to do so, if the CRADA is terminated or if
Collaborator abandons its commercialization efforts.
8.4 Proprietary/Confidential Information. Each Party agrees to limit its
disclosure of Proprietary/Confidential Information to the amount
necessary to carry out the Research Plan of this CRADA, and shall place
a confidentiality notice on all such information. Confidential oral
communications shall be [REDACTED.] Each Party receiving
Proprietary/Confidential Information agrees that any information so
designated shall be used by it only for the purposes described in the
attached Research Plan. Any Party may object to the designation of
information as Proprietary/Confidential Information by another Party
and may decline to accept such information. Subject Data and Research
Materials developed solely by the Collaborator may be designated as
Proprietary/Confidential Information when they are wholly
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separable from the Subject Data and Research Materials developed
jointly with PHS investigators, and advance designation of such data
and material categories is set forth in the RP. The exchange of other
confidential information, e.g., patient-identifying data, should be
similarly limited and treated. Jointly developed Subject Data and
Research Material derived from the Research Plan may be disclosed by
Collaborator to a third party under a confidentiality agreement for the
purpose of possible sublicensing pursuant to the Licensing Agreement
and subject to Article 8.7.
8.5 Protection of Proprietary/Confidential Information.
Proprietary/Confidential Information shall not be disclosed, copied,
reproduced or otherwise made available to any other person or entity
without the consent of the owning Party except as required under court
order or the Freedom of Information Act (5 U.S.C. ss. 552). Each Party
agrees to use its best efforts to maintain the confidentiality of
Proprietary/Confidential Information. Each Party agrees that the other
Party is not liable for the disclosure of Proprietary/Confidential
Information which, after notice to and consultation with the concerned
Party, the other Party in possession of the Proprietary/Confidential
Information determines may not be lawfully withheld, provided the
concerned Party has been given an opportunity to obtain a court order
to enjoin disclosure.
8.6 Duration of Confidentiality Obligation. The obligation to maintain the
confidentiality of Proprietary/Confidential Information shall expire at
the earlier of the date when the information is no longer Proprietary
Information as defined in Article 2.5 or three (3) years after the
expiration or termination date of this CRADA. The Collaborator may
request an extension to this term when necessary to protect
Proprietary/Confidential Information relating to products not yet
commercialized.
8.7 Publication. The Parties are encouraged to make publicly available the
results of their research. Before either Party submits a paper or
abstract for publication or otherwise intends to publicly disclose
information about a Subject Invention, Subject Data or Research
Materials, the other Party shall be provided thirty (30) days to review
the proposed publication or disclosure to assure that
Proprietary/Confidential Information is protected. The publication or
other disclosure shall be delayed for up to thirty (30) additional days
upon written request by any Party as necessary to preserve U.S. or
foreign patent or other IP rights.
Article 9. Representations and Warranties
9.1 Representations and Warranties of PHS. PHS hereby represents and
warrants to the Collaborator that the official signing this CRADA has
authority to do so.
9.2 Representations and Warranties of the Collaborator.
(a) The Collaborator hereby represents and warrants to PHS that the
Collaborator has the requisite power and authority to enter into this
CRADA and to perform according to its terms, and that the
Collaborator's official signing this CRADA has authority to do
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CONFIDENTIAL TREATMENT REQUESTED
so. The Collaborator further represents that it is financially able to
satisfy any funding commitments made in Appendix B.
(b) The Collaborator certifies that the statements herein are true,
complete, and accurate to the best of its knowledge. The Collaborator
is aware that any false, fictitious, or fraudulent statements or claims
may subject it to criminal, civil, or administrative penalties.
Article 10. Termination
10.1 Termination By Mutual Consent. PHS and the Collaborator may terminate
this CRADA, or portions thereof, at any time by mutual written consent.
In such event the Parties shall specify the disposition of all
property, inventions, patent or other IP applications and other results
of work accomplished or in progress, arising from or performed under
this CRADA, all in accordance with the rights granted to the Parties
under the Terms of this Agreement.
10.2 Unilateral Termination. Either PHS or the Collaborator may unilaterally
terminate this entire CRADA at any time by giving written notice at
least thirty (30) days prior to the desired termination date, and any
rights accrued in property, patents or other IP rights shall be
disposed of as provided in paragraph 10.1.
10.3 Staffing. If this CRADA is mutually or unilaterally terminated prior to
its expiration, funds will nevertheless remain available to PHS for
continuing any staffing commitment made by Collaborator pursuant to
Article 5.1 above and Appendix B, if applicable, for a period of
[REDACTED] after such termination. If there are insufficient funds to
cover this expense, [REDACTED].
10.4 New Commitments. No Party shall make new commitments related to this
CRADA after a mutual termination or notice of a unilateral termination
and shall, to the extent feasible, cancel all outstanding commitments
and contracts by the termination date.
10.5 Termination Costs. Concurrently with the exchange of final reports
pursuant to Articles 4.2 and 5.2, PHS shall submit to the Collaborator
for payment a statement of all costs incurred prior to the date of
termination and for all reasonable termination costs including the cost
of returning Collaborator property or removal of abandoned property,
for which Collaborator shall be responsible.
Article 11. Disputes
11.1 Settlement. Any dispute arising under this CRADA which is not disposed
of by agreement of the Principal Investigators shall be submitted
jointly to the signatories of this CRADA. If the signatories are unable
to jointly resolve the dispute within thirty (30) days after
notification thereof, the Assistant Secretary for Health (or his/her
designee or successor) shall propose a resolution. Nothing in this
Article shall prevent any Party
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from pursuing any additional administrative remedies that may be
available and, after exhaustion of such administrative remedies,
pursuing all available judicial remedies.
11.2 Continuation of Work. Pending the resolution of any dispute or claim
pursuant to this Article, the Parties agree that performance of all
obligations shall be pursued diligently in accordance with the
direction of the PHS signatory.
Article 12. Liability
12.1 Property. The U.S. Government shall not be responsible for damages to
any Collaborator property provided to PHS, where Collaborator retains
title to the property, or any property acquired by Collaborator for its
own use pursuant to this CRADA.
12.2 NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 10, THE PARTIES
MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER,
INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY INVENTION OR PRODUCT,
WHETHER TANGIBLE OR INTANGIBLE, MADE, OR DEVELOPED UNDER THIS CRADA, OR
THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF
THE RESEARCH OR ANY INVENTION OR PRODUCT.
12.3 Indemnification. The Collaborator agrees to hold the U.S. Government
harmless and to indemnify the Government for all liabilities, demands,
damages, expenses and losses arising out of the use by the Collaborator
for any purpose of the Subject Data, Research Materials and/or Subject
Inventions produced in whole or part by PHS employees under this CRADA,
unless due to the negligence or willful misconduct of PHS, its
employees, or agents. The Collaborator shall be liable for any claims
or damages it incurs in connection with this CRADA. PHS has no
authority to indemnify the Collaborator.
12.4 Force Majeure. Neither Party shall be liable for any unforeseeable
event beyond its reasonable control not caused by the fault or
negligence of such Party, which causes such Party to be unable to
perform its obligations under this CRADA, and which it has been unable
to overcome by the exercise of due diligence. In the event of the
occurrence of such a force majeure event, the Party unable to perform
shall promptly notify the other Party. It shall further use its best
efforts to resume performance as quickly as possible and shall suspend
performance only for such period of time as is necessary as a result of
the force majeure event.
Article 13. Miscellaneous
13.1 Governing Law. The construction, validity, performance and effect of
this CRADA shall be governed by Federal law, as applied by the Federal
Courts in the District of Columbia. Federal law and regulations will
preempt any conflicting or inconsistent provisions in this CRADA.
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13.2 Entire Agreement. This CRADA constitutes the entire agreement between
the Parties concerning the subject matter of this CRADA and supersedes
any prior understanding or written or oral agreement.
13.3 Headings. Titles and headings of the articles and subarticles of this
CRADA are for convenient reference only, do not form a part of this
CRADA, and shall in no way affect its interpretation.
13.4 Waivers. None of the provisions of this CRADA shall be considered
waived by any Party unless such waiver is given in writing to the other
Party. The failure of a Party to insist upon strict performance of any
of the terms and conditions hereof, or failure or delay to exercise any
rights provided herein or by law, shall not be deemed a waiver of any
rights of any Party.
13.5 Severability. The illegality or invalidity of any provisions of this
CRADA shall not impair, affect, or invalidate the other provisions of
this CRADA.
13.6 Amendments. If either Party desires a modification to this CRADA, the
Parties shall, upon reasonable notice of the proposed modification or
extension by the Party desiring the change, confer in good faith to
determine the desirability of such modification or extension. Such
modification shall not be effective until a written amendment is signed
by the signatories to this CRADA or by their representatives duly
authorized to execute such amendment.
13.7 Assignment. Neither this CRADA nor any rights or obligations of any
Party hereunder shall be assigned or otherwise transferred by either
Party without the prior written consent of the other Party.
13.8 Notices. All notices pertaining to or required by this CRADA shall be
in writing and shall be signed by an authorized representative and
shall be delivered by hand or sent by certified mail, return receipt
requested, with postage prepaid, to the addresses indicated on the
signature page for each Party. Notices regarding the exercise of
license options shall be made pursuant to Article 7.2. Any Party may
change such address by notice given to the other Party in the manner
set forth above.
13.9 Independent Contractors. The relationship of the Parties to this CRADA
is that of independent contractors and not as agents of each other or
as joint venturers or partners. Each Party shall maintain sole and
exclusive control over its personnel and operations. Collaborator
employees who will be working at PHS facilities may be asked to sign a
Guest Researcher or Special Volunteer Agreement appropriately modified
in view of the terms of this CRADA.
13.10 Use of Name or Endorsements. By entering into this CRADA, PHS does not
directly or indirectly endorse any product or service provided, or to
be provided, whether directly or indirectly related to either this
CRADA or to any patent or other IP license or agreement which
implements this CRADA by its successors, assignees, or licensees. The
-11-
<PAGE>
Collaborator shall not in any way state or imply that this CRADA is an
endorsement of any such product or service by the U.S. Government or
any of its organizational units or employees. Collaborator issued press
releases that reference or rely upon the work of PHS under this CRADA
shall be made available to PHS at least 7 days prior to publication for
review and comment.
13.11 Exceptions to this CRADA. Any exceptions or modifications to this CRADA
that are agreed to by the Parties prior to their execution of this
CRADA are set forth in Appendix C.
13.12 Reasonable Consent. Whenever a Party's consent or permission is
required under this CRADA, such consent or permission shall not be
unreasonably withheld.
Article 14. Duration of Agreement
14.1 Duration. It is mutually recognized that the duration of this project
cannot be rigidly defined in advance, and that the contemplated time
periods for various phases of the RP are only good faith guidelines
subject to adjustment by mutual agreement to fit circumstances as the
RP proceeds. In no case will the term of this CRADA extend beyond the
term indicated in the RP unless it is revised in accordance with
Article 13.6.
14.2 Survivability. The provisions of Articles 4.2, 5-8,10.3-10.5, 11.1,
12.2-12.4, 13.1, 13.10 and 14.2 shall survive the termination of this
CRADA.
-12-
<PAGE>
NIH/ADAMHA Patent Policy Board CACR - 0345
CRADA SIGNATURE PAGE
FOR NIH:
/s/ Alan S. Rabson 4/11/96
- ------------------------------------------------ --------------------
Alan S. Rabson, M.D. Date
Deputy Director, NCI
Mailing Address for Notices:
National Cancer Institute
Office of Technology Development
9000 Rockville Pike
Building 31, Room 4A51
Bethesda, Maryland 20892
FOR THE COLLABORATOR: (The undersigned expressly certifies or affirms that the
contents of any statements made or reflected in this document are truthful and
accurate.)
/s/ James L. Tyree 4/12/96
- ------------------------------------------------ --------------------
Mr. James L. Tyree Date
President
Mailing Address for Notices:
SUGEN, Inc.
515 Galveston Drive
Redwood City, CA 94063
S-1
<PAGE>
APPENDIX A
RESEARCH PLAN
TITLE OF CRADA: Characterization of the NCI Cancer Screening Panel Regarding
RTK/TK and Phosphatase Expression Status and Profiling of NCI and SUGEN Leads
PHS PRINCIPAL INVESTIGATOR: Dr. George Johnson, DTP, DCTDC, NCI
his/her Laboratory: Developmental Therapeutics Program, NCI
COLLABORATOR PRINCIPAL INVESTIGATOR: Dr. Peter Hirth
TERM OF CRADA: Three (3) years.
The Research Plan which follows this page should be concise but of sufficient
detail to permit reviewers of this CRADA to evaluate the scientific merit of the
proposed collaboration. The RP should explain the scientific importance of the
collaboration and the research goals of PHS and the Collaborator. The respective
contributions in terms of expertise and/or research materials of PHS and
Collaborator should be summarized. Initial and subsequent projects contemplated
under the RP, and the time periods estimated for their completion, should be
described and pertinent methodological considerations summarized. Pertinent
literature references may be cited and additional relevant information included.
Include additional pages to identify the Principal Investigators of all other
Parties to this CRADA.
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<PAGE>
APPENDIX A
RESEARCH PLAN
NCI CRADA # 345
Title of CRADA
Characterization of the NCI Cancer Screening Panel
Regarding RTK / TK and Phosphatase Expression Status
and Profiling of NCI and SUGEN Lead Structures
NIH PRINCIPAL INVESTIGATOR
Dr. George Johnson
Developmental Therapeutics Program, DCTDC, NCI
Collaborator Principal Investigator
Dr. Peter Hirth
SUGEN, Inc.
Term of CRADA
Three (3) years.
A Letter of Intent (LOI) for this CRADA was executed between the
Parties on December 11, 1995.
Research Goals of this CRADA
The proposed Cooperative Research and Development Agreement (CRADA) will
encompass a joint collaborative research effort on the parts of NCI and SUGEN,
Inc. in the projects as detailed below. The general description of the research
project will be molecular target characterization of NCI's cancer screening
panel (Project 1) followed by screening and profiling of both NCI and SUGEN
compounds in each Party's respective screening assays (Projects 2 and 3). Lead
compound(s) identified through these collaborative efforts may be the subject of
a formally executed and mutually agreeable written amendment to the executed
CRADA for further preclinical testing possibly leading to human clinical trials
(Project 4).
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Appendix A - Confidential CRADA 345
NCI/SUGEN
Overview and Objectives of This CRADA
PROJECT 1
Overview
o The Parties will collaborate on the characterization of NCI's cancer
screening panel of sixty selected tumor cell lines regarding the RTK / TK
and specific phosphatase expression status. The scope of the CRADA Research
Plan is defined by the [REDACTED] attached as pages A-5 and A-6 below and
will be modifiable after execution of the CRADA only by written amendment.
o Under this CRADA, SUGEN is designated as the exclusive collaborator with
NCI for the characterization of the NCI cancer screening panel with regard
to the designated molecular target assays. Accordingly, NCI will not
collaborate with any other commercial entity related to [REDACTED]
designated. The Developmental Therapeutics Program has selected this level
of exclusivity to best address the interests of both Parties: the interest
of the Program to pursue other unrelated and non-redundant assays which may
provide additional important data and [REDACTED] and the interests of SUGEN
in securing an exclusive collaborative relationship during the term of the
CRADA.
o Transfers of the cancer panels for [REDACTED] to any non-commercial entity
will be for research purposes only and will not be subject to any
obligations of any commercial entity. SUGEN will be notified of any
non-commercial research requests and, through NCI, will have the
opportunity to approach the non-commercial entity in order to negotiate
future intellectual property option arrangements. Additionally, at the time
of transfer, DTP will notify the non-commercial entity of the existence of
this CRADA and the obligations of NCI. While SUGEN will not have the
opportunity to disapprove any transfers by NCI to a non-commercial entity,
any serious reservations regarding the [REDACTED] will be taken into
consideration by NCI as a factor for the appropriateness of the [REDACTED]
to the non-commercial entity (in light of any potential conflicts with the
goals of this CRADA) prior to NCI making a final decision regarding the
transfer.
o NCI's computer screening database will be searched for compounds with
cytotoxicity profiles which correlate with expression profiles.
o SUGEN will perform verification testing of the open listed (see Project 2
Overview) correlates against the molecular target.
A-2
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Appendix A - Confidential CRADA 345
NCI/SUGEN
Objectives
o With this information, the Collaborators will learn if the NCI tumor panel
contains many of the recently discovered dominant mechanisms underlying
cancer growth.
o The results from obtaining this information could be the [REDACTED]
information to help evaluate [REDACTED] data stored in the NCI databases
and SUGEN would be able to adopt (through CRADA amendment(s) and/or
licensing if necessary) NCI leads as part of SUGEN's Drug Discovery
Program.
Resources
o NCI will provide cell lines to SUGEN.
o SUGEN will perform transcript imaging of "targets" at the expected expense
of [REDACTED] per 1 year.
o SUGEN and NCI will jointly develop query software and code for pattern and
data analysis.
PROJECT 2
Overview
o SUGEN's [REDACTED] from SUGEN's screening program will be profiled in NCI's
tumor cell line panel.
o NCI's computer screening database will be searched for [REDACTED] which
best match that of the lead structure. [REDACTED]
o SUGEN will perform verification testing of the SUGEN compounds against the
target.
Objectives
o The profiling of SUGEN's [leads] in NCI's [REDACTED] could identify utility
in different cancer indications.
o The screening results might help SUGEN to test certain [REDACTED] in the
appropriate preclinical models and in the case of more advance [REDACTED],
to include certain [REDACTED] in Phase II / III studies.
A-3
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Appendix A - Confidential CRADA 345
NCI/SUGEN
o From the search of NCI's computer database, [REDACTED] could be identified
for development.
Resources
o SUGEN will provide compounds with a synthesis cost estimated at [REDACTED]
per year.
o NCI will test compounds in cell panel.
o NCI will analyze cytotoxicity database and provide available correlating
compounds to SUGEN for verification testing.
PROJECT 3
Overview
o Compounds selected from NCI's open repository (See Project 2 definition)
will be screened against SUGEN's primary screening assays.
Objectives
o SUGEN would have increased access to small molecules for inclusion into its
screen as well as increase the diversity for [REDACTED].
o More specifically, it is anticipated that selection and providing of
compounds under this Agreement from NCI's [REDACTED] for use in other
screening assays will enable NCI and SUGEN to explore fully the therapeutic
potential of the compounds identified as "hits" on SUGEN's targets.
Resources
o NCI will format and provide compounds to SUGEN for testing.
o SUGEN will provide a [REDACTED] payment to NCI under the CRADA (per sample
basis) for the formatting, shipping and other costs associated with the
sampling and transfer of the compounds.
o SUGEN will [REDACTED].
PROJECT 4
Preclinical Studies and Clinical Trials
Should a lead compound(s) be isolated, preclinical testing (and ultimately,
clinical trials) may be possible under this CRADA. However, preclinical testing
and clinical trials shall not be initiated without an appropriate mutually
agreeable written amendment to this CRADA.
A-4
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Appendix A - Confidential CRADA 345
NCI/SUGEN
[REDACTED] The written amendment(s) to the executed CRADA should clearly define
the roles, contributions and obligations of the Parties under the CRADA, as they
may relate to any preclinical testing or clinical studies. The Parties
understand that these obligations will likely involve [REDACTED], as negotiated
by the Parties at that time, for CRADA-related research which is the subject of
the amendment(s).
Resources
The resources as they may relate to Project 4 collaboration for preclinical or
clinical studies will be determined upon the identification of any lead
compound(s). The CRADA will be amended appropriately.
A-5
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-6
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-7
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-8
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-9
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-10
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-11
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-12
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
[REDACTED]
A-13
<PAGE>
Appendix A - Confidential CRADA 345
NCI/SUGEN
Abstract for Public Release
The proposed Cooperative Research and Development Agreement (CRADA) will
encompass a joint collaborative research effort on the parts of NCI and SUGEN,
Inc. The general description of the research project will be molecular target
characterization of NCI's cancer screening panel followed by screening and
profiling of both NCI and SUGEN compounds in each Party's respective screening
assays. Lead compound(s) identified through these collaborative efforts may be
the subject of a formally executed and mutually agreeable written amendment to
the executed CRADA for further preclinical testing possibly leading to human
clinical trials.
A-14
<PAGE>
APPENDIX B
FINANCIAL AND STAFFING CONTRIBUTIONS OF THE PARTIES
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<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Confidential
APPENDIX B
Financial and Staffing Contributions of the Parties
For NIH:
The Developmental Therapeutics Program, (DTP) DCTDC estimates that [REDACTED] of
effort will be dedicated to its participation in the research under this CRADA.
(An average of [REDACTED] per year under the CRADA.)
NCI will provide no funding to Company for collaborative research and
development pursuant to this CRADA, inasmuch as financial contributions by the
U.S. government to non-Federal parties under a CRADA is prohibited under the
Federal Technology Transfer Act of 1986 (15 U.S.C. ss.3710 a(d)(1)).
For SUGEN, Inc.:
Personnel:
SUGEN, Inc. intends to commit [REDACTED] of effort to permit the timely
execution of the studies implemented under this CRADA. More specifically, this
staffing shall include SUGEN [REDACTED] dedicated to the research and
development for the screening characterization studies performed under this
CRADA.
Funding:
For the molecular target characterization portion of this CRADA, SUGEN will not
provide any funding to the DTP except that SUGEN may provide a [REDACTED]
payment to NCI under the CRADA or directly to the NCI contractor (per sample
basis) for the formatting, shipping and other costs associated with the sampling
and transfer of the compounds.
SUGEN will also provide funds, in the amount of [REDACTED] per year to provide
for appropriate and mutually agreeable travel and training for NCI staff related
to the research and development under this CRADA
No funds provided under this CRADA by SUGEN will be used by NCI to [REDACTED].
Should any of the nominal funds remain, NCI or the NCI contractor will return
excess funds to the Collaborator when it sends its final fiscal report.
Payments for the [REDACTED] under this CRADA shall be made to DTP or to DTP
contractors as appropriate.
B-1
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Confidential
Payments by SUGEN to NCI for [REDACTED] will be made only after execution of a
separately negotiated and mutually agreeable written amendment to this CRADA.
B-2
<PAGE>
APPENDIX C
EXCEPTIONS OR MODIFICATIONS TO THIS CRADA
-16-
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Confidential
APPENDIX C
EXCEPTIONS OR MODIFICATIONS TO THIS CRADA
Add a new Article 3.3 as follows:
3.3 Research Team. The Parties agree to establish a joint research and
development team (hereinafter referred to as the "Team") comprising at
least the Principal Investigators designated pursuant to Article 3.1 to
conduct and monitor the research in accordance with the RP. Although the
members of the Team shall be considered as having been delegated to the
Team, they shall continue to remain employed by their respective employers
under their respective terms of employment. The initial composition of the
Team shall be 2 voting members on behalf of SUGEN, including the
Collaborator Principal Investigator designated pursuant to Article 3.1, and
[REDACTED] designated pursuant to Article 3.1. The chair of the Team will
alternate on a yearly basis between NCI and SUGEN. The membership of the
Team may be changed from time to time as mutually agreed by NCI and SUGEN
Add a new Article 3.4 as follows:
3.4 Exclusive Collaborator for Subject Research Project: The scope of the CRADA
Research Plan (Appendix A) will be appropriately and explicitly defined by
the list of molecular targets and the corresponding RNA screening assays
(see pages A-5 and A-6), as agreed upon by the Parties prior to the
execution of this Agreement, and will be modifiable after execution of the
CRADA only by written amendment. NCI agrees that SUGEN will be designated
as the exclusive collaborator with NCI with regard to RNA screening assay
characterization of the NCI cancer screening panel for the RTK / TK and
specific phosphatase expression status for the molecular targets designated
and, accordingly, NCI will not collaborate with any other commercial entity
with regard to the designated target assays.
Add a new Article 3.5 as follows:
3.5 Additional Research: SUGEN and NCI shall be free to sponsor additional
molecular targeting research relating to the characterization of tumor cell
panels outside the scope of this CRADA. As agreed by the Parties, molecular
target screening research by SUGEN with NCI tumor cell panels is limited to
the scope of this CRADA.
Add the following to the end of Article 4.1 Interim Reports:
"Reports from the Research Team or copies of screening results updating the
progress of the CRADA research shall satisfy the reporting requirements
under this Article 4.1."
Revise the first two sentences of Article 7.2 to read as follows:
C-1
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Appendix C - Confidential CRADA 345
NCI/SUGEN
"The option of Article 7.1 must be exercised by written notice mailed
within [REDACTED] after collaborator receives written notice that the
patent or other IP application is filed. Exercise of this option by the
Collaborator initiates a negotiation period that expires [REDACTED] of said
license option."
Article 8.6 shall be modified by adding the following paragraphs to the end:
Notwithstanding the previous paragraph, target data produced by SUGEN,
provided to NCI for database analysis and incorporation under the CRADA
will be held in confidence by the parties for a period not to exceed one
year. For [REDACTED], will be accommodated by NCI only upon mutual
agreement of the Parties. Conversely, [REDACTED] produced by SUGEN and
analyzed by NCI may become publicly available during the one year period
only upon mutual agreement of the Parties. The time period begins when NCI
provides SUGEN with [REDACTED] obtained from its analysis of data which
SUGEN had provided for each [REDACTED]. SUGEN understands that NCI may
periodically make requests to publish data during the one year period when
it would be beneficial to the fundamental technology underlying the NCI
National Screening Program and the advancement of cancer research in
general. These requests by NCI will be primarily for dissemination of
important information and shall not be unreasonably denied by SUGEN.
Data which relates either to receptor targets or lead compounds which is
jointly produced by the Parties may be published by NCI only after SUGEN
has had the opportunity to review the manuscript in accordance with Article
9.6 of this Agreement. SUGEN may redact any proprietary and confidential
information as reasonably appropriate.
Provided that the Parties either individually or jointly (as mutually
agreed) are actively developing any lead compound, the Parties agree that
the proprietary information relating to the identity and nature of the lead
compounds produced by NCI and SUGEN will not be disclosed to any other
party prior to entrance of the compound into the NCI Decision Network Level
III (clinical) decision point. Active development should be interpreted by
the parties to mean a reasonable rate of progress on any promising
compounds along a development plan as measured in comparison to the general
NCI Decision Network process. The active development of each compound shall
be addressed in each regular Interim Report pursuant to Article 4 of this
Agreement. Concerns by NCI related to the progress of compound development
by SUGEN shall be forwarded to SUGEN in writing and subsequently addressed
by SUGEN in the next Interim Report or six months later, whichever date is
later.
For the purposes of this Agreement, "Publication" means any written or oral
dissemination or any other public dissemination of the information
including posting of the information on the World Wide Web or Internet.
C-2
<PAGE>
Appendix C - Confidential CRADA 345
NCI/SUGEN
Add a new Article 8.8 as follows:
8.8 Providing Subject Data produced by NCI to non-CRADA Parties by SUGEN.
Because NCI has a duty to protect the integrity and quality of the Data
generated by the NCI under this Agreement, Subject Data which have been
provided to Collaborator may be made available to a third party by
Collaborator subject to the following conditions:
a. Access to the NCI-produced Subject Data by a third party must be
deemed necessary by Collaborator for the development and/or
commercialization of the CRADA technology (ie. Said third party will
play a role in the development or regulatory approval of the
technology or any agent(s);
b. Collaborator agrees to keep accurate records of all transfers of NCI
Subject data to a third party;
c. All transfers of NCI Subject data to a third party by Collaborator
shall be protected by terms of Confidentiality at least as restrictive
as the terms of Confidentiality which bind the transfer of data from
NCI to Collaborator;
d. NCI data may not be sold or transferred for any consideration to a
third party by Collaborator; and
e. Data which is transferred either to Collaborator by NCI or to a third
party by Collaborator shall be maintained in essentially the same form
as it was received from the NCI.
C-3
<PAGE>
Appendix D - Confidential CRADA 345
NCI/SUGEN
APPENDIX D
Intellectual Property, Licensing, and Other Related Agreements
1) A Letter of Intent (LOI) for the Subject CRADA was executed between the
Parties on December 11, 1995. A copy is attached hereto.
2) SUGEN currently is the CRADA collaborator with NCI for the Clinical
Development of SU-101. NCI CRADA # 294 was executed on August 14, 1995 with an
effective date of May 25, 1995.
D-1
<PAGE>
Tom Mays
Document Type: Lett
File Number: CRADA #00345
DEPARTMENT OF HEALTH & HUMAN SERVICES
- --------------------------------------------------------------------------------
National Institutes of Health
National Cancer Institute
Office of Technology
Development
9000 Rockville Pike
Bldg. 31, Room 4A51
Bethesda, Maryland 20892
(301) 496-0477
(301) 402-2117 fax
December 4, 1995
Mr. Stephen Evans-Freke
Chairman and CEO
SUGEN, Inc.
515 Galveston Drive
Redwood City, CA 94063
Re: Proposed Cooperative Research and Development Agreement (CRADA)
CRADA #: 345
NCI Principal Investigator: Dr. George Johnson
Collaborator Investigator: Dr. Peter Hirth
Title: Characterization of the NCI Cancer Screening Panel Regarding RTK/TK and
Phosphatase Expression Status and Profiling of NCI and SUGEN Lead
Structures.
Dear Mr. Evans-Freke,
It is my understanding that a cooperative research and development project
between the parties referenced below is being considered. Accordingly, until a
formal Collaborative Research and Development Agreement (CRADA) is reviewed by
the CRADA Subcommittee and approved by the Director, National Cancer Institute
(NCI), this Letter is offered to permit joint research to commence.
It is acknowledged by the parties below that cooperative research pursuant to
the Research Plan, attached as Appendix A, will be conducted informally by the
NCI Principal Investigator and Collaborator pending formal approval of this
CRADA. It is further acknowledged that patentable inventions may be made by NCI
employees and employees of the Collaborator. Pursuant to its authority under
Federal Technology Transfer Act of 1986, NCI agrees that should this CRADA be
approved, it will have retroactive effect to the date that the last party has
executed the Letter for any inventions that may be made under this Research
Plan. NCI further agrees that this CRADA will have retroactive effect to the
date
-1-
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
that the last party has executed this Letter for confidentiality obligations
specified in the NIH Model CRADA. The NIH Model CRADA provisions for the
protection of proprietary information are incorporated by reference and are
considered controlling. These provisions include, but are not limited to,
Articles 2.2 and 9.1-9.7. The NIH Model CRADA is attached as Appendix B.
Prior to the execution of the CRADA, SUGEN and NCI will jointly generate a
[REDACTED] which will be the subject of this CRADA. The scope of the CRADA
Research Plan will be appropriately and explicitly defined by the [REDACTED] and
will be modifiable after execution of the CRADA only by written amendment.
Additionally, NCI agrees that the CRADA will designate SUGEN as the exclusive
collaborator with NCI for the characterization of the NCI cancer screening panel
with regard to the designated molecular targets and, accordingly, NCI will not
collaborate with any other commercial entity with regard to the designated
targets.
Finally, the Parties recognize that the U.S. Public Health Service policy
relating to the "Pricing" clause formerly at Article 8.3 of the NIH Model CRADA
and at Article 5.04 of the PHS Model Exclusive License Agreement has been
rescinded. Consequently, said "Pricing" clause will be deleted and will be of no
force and effect in this CRADA, if subsequently approved and executed, or in any
subsequent exclusive licenses granted on Subject Inventions under this CRADA.
You understand, however, that this letter is not a commitment on the part of
either party to enter into a CRADA. Further, this Letter is effective for a term
of [REDACTED] The [REDACTED] term may be extended, provided the CRADA is under
active negotiation and the collaborative research is continuing. Assuming the
necessary approvals are forthcoming, we look forward to a successful
collaboration.
Sincerely,
/s/ Thomas D. Mays
Thomas D. Mays, Ph.D., J.D.
Director, NCI Office of Technology Development
- --------------------------------------------------------------------------------
ACCEPTED AND AGREED TO:
National Cancer Institute SUGEN, Inc.
/s/ Alan S. Rabson /s/ Stephen Evans-Freke
- ----------------------------- ----------------------------------
Alan S. Rabson, M.D. Mr. Stephen Evans-Freke
Deputy Director, NCI Chairman and CEO
12/6/95 12/11/95
- ----------------------------- ----------------------------------
Date Date
-2-
<PAGE>
Attachments:
Appendix A: LOI Research Plan
Appendix B: NCI Model CRADA
cc: Mr. Dan Kiser, Esq., Fox, Bennett & Turner
Dr. George Johnson, DCTDC, NCI
-3-
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
Letter of Intent Research Plan Appendix A
Introduction
The proposed Cooperative Research and Development Agreement (CRADA) will
encompass a joint collaborative research effort on the parts of NCI and SUGEN,
Inc. in the projects as detailed below. The general description of the research
project will be molecular target characterization of NCI's cancer screening
panel (Project 1) followed by screening and profiling of both NCI and SUGEN
compounds in each Party's respective screening assays (Projects 2 and 3). Lead
compound(s) identified through these collaborative efforts may be the subject of
a formally executed and mutually agreeable written amendment to the executed
CRADA for further preclinical testing possibly leading to human clinical trials
(Project 4).
Overview and Objectives of This CRADA
PROJECT 1
Overview
o The Parties will collaborate on the characterization of NCI's cancer
screening panel of sixty selected tumor cell lines regarding the RTK / TK
and specific phosphatase expression status. (Prior to the execution of the
CRADA, SUGEN and NCI will provide a [REDACTED] which will be the subject of
this CRADA. The scope of the CRADA Research Plan will be appropriately and
explicitly defined by the [REDACTED] and will be modifiable after execution
of the CRADA only by written amendment. The CRADA will designate SUGEN as
the [REDACTED] collaborator with NCI for the characterization of the NCI
cancer screening panel with regard to the designated molecular targets and,
accordingly, NCI will not collaborate with any other commercial entity with
regard to the designated targets.)
o NCI's computer screening database will be searched for [REDACTED]
o SUGEN will perform verification testing of the open listed (see Project 3
Overview) correlates against the molecular target.
Objectives
o With this information, the Collaborators will learn if the NCI tumor panel
contains many of the recently discovered dominant mechanisms underlying
cancer growth.
o The results from obtaining this information could be the [REDACTED] SUGEN
and NCI could also use the [REDACTED] information to help evaluate
[REDACTED] stored in the NCI databases and
LOI-A-1
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
CRADA Letter of Intent Research Plan CRADA 345
NCI-SUGEN Appendix A
SUGEN would be able to adopt (through CRADA amendment(s) and/or licensing
if necessary) NCI leads as part of SUGEN's Drug Discovery Program.
Resources
o NCI will provide cell lines to SUGEN.
o SUGEN will perform [REDACTED] at the expected expense of [REDACTED] per 1
year.
o SUGEN and NCI will jointly develop [REDACTED]
PROJECT 2
Overview
o SUGEN's lead structures from SUGEN's screening program will be profiled in
NCI's tumor cell line panel.
o NCI's computer screening database will be searched for compounds with
cytotoxicity profiles which best match that of the lead structure.
o SUGEN will perform verification testing of the SUGEN compounds against the
target.
Objectives
o The profiling of SUGEN's leads in NCI's tumor panel could identify utility
in [REDACTED]
o The screening results might help SUGEN to test certain leads in the
appropriate preclinical models and in the case of more advance compounds,
[REDACTED] in Phase II / III studies.
o From the search of NCI's computer database, new leads could be identified
for development.
Resources
o SUGEN will provide compounds with a synthesis cost estimated at [REDACTED]
per year.
o NCI will test compound in cell panel.
o NCI will analyze cytotoxicity database and provide available correlating
compounds to SUGEN for verification testing.
LOI-A-2
<PAGE>
CONFIDENTIAL TREATMENT REQUESTED
CRADA Letter of Intent Research Plan CRADA 345
NCI-SUGEN Appendix A
PROJECT 3
Overview
o Compounds selected from NCI's open repository [REDACTED] will be screened
against SUGEN's primary screening assays.
LOI-A-3
