CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.22
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 OF THE SECURITIES ACT OF 1933
CONFIDENTIAL TREATMENT IS REQUESTED AND IS NOTED WITH "[CONFIDENTIAL TREATMENT
REQUESTED]." AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN PREVIOUSLY FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION.
AGREEMENT REGARDING ACADEMIC
CLINICAL STUDY
BETWEEN
THE CANCER RESEARCH INSTITUTE
OF CONTRA COSTA
AND
SOMANTA LIMITED
CONFIDENTIAL TREATMENT REQUESTED
AGREEMENT REGARDING ACADEMIC CLINICAL STUDY
THIS AGREEMENT REGARDING ACADEMIC CLINICAL STUDY (the "Agreement") is
entered into as of August 18, 2005 (the "Effective Date") by and between SOMANTA
LIMITED, a corporation organized under the laws of England ("Somanta"), and THE
CANCER RESEARCH INSTITUTE OF CONTRA COSTA, a non-profit research institution
("CRICC"), each individually referred to in this Agreement as a "Party" and both
collectively as the "Parties".
RECITALS
WHEREAS, Somanta is the sublicensee under that certain Patent and
Know-how Exclusive Sublicense Agreement dated as of even date herewith with
Immunodex, Inc. ("Immunodex"), licensee of CRICC, related to certain patents
covering the antibody know as HuBrE-3 and certain patents covering the antibody
known as HuMc-3;
WHEREAS, CRICC desires to continue to coordinate a Phase I-II clinical
trial with escalating dose protocol of 90Y-HuBrE-3 and/or protocol combining
90Y-HuBrE-3 and Xeloda to be conducted within the United States of America (the
"Clinical Trial"); and
WHEREAS, Somanta desires to provide funding to CRICC to enable the
Clinical Trial, subject to the terms and conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and promises
set forth herein, the parties hereby agree as follows:
1. Selection of Clinical Trial Site. CRICC shall identify an
appropriate institution (or institutions) that has the experience, facilities
and resources to undertake the Clinical Trial. CRICC shall enter into an
agreement with each applicable institution which shall, among other things,
require such institution to undertake the Clinical Trial in accordance with
generally accepted good clinical practices that are consistent with the Clinical
Trial's approved protocol. Before any patient is treated in the Clinical Trial,
the institution conducting the Clinical Trial shall have received approval from
its institutional review board and any relevant human subject protection
committee.
2. Provision of Materials. CRICC, or Immunodex, shall provide
[CONFIDENTIAL TREATMENT REQUESTED] HuBrE-3 for the Clinical Trial to each
applicable institution in accordance with any applicable regulations or consents
of the U.S. Food and Drug Administration.
3. Payment Schedule. In connection with the conduct of the
Clinical Trial and in consideration for the services to be performed by CRICC in
connection therewith, Somanta will make payments to CRICC in accordance with
this Section 3. At such time as Somanta shall have received a completed case
reporting form for a patient in accordance with the Clinical Trial protocol,
Somanta will (i) [CONFIDENTIAL TREATMENT REQUESTED] CRICC in an amount equal to
[CONFIDENTIAL TREATMENT REQUESTED] conducting the Clinical Trial with respect to
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CONFIDENTIAL TREATMENT REQUESTED
such [CONFIDENTIAL TREATMENT REQUESTED], plus (ii) [CONFIDENTIAL TREATMENT
REQUESTED]. The parties acknowledge and agree that CRICC is currently obligated
to pay [CONFIDENTIAL TREATMENT REQUESTED] per patient in connection with the
Clinical Trial. To the extent CRICC engages additional institutions in
connection with conduct of the Clinical Trial, CRICC shall use reasonable
efforts to negotiate a price to be paid by CRICC for each patient included in
the Clinical Trial at such institution shall not exceed the amount to be paid to
the [CONFIDENTIAL TREATMENT REQUESTED] per patient.
4. Supervision of Trial. The Parties acknowledge and agree that
the Clinical Trial shall be supervised by a committee comprised of Drs. Xxxxx
Xxxxxxxx and Xxxxxxx Xxxxxxx and each applicable principal investigator at the
Clinical Trial site institution(s) (the "Committee"). Drs. Xxxxxxxx and Xxxxxxx,
to the extent permitted by the clinical trial site, shall have direct access to
all data produced in and related to the Clinical Trial and the ability to
interact with all scientific and clinical members of the Clinical Trial at each
institution in addition to each applicable principal investigator. In addition,
CRICC or the Clinical Trial site will file, or cause to be filed, any and all
reports related to the Clinical Trial as required by applicable law (the "FDA
Reports").
In view of Drs. Xxxxxxxx'x and Xxxxxxx'x expertise in the area of the
conduct of clinical trials and longstanding involvement in the research and
clinical work that has lead to the Clinical Trial, and to avoid any lack of
coordination or confusion, Somanta shall, if it receives any inquiry from a
clinical site or clinical investigator participating in the Clinical Trial
regarding a regulatory, clinical or technical matter, refer such person to one
of Drs. Xxxxxxxx and Xxxxxxx. Drs. Xxxxxxxx and Xxxxxxx will keep Somanta
informed of the resolution of such inquiries.
5. Confidentiality.
---------------
(a) Confidentiality Obligation. During the term of this
Agreement and for a period of five (5) years thereafter, the parties hereto will
maintain all Confidential Information (as defined below) as confidential and
will not disclose any Confidential Information or use any Confidential
Information for any purpose, except (i) as expressly authorized by this
Agreement, (ii) as required by law, rule, regulation or court order (provided
that the Disclosing Party (as defined below) uses reasonable efforts to obtain a
protective order or to seek confidential treatment of any such information
required to be disclosed), or (iii) to its employees, agents, consultants and
other representatives who require access to such information to accomplish the
purposes of this Agreement so long as such persons are under an obligation of
confidentiality no less stringent than as set forth herein. Notwithstanding
anything to the contrary herein, (A) CRICC acknowledges and agrees that Somanta
may disclose Confidential Information to (i) the U.S. Food and Drug
Administration ("FDA") and/or corresponding foreign regulatory authorities in
connection with the regulatory filings related to the development of Somanta
products, and (ii) potential investors of Somanta in connection with such
investors' due diligence investigation of Somanta; and (B) Somanta acknowledges
and agrees that CRICC may disclose Confidential Information to the FDA in
connection with the filing of the FDA Reports.
(b) Definition. For purpose of this Agreement,
"Confidential Information" means all information provided by or on behalf of one
Party (the "Disclosing Party") to the other Party (the "Receiving Party") in
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CONFIDENTIAL TREATMENT REQUESTED
connection with the Clinical Trial and all data and information developed
pursuant to the Clinical Trial, whether in oral, written, graphic or electronic
form. Notwithstanding the foregoing, Confidential Information will not include
any information which the Receiving Party can prove by competent written
evidence: (i) is now, or hereafter becomes, through no act or failure to act on
the part of the Receiving Party, generally known or available; (ii) is known by
the Receiving Party at the time of receiving such information; (iii) is
hereafter furnished to the Receiving Party by a third party, as a matter of
right and without restriction on disclosure; (iv) is the subject of a written
permission to disclose provided by Disclosing Party, or (v) is published in
accordance with Section 6. The Receiving Party may disclose the Confidential
Information to comply with applicable governmental regulations, provided that if
such disclosure is required, Receiving Party will, to the extent practicable,
give reasonable advance notice to Disclosing Party of such disclosure
requirement and will use its best efforts to secure confidential treatment of
such information required to be disclosed.
6. PUBLICATIONS. In the event that either Party and/or their
respective employees, agents, consultants or other representatives, or those of
a clinical site or clinical investigator participating in the Clinical Trial,
wish to make a publication (including any oral disclosure made without
obligation of confidentiality) relating to the Clinical Trial such Party will
deliver to the other Party a copy of the proposed written publication or an
outline of such oral disclosure at least thirty (30) days prior to submission
for publication or presentation, as applicable. Such other Party will have the
right (a) to propose modifications to the publication for protection of
Confidential Information or other reasons (however, to avoid any doubt, beyond
the delay time period set forth herein to enable patent filing as set forth
below, clinical investigators, including without limitation Drs. Xxxxxxxx and
Xxxxxxx, shall not be prohibited from publishing data, results and information
from the Clinical Trial), and (b) to request a delay in publication in order to
protect patentable information. If such other Party requests such a delay, the
Party desiring to publish will delay submission or presentation of the
publication for a period of sixty (60) days to enable patent applications
protecting such other Party's rights in such information to be filed. Upon the
expiration of thirty (30) days from delivery of the proposed written publication
or the outline of any oral disclosure, as applicable, to such other Party the
Party desiring to publish will be free to proceed with the written publication
or the oral presentation, respectively, unless such other Party has requested
the delay described above. In no event shall a Party publish any Confidential
Information in such proposed publication without the other Party's prior written
consent. In addition, CRICC shall require each institution conducting the
Clinical Trial to enter into covenants with respect to Confidential Information
and publications substantially similar to those contained in Sections 5 and 6
this Agreement.
7. Rights to Data.
--------------
(a) No License. Except as expressly set forth in this
Agreement, nothing herein shall be construed as a license, assignment or any
other right to practice or use any invention or other intellectual property of
any Party to this Agreement.
(b) Results and Data. Somanta shall be provided with, and
shall have the right to access and use, all data collected or generated in the
course of conducting the Clinical Trial, including, without limitation, records,
reports, specimens, and other work product generated by or on behalf of any
principal investigator in the course of performing the Clinical Trial, whether
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CONFIDENTIAL TREATMENT REQUESTED
in written, graphic or electronic form or contained in any computer database or
in any computer readable form ("Data"). CRICC agrees to attempt to require the
principal investigator to ensure the accuracy, completeness, legibility and
timeliness of all Data provided.
8. INDEMNIFICATION.
---------------
(a) By CRICC. CRICC will defend, indemnify and hold
harmless Somanta and its directors, officers, agents, consultants and employees,
from and against all claims, demands, actions, suits and proceedings that may be
brought or instituted by a third party ("Claims"), and all judgments, damages,
losses, liabilities, costs and expenses resulting therefrom, resulting directly
from (i) [CONFIDENTIAL TREATMENT REQUESTED], or (ii) [CONFIDENTIAL TREATMENT
REQUESTED].
(b) By Somanta. Somanta will defend, indemnify and hold
harmless CRICC, Immunodex and their trustees, directors, officers, agents,
consultants and employees (collectively, the "CRICC Indemnitees") as well as
each institution at which the Clinical Trial takes place (including, without
limitation, their directors, officers, agents, consultants and employees ("Site
Indemnitees"), from and against all Claims, and all judgments, damages, losses,
liabilities, costs and expenses (including without limitation attorneys' fees)
resulting therefrom, arising out of or resulting from the Clinical Trial, except
solely to the extent resulting directly from (i) the gross negligence,
recklessness or willful misconduct of any CRICC Indemnitee, (ii) any failure by
any CRICC Indemnitee to perform his or her obligations under this Agreement in
compliance with applicable laws, rules or regulations, or solely with respect to
indemnification of the Site Indemnitees (iii) (a) the gross negligence,
recklessness or willful misconduct of any Site Indemnitee, or (b) any failure by
any Site Indemnitee to perform his or her obligations under the written
agreement contracting for such obligations, in compliance with applicable laws,
rules or regulations.
(c) Procedure. In the event either Party seeks
indemnification under this Section 8, it will inform the other Party of a Claim
as soon as reasonably practicable after it receives notice of the claim, will
permit the other Party to assume direction and control of the defense of the
Claim (at the indemnifying Party's expense) (including the right to settle the
Claim solely for monetary consideration), and will cooperate as requested (at
the expense of the other Party) in the defense of the Claim. Any failure to
promptly provide notice as required in the foregoing sentence shall only relieve
the indemnifying Party of its indemnification obligation to the extent the delay
prejudices defense of the Claim.
9. REPRESENTATIONS AND WARRANTIES; LIMITATION OF LIABILITY.
-------------------------------------------------------
(a) Authority. Each Party represents and warrants that it
has full power and authority to enter into this Agreement and to perform all of
its obligations hereunder.
(b) Due Authorization. Each Party hereby represents and
warrants that such Party is duly authorized to execute and deliver this
Agreement and to perform its obligations hereunder.
(c) Binding Agreement. Each Party hereby represents and
warrants that this Agreement is a legal and valid obligation binding upon it and
is enforceable in accordance with its terms. The execution, delivery and
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CONFIDENTIAL TREATMENT REQUESTED
performance of this Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a Party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
(d) Disclaimer of Warranties. EXCEPT AS EXPRESSLY SET
FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO
THE OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
ANY WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
10. TERM AND TERMINATION.
--------------------
(a) Term. The term of this Agreement will commence on the
Effective Date and will expire upon completion of the Clinical Trial, unless
terminated earlier as provided herein or extended by mutual written agreement of
the parties. "Completion of the Clinical Trial" for those purposes will be
deemed to occur the moment all data from the Clinical Sites has been received,
reviewed, and submitted by CRICC and approved by Somanta and the final/closure
report is filed with the FDA.
(b) Termination. This Agreement may be terminated by
either Party with thirty (30) days advance written notice upon material breach
of this Agreement by the other Party, unless such breach is cured within such
thirty (30) day period. This Agreement may be terminate by the mutual agreement
of the Parties. This Agreement will terminate automatically if: (i) at least ten
(10) patients participating in the Clinical Trial are not dosed within
twenty-four (24) months after the date of this Agreement on the date that is
twenty-four (24) months after the date of this Agreement, or (ii) Somanta
becomes obligated to make payments to Immunodex pursuant to Section 8.4.2(f) of
the Patent and Know-how Exclusive Sublicense Agreement of even date herewith
between Somanta and Immunodex (the "Sublicense Agreement") on the date such
obligation arises, or (iii) if the Sublicense Agreement is terminated in its
entirety or as to BrE-3 and Somanta is not obligated to make payments to
Immunodex pursuant to Section 8.4.2(f) of the Sublicense Agreement pursuant to
the terms of Section 8.4.2(f) of the Sublicense Agreement (i.e., Somanta has
already paid for at least ten (10) patients pursuant to this Agreement) on the
date of such termination of the Sublicense Agreement or portion thereof.
(c) Survival Upon Termination. Expiration or termination
of this Agreement will not relieve the parties of any obligation accruing prior
to such expiration or termination. Sections 5, 6, 7, 8, 9, 10(c) and 11 will
survive termination of this Agreement.
11. MISCELLANEOUS
-------------
(a) Assignment. Except as expressly provided hereunder,
neither this Agreement nor any rights or obligations hereunder may be assigned
or otherwise transferred by either Party without the prior written consent of
the other Party; provided, however, that Somanta may assign this Agreement and
its rights and obligations hereunder without such consent to the extent it has
the right to assign the Patent and Know-how Exclusive Sublicense Agreement of
even date herewith between it and Immunodex, solely to its assignee of such
license agreement. The rights and obligations of the parties under this
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CONFIDENTIAL TREATMENT REQUESTED
Agreement will be binding upon and inure to the benefit of the successors and
permitted assigns of the parties. Any assignment not in accordance with this
Agreement will be void.
(b) Governing Law. This Agreement will be governed by,
and construed and enforced in accordance with, the laws of the State of
California, as such laws apply to agreements between California residents
performed entirely within the State of California.
(c) Waiver. Except as specifically provided for herein,
the waiver from time to time by either Party of any right or failure to exercise
any remedy will not operate or be construed as a continuing waiver of the same
right or remedy or of any other of such Party's rights or remedies provided
under this Agreement.
(d) Severability. In case any provision of this Agreement
will be invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions will not in any way be affected or
impaired thereby.
(e) Entire Agreement; Amendment. This Agreement sets
forth all of the agreements and understandings between the parties hereto with
respect to the subject matter hereof, and supersedes and terminates all prior
agreements and understandings between the parties with respect to the subject
matter hereof, including, without limitation that certain Agreement between
Somantis and the Cancer Research Institute of Contra Costa (CRICC) for
Conduction of Academic Clinical Trial with 90Y-HuBrE3, and 90Y-HuBrE3 and
Chemotherapy dated October 13, 2003 between Somantis Limited and the Cancer
Research Institute of Contra Costa, as amended or modified to date. There are no
agreements or understandings with respect to the subject matter hereof, either
oral or written, between the parties other than as set forth herein. Except as
expressly set forth in this Agreement, no subsequent amendment, modification or
addition to this Agreement will be binding upon the parties hereto unless
reduced to writing and signed by the respective authorized officers of each
Party. To avoid any doubt, this Agreement in no way amends or supersedes the
Patent and Know-how Exclusive Sublicense Agreement of even date herewith between
Somanta and Immunodex.
(f) Independent Contractors. It is expressly agreed that
the parties will be independent contractors and that the relationship between
the parties will not constitute a partnership, joint venture or agency of any
kind. Neither Party will have the authority to make any statements,
representations or commitments of any kind, or to take any action, which will be
binding on the other Party, without the prior written consent of the other
Party.
(g) Notice. All notices and other communications provided
for hereunder will be in writing and will be mailed by first-class, registered
or certified mail, postage paid, or delivered personally, by overnight delivery
service or by facsimile, with confirmation of receipt, addressed as follows:
If to Somanta: Somanta Incorporated
00 Xxx Xxxxxx Xxxxx
Xxxxxxx Xxxxx, XX 00000
Attention: Xxxxxxxx Xxxxxxxxx
Facsimile: 000-000-0000
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CONFIDENTIAL TREATMENT REQUESTED
If to CRICC: Cancer Research Institute of Contra Costa,
New York Office
[CONFIDENTIAL TREATMENT REQUESTED]
Either Party may by like notice specify or change an address to which
notices and communications will thereafter be sent. Notices sent by facsimile
will be effective upon confirmation of receipt, notices sent by mail or
overnight delivery service will be effective upon receipt, and notices given
personally will be effective when delivered.
(h) Headings. The captions contained in this Agreement
are not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several Sections hereof.
(i) Counterparts. This Agreement may be executed in two
or more counterparts, by facsimile, or both, each of which will be deemed an
original, but all of which together will constitute one and the same instrument.
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CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
Effective Date.
SOMANTA LIMITED THE CANCER RESEARCH INSTITUTE OF
CONTRA COSTA
By: /s/ XXXXXXXX X. XXXXXXXXX By: /s/ XXXXX X. XXXXXXXX
-------------------------------- ----------------------------------
Name: Xxxxxxxx X. Xxxxxxxxx Name: Xxxxx X. Xxxxxxxx
-------------------------------- ----------------------------------
Title: Chairman Title: Chief Executive Officer
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