CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.11
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(b)(2) OF THE SECURITIES AND
EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED 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.
PATENT AND KNOW-HOW
EXCLUSIVE SUBLICENSE
AGREEMENT
BY AND AMONG
IMMUNODEX, INC.
AND
SOMANTA LIMITED
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CONFIDENTIAL TREATMENT REQUESTED
Patent and Know-how Exclusive Sublicense Agreement
THIS PATENT AND KNOW-HOW EXCLUSIVE SUBLICENSE AGREEMENT (the "Agreement") dated
August 18, 2005 is between:
(1) IMMUNODEX ("Immunodex") a United States company incorporated under the
laws of the State of California whose principal address is 1230 H
Street, Eureka, CA, United States Of America; and
(2) SOMANTA LIMITED ("Somanta") a company incorporated in England and Wales
whose principal place of business is at 80 Harley Street, London, W1G
7HB, United Kingdom, and formerly known as Somantis Limited.
RECITALS:
A. Immunodex has an exclusive license and rights to sub-license the BrE-3
Patents and the Mc-3 Patents and related know-how from Cancer Research
Institute of Contra Costa ("CRICC").
B. Immunodex is willing to grant to Somanta and Somanta is willing to
accept, an exclusive sublicense, with the right to further sublicense,
to the BrE-3 Patents and Mc-3 Patents and related know-how for the
treatment of human cancer worldwide, in accordance with the provisions
of this Agreement.
C. Immunodex and Somanta were previously parties to that certain Patent and
Know-how License Option Agreement dated March 1, 2002 as amended by that
certain Amendment No. 1 to Patent and Know-how License Option Agreement
dated January 2, 2003, Amendment No. 2 to Patent and Know-how License
Option Agreement dated October 14, 2003 and Amendment No. 3 to Patent
and Know-how License Option Agreement dated October 29, 2004
(collectively, referred to herein as the "Option Agreement"), such
Option Agreement related to the subject matter hereof.
D. Immunodex and Somanta now desire to terminate the Option Agreement in
its entirety and to supersede the Option Agreement with this Agreement.
IT IS AGREED as follows:
1. Definitions
In this Agreement, the following words shall have the following meanings:
Affiliate In relation to a Party, means a person, corporation
partnership, or other entity that controls, is
controlled by, or is under common control with that
Party. For the purposes of this Section, the word
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CONFIDENTIAL TREATMENT REQUESTED
"control" (including, with correlative meaning, the
terms "controlled by" or "under the common control
with") means the actual power, either directly or
indirectly through one or more intermediaries, to direct
the management and policies of such entity, either by
the ownership of at least fifty percent (50%) of the
voting stock of such entity or by contract law or
otherwise.
BrE-3 The antibody known as BrE-3 and all forms and
derivatives thereof, including, without limitation,
humanized and non-humanised forms, its native form and
radio-labelled forms for a pharmaceutical formulation
for human use, and all fragments thereof.
BrE-3 Patents BrE-3 Patents are the Patents described in Schedule 1
Part A; all substitutions, extensions, registrations,
confirmations, reissues, reexaminations, renewals and
like filings of any of the foregoing patents; all
non-United States Patents that are counterparts to any
of the foregoing patents and/or any patent applications
that gave rise to any of the foregoing patents, together
with all Patents claiming priority thereto and issuing
therefrom (but excluding the claims of any such Patents
to the extent directed to any new matter that may be
claimed in any continuation-in-part or similar
application outside the United States).
Chelate License The sub-license agreement between Cancer Research
Institute of Contra Costa and Coulter Corporation dated
January 18, 1994.
Commencement Date The date of this Agreement as set forth in the first
paragraph hereof.
Control Owned or in-licensed with the right to grant a license
or sublicense (as applicable) as set forth herein
without violating the terms of any agreement or other
arrangement with any third party, or the license
agreement between Immunodex and CRICC dated April 19,
2002.
CRICC The meaning given in Recital A.
Escrow Amount 1 The amount of money to be deposited upon the signing of
this Agreement in accordance with Section 4.1(c), and
distributed in accordance with 2.3.1 (a).
Escrow Amount 2 The amount of money to be deposited at the time and as
set forth in Section 4.1(d), and destributed in
accordance with 2.3.1(b).
Field The diagnostic imaging and treatment of human cancer.
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CONFIDENTIAL TREATMENT REQUESTED
First Commercial Sale With respect to any Royalty-bearing Product, the first
sale for end use or consumption of such Royalty-bearing
Product in a country after the governing health
regulatory authority of such country has granted
regulatory approval of such Royalty-bearing Product (in
countries where regulatory approval is required).
Funding The date on which Somanta or its successor, assignee,
Affiliate and/or Bridge Oncology Products, Inc. or its
successor, assignee or Affiliate closes an equity
transaction with gross proceeds to Somanta or such
entity of no less than US$10 million.
Know-how All technical information or confidential information or
materials in the Field to the extent Controlled by
Immunodex as of the Effective Date relating to the
inventions claimed in the BrE-3 Patents and/or the Mc-3
Patents or relating to the antibodies BrE-3 or Mc-3,
including, but not limited to all pharmaceutical
formulations, chemistry, manufacturing and purification
and labelling, pre-clinical and clinical data, results,
applications for regulatory approvals and other
information.
Licensed Patents The BrE-3 Patents and the Mc-3 Patents.
Mc-3 The antibody known as Mc-3 and all forms and derivatives
thereof, including, without limitation, humanized and
non-humanised forms, its native form and radio-labelled
forms for a pharmaceutical formulation for human use,
and all fragments thereof.
Mc-3 Patents Mc-3 Patents are the Patents described in Schedule 1
Part B; all substitutions, extensions, registrations,
confirmations, reissues, reexaminations, renewals and
like filings of any of the foregoing patents; all
non-United States Patents that are counterparts to any
of the foregoing patents and/or any patent applications
that gave rise to any of the foregoing patents, together
with all Patents claiming priority thereto and issuing
therefrom (but excluding the claims of any such Patents
to the extent directed to any new matter that may be
claimed in any continuation-in-part or similar
application outside the United States).
Net Sales Value The [CONFIDENTIAL TREATMENT REQUESTED] of
Royalty-bearing Products sold or in any way transferred
of like kind by Somanta or Sub-Licensees or its
Affiliates to independent third parties in arm's length
transactions or, where the Royalty-bearing Products are
sold or in any way transferred, loaned or given and this
sale or transference is not at arm's length, the price
that would have been so [CONFIDENTIAL TREATMENT
REQUESTED] if it had been at arm's length, after
deduction of normal trade discounts actually granted and
any credits actually given and, provided the amounts are
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CONFIDENTIAL TREATMENT REQUESTED
separately charged on the relevant [CONFIDENTIAL
TREATMENT REQUESTED], any costs of packaging, insurance,
carriage and freight, any value added tax or other sales
tax, and any import duties or similar applicable
government levies.
NIH License The license agreement between CRICC and the US National
Institutes of Health dated 9/29/2000.
Ongoing Clinical Those clinical trials of Royalty bearing Products that
Trials are ongoing or planned with an approved protocol as of
the Commencement Date (i.e. that certain trial entitled
"Phase I Study of Combination Yttrium-90 MX-DTPA
Humanized BrE-3 Monoclonal Antibody (90-Y-MX-DTPA
huBrE-3 mAb; 90-Y huBrE-3) and Capecitabine in
Metastatic/Recurrent Breast Cancer").
Parties Immunodex and Somanta, and "Party" shall mean either of
them.
Patents Any and all patents and patent applications, including
any continuations, continuations in part, extensions,
reissues, divisions, and any patents, re-examination
certificates, foreign counterparts and other patents or
applications, supplementary protection certificates and
similar rights that are based on or derive priority from
the foregoing.
Royalty-bearing Any and all products in the Field that are manufactured,
Products sold or otherwise supplied by Somanta (or its Affiliate
or sublicensee hereunder) and contain BrE-3 and/or Mc-3
and are at any time within any Valid Claim of the BrE-3
Patents or the Mc-3 Patents (including, without
limitation, diagnostic imaging products and therapeutic
products), but excluding products based on the antigen
used to generate Mc-3 for use outside the Field (the
"Antigen Products").
It is understood and agreed that Immunodex retains all
rights with respect to such Antigen Products, which such
products shall not in any event be developed for use in
the Field.
Territory The World.
Valid Claim A claim of a patent application or patent that (a) in
the case of a pending claim, has been pending for no
more than [CONFIDENTIAL TREATMENT REQUESTED] and has not
been permanently abandoned or permanently permitted to
lapse, and (b) in the case of an issued claim, (i) has
not expired or been held invalid or unenforceable in a
final binding court decision from which no appeal can be
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CONFIDENTIAL TREATMENT REQUESTED
or is taken, or (ii) has not been admitted to be invalid
or unenforceable through reissue, disclaimer or
otherwise.
2. Grant of rights, etc.
2.1 License. Subject to the terms hereof, Immunodex hereby grants Somanta,
effective from the Commencement Date, the following sub-licenses in the
Territory:
(a) An exclusive sub-license, with the right to sub-license solely
as set forth in Section 2.2, under the BrE-3 Patents and Mc-3
Patents solely as provided in Section 2.2; and
(b) an exclusive sub-license in the Field to use the Know-how
relating to BrE-3 and an exclusive sub-license in the Field to
use the Know-how related to Mc-3;
(c) If requested in writing by Somanta (within a reasonable time
after the Commencement Date), Immunodex will seek to obtain for
Somanta an exclusive sub-license of CRICC's rights and licenses
under the Chelate MXDTPA License, including, without limitation
a consent to such sub license from Coulter Corporation, the cost
for such sub-license to be at Somanta's expense (this means,
without limitation, that Somanta shall pay all sublicense issue
fees, maintenance fees, milestones, royalties and other fees
under the Chelate MXDTPA License that relate to the sublicense
granted hereunder (including without limitation any activities
in exercise of it), and shall pay such fees to Immunodex within
2 weeks after receiving a written invoice for same, which
written invoice Immunodex will provide no earlier than 2.5 weeks
before the applicable payment is due to Coulter Corporation);
and
(d) If requested in writing by Somanta (within a reasonable time
after the Commencement Date), Immunodex will seek to obtain for
Somanta a non-exclusive sub-license of CRICC's rights and
licenses under the NIH License, including, without limitation a
consent to such sub-license from the appropriate third parties,
the cost for such sublicense to be at Somanta's expense (this
means, without limitation, that Somanta shall pay all sublicense
issue fees, maintenance fees, milestones, royalties and other
fees under the NIH License that relate to the sublicense granted
hereunder (including without limitation any activities in
exercise of it), and shall pay such fees to Immunodex within 2
weeks after receiving a written invoice for same, which written
invoice Immunodex will provide no earlier than 2.5 weeks before
the applicable payment is due to the NIH or its representative);
(e) in each case to develop, manufacture, have manufactured, use,
sell, offer for sale and import Royalty-bearing Products for the
Field.
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CONFIDENTIAL TREATMENT REQUESTED
All sublicenses granted to Somanta hereunder are explicitly subject to the terms
and conditions of the agreement between Immunodex and/or CRICC and the third
party that has licensed Immunodex the rights being sublicensed and to the CRICC
- - Immunodex license agreement as it exists as of the Effective Date.
2.2 Sub-licensing. Somanta shall be entitled to grant sub-licenses of its
rights under this Agreement to any person, provided that:
(a) Somanta discloses to Immunodex not later than thirty (30) days
before the date any such sublicense is entered into the identity
of such proposed sub-licensee;
(b) the royalties and other consideration provided for in the
sub-license shall be at an amount or rate which is not less than
the amount or rate provided for in this Agreement to Immunodex
(and in any event, Somanta shall remain obligated to pay
Immunodex the milestones and royalties set forth herein based on
the sublicensees' achievements and sales as if they were
Somanta's);
(c) the sublicense does not violate and shall include obligations on
the sub-licensee which are equivalent to or at least as
stringent as the obligations on Somanta under this Agreement and
does not violate any provision of the license agreement between
Immunodex and CRICC with respect to the subject matter hereof as
in effect on the Effective Date;
(d) At least 30 days prior to the proposed date of the grant of any
sub-license Somanta shall provide to Immunodex a copy of
proposed agreement;
(e) Immunodex shall have the right to reject any proposed
sublicensee that Immunodex can demonstrate by competent written
evidence (including, without limitation, evidence of such
proposed sublicensee's debarment): [CONFIDENTIAL TREATMENT
REQUESTED]; and
(f) within fifteen (15) days after the date of the sub-license
agreement, Somanta delivers a copy of such sublicense agreement
to Immunodex.
(g) any required consents from Immunodex's licensor(s) --and CRICC's
to the extent than any sublicense is obtained and granted
hereunder under Section 2.1(c) and/or 2.1(d) -- shall have been
obtained (it being understood and agreed that Immunodex shall
use all reasonable efforts to cause CRICC to give its consent if
required under the CRICC-Immunodex license agreement dated April
19, 2002 as such agreement exists as of the Effective Date).
(h) With respect to each sublicense granted by Somanta to a
sublicensee hereunder (excluding any Affiliate of Somanta),
Somanta agrees to pay to Immunodex a fee equal to [CONFIDENTIAL
TREATMENT REQUESTED] of the initial cash fee and other (whether
initial or not) monies received by Somanta from such sublicensee
(other than royalties which are governed by Section 4.4 hereof)
for the grant of a sublicense to the Licensed Patents and
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CONFIDENTIAL TREATMENT REQUESTED
Know-how (such fee(s) and monies received from the sublicensee,
"Sublicensing Revenue" and Immunodex's share thereof the
"Sublicensing Fee"); provided, however, that:
(i) Immunodex's Sublicensing Fee based on a share of any
Sublicensing Revenue received in the form of
[CONFIDENTIAL TREATMENT REQUESTED] from a sublicensee
[CONFIDENTIAL TREATMENT REQUESTED] shall not in any
event exceed [CONFIDENTIAL TREATMENT REQUESTED];
(ii) if the Sublicensing Fee based on the [CONFIDENTIAL
TREATMENT REQUESTED] from any particular licensee would
be less than [CONFIDENTIAL TREATMENT REQUESTED], then
Somanta shall pay Immunodex [CONFIDENTIAL TREATMENT
REQUESTED] on the date of [CONFIDENTIAL TREATMENT
REQUESTED] and [CONFIDENTIAL TREATMENT REQUESTED] on
each of the [CONFIDENTIAL TREATMENT REQUESTED] of such
date (for a total aggregate payment of [CONFIDENTIAL
TREATMENT REQUESTED] in lieu of such Sublicensing Fee
based on such [CONFIDENTIAL TREATMENT REQUESTED]; and
(iii) with respect to Sublicensing Fees based on
Sublicensing Revenues other than [CONFIDENTIAL TREATMENT
REQUESTED] (for example but without limitation, in the
form of [CONFIDENTIAL TREATMENT REQUESTED] received by
Somanta in a particular calendar year, Somanta shall be
entitled to [CONFIDENTIAL TREATMENT REQUESTED] the
entire amount of [CONFIDENTIAL TREATMENT REQUESTED] with
respect to the same time period under [CONFIDENTIAL
TREATMENT REQUESTED] such that [CONFIDENTIAL TREATMENT
REQUESTED] under this subsection 2.2(h)(iii) unless the
[CONFIDENTIAL TREATMENT REQUESTED] exceeds the
[CONFIDENTIAL TREATMENT REQUESTED] and then only to the
extent [CONFIDENTIAL TREATMENT REQUESTED] exceeds the
[CONFIDENTIAL TREATMENT REQUESTED]; provided, however,
that the [CONFIDENTIAL TREATMENT REQUESTED] of
Sublicensing Fees [CONFIDENTIAL TREATMENT REQUESTED] (to
avoid any doubt, this means other than through
[CONFIDENTIAL TREATMENT REQUESTED]) pursuant to this
subsection 2.2(h)(iii) in [CONFIDENTIAL TREATMENT
REQUESTED] to [CONFIDENTIAL TREATMENT REQUESTED] an
amount equal to [CONFIDENTIAL TREATMENT REQUESTED], the
amount paid or to be paid to Immunodex pursuant to
[CONFIDENTIAL TREATMENT REQUESTED], whichever is
applicable for that sublicense. This [CONFIDENTIAL
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CONFIDENTIAL TREATMENT REQUESTED
TREATMENT REQUESTED] per sublicense is explicitly not
subject to [CONFIDENTIAL TREATMENT REQUESTED] of any
[CONFIDENTIAL TREATMENT REQUESTED].
Notwithstanding the definition of Sublicensing Revenues provided
above, Sublicensing Revenues do not include and Immunodex shall
not receive any share of payments with respect to monies (or
equivalent value) received by Somanta which are (a) for future
(after Somanta grants the sublicense) support, at fair market
value, of Somanta's laboratory research, screening and
development programs or for reimbursement of any amounts to be
(and ultimately actually) expended on the foregoing pursuant to
and after the signing of a written agreement requiring such
expenditure, (b) equity investments in Somanta at fair market
value (it being understood that any premium paid with respect to
such an equity investment made in connection with such a
sublicense would be included in Sublicensing Revenues and
subject to payment of a Sublicensing Fee hereunder), (c) bona
fide loans or other financing provided at market-based rates
(and specifically excluding any loan forgiveness), (d) payments
to Somanta in consideration of the grant of rights to any other
intellectual property of Somanta provided however that no
greater than one half (1/2) the value of any licensing deal or
relationship may be attributed to such other Intellectual
Property, and (e) any prepayments on any of the items listed in
subsections (a), (b), (c) or (d) above. This paragraph, however,
shall not be used to contradict proviso (ii) stated above in
this Section 2.1(h) and Somanta shall pay Immunodex at least the
amount set forth in such proviso with respect to each sublicense
granted hereunder.
2.3 Supply of materials and materials related to Know-how.
2.3.1 Immunodex shall disclose, provide, transfer or make available for
transfer (as applicable and noted below) to Somanta or its nominee:
(a) Within five (5) days after deposit of Escrow Amount 1 (set forth
in Section 4.1(c)) into the escrow account (and provided that
the payment of Section 4.1(a) has also been paid, in this case
directly to Immunodex) Immunodex shall make available at CRICC's
facility 10 frozen vials from the working cell bank containing
huBre-3v1 cells to Somanta (or its carrier) for Somanta (or its
carrier) to provide to one of the following third parties:
[CONFIDENTIAL TREATMENT REQUESTED] for the purpose of verifying
the viability of such cell line as to [CONFIDENTIAL TREATMENT
REQUESTED]. Immunodex shall be entitled to provide the cell
lines and all antigens and other materials it may agree to
provide for such testing in coded fashion, and Somanta shall not
reveal the identity of the cell lines and antigens to any third
party involved in the testing. Somanta shall be responsible at
its expense for making and effecting the shipping arrangements.
Somanta shall be responsible to select one of these third-party
laboratories and to pay for their services. Such third party
shall be under reasonable confidentiality and non-use
obligations to Immunodex. Such third party shall complete the
testing and provide its report (described below) within two (2)
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CONFIDENTIAL TREATMENT REQUESTED
months after Immunodex makes such 10 vials available. Such third
party upon completion of all relevant testing, shall provide to
the Parties a detailed written report related to the tests
conducted and a conclusion as to each of the foregoing 3 factors
(i) - (iii). If the report concludes that the cell line:
[CONFIDENTIAL TREATMENT REQUESTED], the Parties shall promptly
instruct the escrow agent to release Escrow Amount 1 to
Immunodex. Within ten (10) days thereafter, Immunodex shall
transfer to Somanta the majority of the quantities of the
huBrE-3 master cell and working cell banks in its possession,
provided however that Immunodex reserves the right to retain
reasonable quantities of samples of such cell banks (x) for
non-clinical research while the licenses to Somanta for BrE-3
remain in effect, and (y) to use for any and all purposes if
Somanta's licenses to BrE-3 hereunder terminate. If the report
concludes that the cell line [CONFIDENTIAL TREATMENT REQUESTED],
the Parties shall promptly instruct the escrow agent to release
Escrow Amount 1 to Somanta and Immunodex shall promptly refund
to Somanta the entire amount paid to Immunodex pursuant to
Section 4.1(a). The Parties hereby agree to be bound by the
conclusions set forth in the third party's report;
(b) Prior to the earlier of: (i) six months after the Commencement
Date or (ii) 5 business days after receiving written notice from
Somanta of the Funding, and provided in each case that Somanta
has paid Escrow Amount 2 into the escrow account and paid the
payment of Section 4.1(b) directly to Immunodex, Immunodex shall
make available to Somanta (or its carrier) at CRICC's facility
10 frozen vials from the working cell bank containing huMc-3v1
cells for Somanta (or its carrier) to provide to one of the
following third parties: [CONFIDENTIAL TREATMENT REQUESTED] for
the purpose of verifying the viability of such cell line as to
[CONFIDENTIAL TREATMENT REQUESTED]. Immunodex shall be entitled
to provide the cell lines and all antigens and other materials
it may agree to provide for such testing in coded fashion, and
Somanta shall not reveal the identity of the cell lines and
antigens to any third party involved in the testing. Somanta
shall be responsible at its sole expense for making and
effecting the shipping arrangements. Somanta shall be
responsible to select one of these third-party laboratories and
to pay for their services. Such third party shall be under
reasonable confidentiality and non-use obligations to Immunodex.
Such third party shall complete the testing and provide its
report (described below) within two (2) months after Immunodex
makes such 10 vials available. Such third party upon completion
of all relevant testing, shall provide to the Parties a detailed
written report related to the tests conducted and a conclusion
as to each of the foregoing viability factors. If the report
concludes that the cell line [CONFIDENTIAL TREATMENT REQUESTED],
then the Parties shall promptly instruct the escrow agent to
release Escrow Amount 2 to Immunodex. Within ten (10) days
thereafter, Immunodex shall transfer to Somanta the majority of
the quantities of the huMc-3 master cell bank and working cell
bank in its possession; provided, however that Immunodex
reserves the right to retain reasonable quantities of samples of
such cell banks (x) for non-clinical research while the licenses
to Somanta for Mc-3 remain in effect, and (y) to use for any and
all purposes if Somanta's licenses to Mc-3 hereunder terminate.
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CONFIDENTIAL TREATMENT REQUESTED
If the report concludes that the cell line: [CONFIDENTIAL
TREATMENT REQUESTED], then the Parties shall promptly instruct
the escrow agent to release Escrow Amount 2 to Somanta. The
Parties hereby agree to be bound by the conclusions set forth in
the third party's report; and
(c) Within 30 days after the Commencement Date, authorize (in
writing) Immunodex's third-party contractors for BrE-3 (these
are: [CONFIDENTIAL TREATMENT REQUESTED]) to disclose
manufacturing information, SOP's, assays and protocols
(including those related to radio-labeling), that are within the
Know-How to Somanta, (and, to the extent Controlled by Immunodex
as of the Effective Date, provide all necessary rights to use
such information, including, without limitation to avoid any
doubt, to the extent Controlled by Immunodex, any rights under
any patent/cell depository agreements with American Tissue
Culture Collection or any other third party) and assist Somanta
in obtaining any such information, SOP's, assays and/or
protocols; and
(d) Within 30 days after the Commencement Date, disclose the
contents of all laboratory, pre-clinical data, animal studies
data, stability studies, sterility studies, regulatory filings,
clinical data (including without limitation such data on a Phase
I study conducted by CRICC entitled Phase I Study of Yttrium 90
labeled humanized Monoclonal Antibody BrE-3 and Indium In 111
Humanized Monoclonal antibody BrE-3 followed by autologous bone
marrow or Peripheral Blood Stem Cell Transplantation in Patients
with Metastatic Breast Cancer) and any correspondence with the
U.S. Food and Drug Administration or equivalent foreign body, in
each case related to either BrE-3 or Mc-3. To avoid any doubt,
any CRICC and/or Immunodex or other investigator-sponsored IND
for any Royalty-bearing Product is not required to be
transferred to Somanta (or its nominee), and it is intended by
the Parties that same shall be retained by CRICC and/or
Immunodex, as the case may be (although the results of clinical
trials under them shall be disclosed to Somanta to the extent
set forth in a separate written agreement between Somanta and
CRICC related to such trials). Both parties recognize that as of
the Commencement Date, given the stage of research and
development on Mc-3, there is no correspondence with the FDA
regarding Mc-3, thus none will be provided.
(e) To avoid any doubt, pursuant to the Know-how disclosure
provisions of this Agreement, Immunodex is disclosing to Somanta
the procedures used to produce the current clinical materials.
Immunodex is under no obligation to develop a scaled-up method
of production for either BrE-3 or Mc-3 or both, and has no
process development nor manufacturing process "trouble-shooting"
obligations hereunder. Somanta is solely responsible for such
work, in accordance with and without limiting its
responsibilities under Section 3.3.
2.3.2. Somanta agrees to adhere to any obligations of confidentiality,
non-distribution and limited use that relate to the materials delivered
by Immunodex to Somanta pursuant to this Section 2.3. To protect against
any unauthorized distribution of any cell or cell culture, Somanta will
maintain a log related to the use, distribution and storage of any cell
11
CONFIDENTIAL TREATMENT REQUESTED
line delivered by Immunodex to Somanta pursuant to this Section 2.3.
Somanta must disclose quarterly to Immunodex such log and all updates,
changes and corrections to it. Somanta will obtain insurance to cover
the loss or destruction of the GMP Materials in an amount not to exceed
[CONFIDENTIAL TREATMENT REQUESTED], and will name Immunodex as an
additional insured under such policy.
Without limiting any other restrictions and obligations set forth in
this Agreement, Somanta and its Affiliates and sublicensees hereunder shall not
use any cell lines or other materials provided hereunder, nor any derivatives
(including without limitation progeny of cells) of any such materials, outside
the scope of the sublicenses granted Somanta hereunder.
2.4 Reservation of rights. Immunodex reserves all rights outside the Field
and the non-exclusive right for itself and other academic and/or
not-for-profit researchers, to use the Know-how and to practice the
subject matter of the BrE-3 and Mc-3 Patents in the Field for the
purposes of academic, non-commercial research (which may, to avoid
doubt, include clinical trials), subject to the confidentiality
provisions set out in clause 3 below; provided, however, that any such
other academic and/or not-for-profit researcher may not sublicense such
rights to any third party not itself falling within the category of
entities for which rights are reserved (i.e. they may only sublicense to
other academics and not-for-profits).
2.5 Security Interest. To secure Somanta's obligations under this Agreement,
Somanta hereby grants to Immunodex a security interest in each of the
BrE-3 and Mc-3 cell lines transferred to Somanta pursuant to this
Agreement.
3. Know-how and Confidential Information
3.1 Provision of Know-how. To the extent the disclosure is not addressed in
Section 2.3.1, within 30 days after the date of this Agreement,
Immunodex shall disclose to Somanta all Know-how (in its legal
possession and Control as of the Effective Date) that Immunodex has not
previously disclosed to Somanta and that is necessary or desirable to
enable Somanta to undertake the further development of the
Royalty-bearing Products. The way in which the Know-How will be
disclosed shall consist of, first, up to 2 days from each of Drs.
Roberto Ceriani and Jerry Peterson, and thereafter, after Somanta has
reviewed the Know-how thus transferred, up to one additional day from
each such person to the extent requested by Somanta, all at no
additional consideration for their time (if there are travel expenses
for travel required by Somanta, Somanta will cover these expenses). Any
further consultation by such Drs. shall be pursuant to the consulting
agreements that CRICC and Dr. Roberto Ceriani are entering into with
Somanta contemporaneously with this Agreement.
3.2 Status of Know-how. Somanta acknowledges that the Know-how is at an
early stage of development. Accordingly, specific results cannot be
guaranteed and any results, materials, information or other items
(together "Delivered Items") provided under this Agreement are provided
"as is" and without any express or implied warranties, representations
or undertakings. As examples, but without limiting the foregoing,
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Immunodex does not give any warranty that Delivered Items are of
merchantable or satisfactory quality, are fit for any particular
purpose, comply with any sample or description, or are viable,
uncontaminated, safe or non-toxic, except as required by Section 2.3.1
(a) and (b).
3.3 Responsibility for development of Royalty-bearing Products. Somanta
shall be solely and exclusively responsible for the technical and
commercial development and manufacture of Royalty-bearing Products and
for incorporating any modifications or developments thereto that may be
necessary or desirable and for all Royalty-bearing Products sold or
supplied, and accordingly Somanta shall indemnify Immunodex in the terms
of Clause 7.4 (without limiting such Clause).
3.4 Use of Know-how. Somanta undertakes that for a period of [CONFIDENTIAL
TREATMENT REQUESTED] from the Commencement Date or for so long as any
substantial part of the Know-how remains subject to the obligations of
confidence of Clause 3.5, whichever is the shorter, it will not use the
Know-how for any purpose except as expressly licensed hereby and in
accordance with the provisions of this Agreement.
3.5 Confidentiality obligations. Each Party ("Receiving Party") undertakes:
(a) to maintain as secret and confidential all know-how and other
technical or commercial information obtained directly or
indirectly from the other Party ("Disclosing Party") in the
course of or in anticipation of this Agreement and to respect
the Disclosing Party's rights therein,
(b) to use the same exclusively for the purposes of this Agreement,
and
(c) to disclose the same only to those of its employees, contractors
and licensees or sublicensees pursuant to this Agreement (if
any) to whom and to the extent that such disclosure is
reasonably necessary for the purposes of this Agreement,
including clinical investigators, institutional review boards
and to any regulatory body for the purpose of obtaining
registration of or regulatory approval for a Royalty-bearing
Product.
3.6 Exceptions to obligations. The provisions of Clause 3.5 shall not apply
to know-how and other information which the Receiving Party can
demonstrate by reasonable, written evidence:
(a) was, prior to its receipt by the Receiving Party from the
Disclosing Party, in the possession of the Receiving Party and
at its free disposal; or
(b) is subsequently disclosed to the Receiving Party without any
obligations of confidence by a third party who has not derived
it directly or indirectly from the Disclosing Party; or
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CONFIDENTIAL TREATMENT REQUESTED
(c) is or becomes generally available to the public through no act
or default of the Receiving Party or its agents, employees,
Affiliates or licensees or sublicensees; or
(d) the Receiving Party is required to disclose to the courts of any
competent jurisdiction, or to any government regulatory agency
or financial authority, provided that the Receiving Party shall
(i) inform the Disclosing Party as soon as is reasonably
practicable, and (ii) at the Disclosing Party's request seek to
persuade the court, agency or authority to have the information
treated in a confidential manner, where this is possible under
the court, agency or authority's procedures (iii) limit its
disclosure and use to the extent required by the court or
government regulatory agency; or
(e) in the case of information disclosed by Immunodex to Somanta, is
disclosed to actual or potential customers for Royalty-bearing
Products in so far as such disclosure is reasonably necessary to
promote the sale or use of Royalty-bearing Products, provided
that the customers sign a written confidentiality undertaking at
least as restrictive as Clauses 3.5 and 3.6.
3.7 Disclosure to employees. The Receiving Party shall procure that all of
its employees, contractors, licensees or sub-licensees pursuant to this
Agreement (if any) who have access to any of the Disclosing Party's
information to which Clause 3.5 applies, shall be made aware of and
subject to these obligations and shall have entered into written
undertakings of confidentiality at least as restrictive as Clauses 3.5
and 3.6 and which apply to the Disclosing Party's information.
4. Payments
4.1. Initial consideration. Somanta shall:
(a) on or before the date that is ten (10) days after the date of
this Agreement, pay to Immunodex an initial license fee of
[CONFIDENTIAL TREATMENT REQUESTED]; provided, however, that this
initial license fee of [CONFIDENTIAL TREATMENT REQUESTED] shall
be promptly refunded to Somanta in full in accordance with
Section 2.3.1(a) if Immunodex is unable to deliver the BrE-3
cell line in a viable condition.
(b) on the earlier of (i) the date that is six (6) months after the
date of this Agreement, or (ii) upon the closing of a Funding
pay to Immunodex an additional license fee of [CONFIDENTIAL
TREATMENT REQUESTED].
(c) promptly after the date of this Agreement, deposit into an
escrow account with a national banking institution [CONFIDENTIAL
TREATMENT REQUESTED] ("Escrow Amount 1") to be distributed in
accordance with Section 2.3.1(a);
(d) on the earlier of (i) the date that is six (6) months after the
date of this Agreement, or (ii) upon the closing of a Funding,
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CONFIDENTIAL TREATMENT REQUESTED
pay into an escrow account with a national banking institution a
one-time fee of [CONFIDENTIAL TREATMENT REQUESTED] ("Escrow
Amount 2") to be distributed in accordance with Section
2.3.1(b).
4.2 License Maintenance. On each anniversary of the date of this Agreement,
Somanta shall pay Immunodex a license maintenance fee of [CONFIDENTIAL
TREATMENT REQUESTED], until the First Commercial Sale of a
Royalty-bearing Product at which time this fee will be automatically
reduced to [CONFIDENTIAL TREATMENT REQUESTED] and shall be in
consideration of the maintenance of the license to the BrE-3 Patents or
the Mc-3 Patents, as the case may be, that do not cover the first
Royalty-bearing Product (the "Non-Commercialized Patents"); provided,
however, that Somanta's obligation to pay this [CONFIDENTIAL TREATMENT
REQUESTED] license maintenance fee with respect to the
Non-Commercialized Patents shall terminate and be of no further force or
effect upon the earlier of: (i) approval of a Royalty-bearing Product by
the U.S. Food and Drug Administration covered by the Non-Commercialized
Patents, or (ii) termination of the license with respect to the
Non-Commercialized Patents; and provided, further, that nothing in the
choice of defined term of "Non-Commercialized Patents" shall be read to
imply that Somanta is not required to be diligent with respect to the
subject matter of the patent applications and patents included within
such term.
4.3 Payment terms. Except for the payment set forth in clause 4.1(a) above
(which is refundable solely under the circumstances and to the extent
set forth in Section 2.3.1(a), all above payments from Somanta to
Immunodex are non-refundable and are not considered advances against
royalty or other payments due hereunder. The royalty payments to be made
pursuant to Section 4.4 below shall be made within thirty (30) days
after the end of each calendar quarter in which Royalty-bearing Products
are sold, beginning with the quarter in which the First Commercial Sale
is made.
4.4. Royalties. Somanta shall pay Immunodex, on a country-by-country basis, a
royalty equal to [CONFIDENTIAL TREATMENT REQUESTED] of Net Sales Value
of any Royalty-bearing Product that comes within the scope of a Valid
Claim of the BrE-3 Patents and [CONFIDENTIAL TREATMENT REQUESTED] of Net
Sales Value of any Royalty-bearing Product that comes within the scope
of a Valid Claim of the Mc-3 Patents. Such royalties shall be payable on
each Royalty-bearing Product from the date of First Commercial Sale of
such Royalty-bearing Product in such country until the later of (a) the
expiration of the last Valid Claim covering such Royalty-bearing Product
or its manufacture or use, and (b) [CONFIDENTIAL TREATMENT REQUESTED]
after such date of first Commercial Sale; provided however, that if the
royalty is being paid based on the time in (b) but the time in (a) has
expired, then the applicable royalty rate shall be reduced to
[CONFIDENTIAL TREATMENT REQUESTED] of the regular rate prior to patent
expiry. If Somanta markets a combination product that combines BrE-3
with Mc-3 Antibodies then the [CONFIDENTIAL TREATMENT REQUESTED] rate
shall apply to the entire Net Sales Value of the combination product.
4.5. All sums due under this Agreement:
(a) are exclusive of Value Added Tax which, where applicable, will
be paid by Somanta to Immunodex in addition;
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CONFIDENTIAL TREATMENT REQUESTED
(b) shall be paid in U.S. dollars by check or wire transfer made
payable to Immunodex, Inc., and in the case of sales or
sub-license income received by Somanta in a currency other than
U.S. dollars, the royalty shall be calculated in the other
currency and then converted into equivalent U.S. dollars at the
buying rate of such other currency as quoted by The Wall Street
Journal, Western Edition, as at the close of business on the
last business day of the quarterly period with respect to which
the payment is made;
(c) shall be made without deduction of income tax or other taxes
charges or duties that may be imposed, except insofar as Somanta
is required to deduct the same to comply with applicable laws.
The Parties shall cooperate and take all steps reasonably and
lawfully available to them, at the expense of Immunodex to avoid
deducting such taxes and to obtain double taxation relief. If
Somanta is required to make any such deduction it shall provide
Immunodex with such certificates or other documents as it can
reasonably obtain to enable Immunodex to obtain appropriate
relief from double taxation of the payment in question; and
(d) shall be made by the due date set forth in this Agreement,
unless otherwise agreed to by Immunodex (with Immunodex being
entitled to withhold its agreement in its sole discretion).
4.6. If, at any time during the continuation of this Agreement, Somanta is
prohibited from making any of the payments required hereunder by a
governmental authority in any country then Somanta will within the
prescribed period for making the said payments in the appropriate manner
use its best endeavours to secure from the proper authority in the
relevant country permission to make the said payments and will make them
within 7 days of receiving such permission. If such permission is not
received within 30 (thirty) days of Somanta making a request for such
permission then, at the option of Immunodex, Somanta shall deposit the
royalty payments due in the currency of the relevant country either in a
bank account designated by Immunodex within such country or such royalty
payments shall be made to an associated company of Immunodex designated
by Immunodex and having offices in the relevant country designated by
Immunodex.
4.7. Records
4.7.1. Somanta shall keep at its normal place of business detailed and up to
date records and accounts showing the quantity, description and value of
Royalty-bearing Products sold by it, and the amount of sublicensing
revenues received by it in respect of Royalty-bearing Products, on a
country by country basis, and being sufficient to ascertain the
royalties due under this Agreement for a period of at least five (5)
years after the time periods to which the records relate.
4.7.2. Somanta shall make such records and accounts available, on five (5)
business days notice, for inspection during business hours by an
independent public accountant nominated by Immunodex for the purpose of
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CONFIDENTIAL TREATMENT REQUESTED
verifying the accuracy of any statement or report given by Somanta to
Immunodex under this clause 4. The accountant shall be required to keep
confidential all information learnt during any such inspection, and to
disclose to Immunodex only such details as may be necessary to report on
the accuracy of Somanta's statement or report. Immunodex shall be
responsible for the accountant's charges, unless the report reveals an
underpayment of five percent (5%) or more for the periods audited, in
which case Somanta shall promptly pay the difference as well as the
public accountant's full fees.
4.7.3. Somanta shall ensure that Immunodex has the same rights as those set out
in this Clause 4.7 in respect of any licensee or license or sub-licensee
of Somanta that is licensed or sub-licensed under the Patents and/or
Know-how pursuant to this Agreement.
4.8. Transaction Fee. Somanta will reimburse Immunodex for its legal fees
incurred in connection with the negotiation of this Agreement in an
amount not to exceed [CONFIDENTIAL TREATMENT REQUESTED] within thirty
(30) after Immunodex provides Somanta written documentation
substantiating the actual amount of such fees. This amount is
non-refundable and this payment obligation survives notwithstanding any
termination of this Agreement under circumstances described in Section
2.3.1 or otherwise.
5. Commercialisation
5.1. Somanta shall use commercially reasonable efforts (defined as the
efforts a typical biopharmaceutical company would devote to a product of
similar potential at a similar stage of development that has not been
in-licensed in order to develop and commercialize it in a sustained and
diligent manner without interruption, pause or delay), at its sole cost
and expense, to develop and commercially exploit Royalty-bearing
Products, including, without limitation, all laboratory and clinical
studies performed hereunder, it being understood that any and all costs
and expenses incurred by Somanta in connection with the development of
any Royalty-bearing Product shall not be credited or offset against any
other payments that may be due and owing from Somanta to Immunodex
hereunder. Commercially reasonable efforts with respect to
Royalty-bearing Products covered by the Bre-3 Patents or the Mc-3
Patents, as the case may be, shall include without limitation Somanta
carrying out the following activities, with respect to Royalty-bearing
Products covered by the Bre-3 Patents or Mc-3 Patents, as the case may
be, on or before the agreed upon amount of time has elapsed after the
date of this Agreement as indicated in the Table below (n/a indicates
such milestone is not applicable to such Royalty-bearing Product
development):
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--------------------------------------------------------------------------
Milestone BrE-3 - Mc-3 -
--------- -------- -------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL TREATMENT [CONFIDENTIAL TREATMENT
REQUESTED] REQUESTED] REQUESTED]
--------------------------------------------------------------------------
--------------------------------------------------------------------------
--------------------------------------------------------------------------
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* Each clinical study shall be deemed initiated at such time as Somanta has
entered into an agreement to conduct that specific trial with the applicable
institution at which the clinical study will be conducted.
** The parties will commence negotiating in good faith such diligence milestone
within three (3) months time after the receipt of sufficient data from the
animal studies related to Mc-3, such negotiations to conclude no later than nine
(9) months after such negotiations begin. At such time as the parties have
agreed upon diligence milestones related to the development of Mc-3 (at some
time within such nine (9) months), this agreement will be amended to include
such additional diligence milestones.
If Somanta fails to meet any of the dates set forth in the table of milestones
above, then Immunodex has the right to terminate this Agreement (with respect to
the applicable program) under Section 8.3.2, and, subject to the final paragraph
of this subsection below, Somanta shall pay the following fee based on time
elapsed after the Commencement Date (and, subject to the final paragraph of this
subsection below, any termination by Somanta under Section 8.3.1 without meeting
these milestones shall be deemed a termination by Immunodex under Section 8.3.2
and shall not be a means for evading the diligence requirements or the
cancellation fees):
Time elapsed from Commencement Date
(one year equals 365 days, except for leap years which have 366 days)
BrE-3 Mc3
Payment Payment
1 year [CONFIDENTIAL TREATMENT REQUESTED]
2 year [CONFIDENTIAL TREATMENT REQUESTED]
3 year [CONFIDENTIAL TREATMENT REQUESTED]
4 year [CONFIDENTIAL TREATMENT REQUESTED]
5 year [CONFIDENTIAL TREATMENT REQUESTED]
Notwithstanding anything to contrary herein, Somanta shall not be obligated to
make any payment under this Section 5.1 if this Agreement is terminated (as to
Bre-3, Mc-3, or both) as a result of any of the following:
1) if Somanta discontinues the development of the applicable
Royalty-bearing Product due to the negative results of any toxicity testing or
any clinical trial that the FDA indicates would preclude further testing of the
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CONFIDENTIAL TREATMENT REQUESTED
applicable Royalty Product(s), or with respect to animal testing of Mc3, that
would preclude continued development or would prevent non-rejection of an IND
for an Mc3-based Royalty-bearing Product based on FDA guidance or the prevailing
standards that FDA applies;
2) if Somanta discontinues the development of the applicable
Royalty-bearing Product because a third party is granted orphan drug status by
the FDA for a Yttrium-labelled or -linked monoclonal antibody targeting the same
antigen (as BrE-3 or Mc-3, as applicable) that would be considered the same drug
under applicable law for orphan drug exclusivity purposes, the orphan drug
designation is to treat the same indication for which Somanta's applicable
Royalty-bearing Product is being clinically tested hereunder and the development
of such other drug is at a stage such that such other party will be in a
position to file a BLA or NDA with respect to such other drug prior to the time
that Somanta will be in a position to file a BLA or NDA with respect to the
applicable Royalty-bearing Product (i.e., the entity that benefits from such
orphan drug status designation is further along in clinical development than
Somanta);
3) If the remote possibility occurs that -- after exhausting all
reasonable efforts to optimize production of Royalty-bearing Products to achieve
commercially viable yields of BrE-3 and/or Mc-3 -- Somanta still does not
achieve commercially viable yields of the antibody(ies) for which it is
terminating (BrE-3 and/or Mc-3 as applicable). This remote possibility will be
deemed to have occurred if:
(a) Somanta fails to obtain a commercially viable manufacturing
yield for the relevant antibody(ies) under cGMP conditions, only after Somanta
has tried for at least [CONFIDENTIAL TREATMENT REQUESTED] to increase antibody
production by all currently available methods (these must include but are not
limited to the following techniques and procedures: genetic engineering
approaches, gene splicing, introduction of enhancers, re-hybridization with new
hybridoma partner and techniques to magnify protein production in cells and
hybridomas, gene grafting and redundant gene deletion, and then
(b) Having concluded that (a) has occured, Somanta must notify
Immunodex in writing and within 30 days assemble a panel of 2 to 3 academic
investigators with relevant expertise and specialties. These academic experts
will have 60 days to provide a report proposing new alternative approaches to be
followed by Somanta to seek to obtain commercially viable yields of the relevant
antibody(ies) under cGMP conditions. Somanta shall then dedicate at least
[CONFIDENTIAL TREATMENT REQUESTED] at a total budget of at least [CONFIDENTIAL
TREATMENT REQUESTED] to test the panel recommendations. It will be then and only
then after these last [CONFIDENTIAL TREATMENT REQUESTED] of testing that Somanta
can terminate this Agreement with respect to the relevant antibody(ies) (BrE-3
and/or Mc-3) without incurring a termination penalty to Immunodex as specified
above in this Section 5.1, on the basis of a failure to obtain commercially
viable yields of such antibody(ies) under cGMP conditions
A "commercially viable yield" for BrE-3 shall be deemed to have been achieved if
a cell line produces such antibody at a level of at least [CONFIDENTIAL
TREATMENT REQUESTED] in then state-of-the-art production equipment and
facilities. Similarly, a "commercially viable yield" for Mc-3 shall be deemed to
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CONFIDENTIAL TREATMENT REQUESTED
have been achieved if a cell line produces such antibody at a level of at least
[CONFIDENTIAL TREATMENT REQUESTED] in then state-of-the-art production equipment
and facilities; or
(4) If, with respect to BrE-3, the report delivered by the third party
testing facility as set forth in Section 2.3.1(a) results in Escrow Amount 1
being released to Somanta, and if, with respect to Mc-3, the report delivered by
the third party testing facility as set forth in Section 2.3.1(b) results in
Escrow Amount 2 being released to Somanta.
5.2. Without prejudice to the generality of Somanta's obligations under Clause
5.1, Somanta shall provide at least semi-annually to Immunodex an updated,
written Development Plan, showing all past, current and projected activities
taken or to be taken by Somanta to bring Royalty-bearing Products to market and
sell Royalty-bearing Products worldwide, such Development Plan to be submitted
to Immunodex by May 1 and November 1 of each year. With regard to the items to
be determined, after Somanta has consulted with the FDA regarding the need
and/or extent of such studies, the parties shall amend this agreement to include
mutually agreeable and reasonable time frames related to the completion of such
studies, if necessary.
5.3. Clinical Trials. Somanta intends to enter into an amended and restated
Clinical Trial Agreement with CRICC for the purpose of enabling CRICC to sponsor
clinical trials related to potential Royalty-bearing Products; provided,
however, that any academic institution or hospital conducting such trial or
trials must have appropriate approval by their respective Institutional Review
Board and approval by the U.S. Food and Drug Administration for conducting such
clinical trial or trials. Furthermore, no patient will be treated in any such
clinical trial unless the applicable institution or hospital at which such trial
is conducted releases in writing each of Immunodex and CRICC from any and all
liability associated with the conduct of such clinical trial or trials.
6. Intellectual property
6.1. Obtain and maintain the Patents. Somanta shall at its own cost and
expense (and through counsel of its choosing, which shall initially be
DLA Piper Rudnick Gray Cary (by or under the supervision of Lisa Haile)
and shall be through counsel reasonably acceptable to Immunodex and if
Somanta changes law firms):
(a) prosecute and endeavour to issue patents on each patent
application within the BrE-3 Patents and Mc-3 Patents so as to
secure the broadest claim coverage reasonably available on the
basis of these applications; and
(b) pay all renewal, annuity and maintenance fees in respect of the
BrE-3 Patents and Mc-3 Patents as and when due and provide
notice and evidence to Immunodex of such payments within 30 days
of the effective date of payment;
provided that if Somanta wishes to abandon any such application or not
to maintain any such patent within the Licensed Patents (or to cease
funding such application or Patent) it shall give thirty (30) days'
prior written notice to Immunodex and on the expiry of such notice
period Somanta shall lose all licensing rights to such patent
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CONFIDENTIAL TREATMENT REQUESTED
application or patent identified in the notice, and Immunodex may
thereafter continue to pursue and maintain such patent applications and
patents.
(c) Immunodex will promptly after the date of this Agreement
disclose a copy of all relevant documentation, within its legal
possession and Control related to the prosecution or maintenance
of any patent or patent applications listed on Schedule 1 to
patent counsel identified by Somanta.
With respect to Licensed Patent prosecution conducted by Somanta under
Section 6.1(a), Somanta shall provide to Immunodex no later than thirty
(30) days after the date of anticipated filing (including without
limitation of responses to office actions and the like) a draft of the
anticipated filing. When Somanta provides the draft, it shall disclose
such anticipated date of filing to Immunodex. Somanta shall reasonably
consider and incorporate to the extent reasonable Immunodex's comments
thereon received no later than five (5) days before the date of
anticipated filing and shall confer with Immunodex in person or by
telephone regarding any comments that Somanta does not wish to
incorporate.
The Parties' agreements regarding patent prosecution and maintenance are
subject to the terms of the written agreements by which Immunodex
derives rights in the Licensed Patents, to the full extent applicable.
6.2 Infringement of the Patents
6.2.1 Notice. Each Party shall notify the other in writing of any
suspected infringement of any Licensed Patent(s) by commercial
activities within the Field, promptly after learning of such
infringement or challenge.
6.2.2 Action Against Infringement in the Field. As between the Parties,
Somanta shall have the first right to prosecute and shall bear all
expenses associated with all claims against third parties for
infringement during the term within the Field of the Licensed Patent(s);
provided, however that Somanta's action must be limited to pursuit and
prevention of infringement within the Field that is competitive with
Somanta's activities under this Agreement. If Somanta does not take
action to end the infringement within 180 days after a notice between
the parties under subsection 6.1.1, then Immunodex shall have the right
to bring and control suit to end and/or seek damages for the
infringement.
6.2.3 Recovery. Any recovery, awarded either Party or Parties in
connection with an action pursuant to subsection 6.1.2 shall be
distributed as follows: (i) first, to [CONFIDENTIAL TREATMENT REQUESTED]
by the Parties in connection with the claim of infringement, and (ii)
second, with any additional amounts being allocated to [CONFIDENTIAL
TREATMENT REQUESTED], but if this is [CONFIDENTIAL TREATMENT REQUESTED],
then [CONFIDENTIAL TREATMENT REQUESTED] must pay [CONFIDENTIAL TREATMENT
REQUESTED] an amount equal to the [CONFIDENTIAL TREATMENT REQUESTED]
hereunder on the sales of product underlying such remaining recovery.
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CONFIDENTIAL TREATMENT REQUESTED
6.2.4 Indispensable Party. If either Party reasonably determines that
the other Party is an indispensable party to any action pursuant to this
Section 6.2.4 the other Party hereby consents to be joined and shall
bear its own costs only if that party elects to be represented by
separate counsel.
6.2.5 Settlement. Neither Party shall settle any action pursuant to this
Section 6.2 (excluding 6.2.6) without the other Party's written consent
(such consent not to be unreasonably withheld, delayed or conditioned),
unless the settlement is for money damages alone.
6.2.6 Infringement Outside the Field. To avoid any doubt, Somanta shall
not have any right to enforce any Licensed Patent(s) against
infringement that is not within the Field and competitive with the
Somanta's activities hereunder. This is Immunodex's sole and exclusive
right as between the Parties.
The Parties' agreements regarding patent infringement suits and sharing of
recoveries are subject to the terms of the written agreements by which Immunodex
derives rights in the Licensed Patents, to the full extent applicable. In
particular, the "remaining recovery" after costs are deducted (under subsection
(c)) shall be net of any amounts that may be due Immunodex's licensors.
6.3 Infringement of third party rights
6.3.1 If any warning letter or other notice of infringement is received by a
Party, or legal suit or other action is brought against a Party,
alleging infringement of third party rights in the manufacture, use or
sale of any Royalty-bearing Product or use of any Patents, that Party
shall promptly provide full details to the other Party, and the Parties
shall discuss the best way to respond.
6.3.2 Somanta shall have the right but not the obligation to defend such suit
to the extent that it relates to the Field, and shall have the right to
settle with such third party, provided that if any action or proposed
settlement involves the making of any statement, express or implied,
concerning the validity of any Patent, the consent of Immunodex must be
obtained before taking such action or making such settlement.
Furthermore, this Section 6.3.2 shall in no way alter or limit Somanta's
responsibilities under Article 7.
7. Warranties and liability; Indemnification
7.1 Immunodex warrants, represents and undertakes as follows:-
(a) For avoidance of doubt, Immunodex will transfer and/or disclose
to Somanta all Know-how (by definition Controlled by Immunodex
as of the Commencement Date, including, without limitation, all
manufacturing information, SOP's, assays and protocols in
Immunodex's Control, and Immunodex will use its commercially
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CONFIDENTIAL TREATMENT REQUESTED
reasonable efforts (it being understood that Immunodex shall not
be required to make any payment to any third party in connection
with this Section 7.1) to obtain from Goodwin Biotechnology, New
York University and Anmed/Biosafe any and all additional
information, including, without limitation, manufacturing
information, SOP's, assays or protocols, in each case that are
necessary or useful for the exploitation of the Licensed Patents
and Know-how and have been developed by these entities in the
course of performing work for CRICC and/or Immunodex;
(b) it has the legal capacity and authority to enter into this
Agreement and perform its obligations under this Agreement and,
without prejudice to the generality of the foregoing, is
entitled to sub-license the BrE-3 Patents and Mc-3 Patents and
sub-license the Know-how to Somanta as provided for in this
Agreement subject to United States Government rights conferred
by its participation in the BrE3 Patents: [CONFIDENTIAL
TREATMENT REQUESTED].
(c) it has not done, and will not do nor agree to do during the
continuation of this Agreement, any of the following things in
the Field, if to do so would be inconsistent with the exercise
by Somanta of the rights granted to it under this Agreement,
namely:
(i) grant or agree to grant any right, title or interest in
the BrE-3 Patents or Mc3 Patents or the Know-how or any
improvements thereto that are included within the
Licensed Patents; or
(ii) assign, mortgage, charge or otherwise transfer any of
the BrE-3 Patents or Mc3 Patents or Know-how or (subject
to clause 9.3 below) any of its rights or obligations
under this Agreement.
(iii) grant or agree to grant any right, title or interest in
any Patent or know-how covering or claiming the
Lactadherin technology for use in the Field.
7.2 Somanta Representations and Warranties.
Somanta represents and warrants to Immunodex that Somanta has the legal capacity
and authority to enter into this Agreement and perform its obligations under
this Agreement; that this Agreement represents is the legally binding obligation
of Somanta; and that this Agreement has been authorized by all requisite
corporate action within Somanta.
7.3 No other warranties
7.3.1 Each of Somanta and Immunodex acknowledges that, in entering into this
Agreement, it does not do so in reliance on any representation, warranty or
other provision except as expressly provided in this Agreement, and any
conditions, warranties or other terms implied by statute or common law are
excluded from this Agreement to the fullest extent permitted by law. EXCEPT AS
EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES MAKE NO, AND EXPRESSLY
DISCLAIM ALL, REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, INCLUDING,
WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, TITLE, FITNESS FOR
A PARTICULAR PURPOSE OR NON-INFRINGEMENT.
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7.3.2 Without limiting the scope of Clause 7.3.1, Immunodex does not give any
warranty (and hereby expressly disclaims), representation or undertaking:
(a) as to the efficacy or usefulness of the Licensed Patents or
Know-how; or
(b) that any of the Licensed Patents is or will be valid or
subsisting or (in the case of an application) will proceed to
grant; or
(c) that the use of any of the Licensed Patents or Know-how, the
manufacture, sale or use of the Royalty-bearing Products or the
exercise of any of the rights granted under this Agreement will
not infringe any other intellectual property or other rights of
any other person; or
(d) that the subject matter of the Licensed Patents or Know-how or
any other information communicated by Immunodex to Somanta under
or in connection with this Agreement will produce
Royalty-bearing Products of satisfactory quality or fit for the
purpose for which Somanta intended; or
(e) as imposing any obligation on Immunodex to bring or prosecute
actions or proceedings against third parties for infringement or
to defend any action or proceedings for revocation of any of the
Licensed Patents; or
(f) as imposing any liability on Immunodex in the event that any
third party supplies Royalty-bearing Products to customers
located in the Territory.
7.4 Liability. EXCEPT WITH RESPECT TO A BREACH OF CONFIDENTIALITY AND/OR
NON-USE OBLIGATIONS HEREUNDER OR TO THE EXTENT SOMANTA MAY BE REQUIRED
TO INDEMNIFY IMMUNODEX INDEMNITEES UNDER SECTION 7.4 (INDEMNIFICATION),
NO PARTY SHALL BE LIABLE TO ANY OTHER PARTY TO THIS AGREEMENT IN
CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR
ANY LOSS, DAMAGE, COSTS OR EXPENSES OF ANY NATURE WHATSOEVER INCURRED OR
SUFFERED BY THAT OTHER PARTY OR ITS AFFILIATES OF AN INDIRECT OR
CONSEQUENTIAL NATURE INCLUDING WITHOUT LIMITATION ANY ECONOMIC LOSS OR
OTHER LOSS OF TURNOVER, PROFITS, BUSINESS OR GOODWILL.
7.5 Indemnification. Somanta shall indemnify, defend and hold harmless
Immunodex, CRICC and their respective members of their boards of
directors and trustees, officers, employees, agents and consultants
(each, an "Immunodex Indemnitee") from and against any and all damages,
losses, liabilities, costs and expenses (including, without limitation,
attorneys fees) ("Losses") third-party claims (each, a "Claim") arising
out of or relating to: (1) Somanta's (and its Affiliates' and
sublicensees') research, development, testing, manufacture, use, sale,
offer for sale, importation, exportation, storage and distribution of
Royalty-bearing Products (including, without limitation, products
liability and intellectual property claims),(2) Somanta's use of
materials included within the Know-how (including, without limitation,
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CONFIDENTIAL TREATMENT REQUESTED
the cell lines transferred pursuant to Section 2.3); (3) Somanta's
finding that Immunodex is an indispensable party and requiring Immunodex
to participate in an infringement suit under Section 6.1.1; and (4) the
conduct of the Ongoing Clinical Trial. Such indemnification shall not
apply to the portion of any such Losses to the extent such Losses result
solely from (a) Immunodex's material breach of any of its
representations and warranties granted hereunder, or (b) the gross
negligence or intentional misconduct of any Immunodex Indemnitee
(including without limitation by material failure on their parts to
follow the then-current protocol for the Ongoing Clinical Trial under
the written agreement between the parties regarding the conduct for such
trial being entered into contemporaneously with this Agreement). To the
extent Somanta provides indemnification relating to (4) hereunder, it
shall not be required to Indemnify for the same Losses under such
clinical trial agreement.
8. Duration and Termination
8.1. Commencement. This Agreement shall come into full effect on the first
date set forth on the first page of this Agreement (the "Commencement
Date"); provided, however, that the sublicenses granted hereunder shall
come into effect on the date on which Somanta makes the payments set
forth in Sections 4.1(a) and (c).
8.2 Termination by expiry. Unless terminated earlier in accordance with this
Clause 8 (Duration and Termination), this Agreement and the sub-licenses
granted hereunder shall continue in force as follows:
(i) With respect to the BrE-3 Patents and BrE-3-based Royalty-bearing
Products, they shall remain in force on a country-by-country and
product-by-product basis, until the date on which all the BrE-3 Patents
have expired or been revoked without a right of further appeal, or if
later when the last obligation to pay royalties on Net Sales Revenue of
such BrE-3-based Royalty-bearing Product in such country have expired.
On such latter of the two (2) dates this Agreement and the licenses
granted hereunder shall terminate automatically by expiry with respect
to the BrE-3 Patents and such BrE-3-based Royalty-bearing Product in
such country.
(ii) With respect to the Mc-3 Patents and Mc-3-based Royalty-bearing
Products, they shall remain in force on a country-by-country and
product-by-product basis, until the date on which all the Mc-3 Patents
have expired or been revoked without a right of further appeal, or if
later when the last obligation to pay royalties on Net Sales Revenue of
such Mc-3-based Royalty-bearing Product in such country have expired. On
such latter of the two (2) dates this Agreement and the licenses granted
hereunder shall terminate automatically by expiry with respect to the
Mc-3 Patents and such Mc-3-based Royalty-bearing Product in such
country.
8.3 Early termination
8.3.1. By Somanta. Somanta may terminate this Agreement at any time on 90 days
notice in writing to Immunodex with respect to: (1) this Agreement in
its entirety, (2) with respect to all BrE-3 Patents and all BrE-3-based
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CONFIDENTIAL TREATMENT REQUESTED
Royalty-bearing Products, or (3) with respect to all Mc-3 Patents and
all Mc-3-based Royalty-bearing Products.
8.3.2. By either Party for material breach. Without prejudice to any other
right or remedy, either Party may terminate this Agreement at any time
by notice in writing to the other Party ("Other Party"), such notice to
take effect as specified in the notice:
(a) if the Other Party is in breach of this Agreement and, in the
case of a breach capable of remedy within 90 days, the breach is
not remedied within 90 days of the Other Party receiving notice
specifying the breach and requiring its remedy (provided that
the notice and cure period shall be only 30 days for payment
failures, in accordance with Section 8.3.4; or
(b) if the Other Party becomes insolvent, or if an order is made or
a resolution is passed for the winding up of the Other Party
(other than voluntarily for the purpose of solvent amalgamation
or reconstruction), or if an administrator, administrative
receiver or receiver is appointed in respect of the whole or any
part of the Other Party's assets or business, or if the Other
Party makes any composition with its creditors or takes or
suffers any similar or analogous action in consequence of debt.
8.3.3. By Immunodex for Licensed Patent Challenge. Immunodex may forthwith
terminate this Agreement by giving written notice to Somanta if Somanta
or its Affiliate or licensee or sub-licensee commences legal
proceedings, or assists any third party to commence legal proceedings,
to challenge the validity of any of the Licensed Patents.
8.3.4. Payment Failures. Any failure by Somanta to make payments to Immunodex
by their respective due dates is a material breach of this Agreement.
Somanta shall have 30 days to cure its breach by submitting the payment
due to Immunodex. If the payment due is not made by Somanta within the
30 day period, this Agreement shall terminate on the expiration of such
notice period and all rights, without exception, will revert to
Immunodex. During the delinquent period, Immunodex may charge interest
on any outstanding amount on a daily basis at a rate equivalent to
[CONFIDENTIAL TREATMENT REQUESTED] above the prime rate of lending
published by the U.S. Federal Reserve from time to time (or the maximum
amount permitted by law, whichever is less).
8.4 Consequences of termination
8.4.1 Upon termination of this Agreement by expiry under clause 8.2 above,
Somanta shall have the non-exclusive right to use the Know-how to make,
have made, use, sell, offer to sell and import those Royalty-bearing
Products in those countries in each case with respect to which this
Agreement has expired, and may negotiate with Immunodex to seek to reach
terms upon which it may license such Know-how on an exclusive basis (but
solely if Immunodex is willing to negotiate the terms of such exclusive
rights, recognizing its affiliation with a not-for-profit research
institute and that it may reasonably conclude that it is not willing to
grant exclusive rights to such Know-how after expiry of this Agreement).
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CONFIDENTIAL TREATMENT REQUESTED
8.4.2 Upon termination of this Agreement for any reason otherwise than in
accordance with Clause 8.2 (expiration):
(a) Somanta and its licensee or sublicensees shall be entitled to
sell, use or otherwise dispose of any unsold or unused stocks of
the Royalty-bearing Products, subject to the payment of
royalties on such Royalty-bearing Products;
(b) subject to paragraph (a) above, Somanta shall no longer be
entitled as licensee to use or otherwise exploit in any way,
either directly or indirectly, the BrE-3 Patents or the Mc3
Patents, in so far and for as long as any of the same remain in
force, or the Know-how;
(c) any sublicense granted by Somanta pursuant to Section 2.2 hereof
may, at the option of the sub-licensee, be converted into a
sub-license directly with Immunodex upon the same terms as set
forth in such sublicense agreement; provided that this is only
available if the termination was for a material breach that is
capable of cure, and such sublicensee agrees to make payments
and reports directly to Immunodex and to remedy of any breach by
Somanta of this Agreement as promptly as is reasonably
practicable (with respect to payment breaches, within 30 days);
(d) the provisions of clauses 4 (in respect of events occurring and
sales made prior to termination) and 3.4, 3.5, 7, 8 and 9 shall
survive termination; and
(e) subject to and except as provided in this Clause 8.3.2 and 8.3.3
and 8.3.4, and except in respect of any accrued rights, neither
party shall be under any further obligation to the other.
(f) If this Agreement (as to BrE-3, Mc-3, or both) is terminated for
a reason other than an adverse event (within the meaning of
applicable FDA regulations and related laws) or FDA action, in
either case precluding further clinical testing of BrE-3 or Mc-3
(or if this Agreement is terminated as to both of them, both),
then to the extent not already paid to Immunodex (or CRICC under
the clinical trial agreement between Somanta and CRICC entered
into contemporaneously with this Agreement), Somanta agrees to
pay to Immunodex independent of any other prior consideration or
stipulation contained in this Agreement the sum [CONFIDENTIAL
TREATMENT REQUESTED] for each patient included in the Ongoing
Clinical Trial for whom Somanta receives a completed case
reporting form during the [CONFIDENTIAL TREATMENT REQUESTED]
period following the Effective Date, for up to a maximum of
[CONFIDENTIAL TREATMENT REQUESTED]patients (i.e., a maximum of
[CONFIDENTIAL TREATMENT REQUESTED].
27
CONFIDENTIAL TREATMENT REQUESTED
8.4.3 Upon termination of this Agreement for any reason (other than
expiration) and at Immunodex's request, Somanta shall:
(a) transfer to Immunodex exclusively all clinical and other data
relating to the development of Royalty-bearing Products;
(b) within thirty (30) days after the date of termination of this
Agreement, transfer to Immunodex, or, if, as and to the extent
directed by Immunodex, destroy, all quantities of cell lines
transferred to Somanta hereunder (including, without limitation
all progeny of the cells themselves physically transferred to
Somanta hereunder); all cell banks and any other samples of the
hybridoma kept in vitro or frozen, or if this Agreement is
terminated with respect to only the BrE-3 Patents or the Mc-3
Patents, as the case may be, then only those that relate to the
terminated portfolio of Licensed Patents (i.e., that relate to
BrE-3 or Mc-3, respectively); and in either case within thirty
(30) days of termination of the Agreement, an officer of Somanta
shall certify in writing on Somanta letterhead Somanta's
compliance with this Section (such certification to speak
specifically to each place and each person where cells required
to be returned or destroyed were stored or into whose physical
possession they came, and indicate the disposition of the cells
held at such place or by such person);
(c) have any product licenses, pricing approvals and other permits
and applications transferred into the name of Immunodex or its
nominee;
(d) transfer all rights granted to Somanta under this agreement to
Immunodex, including without limitation any rights in the
materials set forth in subsection (b) above and any antibody
produced by the cell lines then in Somanta's possession;
(e) grant Immunodex an exclusive, worldwide license, with the rights
to grant license or sub-licenses, under any improvements and
other intellectual property owned or controlled by Somanta
relating to the Royalty-bearing Products; and
(f) grant Immunodex or its nominee the right to continue to use any
product name that had been applied to the Royalty-bearing
Products prior to termination of this Agreement.
8.4.4. If the Parties are unable to agree the terms of a written agreement to
evidence, record or effect any of Immunodex's rights or any of the
transfers to Immunodex (should any further written document be
reasonably required, for example any reasonably required assignment or
letter of transfer) as described in Clause 8.4.3 within 90 days of
Immunodex requesting the negotiation of such an agreement, Immunodex may
refer the terms for settlement by an independent arbitration expert who
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CONFIDENTIAL TREATMENT REQUESTED
shall be appointed in accordance with the provisions of Schedule 2 and
whose decision shall be final and binding on the Parties. The Parties
shall promptly execute an agreement on the terms agreed between them or
settled by the expert.
8.4.5. Nothing in this Agreement shall prevent Immunodex from seeking
injunctive relief in the case of material breach of this Agreement.
9. General
9.1. Force majeure. Neither Party shall have any liability or be deemed to be
in breach of this Agreement for any delays or failures in performance of
this Agreement enduring no more than 12 months, which result from
circumstances beyond the reasonable control of that Party, such as
earthquake, flood, fire, other natural disaster, and acts of God, war
and terrorism and including without limitation labour disputes involving
that Party. The Party affected by such circumstances shall promptly
notify the other Party in writing when such circumstances cause a delay
or failure in performance and when they cease to do so.
9.2. Amendment. This Agreement may only be amended in writing signed by duly
authorised representatives of Immunodex and Somanta.
9.3. License and third party rights.
9.3.1. Except as provided in clause 9.3.2 or 9.3.3, neither Party may assign or
transfer any or all of its rights and obligations hereunder.
9.3.2. Neither Party may assign its rights and obligations under this Agreement
to any entity without the prior written consent of the other Party;
provided, however, that either Party may assign its rights and
obligations to any entity succeeding to all or substantially all of such
Party's business or assets whether by merger or a transaction of another
form without the written consent of the other Party; provided, further,
however, that (a) the assignee undertakes to the non-assigning Party to
be bound by and perform the obligations of the assignor under this
Agreement, and (b) if Somanta is the assigning Party and the assignment
is made prior to the Funding (and to avoid any doubt, if committed to
prior to the Funding, only actually occurs after the Funding), then
because the licenses granted hereunder will be transferred by the
assignment and Somanta's other assets prior to the Funding are not
considered to provide reasonable assurance that assignment will not be a
mechanism to evade the Parties' agreement as set forth herein regarding
sublicenses, Immunodex's approval is required on the same conditions as
for sublicensing set forth in Section 2.2. Notwithstanding anything to
the contrary in this Agreement (but subject of course to proviso (a)
above regarding the assignee's undertakings and the requirements of the
next paragraph regarding an informational meeting with the assignee
after assignment), this Agreement and all the rights and obligations
under this Agreement may be assigned without the prior written consent
of Immunodex or the approval of Immunodex or its licensors as required
by Section 2.2 hereof to: (i) Bridge Oncology Products, Inc. (or Somanta
Incorporated if Bridge Oncology Products, Inc. so changes its name), a
29
CONFIDENTIAL TREATMENT REQUESTED
Delaware corporation, (ii) a to be identified entity that is subject to
the reporting requirements of the Securities and Exchange of 1934, as
amended (the "Public Shell") in connection with a reverse merger with
such Public Shell, provided that the shareholders of Somanta
Incorporated hold a majority of the outstanding voting securities of
such Public Shell immediately after such assignment, and (iii) to any
entity succeeding to all or substantially all of the assigning party's
business or assets whether by merger or a transaction of another form
after the Funding.
If Somanta assigns this Agreement, Somanta will use commercially
reasonable efforts to include as a condition of such assignment the
obligation that the assignee shall meet with Immunodex to review
development (and if applicable at that stage, commercialization) plans
for the Royalty-bearing Products, within 6 months after the assignment.
This meeting is for communication and information sharing purposes only
and does not impose any additional diligence requirements on the
assignee.
9.3.3. In connection with monetizing its royalty stream under this Agreement,
Immunodex may assign this Agreement to an entity purchasing from
Immunodex the right to receive payments from Somanta hereunder.
9.4. Waiver. No failure or delay on the part of either Party to exercise any
right or remedy under this Agreement shall be construed or operate as a
waiver thereof, nor shall any single or partial exercise of any right or
remedy preclude the further exercise of such right or remedy.
9.5. Invalid clauses. If any provision or part of this Agreement is held to
be invalid, illegal or unenforceable, amendments to this Agreement may
be made by the addition or deletion of wording as appropriate to remove
the invalid, illegal or unenforceable part or provision but otherwise
retain the provision and the other provisions of this Agreement to the
maximum extent permissible under applicable law.
9.6. No Agency, Joint Venture or Partnership. Neither Party shall act or
describe itself as the agent of the other, nor shall it make or
represent that it has authority to make any commitments on the other's
behalf. This Agreement does not create any joint venture or partnership
between the Parties and they are operating as independent contractors
with respect to one another.
9.7. Interpretation. In this Agreement:
(a) the headings are used for convenience only and shall not affect
its interpretation;
(b) references to persons shall include incorporated and
unincorporated persons; references to the singular include the
plural and vice versa; and references to the masculine include
the feminine;
(c) references to Clauses and Schedules mean clauses of, and
schedules to, this Agreement; and
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CONFIDENTIAL TREATMENT REQUESTED
9.8 Notices
i. Any notice to be given under this Agreement shall be in writing and
shall be sent by first class mail or air mail, or by fax (confirmed by
first class mail or air mail) to the address of the relevant Party set
out at the head of this Agreement, or to the relevant fax number set out
below, or such other address or fax number as that Party may from time
to time notify to the other Party in accordance with this Clause 9.8.
The fax numbers of the Parties are as follows: Immunodex- (707)
441-1822; Somanta 940-706-3698.
ii. Notices sent as above shall be deemed to have been received three
working days after the day of posting (in the case of inland first class
mail), or seven working days after the date of posting (in the case of
air mail), or on the next working day after transmission (in the case of
fax messages, but only if a transmission report is generated by the
sender's fax machine recording a message from the recipient's fax
machine, confirming that the fax was sent to the number indicated above
and confirming that all pages were successfully transmitted).
b. Law and Jurisdiction. The validity, construction and performance of this
Agreement shall be governed solely and exclusively by the laws of the
State of California of the United States of America and shall be subject
to exclusive jurisdiction of the courts located in the State of
California within the United States of America. Each party hereby
consents to the jurisdiction (including, without limitation, personal
jurisdiction) and venue of the courts of such State of California, and
waives any and all defenses it may have to the jurisdiction and venue of
such courts, including, without limitation, the defense of forum non
conveniens.
c. Further action. Each Party agrees to execute, acknowledge and deliver
such further instruments, and do all further similar acts, as may be
necessary or appropriate to carry out the purposes and intent of this
Agreement.
d. Announcements. Neither Party shall make any press or other public
announcement concerning any aspect of this Agreement, or make any use of
the name of the other Party in connection with or in consequence of this
Agreement, without the prior written consent of the other Party, except
in connection with any fundraising by Somanta or as required by
applicable law, unless required to make such announcement by applicable
law, including, without limitation, the rules and regulations
promulgated by the Securities and Exchange Commission of the United
States of America. If Somanta is required to publicly file a copy of
this Agreement, then it shall seek confidential treatment of the terms
of this Agreement to the extent reasonably requested by Immunodex and
reasonably available under applicable law (as advised by outside
counsel). Somanta shall afford Immunodex no less than one (1) working
week (excluding US holidays) to comment on any proposed redactions.
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CONFIDENTIAL TREATMENT REQUESTED
e. Entire agreement. This Agreement, including its Schedules, constitutes
the entire Agreement between Somanta and Immunodex with respect to the
subject matter hereof and supersedes all prior or contemporaneous
agreements between Somanta and Immunodex related to the subject matter
hereof, including, without limitation, that certain Patent and Know-how
License Option Agreement dated March 1, 2002 as amended by that certain
Amendment No. 1 to Patent and Know-how License Option Agreement dated
January 2, 2003, that certain Amendment No. 2 to Patent and Know-how
License Option Agreement dated October 14, 2003 and that certain
Amendment No. 3 to Patent and Know-how License Option Agreement dated
October 29, 2004. The Parties hereby acknowledge and agree that the
Patent and Know-how License Option Agreement dated March 1, 2002, as
amended to date is hereby terminated and shall no longer have any
further force or effect.
9.9 The terms of this agreement are confidential and are not to be disclosed
to any third party by Immunodex, CRICC or Somanta without prior written
approval of the other parties, subject to subsection 9.8(d) above.
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CONFIDENTIAL TREATMENT REQUESTED
AGREED by the parties through their authorised signatories:-
For and on behalf of For and on behalf of
IMMUNODEX, Inc. SOMANTA LIMITED
/s/ ROBERTO L. CERIANI /s/ TERRENCE J. BRUGGEMAN
- ---------------------------------- ----------------------------------
signed signed
Roberto L. Ceriani Terrence J. Bruggeman
- ---------------------------------- ----------------------------------
print name print name
President Chairman
- ---------------------------------- ----------------------------------
title title
8/18/05 8/15/05
- ---------------------------------- ----------------------------------
date date
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CONFIDENTIAL TREATMENT REQUESTED
Schedule 1
The Patents
Part A - BrE-3 Patents
1. [CONFIDENTIAL TREATMENT REQUESTED]
2. [CONFIDENTIAL TREATMENT REQUESTED]
3. [CONFIDENTIAL TREATMENT REQUESTED]
Part B - Mc-3 Patent
4. [CONFIDENTIAL TREATMENT REQUESTED]
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CONFIDENTIAL TREATMENT REQUESTED
Schedule 2
Appointment of expert
1. Pursuant to Clause 8.4.4, Immunodex, may serve notice on Somanta
("Referral Notice") that it wishes to refer to an expert (the "Expert")
the questions set out in Clause 8.4.4.
2. The parties shall agree the identity of a single independent, impartial
expert to determine such questions. In the absence of such agreement
within 30 days of the Referral Notice, the questions shall be referred to
an expert appointed by the California Bar Association.
3. 60 days after the giving of a Referral Notice, both parties shall exchange
simultaneously statements of case in no more than 10,000 words, in total,
and each side shall simultaneously send a copy of its statement of case to
the Expert.
4. Each party may, within 30 days of the date of exchange of statement of
case pursuant to paragraph 3 above, serve a reply to the other side's
statement of case of not more than 10,000 words. A copy of any such reply
shall be simultaneously sent to the Expert.
5. The Expert shall make his decision on the said questions on the basis of
written statements and supporting documentation only and there shall be no
oral hearing. The Expert shall issue his decision in writing within 30
days of the date of service of the last reply pursuant to paragraph 4
above or, in the absence of receipt of any replies, within 60 days of the
date of exchange pursuant to paragraph 3 above.
6. The Expert's decision shall be final and binding on the parties.
7. The Expert's charges shall be borne equally by the parties.
35