COOPERATION AND PROJECT FUNDING AGREEMENT
EXHIBIT
10.4
PREAMBLE
Agreement
made this 26th day of May, 2008, by
and
BETWEEN
The
ISRAEL-UNITED STATES BINATIONAL INDUSTRIAL RESEARCH AND DEVELOPMENT FOUNDATION,
a legal entity created by
Agreement between the Government of the State of Israel and the Government of
the United States of America (hereinafter referred to as the
“Foundation”).
AND
BioCancell
Therapeutics Ltd.
AND
Virginia
Biosciences Commercialization Center (VBCC), dba – Virginia-Israel
Biosciences Commercialization
Center
severally
and jointly (hereinafter collectively referred
to as the “Proposer” and separately as the “Participants”).
WHEREAS
the Foundation has been established under an Agreement between the Government of
the State of Israel and the Government of the United States of America to
promote and support joint non-defense industrial research and development
activities of mutual benefit to Israel and the United States, and
WHEREAS
the Proposer has heretofore submitted to the Foundation a proposal (hereinafter
the “Proposal”), entitled “Phase 1 – Safety & dosing Trial for
Pancreatic Cancer Therapy” and on the basis
of the Proposal has applied to the Foundation for certain funding assistance for
the development of the Product therein described; and
WHEREAS
the Foundation has examined and duly approved the Proposal and is willing to
provide certain funding for the implementation of the Proposal on the terms and
conditions hereinafter set forth;
1
Now
therefore the parties hereto agree as follows:
A.
|
GENERAL
|
A.1.
|
The
preamble to this Agreement shall be deemed an integral part
hereof.
|
A.2.
|
The
Participants shall be bound and obliged jointly and severally, as herein
provided.
|
A.3.
|
The
Foundation represents that the Executive Director of the Foundation is
empowered by its Board of Governors to execute this Agreement and to
perform and cause to be performed all acts under the terms hereof on
behalf of the Foundation.
|
A.4.
|
The
following documents are incorporated by reference and made a part of this
Agreement:
|
A.4.1.
|
The
Proposal, dated the 29th day of October, 2007, as stamped with the
Foundation’s approval of the 18th day of December, 2007. Nonetheless,
should any provision of the Proposal be inconsistent with any
provision of this Agreement, the provisions of this Agreement shall
control.
|
A.4.2.
|
BIRD
Foundation Procedures Handbook.
|
A.5.
|
The
following definitions shall apply:
|
“Affiliate” – is an
entity under common control, controlled by or controlling either of the
Participants
“Agreement” – this
Cooperation and Project Funding Agreement
“Approved Project
Budget” – the schedule of expenses contemplated to be spent by a
Participant as set out in Annex A
“BIRD Foundation
Procedures Handbook” – the most recent
version available as of the date of this Agreement or its copy on the
Foundation’s website
“Calculation Date” – a
point in time at which the calculation of the then current balance due by the
Proposer is made
“Commercial
Transaction” – gross sales derived by the Proposer, either Participant or
any Affiliate
“Conditional Grant” –
funds provided by the Foundation for the implementation of the
Proposal
“Foundation” – The Israel-United States
Binational Industrial Research and Development Foundation, as referred to in the
first paragraph of this Agreement
“Foundation’s pro rata share” – the
percentage of the actual expenditures which the Foundation
provides
2
“Full Repayment to the
Foundation” – the repayment to the
Foundation by the Proposer of its entire obligation pursuant to this Agreement
as determined in accordance with Annex C
“Grant Base Index” – the
index last published prior to the date of payment of each increment of the
grant
“Index” – the U.S.
Consumer Price Index, CPI-U
“Indexed Payments”
– the result of multiplying each grant payment received by the Proposer by the
last known Index on the Calculation Date and dividing by the Grant Base
Index
“Indexed Repayment” –
the result of multiplying the Repayment received by the Foundation by the last
known Index on the Calculation Date and dividing by the Repayment Base
Index
“Intellectual
Property” – patents, copyrights, trademarks, inventions, trade secrets,
confidential information, product design, engineering specifications and
drawings, technical information and all types of computer programs
“Interim Reporting Segment” –
an interim period of time for which technical and fiscal reports need to be
submitted
“Late Payment Interest
Rate” – 4% more than the average prime rate prevailing at the XX Xxxxxx
Xxxxx Bank, N.Y.C. (or any successor bank to that bank), during the period from
the date payment was due until payment is actually made
“License Agreement” –
an agreement between the Proposer, or either Participant, or
any Affiliate of either Participant and a third party, whereby such third party
receives the right to use the Product in exchange for a payment. “License
Agreements” shall not include any license agreements, which Proposer, or either
Participant, or any Affiliate of either Participant enters into as a necessary,
common or convenient means by which products are sole to end-users in the
ordinary course of business
“Participants” – the
term used for the Israeli Company and the U.S.
Company signing this Cooperation and Project Funding agreement
“Product” – the
outcome of the
development work or any derivative thereof carried out by the Proposer pursuant
to the terms of this Agreement, including patented inventions
“Program Plan” –
schedule of program activities as described in the Proposal and as presented in
graphical form (XXXXX chart) in Annex D
“Project” – the
process for the development of the Product with the funding assistance of the
Foundation
“Proposal” – the
documents submitted by the Participants to the Foundation describing the
technical and business aspects of the proposed program
“Proposer” – as
defined in the preamble
3
“Repayment” – the
grant repayment due by the Proposer to the Foundation in the event of the
successful completion of the development work and Repayments will be made upon
the successful completion of the project and not as a percentage of future
sales. Successful completion is broadly defined as reaching the phase defined
(in the BIRD CPFA) as the project’s goal; or licensing the technology (or
selling it outright) to a third party and from proceeds derived from the
outright sale of any portion of the Product to a third party or the licensing of
any portion of the Product to a third party
“Repayment Base Index”
– the Index last published prior to the date on which a Repayment is received by
the Foundation from Proposer
“Termination of Product
Development” – the conclusion of the development of the Product pursuant
to and in accordance with the Proposal, including the Product being ready for
commercialization
“Termination of this
Agreement” – termination deriving from the payment by the Proposer of any
and all of its obligations pursuant to Section B, termination resulting from
revocation by the
Foundation of the Agreement, or termination of the Agreement by the Proposer
with the consent of the Foundation, the effective date in each instance being
the earlier of notice from the Foundation that the examination contemplated by
Section K.3. has been completed, or the expiration of one (1) year after the
specific termination event as aforesaid.
“Total Indexed Grant”
– the result of multiplying the total of the Indexed Payments by the appropriate
percentage level from the table shown in Section B.3.1
“Total Indexed
Repayments” – the total of the Indexed Repayments.
B.
|
PROJECT
FINANCING
|
B.1.
|
The
Foundation hereby agrees to fund, by Conditional Grant, the implementation
of the Proposal in the maximum sum of $950,000 or 50% of the actual
expenditures on the Project, as contemplated in the Approved Project
Budget, whichever is less, and at the times and as may otherwise be set
forth in Annex B hereto.
|
B.2.
|
The
Proposer shall provide in timely fashion all
budgetary funds in excess of those provided hereunder by the
Foundation.
|
B.3.
|
Proposer
shall make Repayments to the Foundation in the event of the successful
completion of the development work. Such Repayments shall be based on the
conditions as set out in Section B.3.1., Section B.5. and Section
B.6.
|
B.3.1.
|
The
Repayments by the Proposer shall
be made on the following basis upon the successful completion of the
development work being carried out by Proposer, the Conditional Grant
provided by the Foundation shall be repayable in accordance with
Sub Section B.3.1a. unless the provisions of Section B.5 or Section B.6.
apply, in which event repayment stall be made pursuant to either or
both of those Sections,
applicable.
|
4
a)
|
Upon
the successful completion of the development work, the Conditional Grant
and Other Sums provided to the Proposer by the Foundation shall be repayable by the
Proposer. Such repayment will be due within 12 months following the
Project completion (i.e. since the Project duration is for a period of 24
months, repayment will be due by no later than 36 months from the
effective date stated in Section O) in an amount equal to the total grant
paid to Proposer linked to the U.S. Consumer Price Index. Should the
Proposer request the Foundation to extend the due date of the repayment
for up to 12 months, the Proposer will then repay to the Foundation on
this new due date 113% of the total Conditional Grant paid linked to the
U.S. Consumer Price Index, and so on, pursuant to the
timeframe and the maximum percentages set forth in the table set out in
Section B.3.1.b., and to the extent of the monetary obligation described
in Section B.3.
|
|
Maximum Percentage of
|
||||
Years Following Original
|
Conditional Grant to be
|
||||
Date of Termination of
|
Repaid (indexed according to
|
||||
Project Development
|
Annex C of this Agreement)
|
||||
1 | 100 | % | |||
2
|
113 | % | |||
3
|
125 | % | |||
4
|
138 | % | |||
5
or more
|
150 | % |
B.4.
|
All
Repayments due the Foundation shall be calculated on a semi-annual
calendar basis, and statements, certified by each Participant’s chief
financial officer (or other senior financial officer acceptable to the
Foundation), rendered with payment in and within 90 calendar days
following the end of each semi-annual period. Repayments to the Foundation
shall commence at the end of the semi-annual period during which the first
sale was made. All late Repayments shall bear interest at the Late Payment
Interest Rate.
|
B.5.
|
The
Proposer shall not sell outright to a third party any portion of the
Product without the prior written consent of the
Foundation.
|
B.5.1.
|
The
Proposer shall furnish to the Foundation reasonable prior notice with
respect to any proposed sale as referred to in Section B.5., the notice to
include the name of the prospective purchaser, the price and the other
terms of the proposed sale, and all other relevant information concerning
the proposed sale.
|
B.5.2.
|
The
Foundation shall promptly provide consent to a sale as referred to in
Section B.5, after receipt and review of the notice referred to above,
provided that its rights pursuant to this Agreement are fully guaranteed
to the Foundation’s satisfaction, and that the Foundation is satisfied
that the proposed sale is at a price and upon terms no less than the
actual market value of the portion of the Product. The Foundation shall be
entitled in its sole discretion to designate a representative or
representatives to review the terms of the proposed sale and to seek to
determine the actual market value of the Product, and the Proposer shall
cooperate with, and furnish all pertinent information, to any such
representative or
representatives.
|
5
B.5.3.
|
Should
any portion of the Product be sold outright to a third party by the
Proposer, by either Participant, or by any Affiliate of either
Participant, one-half of all proceeds of the sale shall be applied as
received until there has been full repayment to the Foundation of amounts
due to the Foundation hereunder. If any such sale is (i) in exchange for a
non-cash asset or (ii) part of the sale of a group of assets, and no
separate value is assigned by the parties to the portion of the Product
sold, the Proposer and the Foundation shall seek to agree: as to clause
(i) the value of the asset received; and as to clause (ii) the portion of
the consideration reasonably allocatable to the sale. If no such agreement
is reached within a reasonable time, or if any value assigned by the
parties is in the view of the Foundation not reasonable under all of the
circumstances, the matter shall be resolved pursuant to Section M.4. Payments due and
not made following receipt of proceeds by the Proposer shall bear interest
at the Late Payment Interest Rate.
|
B.5.4.
|
The
Proposer shall provide notice to the Foundation, either prior to, or
immediately after, of any transfer of control of
either Participant as a result of the sale of shares, or a merger or an
amalgamation of either of the Participants with any other
company.
|
B.5.5.
|
In
the case of any transfer of control of a Participant as referred to in
Section B.5.4., if that Participant, or in the case of a merger or
amalgamation if the merged or amalgamated company, terminates the Project
prior to the Termination of Product Development, such event shall be
deemed to constitute an outright sale of the Product to a third party
pursuant to Section B.5.3. notwithstanding any other provision of this
Agreement.
|
B.6.
|
License
agreements involving the Product developed in whole or in part during
this Foundation-supported project shall be subject to Annex
E.
|
C.
|
CONDUCT
OF THE PROJECT
|
C.1.
|
The
Proposer agrees to do the work set out in the Proposal in accordance with
good standards relevant to such undertakings, and shall expend funds
received hereunder only in accordance with such Proposal and the
requirements of this Agreement.
|
C.2.
|
The
Proposer agrees to comply with the Program Plan as set forth in Annex
D.
|
C.3.
|
The
Proposer hereby appoints Xxxxx Xxxx as Israel project manager and Xxxxx
Xxxxxxx as U.S. project manager for the implementation of the project
during the period of this Agreement and in accordance with the Program
Plan.
|
C.4.
|
The
Proposer shall not make substantial transfers of funds from one budget
item to another, change key personnel or their duties and
responsibilities, or diminish their time allocated to the proposed work
hereunder without prior written approval by the Foundation, which approval
shall not be unreasonably with
held.
|
6
C.4.1.
|
Should
any key person be absent from work,
or should such absence be expected, for 90
days or more, or should there be any significant reduction in the total
personnel force assigned the project under the Proposal, the Proposer
shall forthwith notify the
Foundation.
|
D.
|
REPORTING
REQUIREMENTS
|
D.1.
|
The
Proposer shall submit to the Foundation, in writing, the following
reports:
|
a)
|
interim
fiscal and technical reports to be submitted
simultaneously within 30 days following the expiration of the first
6-month period;
|
b)
|
interim
fiscal and technical reports to be submitted simultaneously within 30 days
following the expiration of the second 6-month
period;
|
c)
|
interim
fiscal and technical reports to be submitted simultaneously within 30 days
following the expiration of the third 6-month
period;
|
d)
|
final
fiscal and technical reports to be submitted simultaneously within 60 days
following Termination of Product Development.
|
D.1.1.
|
Any
failure to submit reports in a timely fashion pursuant to Section D.1
shall be deemed a fundamental breach and a breach for cause pursuant to
this Agreement.
|
D.1.2.
|
The
reports to be submitted pursuant to this Section D shall be in form and
substance in accordance with the most recent Formats for Technical and
Fiscal Reports, as shown on the Foundation’s web
site.
|
D.2.
|
Proposer
shall provide to the Foundation at its expense, briefings on the progress
of the work hereunder, within 45 days following any request from time to
time by the Foundation. Such briefings shall be in accordance with such
form and detail as the Foundation may reasonably
request.
|
E.
|
PUBLICATIONS
|
E.1.
|
In
any publication in scientific or technical journals of data or other
information derived from the work hereunder, or any publication related to
the work, but not including product literature or manuals, the support of
the Foundation shall be
acknowledged.
|
E.2.
|
To
the extent so required to permit the Foundation free dissemination of
such publications or information, which the Foundation is privileged to
disseminate, subject to the limitations of Section F, the Proposer shall
be deemed hereby to wave any claim with respect to such dissemination for
infringement of any copyright it may have or may
obtain.
|
E.3.
|
The
Proposer shall furnish to the Foundation two (2) copies of all publications
resulting from Foundation-supported work as soon as possible after
publication.
|
7
F.
|
PROPRIETARY
INFORMATION, INTELLECTUAL PROPERTY
|
F.1.
|
Proprietary
information, clearly identified as such, submitted to the Foundation in
the Proposal, in any report or verbally, or obtained by Foundation
personnel observation pursuant to any request or briefing, shall be
treated by the Foundation as confidential. At the request of Proposer or
either Participant, a confidential disclosure agreement may be entered
into separately by the parties. Nothing contained in the foregoing
shall restrict the right
of the Foundation to make public the
fact of the Foundation’s support for the Project, and the identification
of the Participants therein. The details of any such publication, except
for those permitted by the immediately preceding sentence of this Section
F.1, shall be subject to prior approval by the
Participants.
|
F.2.
|
The
Proposer represents and warrants that, to the best of its knowledge,
information and belief, the Proposer has good, valid and enforceable title
to all of the Intellectual Property necessary for purposes of
implementation of the Proposal, free and clear of all third party
interests, or otherwise possesses adequate rights to use the Intellectual
Property (subject to the fact that no patent may have been obtained). To
the best of the Proposer’s knowledge, information and belief, no
Intellectual Property used or proposed to be used with respect to the
Proposal infringes upon any Intellectual Property rights of others, and
the use of such Intellectual Property with respect to the Proposal does
not constitute an infringement, misappropriation or misuse of any
intellectual property rights of any third
party.
|
G.
|
PATENTS
AND ROYALTIES
|
G.1.
|
If
Proposer or either of the Participants elects to apply for letters patent
on any Product developed in whole or in part from performance of
Foundation-supported activity, such applicant shall, at his own expense,
so apply in the United States and in Israel, and in such other countries
and at such times as the Proposer or either of the Participants may deem
appropriate.
|
H.
|
RIGHTS
OF THE GOVERNMENTS OF ISRAEL AND THE UNITED
STATES
|
H.1.
|
Regardless
of the patent rights acquired by Participants by mutual agreement or
pursuant to Section G.1., the Governments of Israel and of the United
States shall each have a non-exclusive, irrevocable, royalty-free license
to make or have made, to use or have used, and to sell or have sold any
such Product specified, throughout the world for all governmental
purposes: provided, however, that in any contracting situation involving a
Product made under this Agreement, the Government of Israel shall give
preference to the Participant retaining the entire right, title, and
interest in the Product in Israel, and provided that “governmental
purposes” shall not include manufacture of such Product where it is
commercially available at reasonable prices. Notwithstanding the
foregoing, except for military purposes or in emergency situations,
neither the Government of Israel nor the Government of the United States,
nor the Foundation, shall have the right to sell or otherwise dispose of
in any third country any product incorporating the Product or part of the
Product without the prior written permission of the Participant which
has acquired
the entire right and interest in the Product in that third country. Such
Participant shall not withhold permission where appropriate royalties are
paid by the Foundation or government(s)
concerned.
|
8
H.2.
|
In
addition to the patent rights specified In Section H.1. the Foundation
reserves for itself and the Governments of Israel and the United States
the right to use the Product, technical information, data, know-how and
Intellectual Property arising out of, or developed under, this Agreement
for any noncommercial purpose, and without
charge.
|
H.3.
|
In
order that the rights of the Foundation and the Governments of Israel and
the United States described herein shall be exercisable, the Participants
agree that any component, element or other part of the system described as
the Product in the Preamble to this Agreement, whose use is necessary to
the full enjoyment of the Product, will be made available, at reasonable
prices, by the Participants either as a commercially purchasable item, or
by special arrangement, and will be sold to the Foundation and/or the
Government of Israel and/or the Government of the United States, also at
reasonable prices.
|
H.4.
|
Notwithstanding
the foregoing provisions of this Section H., it is understood and agreed
that, so long as any Intellectual Property that comprises part or all of
the Product is marketed by Proposer, by either Participant,
or by others with the rights to market such Intellectual Property, neither
the Government of Israel nor the Government of the United States shall
have the right to obtain a
license to
use such Intellectual Property unless the license fee normally imposed in
the ordinary course of business by either of the Participants or by others
with the rights to market such Intellectual Property is paid, and the
standard license agreement is
executed.
|
I.
|
TERMINATION
OF THE AWARD
|
I.1.
|
The
Foundation may revoke the Conditional Grant, in whole or in part, for cause, as defined
in the laws of the State of New
York.
|
I.2.
|
Upon
receipt of notice of revocation for a default, which constitutes
a cause, the Proposer may cure the default in and within thirty (30)
calendar days after the date of receipt of the
notice.
|
I.3.
|
Notwithstanding
any other provision in this Agreement to the contrary, the Foundation
shall not be obliged to provide any further funding after notice of
revocation until and unless the said default is cured and so demonstrated
to the reasonable satisfaction of the
Foundation.
|
I.4.
|
Should
the Conditional Grant be revoked for reason of cause, in addition to the
Foundation’s rights under Section I.5., the Foundation and the Governments
of Israel and the United States shall continue to be entitled to all of
their rights pursuant to Section H.
|
I.5.
|
If
the Foundation shall revoke the Conditional Grant as aforesaid, all funds
given to Proposer in accordance with Section B.1. shall become due
immediately, without need for demand. Such funds shall be repaid with
interest at the Late Payment Interest Rate from the date of notice of the
revocation.
|
I.6.
|
The
Proposer may not terminate this Agreement or abandon the Project without
the prior written consent of the Foundation, which consent
shall not be unreasonably withheld. The Foundation declares that it will
furnish such a consent if it is satisfied that, despite good faith
efforts, the Proposer has not succeeded in developing the Product, or if
the Product has been developed the Proposer has not succeeded in effecting
any sales or other commercial exploitation of the Product, except in the
cases referred to in Section
B.5.5.
|
9
I.7.
|
If
upon termination of the Project development work for any reason, the
entire budgeted sum has not been expended, the Proposer shall forthwith
return to the Foundation its pro rata share
of such unexpended portion. If not repaid forthwith, such sum shall bear
interest in accordance with Section
I.5.
|
J.
|
SURVIVAL
OF PROVISIONS
|
Notwithstanding
revocation or other termination of this Agreement, the following provisions
shall survive such revocation or other termination of this Agreement: Sections
B., D., E., F., G., H., I.3., I.4., I.5., I.7., K., L., M., N., Annex C and
Annex E if, however, the termination of this Agreement derives from the payment
by the Proposer of all of its obligations to the Foundation pursuant to Section
B, the following provisions only shall survive the termination of this
Agreement: Sections E., F., H., K., L. and M.
K.
|
FINANCIAL
RECORDS
|
K.1.
|
The
Proposer shall maintain business and financial records and books of
account for the work hereunder identifiable within the framework of the
business and financial records
of the Proposer. Such books and records shall be in usual and accepted
form.
|
K.2.
|
Books
and records of the work hereunder shall show Proposer’s contribution. Upon
request by the Foundation, the Proposer shall provide evidence of its
compliance herewith.
|
K.3.
|
The
Foundation may examine, or cause to be examined, the financial books,
vouchers, records and any other documents of the Proposer relating to this
Agreement at reasonable times and
intervals and upon reasonable
notice during the term of this
Agreement.
|
L.
|
SUITS
AGAINST THE FOUNDATION
|
L.1.
|
The
Proposer shall defend all suits brought
against the Foundation, its officers or personnel, indemnify them for all
liabilities and costs and otherwise hold
them harmless on account of any and all claims,
actions, suits, proceedings and the like arising out of, or
connected with or resulting from the performance of this Agreement by the
Proposer, or from the manufacture, sales, distribution or use by the
Proposer of the Product, whether brought by Proposer or its personnel or
by third parties.
|
L.2.
|
The
Proposer agrees that persons employed by it, or otherwise retained by the
Proposer, if connection with the Project, shall be deemed to be solely its own
employees or agents, and that no relationship of employer and
employee or principal and agent shall be created between such employees
or agents and
the Foundation, either for purposes of tort liability,
social benefits, or for any other purpose. The Proposer shall indemnify the
Foundation and hold it harmless from court costs and legal fees, and for
any payment, which the Foundation may be obliged to make as a result of a
cause of action based upon an employee-employer or principal-agent
relationship as aforesaid.
|
10
M.
|
MISCELLANEOUS
CONDITIONS
|
M.1.
|
The
Foundation makes no representation, by virtue of its funding the work
hereunder, or receiving any payments or
royalties as a result of this Agreement, as
to the safety, value or utility of the Product or the work undertaken, nor
shall the fact of participation of the Foundation,
its funding or exercise of its rights hereunder be deemed an endorsement
of the Product or of the Proposer, nor
shall the
name of the Foundation be used for any commercial purpose or be publicized
in any way by the Proposer except within the strict limits of this
Agreement.
|
M.2.
|
The
Proposer may not assign this
Agreement or any of the work
undertaken pursuant to it without the prior written
consent of the Foundation, which consent shall not be unreasonably
withheld.
|
M.3.
|
This
Agreement shall be construed under the laws of the State of New York. The
exclusive forums for the resolution of any dispute
arising from this Agreement shall be the State of Israel or Washington,
D.C. in the U.S., as the moving party may elect. Execution of this
Agreement shall be taken as submission to the forum selected pursuant to
this Section.
|
M.4.
|
Any dispute concerning the
subject matter of this Agreement shall be resolved through arbitration,
unless the Foundation and the other parties to such dispute agree
otherwise, in writing. If the forum is in Israel, the arbitration
will be conducted pursuant to the rules of the Israeli Institute for
Commercial Arbitration. If the forum is in the United States, the
arbitration will be conducted pursuant to the rules of the American
Arbitration Association.
|
M.5.
|
Proposer
undertakes to comply with all applicable laws, rules and regulations of
the State of Israel and the United Stales of America and any applicable
State or Commonwealth, and will apply for and obtain all necessary
licenses and permits for the carrying out of its obligations
hereunder.
|
M.6.
|
Under
Israeli law, no stamp duty is required on BIRD Foundation Cooperation and
Project Funding Agreements.
|
11
M.7.
|
Notices,
communications and reports shall be hand-delivered or mailed by prepaid
first-class mail (airmail if transmitted internationally) addressed
to:
|
|
a.
|
The
Israel-U.S. Binational Industrial Research and Development
Foundation
|
Office
Address:
|
Mailing
Address:
|
|
Kiryat
Atidim, Xxxxxxxx 0
|
|
X.X.
Xxx 00000
|
Xxx
Xxxx 00000
|
Xxx
Xxxx 00000
|
|
Xxxxxx
|
Xxxxxx
|
|
b.
|
BioCancell
Therapeutics Ltd.
|
Office
Address:
|
|
Mailing
Address:
|
0
Xxxxxx Xx
|
8
Hartom St
|
|
Xxxx
Science Center
|
Xxxx
Science Center
|
|
Har
Hotzvim
|
Har
Hotzvim
|
|
Jerusalem
91487
|
Xxxxxxxxx
00000
|
|
Xxxxxx
|
Xxxxxx
|
|
c.
|
Virginia
Biosciences Commercialization Center (VBCC), dba
– Virginia-Israel Biosciences Commercialization
Center
|
Office
Address:
|
Mailing
Address:
|
|
000
Xxxx Xxxxx Xxxxxx
|
000
Xxxx Xxxxx Xxxxxx
|
|
Xxxxxxxx,
XX 00000
|
Xxxxxxxx,
XX 00000
|
|
X.X.X.
|
X.X.X.
|
N.
|
LIMITATION
ON PAYMENTS
|
Notwithstanding
any contrary interpretation of this Agreement or the Annexes hereto, Proposer's
total obligation hereunder for payments to the Foundation shall not exceed the
amount calculated in accordance with the applicable percentage provided in
Sections B.3.1(a) and (b) in equivalent dollars valued at time of repayment as
determined in accordance with Annex C.
12
O.
|
EFFECTIVE
DATE
|
The
effective date of this Agreement shall be the 1st day of January, 2008. The
development work shall commence on the aforementioned date and, unless sooner
terminated by the Foundation in accordance with Section I., the development work
shall terminate 24 months following the effective date.
Signed
the day and date above first given
|
|
Printed
Name:
|
Eltan
Yudilevlon
|
Signature:
|
/s/
Eltan Yudilevlon
|
Title:
|
Executive
Director
|
(for
the BIRD Foundation)
|
|
Printed
Name:
|
/s/Xxx Xxxxx
|
Signature:
|
Xxx
Xxxxx
|
Title
:
|
Chief
Executive Officer
|
(for
BioCancell Therapeutics Ltd.)
|
|
Printed
Name:
|
Xxxxxx
X. Xxxxx
|
Signature:
|
/s/
Xxxxxx X. Xxxxx
|
Title:
|
President
|
(for
Virginia Biosciences Commercialization Center (VBCC), dba – Virginia-Israel
Biosciences Commercialization Center)
13
14
15
16
17
ANNEX
B
PAYMENT
OF CONDITIONAL GRANT
1.
|
First
Payment – On signing –
|
Israeli
Company:
|
$ |
107,128
|
U.S.
Company:
|
$ |
66,293
|
2.
|
Second
Payment –
|
After
receipt and approval of the first interim technical and fiscal reports for the
first 6-month period, or after actual expenditure, on the project have equaled
or exceeded the required expenditures whichever is later.
Required
|
Payment
|
|||||||
Expenditure
|
||||||||
Israeli
Company:
|
$ | 267,819 | $ | 107,128 | ||||
U.S.
Company:
|
$ | 165,745 | $ | 99,447 |
However,
if at the required time of submission of the first interim technical and fiscal
reports, work on the project or expenditures thereon prove to be materially
behind plan, in accordance with Annex D and Annex A, respectively, the
Foundation will review the project with Proposer and determine a suitable course of action
with respect to further payments against the Conditional Grant, if
any.
3.
|
Third
Payment –
|
After
receipt and approval of the second interim technical and fiscal reports for the
second 6-month period, or after actual expenditures on the project have equaled
or exceeded the required expenditure, whichever is later.
Required
|
Payment
|
|||||||
Expenditure
|
||||||||
Israeli
Company:
|
$ | 535,638 | $ | 107,128 | ||||
U.S.
Company:
|
$ | 414,362 | $ | 82,872 |
However,
if at the required time of submission of the second interim technical and fiscal
reports, work on the project or expenditures thereon prove to be materially
behind plan, in accordance with Annex D and Annex A, respectively, the
Foundation will review the project with Proposer and determine a suitable course
of action with respect to further payments against the Conditional Grant, if
any.
18
4.
|
Fourth
Payment –
|
After
receipt and approval of the third interim technical and fiscal reports for the
third 6-month period, or after actual expenditures on the project have equaled
or exceeded the required expenditure, whichever is later.
Required
|
Payment
|
|||||||
Expenditure
|
||||||||
Israeli
Company:
|
$ | 803,457 | $ | 107,128 | ||||
U.S.
Company:
|
$ | 621,542 | $ | 82,872 |
However,
if at the required time of submission of the third interim technical and fiscal
reports, work on the project or expenditures thereon prove to be materially
behind plan, in accordance with Annex D and Annex A, respectively, the
Foundation will review the project with Proposer and determine a suitable course
of action with respect to further payments against the Conditional Grant, if
any.
5.
|
Final
Payment - After receipt and approval of the final technical and fiscal
reports - the balance due Proposer up to the total sum of the Conditional
Grant in accordance with Section
B.1.
|
19
ANNEX
C
LINKAGE
OF CONDITIONAL GRANT REPAYMENTS
The
monies given as a Conditional Grant shall be linked in value, until full
Repayment, to the Index. As each increment of the grant is given, it shall
thereafter be linked to the Grant Base Index. Upon Repayment of any portion of
Proposer's obligations under Section B.3, Section B.5, Section B.6. or Annex
E, such Repayment shall be linked to
the Repayment Base Index.
At any
Calculation Date, Proposer's obligations shall be calculated according to the
following formula:
The Total
Indexed Grant less the Total Indexed Repayments.
20
D.4. Program Plan
(XXXXX)
1Q07 | 1Q08 |
2Q08
|
1Q08 | 1Q09 |
2Q09
|
2Q09 | 3Q09 | 4Q09 | 1Q10 |
2Q10
|
||||||||||||||||||||||||||||||||||
Receipt
of BIRD Grant
|
||||||||||||||||||||||||||||||||||||||||||||
1.
Development of IND
|
||||||||||||||||||||||||||||||||||||||||||||
2.
Protocol development
|
||||||||||||||||||||||||||||||||||||||||||||
3.
Site contract
|
||||||||||||||||||||||||||||||||||||||||||||
4.
Case report forms/ patient consents
|
||||||||||||||||||||||||||||||||||||||||||||
5.
IRB/Helsinki Committee submission
|
||||||||||||||||||||||||||||||||||||||||||||
6.
Site set up
|
||||||||||||||||||||||||||||||||||||||||||||
7.
Per patient enrollment process and fees
|
||||||||||||||||||||||||||||||||||||||||||||
8.
PI and faculty training development
|
||||||||||||||||||||||||||||||||||||||||||||
9.
Site monitoring and coordination
|
||||||||||||||||||||||||||||||||||||||||||||
10.
Site grant administration
|
||||||||||||||||||||||||||||||||||||||||||||
11.
Product manufacture and shipping
|
||||||||||||||||||||||||||||||||||||||||||||
12.
Marketing communications of the trial
|
||||||||||||||||||||||||||||||||||||||||||||
13.
Honoraria, conference materials, attendance
|
||||||||||||||||||||||||||||||||||||||||||||
14.
Data collection, management and analysis
|
||||||||||||||||||||||||||||||||||||||||||||
15.
Summary and report
|
||||||||||||||||||||||||||||||||||||||||||||
Key
|
||||||||||||||||||||||||||||||||||||||||||||
VIBCC
only
|
||||||||||||||||||||||||||||||||||||||||||||
BioCancell
only (assumes CRO fees are here)
|
||||||||||||||||||||||||||||||||||||||||||||
By
both entities concurrently
|
21
ANNEX
E
LICENSE
AGREEMENTS
If
the Product becomes
the subject of any license agreement between Proposer, either Participant, or an
Affiliate of either Participant and a third party, the licensor shall pay to the
Foundation 30% of all payments received by it under such license agreement. Payment under this Annex
E shall be deemed payments against Proposer's obligations under Section B.3. In
no event shall this Annex E be construed as requiring payments of any amount
greater than those indicated in Section B.3.)
22