Contract
CONFIDENTIAL TREATMENT
REQUESTED . Confidential portions of this document have been redacted
and have been separately filed with the Commission.
Exhibit
10.44
Between
YEDA RESEARCH AND
DEVELOPMENT COMPANY LIMITED
a company
duly registered under the laws of Israel
of X.X.
Xxx 00, Xxxxxxx 00000, Xxxxxx (“Yeda”)
and
MOR RESEARCH APPLICATIONS
LTD.
a company
duly registered under the laws of Israel
of 00
Xxxxxxx Xxxxxx., Kiryat Xxxxxxx, X.X. Xxx 0000
Xxxxxx
Xxxxx 00000 (“Mor”)
and
XXXXXXXXXX
LTD.
a company
duly registered under the laws of Gibraltar and
having
its principal place of business at Valmet Nominees
Limited
Xxxxxx 0X & 0X 00
Xxxx Xxxxx Xxxxxxxxx
(the
“Company”)
and
BIOGAL ADVANCED
BIOTECHNOLOGY LTD
A company
duly registered under the laws of the State of
Israel
and having its principal place of business at 0 Xxxxxxxx
Xx. Xxxx
Xxxxx, Xxxxx Xxx, Xxxxxx 00000 (“Biogal Israel”)
WHEREAS:
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A.
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In
the course of conducting research and primary clinical observations,
Xxxxxxxxx Xxxxx Xxxxxxxxx of Xxxxx Medical Center, Hasharon Hospital,
Petach- Tikva (“RMC”) and Xxxxxxxxx
Xxxxxxx Xxxxx-Xxxxx of the department of Immunology of the Weizmann
Institute of Science, Rehovot (the “Institute”), have discovered the
positive effects of the use of recombinant human erythropoietin (“EPO”) as a factor that
may lead to tumor regression in the treatment of myeloma cancer, all as
more particularly described in the patent abstract entitled
“Pharmaceutical Compositions Comprising Erythropoietin for Treatment of
Cancer”, attached hereto as Attachment A, and
forming the basis of certain patent applications submitted in different
jurisdictions and listed in an appendix attached hereto as Attachment B (the “Existing Patent
Applications”, as further defined below). The inventions covered by
the Existing Patents Applications, and all associated discoveries,
products, materials, methods, processes, procedures, techniques, know-how,
data, formulas, clinical and preclinical results (if any), analytical
reference materials, chemical substance and other information shall be
collectively referred to as the “Existing
Technology”.
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B.
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Yeda
and Mor are the joint owners, in accordance with the Ownership Breakdown
(as described in Section 6 below) of the Existing Technology (Yeda and Mor
shall be collectively referred to as the “Licensors”);
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C.
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The
Licensors are interested in entering into an agreement with a party having
an ability and willingness to (i) finance the performance of certain
initial research (“the
Initial Research”) under the leadership of Xxxxxxxxx Xxxxxxx
Xxxxx-Xxxxx (“Xxxx.
Xxxxx-Xxxxx”) and Xxxxxxxxx Xxxxx Xxxxxxxxx (“Xxxx. Xxxxxxxxx”) (Xxxx.
Xxxxx-Xxxxx and Xxxx. Xxxxxxxxx shall be collectively referred to as
“the Chief
Investigators”) as more fully described in the research programs
attached hereto as Attachment Cl for the
Research at the Institute (as defined below) and Attachments C2 for the
Initial Clinical Research (as defined below) (“the Initial Research
Program”) and any further research that will be needed to
accomplish the objectives hereunder (collectively called the “Research”); and to (ii)
pursue clinical studies in order to obtain approval from appropriate
governmental agencies for marketing drugs based upon EPO for the treatment
in human patients of certain types of cancer that are covered by the
license(s) granted to the Company hereunder, as further detailed in
Section 8 herein (the “Product” or “Products”); and (iii) to
the extent to which such rights are covered by an applicable Patent, to
manufacture and market the Products;
and
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D.
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The
Company represents and warrants that it has such ability and wishes to
enter into an agreement as aforesaid with the Licensors, according to
which the Licensors shall grant the Company and the Company shall accept
from the Licensors a worldwide, exclusive license to use the Licensed
Information (as such term is hereinafter defined) for the manufacture,
production, marketing and sale of the Products, all in accordance with,
and subject to, the terms and conditions set forth in this Agreement;
and
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E.
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Yeda
and Mor are willing to procure the performance of the Initial Research,
each with respect to that portion of the Initial Research as is detailed
in Section 2 below, and subject to and in accordance with the terms and
conditions of this Agreement; and
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F.
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By
operation of Israeli law and/or under the terms of employment of Xxxx.
Xxxxx-Xxxxx at the Institute and/or pursuant to an agreement between the
Institute, Yeda and Xxxx. Xxxxx-Xxxxx, all right, title and interest of
Xxxx. Xxxxx-Xxxxx’x or the Institute’s in and to the Licensed Information,
and in any results deriving from the performance of the Research at the
Institute (as defined below in Section 2.2) are and shall be the sole
property of Yeda; and
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G.
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By
operation of Israeli law and/or under the terms of employment of Xxxx.
Xxxxxxxxx, all right, title and interest of Xxxx. Xxxxxxxxx’x in and to
the Licensed Information, and in any results deriving from the performance
of the Initial Clinical Research (as defined below in Section 2.3) are and
shall be the sole property of Mor.
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NOW
THEREFORE IT IS AGREED BETWEEN THE PARTIES HERETO AS FOLLOWS:
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1.
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Preamble,
Appendices and
Interpretation
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1.1
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The
Preamble and Attachments hereto form an integral part of this
Agreement.
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1.2.
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In this Agreement
the terms below shall bear the meanings assigned to them below,
unless the context shall indicate a contrary
intention:
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1.2.1
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“Affiliated Entity” -
shall mean a person, company, corporation, partnership or other entity
(hereinafter collectively (an “Entity”) which directly or indirectly, is
controlled by, or controls, or is under common control with, another
entity. For the purposes of this definition, “control” shall mean the
ability, directly or indirectly, to direct the activities of the relevant
entity and includes without limitation the holding, directly or
indirectly, of 50% (fifty percent) or more of the issued share capital or
of the voting power of the relevant entity or the holding, directly or
indirectly, of a right to appoint 50% (fifty percent) or more of the
directors of such entity;
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1.2.2
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The
“Biogal Group”
shall mean the Company and Biogal
Israel.
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1.2.3
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The
“Effective Date”
shall mean the date of execution of this Agreement and the Founders
Agreement by all of the parties
hereto.
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1.2.4
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An
“Entitling Event”
- shall mean any of the following: (i) the issuance of shares of any class
(including securities convertible to shares) of the Company which grant
the holder(s) thereof 50% or more of the issued and outstanding share
capital of the Company or of any means of control of the Company; or (ii)
a consolidation, merger or reorganization of the Company with or into
another entity, or (iii) a sale or an assignment (other than to an
Affiliated Entity) of all or substantially all of the Company’s assets, or
substantially all of the Company’s issued and outstanding capital stock,
or the granting of an exclusive license in all or substantially all of the
Company’s strategic assets (other than the granting of such license to an
entity within the Biogal Group or an Affiliated Entity thereof) in which
the consideration for the granting of such license is payable in whole or
in part in one or more payments in cash or cash equivalent (provided that
a bona fide transaction with a third party in which the sole consideration
for the granting of such a license shall be royalties based upon future
sales of Products shall not be deemed an “Entitling Event” hereunder). For
the purposes of this definition, references to the Company shall include
any member of the Biogal Group and/or any successor or assign thereof
and/or an Affiliated Entity thereof that is a Sublicensee pursuant to
Section 9 below.
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1.2.5
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“First Commercial Sale”
shall mean the first commercial sale of a Product in any country. For the
purposes of this definition, “commercial sale” shall not include a sale
for an experiment or for test market purposes or for the purposes of use
at a clinical trial.
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1.2.6
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“Founders Agreement”
shall mean the founders agreement executed concurrently with this
Agreement by the founders of the Company, including among others,
Mor.
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1.2.7
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The
“Initial Research
Budget” - shall mean the research budgets, expressed in U.S.
Dollars, attached hereto as Attachment DI for the Research at the
Institute (as defined below) and Attachment D2 for the Initial Clinical
Research (as defined below), as such budgets may be amended, if amended,
by written agreement between the
parties;
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1.2.8
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The
“Initial Research
Period” - shall mean, with respect to the Research at the Institute
(as defined below) the period commencing on the date hereof and ending
thirteen (13) months thereafter, or as extended or shortened by written
agreement of the parties hereto and with respect to the Initial Clinical
Research (as defined below) the period commencing on the date hereto and
ending eighteen (18) month thereafter, or as extended or shortened by
written agreements of the parties
hereto;
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1.2.9
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The
“License” - shall
mean the license granted to the Company by Yeda and Mor pursuant to
Section 8 below;
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1.2.10
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The
“Licensed
Information” - shall mean the Existing Patent Applications, the
Existing Technology and all and any inventions, discoveries, products,
materials, methods, formulas, processes, procedures, techniques, know-how,
trade secrets, data, information and other results whatsoever, which are
discovered or developed in the course of the Research and any development
activities financed or performed by the Company or by any other member of
Biogal Group during the period of the License, and any patent application
filed or issued in respect of the above and any drawings, plans, diagrams,
specification and other documents or files including computer files
containing any of the above.
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1.2.11
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The
“Patents” - shall
mean the Existing Patents Applications and other patent applications or
applications for certificates of invention covering any portion of the
Licensed Information, as well as all continuations, continuations-in-part,
patents of addition, divisions and renewals thereof, and all patents or
certificates of invention which may be granted on any of the foregoing,
and all reissues and extensions
thereof.
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1.2.13
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“Product Approval” -
shall mean an approval given by the U.S. Food and Drug Administration for
the marketing of the Product.
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1.2.14
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“Sublicensee” - shall
mean any permitted sublicensee under the License, in accordance with the
provisions of Section 9.
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1.3
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The
headings in this Agreement are intended solely for convenience or
reference and shall be given no effect in the interpretation of this
Agreement.
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2.
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The
Research
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2.1
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The
Company undertakes to fund and pursue the Initial Research in accordance
with the terms contained herein, and to make its reasonable commercial
efforts to actively pursue the performance of the Research, and to secure
funding for the Research. The parties hereto acknowledge that the
administration of the Company’s research and development activities in
Israel shall be performed by Biogal Israel, as a sublicensee of the
Company, pursuant to the terms and conditions of the Sublicense Agreement
executed concurrently with this Agreement by and between the Company and
Biogal Israel, attached hereto as Attachment E. The
Parties hereto acknowledge that the financing of the Company’s research
and development activities in Israel shall be performed by the Company and
that the Company and Biogal Israel shall be jointly and severally liable
for such financing. The Initial Research shall be performed at the
Institute and certain hospitals and medical institutes as set forth in the
Initial Research Program, and within the framework of the Initial Research
Budget. The Initial Research Budget with regard to the Research at the
Institute shall consist of one thirteen (13) month period and payments for
the performance of the Research at the Institute shall be made in four
installments, as follows (i) for the first nine-month period of the
Initial Research, payment shall be made for each three month period in
advance; and (ii) for the last four month period of the Initial Research,
payment shall be made in one installment in advance. The Initial Research
Budget with regard to the Initial Clinical Research shall consist of one
eighteen (18) month period, and payments for the performance of the
Initial Research Budget shall be made for each three (3) month period in
advance.
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2.2
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Subject
to the terms and conditions hereof, Yeda undertakes to procure the
performance of the laboratory portion of the Initial Research designated
to be performed at the Institute according to the Initial Research Program
(the “Research at the
Institute”), under the supervision of Xxxx. Xxxxx-Xxxxx provided
however that the fact that Xxxx. Xxxxx-Xxxxx shall cease to be available
for the supervision of the performance of the Research at the Institute
shall not constitute a breach of this Agreement by Yeda. In such event,
Yeda shall make its reasonable effort to find from amongst the scientists
of the Institute a replacement scientist acceptable to the Company (such
acceptance to be in writing, and not to be unreasonably withheld) to
continue the supervision of the Research at the Institute, provided
however that Yeda does not undertake to find such a replacement. If no
replacement scientist acceptable to both parties is found within 30
(thirty) days of the date on which Xxxx. Xxxxx-Xxxxx ceases to supervise
the Research at the Institute, the Company shall be entitled, by written
notice to Yeda, to terminate the Research at the Institute, and the
Initial Research Period shall terminate with respect to the Research at
the Institute upon the expiration of 60 (sixty) days from the date of
receipt by Yeda of such written notice. Upon such termination, Yeda shall
be released from any obligation to procure the performance of the Research
at the Institute and the Company shall be released from any obligation to
finance the Research at the Institute with respect to the period following
such termination. The termination of the provisions relating to the
performance and financing of the Research at the Institute shall not
affect the validity of the remaining terms and provisions of this
Agreement, including, without limitation, with respect to the License
granted to the Company pursuant to Section 8 hereto, the Company’s
obligation to pay Compensation pursuant to Section 10 below, and the
continuation of the Initial Clinical Research (as defined in Section 2.3
below). To avoid doubt, in the event that the provisions relating to the
performance and financing of the Research at the Institute have been
terminated as provided herein, the Company shall be entitled to freely
pursue such research as it deems fit outside of the
Institute.
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2.3
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Subject
to the terms and conditions hereof, Mor undertakes to procure the conduct
of the clinical portion of the Initial Research at hospitals or medical
institutes, as set forth in the Initial Research Program (the “Initial Clinical
Research”), and under the supervision of Xxxx. Xxxxxxxxx, provided
however that the fact that Xxxx. Xxxxxxxxx shall cease to be available for
the supervision of the performance of the Initial Clinical Research shall
not constitute a breach of this Agreement by Mor. In such event, Mor shall
attempt to find a replacement scientist acceptable to the Company (such
acceptance to be in writing, and not to be unreasonably withheld) to
continue the supervision of the Initial Clinical Research, provided
however that Mor does not undertake to find such a replacement. If no
replacement scientist acceptable to both parties is found within 30
(thirty) days of the date on which Xxxx. Xxxxxxxxx has ceased to supervise
the Research at the Institute, the Company shall be entitled, by written
notice to Mor, to terminate the Initial Clinical Research, and the Initial
Research Period shall terminate with respect to the Initial Clinical
Research upon the expiration of 60 (sixty) days from the date of receipt
by Mor of such written notice. Upon such termination, Mor shall be
released from any obligation to procure the performance of the Initial
Clinical Research and the Company shall be released from any obligation to
finance the Initial Clinical Research with respect to the period following
such termination. The termination of the provisions relating to the
performance and financing of the Initial Clinical Research shall not
affect the validity of the remaining terms and provisions of this
Agreement, including, without limitation, with respect to the License
granted to the Company pursuant to Section 8 hereto, the Company’s
obligation to pay Compensation pursuant to Section 10 below, the
continuation of the Research at the Institute and the continuation of the
clinical portion of the Research in other medical institutes or hospitals
under the supervision of another
scientist.
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2.4
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The
Company shall make payments to Yeda and Mor in consideration of the
performance of the Research at the Institute and the Initial Clinical
Research in accordance with the Initial Research Budget. All such payments
shall be made in US Dollars at such times and in such amounts as are set
forth in the Initial Research Budget or in the Research Budget (as defined
in Section 2.5. below), as
applicable
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2.5
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It
is agreed that at the request from time to time of the Chief Investigators
or any party hereto, the parties shall consult with a view to considering
the advisability of variations in the Initial Research Program and/or in
the Initial Research Budget. Such variations approved by the parties in
writing shall constitute amendments to the Initial Research Program and/or
in the Initial Research Budget, as applicable. Without limiting the
generality of the foregoing, the parties agree, no fewer than thirty (30)
days prior to the end of the Initial Research Period, to consult in good
faith concerning an extension of the Initial Research Period for a further
one-year period. If, as a result of such consultation, the parties agree
to extend the Initial Research Period, and agree upon a research program
and a budget in respect thereof, the Initial Research Period shall be
extended by such one-year period (the “Extended Research
Period”), and such research program and budget shall be deemed the
“Research program” and the “Research Budget” for such year. This process
shall thereafter be repeated annually for each of the following one-year
periods after the termination of each one-year period of the Extended
Research Period. Nothing herein contained shall be interpreted as imposing
on either party any obligation to agree to any such amendment, extension,
research program or budget.
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2.6
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Charges
in respect of research expenditures made by the Licensors shall be made in
accordance with the procedures then prevailing at the Institute or at Mor,
as applicable, for charging research expenditures to individual projects
of applied research. The Company acknowledges and is aware that the
Institute’s internal regulations and procedures and the internal
regulations and procedures of Mor and its affiliated medical institutions
require that a portion of research funding received from external sources
be allocated to cover overhead expenses, and that amounts to paid to the
Institute and Mor in connection with the Initial Research (and any
subsequent research performed by them) will be subject to such regulations
and procedures, as set forth in the Initial Research
Budget.
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3.
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Reporting
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3.1
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Yeda
shall procure the submission by Xxxx. Xxxxx-Xxxxx to the Company of an
interim written report on the progress and the results deriving from the
Research at the Institute covering each ***** period during the Initial
Research Period and any Extended Research Period thereafter, within *****
of the end of each such ***** period, and of a written report
summarizing the final results of the Research at the Institute within
***** of the end of the Initial Research Period or any Extended Research
Periods thereafter (as applicable). Yeda will notify the Company of any
significant event or results of which it shall become aware (including,
without limitation, any invention) arising out of the Research at the
Institute during the course of any such ***** period. In addition, Yeda
shall submit to the Company, with respect to each ***** period of the
Initial Research Period and any Extended Research Period thereafter, a
separate financial report setting forth the monies received and expended
by it in connection with the Research at the Institute during such *****
period. Each report as aforesaid shall be submitted to the Company not
later than ***** after the end of the period covered by such report. In
the event of a delay exceeding ***** of the submission of any of the
reports mentioned above, the Company shall have the right to postpone the
payments for the Research at the Institute, as set forth in the Initial
Research Budget or in the Research Budget (as applicable), until such
delayed report shall be submitted to the Company in
full.
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* *****Confidential material redacted and filed separately
with the Commission.
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3.2
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Mor
shall procure the submission by Xxxx. Xxxxxxxxx to the Company of an
interim written report on the progress and the results deriving from the
Initial Clinical Research covering each ***** period of the Initial
Research Period and any Extended Research Period thereafter, within *****
of the end of each such ***** period, and of a written report summarizing
the final results of the Initial Clinical Research within ***** of the end
of the Initial Research Period or any Extended Research Period thereafter
(as applicable). Mor will notify the Company of any significant event or
results of which it shall become aware (including, without limitation, any
invention) arising out of the Initial Clinical Research during the course
of any such ***** period. In addition, Mor shall submit to the Company,
with respect to each ***** period of the Initial Research Period and any
Extended Research Period thereafter, a separate financial report setting
forth the monies received and expended by it in connection with the
Initial Clinical Research during such ***** period. Each report as
aforesaid shall be submitted to the Company not later than ***** after the
end of the period covered by such report. In the event of a delay
exceeding ***** of the submission of any of the reports mentioned above,
the Company (or any other company in the Bio-Gal Group) shall have the
right to postpone the payments for the Initial Clinical Research, as set
forth in the Initial Research Budget or in the Research Budget (as
applicable), until such delayed report shall be submitted to the Company
in full.
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4.
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No
Warranties
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4.1
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The
Licensors make no warranties whatsoever as to the Licensed Information,
including, without limitation, regarding the success or results of the
Initial Research, or the scope and validity of the Existing Patent
Applications and/or the Patents (if any) and/or the chances of receiving
approval for Existing Patent Application or future application in any
jurisdiction and/or that the use and exploitation of the Licensed
Information and the exercise of any rights of the License under this
Agreement, including the development of any Product as contemplated
hereunder, will not infringe any third party’s rights and/or with respect
to the technical or commercial feasibility of developing any Product on
the basis of the Licensed Information and/or receiving Product Approval
for any such Product.
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4.2
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Without
derogating from the foregoing, the parties hereto acknowledge that Xxxxxxx
& Xxxxxxx and Xxxxxxx Xxxxxxx currently possess one or more patents
covering the manufacture of EPO (which the Company believes will expire
prior to 2005), and that the production and marketing of the Products may
be dependent, upon securing an arrangement with Xxxxxxx & Xxxxxxx and
Xxxxxxx Xxxxxxx for the purchase and/or production of EPO for
incorporation in the Products.
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5.
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Development
and Commercialization
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5.1
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The
Company will use reasonable efforts to develop, manufacture, produce,
market and sell the Products throughout the world during the term of the
License. For such purpose, and without derogating from the generality of
the foregoing, the Company undertakes to use reasonable efforts to perform
the activities described in the development program attached hereto as
Attachment F, (the “Development Program”, including all additions or
amendments made by written agreement of the parties hereto) with respect
to the development, for the purpose of manufacture and marketing, of the
Products, including the timetable for the completion of the various stages
of such development.
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* *****Confidential material redacted and filed separately
with the Commission.
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5.2
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The
Company shall provide the Licensors with written reports on the progress
and results of the Development Program with respect to each Product. Prior
to the First Commercial Sale of each such Product, such reports shall be
made once every six (6) months. The Company shall notify the Licensors as
soon as practicable of any significant results arising out of the said
Development Program during any six (6) month
period.
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5.3
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For
the removal of doubt, nothing contained in this Agreement shall be
construed as a warranty by the Company that the Development Program to be
carried out by it as aforesaid will achieve its aims and the Company makes
no warranties whatsoever as to any results to be achieved in consequence
of the carrying out of such Development
Program.
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6.
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Title
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6.1
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Subject
only to the License, all right, title and interest in and to the Licensed
Information and in and to the Patents, and all right, title and interest
in and to any drawings, plans, diagrams, specifications, other documents,
models or any other physical matter in any way containing, representing or
embodying any of the Licensed Information, is and shall be the exclusive
property of the Licensors, whose respective rights, title and interest in
the same, as between themselves, shall be divided as follows: ***** (the
“Ownership
Breakdown”).
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For
the avoidance of doubt, the Licensors shall retain exclusive ownership
(according to the Ownership Breakdown) of all right, title and interest in
any and all discoveries, inventions, results, and works of authorship made
during the Research by any person or entity, as well as any modifications,
applications and derivates thereof.
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7.
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Patents;
Patent Infringements
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7.1
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At
the initiative of any party hereto, the parties shall consult with one
another in good faith regarding the filing of patent applications (such
term herein to include any applications for continuations,
continuations-in-part, divisions, patents of addition or renewals) in
respect of any portion of the Licensed Information including, but without
limitation, the jurisdictions in which such applications should be filed,
the timing of the filing of such applications and the contents thereof and
regarding any other applications or filings giving similar statutory
protection to such Licensed Information. Following such consultations, the
Licensors shall, at the Company’s written request, prepare, file and
prosecute patent applications as aforesaid in such jurisdiction or
jurisdictions as shall be specified in the Company’s said request and, in
addition, the Licensors shall make reasonable efforts to prosecute the
Existing Patent Applications and maintain and protect at the applicable
patent office the existing patents, if any, all the above provided that
the Company shall have previously secured, to the satisfaction of the
Licensors, the payment by the Company of the amounts of all costs and fees
involved with such preparation, filing, prosecution, maintenance and
protection. The Parties agree that their joint policy will be to seek a
comprehensive patent protection for all Licensed Information licensed to
the Company hereunder.
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* *****Confidential material redacted and filed separately
with the Commission.
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7.2
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All
applications to be filed by the Licensors in accordance with the
provisions of Section 7.1 above, shall be filed in the name of the
Licensors or, should the law of the relevant jurisdiction so require, in
the name of the inventor and then assigned to the Licensors. As of April
2001, the Company shall bear all costs and fees incurred by the Licensors
in the preparation, filing, prosecution, and the like of all patent
applications filed in accordance with the provisions of Section 7.1 above
and in the maintenance, protection at the appropriate patent office and
the like of all patents issuing therefrom, as well as of the existing
patents, if any, or, if so instructed by the Licensors, shall pay all
costs and fees relating to such patent applications directly to the third
parties to whom they are due, as they come due. The Company agrees to pay
any amounts due to the Licensors or third parties pursuant hereto within
30 (thirty) days of the Licensors’ first written request. Upon request by
the Company, the Licensors shall submit to the Company receipts or other
appropriate documents evidencing such costs and fees. For the avoidance of
doubt, other than amounts already paid by the Company the Licensors shall
not be entitled for reimbursement for out-of-pocket costs and fees
incurred prior to the Effective Date in connection with the Existing
Patent Applications and the existing patents included in the
Patents.
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7.3
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In
the event that, following such consultations between the parties regarding
the filing of patent applications pursuant to Section 7.1 above, the
Company shall not wish to file and/or continue to prosecute a patent
application in relation to any part of the Licensed Information, then the
Licensors may file and/or continue to prosecute such specific patent
application at their own cost and expense. In such event, the License
shall automatically expire with respect to the subject matter of such
patent application (or patent) in the country or countries in which it is
being filed and/or prosecuted, and the Licensors shall be entitled to
freely exploit such patent application and associated portions of the
Licensed Information in such country or countries as they see fit,
including by granting licenses with respect thereto to third parties in
such country or countries. The Company shall be entitled to subsequently
renew the License with respect to any such patent application (or patent)
in any such country or countries, provided that the Licensors have not
granted rights with respect to such patent application or patent to a
third party, by reimbursing the Licensors for the Licensors’ aggregate
out-of-pocket costs and fees (as supported by receipts or other
appropriate documents evidencing such costs and fees) incurred in
connection with the said patent application (in the preparation, filing,
prosecution, maintenance and the like of such application) and in
connection with the patent received as aforesaid as a result of such
application (in the maintenance, protection and the like of such patent),
such costs and fees to be expressed in the currency in which paid by the
Licensors and to be reimbursed by the Company to the Licensors in US
Dollars , as well as interest thereupon for the period from the date of
such payments by the Licensors until the date on which they are
reimbursed, in accordance with the provisions relating to late payments
set forth in Section 14 below. The Company shall bear all additional and
future expenses relating to such patent application or patent, and the
provisions of Section 7.2 shall apply as if the relevant patent
application had been filed in accordance with Section 7.1
above.
|
|
7.4
|
Nothing
herein contained shall be deemed to be a warranty by the Licensors that
they can or will be able to obtain any patent or patents on any Patent
Application or applications relating to the Licensed Information or any
portion thereof, or that the Patents or any patents obtained on any of the
said patent applications, if obtained, are or will be valid or will afford
proper protection.
|
|
7.5
|
(a)
|
Each
party shall promptly notify the other in writing of any alleged
infringement or misappropriation by third parties of the Licensed
Information and provide any information available to that party relating
to such alleged infringement or
misappropriation
|
|
|
(b)
|
Should
the Company (i) determine that a third party is infringing one or more of
the Patents, by manufacturing, using or selling any Product; or (ii) be
sued on the grounds that the manufacture, use or sale of a Product by it
or by a Sublicensee infringes upon the patent rights of a third party,
then the Company shall be entitled to xxx for such infringement or defend
such action (as the case may be), and, to the extent required by the
relevant law, the Licensors shall consent to being named as a party in any
such litigation and shall cooperate with the Company, its attorneys and
its agents, and upon request, provide the Company with the complete copies
of any and all documents or other materials that the Company may
reasonably deem necessary in order to undertake such responsibilities and
shall use its best efforts to cause the Chief Investigators to cooperate
with the Company in prosecuting or defending such litigation, provided
that any expenses or costs incurred in connection with such litigation
(including, without limitation, legal costs and other sums awarded to the
counter party in such action) shall be borne by the Company, who (without
derogating from the provisions of Section 13 below) shall indemnify the
Licensors against any such expenses or
costs.
|
|
(c)
|
In
the event that the Company receives any monetary awards due to action or a
suit, then such monetary awards shall be allocated to defray the costs and
expenses (including reasonable attorneys’ fees) incurred by the Company,
and any remaining balance will be divided as follows:
*****.
|
|
|
(d)
|
Notwithstanding
that stated in subsection (b) above, the Company shall not be entitled to
oblige the Licensors to take any action whatsoever for the protection of
or against infringement of any Patents. In the event that the Company
shall not exercise its right under this Section 7.6, any action of the
Licensors shall be entirely at the Licensors’ discretion, and the costs of
any such action, as well as any costs or other sums awarded to any
counter-party in such action, shall be paid by the Licensors exclusively,
and any recovery in any such action shall be retained exclusively by the
Licensors.
|
* *****Confidential material redacted and filed separately
with the Commission.
|
8.
|
License
|
|
8.1
|
The
Licensors hereby grants to the Company and the Company hereby accepts from
the Licensors, an exclusive worldwide license under the Patents and the
Licensed Information for the development, use, marketing, distribution and
sale of the Products, and, to the extent to which such rights are covered
by an applicable Patent, to manufacture the Products (“the License”), all
for such period, for such consideration and upon such terms and conditions
as are set forth in this Agreement. The License granted herein, and the
use of the terms “Product” or “Products” in connection therewith, shall
apply to the treatment in human patients of myeloma, and to any other
additional cancer indications within the scope of the Patents and the
Licensed Information with respect to which the Company has submitted to
the Licensors a satisfactory detailed research and development plan
including a timetable and budget substantially similar to Attachments C
and D hereto (each an “Additional Indication”). The term of the License
with respect to such Additional Indication shall commence upon the
confirmation by the Licensors that an appropriate research and development
program has been submitted by the Company and extend for the period set
forth in Section 8.2 below and all undertakings, obligations, liabilities
and responsibilities hereunder shall apply also to such Additional
Indication (myeloma and any Additional Indication shall be referred to
hereunder as an “Indication”). For the avoidance of any doubt, the
Licensors shall be entitled to freely grant licenses to third parties
under the Patents and the Licensed Information relating to the treatment
of any medical indication that is not an
Indication.
|
|
8.2
|
The
License shall remain in force with respect to any of the Products for each
particular Indication in any country (if not previously terminated
according to the provisions of this Agreement) as
follows:
|
|
8.2.1
|
In
a country where a Patent or Patents has been issued relating to such
Product, until the latter of (i) the date of expiry of the Patent (or the
last of the Patents) covering such Product in such country or (ii) the
fifteenth (15th) anniversary of the date of the First Commercial Sale by
the Company (or a Sublicensee) in such
country;
|
|
8.2.2
|
In
any other country, upon the fifteenth (15th) anniversary of the date of
the First Commercial Sale (with respect to such Indication) by the Company
(or a Sublicensee) in such country.
|
|
8.2.3
|
The
Company shall promptly notify the Licensors in writing upon the occurrence
of a First Commercial Sale for any given Product, specifying the date, the
country in which such sale took place and the type of Product
sold.
|
|
9.
|
Sublicense
|
|
9.1
|
A
sublicense to all or any portion of the rights granted under the License
(a “Sublicense”)
may be granted by the Company only if: (1) the proposed sublicense is for
monetary consideration or its equivalent (ii) the proposed sublicense is
to be granted in a bona fide arms-length commercial transaction,
including, for the avoidance of doubt, a bona fide subcontracting
agreement for the manufacture of a Product by a third party on the
Company’s behalf (to the extent that the Company has received a license to
manufacture such Product from the Licensors) , and (iii) the proposed
sublicense is made by written agreement, whose provisions are consistent
with the terms of the License and contain, inter alia, the following terms
and conditions:
|
|
9.1.1
|
The
Sublicense shall expire automatically on the termination of the License
for any reason;
|
|
9.1.2
|
The
Sublicensee shall undertake in writing to the Licensors to be bound by
provisions substantially similar to those contained in Sections 11 and 13
below;
|
|
9.1.3
|
Such
terms necessary to enable performance by the Company of its obligations
hereunder;
|
|
9.1.4
|
Any
act or omission by the Sublicensee which would have constituted a breach
of this Agreement by the Company had it been committed (or failed to be
performed) by the Company, shall constitute a breach of the sublicense
agreement with the Company entitling the Company to terminate the
sublicense.
|
|
9.1.5
|
The
sublicense shall not be assignable, transferable or subject to further
sublicensing without the express prior written consent of the
Licensors;
|
|
9.2
|
Sublicenses
under the License may be granted by the Company to Affiliated Entities of
the Company, provided that, in addition to the terms and conditions listed
in Sections 9.1.1. to 9.1.5 above, the sublicense agreement shall
stipulate that the sublicense shall automatically expire in the event that
the Sublicensee ceases to be an Affiliated Entity of the
Company;
|
|
9.3
|
A
copy of the proposed agreement granting a sublicense pursuant to Sections
9.1 or 9.2 above
shall be submitted to each of the Licensors for review at least twenty-one
(21) days prior to its execution, and an executed copy shall be provided
to each of the Licensors promptly upon execution
thereof.
|
|
9.4
|
The
Company hereby undertakes to promptly inform the Licensors upon receipt of
knowledge by the Company of any breach of the sublicense agreement by a
Sublicensee, and, if so requested by the Licensors, to exercise the
Company’s right of termination under said agreement with the
Sublicensee.
|
|
10.
|
Consideration
|
|
10.1.1
|
The
Company shall pay to Yeda a license grant fee of ***** (the “License Grant
Fee”).
|
* *****Confidential material redacted and filed separately
with the Commission.
|
10.1.2.
|
The
License Grant Fee shall be payable in four installments, the first of
which shall be in the amount of *****, due and payable upon completion of
three months from the Effective Date; the second of which shall be in the
amount of *****, due and payable upon completion of four months from the
Effective Date; the third of which shall be in the amount of *****, due
and payable upon the completion of eight months from the Effective Date;
and the fourth of which shall be in the amount of *****, due and payable
upon the completion of twelve (12) months from the Effective Date. The
first and second installments (in the total amount of ***** shall be
payable regardless of the prior termination of this agreement for any
reason whatsoever, however the payment of the third and fourth
installments shall not apply in the event that this Agreement has been
terminated in accordance with the terms and conditions of this Agreement
prior to the date upon which such payment is due. All payments of the
License Grant Fee hereunder shall be made in US
dollars.
|
|
10.2
|
Annual
License Fees.
|
|
10.2.1
|
In
addition to the License Grant Fee, the Company shall pay to Yeda an annual
license fee of ***** per year (“Annual License Fee”),
subject to the terms and conditions set out in this Section 10.2 and
Section 14 below.
|
|
10.2.2
|
The
initial payment of Annual License Fees shall be due and payable upon the
first anniversary of the Effective
Date.
|
|
10.2.3
|
Subsequent
Annual License Fees shall be payable on each anniversary of the Effective
Date thereafter, for the duration of the period in which the License is in
effect.
|
|
10.2.4
|
Upon
receipt of Product Approval, during the term of the License, the Annual
License Fees shall be increased to ***** per
year.
|
|
10.3
|
Payment Upon Approval
of Patents. In addition, the Company shall pay to Yeda a one-time
payment of ***** upon the later of (i) the first anniversary of the
Effective Date or (ii) within fourteen (14) days of issuance or
registration of the first Patent registered hereunder. For the removal of
doubt, Yeda shall not be entitled to receive any payment upon the approval
of any subsequent Patent.
|
|
10.4
|
Payment upon Product
Approval. In addition, the Company shall pay to Yeda a onetime
payment of *****, within fourteen (14) days of receipt of the Product
Approval for the first Product. To remove doubt, Yeda shall be entitled to
payment under this Section 10.4 once, for the first Product to receive
Product Approval only.
|
|
10.5
|
Payment upon an
Entitling Event. In addition, within fourteen (14) days of receipt
of the proceeds from an Entitling Event, Yeda shall be entitled to receive
from the Company an/or other member(s) of the Biogal Group and/or
its/their shareholders (as the case may be) *****. Notwithstanding the
aforesaid, if the consideration paid in the Entitling Event is in the form
of securities of a third party, Yeda will be entitled to receive such
number of the same type of securities being offered in the Entitling Event
having equal value to the cash consideration to which Yeda is entitled
hereunder for such Entitling Event. In the event that the consideration
received in the context of an Entitling Event is payable in installments,
Yeda shall be entitled to receive payments from each installment paid in
accordance with the provisions of this Section 10.5, until its entitlement
to payment hereunder has been fully
satisfied.
|
* *****Confidential material redacted and filed separately
with the Commission.
|
10.6
|
Acknowledgement by
Mor. Mor acknowledges and confirms that it has been issued an
equity interest in the Company in consideration of the granting of the
License, and accordingly, shall not be entitled to any additional fee or
payment for the granting of the License. The foregoing shall not derogate
in any manner from Mor’s entitlement to receive funds hereunder in
connection with the Initial Research (or in connection with any further
Research or services it may provide to a member of the Biogal
Group).
|
|
11.
|
Confidentiality
|
|
11.1
|
Each
member of the Biogal Group shall maintain in confidence of all
confidential information relating to the Research and all technical,
medical, financial or other information or data relating to the Licensed
Information, or to any patent applications included in the Patents, except
and to the extent that :(a) any such information or data is in the public
domain at the date of the signing hereof or becomes part of the public
domain thereafter (other than through a violation by the Company or a
Sublicensee of this obligation of confidentiality); or (b) such
confidential information (or any portion thereof) that is expressly
released by the Licensors from this obligation of confidentiality by
notice in writing to the Company to such effect; or (c) the Licensed
Information was received by the Company from a third party legally
entitled to disclose it without breach of a confidentiality undertaking to
Yeda. Notwithstanding the foregoing, the Company may disclose to its
personnel and other third parties (including Sublicensees) the Licensed
Information to the extent necessary for the exercise by it of its rights
hereunder or in the fulfillment of its obligations hereunder, provided
that such personnel and other third parties shall be subject to written
confidentiality undertakings no less strict than those contained
herein.
|
|
11.2
|
The
Licensors shall maintain in confidence of all information and data
received from the Company and explicitly identified in writing as
confidential, except and to the extent that: (a) any such information or
data is in the public domain at the date of the signing hereof or becomes
part of the public domain thereafter (other than through a violation by
the Licensors of this obligation of confidentiality); or (b) any such
information or data is expressly released by the Company from this
obligation of confidentiality by notice in writing to the Licensors to
such effect; or (c) the information was rightfully received by the
Licensors from a third party without any restrictions on disclosure or
use. Notwithstanding the foregoing, the Licensors may disclose to its
personnel any such confidential information or data to the extent
necessary for the exercise by it of its rights hereunder or in the
fulfillment of its obligations hereunder, provided that such personnel
shall be subject to written confidentiality undertakings no less strict
than those contained herein.
|
|
11.3
|
In
addition to and without derogating from the foregoing, the Company
undertakes not to make mention of the names of Yeda, Mor, the Institute or
any scientists or other employee thereof in any manner or for any purpose
whatsoever in relation to this Agreement, its subject matter and any
matter arising from this Agreement or otherwise, without the prior written
approval of Yeda or Mor (as applicable) which will not be unreasonably
withheld.
|
|
11.4
|
Notwithstanding
the provisions of Sections 11.1, 11.2 and 11.3 above, the Company shall
not be prevented from mentioning the name of Yeda, Mor, the Institute, or
any hospital or medical institute which was involved in the Research
and/or any scientists or other employees thereof or from disclosing any
information:
|
|
|
(a)
|
If,
and to the extent that such mention or disclosure (i) is to competent
authorities for the purposes of obtaining approval or permission for the
exercise of the License, or is in the fulfillment of any legal duty owed
to any competent authority (including, without limitation, a duty to make
regulatory filings); or (ii) is the fact of the execution of this
Agreement to any third party; or (iii) relates to any information relating
to this Agreement (to the extent necessary and to the extent such
information does not constitute Licensed Information or any other
information that the Company is obliged to maintain in full confidence
pursuant to clause 11.1 above); or
|
|
|
(b)
|
In
the event of (i) a private placement; or (ii) an initial public offering
of shares of the Company; or (iii) a merger or acquisition of the Company,
the Company will be authorized to disclose any information to any
prospective investor or any other relevant party, subject to the written
undertaking of confidentiality addressed to the Company in a form
reasonably acceptable to the Licensors, of such prospective investor or
recipient of such information (and provided that it shall be clearly
indicated any document so provided to such a party, that Yeda has not
reviewed or approved the information so provided);
or
|
|
|
(c)
|
The
Company shall be entitled to mention that the Company is a Licensee of
Yeda and Mor to develop, use, market, manufacture (if applicable), sell
and distribute the Products, in any business presentations, press
interviews, brochures and company profiles, copies of which shall be
provided to the Licensors within a reasonable time of printing,
publication or disclosure thereof.
|
|
11.5
|
The
termination of this Agreement for any reason whatsoever, shall not release
the Company from any of its obligations under this Section 11 and such
obligations shall survive any such
termination.
|
|
11.6
|
Yeda,
the Institute and the scientists of the Institute may publish articles
relating to the Licensed Information in scientific journals or posters or
to give lectures or seminars to third parties relating to the Licensed
Information, or in any other way to publish the Research or the results
thereof, on condition that, to the extent that the information to be
published or disclosed is not in the public domain, a draft copy of the
said contemplated publication or disclosure shall have been furnished to
the Company at least sixty (60) days before the making of any such
publication or disclosure and the Company shall have failed to notify Yeda
in writing, within thirty (30) days from receipt of the said draft
publication or disclosure, of its opposition to the making of the
contemplated publication or disclosure. Should the Company notify Yeda in
writing within thirty (30) days from the receipt of the draft contemplated
publication or disclosure that it opposes the making of such publication
or disclosure because it includes material information (which has been
specified in said notice), in respect of which there are reasonable
grounds, such grounds also to be specified in the said-notice, requiring
the preventing or postponement, as the case may be, of such publication or
disclosure so as not adversely to affect the patentability of the Licensed
Information, then Yeda shall not permit such publication or disclosure
unless there shall first have been filed an appropriate patent application
in respect of the material information to be published or disclosed as
aforesaid, and if this cannot reasonably be undertaken, then Yeda shall
not permit such publication or disclosure unless the material information
specified in the Company’s notice as aforesaid has been deleted therefrom.
The Company acknowledges that it is aware of the importance to the
researchers of publishing their work and, accordingly, the Company will
use its best efforts not to oppose such
publications.
|
|
12.
|
No
Assignment
|
|
|
The
Company may assign, transfer or encumber all or any of its rights or
obligations under this Agreement or arising therefrom, provided it has
received the prior written consent of both of the Licensors, which shall
not be unreasonably withheld. A Licensor opposing such assignment,
transfer or encumbrance of rights, shall provide the Company with a
written explanation of the grounds for its opposition. The Licensors shall
be entitled to condition their consent to an assignment inter alia on the
receipt of written assurances and/or guarantees (including an undertaking
by the Company to guarantee payment of all fees and payments due hereunder
to Yeda).
|
|
|
Notwithstanding
the foregoing, the Company shall be entitled to make an assignment of all
(but not part) of its rights and obligations under this Agreement to an
Affiliated Entity without prior written consent of the Licensors, provided
that: (i) prior written notice of such intended assignment, together with
the copy of the agreement of the proposed assignment shall be submitted to
the Licensors at least 30 (thirty) days before signing; (ii) the terms of
the assignment shall ensure that it shall be consistent with the
provisions of this Agreement and will not derogate in any manner from the
rights of the Licensors hereunder; (iii) the assignment shall expire
automatically if the assignee ceases to be an Affiliated Entity of the
Company; (iv) the Affiliated Entity shall assume all obligations of the
Company under this Agreement without releasing the Company of its
obligations hereunder. Any assignment or attempted assignment contrary to
the provisions hereof shall be null and
void.
|
|
13.
|
Exclusion
of Liability and
Indemnification
|
|
13.1
|
Yeda,
Mor, the Institute, RMC and the directors, officers and employees thereof
(hereinafter collectively “the Indemnitees”) shall
not be liable for any claims, demands, liabilities, costs, losses, damages
or expenses (including legal costs and attorney’s fees) of whatever kind
or nature caused to or suffered by any person or entity (including,
without limitation, to the Company or any Sublicensee) that directly or
indirectly arises out of or result from or are encountered in connection
with this Agreement or the exercise of the License, including, without
limiting the generality of the foregoing, directly or indirectly arising
out of or resulting from or encountered in connection with the
development, manufacture, sale or use of any Product by any member of the
Biogal Group, any Sublicensee or any person acting in the name of or on
behalf of any of the foregoing, or acquiring any of the Products from any
of the foregoing, or directly or indirectly arising out of or resulting
from or encountered in connection with the exploitation or use by any
member of the Biogal Group or any Sublicensee of the Licensed Information
or any part thereof, including, without limitation, of any data or
information given, if given, in accordance with this
Agreement.
|
|
13.2
|
In
the event that any of the Indemnitees should suffer any damages, claim,
demand, liability, loss, cost or expense as aforesaid in Section 13.1, or
shall be requested or obliged to pay to any person or entity any amount
whatsoever as compensation for any damages, demand, claim, liability,
cost, loss or expense as aforesaid, then the Company, the Biogal Group
and/or each of their successors or assigns (each jointly and severally)
shall defend, indemnify and hold harmless such Indemnitees from and
against any and all such damages, claim, demand, liability, cost, loss or
expense (including attorney fees and legal costs) of whatever kind or
nature as aforesaid. Without limiting the generality of the foregoing, the
foregoing indemnification and the exclusion of liability set forth in
Section 13.1 above shall extend to product liability claims and to
damages, claims, demands, liabilities, losses, costs and expenses
attributable to death, personal injury or property damage or to penalties
imposed on account of the violation of any law, regulations or
governmental requirement. Notwithstanding the foregoing, the Company, the
Biogal Group shall have no obligation to indemnify an Indemnitee in the
event and to the extent that any damages, claim, liability, demand, loss,
cost or expense as aforesaid results from the fraudulent misconduct of
such Indemnitee.
|
|
13.3
|
The
Company and Biogal Israel shall each, at its own expense, insure its
liability pursuant to Section 13.2 above during the period beginning on
the date of (i) the commencement of the clinical trials of a Product in
any country or in-vivo research, in the case of Products which are drugs,
or (ii) the first sale by a member of the Biogal Group (whether commercial
or for experimental or test-market purposes) in the case of any other
Product, for the entire period that the License is in force, and for an
additional ***** thereafter. Such insurance shall be in reasonable amounts
and on reasonable terms in the circumstances, having regard, in
particular, to the nature of the Products, and shall be subscribed for
from a reputable insurance company. The beneficiaries of such insurance
shall be the Company, Yeda and Mor. The policy or policies so issued shall
include a “cross-liability” provision pursuant to which the insurance is
deemed to be separate insurance for each insured party (without right of
subrogation as against any of the insured under the policy, or any of
their representatives, employees, officers, directors or anyone in their
name) and shall further provide that the insurer will be obliged to notify
each insured in writing at least 60 days in advance of the expiry or
cancellation of the policy or policies. The Company hereby undertakes to
comply with all obligations imposed upon it under such policy or policies
and in particular, without limiting the generality of the foregoing, to
pay in full all premiums and other payments for which it is liable
pursuant to such policy or policies. The Company shall be obliged to
submit to the Licensors, upon issuance, copies of the aforesaid insurance
policy or policies.
|
|
13.4
|
The
provisions of this Section 13 shall survive the termination of this
Agreement for any reason
whatsoever.
|
|
14.
|
Term
and Termination
|
|
14.1
|
Term.
Unless previously terminated in accordance with the provisions hereof,
this Agreement shall terminate upon the expiration of the
License.
|
* *****Confidential material redacted and filed separately
with the Commission.
|
14.2
|
Termination
|
|
14.2.1
|
Without
derogating from the parties’ rights hereunder or by law, to any other or
additional remedy or relief, it is agreed that each of the Licensors or
the Company may terminate this Agreement and the License hereunder by
serving a written notice, effective immediately, on the infringing party
upon the occurrence of:(a) a material breach hereof by the
other (which breach cannot be cured or, if curable, has not been cured by
the party in breach within ***** or, in the case of failure by the Company
to pay any amount due by the Company to Yeda pursuant to or in connection
with this Agreement on or before due date of payment, thirty (30) days
after receipt of a written notice from the other party in respect of such
breach, and in such event this Agreement and the License hereunder shall
be terminated forthwith upon receipt of notice as
aforesaid.
|
|
14.2.2
|
Without
derogating from the provisions of Section 14.2.1 above, each of the
Licensors shall be entitled to cancel this Agreement (including the
License hereunder) with immediate effect, by delivery of a written notice
to such effect to the
Company:
|
|
14.2.2.1
|
If
the Company (or a permitted Sublicensee) shall not within ***** of the
date of expiry of the Initial Research Period have received a Product
Approval and/or commenced the commercial sale or manufacture, of a
Product, or shall cease such manufacture or sale for a period of more than
twelve (12) months, provided however, that such period shall be extended
if the cessation of the manufacture or sale results solely from an act or
omission of a third party, which the Company cannot remedy or repair by
other means, and of which the Company has informed the Licensors in
writing not less than three months from its occurrence or non-occurrence
(the “Preventing Event”), for as long as the Preventing Event exists, but
not to extend more than twenty-four (24)
months.
|
|
14.2.2.2
|
If
the Company shall not have received additional funding for the continued
development of the Products of at least ***** of the Effective Date, at
least ***** of which shall be allocated to research and development
activities of the Company.
|
|
14.2.2.3
|
Upon
the filing of a petition in bankruptcy, liquidation, insolvency,
reorganization or receivership that is not dismissed within sixty (60)
days of the date on which it is filed against or by the Company and/or
Biogal Israel and/or an Affiliated Entity Sublicensee thereof, or if any
of the foregoing shall be subject to an arrangement with creditors,
whether by law or agreement, or shall otherwise becoming
insolvent.
|
* *****Confidential material redacted and filed separately
with the Commission.
|
14.2.2.4
|
Upon
the assignment or transfer of this Agreement or any rights or obligations
hereunder by the Company and/or Biogal Israel and/or an Affiliated Entity
Sublicensee thereof in contravention of the provisions of this
Agreement.
|
|
14.2.2.5
|
Upon
termination of the Founders Agreement for any reason, or upon the
occurrence of an event which would entitle either Licensor to terminate
the Founders Agreement.
|
|
14.2.3
|
For
the purposes of this Section 14.2, a notice of termination of this
Agreement sent by either Yeda or Mor to the Company shall be deemed in all
circumstances to have been jointly issued by both of the
Licensors.
|
|
14.3
|
The
Company shall be entitled, on the giving to the Licensors of one hundred
and twenty (120) days prior written notice to such effect, to terminate
this Agreement, in the event that the Company considers that for
scientific, medical, or commercial reasons, the development of any Product
is not feasible, provided that: (1) such termination shall not take effect
prior to the termination of the Initial Research Period, provided however,
that the Company may terminate this Agreement for sufficient scientific,
medical or commercial grounds upon the completion of a period of *****
from the Effective Date, with three (3) months prior written notice to the
Licensors, if no Product is being marketed, distributed or sold at such
time and (ii) the Company shall continue, after termination of this
Agreement in accordance with the foregoing, to be liable for all expenses
and costs incurred by the Licensors prior to the termination of the
Agreement, in respect of the Initial Research Program or the Research
Program within the scope of the Initial Research Budget or the Research
Budget (or any mutually agreed upon extension thereof) which Yeda or Mor
is not entitled to cancel (pursuant to law or contract) and all costs and
expenses incurred by either of the Licensors, prior the termination of
this Agreement in connection with the Patents pursuant to Section 7.1
above. The provisions of Section 14.3(ii) shall survive termination of
this Agreement.
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14.4
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Upon
the termination of this Agreement for whatever reason, all of the
Company’s rights hereunder in and to the Licensed Information shall revert
to the Licensors and the Company or other members of Biogal Group shall
not be entitled to make any further use of the Licensed Information and
the Company and other members of the Biogal Group shall deliver to the
Licensors all drawings, plans, diagrams, specifications, other
documentation, models or any other physical matter in their possession in
any way containing, representing or embodying the Licensed Information.
Notwithstanding the foregoing, the Company may retain copies of all such
documentation relating to any development and other work performed by the
Company in connection with the Products provided that: (i) such
documentation may be used by the Company for the sole purpose of defending
itself in any future claims relating to the exercise by the Company (prior
to termination) of its rights hereunder; (ii) the Company shall otherwise
maintain such documentation in strict confidence as long as the obligation
of confidentiality under Section 11 shall continue to apply thereto; and
(iii) the retention of such documentation shall in no way be deemed to
establish any right to the further exercise of the License or of the
Licensed Information.
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* *****Confidential material redacted and filed separately
with the Commission.
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14.5
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The
termination of this Agreement for any reason shall not relieve the parties
of any obligations, which shall have accrued prior to such
termination.
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15.
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Late
Payments
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Any
amount payable hereunder by one of the parties to another, that has not
been paid by its due date of payment shall bear interest from its due date
of payment until the date of actual payment, at the average LIBOR rate for
Dollar deposits for a period of 3 (three) months prevailing from time to
time during the period of arrears, *****.
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16.
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Notices.
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|
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Any
notice to be given pursuant to or in connection with this Agreement shall
be given, in writing, by facsimile or by prepaid registered mail, to the
following address (or such other address in Israel as a party may from
time to time notify the other parties hereto in writing shall serve as its
address for this purpose):
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For Yeda:
To the address set forth in the Preamble,
Fax: 00-0000000.
For Mor:
To the address set forth in the Preamble.
Fax: 00-0000000
For the
Company and/or Biogal Israel:
and shall
be deemed to be received by such party: (a) if sent by courier, upon receipt;
(b) if sent by facsimile, on the first business day after the date of
transmission or (c) if by registered letter (or nearest equivalent), four (4)
days after the time at which it was posted.
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17.
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Guarantee.
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The
Company hereby undertakes to serve as guarantor for the full and timely
performance by the Company and/or Biogal Israel of all of its/their
obligations hereunder, including without limitation, the full and prompt
payment of all fees and payments (including license fees and payments,
payment of the Research Budget and the reimbursement of costs and
expenses) due to Yeda and Mor under this
Agreement.
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* *****Confidential material redacted and filed separately
with the Commission.
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18.
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Value
Added Tax.
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Each
party shall reimburse the other party against submission of appropriate
tax invoices, all amounts of Value Added Tax imposed on such other party
in connection with the transactions under this
Agreement.
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19.
|
Miscellaneous.
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|
19.1
|
Entire
Agreement. This Agreement and the Founders Agreement constitutes
the entire agreement between the parties hereto in respect of the subject
matter hereof, and supersedes all prior agreements or understandings
between the parties relating to the subject matter hereof, and this
Agreement may be amended only by a written document signed by both parties
hereto.
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19.2
|
Counterparts.
This Agreement may be signed in any number of counterparts, no one of
which need be signed by more than one party, and all such copies, when
duly executed, shall be considered an original of one and the same
document.
|
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19.3
|
Waiver. No
waiver by any party hereto, whether express or implied, of its rights
under any provision of this Agreement shall constitute a waiver of such
party's rights under such provisions at any other time or a waiver of such
party's rights under any other provision of this Agreement. No failure by
any party hereto to take any action against any breach of this Agreement
or default by another party hereto shall constitute a waiver of the former
party's rights to enforce any provision of this Agreement or to take
action against such breach or default or any subsequent breach or default
by such other party.
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19.4
|
Governing Law;
Venue. This Agreement shall be governed in all respects by the laws
of Israel, and the courts of Israel shall have exclusive jurisdiction over
all disputes arising hereunder
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19.5
|
Independent
Contractors. Nothing contained in this Agreement shall be construed
to place the parties in relationship of partners or parties to a joint
venture or to constitute either party an agent, employee or legal
representative of the other party and neither party shall have power or
authority to act on behalf of the other party or to bind the other party
in any manner whatsoever.
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19.6
|
Severability.
In the event that any provision of this Agreement is held invalid or
unenforceable in any circumstances by a court of competent jurisdiction,
the remainder of this Agreement, and the application of such provision in
any other circumstances, shall not be affected
thereby.
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19.7
|
No Set-Off. All
payments to be made to the Licensors hereunder shall be made free and
clear of and without any deduction for or on account of any set-off,
counterclaim or tax.
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IN
WITNESS WHEREOF the parties hereto have set their signatures as of this 7th day
of January, 2002.
|
YEDA
RESEARCH AND
DEVELOPMENT
COMPANY LTD
|
MOR
RESEARCH APPLICATIONS
LTD.
|
|||
|
By:
|
By:
|
|||
|
Title:
|
Title:
|
|||
|
XXXXXXXXXX
LTD.
|
||||
|
By:
|
||||
|
Title:
|
||||
|
BIOGAL
ADVANCED BIOTECHNOLOGY LTD
|
||||
|
By:
|
||||
|
Title:
|
||||
