Portions of this exhibit have been omitted pursuant to a request
for confidential treatment. The omitted portions, marked by [***],
have been separately filed with the Securities and Exchange
Commission.
RESEARCH AND LICENCE AGREEMENT
YEDA RESEARCH AND DEVELOPMENT COMPANY LIMITED
a company duly registered under the laws of Israel of
P O Box 95, Rehovot 76100, Israel
PROTALIX BIOTHERAPEUTICS LIMITED
a company duly registered under the laws of Israel,
having its principal place of business at 2 Snunit St,
Science Park, POB 455, Carmiel 20100, Israel
(hereinafter, “the Company” )
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(A)
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in the course
of research conducted at the Weizmann Institute of Science (
“the Institute” ), under the supervision of
Professor Anthony H. Futerman of the Department of Biological
Chemistry, Professor Joel L. Sussman of the Department of
Structural Biology and Professor Israel Silman of the Department of
Neurobiology ( “the Scientists” ), the
Scientists together with other scientists of the Institute, all of
the aforementioned persons, collectively “the
Inventors” arrived at an invention entitled [***](
“the Invention” ), being the subject of and more
fully described in PCT patent application number [***] and the
other patent applications listed in Appendix A hereto
[***]( “the Existing Patent Applications” ) and
created and/or generated the know-
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[***]
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Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
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- 2 -
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how and other
information relating to the Invention as described in
Appendix B hereto ( “the Know-How”
); and
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(B)
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the Company is:
(i) interested in the performance of further research at the
Institute under the supervision of the Scientists in the field of
the Invention, as specified in the research program attached
hereto, marked Appendix C ( “the Research
Program” and “the Research” ); and
(ii) willing, subject to and in accordance with the terms and
conditions of this Agreement, to finance the performance of the
Research in accordance with the budget attached hereto and marked
Appendix D ( “the Research Budget” );
and
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(C)
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Yeda is
willing, subject to and in accordance with the terms and conditions
of this Agreement, to procure the performance of the Research at
the Institute as aforesaid; and
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(D)
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by operation of
Israeli law and/or under the terms of employment of the Inventors
at the Institute and pursuant to an agreement between the
Institute, Yeda and the Inventors, all right, title and interest of
the Inventors and/or the Institute in and to the Invention, in any
results deriving from the performance of the Research at the
Institute and in the Existing Patent Applications vests and shall
vest in Yeda; and
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(E)
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subject to and
in accordance with the terms of this Agreement, the Company wishes
to receive, and Yeda is willing to grant to the Company, a
worldwide exclusive licence in respect of the Licensed Information
(as hereinafter defined) and under the Patents (as hereinafter
defined), for the development, manufacture, production, and sale of
enzymatically active mutants of glococerebrosidase and derivatives
therefrom for the treatment of Gaucher disease and/or any other
indication ( “Products” ), all subject to and in
accordance with the terms and conditions of this Agreement below;
and
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(F)
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the Company
declares that on 12 January 2006 the Magneton Committee
(appointed by the General Manager of the Ministry of Industry,
Trade and Employment (“ MITE ”)) approved the
application filed by the Company
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- 3 -
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for the receipt
of government grants within the framework of the Magneton Program
(as hereinafter defined) for the performance of the Research and
for research and development activities by the Company in respect
of the Products, pursuant to a letter dated 15 January 2006
from the manager of the Magneton Program, a copy of which is
annexed hereto as Appendix E (“ the Magneton
Approval ”),
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NOW THEREFORE IT IS AGREED BETWEEN THE PARTIES HERETO AS
FOLLOWS:
1. PREAMBLE, APPENDICES AND INTERPRETATION
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1.1.
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The
Preamble and Appendices 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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“Affiliated Entity”
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—
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shall mean,
with respect to any party hereto, any company, corporation, other
entity or person (hereinafter, collectively,
“entity” ), which directly or indirectly, is
controlled by, or controls, or is under common control with, such
party. For the purposes of this definition,
“control” shall mean the ability, directly or
indirectly, to direct the activities of the relevant entity (save
for an ability flowing solely from the fulfilment of the office of
director or another office) and shall include, without limitation,
the holding, directly or indirectly, of more than 30% (thirty
percent) 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 more than 30% (thirty percent) of the directors of such
entity or of a right to appoint the chief executive officer of such
entity;
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- 4 -
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“Development Program”
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—
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shall mean,
with respect to any Product or Products, a development program
specifying the activities and timetable necessary to develop such
Products to commercialisation, including the performance of steps
required for obtaining regulatory approvals from all relevant
authorities for such Products and/or the sale of such Products
;
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“Exchange Rate”
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—
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shall mean,
with respect to any amount to be calculated, or which is paid or
received in a currency other than US Dollars, the average of the
selling and buying exchange rates of such currency (in respect of
cheques and remittances) and the US Dollar prevailing at Bank
Hapoalim B.M. at the end of business on the date of calculation,
payment or receipt, as the case may be;
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“First
Commercial Sale”
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—
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shall mean,
with respect to any Product in any country, the first commercial
sale of such Product in such country after U.S. Food and Drug
Administration (“ FDA ”) New Drug Approval,
European Medicines Agency (“ EMEA ”) or national
medicinal agency marketing approval or equivalent approval in such
country has been obtained for such Product;
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“Licence”
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—
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shall mean an
exclusive worldwide licence under the Licensed Information and the
Patents, for the development, manufacture, production, use,
marketing, distribution and sale of the Products, subject to the
provisions of clause 7.1 below and the other terms and conditions
of this Agreement;
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“Licensed
Information”
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—
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shall mean:
(i) the Invention; (ii) the Know-How; and (iii) all
and any inventions, products,
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- 5 -
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materials,
compounds, compositions, substances, methods, processes,
techniques, know-how, data, information, discoveries and other
results of whatsoever nature discovered or occurring in the course
of, or arising from, the performance of the Research;
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“Magneton Directive”
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—
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shall mean
Directive 8.6 of the General Manager of MITE dated 22
August 2001 entitled “The Encouragement of Technology
Transfer from Academia to Industry –
Magneton”
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“Magneton Program”
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—
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shall mean the
program for the encouragement of the transfer of generic technology
from academic to commercial bodies administered by MITE, as
described in the Magneton Directive;
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“Net
Sales”
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—
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shall mean the
total amount invoiced by the Company and the total amount invoiced
by each Sublicensee (and, subject to clause 7.4.4.6 below, each
Further Sublicensee (as hereinafter defined)) in connection with
the sale of Products (for the removal of doubt, whether such sales
are made before or after the First Commercial Sale of any Product
in any country); provided that, with respect to sales which are not
at arms-length and/or are not in the ordinary course of business
and/or are not according to then current market conditions for such
a sale, the term “Net Sales” shall mean the
total amount that would have been due in an arms-length sale made
in the ordinary course of business and according to the then
current market conditions for such sale or, in the absence of such
current market conditions, according to market conditions
for
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- 6 -
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sale of
products similar to the Products, in all cases after deduction
of:
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(i)
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sales taxes
(including value added taxes) or customs duties to the extent
applicable to such sale and included in the invoice in respect of
such sale;
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(ii)
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credits or
allowances, if any, actually granted on account of price
adjustments, recalls, rejections or returns of Products previously
sold;
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(iii)
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freight and
insurance charges to the extent such items are applicable to such
sale and are separately itemised on invoices; and
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(iv)
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bad debts (as
determined in accordance with relevant GAAP rules) deriving from
Net Sales in respect of which royalties were paid by the Company
pursuant hereunder;
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and provided
further that, with respect to sales by the Company and/or a
Sublicensee and/or a Further Sublicensee, as applicable, to any
Affiliated Entity of the Company or of such Sublicensee or Further
Sublicensee, as the case may be, the term, “Net
Sales” shall mean the higher of (but for the avoidance of
doubt, not both of): (a) “Net Sales”, as defined above,
with respect to sales which are not at arms-length and/or in the
ordinary course of business and/or according to current market
conditions; and (b) the total amount invoiced by such
Affiliated Entity on resale to an independent third party purchaser
after the
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- 7 -
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deductions
specified in subparagraphs (i) and (ii) above, to the extent
applicable;
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“
OCS ”
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—
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shall mean the
Office of the Chief Scientist at MITE;
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“Patents”
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—
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shall mean:
(i) the Existing Patent Applications and all patents which may
be granted thereon; and (ii) all other patent applications or
applications for certificates of invention covering portions of the
Licensed Information and all patents or certificates of invention
which may be granted thereon; as well as all continuations,
continuations-in-part, patents of addition, divisions, renewals,
reissues and extensions (including any patent term extension) of
any of the aforegoing patents, but excluding: (a) patents that have
been invalidated or cancelled pursuant to the final ( i.e.,
unappealed or unappealable) judgment of a competent court; and
(b) patent applications that have been withdrawn or have
expired, in each case such exclusion to be effective only from the
date of such invalidation, cancellation, withdrawal or expiry, as
the case may be.
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For the
purposes of this Agreement, the term “Patent”
shall also mean a Supplementary Protection Certificate (within the
meaning of such term under Council Regulation (EU) No.
1768/92) or any other similar statutory or supplementary
protection;
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“Research Period”
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—
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shall mean the
[***]period commencing on the date of signature of this Agreement,
as may be extended in accordance with clause 2.1 below;
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[***]
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Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
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- 8 -
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1.2.13.
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“Sublicence” and
“Sublicensee”
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—
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“Sublicence” shall mean any right granted, licence given, or
agreement entered into, by the Company (or, but without derogating
from clause 7.4.4.6 below, a Sublicensee) to or with any other
person or entity, permitting any use of the Licensed Information
and/or the Patents (or any part thereof) for the independent
development and/or manufacture and/or production and/or marketing
and/or distribution and/or sale of Products (whether or not such
grant of rights, licence given or agreement entered into is
described as a sublicence or as an agreement with respect to the
development and/or manufacture and/or production and/or
distribution and/or marketing and/or sale of Products or otherwise)
and the term “Sublicensee” shall be construed
accordingly;
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1.2.14.
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“Sublicensing
Receipts”
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—
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shall mean
consideration, whether monetary or otherwise, received (for the
removal of doubt, whether received before or after the First
Commercial Sale in any country) by the Company for or from the
grant of Sublicences or Further Sublicences and/or pursuant
thereto, or in connection with the grant of an option for a
Sublicence, except for:
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(i)
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amounts
received by the Company which constitute royalties based on sales
of the Products by Sublicensees in respect of which the Company has
paid royalties to Yeda; and
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(ii)
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amounts
received by the Company from a Sublicensee and actually
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- 9 -
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expended by the
Company (as evidenced by invoices, receipts or other appropriate
documentation) in respect of Product-related research and/or
development activities to be performed by the Company for such
Sublicensee after the date of signature of the relevant Sublicence
(or, as the case may be, option for a Sublicence), provided
that:
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(a)
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any such
amounts constitute research and/or development funding only and not
payment for Products nor any other type of grant or
benefit,
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(b)
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such research
and/or development activities are performed pursuant to a defined
research and development program and research and development
budget agreed with the relevant Sublicensee, a copy of which is
provided to Yeda; and
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(c)
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the Company
submits to Yeda a written expense report, confirmed by the
Company’s independent accountant or chief financial officer,
setting out the time and materials utilised, and reasonable
overhead costs and other expenses actually incurred by the Company
in the conduct of the said research and
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- 10 -
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development
activities, which report demonstrates that such amounts have
actually been expended by the Company in the conduct of such
research and/or development activities in accordance with such work
program and budget,
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it being
agreed, for the removal of doubt, that any amounts received by the
Company as aforesaid, but not expended as set out above, shall be
deemed to be Sublicensing Receipts.
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1.2.15.
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the terms:
“Yeda” , “the Company” ,
“the Institute” , “the
Scientist” , “the Inventors” ,
“the Invention” , “the Existing Patent
Applications” , “the Know-How” ,
“ the Magneton Approval" , “ the Magneton
Directive ”, “the Magneton Program”, "
MITE ”, “the Research Program” ,
“the Research” , “the Research
Budget” and “Products”
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—
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shall bear the
definitions assigned to them respectively in the heading or the
preamble hereto, as the case may be.
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1.3. In this
Agreement:
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1.3.1.
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words importing
the singular shall include the plural and vice-versa and
words importing any gender shall include all other genders and
references to persons shall include partnerships, corporations and
unincorporated associations;
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1.3.2.
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any reference
in this Agreement to the term “patent” shall also
include any re-issues, divisions, continuations or extensions
thereof (including measures having equivalent effect);
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- 11 -
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1.3.3.
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any
reference in this Agreement to the term “patent
applications” shall include any provisional patent
applications, PCT, national or regional patent applications,
applications for continuations, continuations-in-part, divisions,
patents of addition or renewals, as well as any other applications
or filings for similar statutory protection;
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1.3.4.
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any
reference in this Agreement to the term “sale” shall
include the sale, lease, rental or other disposal of any Product
with the exception of disposition, without charge, for
demonstration and/or testing purposes; and
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1.3.5.
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“including”
and
“includes” means including, without limiting the
generality of any description preceding such terms.
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2. PERFORMANCE OF THE RESEARCH
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2.1.
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In
consideration of the sums to be paid by the Company to Yeda
pursuant to clause 3.1 below and, subject to the execution of such
payments and to clause 3.2 below, Yeda undertakes, subject to
clause 2.2 below, to procure the performance of the Research at the
Institute under the supervision of the Scientists during the
Research Period. By written agreement of the parties, the Research
Period may be extended by such period and upon such terms and
conditions as the parties shall so agree.
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2.2.
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If
all of the Scientists shall cease to be available for the
supervision of the performance of the Research, such cessation
shall not constitute a breach of this Agreement by Yeda. In the
event that all of the Scientists shall cease to be available as
aforesaid, Yeda shall use its reasonable efforts to find from
amongst the scientists of the Institute a replacement scientist or
scientists acceptable to the Company (such acceptance to be in
writing, and not to be unreasonably withheld), but no undertaking
to find such a replacement is given by Yeda. If all of the
Scientists cease to be available and no acceptable replacement
scientists can be found within 60 (sixty) days of all of the
Scientists becoming unavailable as aforesaid, then the Company
shall be entitled, by written notice to Yeda, to terminate the
Research Period, in which event the Research Period and the
performance of Research hereunder shall cease at the end of a
further period of 60 (sixty) days from the date of receipt by
Yeda of such written notice. In the event of such termination, Yeda
shall be released from any obligation to procure the
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- 12 -
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performance of the Research during
the period after such termination, and the Company shall be
released from any obligation to finance the Research in respect of
the period commencing after such termination, but without affecting
the Licence and all the other terms and conditions of this
Agreement which shall remain in full force and effect (save for
those relating to the performance and financing of the
Research).
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2.3.
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It
is agreed that if the performance of the Research shall involve the
conduct of experiments on and/or using animals, the performance of
the Research and the Research Program shall be subject to the
Israeli Anti-Cruelty Law, 1994 and to the approval of, and any
modifications requested by, the Institutional Animal Care and Use
Committee and the Safety Committee of the Institute, in order to
ensure compliance with the above law. It is agreed that, in view of
the fact that the performance of the Research may involve the
conduct of experiments using human material (such as cells, blood,
tissue, DNA, RNA, lysates, or body fluids) the performance of the
Research and the Research Program shall be subject to the approval
of, and any modifications requested by the Safety Committee of the
Institute and the Institutional Review Board for Human
Experimentation.
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2.4.
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For
the avoidance of doubt, it is agreed that nothing in this Agreement
shall constitute a representation or warranty by Yeda, express or
implied, that any results will be achieved by the Research or that
the Licensed Information or any part thereof or any results
achieved by the Research are or will be commercially exploitable or
of any other value and Yeda furthermore makes no warranties and
representations, express or implied, whatsoever as to the Research,
any results of the Research, the Patents or the Licensed
Information.
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3.1.
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Subject only to clause 3.2 below,
the Company undertakes to pay to Yeda the total amount (in US
Dollars) of the Research Budget (being [***]per year for each year
of the Research Period) in [***] equal [***] instalments, payable
in advance at the beginning of each [***] period during the
Research Period, the first such payment to be made on the date
[***] following the signature of this Agreement. An invoice in
respect of an instalment paid as aforesaid shall be issued by Yeda
promptly after the receipt by Yeda of such instalment. All payments
of the Research Budget shall be made by direct wire transfer to
Yeda’s bank account, the details of which are set out in
clause 17.7
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[***]
|
|
Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
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- 13 -
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below. For the removal of doubt,
nothing contained in this Agreement shall prevent Yeda and/or the
Institute from obtaining further finance for the Research from
other entities (subject to the approval of the OCS should such
approval be required pursuant to the Magneton Program and/or the
Magneton Directive), provided that such other entities are not
granted any rights in respect of the Research and/or the Licensed
Information which prejudice any rights granted to the Company under
the Licence.
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3.2.
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If
funding approved pursuant to the Magneton Program is withheld or
delayed by the OCS solely due to a delay by Yeda in fulfilling its
reporting obligations as required by such Program, then the Company
shall be entitled, by written notice to Yeda, to suspend further
payments to Yeda pursuant to clause 3.1 above until such time as
such reporting obligations are fulfilled by Yeda (and such
suspension shall cease immediately upon the fulfilment by Yeda of
such reporting obligations). In the event of such suspension of
payment, Yeda shall be entitled to discontinue the performance of
the Research and its reporting obligations pursuant to section 4
below until funding recommences.
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4.1.
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Yeda will procure the preparation by
the Scientists of, and shall submit to the Company: (i) during the
time that funding is provided pursuant to the Magneton Program,
interim written reports on the progress of the Research during the
Research Period on a quarterly basis, and, after such time, on a
yearly basis, in both cases within 60 (sixty) days of the end
of the period covered by such report, (ii) a written report
summarising the results of the Research within 60 (sixty) days
of the end of the Research Period; and (iii) reports of any
significant findings in the Research promptly upon such findings
being made.
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4.2.
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Yeda shall submit to the Company
financial reports setting forth the monies received and expended in
connection with the Research on a quarterly basis in accordance
with the requirements of the Magneton Directive. A financial report
as aforesaid shall be submitted to the Company during the Research
Period on a quarterly basis, and, after such time on a yearly
basis, in both cases within 60 (sixty) days after the end of
the period covered by such report. Charges in respect of Research
expenditures shall be made in accordance with the procedures
prevailing at the Institute for charging research expenditures to
individual projects of applied research and in
|
- 14 -
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accordance with the Magneton
Directive and/or the directives of the OCS.
|
Subject only to the Licence, all right, title and interest in and
to the Licensed Information and 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
aforegoing, vest and shall vest in Yeda.
6. PATENTS; PATENT INFRINGEMENTS
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6.1.
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6.1.1.
|
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Subject to clauses 6.3 and 6.4
below, [***]shall prosecute the Existing Patent Applications using
the outside patent counsel retained by [***] for such purpose prior
to the execution of this Agreement, unless otherwise agreed by the
parties in writing, and shall maintain at the applicable patent
office any patents issuing from the Existing Patent Applications.
The Company and Yeda shall consult with one another and cooperate
fully with regard to the prosecution of the Existing Patent
Applications and in maintenance of such patents.
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6.1.2.
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At
the initiative of either party, the parties shall consult with one
another regarding the filing of patent applications in respect of
any portion of the Licensed Information and/or corresponding to the
Existing Patent Applications, including the jurisdictions in which
such applications should be filed, the timing of the filing of such
applications and the contents thereof. Following such
consultations, and subject to clauses 6.3 and 6.4 below, [***]
shall retain outside patent counsel to prepare, file and prosecute
patent applications as aforesaid in such jurisdiction or
jurisdictions as shall be determined by the parties in consultation
as aforesaid. Subject to clauses 6.3 and 6.4 below, [***]shall also
maintain at the applicable patent office any patents granted as a
result of any of the above patent applications. The parties agree
that their joint policy will be to seek comprehensive patent
protection for all Licensed Information licensed to the Company
hereunder. The Company and Yeda shall cooperate fully in the
preparation, filing, prosecution and maintenance of such patent
applications and patents. [***] shall: (i) deliver to [***],
promptly, copies of all documentation prepared in connection with
the maintenance or
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[***]
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Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
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- 15 -
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prosecution of the Existing Patent
Applications; and (ii) procure that [***] receives a copy of
correspondence between [***] and any patent attorney or other
professional or any competent authority (where the Patents may be
filed, maintained or made) all, in each case, relating to the
prosecution and/or maintenance of the Patents.
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6.1.3.
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Without derogating from the
aforegoing, [***] shall, at its expense, take all necessary steps
as commercially feasible in order to obtain, or, at [***] election,
assist [***] to obtain, the extension of each patent referred to in
this clause 6.1 above, or, in the case of a patent in any member
state of the European Union, a Supplementary Protection Certificate
as referred to in clause 1.2.11 above (including the preparation
and filing of applications for such extensions and Supplementary
Protection Certificates), within the period prescribed therefor
under applicable law and, if applicable, take all necessary steps
as commercially feasible in order to obtain “Orphan
Drug” status (within the meaning of such term under the US
Orphan Drug Act or under Council Regulation
(EU) No. 141/2000, as the case may be), or any other form
of protection that affords exclusivity, within the period
prescribed therefor under applicable law. [***] shall notify [***]
promptly in writing and shall provide a copy to [***] of each
marketing authorisation granted in respect of each Product in each
country and, if applicable, of “Orphan Drug” or other
form of protection affording exclusivity granted in respect of a
Product and shall keep [***] informed and shall provide copies to
[***] of all documents regarding all applications, activities
and/or proceedings regarding such extensions and/or any
Supplementary Protection Certificates and/or “Orphan
Drug” or other form of protection affording exclusivity, as
aforesaid.
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6.2.
|
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All
applications to be filed in accordance with the provisions of
clauses 6.1.2 and 6.1.3 above, shall be filed in the name of [***]
or, should the law of the relevant jurisdiction so require, in the
name of the relevant inventors and then assigned to
[***].
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6.3.
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In
the event that, following such consultations between the parties
regarding the filing, prosecuting and/or maintenance (as
applicable) of patent applications and/or patents pursuant to
clauses 6.1.1 and 6.1.2 above, [***]shall not wish to file and/or
continue to prosecute a patent application and/or maintain a patent
in any country in relation to any part of the Licensed Information
(including any of the Existing
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[***]
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Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
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- 16 -
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Patent Applications), then [***], in
its discretion, may elect to file and/or continue to prosecute such
patent application and/or maintain such patent in such country at
its own cost and expense. [***] shall notify [***] in writing of
[***] election to file and/or continue to prosecute such patent
application and/or maintain such patent in such country as
aforesaid, at [***] expense (such notice, “ [***]
” ), and, in the event that [***] shall not, within 30
(thirty) days of receipt of the [***] Notice:
(i) reimburse [***] for all out-of-pocket costs and fees
incurred by [***] until the date of the [***] (the [***] to be
supported by receipts or other appropriate documents evidencing
such costs and fees) in connection with the said patent application
(in the preparation and/or filing and/or prosecution and/or
maintenance of such application) and/or such patent, such costs and
fees to be expressed in the currency in which paid by [***] and to
be reimbursed or paid (as the case may be) by [***] to [***] in US
Dollars in accordance with the Exchange Rate of such currency on
the date of reimbursement or payment; and (ii) undertake in
writing to [***] to bear all additional and future expenses
relating to such patent application and/or patent, then [***] shall
be entitled, at any time after the expiry of the said 30
(thirty) day period after such notice, to terminate the
Licence granted to [***] under this Agreement in respect of such
patent application and/or patent in such country, and to take
whatever action it deems fit (in its sole discretion) with respect
to such patent application and/or patent.
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6.4.
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6.4.1.
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The
Company shall, on the date of signature of this Agreement,
reimburse Yeda the sum of US [***], constituting the costs and fees
paid by Yeda prior to March 14, 2006 in connection with the
Existing Patent Applications, and shall pay to Yeda all additional
amounts incurred, but not as yet paid, by Yeda prior to the date of
signature of this Agreement, within 30 (thirty) days of
Yeda’s first written request.
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6.4.2.
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[***] shall bear and pay all costs
and fees incurred in the preparation, filing, prosecution and the
like of the Existing Patent Applications and of all patent
applications filed in accordance with the provisions of clauses
6.1.2 and 6.1.3 above (including patent applications corresponding
to the Existing Patent Applications), and the maintenance at the
appropriate patent office and the like of all patents issuing from
the Existing Patent Applications and all patent
applications
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[***]
|
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Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
|
- 17 -
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referred to
above, and all costs and fees incurred in undertaking any
activities referred to in clause 6.1.3 above.
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6.4.3.
|
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Unless
otherwise instructed by [***] in writing, [***] shall pay directly
to [***] relevant outside patent counsel amounts payable by [***]
pursuant to this clause 6.4 above or clause 6.3 above.
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(i)
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Should the
Company determine that a third party is infringing one or more of
the Patents, then the Company shall notify Yeda promptly in
writing, giving full particulars thereof and the Company shall,
after first having consulted Yeda, be entitled to sue for such
infringement.
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(ii)
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Yeda may elect,
at its own initiative, to join as a party to such action, or Yeda
may consent to being named as a party to such action (such consent
by Yeda may for the removal of doubt, be conditional upon, inter
alia , the provision by the Company of security, satisfactory
to Yeda, for the payment of the expenses or costs referred to in
subparagraph (a) below).
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(iii)
|
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Yeda shall
cooperate and shall use its reasonable efforts to cause the
Scientists to cooperate with the Company in prosecuting such
litigation.
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The provisions
of paragraphs (i) and (iii) above shall be subject to the
following:
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(a)
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any expenses or
costs or other liabilities incurred in connection with such
litigation (including attorneys’ fees, costs and other sums
awarded to the counterparty in such action) shall be borne by the
Company, which shall indemnify Yeda against any such expenses or
costs or other liabilities, the above without derogating from the
provisions of clause 12 below;
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(b)
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in the event
that Yeda shall be named as a party in any such litigation then
Yeda shall be entitled to select its own legal counsel in such
litigation, at the Company’s expense and, if Yeda elects not
to do so, the selection of the legal counsel representing the
Company and Yeda in such litigation shall be subject to the prior
written approval of
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[***]
|
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Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
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- 18 -
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Yeda, which
approval shall not be withheld unreasonably; and
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(c)
|
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no settlement,
consent order, consent judgment or other voluntary final
disposition of such action may be entered into without the prior
written consent of Yeda.
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(i)
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Should the
Company discover any allegation by a third party that, or be sued
on the grounds that, the manufacture, use or sale of a Product by
it or by a Sublicensee or a Further Sublicensee under any of the
Patents or using the Licensed Information or any portion thereof
infringes upon the patent rights of a third party, then the Company
shall notify Yeda promptly in writing, giving full particulars
thereof, and the Company shall, after first having consulted Yeda,
be entitled to defend such action.
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(ii)
|
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Yeda may elect,
at its own initiative, to join as a party to such
action.
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(iii)
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Yeda shall
cooperate and shall use its reasonable efforts to cause the
Scientists to cooperate with the Company in defending such
litigation.
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(iv)
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If an action is
brought against the Company alleging the invalidity of any of the
Patents, Yeda shall have the right to take over the sole defence of
the action and the Company shall cooperate fully with Yeda in
connection with any such action. In such event, no settlement,
consent order, consent judgment or other voluntary final
disposition of such action may be entered into without the prior
written consent of the Company, which consent shall not be
unreasonably withheld or delayed.
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(v)
|
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All expenses,
costs and/or other liabilities incurred in connection with such
litigation (including attorneys’ fees, costs and other sums
awarded to the counterparty in such action) shall be borne by the
Company.
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(vi)
|
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The provisions
of clause 6.5.1(c) above shall apply, mutatis mutandis
.
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- 19 -
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6.5.3.
|
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Any
recovery in any litigation relating to an infringement as aforesaid
in clauses 6.5.1 and 6.5.2 above shall first be applied to cover
costs and thereafter divided [***]to the Company and [***] to
Yeda.
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6.5.4.
|
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For
the removal of doubt, Yeda shall not itself be obliged to take any
action to sue for any infringement or to defend any action as
referred to in this clause 6.5 above.
|
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6.6.
|
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If
the Company fails to take action to abate any alleged infringement
of a Patent, or to defend any action as aforesaid, within 60
(sixty) days of a request by Yeda to do so (or within a
shorter period, if required to preserve the legal rights of Yeda
under applicable law), then Yeda shall have the right (but not the
obligation) to take such action at its expense and the Company
shall cooperate in such action at the Company’s expense and,
if required under applicable law or contract, consent to be named
as a party to any such action. Yeda shall have full control of such
action and shall have full authority to settle such action on such
terms as Yeda shall determine. Any recovery in any such litigation
shall be for the account of Yeda only.
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6.7.
|
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Each party shall promptly keep the
other informed and provide copies to the other of all documents
regarding all such actions or proceedings instituted by or against
either party as contemplated under any of the provisions of clause
6.5 above.
|
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7.1.
|
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Yeda hereby grants the Licence to
the Company, and the Company hereby accepts the Licence from Yeda,
during the period, for the consideration and subject to the terms
and conditions set out in this Agreement. For the removal of doubt,
no licence is granted hereunder with regard to the Licensed
Information and/or the Patents and/or any portion of any of the
aforegoing, with respect to any exploitation or activities
(including the activities referred to in clause 1.2.5 above)
relating to any product or services, other than
Products).
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7.2.
|
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For
the removal of doubt, nothing contained in this Agreement shall
prevent Yeda or the Institute from using the Licensed Information
and the Patents for academic research or other scholarly purposes,
or from applying for or receiving grants to finance such activities
(provided that such grants do not prejudice the Licence granted
to
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[***]
|
|
Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
|
- 20 -
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the
Company hereunder), or from transferring any materials created in
the course of the performance of the Research financed by the
Company in accordance with the provisions of this Agreement, to
scientists at the Institute or to other scientists at other
institutions for academic research purposes, provided that any such
transfer of materials shall be in accordance with a material
transfer agreement substantially in the form of the specimen
agreement annexed hereto as Appendix F . For the
avoidance of doubt, the materials transferable pursuant to this
clause 7.2 shall not include any derivatives of the human
acid-beta-glucosidase developed and produced by the Company. Should
Yeda obtain rights to any invention or application deriving from
such academic research in connection with the materials transferred
under any such material transfer agreement, as contemplated by such
agreement, Yeda shall immediately grant Protalix a licence (or
sublicence, as the case may be) in respect of such rights upon the
terms of the Licence, mutatis mutandis (subject to any
restrictions upon the rights obtained by Yeda).
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7.3.
|
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7.3.1.
|
|
The
Licence shall remain in force in each of Israel and the United
States of America, with respect to each Product (if not previously
terminated in accordance with the provisions of this Agreement)
until the later of:
|
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7.3.1.1.
|
|
the
date of expiry of the last of any Patent (including, for the
removal of doubt, any patent application, as referred to in the
definition of “Patents” in clause 1.2.11 above) in such
country covering such Product to expire; and
|
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7.3.1.2.
|
|
if
there is any Licensed Information that is identifiable, secret and
of value relating to such Product, the date of expiry of a period
of [***]commencing on the date that FDA, EMEA marketing approval or
equivalent approval is obtained in respect of such Product in such
country, provided that and for so long as such Licensed Information
remains secret and of value.
|
|
7.3.2.
|
|
The
Licence shall remain in force in each country in the world (other
than Israel and the United States of America) with respect to each
Product (if not previously terminated in accordance with the
provisions of this Agreement) until the later of:
|
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[***]
|
|
Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
|
- 21 -
|
7.3.2.1.
|
|
the
date of expiry in such country of the last of any Patent
(including, for the removal of doubt, any patent application, as
referred to in the definition of “Patents” in clause
1.2.11 above) in such country covering such Product to expire;
and
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7.3.2.2.
|
|
if
there is any Licensed Information that is identifiable, secret and
of value relating to such Product, the date of expiry of a period
of [***] commencing on the date that FDA, EMEA marketing approval
or equivalent approval is obtained in respect of such Product in
such country.
|
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For
the purposes of clauses 7.3.1.1 and 7.3.2.1 above and clause 9. 2 (
Royalties) below, a Product shall be deemed to be covered by
a Patent in any country even after the Patent in such country
covering such Product has expired, in the event that, and for so
long as, such Product is protected and/or covered by “Orphan
Drug” status as referred to in clause 6.1.3 above, and/or by
any type of data exclusivity or data protection or by any other
regulations and/or provisions granting similar statutory or
regulatory protection of such Product in such country. The Company
shall notify Yeda in writing immediately upon the obtaining of FDA,
EMEA or equivalent approval in any country, as referred to in
clauses 7.3.1.2 and 7.3.2.2 above, specifying the date thereof, the
country and the type of Product in respect of which such approval
was granted.
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7.4.
|
|
Except as provided in clause 7.5
below, a Sublicence under the Licence may be granted by the Company
only with the prior written consent of Yeda, which shall not be
withheld unreasonably, and Yeda’s response to a request for
consent as aforesaid shall not be delayed unreasonably. The Company
shall only be entitled to request Yeda’s consent
if:
|
|
7.4.1.
|
|
the
proposed Sublicence is for monetary consideration only or other
valuable consideration that can reasonably be assessed in monetary
terms;
|
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|
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7.4.2.
|
|
the
proposed Sublicence is to be granted in a bona fide
arms-length commercial transaction;
|
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|
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7.4.3.
|
|
the
terms of the proposed Sublicence are submitted to Yeda prior to the
signature thereof;
|
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|
|
|
[***]
|
|
Omitted
pursuant to a confidential treatment request. The confidential
portion has been filed separately with the Securities and Exchange
Commission.
|
- 22 -
|
7.4.4.
|
|
the
proposed Sublicence is made by written agreement, the provisions of
which are consistent with the terms of the Licence and contains,
inter alia , the following terms and conditions:
|
|
7.4.4.1.
|
|
the
Sublicence shall expire automatically on the termination of the
Licence for any reason;
|
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|
|
7.4.4.2.
|
|
the
Sublicensee shall be bound by provisions substantially similar to
those in clause 10 below relating to confidentiality binding the
Company (the obligations of the Sublicensee so arising being
addressed also to Yeda directly);
|
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|
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7.4.4.3.
|
|
an
exclusion of liability and indemnification undertaking in the same
form, mutatis mutandis , as the provisions of clause 12
below (the indemnification obligations of the Sublicensee to be
given also in favour of, and shall be actionable by Yeda, the
Institute, any director, officer or employee of Yeda or of the
Institute, or by the Inventors);
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7.4.4.4.
|
|
all
terms necessary to enable performance by the Company of its
obligations hereunder;
|
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|
|
7.4.4.5.
|
|
that the Sublicence shall not be
assignable or otherwise transferable, save as set out in clause
7.4.4.6 below.
|
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7.4.4.6.
|
|
that the Sublicence shall not be
further sublicenseable other than with Yeda’s prior written
consent, w
|
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