EXCLUSIVE LICENSE AGREEMENT
EXHIBIT 10.1(i)
THIS
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT (the “Agreement”) is made in Jerusalem as of this _
day of November 14, 2005 (the “Effective Date”).
BETWEEN:
YISSUM
RESEARCH DEVELOPMENT COMPANY OF THE
HEBREW
UNIVERSITY OF JERUSALEM
(hereinafter
referred to as “Yissum”)
AND
A company incorporated under the laws
of the State of Delaware
(formerly known as DBT
Biopharmaceuticals Inc.)
(hereinafter referred to as
“DBTI”)
AND
BIOCANCELL
THERAPEUTICS LTD.
a company
established under the laws of the State of Israel
formerly
known as DBT Biopharmaceuticals Ltd.)
(hereinafter
referred to as “DBTL”)
(DBTI and
DBTL collectively hereinafter referred to as the “Company”)
WHEREAS Yissum is the owner of
certain rights, title and interest in and to the Licensed Technology (defined
below); and
WHEREAS Yissum and the Company
entered into that certain Exclusive License Agreement dated November 17, 2004
pursuant to which Yissum granted to Company an exclusive worldwide license with
rights to grant sublicenses and sub-sublicenses under the Licensed Technology
(the “Original
Agreement”);
and
WHEREAS Yissum and the Company
wish to amend and restated in full the Original Agreement entered into that
certain Exclusive License, in the form set forth herein.
NOW, THEREFORE, for and in
consideration of the premises and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, Yissum and Company
(hereinafter individually as a “Party”; and collectively as the “Parties”)
expressly agree as follows.
SECTION
1
Recitals and
Definitions
In this
Agreement the following expressions shall have the corresponding meanings,
unless the context otherwise requires:
“Affiliate” shall mean any
corporation, partnership, or other entity that at any time during the term of
this Agreement directly through one or more intermediaries Controls or is
Controlled by or is under common Control with a party to this Agreement, but
only for so long as the relationship exists. A corporation or other entity shall
no longer be an Affiliate when through loss, divestment, dilution or other
reduction of ownership, the requisite Control no longer exists.
“Control” or “Controls” or “Controlled” shall mean: (i) in the
case of a corporation, ownership or control, directly or indirectly, of more
than fifty percent (50%) of the shares of stock entitled to vote for the
election of directors; or (ii) in the case of an entity other than a
corporation, ownership or control, directly or indirectly, of more than fifty
percent (50%) of the assets of such entity.
“First Commercial Sale” means in each country,
the date the Licensed Product is first sold, marketed, or otherwise made
publicly available for sale. Licensed Products that are distributed or used
solely for pre-clinical studies, clinical trials, treatment IND purposes or any
other similar use prior to receiving regulatory approval by the relevant
regulatory authority shall not be considered sold, marketed or made publicly
available for sale and shall not constitute First Commercial Sale
hereunder.
“Licensed Product” shall mean any product
the manufacture, use, sale or importation of which is covered by a Valid
Claim.
“Licensed Technology” shall mean the Patents,
and any technology, trade secrets, methods, processes, know-how, show-how,
formulas, data, information, inventions, improvements, discoveries or results
relating to the Patents, whether patentable or otherwise. Any future patents,
technology, trade secrets, methods, processes, know-how, show-how, formulas,
data, information, inventions, improvements, discoveries or results, relating to
the Patents whether or not patentable, will also be considered as Licensed
Technology.
“Net Sales” shall mean the gross
amount invoiced by Company or Affiliates to third parties, which are not
Sublicensee(s), from sales of Licensed
Products in an arm’s length transaction, less (i) discounts allowed in amounts
customary in the trade for quantity purchases, cash payments, or prompt
payments, to wholesalers and distributors; (ii) sales, tariff duties and/or use
taxes directly imposed and with reference to particular sales, including VAT;
(iii) outbound transportation prepaid or allowed, amounts allowed or credited on
returns, export licenses, import duties, and prepaid freight; (iv) amounts not
actually collected by reason of rejection, return of goods, and retroactive price
reductions; and (iv) Third Party Royalties. No deductions shall be made for
commissions paid to individuals whether they are with independent sales agencies
or regularly employed by Company and on its payroll or for cost of collections.
In the event of sales not made at “arm’s length”, Net Sales shall be calculated
in accordance with arm’s length prices determined by current market conditions.
Yissum will have to establish that sales are not made at arm’s length on the
basis of adequate documentary evidence. Net Sales occur when a Licensed Product
is invoiced. Notwithstanding the immediately preceding sentence, distribution or
sales of Licensed Products by Company to its Affiliates shall not be deemed to
be Net Sales unless such Affiliate is the final end user of such Licensed
Products.
“Patents” shall mean the patents
set forth on Appendix
1 attached hereto, together with any and all registered patents covering
Licensed Technology granted whether in the United States of America or any other
country, including any and all substitutions for and divisions, continuations,
continuations-in-part, provisionals, and non-provisionals, renewals, reissues,
any foreign patent applications and divisionals or national phase applications
which claim priority of any application which issued into one of the patent
applications set forth in Appendix 1.
“Research” shall mean the continued
research regarding the Licensed Technology to be conducted pursuant to the
Research Plan.
“Research Plan” shall mean the
description of the conduct of the Research as attached to this Agreement as
Appendix II.
“Research Results” shall mean the Research,
including any patents, patent applications, information, material, results,
devices and know-how arising therefrom.
“Sublicensee(s)” shall mean any third
party to whom Company has granted a sublicense under the Licensed Technology to
manufacture, develop, distribute and market Licensed Products consistent with
the provisions of this Agreement.
“Sublicensing Revenue” shall mean all cash,
sublicensing fees, running royalties and other consideration paid to Company by
Sublicensee(s) in consideration for the granting of rights to the Licensed
Product and/or Licensed Technology and in connection therewith. Sales of
Licensed Products from Company to Sublicensee(s) shall not be deemed to be
Sublicensing Revenue provided that such Sublicensee(s) is/are not the final end
user of the Licensed Products. Notwithstanding the above, Sublicensing Revenues
shall exclude (a) payments used or reimbursed for research, (b) payments used or
reimbursed for parent costs, and (c) payments received from the issuance of debt
or equity securities of the Company.
“Third Party Royalties” royalties calculated on
any amount invoiced by the Company in connection with the sale of a Licensed
Product and actually paid by the Company to a third party for the right to use
patents or other intellectual property rights of such third party, without which
right of use the Company would not be entitled to develop, manufacture and sell
such Licensed Product; provided that the duty to pay royalties to such third
party has been established at arm’s-length and in good faith and is set out in a
written agreement; and
“Valid Claim” shall mean (i) a claim
of an issued Patents which has not expired and which has not been held revoked,
invalid or unenforceable by decision of a court or other governmental agency of
competent jurisdiction, unappealable or unappealed with the time allowed for
appeal having expired, and which has not been admitted to be invalid through
reissue or disclaimer or otherwise; or (ii) any claim of a pending patent
application covering the Licensed Technology, which was filed in good faith and
which has been prosecuted with due diligence.
SECTION 2
Grant of
License
2.1 Subject
to the terms of this Agreement, Yissum hereby grants to Company an exclusive,
worldwide right and license under the Licensed Technology to develop, have
developed, make, have made, use, manufacture, market, sell, have sold, offer to
sell, commercialize, import, export, sublicense, sub-sublicense and distribute
Licensed Products and/or provide services relating thereto (the “License”).
2.2 Company
shall have the exclusive right to enter into sublicense agreements with respect
to the Licensed Technology. All sublicenses granted by Company hereunder shall
be subject to this Agreement in all respects. Each such sublicense agreement
shall include a requirement that the Sublicensee use its commercially reasonable
efforts to bring the subject matter of the sublicense into commercial use. No
sublicense shall relieve Company of any of its obligations under this Agreement.
Company shall forward to Yissum a complete copy
of each sublicense
agreement (including, without limitation, all amendments and addenda thereto)
granted hereunder within thirty (30) days after execution of such agreement by
the parties thereto. In the event that Company has granted more than one
sublicense, any breach by one Sublicensee will not effect any other
non-breaching Sublicensee(s), such way that the License and the sublicense in
respect of any non-breaching Sublicensee(s) is not effected.
2.3 Notwithstanding
Section 2.1, not later than December 31, 2005 Company shall determine (the
“Determination”): (i) to which of either DBTI or DBTL
the License shall be granted (the “DBT Licensee”), or (ii) which indications or
components of the Licensed Technology shall be granted on an exclusive basis to
DBTI and which shall be granted on an exclusive basis to DBTL. Within ten (10)
days of the Determination, Company shall provide written notice to Yissum of its
determination as aforesaid. Upon the provision of such notice, the License shall
be automatically modified to reflect the Determination and the terms of this
Agreement shall be modified mutatis
mutandis to give effect
thereto.
SECTION
3
Royalties and
Reporting
3.1 In
consideration of the License granted hereunder, Company shall pay royalties to
Yissum in the manner hereinafter provided (the “Royalties”). Company shall pay to
Yissum:
(i) Five
percent (5%) of Net Sales; and
(ii) For
Sublicensing Revenues of up to $30,000,000 per year – Ten Percent (10%);
and
(iii) For
Sublicensing Revenues above $30,000,000 per year – Six and One Half Percent
(6.5%).
3.2 Sixty
(60) days after the end of each 6 month period commencing from the date of the
First Commercial Sale, Company shall furnish Yissum with a bi-annual report
(herein the “Periodic
Report”) detailing the total sales effected
during the reporting period and the total Royalties and Sub-license Revenues due
to Yissum in respect of that period.
3.3 The
Periodic Reports shall state details of Net Sales and Sublicensing Revenues,
including the country in which the sale was made, the number of Licensed
Products, the aggregate Net Sales and Sublicensing Revenues during the period
covered by the report and resulting Royalties due to Yissum for such completed
year.
3.4 On
the date prescribed for the submission of each Periodic Report, Company shall
pay the Royalties and amounts due to Yissum in accordance with the Periodic
Report.
3.5 The
value of each sale shall be computed on the date of sale in US Dollars based on
the rates published in the Wall Street Journal. The Royalties shall be computed
and paid in US dollars. Payment of Value Added Tax (if applicable) shall be
added to each payment in accordance with the statutory rate in force at such
time. In event that Company is prohibited under applicable foreign currency laws
to transact in US Dollars, payment shall be made in New Israeli Shekels
according to the representative rate of exchange prevailing on the date of
payment. Subject to applicable law, Company shall be entitled to withhold and
deduct from any payment made herein to Yissum any and all taxes as required by
law, and such withheld or deducted amount shall be treated as paid over to
Yissum for purposes of this Agreement, unless Yissum provides Company with an
appropriate withholding exemption certificate. Any sum of money due to Yissum
hereunder which is not duly paid shall bear interest from the due date of
payment until the actual date of payment at the maximum rate of default interest
prevailing at Bank Leumi in respect of US dollar lines of credit.
3.6 Company
shall keep full and correct books of accounts in accordance with General
Accepted Accounting Procedures as required by U.S. Accounting Standards enabling
the Royalties to be calculated. Company shall procure that Sublicensee(s), if
any, also keep such books of accounts as aforesaid. Company shall submit to
Yissum a report containing all the particulars mentioned in Section 3.3 above in
respect of each Periodic Report detailing the Royalties and Sublicensing
Revenues due to it in respect of the period covered by the Periodic Report. An
annual report, authorized by a certified public accountant, shall be submitted
not later than sixty (60) days following the end of each calendar
year.
3.7 For
five years following the end of the calendar year to which a Periodic Report
pertain, Yissum may appoint an independent public accountant to examine
Company’s and Sublicensee(s)’ books of accounts and any report or information
relating to the manufacture, marketing, distribution and sale of the Licensed
Products in order to verify the calculation of the Royalties and Sublicensing
Revenue and the accuracy of the information given to Yissum in the aforegoing
reports. Such examination shall be made at Company’s place of business during
ordinary business hours with at least fifteen (15) days prior written notice. If
an error greater than five percent (5%) in the reports of Company will be found,
Company will bear the full cost of the examination. Company shall reasonably
ensure that Yissum is able to exercise its rights pursuant to this section
regarding Sublicensee(s).
SECTION
4
Development;
Commercialization and Research
4.1 Company
undertakes, at its own expense, to use its commercially reasonable efforts to
carry out the development work necessary to develop and commercialize the
Licensed Technology.
4.2 Company
shall provide Yissum with annual reports which shall detail the development
results and other related work effected by Company during the twelve (12) months
prior to the report.
4.3 Company
shall give Yissum written notice of the First Commercial Sale within thirty (30)
days thereof.
4.4 (i) Yissum
shall procure the conduct of the Research at the Laboratory of Xxxx. Xxxxxxx
Xxxxxxxx and under his supervision and in accordance with the Research Plan.
Company undertakes to finance the performance of the Research in accordance with
the budget forming part of the Research Plan.
(ii) Yissum
shall procure that Company be provided with quarterly reports detailing the
results and conclusions of the Research. Yissum shall procure that appropriate
records of the Research are kept in sufficient detail and in good scientific
manner.
(iii) The
initial period of the Research shall be for two years and the parties may agree
to extend this period. Company may cease the financing of the Research upon a
written notice to Yissum of at least 90 days prior to the cessation of
financing. In the event of cessation of financing of the Research, Company shall
reimburse Yissum for: (a) all expenses incurred in relation to the Research
prior to the notice of cessation of the financing of the Research; and (b) all
committed outstanding expenses and obligations payable subsequent to the notice
of cessation of the financing, provided such outstanding expenses and
obligations were incurred prior to the notice of cessation.
SECTION
5
Ownership
All
rights in and to the Licensed Technology shall be owned by Yissum, and Company
shall hold the rights granted pursuant to the License hereunder and make use of
them exclusively in accordance with the terms of this Agreement. The Research
Results resulting from Research conducted in accordance with Section 4.4 shall
be exclusively owned by Yissum, shall form part of the Licensed Technology and
shall be licensed to the Company under the same terms and conditions of this
Agreement.
SECTION
6
Patents
6.1 Company
shall assume full responsibility for and conduct patent prosecution and
maintenance of the Patents and will be responsible for preparing, filing,
prosecuting and maintaining all Patents and shall use patent counsel of its own
choice, subject to the approval of Yissum (such approval not to be unreasonably
withheld), at Company’s own expense. In the time period until the first round of
financing by Company, the decisions regarding preparing, filing, prosecuting and
maintaining all patents will be accepted mutually by Company and Yissum, after
this time period, these decisions will borne only by Company. Company agrees to
pay all costs, incident to the United States and foreign applications, patents
and like protection, including all costs incurred for filing, prosecution,
issuance and maintenance fees as well as any costs incurred in filing
continuations, continuations-in-part, divisional or related applications and any
re-examination or re-issue proceedings. Company shall file and maintain patent
applications corresponding to the Licensed Technology in such countries as
Company in its sole discretion shall select but shall notify and consult with
Yissum as to those countries where it shall not file and maintain patent
applications. Upon the completion of Company’s first round of financing of an
amount of at least $2,500,000 (the “Financing”), Company hereby undertakes to
reimburse Yissum for previous documented expenses and costs incurred by Yissum
up to 2005 relating to the filing, maintenance and prosecution of the Patents
not to exceed $50,000. Company shall pay such reimbursement in eight (8) equal
quarterly installments commencing ninety (90) days from the date of the
Financing.
6.2 Company
agrees to keep Yissum informed of filing and prosecutions pursuant to this
Section 6 including submitting to Yissum copies of all official actions, all
relevant correspondence with the patent attorneys, applications, continuations,
re-examinations, re-issues, divisionals or like proceedings and responses
thereto. Company shall consult with Yissum regarding any abandonment of the
prosecution of patents application within the Patents.
6.3 Each
and every patent application as aforesaid in relation to the Licensed Technology
shall be registered exclusively in the name of Yissum at Company’s sole expense,
and shall be included automatically within the scope of the License granted
pursuant to the terms of this Agreement.
6.4 In
the event that Company decides not to continue prosecution of a Patent
application to issuance or maintain any patent application or patent on
technology within the Patents in a certain jurisdiction, Company shall timely
notify Yissum in writing in order that Yissum may continue said prosecution or
maintenance of such applications at its option and at its own
expense in such jurisdiction. In the event that (i) Company elects not to file
or not to prosecute
or to discontinue or to abandon the filing, prosecution and/or maintenance of
the Patents in certain countries (the “Abandoned Countries”) and (ii) Yissum
decides to do so at its expense, then (iii) Yissum shall notify Company in
writing of its intention to file, prosecute and/or maintain a patent and Company
shall have a ninety (90) day period to decide whether it wishes to bear the
expenses of such actions. In the event the Company shall notify Yissum that it
does not wish to bear the costs of such filing, maintenance and/or prosecution
or in absence of a reply from the Company within the ninety (90) day period, the
License shall no longer be applicable in the Abandoned Countries.
It is
hereby clarified, if Company fails to notify Yissum in a timely manner as
required hereunder, which, for the purpose of this section, shall be the time,
considered reasonably, that would enable Yissum to effectively carry out such
filing, prosecution or maintenance of the Patents, Company shall be considered
in default of this Agreement.
6.5 Company
and its Sublicensee(s) shall xxxx all products covered by Patents with patent
numbers in accordance with the statutory requirements in the country(ies) of
manufacture, use, and sale, and pending the issue of any patents. Company shall
ensure that its Sublicensee(s) comply with the provisions of this
section.
6.6 Company
undertakes to use commercially reasonable efforts at its own expense to protect
against a third party’s infringement of the Patents and forthwith to advise
Yissum upon learning of the infringement. Company shall give Yissum immediate
notice of any approach made to it by a patent examiner and/or attorney in
connection with the subject matter of this Agreement. Company shall reply to
such approaches after consultation with Yissum.
6.7 Company
shall use its commercially reasonable efforts at its own expense to defend any
action, claim or demand made by any entity in connection with rights in the
Patents and/or patents and shall give notice to Yissum immediately upon learning
of any such action, claim or demand as aforesaid. Any assistance that will be
requested by Company from Yissum for the purpose of defending any action, claim
or demand made by any entity in connection with rights in the Patents and/or
patents, will be provided by Yissum without any additional charge to
Company.
6.8 Any
settlement, consent judgment or other voluntary final disposition of any action
pursuant to the provisions of this section, shall not be entered into without
consultation with Yissum and the prior written consent of Yissum which shall not
be reasonably withheld or delayed.
6.9 Subject
to reimbursement of documented reasonable out-of-pocket expenses incurred by
Company in relation to any legal action contemplated under the provisions of
this section, any award in favor of Yissum and/or Company resulting from such
legal action shall be divided by Yissum and the Company pursuant to Section 3.1
as if such award was Sublicensing Revenues. Any recovery of damages by Company
for each such suit shall be applied first in satisfaction of any unreimbursed
documented reasonable expenses and legal fees of Company relating to such
suit.
SECTION
7
Confidentiality
7.1 Licensor
Confidential Information. Company agrees that, without the prior written
consent of Yissum, in each case, during the term of this Agreement, and for
three (3) years thereafter, it will keep confidential, and not disclose or use
Yissum Confidential Information (as defined below) other than for the purposes
of this Agreement or as detailed below. Company shall treat such Yissum
Confidential Information with the same degree of confidentiality as it keeps its
own confidential information, but in all events no less than a reasonable degree
of confidentiality. Company may disclose the Yissum Confidential Information
only to employees, consultants or researchers of Company or of its affiliates
who have a “need to know” such information in order to enable Company to
exercise its rights or fulfill its obligations under this Agreement and provided
such parties are legally bound by agreements which impose confidentiality and
non-use obligations comparable to those set forth in this Agreement. For
purposes of this Agreement. “Yissum Confidential Information” means any
scientific, technical, trade or business information relating to the subject
matter of this Agreement designated as confidential or which otherwise should
reasonably be construed under the circumstances as being confidential disclosed
by or on behalf of Yissum, or any of its employees, consultants or researchers
to Company, whether in oral, written, graphic or machine-readable
form, except to the extent such information:
(i) was known to Company at the time it was disclosed, other than by previous
disclosure by or on behalf of Yissum or any of its employees, consultants or
researchers, as evidenced by Company’s written records at the time of
disclosure; (ii) is at the time of disclosure or later becomes publicly known
under circumstances involving no breach of this Agreement; (iii) is lawfully and
in good faith made available to Company by a third party who is not subject to
obligations of confidentiality to Yissum with respect to such information; (iv)
is independently developed by Company without the use of or reference to Yissum
Confidential Information, as demonstrated by documentary evidence, or (v) is
disclosed pursuant to a court or administrative order, provided however that
Company will first notify Yissum of any such order and afford Yissum the
opportunity to seek a protective order relating to such disclosure.
Notwithstanding
anything to the contrary in this Section 7.1, Company may disclose Yissum
Confidential Information to actual and potential business partners,
collaborators, investors, contractors, service providers and consultants,
provided, in each case, that such recipient of Confidential Information first
enters into a legally binding agreement with Company which imposes
confidentiality and non-use obligations with respect to Confidential Information
comparable to those set forth in this Agreement for a period of at least five
(5) years from the date of disclosure of Yissum Confidential Information to such
recipient.
7.2 Company Confidential Information.
Yissum agrees that, without the prior written consent of Company, in each
case, during the term of this Agreement, and for three (3) years thereafter, it
will keep confidential, and not disclose or use Company Confidential Information
(as defined below) other than for the purposes of this Agreement. Yissum shall
treat such Company Confidential Information with the same degree of
confidentiality as it keeps its own confidential information, but in
all events no less than a reasonable degree of confidentiality. Yissum may
disclose the Company Confidential Information only to employees, consultants or
researchers of Yissum or its affiliates who have a “need to know” such
information in order to enable Yissum to exercise its rights or fulfill its
obligations under this Agreement and provided such parties are legally bound by
agreements which impose confidentiality and non-use obligations comparable to
those set forth in this Agreement. For purposes of this Agreement. “Company
Confidential Information” means any scientific, technical, trade or business
information relating to the subject mailer of this
Agreement designated as confidential or which otherwise should reasonably be
construed under the circumstances as being confidential disclosed by or on
behalf of Company whether in oral, written, graphic or machine-readable form,
except to the extent such information: (i) was known to Yissum at the time it
was disclosed, other than by previous disclosure by or on behalf of Company as
evidenced by Yissum’s written records at the time of disclosure; (ii) is at the
time of disclosure or later becomes publicly known under circumstances involving
no breach of this Agreement; (iii) is lawfully and in good faith made available
to Yissum by a third party who is not subject to obligations of confidentiality
to Company with respect to such information; (iv) is independently developed by
Yissum without the use of or reference to the Company Confidential Information,
as demonstrated by documentary evidence; or (v) is disclosed pursuant to a court
or administrative order, provided however that Yissum will first notify Company
of any such order and afford Company the opportunity to seek a protective order
relating to such disclosure.
7.3 Each
party may disclose the terms of this Agreement to the extent required, in the
reasonable opinion of such party’s legal counsel, to comply with applicable
laws, as well as to sublicensees and prospective and current investors, pursuant
to appropriate non-disclosure arrangements. If a party discloses this Agreement
or any of the terms hereof in accordance with this Section7.3, such party
agrees, at its own expense, to seek confidential treatment of portions of this
Agreement or such terms, as may be reasonably requested by the other
party.
7.4 Without
prejudice to the aforegoing. Yissum agrees that Company shall have the right to
mention or reference the Hebrew University of Jerusalem’s and/or Yissum’s names
without obtaining Yissum’s prior consent to the extent the use of such names is
reasonably consistent with Company’s obligations pursuant to Section 4.1 hereof.
7.5 The
breach of this section, by any person or entity other than Yissum or Company
shall not be deemed a breach of the Agreement, if Yissum or Company establish
that they took all reasonable steps to avoid such breach.
7.6 The
expiration or termination of this Agreement shall not release the Parties from
their obligations pursuant to this section.
7.7 The
provisions of this section shall be subject to permitted publications pursuant
to Section 8 herein.
SECTION
8
Publications
8.1 Yissum
shall ensure that no publications in writing, in scientific journals or orally
at scientific conventions relating to the Licensed Technology are published by
it or its Researchers. For the purposes of this Agreement, the term
“Researchers” means Pro. Xxxxxxx Xxxxxxxx and his scientific research group or
other scientific research group whose work is related to the Licensed
Technology.
8.2 Notwithstanding
Section 8.1 above, Yissum may allow the Researchers to publish any research,
research results or know-how relating to the Licensed Technology provided that
it obtains Company’s prior written consent. Company undertakes to reply to any
request by Yissum for Company’s consent within forty-five (45) days of receiving
such request. Company may only decline such request upon reasonable grounds
which shall be fully detailed in writing. In the event that Company does not
reply to such request within the forty-five (45) day period, then Company shall
be deemed to have consented to Yissum’s request to allow the Researchers to
publish in the manner contemplated herein.
8.3 Should
Company decide not to allow publication as provided in Section 8.2 for reasons
which in Yissum’s opinion are unreasonable, acting reasonably, publication shall
be postponed for a period of three (3) months to enable Company to file patent
applications.
8.4 The
provisions of this Section 8 shall not prejudice any other right that Yissum has
pursuant to this Agreement and at law.
8.5 For
the avoidance of doubt, the provisions of this Section 8 in connection with the
prohibition against publication shall not apply to internal publication by
Yissum made in the Hebrew University of Jerusalem for the Researchers and
employees subject to Section 7.
SECTION
9
Liability and Indemnity
9.1 Except
as set forth herein, Yissum expressly disclaims any and all implied or express
warranties and makes no express or implied warranties of merchantability or
fitness for any particular purpose of the Licensed Technology contemplated by
this Agreement.
9.2 Company
shall be solely liable for any loss, injury and/or damage whatsoever caused to
its employees and/or any person acting on its behalf by reason of Company’s acts
and/or omissions pursuant to this Agreement and/or by reason of any use made of
the Licensed Technology by Company.
9.3 Company
undertakes to indemnify, defend and hold harmless (i) Yissum and any person
acting on its behalf and any of its directors, officers, employees and
representatives,
and (ii) the Hebrew University of Jerusalem and any person acting on its behalf
and any of its directors, officers, employees and representatives (herein
referred to as “Indemnitees”) from and against any liability including without
limitation product liability, damages, losses or expenses including reasonable
legal fees and litigation expenses incurred by or imposed upon the Indemnitees
(collectively, “Losses”) only by reason
of Company’s acts and/or omissions and/or which derive from Company’s use,
development, manufacture, marketing, sale and/or sublicensing of the Licensed
Technology except to the extent such Losses are determined to have resulted from
the gross negligence or willful misconduct of Indemnitees.
9.4 Company
shall obtain prior to the commencement of clinical trials by Company and prior
to the First Commercial Sale, comprehensive general liability insurance which
shall provide:
(i)
product liability coverage,
(ii) contractual
liability coverage for Company’s indemnification under this Agreement and in
particular as stated in Section 9.3, and
(iii) Yissum
as an additional named insured.
Upon the
commencement of any clinical trial, Company shall procure and maintain
comprehensive clinical trial liability insurance in amounts commensurate with
accepted commercial practice. All required insurance will be at Company’s sole
cost and expense.
9.5 Company
shall provide Yissum with written evidence of such insurance upon request of
Yissum. Company shall ensure that it maintains on a continuous basis only during
the relevant term of this Agreement the foregoing insurance coverage, and shall
not cancel or terminate such insurance with any insurance provider unless it has
in place alternative coverage consistent with the foregoing. Company shall
provide Yissum with written notice of any material change in such insurance not
later than fifteen (15) days of such change taking effect.
9.6 Company
shall maintain comprehensive general liability insurance beyond the expiration
or termination of this Agreement during the period that a Licensed Product is
being commercialized, distributed or sold by Company and/or any Sublicensee. In
the event of early termination by Yissum, the cost of such general liability
insurance for a period of three (3) months following the date of termination
will he borne by Company and thereafter will be borne by Yissum.
9.7 Yissum
represents and warrants that to the best of its actual knowledge: (i) the
Patents which have been issued and are listed in Appendix 1 are valid
and enforceable: (ii) it has the full power to enter into this Agreement, to
carry out its obligations under this Agreement, and to grant the rights granted
to Company herein; (iii) it has not previously granted and shall not grant to
any third party any rights which are inconsistent with the rights granted to
Company herein, (iv) it has the rights, title, and interest in and to the
Patents, and (v) the
Licensed Technology constitutes all of the intellectual property rights
developed by Xxxx. Xxxxxxx Xxxxxxxx laboratory in the Hebrew University in the
field of H19 and IGF2 gene.
9.8 Company
represents that: (i) it has full corporate power and authority to enter
into this
Agreement and carry out all the provisions of this Agreement; (ii) it is
authorized to execute this Agreement on its behalf; (iii) the person executing
this Agreement is duly authorized to do so; and (iv) no consent, approval or
authorization of any other party is required in connection with entering into
this Agreement.
SECTION
10
Term and Termination
10.1 Unless
earlier terminated, as hereinafter provided, the term of this Agreement shall
expire on a country-by-country basis at such time when no Valid Claim exists, or
if no Patent was issued in a country, on the eleventh anniversary of the First
Commercial Sale in such country, thereafter the License in such country shall
expire, provided in each case that Company may extend the term of the Agreement
on a country-by-country basis for additional period of one year each by
continuing to pay the consideration set forth in section 3. In countires where a
Patent was registered, after the expiration of Patent, Company shall have a
perpetual, worldwide, royalty-free, fully paid-up and sublicenseable License in
relation to that Patent.
10.2 In
the event of a material default or failure by Company to perform any of the terms,
covenants or provisions of this Agreement, Company shall have
ninety (90) days after the giving of written notice of such default by Yissum to
correct such default, provided, however, that if the breach is not capable of
being cured within ninety (90) days of such written notice, the Agreement may not be terminated so long as Company commences
and is taking commercially reasonable actions to cure such breach as promptly as
practicable. In any event, if a curable breach has not been cured within ninety
(90) days after notice requesting cure, Yissum shall have the right, at its
option, to terminate this Agreement.
10.3 Yissum
shall have the right, at its option, to terminate this Agreement in the event
that Company shall become involved in insolvency, bankruptcy, liquidation,
winding-up or receivership proceedings. Company shall immediately notify Yissum
upon commencement of any bankruptcy, insolvency, liquidation, winding-up or
receivership proceedings or the placing of an attachment on its
assets.
10.4 In
the event of termination of this Agreement for any reason whatsoever, the
License shall terminate and all rights to the Licensed Technology (including
Research Results) shall revert to Yissum and Company may make no further use
thereof. Notwithstanding the aforesaid, the expiration or termination of this
Agreement shall not release Company from its obligation to carry out any
financial or other obligation which it was liable to perform prior to the
Agreement’s expiration or termination, including the payment of Royalties and
Sub-License Revenues.
10.5 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either Party from any obligation that matured prior to the effective
date of such termination; and Articles 1, 5, 7, 8, 9, 10, 11, 12 and 13 shall
survive any such termination.
10.6 No
termination of this Agreement shall constitute a termination or a waiver of any
rights of either Party against the other Party accruing at or prior to the time
of such termination.
10.7 Company
shall have the right to terminate this Agreement at any time on three (3) months
advance notice to Yissum, and upon payment of all amounts due to Yissum through
the effective date of termination.
SECTION
11
Law
11.1 The
provisions of this Agreement and everything concerning the relationship between
the parties in accordance with this Agreement shall be governed by the law of
the State of Israel and, subject to Section 12 below, jurisdiction shall be
granted only to the appropriate court in Jerusalem. Any and all proceedings,
documents and other communications or correspondences between the parties shall
be in the English language.
11.2 Notwithstanding
the above, Company hereby agrees that, in the event that no treaty exists
upholding the enforceability of temporary orders and/or judgments issued by
Israeli courts in the foreign jurisdiction in which Yissum may require such an
order and/or judgment to be upheld, Yissum may, at its own discretion, elect the
place of jurisdiction for the obtaining of orders and/or judgments against
Company. Company undertakes not to object to the enforcement against it of
orders and/or judgments issued by any aforesaid jurisdiction under such
circumstances.
SECTION 12
Arbitration
12.1 All
differences and disputes arising between the parties in connection with this
Agreement and/or its interpretation and/or its performance and/or breach, shall
be referred for the decision of a single arbitrator, who shall be appointed by
Agreement between the parties.
12.2 Should
the parties not reach agreement as to the arbitrator’s identity, the arbitrator
shall be appointed by the Chairman of the Israeli Bar Association on the
application of either of the parties.
12.3 The
arbitration shall be held in Israel. The arbitrator shall not be bound by the
civil procedure regulations and laws of evidence, but shall be bound by the
substantive law of Israel and be liable to give grounds for his
decision.
12.4 The
arbitrator’s decision shall be final and shall bind the parties.
SECTION
13
Miscellaneous
13.1 This
Agreement shall be binding upon and shall inure to the benefit of Yissum and its
assigns and successors in interest, and shall be binding upon and shall inure to
the benefit of Company and its assigns and successors to all or substantially
all of its assets or business to which this Agreement relates, but shall not
otherwise be assignable or assigned by Company without prior written approval by
Yissum being first obtained, which approval shall not be unreasonably
withheld.
13.2 If
any provision of this Agreement shall be declared by a court of competent
jurisdiction to be invalid, illegal or incapable of being enforced in whole or
in part, the remaining conditions and provisions or portions thereof shall
nevertheless remain in full force and effect and enforceable to the extent they
are valid, legal and enforceably, and no provision shall be deemed dependent
upon any other covenant or provision unless so expressed herein.
13.3 Each
Party hereby agrees that it does not intend to violate any public policy,
statutory or common law, rule, regulation, treaty or decision of any government
agency or executive body thereof of any country or community or association of
countries; that if any word, sentence, paragraph or clause or combination
thereof of this Agreement is found, by a court or executive body with judicial
powers having jurisdiction over this Agreement or any of its Parties hereto, in
a final unappealed order to be in violation of any such provision in any country
or community or association of countries, such words, sentences, paragraphs or
clauses or combination shall be inoperative in such country or community or
association of countries, and the remainder of this Agreement shall remain
binding upon the Parties hereto.
13.4 The
Parties covenant and agree that if a Party fails or neglects for any reason to
take advantage of any of the terms provided for the termination of this
Agreement or if a Party, having the right to declare this Agreement terminated,
shall fail to do so, any such failure or neglect by such Party shall not be a
waiver or be deemed or be construed to be a waiver of any cause for the
termination of this Agreement subsequently arising, or as a waiver of any of the
terms, covenants or conditions of this Agreement or of the performance thereof.
None of the terms, covenants and conditions of this Agreement may be waived by a
Party except by its written consent. A waiver by Yissum of any breach by Company
of any provision or condition of this Agreement to be performed by Company shall
not be deemed a waiver of similar or dissimilar provisions or conditions at the
same or any prior or subsequent time.
13.5 This
Agreement contains the entire agreement and understanding of the Parties with
respect to the subject matter hereof, supersedes any prior agreements and
understandings with respect thereto and cannot be modified, amended or waived,
in whole or in part, except in writing signed by the Parties.
13.6 Each
Party shall bear its own legal expenses involved in the making of this
Agreement.
13.7 The
headings to the sections in this agreement are for the sake of convenience only
and shall not serve in the Agreement’s interpretation.
13.8 Company
shall disclose to Yissum any existing agreement and/or arrangement or
relationship of any kind between it and employees of Yissum and/or the Hebrew
University of Jerusalem with respect to the Licensed Technology and in
connection therewith and shall not enter into any agreement or arrangement with
any employees of Yissum and/or the Hebrew University of Jerusalem, as aforesaid,
without the prior written consent of Yissum.
13.9 The
appendixes annexed hereto constitute an integral part hereof and shall be read
jointly with its terms and provisions.
13.10 The
recitals hereto constitute an integral part hereof. In this Agreement, unless
otherwise required or indicated by the context, the singular shall include the
plural and vice-versa, and the masculine gender shall include all other
genders.
SECTION
14
Notices
All
notices and communications pursuant to this Agreement shall be made in writing
and sent by registered mail to or served in person at the following
addresses:
(i) If
to Yissum:
YISSUM
RESEARCH DEVELOPMENT COMPANY
OF THE
HEBREW UNIVERSITY OF
JERUSALEM
Hi-Tech
Park, Xxxxxx X. Xxxxx
Campus
Givat
Ram, X.X.Xxx 39135, Xxxxxxxxx 00000, Xxxxxx
(xx) If
to Company:
BIOCANCELL
PHARMACEUTICALS INC.
0000
Xxxxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx,
Xxx Xxxxxx Xxxxxx, Xxxxxxxx, 00000
and
BIOCANCELL
PHARMACEUTICALS LTD.
Hi-Tech
Park, Xxxxxx X. Xxxxx Campus
Xxxxx
Xxx, X.X.Xxx 00000, Xxxxxxxxx, 00000, Xxxxxx
or such
other address furnished in writing by one Party to the other. Any notice sent as
aforesaid shall be deemed to have been received five (5) days after being posted
by registered mail, or one (1) day following the date of personal
service.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK)
IN
WITNESS WHEREOF, the Parties hereto have executed and delivered this Agreement
in multiple originals by their duly authorized officers and representatives on
the respective dates shown below, but effective as of the Effective
Date.
YISSUM
RESEARCH DEVELOPMENT COMPANY
OF
THE HEBREW UNIVERSITY OF JERUSALEM
|
By:
|
/s/
Herve Bercovier
|
By:
|
/s/
Xxxxxx Xxx
|
|
|
Name:
|
Prof.
Herve Bercovier
|
Name:
|
Xxxxxx
Xxx
|
|
|
Title:
|
Director
|
Title:
|
VP
Marketing
|
|
|
Date:
|
November
14, 2005
|
Date:
|
November
14,
2005
|
BIOCANCELL
PHARMACEUTICALS INC.
|
By:
|
/s/
Xxx Xxxxx
|
By:
|
/s/
Xxx Xxxxx
|
|
|
Name:
|
Xxx
Xxxxx
|
Name:
|
Xxx
Xxxxx
|
|
|
Title:
|
Chairman
|
Title:
|
President
|
|
|
Date:
|
Nov
14, 2005
|
Date:
|
November
14,
2005
|
BIOCANCELL
PHARMACEUTICALS LTD.
|
By:
|
/s/
Xxx Xxxxx
|
By:
|
/s/
Xxx Xxxxx
|
|
|
Name:
|
Xxx
Xxxxx
|
Name:
|
Xxx
Xxxxx
|
|
|
Title:
|
Chairman
|
Title:
|
President
|
|
|
Date:
|
Nov
14, 2005
|
Date:
|
November
14,
0000
|
XXXXXXXX
1 - PATENTS
|
2148
|
DIAGNOSTIC
ASSAY FOR MALIGNANCIES USING H-19 GENE,
KIT
|
Inventors:
ARIEL XXXXX, XXXXXXXX XXXXXXX
|
File
|
Country
|
Status
|
Appl
Date
|
Appl
No
|
Reg
Date
|
Reg
No
|
Pub
Date
|
Pub
No
|
||||||||
|
0000-00
|
Xxxxxx
|
Granted
|
7/Mar/94
|
108879
|
3/Dec/00
|
108879
|
||||||||||
|
2148-01
|
PCT
|
Published
|
6/Mar/95
|
PCT/EP95/00823
|
14/Sep/95
|
WO95/24503
|
||||||||||
|
2148-03
|
US
|
Granted
|
6/Sep/96
|
08/704,786
|
21/Sep/99
|
5,955,273
|
||||||||||
|
2148-04
|
|
Europe
|
|
Granted
|
|
6/Mar/95
|
|
95927570.2
|
|
29/May/02
|
|
0759092
|
|
|
|
2324
|
METHODS
AND COMPOSITIONS FOR INDUCING TUMOR-SPECIFIC
CYTOTOXICITY
|
Inventors:
XXXXX XXXXXX, XXXXXXXX XXXXXXX
|
File
|
Country
|
Status
|
Appl
Date
|
Appl
No
|
Reg
Date
|
Reg
No
|
Pub
Date
|
Pub
No
|
||||||||
|
2324-00
|
US
|
Abandoned
|
3/Oct/97
|
08/943,608
|
||||||||||||
|
2324-01
|
PCT
|
Published
|
4/Oct/98
|
PCT/IL98/00486
|
15/Apr/99
|
WO
99/18195
|
||||||||||
|
2324-02
|
PCT
|
Published
|
22/Oct/02
|
PCT/IL02/00843
|
1/May/03
|
WO
03/035883
|
||||||||||
|
0000-00
|
Xxxxxx
|
Filed
|
4/Oct/98
|
PI9812717-9
|
||||||||||||
|
2324-03
|
US
|
Granted
|
l/Oct/98
|
09/165,240
|
11/Jul/00
|
6,087,164
|
||||||||||
|
0000-00
|
Xxxxx
|
Exam
|
4/Oct/98
|
98811833.5
|
||||||||||||
|
2324-05
|
Europe
|
Published
|
4/Oct/98
|
98947759.1
|
1019499
|
|||||||||||
|
0000-00
|
Xxxxxxx
|
Filed
|
4/Oct/98
|
P0003745
|
||||||||||||
|
0000-00
|
Xxxxxx
|
Filed
|
4/Oct/98
|
135430
|
||||||||||||
|
2324-08
|
Korea
|
Exam
|
4/Oct/98
|
2000-7003609
|
||||||||||||
|
Mexico
|
Filed
|
4/Oct/98
|
2000003251
|
|||||||||||||
|
0000-00
|
Xxxxxx
|
Filed
|
4/Oct/00
|
0000-000000
|
||||||||||||
|
2324-10
|
New
Zealand
|
Filed
|
4/Oct/98
|
503843
|
||||||||||||
|
2324-11
|
Norway
|
Filed
|
4/Oct/98
|
20001684
|
||||||||||||
|
2324-12
|
Poland
|
Filed
|
4/Oct/98
|
P339949
|
||||||||||||
|
2324-13
|
Russia
|
Granted
|
4/Oct/98
|
2000111553
|
22/Oct/03
|
2214280
|
||||||||||
|
2324-14
|
US
|
Granted
|
10/May/00
|
09/568,059
|
23/Oct/01
|
6,306,833
|
||||||||||
|
2324-15
|
US
|
Exam
|
22/Oct/01
|
10/012,131
|
|
US-2004-0082529
|
||||||||||
|
2324-16
|
Australia
|
Granted
|
4/Oct/98
|
94571/98
|
19/Dec/02
|
755774
|
||||||||||
|
0000-00
|
Xxxxx
|
Exam
|
4/Oct/00
|
0000-000000
|
||||||||||||
|
2324-18
|
Canada
|
Exam
|
4/Oct/98
|
2,308,124
|
||||||||||||
|
0000-00
|
Xxxxxxxxx
|
Granted
|
4/Oct/98
|
200001824-2
|
4/Jun/02
|
00000
|
||||||||||
|
0000-00
|
Xxxxx
Xxxxxxxx
|
Exam
|
4/Oct/98
|
PV2000-1201
|
||||||||||||
|
2324-21
|
Europe
|
Published
|
22/Oct/02
|
02779859.4
|
1438412
|
|||||||||||
|
0000-00
|
Xxxxx
|
Filed
|
22/Oct/02
|
02825940.8
|
||||||||||||
|
0000-00
|
Xxxxx
|
Filed
|
22/Oct/00
|
0000-000000
|
||||||||||||
|
0000-00
|
Xxxxxx
|
Filed
|
22/Oct/02
|
161553
|
||||||||||||
|
2324-25
|
Canada
|
Filed
|
22/Oct/02
|
2,464,394
|
||||||||||||
|
0000-00
|
Xxxxxxxxx
|
Filed
|
22/Oct/02
|
2002343189
|
||||||||||||
|
0000-00
|
Xxxxxx
|
Filed
|
00/Xxx/00
|
XXx0000/000000
|
||||||||||||
|
0000-00
|
|
Xxxxx
Xxxxxxxx
|
|
Filed
|
|
18/Jun/04
|
|
PV
2004-741
|
|
|
|
|
|
2617
|
TRACKING
GENE EXPRESSION
|
|
|
Inventors:
XXXXXXXX XXXXXXX, XXXXXXXX XXXX, XXXXX XXXXXX, XXXXXXX XXXXXXXX, XXXXXX
XXXXX, XXXXX XXXXX, XXXXXX XXXX, XXXXX
XXXXX
|
|
File
|
Country
|
Status
|
Appl
Date
|
Appl
No
|
Reg
Date
|
Reg
No
|
Pub
Date
|
Pub
No
|
||||||||
|
2617-00
|
US
|
Provisional
|
31/Jan/00
|
60/179,139
|
||||||||||||
|
2617-01
|
US
|
Provisional
|
27/Dec/00
|
|
60/758,038
|
|
|
|
|
|
2807
|
METHOD
FOR DETECTION OF MICRO-METASTASIS
|
|
|
Inventors:
XXXXXXXX XXXXXXX
|
|
File
|
Country
|
Status
|
Appl
Date
|
Appl
No
|
Reg
Date
|
Reg
No
|
Pub
Date
|
Pub
No
|
||||||||
|
2807-00
|
US
|
Exhausted
|
12/Sep/02
|
60/409,975
|
||||||||||||
|
2807-01
|
|
PCT
|
|
Published
|
12/Sep/03
|
|
PCT/US03/28807
|
|
|
|
|
WO
2004/024957
|
|
2808
|
METHOD
FOR REGULATING EXPRESSION GENES
Inventor: XXXXXXXX XXXXXXX, XXXXX XXXXXX, XXXXXXXX
XXXXXXX
|
|
File
|
Country
|
Status
|
Appl
Date
|
Appl
No
|
Reg
Date
|
Reg
No
|
Pub
Date
|
Pub
No
|
||||||||
|
2808-00
|
US
|
Provisional
|
3/Oct/02
|
60/415,528
|
||||||||||||
|
2808-01
|
PCT
|
Published
|
3/Oct/03
|
PCT/US2003/031306
|
|
WO
2004/031359
|
