LICENSE AGREEMENT
Exhibit
10.1
Made
this
20th
day of
January 2008 (the "Effective
Day"),
by
and between Synvista, with its principal place of business at
______________________________________________________________________________
(hereinafter the "Company")
and
Novel Therapeutic Technology Inc with its principal place of business at POB
12006, 7 Yad Harutzim, Herzliya Pituach 00000 XXXXXX (hereinafter "NTT");
WHEREAS,
NTT has
sole and exclusive rights under an Exclusive License Agreement (the
"Yissum
Agreement")
from
Yissum Research Development Company of the Hebrew University of Jerusalem
("Yissum"),
for
drug delivery technology known as the ETHOSOME™ Delivery System know-how and
formulations using such delivery system ("Ethosome")
, and
is able and willing to enter into a licensing agreement with the Company for
Ethosome and the formulation of a drug of the Company using the Ethosome
formulation technology,
WHEREAS,
the
Company is the exclusive licensee of the rights in and to certain organoselenium
Drug as further detailed below; and
WHEREAS,
The
Company wishes to obtain a license from NTT and NTT wishes to grant a license
to
the Company for the Product (as hereinafter defined), Drug Formulation (as
defined hereinafter), Development Results (as hereinafter defined), Resulting
Patents (as hereinafter defined), NTT Patents (as hereinafter defined) and
NTT
Formulation Technology (as hereinafter defined), subject to the terms
and
conditions
of this Agreement
NOW
THEREFORE THE PARTIES DO HEREBY AGREE AS FOLLOWS:
1. Interpretation
and Definitions
1.1 The
preamble and appendices annexed to this Agreement constitute an integral part
hereof and shall be read jointly with its terms and conditions.
1.2 In
this
Agreement, unless otherwise required or indicated by the context, the singular
shall include the plural and vice-versa,
the
masculine gender shall include the female gender, and the use of the word "or"
means "and/or”.
1.3 The
headings of the sections in this Agreement are for the sake of convenience
only
and shall not serve in the interpretation of the Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
1.4
In
this
Agreement, the following capitalized terms shall have the meanings appearing
alongside them, unless provided otherwise:
1.4.1 "Affiliate"
means
any person or organization controlling, controlled by or under common control
with the Company, including any parent, subsidiary or affiliate company. The
term "control" means direct or indirect ownership of more than fifty percent
50%
of the outstanding stock or other voting interest, entitled to vote for the
election of a majority of directors or to direct the management and policies
of
any party, directly or indirectly.
1.4.2 "Agreement"
means
this agreement together with all the appendices and annexes hereto.
1.4.3 "Company
Confidential Information"
means
the Drug and all technical, scientific and commercial information including
but
not limited to any data, trade secrets, know-how, assays, materials,
formulations, solubility, stability, analytical methods, compositions, reports,
notebooks, certificates, regulatory information, authorizations, approvals,
synthesis, materials, methods, results, and/or processes, of the Company; which
either are disclosed by the Company, or, resulting from use of the Drug and
are
directly related thereto, whether disclosed orally, in writing or
electronically. Company Confidential Information shall not include the Drug
Formulation.
1.4.4 "Development
Plan"
means
the written plan, and any amendments thereof, attached hereto as Exhibit
A,
which
sets forth the development of Drug Formulation.
1.4.5 "Development
Results"
means:
i) the Product; ii) Drug Formulation; iii) any and all data, information,
experiments, trade secrets, know-how, assays, solubility, stability, analytical
methods, compositions, derivatives, synthesis, materials, results, and/or
processes; and certificates, authorizations, approvals, reports, which results
from, or arises under the Development Plan; and iv) any and all conceptions,
inventions arising under or resulting from the Development Plan; and/or claim
or
disclose the Product, Drug Formulation except for Intellectual Property Rights
of NTT and Company existing prior to the Effective Date.
1.4.6 "Drug"
means
the Company's organoselenium drug or materials, as specified in Exhibit
B
hereto,
and its racemate, metabolite, derivatives, isomers, polymorphs,
crystals.
1.4.7 "Drug
Formulation"
means
the formulation of the Drug utilizing NTT's Formulation Technology.
1.4.8 "First
Commercial Sale"
means,
with respect to any country, the first bona fide arm's-length sale of the
Product in such country following receipt of all regulatory approvals necessary
to commence regular, commercial scale sales of the Product in such country,
excluding, however, any sale or other distribution for use in a clinical trial.
Any sale prior to receipt of all approvals necessary to commence commercial
sales, such as any so-called "named patient sale" or "compassionate use" sale,
shall not be deemed a First Commercial Sale.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
2
"Intellectual
Property Rights"
shall
mean any and all patents and patent applications and the rights in such patents,
in the Territory, including any and all divisionals, continuations,
continuations-in-part, reissues, renewals, substitutions, registrations,
re-examinations, revalidations, extensions, supplementary protection
certificates, pediatric exclusivity periods and the like of any such patents
and
patent applications, and foreign equivalents
"Intercompany
Consideration"
means
consideration received by the Company and its Affiliates from among the Company
and its Affiliates.
"License"
means
the license granted by NTT to the Company under Section 3.1
hereto.
1.4.9 "Net
Sales"
means
the gross amount invoiced for sales of Product by or on behalf of the Company,
its Affiliates or Sublicensees to any third party (whether an end-user, or
a
distributor), exclusive of Inter-Company transfers or sales to or from
Affiliates or Sublicensees, less the following deductions from such gross
amounts only to the extent reasonable and customary, and which are actually
incurred and included in gross amounts invoiced (i) all discounts, returns,
rejections and retroactive price reductions given in respect of such sales
and
credits or allowances actually paid or granted, (ii) deducting sales, excise
and
similar taxes (including VAT) or other relevant governmental charges, and (iii)
transportation, packaging and insurance charges; amounts actually credited,
rebated or allowed for rejections or returns of Product; retroactive price
reductions that are actually allowed or granted, bad debt, transportation
expenses related to the sale of Product and custom duties imposed and with
reference to the sale of Product. Such deductions shall be directly related
to
the sale of Products that were awarded within the regular running of the
business of the Company and made at "arms length". In the event of sales not
made at "arms length", Net Sales shall be calculated in accordance with the
current market conditions, or in the absence of such conditions, according
to
reasonable conditions for such sale.
1.4.10 "NTT
Confidential Information"
means
the NTT Formulation Technology, the Ethosome Drug Delivery System, as defined
below, and all technical, scientific and commercial information including but
not limited to any data, trade secrets, know-how, assays, materials,
formulations, solubility, stability, analytical methods, compositions, reports,
notebooks, certificates, regulatory information, authorizations, approvals,
synthesis, materials, methods, results, and/or processes, of NTT; whether
disclosed orally, in writing or electronically.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
3
1.4.11 "NTT
Formulation Technology"
means a
drug delivery technology and know-how, information, trade secrets and NTT
Patents in formulations of drugs known as the ETHOSOMETM
Drug
Delivery System "(Ethosome")
1.4.12 "NTT
Patents"
shall
mean the patents and/or patent applications covering or disclosing NTT
Formulation Technology; and including but not limited to, U.S. Patent No. [***],
U.S. Patent No. [***] and PCT International Application No. [***] and any
continuations, continuations-in-part, extensions, divisions, substitutions
or
additions to such applications and all patents which are reissues thereof,
re-validations and registrations based thereon, and any and all foreign patents
and patent applications corresponding thereto.
1.4.13 "Party"(
collectively: the "Parties")
means
each of the Company and NTT.
1.4.14
"Product"
means a
pharmaceutical preparation or composition containing the Drug Formulation which
is covered by a Valid Patent Claim.
1.4.15 "Regulatory
Approval"
means
any approvals (including supplements, amendments, pre- and post-approvals and
price approvals), licenses, registrations or authorizations of any national,
supra-national (e.g., the European Commission or the Council of the European
Union), regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, necessary for the manufacture,
distribution, or sale of Products in a regulatory jurisdiction.
1.4.16
"Reporting
Period"
means,
with respect to the Product in any country in the Territory, on a bi-annual
basis, commencing with the First Commercial Sale of such Product in such country
and ending upon termination of the this Agreement.
1.4.17 "Resulting
Patents"
means
patents and patent applications and the rights in such patents, in the
Territory, including any and all divisionals, continuations,
continuations-in-part, reissues, renewals, substitutions, registrations,
re-examinations, revalidations, extensions, supplementary protection
certificates, pediatric exclusivity periods and the like of any such patents
and
patent applications, and foreign equivalents of the foregoing that incorporate
information or results arising under or resulting from the Development Plan,
and/or claim or disclose the Product, Drug Formulation; except for Intellectual
Property Rights of NTT and Company existing prior to the Effective
Date.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
4
1.4.18 "Sublicensee"
shall
mean the granting or licensing of any rights to a third party by the Company
or
its Affiliates to make, commercialize, use, sell and/or import (except where
the
implied right to use accompanies the sale to the third party end user the
Product by the Company or its Affiliates or Sublicensees).
1.4.19 "Sub-License
Consideration"
means
the consideration received by the Company for the granting of a Sublicense.
Notwithstanding the foregoing, Sublicense Consideration shall not include:
i)
consideration received by the Company and its Affiliates from among the Company
and its Affiliates ("Intercompany
Consideration");
and
ii) payments made to the Company by a licensee for research and development
expenses directly related to the Products as defined by FASB accounting; iii)
payments made to the Company by a licensee for any equity investment or
financing at a price per share (or other security or debt, warrant of other
financial instrument) equal to or lower than the market value of such shares
(or
other securities).
1.4.20 "Territory"
means
worldwide.
1.4.21 "Valid
Patent Claim"
shall
mean a claim of an issued and unexpired patent, including those with an extended
term under patent term adjustment, patent term extension or pediatric
exclusivity claiming the Drug or Drug Formulation, including NTT Patents and
Resulting Patents, which would be infringed by the unauthorized sale or use
of
the Product in the country of sale, which claim has not been revoked or held
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction (which decision is no longer appealable), and which
claim has not been disclaimed, denied or admitted to be invalid or unenforceable
through reissue, re-examination or disclaimer or otherwise (including such
claim
during the term of any statutory or regulatory exclusivity periods that relate
back to or apply to that claim).
2. Development
Plan
2.1 Performance
NTT will
use its reasonable efforts to perform the Development Plan in accordance with
the timetable set forth therein. Performance of the Development Plan will be
subject to the Company's provision to NTT such information regarding suggested
Drug concentrations and any relevant data requested by NTT as set forth in
the
Development Plan. NTT shall provide personnel, facilities, and resources as
required to accomplish the work necessary to complete and accordance with the
Project. NTT shall retain separate laboratory data books and notebooks for
any
and all data, results, experiments, and information of the Development Results;
copies of all such records shall be provided to Company upon Company's written
request. NTT shall not co-mingle Drug or Company Confidential Information with
that of a third party; or with any NTT Formulation Technology of NTT not under
this Agreement.
NTT,
upon
written request from the Company, and/or upon Termination, shall provide to
Company a detailed Report. In addition, NTT shall provide such additional
periodic written reports or attend such additional meetings with Company as
Company shall determine are necessary with respect to the status of NTT's
activities under this Agreement and the Project, at the Company 's expense
and
on reasonable notice from Company. NTT shall conduct regular telephone
conferences and no less frequently than once every two weeks with Company to
discuss the details, results and progress of the Development Plan.
NTT
expressly disclaims any and all implied or express warranties pertaining to
the
Development Results and makes no express or implied warranties of
merchantability, fitness for any particular purpose of the Development Results,
chemical stability, toxicology and/or tolerability thereof.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
5
2.2 Compliance.
In
carrying out the Development Plan, NTT agrees that if applicable it will comply
with all generally accepted standards of Good Laboratory practices and all
applicable local, state and federal laws.
2.3 Regulatory
Cooperation.
NTT
shall cooperate with US and European regulatory authorities, and allow them
access to NTT's facilities and premises and to records and data that are
relevant for the Development Plan. Each Party shall promptly inform the other
Party of any request or effort by any such regulatory authority to review
records and data, or to contact, visit, or inspect NTT or NTT's records and
data, relating to the Development Plan, and shall notify the other Party within
two (2) business days, or as reasonably practicable, if any regulatory authority
issues or gives any notice of intent to inspect, notice of inspection, notice
of
inspectional observations, warning letter, or other written communication
concerning the Development Plan. The Company shall have the sole right and
responsibility with respect to interactions with regulatory authorities
regarding the development, marketing, sale and/or manufacturing of Products,
including but not limited to any IND, marketing authorization. Each party agrees
to notify (the "Notifying Party") the other party within two (2) working days
of
any information of which the Notifying Party becomes aware concerning any side
effect, injury, toxicity or sensitivity reaction, or any unexpected incident,
and the severity thereof, whether or not determined to be attributable to any
NTT Formulation Technology, Drug Formulation, and/or Product (hereinafter
"Adverse
Experience"),
where
such Adverse Experience is (i) serious and associated with the clinical uses,
studies, investigations, tests and marketing of Product, whether or not
determined to be attributable to Product. With respect to all other adverse
experiences (non-serious expected or non-serious unexpected adverse
experiences), the Notifying Party shall furnish the other party with copies
of
such non-serious adverse experiences in connection with the marketing of Product
within 10 working days after receipt. "Serious" as used in this Section refers
to an experience which results in death, is immediately life threatening,
results in persistent and significant disability/incapacity or requires
in-patient hospitalization, or prolongation of existing hospitalization, or
is a
congenital anomaly, cancer or an overdose. Other important medical events that
may jeopardize the patient or may require intervention to prevent one of the
outcomes previously listed should also be considered serious. "Unexpected"
as
used in this Section refers to a condition or development not listed in the
current labeling for Product, and includes an event that may be symptomatically
and pathophysiologically related to an event listed in the labeling, but differs
from the event because of increased frequency or greater severity or
specificity. Furthermore, each party agrees throughout the Term to notify the
Company of any "Serious" Adverse Experience which occurs in the Territory within
2 working days after the Notifying Party becomes aware of such event and of
any
Non-serious Adverse Experience which occurs in the Territory within 10 working
days after the Notifying Party becomes aware of such event.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
6
2.4 Company's
Information and License.
The
Company will provide NTT, Drug and related know how as set forth in the
Development Plan ("Company's
Information").
The
Company hereby grants NTT the right to use the Company's Information solely
for
conducting the Development Plan. NTT may not use the Drug or Company
Confidential Information for any other purpose. Any information, data, results,
know, how, materials, derivatives, methods, and/or composition related directly
to the Drug resulting from the Development Plan, and which is not the Drug
Formulation, shall be solely and exclusively owned by the Company ("New
Company Information”),
and
NTT has not rights to use. Upon termination of this Agreement, NTT shall have
no
use right under this Section.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
7
2.5 Changes
to the Development Plan.
Any
variation of the Development Plan must be agreed in writing by NTT and
Company.
2.6 Limitation
on Use.
NTT
will not use the Drug, Product, Drug Formulation, Development Results,
Intellectual Property Rights including Resulting Patents that result from the
Development Plan and/or Development Results, Company Confidential Information
for any purpose other than as explicitly set forth in this Agreement. Upon
termination or completion of the Development Plan, all Company Confidential
Information, Drug shall be returned to Company or destroyed at Company's sole
option and at Company's expense. However, nothing herein shall affect NTT's
rights to use NTT's Formulation Technology for any purpose, including
without
limitation, for the purpose of other drugs formulation.
2.7 NTT
shall
provide to the Company at Termination and/or upon written request from the
Company, a detailed Report including the Developmental Results. In addition,
NTT
shall provide such additional periodic written reports or attend such additional
meetings with Company as Company shall determine are necessary with respect
to
the status of NTT's activities under the Development Plan, at the Company's
expense and on reasonable notice from Company.
2.8 At
the
expiration or termination of this Agreement, and subject to the provisions
of
Section 8A below, (i) all Drug, and (ii) any materials, information, databases
and records, accounts, notes, reports and data obtained or generated by NTT
in
the course of providing services under this Agreement, which constitute Company
Confidential Information, and (iii) any Development Plan Results which
constitute New Company Information, shall, at Company's option and at its
direction and written request, and wherever reasonably practicable, and subject
to the provisions of Section 8.1 below be (a) delivered to Company at its
offices in such form(s) as Company shall request, (b) retained by NTT in
accordance with applicable law, regulation, and NTT policy, or (c) disposed
of,
unless NTT is otherwise required to retain such materials, information,
databases and records, accounts, notes, reports or data, or copies thereof,
under applicable law or regulations. All costs of delivering the same to
Company, including without limitation shipping costs, or of disposing or
retaining the same shall be borne by Company.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
8
3. Grant
of License by NTT
3.1 Grant
of License.
NTT
hereby grants to the Company an exclusive worldwide through multiple tier
license, in the Territory, to: 1) the Intellectual Property Rights resulting
from and/or arising under the Development Plan and/or Development Results
including Resulting Patents, and/or the Drug Formulation and/or Product ; and
2)
to make, have made, use, have used and/or license the Drug Formulation and/or
the Development Results, and 3) to make, have made, sell, have sold, use, have
used, license, and/or import Product; and 4) an exclusive license in the
Territory to any Patents covering the Drug Formulation and Product to enable
the
Company to make, have made, sell, have sold, and/or use Products. The Company
shall not use the Drug Formulation and/or the Development Results for any
purpose other than exercise of the License. NTT hereby grants to the Company
a
non-exclusive license, in the Territory under the NTT Patents, to use the NTT
Formulation Technology to 1) develop, make, have made, and use, the Drug
Formulation, and 2) develop, make, have made, sell, have sold, and use,
Product.
No
Implied Licenses.
Except
as explicitly set forth in this Agreement, neither Party shall acquire any
license or other intellectual property interest, by implication or otherwise,
in
any proprietary information disclosed to it under this Agreement or under any
trademarks, patents or patent applications owned or controlled by the other
Party or its Affiliates.
3.2 Rights
to Sublicense.
The
Company shall have the right to grant sublicenses, through multiple tiers of
sublicenses, provided that ally such sublicense shall expressly provide for
the
Sublicensee to be bound by obligations consistent with those provided in this
Agreement.
The
Company shall provide NTT with prompt written notice of each sublicense
agreement, as well as a copy of such sublicense agreement; provided that the
Company may redact from such copy any terms not necessary to confirm compliance
with this Agreement.
3.3 Term
of the License.
The
License shall commence on the effective day and shall end, if not ended or
terminated prior thereto pursuant to the provisions hereof, at the earlier
of
the following:
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
9
(a)
the
date the Company notifies NTT that the Company does not intend to proceed with
further development of the Drug Formulation, such notice to be made promptly
after the Company makes such determination; or
(b)
the
date the Company notifies NTT that the Company does not intend to continue
to
commercialize Product(s) based upon NTT Formulation Technology, such notice
to
be made promptly after the Company makes such determination; or
(c)
The
later to occur of (i) date of expiration of the last valid registered NTT Patent
or Resulting Patent in the Territory upon which the Product, absent the License,
would infringe any Valid Patent Claim included in the registered NTT Patents
and/or Resulting Patent, or any portion thereof, and (ii) the end of a period
of
15 years from the date of making the First Commercial Sale pursuant to the
License.
4. Consideration
and Reporting.
4.1 License-fee
milestone payments.
In
consideration for the rights granted herein to the Company, the Company will
make the following non-refundable license-fee milestone payments to
NTT:
Milestone
|
Payment (in US Dollars)
|
|
Within 5 days
following the Effective Date
|
[***]
|
|
90
days from the Effective Day
|
[***]
|
|
The
earliest of (a) within 30 days of the first enrollment in any country
of
the first patient in a Phase III clinical trial study (or equivalent
clinical program outside of the United States) or, (b) 36 months
from
Effective Day.
|
[***]
|
|
The
earliest of (a) Within 30 days of first received Regulatory Approval
or,
(b) 72 months form the effective day.
|
[***]
|
4.2
Royalties.
In
addition to the fees set forth in Section 4.1 above, in consideration of the
rights granted to the Company by NTT hereunder, for sales of the Product by
the
Company, its Affiliates and Sublicensees, the Company shall pay to NTT a [***]%
royalty on Net Sales of the Product. No royalty shall accrue under this Section
4.2 on sales among the Company, its Affiliates and Sublicensees, unless the
Company or such Affiliate or Sublicensee is the end user of a
Product.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
10
4.3 Sub-License
Fee.
As
additional consideration for the license granted to the company the Company
shall pay NTT a Sub-License Fee of [***] percent ([***] %) of all Sub-License
Consideration for rights in the Drug Formulation or Product by Sublicensee.
Any
consideration paid to a third party for a license to patents covering the Drug
Formulation or Products, shall, in the event necessary to enable the
commercialization of the Product and related to NTT Formulation Technology,
and
subject to NTT's consent to such sub-license, which will not be unreasonably
withheld or delayed, be credited against the Royalties and Sub-License Fees
due
to NTT.
4.4 Reporting.
Ten (10)
days after the end of each Reporting Period, the Company shall furnish NTT
with
a report (herein "Periodic
Report")
detailing the total sales effected during the Reporting Period and the total
Royalties due to NTT in respect of that period (each, a "Royalty
Period").
The
Periodic Reports shall contain full particulars of all sales made by the Company
and/or Sub-Licensees and all of the proceeds obtained by the Company in respect
of granting Sub-Licenses, including sales broken down according to countries,
a
breakdown of the number of Products sold, discounts, returns, the currency
in
which the sales were made, invoice date and all other relevant information
enabling the Royalties and Sub-License Consideration payable to be calculated.
The Periodic Reports shall also specify any sale to an Affiliate and shall
set
forth full details thereof.
4.5 Terms
of Payment.
On the
date prescribed for the submission of each Periodic Report, the Company shall
pay the Royalties due to NTT in accordance with the Periodic Report; provided
that, for royalties due to NTT with respect to Net Sales of Products by the
Company's Sublicensees, such payment shall be due within the 30 days after
the
Company receives such royalties from such Sublicensee, but in no event later
than 60 days after the end of such calendar quarter.
All
amounts payable under this Section will first be calculated in United Stated
dollars after converted from the currency of sale. The buying rates involved
for
the currency of the United States into which the currencies involved are being
exchanged shall be the arithmetic averages of the ones quoted by the Western
Edition of The Wall Street Journal at the close of business on the last business
day of each calendar month of the applicable Royalty Period. In the event that
such publication no longer publishes such rates, another financial publication
mutually agreed on by the Parties shall be substituted.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
11
4.6 Payments
by the Company to NTT.
All
payments due under this Agreement shall be payable in United States dollars.
The
Company shall make all payments to NTT by bank wire transfer in immediately
available funds, or as otherwise specified by NTT in writing.
4.7 Records.
The
Company and its Affiliates shall maintain complete and accurate records of
the
Product made, used or sold by them or their Sublicensees under this Agreement,
and any amounts payable to NTT in relation to the Product, which records shall
contain sufficient information to NTT to confirm the accuracy of any reports
delivered to them in accordance with Section 4. The Company and its Affiliates
shall retain such records relating to a given Royalty Period for at least two
(2) years after the conclusion of that Royalty Period.
4.8 Audit
Rights.
NTT
(acting as the "Auditing
Party")
shall
have the right, at its own expense, to cause an independent certified public
accountant reasonably acceptable to the Company, to inspect such records of
the
Company or its Affiliates (the "Audited
Party")
during
normal business hours for the sole purpose of verifying any reports and payments
delivered under this Agreement. Such accountant shall be bound by a
confidentiality agreement, and shall not disclose to the Auditing Party any
information other than information relating to accuracy of reports and payments
delivered under this Agreement and shall provide the Audited Party with a copy
of any report given to the Auditing Party. The Parties shall reconcile any
underpayment or overpayment within 30 days after the accountant delivers the
results of the audit. The Auditing Party shall bear the full cost of the audit
unless the audit performed under this Section reveals an underpayment in excess
of [***]% in any Royalty Period, in which case the Audited Party shall bear
the
full cost of such audit. NTT may exercise its rights under this Section no
more
than once every calendar year and only with reasonable prior notice to the
Company. The Company shall require that its Affiliates and its Sublicensees
shall have the obligation to account and provide records to the Company for
all
their sales of Products as annual Net Sales by the Company.
4.9 Late
Payments.
In the
event that any payment, including royalty payments, due hereunder is not made
within 30 days of receiving written notice of the date due, the payment shall
accrue interest from that date due at the rate of [***]% per
month.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
12
4.10 Taxes.
Payment
of Value Added Tax (if charged) shall be added to each payment in accordance
with the statutory rate in force at such time. NTT shall pay any and all taxes
levied on account of royalties and other payments it receives under this
Agreement. If laws or regulations require that taxes be withheld, the Company
will deduct such taxes from the amount due to NTT, pay such taxes to the proper
tax authority, and send evidence of the obligation together with proof of
payment to NTT promptly after making such payment.
4.11 The
provisions of this Section 4 are material terms of the Agreement and the breach
thereof shall constitute a material breach of the Agreement.
5. Development
and Commercialization
5.1 Development
and Commercialization.
The
Company shall use commercially reasonable efforts to develop and commercialize
the Product. The Company undertakes, at its own expense, to carry out the
regulatory work necessary to receive regulatory approval for the Product in
a
timely manner.
5.2 Development
Reporting.
The
Company shall provide NTT with bi-annual reports, which shall proved a timeline
and description of the clinical studies to be conducted or which are in progress
during the six months prior to the report. Such report shall also set forth
a
general assessment regarding the completion date of the development of the
Product and the marketing thereof.
6.
Ownership
6.1 Ownership
by the Company.
All
rights to the Drug, and Company Confidential Information and New Company
Information shall be solely and exclusively owned by the Company, and no right,
title, and/or interest is granted, licensed, transferred, conveyed implicitly
or
explicitly to NTT.
6.2 Ownership
by NTT.
All
rights in the NTT Formulation Technology, Drug Formulation, Development Results
and Resulting Patents, except for the New Company Information, and all NTT
Patents and all NTT Confidential Information shall, as between the Parties,
be
solely owned by NTT.
NTT
shall
not include any Company Confidential Information in any regulatory application
or filing; and shall not, except in connection with the registration of patents,
as set forth in Section 8A below, include any Company Confidential Information
in any patent application.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
13
6.3 Execution
of Documents.
(a) NTT
will
at the expense of the Company execute all documents or instruments or take
such
other steps as shall be reasonably necessary to vest in the Company full title
to all patents in and to the Drug, free and clear of all liens, encumbrances,
agreements, understandings, requirements of charges, fees, rights, conditions
or
restrictions of any kind
b) The
Company will, at the expense of NTT execute all documents or instruments or
take
such other steps as shall be reasonably necessary to vest in NTT full title
to
all patents claiming and including the Drug Formulation and Development Results
free and clear of all liens, encumbrances, agreements, understandings,
requirements of charges, fees, rights, conditions or restrictions of any
kind.
6.4 Regulatory
Applications.
NTT
shall provide Company with the information and data relating to the Drug
Formulation and Product in order to permit Company in the filing and obtaining
regulatory approval for the Products. If needed, and if applicable NTT shall
provide the Company with the information and data relating to NTT Formulation
Technology and a cross reference letter to the NTT Formulation
Technology.
6.5 United
States Bankruptcy Code.
To the
extent applicable, in the event of the rejection of this Agreement by or on
behalf of either Party under Section 365 of the United States Bankruptcy Code
(the "Code"),
all
licenses and rights to licenses granted under or pursuant to this Agreement
by
one Party to the other are, and shall otherwise be deemed to be, for purposes
of
Section 365(n) of the Code, licenses of rights to "intellectual property" as
defined under Section 101(35A) of the Code The Parties agree that each Party,
as
the licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Code, and that upon
commencement of a bankruptcy proceeding by or against either Party under the
Code, the other Party shall be entitled to a complete duplicate of or complete
access to (as other Party deems appropriate), any such intellectual property
and
all embodiments of such intellectual property. Such intellectual property and
all embodiments thereof shall be promptly delivered to non-rejecting Party
(i)
upon any such commencement of a bankruptcy proceeding upon written request
therefore by the non-bankrupt Party, unless the bankrupt Party elects to
continue to perform all of its obligations under this Agreement or (ii) if
not
delivered under (i) above, upon the rejection of this Agreement by or on behalf
of a Party upon written request therefore by the other Party. The foregoing
provisions of Section 6.5 are without prejudice to any rights the non-bankrupt
Party may have arising under the Code or other applicable.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
14
7. Confidentiality
7.
1 Confidentiality
and Non-Use.
The
parties warrant and undertake towards each other that during the term of this
Agreement and subsequent thereto, they shall maintain full and absolute
confidentiality and shall also be liable for their respective employees and/or
representatives and/or persons acting on their behalf maintaining Confidential
Information of the other Party absolute confidentiality, which is in and/or
comes to their knowledge and/or that of their employees, representatives and/or
any person acting on their behalf directly in connection with this Agreement.
The parties undertake not to convey or disclose anything in connection with
the
foregoing to any entity. Neither Party may use Confidential Information of
the
other Party, without the other Party's prior written consent, except as
expressly permitted in this Agreement.
7.2 Exceptions.
The
obligations contained in Section 7.1 shall not apply to information which (a)
is
in the public domain as at the date hereof or to information which hereafter
comes into the public domain, unless due to a breach of the obligations pursuant
to this Agreement and as a result thereof the information comes into the public
domain, or (b) was lawfully in the receiving party's possession or control
prior
to the time such information was disclosed to such receiving party by the
disclosing party to whom the information relates, or (c) such information was
developed by the receiving party independently of and without reference to
the
Confidential Information of the disclosing party, or (d) such information was
lawfully obtained by the receiving party from a third party under no obligation
of confidentiality to the party to whom such information relates. Any
combination of features or disclosures shall not be deemed to fall within the
foregoing exclusions merely because individual features are published or
available to the general public or in the rightful possession of the Receiving
Party unless the combination itself and principle of operation are published
or
available to the general public or in the rightful possession of the Receiving
Party. Without derogating from the Company's obligations and liability
hereunder, the Company may disclose NTT's Confidential Information in the event
that such disclosure is necessary for the commercialization of the Product;
provided that any such disclosure shall be made to the minimum extent required
and subject to written confidentiality undertakings.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
15
7.3 Disclosure
to Governmental Entities.
Notwithstanding the obligations in Section 7.1, the Company may disclose the
other Party's Confidential Information to the extent that such disclosure is
made: (a) to governmental or other regulatory agencies as required thereby
in
order to protect Intellectual Property Rights or to gain or maintain approval
to
conduct clinical trials or to market Products under this Agreement; or (b)
otherwise as required to comply with applicable laws or regulations, or (c)
is
required to be disclosed by judicial, regulatory, or administrative process
or
agencies; provided that disclosure may be only to the minimal extent reasonably
necessary to obtain such patents or authorizations or comply with such
applicable law or regulation, and provided that reasonable steps are taken
to
ensure confidential treatment of such Confidential Information (if applicable
or
available). The Company will, in (b) and (c) above, provide NTT with prompt
notice so that it may seek a protective order or other appropriate
remedy.
In
the
event that NTT is requested or become legally compelled (by oral questions,
interrogatories, requests for information or documents, subpoena, civil
investigative demand or similar process) to disclose any Confidential
Information, NTT will provide the Company with prompt notice so that it may
seek
a protective order or other appropriate remedy and/or waive compliance with
the
provisions of this Agreement. In the event that such protective order or other
remedy is not obtained, NTT will furnish only that portion of the Confidential
Information that is legally required Further, Company acknowledges that if
NTT
is a public entity that NTT may be legally required to make public disclosures
(including in filings with the SEC or other agency) of certain material
developments or material Information generated under this Agreement and agrees
that Company may make such disclosures as required by law, subject to Company's
prior written consent to the content of such disclosure, which consent shall
not
be unreasonably withheld or delayed.
Confidential
Information that is disclosed as set forth in this Section 7.3, shall (except
for registration of patents) remain otherwise subject to the confidentiality
and
non-use provisions of this agreement, and the Party disclosing Confidential
Information pursuant to law or court order shall take all steps reasonably
necessary, including without limitation obtaining an order of confidentiality,
to ensure the continued confidential treatment of such Confidential
Information,
Further,
NTT acknowledges that Company may be legally required to make public disclosures
(including in filings with the SEC or other agency) of certain material
developments or material Information generated under this Agreement and agrees
that Company may make such disclosures as required by law, subject to NTT's
prior written consent to the content of such disclosure, which consent shall
not
be unreasonably withheld or delayed.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
16
7.4 Termination
of this Agreement.
The end
or termination of this Agreement shall not release the parties from their
obligations pursuant to this section.
8. Representations
Disclaimers and Warranties.
8.1 Mutual
Representations.
Each of
the Parties hereby represents to the other Party that: The execution and
delivery of this Agreement and the fulfillment of the terms hereof (i) will
not
constitute a default under or conflict with any agreement or other instrument
to
which he or it is a party or by which he or it is bound; and (ii) does not
require third party consents. This Agreement constitutes the valid and binding
obligation of such party enforceable against such party in accordance with
its
terms subject to applicable bankruptcy, insolvency, moratorium and similar
laws
affecting creditors' rights generally, and subject, as to enforceability, to
general principles of equity (regardless if enforcement is sought in a
proceeding in equity or at law).
8.2 Disclaimers.
Each
Party hereby acknowledges that the data and any materials to be provided to
such
Party by the other Party under this Agreement will be of an experimental nature,
provided without warranties, and neither Party shall accept any liability in
connection with their use by the other Party.
EXCEPT
AS
EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION
OR
WARRANTY TO THE OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR
A
PARTICULAR PURPOSE OR NON-INFRINGEMENT. WITHOUT LIMITING THE GENERALITY OF
THE
FOREGOING, EACH PARTY ACKNOWLEDGES THAT THIS AGREEMENT PROVIDES FOR AN
INNOVATIVE PROGRAM USING NEW TECHNOLOGIES AND THAT NO WARRANTY IS MADE REGARDING
THE SUCCESS OF ANY RESEARCH DONE PURSUANT TO THIS AGREEMENT OR THE UTILITY
OF
ANY INFORMATION, MATERIALS OR TECHNOLOGY PROVIDED HEREUNDER. EACH PARTY
EXPRESSLY DISCLAIMS ALL WARRANTIES AS TO THE VALIDITY OR SCOPE OF PATENTS AND
PATENT CLAIMS, ISSUED AND PENDING, PROTECTING ITS TECHNOLOGY OR THAT ANY
TECHNOLOGY WILL BE FREE FROM INFRINGEMENT OF PATENTS OR PROPRIETARY RIGHTS
OF
THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING PATENT
RIGHTS.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
17
8.3. NTT's
Representations and Warranties.
NTT
warrants and represents to the Company that:
(a) It
has
the ability, licenses, experience, and professional staff to perform all its
duties under this Agreement; the Development Plan shall be performed in a manner
and with professional diligence and skill;
(b) It
has
all the rights required in order to assign, grant, license, convey and transfer
any and all applicable rights under this Agreement to the Company, all of which
are free and clear of any liens, charges and encumbrances, and except for Yissum
in regard to NTT Patents, no other person, corporate or other private entity,
or
governmental entity or subdivision thereof, has or shall have any claim of
ownership whatsoever;
(c) Any
and
all Development Results, Drug Formulation, Products, and any Intellectual
Property Rights that result from the Development Plan and/or Development Results
and/or which cover the Drug Formulation and Product under this Agreement
Resulting Patents are made by NTT, and are not made, conceived or reduced to
practice by Hebrew University and/or Yissum, or any employee of Hebrew
University. Hebrew University and/or Yissum will have no rights, xxxxxx, or
interest in and to the Drug Formulation, Products, and Developmental Plan
Results, or Intellectual Property Rights that result from the Development Plan
and/or Development Results and/or which cover the Drug Formulation and Product
(d) NTT shall not assign, license, convey, transfer or grant rights or title
to
any Development Plan Results, and/or Drug Formulation, and/or Product; and/or
Intellectual Property Rights that result from the Development Plan and/or
Development Results and/or cover the Drug Formulation and Product to a third
party. It is hereby clarified that the above provision does not apply to NTT
Patents.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
18
(d) To
NTT's
knowledge, there are no claims, judgments or settlements against or owed by
NTT
and no pending or threatened claims or litigation relating to the NTT Patents
covering the NTT Formulation Technology.
8.3 The
Company's Representations and Warranties.
The
Company hereby represents and warrants to NTT that it is the owner of the Drug
and all Intellectual Property Rights therein and thereto and that NTT's use
of
the Drug in the performance of the Development Plan shall not constitute a
breach of any third party Intellectual Property Rights or other
rights.
8A. Intellectual
Property.
8A.l Company
Option.
The
Company has the first and exclusive option ("Option")
to
exercise file, prosecute and maintain any Intellectual Property Rights that
result from the Development Plan and/or Development Results, including Resulting
Patents and/or disclose and/or claim the Drug Formulation and Product
("Prosecute"
or
"Prosecution”)
in the
Territory. The Company (i) shall give NTT an opportunity to review the text
of
the patent documents in a timely manner before filing, and shall supply NTT
with
a copy of the patent documents and responses as filed; (ii) shall report and
provide NTT with all prosecution in a foreign jurisdiction in a timely manner,
(iii) promptly give notice to NTT of the grant, lapse, revocation, surrender,
invalidation or abandonment of patents filed under this Agreement. The Company
shall bear the fees and expenses related to the Prosecution of the patents
under
this section 8A.1 covering the Products.
In
the
event that Company does not exercise the Option, it shall so notify NTT and
NTT
shall
be
entitled to Prosecute.
8A.2 Interference,
Opposition, Reexamination and Reissue.
Each
Party shall, within ten (10) days of learning of an interference, opposition
proceeding, or reexamination and/or reissue of one of its patents in and to
the
Drug, NTT Formulation Technology, Drug Formulation, Development Results,
including Resulting Patents and/or Products, inform the other Party of any
request for, or filing or declaration of, any interference, opposition, reissue
or reexamination relating to the NTT Patents and Resulting Patents covering
the
Products. NTT and the Company shall thereafter consult and cooperate fully
to
determine a course of action with respect to any such proceeding and provide
any
information or assistance that the Company may reasonably request. The Company
shall take the lead and have the first, sole and exclusive right to defend,
respond, prosecute such actions hereunder; provided that no settlement shall
be
entered into without NTT's prior written consent which shall not be unreasonable
withheld.
The
Company shall bear the expense of any interference, opposition, reexamination,
or reissue proceeding.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
19
8A.3 Enforcement
and Defense.
Each
Party shall, promptly after it becomes aware of such an event, give the other
Party notice of any infringement of the [NTT and] Resulting Patents and any
misappropriation or misuse of NTT Formulation Technology or Drug Formulation
and/or proprietary know-how developed through the Development Plan. NTT and
the
Company shall thereafter consult and cooperate fully to determine a course
of
action with respect to any such proceeding, and NTT shall provide any
information or assistance that the Company may reasonably request. The Company
shall take the lead and have the first, sole and exclusive right to will defend,
respond, prosecute such actions hereunder; provided that no settlement shall
be
entered into without NTT's prior written consent which shall not be unreasonable
withheld.
9. Liability,
Indemnity and Insurance
9.1 Indemnification.
Each of
the Parties hereby agrees to indemnify, defend, and hold the other Party, its
officers, employees, and service providers, harmless from and against any
liability, damages, costs or expenses (including reasonable attorneys' fees)
resulting from any claim, demand, loss, injury, or liability of any kind or
nature made or incurred by any third party, as the case may be, arising from
(a)
any breach by the indemnifying party of its obligations hereunder (b) the
falsity or breach of any of the indemnifying party's representations, warranties
or covenants hereunder, or v) the gross negligence or willful misconduct. In
addition, (c) NTT will indemnify the Company and hold it harmless from and
against any claim or action alleging infringement of any patent, trademark,
copyright or other intellectual property of any third party by the manufacture,
sale or use of the Drug Formulation; and (d) the Company will indemnify NTT
and
hold it harmless from and against any claim or action alleging infringement
of
any patent, trademark, copyright or other intellectual property of any third
party by the use of the Drug.
9.2 Insurance.
Each
Party shall obtain and maintain throughout the term of this Agreement, insurance
policies covering its liabilities hereunder and liabilities resulting from
this
Agreement and the performance hereunder, for such insurance amounts as are
customary in the industry. Upon request from the other Party, each Party shall
deliver to the other Party a copy of such insurance policies.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
20
9.3 Limitation
of Liability.
UNDER
NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE FOR INCIDENTAL, INDIRECT, SPECIAL
OR CONSEQUENTIAL DAMAGES (HOWEVER ARISING) OF THE OTHER PARTY AND WHETHER IN
RESPECT OF DEATH, PERSONAL INJURY, DAMAGES TO OR LOSS OF PROPERTY OR EQUIPMENT,
INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFIT, LOSS OF USE, LOSS OF REVENUES
OR
DAMAGES TO BUSINESS OR REPUTATION ARISING FROM THE PERFORMANCE OR
NON-PERFORMANCE OF ANY ASPECT OF THIS AGREEMENT OR ANY PURCHASE ORDERS
THEREUNDER WHETHER OR NOT SUCH PARTY SHALL HAVE BEEN MADE AWARE OF THE
POSSIBILITY OF SUCH LOSS.
10. Termination
of the Agreement
10.1 Termination
due to Cease of Development or Commercialization.
In the
event that the Company decides to cease the development and commercialization
of
the Product, as set forth in Section 5, it shall promptly provide a notice
detailing the reasons for termination to NTT, and this Agreement shall
immediately terminate.
10.2 Material
Breach.
Either
party may terminate this Agreement at any time in the event of a material breach
by the other party of any of the terms and conditions of this Agreement,
subject, provided the non breaching party provide a 30 day notice detailed
the
nature of the breach and the other party does not cure the breach within 30
days.
10.3 Termination
by Either Party.
Either
Party may terminate this Agreement upon the occurrence of any of the following
events:
If
a
receiver or liquidator is appointed for the other Party and/or the other Party
passes a resolution for voluntary winding up or a winding up application is
made
against the other Party and not set aside within 60 days.
(b)
If an
attachment is made over the other Party's major assets and/or if execution
proceedings are taken against other Party and the same are not set aside within
60 days of the date the attachment is made or the execution proceedings are
taken.
The
Party
undergoing the events described above shall provide a written notice to the
first Party of the occurrence of such events.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
21
10.4 Effects
of Termination.
The
following provisions shall apply upon termination of this Agreement for any
reason:
(a)
The
provisions regarding confidentiality, non-use, and ownership, indemnification,
and insurance shall survive or termination of this Agreement howsoever caused.
Notwithstanding the aforesaid, the end or termination of this Agreement shall
not release the Company from its financial obligation incurred prior to the
Agreement's end or termination.
(b)
Each
Party shall, within 14 days after such termination, return to the other Party
or
destroy (which destruction shall he accompanied by a declaration of the CEO
of
Party, confirming such destruction) all Confidential Information and any
proprietary materials, information, databases and records, accounts, notes,
reports and data of the other Party, without maintain any copies thereof or
containing Confidential Information of the other Party.
11. Relationship
between the Parties.
It
is
hereby agreed and declared between the parties that they shall act in all
respects relating to this Agreement as an independent contractor and there
neither is nor shall be agent relationship and/or partnership in the
relationship between them.
12.
Law
The
provisions of this Agreement and everything concerning the relationship between
the parties in accordance with this Agreement shall be governed solely by
Israeli law and both Parties consent to exclusive jurisdiction by the competent
courts of the Tel Aviv-Jaffa district.
13.
Miscellaneous
13.1 Assignment.
The
Parties may not transfer and/or assign and/or endorse their rights and/or duties
and/or any of them pursuant to this Agreement to another.
13.2 Binding
Effect. This
Agreement and all rights and obligations hereunder shall inure to the benefit
of
and be binding upon the Parties, their Affiliates, and their respective lawful
successors and assigns (including, without limitation, any successor to a Party
upon a Change of Control).
13.3 Waiver.
The
failure or delay of a Party to the Agreement to claim the performance of an
obligation of the other Party shall not be deemed a waiver of the performance
of
such obligation.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
22
13.4 Full
Agreement.
This
Agreement constitutes a full and complete Agreement between the Parties with
respect to the subject matter hereof, and may only be amended by a document
signed by both parties.
13.5 Notices.
All
notices and communications pursuant to this Agreement shall be made in writing
and sent to or served at the following addresses:
NTT:
|
Novel
Therapeutic Technologies Inc.
|
POB
12006,
|
|
7
Yad Harutzim
|
|
Herzliya
Pituach 00000
|
|
XXXXXX
|
|
Tel
- 000-0-000-0000
|
|
Fax
- 000-0-000-0000
|
|
Attention
Xxx Xxxxxxx
|
|
With
a copy to: Gross, Kleinhendler, Hodak, Berkman & Co. Law
Offices
|
|
One
Azrieli Xxxxxx (Xxxxx Xxxxxxxx)
|
|
Xxx
Xxxx 00000, Xxxxxx
|
|
Tel:
x000-0-0000000
|
|
Fax:
x000-0-0000000
|
|
Attention:
Adv. Xxxxxxx X. Xxxxx
|
|
The
Company:-
|
|
000
Xxxx Xxxxx Xxxxxx, Xxxxx 000
|
|
Xxxxxxxx,
Xxx Xxxxxx 00000
|
|
Tel:
000-000-0000
|
|
Fax:
000-000-0000
|
|
Attention:
Xx. Xxxx Xxxxxxxxx
|
|
With
a copy to
|
|
Xxxxx
Xxxxx Zedek Xxxxxx, LLP
|
|
0000
Xxxxxxxx, 00xx Xxxxx
|
|
Xxx
Xxxx, XX 00000
|
|
Tel:
000-000-0000
|
|
Fax:
000-000-0000
|
|
Attention:
Xxxx X. Xxxxx
|
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
23
or
such
other address furnished in writing by one party to the other. If the notice
is
sent by registered mail, it shall be deemed to have been received seven days
after being posted by registered mail, if by facsimile, within one business
day
and if in person, upon actual delivery.
IN
WITNESS THE HANDS OF THE PARTIES
THE
COMPANY
|
||||
By:
|
/s/
Xxx Xxxxxxx
|
By:
|
/s/ Xxxx Xxxxxxxxx | |
Name:
|
Xxx
Xxxxxxx
|
Name:
|
Xxxx Xxxxxxxxx, MD, PhD | |
Title:
|
CEO
|
Title:
|
President & CEO | |
Date:
|
January
20, 2008
|
Date:
|
January
20, 2008
|
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
24
Exhibit
A
Development
Plan
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
25
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
26
Exhibit
B
The
Drug
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
27
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
28
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
29
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
30
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
31
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
32
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
33
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
34
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
35
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
36
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
37
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
38
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
39
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
40
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
41
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
42
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
43
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
44
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
45
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
46
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
47
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
48
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
49
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
50
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
51
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
52
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
53
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
54
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
55
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
56
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
57
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
58
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
59
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
60
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
61
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the
Company’s
application requesting confidential treatment under Rule 24b-2 of the
Securities
Exchange Act of 1934.
62
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
63
Provid
Number
|
Lab
Journal Reference
|
Molecular
Formula
|
Molecular
Weight
|
Structure
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Portions
of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities
Exchange Act of 1934.
64