LICENSE AGREEMENT
CONFIDENTIAL
MATERIALS OMITTED AND FILED SEPARATELY WITH
THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
EXHIBIT
10.16
THIS
LICENSE AGREEMENT (the “Agreement”) is entered into as
of this 25 day of November, 2007 (the “Effective Date”), by and among
BioLine Innovations Jerusalem, LP, a limited partnership formed and existing
under the laws of the State of Israel, having a place of business at 00 Xxxxxx
Xxxxxx, X.X. Xxx 00000, Xxxxxxxxx, 00000, Xxxxxx (“BioLine”), and Innovative
Pharmaceutical Concepts (IPC) Inc., a company formed and existing under the laws
of the British Virgin Islands, having a place of business at Xxxxxx Xxxxx, 0xx
Xxxxx, 333 Waterfront Drive, P.O. Box 3339, Road Town, Tortola, British Virgin
Islands (“Licensor”).
WHEREAS,
Licensor is the owner of inventions related to Pharmaceutical Preparations
useful for Treating Tumors and Lesions of the Skin; and
WHEREAS,
BioLine wishes to obtain an exclusive license with respect to the foregoing
invention(s) in order to develop and commercialize products based thereon, and
Licensor wishes to grant BioLine a license with respect thereto, all in
accordance with the terms and conditions of this Agreement;
NOW, THEREFORE, for good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties hereto, intending to be legally bound, hereby agree as
follows:
1. Definitions.
Whenever
used in this Agreement with an initial capital letter, the terms defined in this
Section 1, whether used in the singular or the plural, shall have the meanings
specified below.
“Additional Ingredient” shall
mean any compound or substance which (i) is contained in a product and (ii) when
administered to a patient has a therapeutic or prophylactic clinical effect
independent of a Licensed Product, either directly or by acting synergistically
with or otherwise enhancing the effect of other compounds or substances
contained in such product.
“Affiliate” shall mean, with
respect to a party, any person, organization or entity controlling, controlled
by or under common control with, such party, including, with respect to a
limited partnership, its limited partners, general partners, and any person,
organization or entity controlling, controlled by or under common control with,
such party. For purposes of this definition only, “control” of
another person, organization or entity shall mean the possession, directly or
indirectly, of the power to direct or cause the direction of the activities,
management or policies of such person, organization or entity, whether through
the ownership of voting securities, by contract or otherwise. Without
limiting the foregoing, control shall be presumed to exist when a person,
organization or entity (i) owns or directly controls fifty percent (50%) or more
of the outstanding voting stock or other ownership interest of the other
organization or entity, or (ii) possesses, directly or indirectly, the power to
elect or appoint fifty percent (50%) or more of the members of the governing
body of the organization or other entity.
1
“Calendar Quarter” shall mean
the respective periods of three (3) consecutive calendar months ending on March
31, June 30, September 30 or December 31, for so long as this Agreement is in
effect.
“Combination Product” shall
mean a product, substance or devise which comprises a Licensed Product and at
least one Additional Ingredient.
“Commercially Reasonable
Efforts” shall mean (i) with respect to any objective by an entity,
reasonable, diligent, good faith efforts to accomplish such objective as other
entities in the business of such entity (together with its Affiliates as a
group) would normally use in the ordinary course of business and research to
accomplish a similar objective under similar circumstances; and (ii) with
respect to research, development and commercialization of any Licensed Product
hereunder, shall mean those efforts and resources normally used by other
entities in the business of such entity (together with its Affiliates as a
group) for a product owned by it or to which it has rights, which is of similar
market potential at a similar stage in its development or product life as such
Licensed Product.
“Development Plan” shall have
the meaning set out in Section 5.1.
“Development Results” shall
mean all data, summaries, analyses, reports and other results and information
relating to the Licensed Technology generated by or on behalf of BioLine in the
exercise of its rights and its performance under this Agreement.
“First Commercial Sale” shall
mean the first sale of a Licensed Product by BioLine, an Affiliate of BioLine or
a Sublicensee to an unaffiliated third party after Regulatory Approval has been
achieved in the country in which such Licensed Product is sold. Sales
for test marketing, sampling and promotional uses, clinical trial purposes or
compassionate or similar use shall not be considered to constitute a First
Commercial Sale.
“FDA” shall mean the United
States Food and Drug Administration.
“Government Programs” shall
mean the Biotech Incubators Program of the Office of the Chief Scientist of the
Israeli Ministry of Industry and Trade, and any other funding programs sponsored
by the Israeli or other governments.
“Grants” shall mean any funds
or benefits received by BioLine from governmental, quasi-governmental or other
non-profit sources for the development of Licensed Products or other benefits,
including but not limited to grants provided within the context of Government
Programs.
“IND” shall mean (i) an
Investigational New Drug Application, as defined in the U.S. Federal Food, Drug,
and Cosmetic Act, as amended, and the regulations promulgated thereunder, that
is required to be filed with the FDA before beginning clinical testing of a
Licensed Product in human subjects, or any successor application or procedure,
and (ii) any comparable application filed with a Regulatory Agency in any other
country or jurisdiction.
2
“Licensed Product” shall mean
any product that comprises, contains or incorporates Licensed
Technology.
“Licensed Technology” shall
mean the Licensed Patents, and all inventions, know-how and other intellectual
property owned by or licensed to Licensor related thereto.
“Licensed Patents” shall mean
(i) the patents and/or patent applications set forth on Exhibit A attached
hereto, (ii) all national-phase member patents and patent applications
corresponding thereto, (iii) all improvements, updates, modifications and
enhancements thereto made by Licensor by the Effective Date (if any), and (iv)
all provisional applications, continuations, continuations-in-part, divisions,
reissues, renewals, and patents granted thereon, all patents-of-addition,
reissue patents, re-examinations and extensions or restorations by existing or
future extension or restoration mechanisms, including, without limitation,
supplementary protection certificates or the equivalent thereof, all related to
the foregoing. Exhibit A shall
include and shall be updated from time to time to reflect inclusion of new
Licensed Patents.
“M&A Transaction” shall
mean a transaction in which all or substantially all of the partnership
interests of BioLine and/or all or substantially all of the assets or share
capital of its general and/or limited partner(s) are acquired by or assigned to
a third party.
“Net Sales” shall mean the
gross amount billed or invoiced by or on behalf of BioLine and/or its Affiliates
(the “Invoicing Entity”)
on sales of Licensed Products (whether made before or after the First Commercial
Sale of the Licensed Product), less the following:
(a) customary trade, quantity, or cash discounts to the extent actually allowed
and taken; (b) amounts repaid or credited by reason of rejection or return; (c)
to the extent separately stated on purchase orders, invoices, or other documents
of sale, any taxes or other governmental charges levied on the production, sale,
transportation, import, export, delivery, or use of a Licensed Product which is
paid by or on behalf of the Invoicing Entity; (d) payment to one or more third
parties to obtain a Third Party License from such third party(ies) in order to
practice the Licensed Technology; and (e) outbound transportation, packing and
delivery charges, as well as prepaid freight (including shipping insurance)
actually incurred; provided,
however, that:
(i) In
any transfers of Licensed Products between the Invoicing Entity and an Affiliate
of the Invoicing Entity not for the purpose of resale by such Affiliate, Net
Sales shall be equal to the fair market value of the Licensed Products so
transferred, assuming an arm’s length transaction made in the ordinary course of
business; and
(ii) In
the event that the Invoicing Entity, or the Affiliate of the Invoicing Entity,
receives non-monetary consideration for any Licensed Products or in the case of
transactions not at arm’s length with a non-Affiliate of the Invoicing Entity,
Net Sales shall be calculated based on the fair market value of such
consideration or transaction, assuming an arm’s length transaction made in the
ordinary course of business.
3
Sales of
Licensed Products by an Invoicing Party to an Affiliate of such Invoicing Party,
for resale by such Affiliate, shall not be deemed Net Sales and Net Sales shall
be determined based on the total amount invoiced or billed by such Affiliate on
resale to an independent third party purchaser.
“Regulatory Agency” shall mean
the FDA or equivalent agency or government body of another country.
“Regulatory Approval” shall
mean (i) approval by the FDA permitting commercial sale of a Licensed Product,
or (ii) any comparable approval permitting commercial sale of a Licensed Product
granted by the applicable Regulatory Agency in any other country or
jurisdiction.
“Sublicense” shall mean any
right granted, license given, or agreement entered into, by BioLine to or with
any other person or entity, under or with respect to or permitting any use of
any of the Licensed Technology (or any part thereof) or otherwise permitting the
development, manufacture, marketing, distribution and/or sale of Licensed
Products (regardless of whether such grant of rights, license given or agreement
entered into is referred to or is described as a sublicense or as an agreement
with respect to the development and/or manufacture and/or sale and/or
distribution and/or marketing of Licensed Products).
“Sublicense Receipts” shall
mean any payments or other consideration that BioLine or an Affiliate of BioLine
actually received in connection with a Sublicense, or the grant of an option to
obtain a Sublicense, including without limitation royalties, license fees,
milestone payments, license maintenance fees and equity; provided, however, that in
the event that BioLine or an Affiliate of BioLine receives non-monetary
consideration in connection with a Sublicense or the grant of an option to
obtain a Sublicense or in the case of transactions not at arm’s length,
Sublicense Receipts shall be calculated based on the fair market value of such
consideration or transaction, assuming an arm’s length transaction made in the
ordinary course of business; and provided further that
Sublicensing Receipts will be reduced by any amounts returned by BioLine or an
Affiliate to a Sublicensee on account of refunds or rebates given in respect of
Sublicense Receipts or payment to one or more third parties to obtain a Third
Party License from such third party(ies) in order to practice the Licensed
Technology. For the avoidance of doubt, Sublicensing Receipts shall
not include any amounts received as Grants, in connection with Government
Programs, or otherwise as research grants from national or international
not-for-profit funding bodies, or in connection with an M&A
Transaction.
“Sublicensee” shall mean a
person or entity granted a Sublicense in accordance with Section 2.2, including
any sublicensees of other Sublicensees.
“Third Party License” shall
mean a license from an unaffiliated third party to one or more valid and
enforceable patents issued in the United States or any other jurisdiction, the
claims of which cover one or more functional components that is essential for
the efficacy of the Licensed Product.
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“Trial” shall mean a clinical
trial or trials performed by BioLine or a third party engaged by BioLine either
in countries of the European Union or in the USA, as part of Phase I and Phase
II clinical trials, pursuant to which treatment based on the Licensed Technology
is administered to not less than sixty (60) subjects. It is agreed that
following the receipt of the Trial's Final Clinical Study Report from the
Clinical Research Organization (CRO), it shall have the right to treat more
subjects in Israel.
2. License Grant.
2.1. License. Subject to
the terms of this Agreement, Licensor hereby grants to BioLine an exclusive,
worldwide license under Licensor’s rights in the Licensed Technology to
research, have researched, develop, have developed, manufacture, have
manufactured, use, market, distribute, offer for sale, sell, have sold, export
and import Licensed Products and/or provide services relating thereto, and to
conduct or have conducted clinical trials. For purposes of this
Section 2.1, the term “exclusive” means that Licensor shall not have any right
to grant such licenses or rights to any third party or engage in any of the
foregoing.
2.2. Sublicenses.
2.2.1. Sublicense Grant. BioLine shall be
entitled to grant Sublicenses or other rights to third parties under the license
granted pursuant to Section 2.1. Such Sublicenses shall be made for
consideration and in arm’s length transactions.
2.2.2. Sublicense
Agreements. Sublicenses shall only be granted pursuant to
written agreements. BioLine shall provide Licensor with a copy of
each sublicense agreement within (30) days of receipt of an executed draft
thereof from the Sublicensee. Each such sublicense agreement shall
contain, inter alia,
provisions to the following effect:
2.2.2.1. All provisions
necessary to ensure BioLine’s ability to perform its obligations under this
Agreement, including reporting and audit requirements;
2.2.2.2. In the
event of termination of the license set forth in Section 2.1 above (in whole or
in part – e.g. termination in a particular country), any existing agreements
that contain a Sublicense of, or other grant of right with respect to, Licensed
Technology shall terminate to the extent of such Sublicense or other grant of
right; provided,
however, that, for each Sublicensee, upon termination of the Sublicense
agreement with such Sublicensee, if the Sublicensee is not then in breach of
such Sublicense agreement with BioLine such that BioLine would have the right to
terminate such Sublicense, Licensor shall be obligated, at the request of such
Sublicensee, to enter into a new agreement with such Sublicensee on
substantially the same terms as those contained in such Sublicense agreement;
and provided, further,
that such terms shall be amended, if necessary, to the extent required to ensure
that such Sublicense agreement does not impose any obligations or liabilities on
Licensor which are not included in this Agreement; and
5
2.2.3. A
Sublicensee shall be entitled to Sublicense its rights under a Sublicense
agreement, and so forth through a chain of sublicenses, provided that each such
sublicense shall be subject to execution of a written agreement consistent with
the terms of this Section, and shall be made for consideration and in arm’s
length transactions.
2.3. Contractors and
Affiliates. BioLine shall have the right to utilize third
party contractors in connection with BioLine’s activities in exploiting the
license granted hereunder. Provided that such contractors perform
activities on BioLine’s behalf, and BioLine
maintains control of and remains solely responsible for such activities, the
provisions of Section 2.2 shall not apply with respect to such
contractors. Sublicenses to Affiliates of BioLine shall not be
considered Sublicenses under this Agreement.
3. Title.
Subject
to the license granted to BioLine pursuant to the terms of this Agreement, all
rights, title and interest in and to the Licensed Technology are and shall be
owned solely and exclusively by Licensor. Licensor shall not accept
any funding from any third party for research relating or connected to the
Licensed Technology without the prior written consent of BioLine.
4. Patent
Filing, Prosecution and Maintenance.
4.1. Filing, Prosecution and
maintenance. BioLine shall have the first right to prepare,
file, prosecute and maintain any patent applications and patents, in respect of
the Licensed Technology and/or any part thereof, and at BioLine’s sole expense,
provided that such patent applications and patents shall be registered in the
name of Licensor. BioLine shall provide Licensor with copies of all
patent applications and Licensor undertakes to cooperate in a timely manner with
BioLine’s efforts to register the patent, including by executing any documents
as may be required for such purpose. BioLine shall have to pay, on
time, all future payments necessary to prosecute and maintain all patent
applications and/or patents in respect of the Licensed Technology, as set forth
on Exhibit A
attached hereto, and all patent applications and/or patents which BioLine
decided to file under this Section 4.1.
4.2. [***]
4.3 Consultation. BioLine
shall consult with Licensor regarding the preparation, filing and prosecution of
all patent applications, and the maintenance of all patents, included within the
Licensed Patents, including, without limitation, the content, timing and
jurisdiction of the filing of such patent applications and their prosecution,
and other details and overall global strategy pertaining to the procurement and
maintenance of the Licensed Patents. To avoid doubt, Licensor and
BioLine may agree not to pursue the filing and/or maintenance of patents in
certain jurisdictions. All Licensed Patents shall be filed,
prosecuted and maintained by the parties through a law or patent attorney firm
selected by BioLine, subject to Licensor’s approval, not to be unreasonably
withheld. BioLine shall reimburse Licensor for all documented
patent-related expenses incurred by Licensor with respect to the filing,
prosecution and maintenance of the Licensed Patents within thirty (30) days
after Licensor invoices BioLine in respect thereof; provided, however, that (i)
BioLine is copied on all correspondence in respect of the aforementioned filing,
prosecution and maintenance activities, and (ii) all such expenses are approved
in advance and in writing by BioLine.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
6
4.4. No
Warranty. Nothing contained herein shall be deemed to be a
warranty by any of the parties that they can or will be able to obtain patents
on patent applications included in the Licensed Patents, or that any of the
Licensed Patents will afford adequate or commercially
worthwhile protection.
5. Diligence
and Information Exchange.
5.1. Diligence. BioLine
shall use Commercially Reasonable Efforts, and/or shall cause its Affiliates
and/or Sublicensees to use Commercially Reasonable Efforts, to develop Licensed
Products based upon the road-map and timetable for the development of the
Licensed Products in accordance with a development plan (the “Development Plan”) set out in
Exhibit B attached hereto. It is understood that the Development Plan
is subject to change at BioLine’s discretion in order to meet the development
obligations set out above. Notwithstanding the foregoing, BioLine
shall [***]. It is hereby agreed that BioLine shall consider in good faith to
further invest in research and development based on the Licensed Technology,
including the design of a disposable pen-like application device, improvement of
tissue preservation and histopathology and treatment of additional skin
conditions such as viral and/or fungal infections of the skin.
5.2. Steering Committee, Consultation and
Progress Reports. The parties shall establish a steering
committee (the “Committee”) to oversee the
exercise of the License. Each party shall be entitled to designate
one representative to the Committee (the “Representative”), which shall
meet at least twice per calendar year. The Representatives shall be
bound by the confidentiality arrangements set out in this
Agreement. BioLine agrees to consult with Licensor, via the Licensor
Representative, in respect of significant decisions related to the exercise of
the License. In the context of the Steering Committee, BioLine shall
(i) provide Licensor via Licensor’s Representative with periodic reports
concerning all material activities undertaken in respect of the exercise of the
License, and (ii) keep Licensor fully informed via Licensor’s Representative
concerning all material activities undertaken in respect of the exercise of the
License. For the avoidance of doubt, the Committee shall be a forum
for the exchange of information between the parties with respect to the
foregoing, shall act only in an advisory capacity and shall not have any
decision-making powers.
[***]
Omitted
pursuant to a confidential treatment request. The confidential portion has been
filed separately with the SEC.
7
5.3. Grants and Government
Programs. Licensor acknowledges and agrees that BioLine may
apply for Grants as part of Government Programs for the funding of the
development and commercialization of Licensed Products. Licensor
agrees to perform such further acts and execute such further documents as may
reasonably be necessary to support the preparation and submission of the
aforementioned Grants. If BioLine receives Grants and the associated
Government Programs so require, this Agreement will become subject to the
applicable laws and regulations governing such Grants including, without
limitation, the Law for the Encouragement of Industrial Research and
Development, 5744-1984 as amended or supplemented from time to time and all
regulations promulgated thereunder, the rules and regulations of the Office of
the Chief Scientist (the “OCS”) and the relevant
directives of the Director General of the Ministry of Trade, Industry and
Employment, and the rules and regulations of the Incubator Program of the
OCS.
6. Consideration.
6.1. Payments. Subject to the terms below, BioLine shall pay Licensor a license fee of
[***]
(the “Licensee
Fee”). The License Fee shall be
payable as follows:
6.1.1. [***] shall be paid
to Licensor within ten (10) days following
the execution of this Agreement.
6.1.2. [***]
6.1.2.1. [***]
6.1.2.2. [***]
6.1.3. [***]
[***]
Omitted
pursuant to a confidential treatment request. The confidential portion has been
filed separately with the SEC.
8
6.1.4. The
License Fee shall be non-refundable.
6.2 Royalty Payments. In the event that BioLine itself will
actually manufacture and/or sell Licensed Products under the license, then
BioLine will pay to Licensor [***]of Net Sales on a
Licensed Product-by-Licensed Product and country-by-country basis until the last
to expire of any patent included within the Licensed Technology in such
country.
6.3. Payments on Sublicense
Receipts. BioLine shall pay Licensor an amount equal to [***]
of all Sublicense Receipts received by BioLine from the exploitation of the
license granted hereunder (the “Sublicense
Payment”).
6.4. Combination
Products. Notwithstanding anything to the contrary set forth
herein, in the event a Licensed Product is sold by BioLine or an Affiliate of
BioLine in the form of a Combination Product, Net Sales from such Combination
Product, for purposes of determining royalty payments, shall be determined by
multiplying the actual Net Sales of such Combination Product during the
applicable royalty reporting period, by the fraction A/(A+B) where: “A” is the
average sale price of the Licensed Product contained in the Combination Product
when sold separately by BioLine or its Affiliate; and “B” is the average price
of the other Additional Ingredients included in the Combination Product when
sold separately by its supplier, in each case during the applicable royalty
reporting period or if sales of both the Licensed Product and/or other
Additional Ingredients did not occur in such period, then in the most recent
royalty reporting period in which sales of both occurred. In the
event that such average sale price cannot be determined for both the Licensed
Product and all other Additional Ingredients included in the Combination
Product, Net Sales for the purpose of determining royalty payments shall be
calculated by multiplying the Net Sales of the Combination Products by the
fraction of C/(C+D) where “C” is the fair market value of the Licensed Product;
and “D” is the fair market value of all other Additional Ingredients included in
the Combination Product. In such event, the parties shall negotiate
in good faith to arrive at a determination of the respective fair market values
of the Licensed Product and all other Additional Ingredients included in the
Combination Product.
7. Reports,
Payments and Records.
7.1. Reports
and Payments.
7.1.1. Reports. Within thirty (30) days
after the conclusion of each Calendar Quarter commencing with the first Calendar
Quarter in which BioLine or an Affiliate of BioLine first receives Net Sales or
Sublicense Receipts, BioLine shall deliver to Licensor a report containing the
following information:
(a) the
number of units of Licensed Products sold by BioLine and its Affiliates in each
country for the applicable Calendar Quarter;
(b) the
gross amount billed for the Licensed Product sold by BioLine and its Affiliates
in each country during the applicable Calendar Quarter;
[***]
Omitted
pursuant to a confidential treatment request. The confidential portion has been
filed separately with the SEC.
9
(c) a
calculation of Net Sales for the applicable Calendar Quarter in each country,
including a listing of applicable deductions;
(d) the
total amount payable to Licensor in U.S. dollars on Net Sales for the applicable
Calendar Quarter, together with the exchange rates used for conversion on the
date that the sale was recognized in accordance with IFRS (IAS 21);
and
(e) a
calculation of any Sublicense Receipts for the applicable Calendar
Quarter.
The
report shall state if no amounts are due to Licensor for any Calendar
Quarter.
7.1.2. Payment. Concurrent
with the delivery of each report delivered pursuant to Section 7.1.1, BioLine
shall remit to Licensor all amounts due pursuant to Section 6 for the applicable
Calendar Quarter.
7.2. Records. BioLine
shall maintain, and shall cause its Affiliates and Sublicensees to maintain,
complete and accurate records of Licensed Products that are made, used, marketed
or sold under this Agreement, any amounts payable to Licensor in relation to
such Licensed Products and all Sublicense Receipts received by BioLine and its
Affiliates, which records shall contain sufficient information to permit the
Licensor to confirm the accuracy of any reports or notifications delivered to
Licensor under Section 7.1. The relevant party shall retain such
records relating to a given Calendar Quarter for at least seven (7) years after
the conclusion of that Calendar Quarter. During such seven (7) year
period, Licensor shall have the right, at Licensor’s expense, to cause an
independent, certified public accountant, who is bound by a suitable
confidentiality arrangement with BioLine, to inspect BioLine’s and the relevant
Affiliates’ records during normal business hours for the sole purpose of
verifying any reports and payments delivered under this
Agreement. Such accountant shall not disclose to Licensor or any
third party any information gained during the course of such inspection, except
that such accountant may disclose to Licensor and BioLine information gained
during the course of such inspection relating to the accuracy of reports and
payments delivered under this Agreement. The parties shall reconcile
any underpayment or overpayment within thirty (30) days after the accountant
delivers the results of the audit. In the event that any audit
performed under this Section 7.2 reveals an underpayment in excess of five
percent (5%) in any calendar year, the audited party shall bear the full cost of
such audit. Licensor may exercise its rights under this Section 7.2
only twice every year per audited party and only with twenty (20) business days
prior notice to the audited party. BioLine shall cause its Affiliates
and Sublicensees to comply with the terms of this Section 7.2.
7.3. Audited
Report. BioLine shall furnish Licensor, and shall cause its
Affiliates who make, use, market or sell Licensed Products to furnish Licensor,
within ninety (90) days after the end of each calendar year, commencing at the
end of the calendar year of the First Commercial Sale, with a report, certified
by an independent certified public accountant, relating to royalties and other
payments due to Licensor pursuant to this Agreement in respect to the previous
calendar year and containing the same details as those specified in Section 7.1
in respect to the previous calendar year.
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7.4. Payment
Method. Each payment due to Licensor under this Agreement
shall be made by wire transfer of funds to Licensor’s accounts in accordance
with written instructions provided by Licensor.
7.5. Withholding and Similar
Taxes. If applicable laws require that taxes be withheld from
any amounts due to Licensor under this Agreement, BioLine shall (a) deduct these
taxes from the remittable amount, (b) pay the taxes to the proper taxing
authority, and (c) promptly deliver to Licensor a statement including the amount
of tax withheld and justification therefore, and such other information as may
be necessary for tax credit purposes. For the avoidance of doubt, all
amounts to be paid to Licensor pursuant to this Agreement are exclusive of Value
Added Tax. BioLine shall add value added tax, as required by law, to
all such amounts.
11
8. Confidential
Information
8.1. Confidentiality.
8.1.1. Licensor Confidential
Information. BioLine agrees that, without the prior written
consent of Licensor, in each case, during the term of this Agreement and for a
period of seven (7) years from date of disclosure, it will keep confidential,
and not disclose or use Licensor Confidential Information (as defined below)
other than for the purposes of this Agreement. BioLine shall treat
such Licensor 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. BioLine may disclose the
Licensor Confidential Information only (a) to employees and consultants of
BioLine or of its Affiliates or Sublicensees who have a “need to know” such
information in order to enable BioLine to exercise its rights or fulfill its
obligations under this Agreement and are legally bound by agreements which
impose confidentiality and non-use obligations comparable to those set forth in
this Agreement, and (b) to actual and potential business partners,
collaborators, investors, contractors, service providers and consultants, provided, however, in each
case, that such recipient of Confidential Information first enters into a
legally binding agreement with BioLine which imposes confidentiality and non-use
obligations with respect to Confidential Information comparable to those set
forth in this Agreement and has a minimum term of five (5) years from date of
signature of the binding agreement. For purposes of this Agreement,
“Licensor 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 the Licensor or
any of its employees or researchers to BioLine, whether in oral, written,
graphic or machine-readable form, except to the extent
such information: (i) was known to BioLine at the time it was disclosed, other
than by previous disclosure by or on behalf of the Licensor or any of its
employees or researchers, as evidenced by BioLine’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 BioLine by a third party who is not subject to
obligations of confidentiality to the Licensor with respect to such information;
(iv) is explicitly approved for release by written authorization of Licensor;
(v) is required by law or court order to be disclosed; or (vi) is independently
developed by BioLine without the use of or reference to the Licensor
Confidential Information, as demonstrated by documentary evidence.
8.1.2. BioLine Confidential
Information. Licensor agree that,
without the prior written consent of BioLine, in each case, during the term of
this Agreement and for a period of seven (7) years thereafter, it will keep
confidential, and not disclose or use BioLine Confidential Information (as
defined below) other than for the purposes of this
Agreement. Licensor shall treat such BioLine 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. Licensor may disclose the BioLine Confidential
Information only to employees and consultants of Licensor or of its Affiliates
who have a “need to know” such information in order to enable Licensor to
exercise its rights or fulfill its obligations under this Agreement and 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, “BioLine
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 BioLine
pursuant to this Agreement, whether in oral, written, graphic or
machine-readable form, except to the extent
such information: (i) was known to Licensor at the time it was disclosed, other
than by previous disclosure by or on behalf of BioLine as evidenced by
Licensor’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
Licensor by a third party who is not subject to obligations of confidentiality
to BioLine with respect to such information; (iv) is explicitly approved for
release by written authorization of BioLine; (v) is required by law or court
order to be disclosed; or (vi) is independently developed by Licensor without
the use of or reference to the BioLine Confidential Information, as demonstrated
by documentary evidence.
12
8.2. Disclosure of
Agreement. 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 Section 8.2, 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.
8.3. Publicity. Without
derogating from Section 8.2, BioLine may make announcements, publications,
presentations and similar disclosures (i) relating to the subject matter of this
Agreement, (ii) in connection with the marketing or sale of any Licensed
Products, or (iii) in respect of the progress of the exercise of the license
granted hereunder without the approval of Licensor, provided, however, that in so
doing BioLine does not disclose any Licensor Confidential Information without
having obtained the prior written consent of Licensor. Except as
provided in the immediately preceding sentence, no party will make any public
announcement regarding this Agreement without the prior written approval of the
other party.
9. Patent
Infringement.
9.1 Enforcement
of Patent Rights.
9.1.1. Notice. In the
event any party becomes aware of any possible or actual infringement or
unauthorized possession, knowledge or use of any Licensed Patents (collectively,
an “Infringement”), that
party shall promptly notify the other parties and provide them with details
regarding such Infringement.
13
9.1.2. Suit by BioLine. BioLine shall have the
right, but not the obligation, to take action in the prosecution, prevention, or
termination of any Infringement of Licensed Patents. Should BioLine
elect to bring suit against an infringer and Licensor is joined as party
plaintiff in any such suit, Licensor shall have the right to approve the counsel
selected by BioLine to represent BioLine and Licensor, such approval not to be
unreasonably withheld. The expenses of such suit or suits that
BioLine elects to bring, including any expenses of Licensor incurred in
conjunction with the prosecution of such suits or the settlement thereof, shall
be paid for entirely by BioLine and BioLine shall hold Licensor free, clear and
harmless from and against any and all costs of such litigation, including
reasonable attorneys’ fees. BioLine shall not compromise or settle
such litigation without the prior written consent of Licensor, which consent
shall not be unreasonably withheld or delayed. In the event BioLine
exercises its right to xxx pursuant to this Section 9.1.2, it shall first
reimburse itself out of any sums recovered in such suit or in settlement thereof
for all costs and expenses of every kind and character, including reasonable
attorneys’ fees, necessarily involved in the prosecution of any such
suit. If, after such reimbursement, any funds shall remain from said
recovery, then Licensor shall receive an amount equal to [***] of such funds and
the remaining [***] of such funds shall be retained by BioLine.
9.1.3. Suit by Licensor. If BioLine does not take
action in the prosecution, prevention, or termination of any Infringement
pursuant to Section 9.1.2 above, and has not commenced negotiations with the
infringer for the discontinuance of said Infringement, within ninety (90) days
after receipt of notice to BioLine by Licensor of the existence of an
Infringement, Licensor may elect to do so. Should Licensor elect to
bring suit against an infringer and BioLine is joined as party plaintiff in any
such suit, BioLine shall have the right to approve the counsel selected by
Licensor to represent Licensor and BioLine, such approval not to be unreasonably
withheld. The expenses of such suit or suits that Licensor elects to
bring, including any expenses of BioLine incurred in conjunction with the
prosecution of such suits or the settlement thereof, shall be paid for entirely
by Licensor and Licensor shall hold BioLine free, clear and harmless from and
against any and all costs of such litigation, including reasonable attorneys’
fees. Licensor shall not compromise or settle such litigation without
the prior written consent of BioLine, which consent shall not be unreasonably
withheld or delayed. In the event Licensor exercise its right to xxx
pursuant to this Section 9.1.3, it shall first reimburse itself out of any sums
recovered in such suit or in settlement thereof for all costs and expenses of
every kind and character, including reasonable attorneys’ fees, necessarily
involved in the prosecution of any such suit. If, after such
reimbursement, any funds shall remain from said recovery, [***].
9.1.4. Own Counsel. Each
party shall always have the right to be represented by counsel of its own
selection and at its own expense in any suit instituted under this Section 9 by
another party for Infringement.
9.1.5. Cooperation. Each party agrees to
cooperate fully in all reasonable respects in any action under this Section 9
which is controlled by another party, provided that the controlling party
reimburses the cooperating party promptly for any reasonable costs and expenses
incurred by the cooperating party in connection with providing such
assistance.
9.1.6. Standing. If a party lacks
standing and the other party has standing to bring any such suit, action or
proceeding, then such other party shall do so at the request of and at the
expense of the requesting party. If the non-controlling party is
joined in any such suit, action or proceeding, such party shall execute all
papers and perform such other acts as may be reasonably required in the
circumstances.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
14
9.2 Legal Action against a
Party. Each Party will provide the others with prompt notice
of any action, suit or proceeding brought against it, alleging the infringement
of the intellectual property rights of a third party by reason of the discovery,
development, manufacture, use, sale, importation, or offer for sale of a
Licensed Product or otherwise due to the use or practice of the Licensed
Technology.
10.
|
Warranties;
Limitation of Liability.
|
10.1. Representations
and Warranties.
10.1.1. Licensor
hereby represents and warrants that (i) it has sole and exclusive ownership of
the patents and/or patent applications listed in Exhibit A attached
hereto; (ii) it has not granted any rights in or to Licensed Technology that are
inconsistent with the rights granted to BioLine under this Agreement; (iii) it
has the right to grant the license granted under this Agreement free and clear
of any third party rights or claims; (iv) it will not transfer, assign, grant
rights to, sell, lease or otherwise dispose of or encumber the Licensed
Technology other than as may be expressly permitted herein; and (v) there are no
legal claims, demands, threats or proceeding of any sort by any third party
against the Licensor contesting the ownership or validity of the Licensed
Patents, or claiming that the practice of the Licensed Patents in the manner
contemplated by this Agreement would infringe the rights of such third
party.
10.1.2. BioLine
hereby represents and warrants that it (i) is a drug development company, (ii)
has received and carefully reviewed, to its satisfaction, all the information it
considers necessary or appropriate for deciding whether to enter into this
Agreement, and (iii) has reached the decision to fulfill its obligations
hereunder as a result of careful consideration. Without derogating
from the aforementioned, BioLine further represents that it has had an
opportunity to ask questions of and receive answers from Licensor regarding the
intellectual property and the inventions of Licensor and has performed its
independent due diligence with respect thereto after having received from
Licensor the due diligence materials it requested.
10.2. Compliance with
Law. BioLine warrants that it will comply with applicable laws
and regulations relating to the development, manufacture, use, and sale of
Licensed Products.
10.3. No Warranty. Except
as otherwise expressly provided in this Agreement, neither party makes any
warranty with respect to any technology, patents, goods, services, rights or
other subject matter of this Agreement, and each party hereby disclaims
warranties of merchantability, fitness for a particular purpose and
non-infringement with respect to any and all of the foregoing. It is
further specifically agreed that no claim shall be made by either party against
the other party (including such party’s directors, officers, employees,
shareholders and agents and their respective successors, heirs and assigns)
based on representations, written and/or oral, that are not specifically
mentioned in this Agreement.
15
10.4. Limitation of
Liability. Notwithstanding anything else in this Agreement or
otherwise, neither Licensor nor BioLine will be liable to the other with respect
to any subject matter of this Agreement under any contract, negligence, strict
liability or other legal or equitable theory for (i) any indirect, incidental,
consequential or punitive damages or lost profits or (ii) cost of procurement of
substitute goods, technology or services.
11.
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Indemnification.
|
11.1. Indemnity. BioLine
shall indemnify, defend, and hold harmless Licensor, its directors, officers,
employees and agents and their respective successors, heirs and assigns (the
“Licensor Indemnitees”),
against any liability, damage, loss, or expense (including reasonable attorneys’
fees and expenses of litigation) incurred by or imposed upon any of the Licensor
Indemnitees in connection with any claims, suits, actions, demands or judgments
(“Claims”) arising out
of any theory of liability (including without limitation actions in the form of
tort, warranty, or strict liability and regardless of whether such action has
any factual basis) concerning the use of any Licensed Technology by BioLine, or
any of its Affiliates or Sublicensees, or concerning any product, process, or
service that is made, used, or sold pursuant to any right or license granted by
Licensor to BioLine under this Agreement (except in cases where, and to the
extent that, such claims, suits, actions, demands or judgments result from the
negligence or willful misconduct on the part of any of the Licensor Indemnitees
in which case Licensor shall indemnify BioLine and the provisions hereof shall
apply mutatis
mutandis).
11.2. Procedures. If any
Licensor Indemnitee receives notice of any Claim, Licensor shall, as promptly as
is reasonably possible, give BioLine notice of such Claim; provided, however, that
failure to give such notice promptly shall only relieve BioLine of any
indemnification obligation it may have hereunder to the extent such failure
diminishes the ability of BioLine to respond to or to defend the Licensor
Indemnitee against such Claim. Licensor and BioLine shall consult and
cooperate with each other regarding the response to and the defense of any such
Claim and BioLine shall, upon its acknowledgment in writing of its obligation to
indemnify the Licensor Indemnitee, be entitled to and shall assume the defense
or represent the interests of the Licensor Indemnitee in respect of such Claim,
that shall include the right to select and direct legal counsel and other
consultants to appear in proceedings on behalf of the Licensor Indemnitee and to
propose, accept or reject offers of settlement, all at its sole cost; provided, however, that no
such settlement shall be made without the written consent of the Licensor
Indemnitee, such consent not to be unreasonably withheld. Nothing
herein shall prevent the Licensor Indemnitee from retaining its own counsel and
participating in its own defense at its own cost and expense.
11.3. Insurance. BioLine
shall maintain insurance that is reasonably adequate to fulfill any potential
obligation to the Licensor Indemnitees consistent with industry
standards. BioLine shall provide Licensor, upon request, with written
evidence of such insurance.
12.
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Term
and Termination.
|
12.1. Term. The term of
this Agreement shall commence on the Effective Date and, unless earlier
terminated as provided in this Section 12, shall continue in full force and
effect on a Licensed Product-by-Licensed Product and country-by-country basis
until the expiration of all payment obligations pursuant to Section 6 for such
Licensed Product.
16
12.2. Effect of
Expiration. Following the expiration of this Agreement
pursuant to Section 12.1 (and provided the Agreement has not been earlier
terminated pursuant to Section12.3, in which case Section 12.4.1 shall apply),
BioLine shall have a fully-paid up, non-exclusive, worldwide license (with the
right to grant sublicenses) under the Licensed Technology to research, have
researched, develop, have developed, manufacture, have manufactured, use,
market, distribute, offer for sale, sell, have sold, export and import Licensed
Products and/or provide services relating thereto.
12.3. Termination.
12.3.1. Termination Without Cause and for
Scientific, Regulatory or Medical Reasons.
12.3.1.1. BioLine may
terminate this Agreement without cause upon thirty (30) days prior written
notice to Licensor; provided,
however, that in the event that BioLine exercises such right prior to the
completion of the Trial, BioLine shall pay for the completion of the Trial; and
provided further that
the total amount that BioLine shall be obligated to pay in respect of the Trial
(including amounts spent by BioLine prior to the exercise of the termination
right hereunder, but excluding the Licensee Fee mentioned in Section 6.1) shall
in no event exceed the sum of six hundred thousand United States Dollars (US
$600,000). For the avoidance of doubt, BioLine shall not be obligated
to pay any amounts hereunder in the event that BioLine terminates the Agreement
pursuant to this subsection 12.3.1.1 after the completion of the
Trial.
12.3.1.2. BioLine may
terminate this Agreement at any time upon sixty (60) days’ prior written notice
to Licensor for scientific, regulatory or medical reasons which would prevent
BioLine from continuing the development of the Licensed Technology pursuant to
the Development Plan as may be determined by BioLine’s Scientific Advisory Board
(“SAB”). Prior to the
exercise of such right, Licensor shall have the right to present orally and/or
in writing its opinion regarding the proposed termination to the SAB and offer
its solutions for the obstacles and/or problems raised by the
SAB. For the purpose of preparing for its presentation to the SAB,
Licensor may contract with an independent expert to assist with such preparation
and such expert shall have the right to present before the
SAB. BioLine agrees to contribute up to [***] to offset any
documented costs directly incurred by Licensor in retaining such expert against
presentation of appropriate invoices. It is specifically agreed
between the parties that in the event that BioLine terminates the Agreement
pursuant to this subsection 12.3.1.2, regardless of whether such termination
occurs prior to the completion of the Trial, BioLine shall not be obligated to
pay any amounts in respect of the completion of the Trial.
12.3.2. Termination for
Default.
12.3.2.1. In the event that
BioLine commits a material breach of its obligations under this Agreement and
fails to cure that breach within thirty (30) days after receiving written notice
thereof from Licensor, Licensor may terminate this Agreement immediately upon
written notice to BioLine. Notwithstanding the foregoing, in the
event that any
breach is not susceptible of cure within the stated period and BioLine uses
diligent good faith efforts to cure such breach, the stated period will be
extended by an additional thirty (30) days. In the event
of an uncured material breach by BioLine, Licensor may elect not to terminate
this Agreement but, instead, to xxx BioLine for damages arising from such
breach.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
17
12.3.2.2. In the event that
Licensor commits a material breach of its obligations under this Agreement and
fails to cure that breach or default within thirty (30) days after receiving
written notice thereof from BioLine, BioLine may terminate this Agreement
immediately upon written notice to Licensor. Notwithstanding the
foregoing, in the event that any breach or default is not susceptible of cure
within the stated period and Licensor uses diligent good faith efforts to cure
such breach or default during the initial thirty (30) day cure period, the
stated period will be extended by an additional thirty (30) days. In
the event of an uncured material breach by Licensor, BioLine may elect not to
terminate this Agreement but, instead, to xxx Licensor for damages arising from
such breach.
12.3.3. Bankruptcy.
12.3.3.1. Either
BioLine or Licensor may terminate this Agreement upon notice to the other if the
other party becomes insolvent, is adjudged bankrupt, applies for judicial or
extra-judicial settlement with its creditors, makes an assignment for the
benefit of its creditors, voluntarily files for bankruptcy or has a receiver or
trustee (or the like) in bankruptcy appointed by reason of its insolvency, or in
the event an involuntary bankruptcy action is filed against the other party and
not dismissed within ninety (90) days, or if the other party becomes the subject
of liquidation or dissolution proceedings or otherwise discontinues
business.
12.3.3.2. Notwithstanding the
foregoing, in the event a receiver or trustee (or the like) is appointed or
BioLine has entered into a settlement with its creditors and BioLine is
otherwise meeting its obligations pursuant to this Agreement, Licensor shall not
be entitled to terminate this Agreement as contemplated under Section 12.3.3.1
during such period.
12.4. Effect
of Termination.
12.4.1. Termination of Rights. Upon termination by
BioLine pursuant to Section 12.3.1, 12.3.2 or 12.3.3 hereof, or by Licensor
pursuant to Sections 12.3.2 or 12.3.3 hereof (except in the circumstances set
out in Section 12.3.3.2): (a) the rights and licenses granted to BioLine under
Section 2 shall terminate; (b) all rights in and to the Licensed Technology
shall revert to Licensor and BioLine shall not be entitled to make any further
use whatsoever of the Licensed Technology nor shall BioLine research,
develop, manufacture, use, market, distribute, offer for sale, sell, export or
import Licensed Products and/or provide services relating thereto; and (c) any
existing agreements that contain a sublicense of the Licensed Technology shall
terminate to the extent of such sublicense; provided, however, that, for
each Sublicensee, upon termination of the sublicense agreement with such
Sublicensee, Licensor shall be obligated, at the request of such Sublicensee, to
enter into a new license agreement with such Sublicensee on substantially the
same terms as those contained in such Sublicense agreement and provided further that such
terms shall be amended, if necessary, to the extent required to ensure that such
sublicense agreement does not impose any obligations or liabilities on Licensor
which are not included in this Agreement.
18
12.4.2 Transfer of Development
Results. In the event BioLine terminates this Agreement
pursuant to Section 12.3.1 or Licensor terminates this Agreement pursuant to
Sections 12.3.2 or 12.3.3 hereof (except in the circumstances set out in Section
12.3.3.2), BioLine shall promptly transfer and assign to Licensor all
Development Results and all right, title and interest therein; subject, however, to any
conditions preventing or governing such transfer and assignment set out in the
applicable laws and regulations governing the Grants received by BioLine and
used in generation of the Development Results, (“Grant Transfer Conditions”),
in which case BioLine will not be required to transfer and assign the
Development Results as contemplated above unless and until Licensor
either (i) agrees in writing to assume all obligations required by the Grant
Transfer Conditions, or (ii) reaches another arrangement with the grantors of
the Grants which absolves BioLine of any liability to such grantors with respect
to the transfer and/or assignment of the Development Results. In the
event that the Development Results are transferred and assigned to Licensor as
set out above, BioLine shall receive a perpetual carried interest in the
commercial proceeds of the exploitation of the Licensed Technology as follows:
[***]
12.4.3. Accruing Obligations. Termination of this
Agreement shall not relieve the parties of obligations occurring prior to such
termination, including obligations to pay amounts accruing hereunder up to the
date of termination.
12.5. Survival. The
parties’ respective rights, obligations and duties under Sections 8, 10.2, 10.4,
11, 12 and 13, as well as any rights, obligations and duties which by their
nature extend beyond the expiration or termination of this Agreement, shall
survive any expiration or termination of this Agreement.
13.
|
Miscellaneous.
|
13.1. Entire
Agreement. This Agreement (together with all schedules and
exhibits attached hereto, which constitute an integral part of the Agreement) is
the sole agreement with respect to the subject matter hereof and, except as
expressly set forth herein, supersedes all other agreements and understandings
between the parties with respect to same.
13.2. Notices. Unless
otherwise specifically provided, all notices required or permitted by this
Agreement shall be in writing and may be delivered personally, or may be sent by
facsimile or certified mail, return receipt requested, to the following
addresses, unless the parties are subsequently notified of any change of address
in accordance with this Section 13.2:
If
to BioLine:
|
BioLine
Innovations Jerusalem, LP
00
Xxxxxx Xxxxxx
X.X.
Xxx 00000
Xxxxxxxxx 00000
Xxxxxx
Attention: VP
Finance, BioLineRx, Ltd.
Fax: 000-0-000-0000
|
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
19
With
a copy (which shall not constitute notice) to:
|
Xxxxx
Xxxxx & Co., Law Offices
00
Xxxxxx Xxxxxx
Xxxxxxxxx,
00000
Israel
Attention: Xxxxx
Xxxxxxxxx, Adv.
Fax: 000-0-000-0000
|
|
If
to the Licensor:
|
Innovative
Pharmaceutical Concepts (IPC) Inc.
Xxxxxx
Xxxxx, 0xx Xxxxx, 000 Xxxxxxxxxx Xxxxx
P.O.
Box 3339, Road Town, Tortola
British
Virgin Islands
Attention:
Xx. X. Xxxxxxxx
Fax: 000-0-000-0000
|
|
With
a copy (which shall not constitute notice) to:
|
Xxxxx
X. Xxxxx, Ashlagi, Fisher, Eshel – Law Offices
0
Xxxxxxx Xxxxxx
Xxx-Xxxx,
00000
Xxxxxx
Attention:
Xxx Xxxxxx, Adv.
Fax: 000-0-000-0000
Email:
xxx@xxxxxx.xx.xx
|
Any
notice shall be deemed to have been received as follows: (i) by personal
delivery, upon receipt; (ii) by facsimile or email, receipt confirmed, one
business day after transmission or dispatch; (iii) by airmail, three (3)
business days after delivery to the postal authorities by the party serving
notice.
13.3. Governing Law and
Jurisdiction. This Agreement shall be governed by and
construed in accordance with the laws of the State of Israel, without regard to
the application of principles of conflicts of law, except for matters of patent
law, which, other than for matters of inventorship on patents, shall be governed
by the patent laws of the relevant country of the patent. The parties
hereby consent to personal jurisdiction in Tel Aviv, Israel and agree that any
lawsuit they file to enforce their respective rights under this Agreement shall
be brought in the competent court in Tel Aviv.
13.4. Binding
Effect. This Agreement shall be binding upon and inure to the
benefit of the parties and their respective legal representatives, successors
and permitted assigns.
13.5. Headings. Section
and subsection headings are inserted for convenience of reference only and do
not form a part of this Agreement.
13.6. Counterparts. This
Agreement may be executed simultaneously in two or more counterparts, each of
which when taken together shall constitute one and the same
instrument.
20
13.7. Amendment;
Waiver. This Agreement may be amended, modified, superseded,
and any of the terms may be waived, only by a written instrument executed by
each party or, in the case of waiver, by the party waiving
compliance. The delay or failure of any party at any time or times to
require performance of any provisions hereof shall in no manner affect the
rights at a later time to enforce the same. No waiver by either party
of any condition or of the breach of any term contained in this Agreement,
whether by conduct, or otherwise, in any one or more instances, shall be deemed
to be, or considered as, a further or continuing waiver of any such condition or
of the breach of such term or any other term of this Agreement.
13.8. No Agency or
Partnership. The parties to this Agreement are independent
contractors. Nothing contained in this Agreement shall give any party
the right to bind another, or be deemed to constitute either parties as agents
for each other or as partners with each other or any third party.
13.9. Assignment and
Successors. This Agreement may not be assigned by either party
without the consent of the other, which consent shall not be unreasonably
withheld, except that each party may, without such consent, assign this
Agreement and the rights, obligations and interests of such party, in whole or
in part, to any of its Affiliates, to any purchaser of all or substantially all
of its assets or research to which the subject matter of this Agreement relates,
or to any successor corporation resulting from any merger or consolidation of
such party with or into such corporation.
13.10. Force
Majeure. Neither party will be responsible for delays
resulting from causes beyond the reasonable control of such party, including
without limitation, regulatory delay, fire, explosion, flood, war, strike, or
riot, provided that the non-performing party uses commercially reasonable
efforts to avoid or remove such causes of non-performance and continues
performance under this Agreement with reasonable dispatch whenever such causes
are removed.
13.11. Interpretation. The
parties hereto acknowledge and agree that: (i) each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement and have
contributed to its revision; (ii) the rule of construction to the effect that
any ambiguities are resolved against the drafting party shall not be employed in
the interpretation of this Agreement; and (iii) the terms and provisions of this
Agreement shall be construed fairly as to both parties hereto and not in favor
of or against either party, regardless of which party was generally responsible
for the preparation of this Agreement.
13.12. Severability. If
any provision of this Agreement is or becomes invalid or is ruled invalid by any
court of competent jurisdiction or is deemed unenforceable, such provision or
provisions shall be reformed to approximate as nearly as possible the intent of
the parties, and it is the intention of the parties that the remainder of this
Agreement shall not be affected.
[Remainder
of page intentionally left blank]
21
[Signature
page to License Agreement]
IN WITNESS WHEREOF, the
parties have caused this Agreement to be executed by their duly authorized
representatives as of the Effective Date.
Innovative
Pharmaceutical Concepts
|
BioLine
Innovations Jerusalem L.P.
|
(IPC)
Inc.
|
By
its General Partner:
|
BioLine
Innovations Jerusalem Ltd.
|
|
By:
/s/
X.
Xxxxxxxx
|
By:
/s/ Xxxxxx Xxxxxx /s/ Xxxxx
Xxxxxx
|
Name:
Xx. Xxxxxxx
Xxxxxxxx
|
Name:
________________________
|
Title:
Director
|
Title:
_________________________
|
22
Exhibit
A
Patents
and/or Patent Applications
[***]
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
23
Exhibit
B
Development
Plan
ID
|
Task
Name
|
Start
|
Finish
|
Cost
|
2005
|
2006
|
2007
|
2008
|
2009
|
2010
|
||||||||||
|
|
|
|
|
|
|
|
|
|
[***]
24
Non-surgical
removal of benign tumors and lesions of the skin
Development
Plan
[***]
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
25