RESEARCH AND LICENSE AGREEMENT
CONFIDENTIAL
MATERIALS OMITTED AND FILED SEPARATELY WITH
THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS
EXHIBIT
10.8
RESEARCH
AND LICENSE AGREEMENT
This License Agreement is entered
into as of this 15 day of April, 2004 (the “Effective Date”), by and among
BioLineRx Ltd., a company formed under the laws of Israel, having a place of
business at 00 Xxxxxx Xxxxxx, X.X. Xxx 00000, Xxxxxxxxx, 00000, Xxxxxx (“BioLine”); Bar-Ilan Research
and Development Company Ltd., a company formed under the laws of Israel, having
a place of business at Bar-Ilan University, Xxxxx Xxx, 00000 (“BIRAD”); and Ramot at Tel Aviv
University Ltd., a company formed under the laws of Israel, having a place of
business at Tel Aviv University in Xxxxx-Xxxx, Xxx Xxxx 00000, Xxxxxx (“Ramot”). BIRAD and
Ramot shall be referred to together as the “Licensors”.
WHEREAS,
the Licensors are joint owners of an invention developed by Xxxxxxxxx Xxxxxxx
Xxxxxxx, Xx. Xxxx Xxx-Ad and Xx. Xxx Xxxxxxxx of the Felsenstein Medical
Research Center of Tel Aviv University (“TAU”) and Xxxxxxxxx Xxxxxxx
Xxxxxxxx of Xxx-Xxxx University (“BIU”), relating to conjugated
anti-psychotic drugs and the use thereof; and
WHEREAS,
BioLine wishes to fund further research at TAU and BIU through Ramot and BIRAD,
respectively, for the purpose of furthering research related to such invention;
and
WHEREAS,
BioLine wishes to obtain a license with respect to such invention and the
results of such research, in order to develop, obtain regulatory approval for
and commercialize products based on such invention, and the Licensors wish to
grant BioLine a license with respect to such technology and the results of such
research, all in accordance with the terms and conditions of this
Agreement.
NOW, THEREFORE, the parties
hereto, intending to be legally bound, hereby agree as follows:
1.
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Definitions.
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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.
1.1. “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,
either directly or by acting synergistically with or otherwise enhancing the
effect of other compounds or substances contained in such
product.
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1.2 “Affiliate” shall mean, with
respect to a party, 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
twenty percent (20%) 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 twenty percent (20%) or
more of the members of the governing body of the organization or other
entity.
1.3. “BIRAD Research” shall mean
the research actually conducted by the BIU Team under the terms of this
Agreement in accordance with the BIRAD Research Plan.
1.4. “BIRAD Research Plan” shall
mean the research plan attached hereto as Exhibit 1.4, as amended from time to
time in accordance with the provisions of this Agreement with the mutual
agreement of the parties, which sets forth the research to be undertaken by the
BIU Team under the direction of the BIU Principal Investigator during the
Research Period.
1.5. “BIU Principal Investigator”
shall mean Xxxxxxxxx Xxxxxxx Xxxxxxxx, or such other principal
investigator who may replace Xxxxxxxxx Xxxxxxxx pursuant to Section
2.2.1.2.
1.6. “BIU Team” shall mean the BIU
Principal Investigator and those students, scientists and technicians working at
BIU under his direction on the BIRAD Research.
1.7. “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.
1.8 “Combination Product” shall
mean a product, substance or devise which comprises a Licensed Product and at
least one other essential Additional Ingredient.
1.9. “Commercially
Reasonable Efforts” shall mean (i) with respect to any objective by an
entity, reasonable, diligent, good faith efforts to accomplish such objective as
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 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.
1.10. “Current Inventions” the
inventions disclosed in the patent application described in Exhibit
1.20.
1.11. “Development Plan” shall mean
the plan for the development of Licensed Products attached hereto as Exhibit
1.11, as such plan may be amended from time to time pursuant to Sections
6.2.
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1.12. “Far East Countries” shall
mean Xxxxxxxxx, Xxx Xxxxxxx, Xxxxx, Xxxxx Xxxxx, Xxxxx Xxxxx, Mongolia, the
People’s Republic of China (including Hong Kong and Macau), Taiwan, Quemoy, and
Matsu, Brunei, Cambodia, East Timor, Indonesia, India, Laos, Malaysia, Myanmar
(Burma), The Philippines, Singapore, Thailand and Vietnam.
1.13. “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.
1.14. “FDA” shall mean the United
States Food and Drug Administration.
1.15. “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.
1.16. “Joint Inventions” shall mean
any and all inventions made jointly by one or more members of the Licensor Teams
and one or more employees or consultants of BioLine.
1.17. “Joint Patent Rights” shall
mean any and all Patent Rights claiming Joint Inventions.
1.18. “Joint Technology” shall mean
Joint Patent Rights and Joint Inventions.
1.19. “Licensed Patent Rights” shall
mean the Licensor Patent Rights and the Joint Patent Rights.
1.20. “Licensor Patent Rights” shall
mean (i) the Patent Rights described on Exhibit 1.20(a) attached hereto, and
(ii) all Patent Rights owned by Ramot and/or BIRAD which claim, and only to the
extent they so claim, any of the Research Results. Exhibit 1.20(b)
shall include and shall be updated from time to time to include new Licensor
Patent Rights.
1.21. “Licensed Product” shall mean
any therapeutic product that comprises, contains or incorporates a compound
described in Exhibit 1.21.
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1.22. “Licensor Proposed Product”
shall mean a potential Licensed Product proposed by one or both of the Licensors
that (a) does not incorporate a compound included in a Licensed Product being
developed, manufactured, used, marketed or sold by BioLine or any of its
Affiliates or Sublicensees and (b) is aimed at an indication that is not
targeted by any Licensed Product being developed, manufactured, used, marketed
or sold by BioLine or any of its Affiliates or Sublicensees.
1.23. “Licensor Teams” shall mean
the TAU Team and the BIU Team.
1.24. “Licensor Technology” shall
mean the Current Invention, the Licensor Patent Rights and the Research
Results.
1.25. “NDA” shall mean an FDA New
Drug Application or Product License Application (or Biologics License
Application), as appropriate, and all supplements filed pursuant to the
requirements of the FDA, including all documents, data and other information
concerning Licensed Products that are necessary for or included in FDA approval
to market a Licensed Product, or the equivalent application in any other country
or jurisdiction.
1.26. “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; and (d) outbound transportation,
packing and delivery charges, as well as prepaid freight (including shipping
insurance) actually incurred; provided that:
(i)
In any transfers of Licensed Products between the Invoicing Entity and an
Affiliate of the Invoicing Entity, Net Sales shall be equal to the higher of:
(x) the fair market value of the Licensed Products so transferred, assuming an
arm’s length transaction made in the ordinary course of business, and (y) the
total amount invoiced by such Affiliate on resale to an independent third party
purchaser, in each case, after deducting the amounts referred to in clauses (a)
through (d) above, to the extent applicable; 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.
1.27. “Orphan Drug” shall mean a
Licensed Product that is protected (a) by
“Orphan Drug” status under the U.S. Orphan Drug Act, (b) by a Supplementary
Protection Certificate, as such term is defined in Council Regulation (EU) No.
1768/92, or (c) by a similar status granted under similar statutory provisions
of another jurisdiction granting exclusive marketing rights in such
jurisdiction.
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1.28. “Patent Rights” shall mean any
and all (a) patents, (b) pending patent applications, including, without
limitation, all provisional applications, continuations, continuations-in-part,
divisions, reissues, renewals, and all patents granted thereon, and (c) all
patents-of-addition, reissue patents, reexaminations and extensions or
restorations by existing or future extension or restoration mechanisms,
including, without limitation, supplementary protection certificates or the
equivalent thereof.
1.29. “Principal
Investigators” shall mean the TAU Principal Investigators and the BIU
Principal Investigator.
1.30. “Ramot Research” shall mean
the research actually conducted by the TAU Team under the terms of this
Agreement in accordance with the Ramot Research Plan.
1.31. “Ramot Research Plan” shall
mean the research plan attached hereto as Exhibit 1.31, as amended from time to
time in accordance with the provisions of this Agreement, with the mutual
agreement of the parties, which sets forth the research to be undertaken by the
TAU Team under the direction of the TAU Principal Investigators during the
Research Period.
1.32. “Research Period”
shall mean a period of two (2) years commencing on the Effective Date, or
such longer period as the parties may mutually agree upon in
writing.
1.33. “Research Results” shall mean
any and all inventions, materials, methods, processes, know-how and results
discovered or acquired by, or on behalf of, members of the Licensor Teams in the
course of the performance of the BIRAD Research and/or the Ramot Research during
the Research Period.
1.34. “Regulatory Agency”
shall mean the FDA or equivalent agency or government body of another
country.
1.35. “Regulatory Approval” shall
mean (i) approval of an NDA 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.
1.36. “Sublicense Receipts” shall
mean any payments or other consideration that BioLine or an Affiliate of BioLine
actually received in connection with the sublicense or other grant of rights
with respect to some or all of the rights granted to BioLine under Section 5.1,
or the grant of an option to obtain such sublicense or other rights, including
without limitation royalties, license fees, milestone payments, license
maintenance fees and equity; provided that in the event that BioLine or an
Affiliate of BioLine receives non-monetary consideration for any such sublicense
or other grant of rights 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. For the avoidance of doubt, research grants received by
BioLine from national or international not-for-profit funding bodies shall not
be considered Sublicensing Receipts.
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1.37. “Sublicensee”
shall mean a person or entity to whom BioLine or its Sublicensee grants a
sublicense or other rights with respect to some or all of the rights granted to
BioLine under Section 5.1, pursuant to Section 5.2.
1.38. “TAU Principal Investigators”
shall mean Xxxxxxxxx Xxxxxxx Xxxxxxx, Xx. Xxxx Xxx-Ad and Xx. Xxx
Xxxxxxxx, or such other principal investigator(s) who may replace them pursuant
to Section 2.1.1.2.
1.39. “TAU Team” shall mean the
Principal Investigators and those students, scientists and technicians working
at TAU or at the TAU Felsenstein Medical Research Center under their direction
on the Research.
1.40. “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.
2.
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Research.
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2.1.
Ramot Research.
2.1.1.
Performance.
2.1.1.1. Ramot shall
cause the TAU Team, under the direction of the TAU Principal Investigators, to
use reasonable efforts to perform the Ramot Research in accordance with the
Ramot Research Plan; however, Ramot and the TAU Team make no warranties
regarding the achievement of any particular results.
2.1.1.2. The Ramot Research
will be directed and supervised by the TAU Principal Investigators, who shall
have primary responsibility for the performance of the Ramot
Research. If any of the TAU Principal Investigators cease to
supervise the Ramot Research for any reason, Ramot will promptly so notify
BioLine. If any two (2) or more of the TAU Principal Investigators
cease to supervise the Ramot Research for any reason, Ramot shall endeavor to
find among the scientists at TAU, a scientist or scientists, as the case may be,
acceptable to BioLine to continue the supervision of the Ramot Research in place
of such TAU Principal Investigator(s). If (i) Ramot is unable to find
such a scientist or scientists, as the case may be, acceptable to BioLine within
sixty (60) days after such notice to BioLine, or (ii) BioLine notifies Ramot
that as a result of the cessation of such TAU Principal Investigator’s(s’)
supervision of the Research Ramot need not find a replacement, BioLine shall
have the option to terminate the funding of the Ramot
Research. BioLine shall promptly advise Ramot in writing if BioLine
so elects. Such termination of funding shall terminate Ramot’s and TAU’s
obligations pursuant to Section 2.1.1.1 above with respect to the Ramot
Research, but shall not terminate this Agreement or any of the other rights or
obligations of the parties under this Agreement. Nothing contained in this
Section 2.1.1.2, shall be deemed to impose an obligation on Ramot or TAU to
successfully find a replacement for the Principal Investigator(s), as opposed to
the obligation to endeavor to do so.
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2.1.2. Funding of Ramot
Research. BioLine shall fund the Ramot Research during the
Research Period in accordance with the payment schedule set forth in Exhibit
2.1.2.
2.2. BIRAD
Research.
2.2.1.
Performance.
2.2.1.1.
BIRAD shall cause the BIU Team, under the direction of the BIU Principal
Investigator, to use reasonable efforts to perform the BIRAD Research in
accordance with the BIRAD Research Plan; however, BIRAD and the BIU Team make no
warranties regarding the achievement of any particular results.
2.2.1.2. The BIRAD Research
will be directed and supervised by the BIU Principal Investigator, who shall
have primary responsibility for the performance of the BIRAD
Research. If the BIU Principal Investigator ceases to supervise the
BIRAD Research for any reason, BIRAD will so notify BioLine, and BIRAD shall
endeavor to find among the scientists at BIU, a scientist or scientists
acceptable to BioLine to continue the supervision of the BIRAD Research in place
of BIU Principal Investigator. If (i) BIRAD is unable to find such a
scientist acceptable to BioLine within sixty (60) days after such notice to
BioLine, or (ii) BioLine notifies BIRAD that as a result of the cessation of BIU
Principal Investigator’s supervision of the BIRAD Research BIRAD need not find a
replacement, BioLine shall have the option to terminate the funding of the BIRAD
Research. BioLine shall promptly advise BIU in writing if BioLine so
elects. Such termination of funding shall terminate BIRAD’s and BIU’s
obligations pursuant to Section 2.2.1.1 above with respect to the BIRAD
Research, but shall not terminate this Agreement or any of the other rights or
obligations of the parties under this Agreement. Nothing contained in
this Section 2.2.1.2, shall be deemed to impose an obligation on BIRAD or BIU to
successfully find a replacement for the BIU Principal Investigator, as opposed
to the obligation to endeavor to do so.
2.2.2. Funding of BIRAD
Research. BioLine shall fund the BIRAD Research during the
Research Period in accordance with the payment schedule set forth in Exhibit
2.2.2.
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2.3 Credit of Sublicense
Receipts. Notwithstanding the foregoing, in the event BioLine
receives Sublicense Receipts that are specifically earmarked to fund further
research and development with respect to a Licensed Product, any and all amounts
paid by BioLine to Licensors pursuant to Section 7.2 with respect to such
Sublicense Receipts that are so specifically earmarked shall be creditable
against future amounts to be paid by BioLine to Licensors pursuant to Sections
2.1 and 2.2.
2.4. Other
Funding.
Nothing
in this Agreement shall be interpreted to prohibit Ramot, TAU, BIRAD, BIU, or
the Principal Investigators from seeking and receiving funding from
non-commercial sources,
including government agencies and foundations, or from commercial entities for
non-commercial purposes, to further support the Ramot Research and/or the BIRAD
Research; provided that
such funding shall not (i) be on terms that give such entity(ies) any rights to
any Research Results (subject to any non-exclusive license for non-commercial
governmental purposes or other governmental rights as may be generally required
as a condition for such non-commercial funding), and (ii) limit in any manner
the scope or terms of the license and rights granted to BioLine
hereunder. Ramot or BIRAD, as applicable, shall notify BioLine upon
such application for and receiving any such funding, which notice shall include
a copy of any notices awarding such funding.
3.
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Title.
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3.1. Licensor
Technology. Subject to the licenses granted to BioLine
pursuant to Section 5 below, all rights, title and interest in and to the
Licensor Technology are and shall be owned solely and exclusively by
Licensors.
3.2. Joint
Technology. All rights, title and interest in and to the Joint
Technology are and shall be owned jointly by Licensors and BioLine, subject to
the license in such Joint Technology granted to BioLine hereunder.
3.3. Determination. All
determinations of inventorship under this Agreement shall be made in accordance
with United States patent law. In case of dispute between Ramot and
BioLine over inventorship, a mutually acceptable outside patent counsel shall
make the determination of the inventor(s) by applying the standards contained in
United States patent law.
4.
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Patent
Filing, Prosecution and
Maintenance.
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4.1. Consultation. Licensors
and BioLine shall consult each other regarding the preparation, filing and
prosecution of all patent applications, and the maintenance of all patents,
included within the Licensed Patent Rights, 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 Patent
Rights. Subject to the payments pursuant to Section 4.3 below, if
BioLine requests that an application be filed or maintained in a given country,
Licensors shall cooperate with BioLine to do so and Licensors will not abandon
any application in any country without BioLine’s written
consent.
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4.2. Filing. All
Licensed Patent Rights shall be filed, prosecuted and maintained by the parties
through a law or patent attorney firm mutually agreed upon by Licensors and
BioLine. Such counsel shall be charged with the duty to act in the
best interests of each of BioLine and the Licensors, taking into account their
relative status as licensors/licensee under this Agreement and the parties’
intention to prepare, file, prosecute, obtain and maintain the Licensed Patent
Rights in a manner that will provide the maximum economic advantage and return
to the parties. Such counsel shall confer with each of Licensors and
BioLine and attempt to achieve a consensus in all decisions made relative to the
content of applications, the prosecution of the Licensed Patent Rights and the
content of communications with the relevant patent agencies, prior to any
communications with such agencies.
4.3. Expenses. Subject
to Section 4.4 below, [***]
4.4. Abandonment. Should
BioLine elect not to pay for the filing, prosecution or maintenance of a patent
application in any country, on any invention or claim included in the Licensed
Technology or to cease reimbursing Licensors for the prosecution, protection
and/or maintenance of any such Patent Right in any such country (an “Abandoned Country”), BioLine
shall provide Licensors and the parties’ outside patent counsel with prompt
written notice of such election. Upon written receipt of such notice
by Licensors, BioLine shall be released from its obligations to reimburse
Licensors for the expenses incurred thereafter as to such Abandoned Country in
conjunction with such Patent Rights. [***]
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[***]
4.5. 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 Patent Rights, or that any of
the Licensed Patent Rights will afford adequate or commercially worthwhile
protection.
5.
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License
Grant.
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5.1. License. Subject to
the terms and conditions set forth in this Agreement, Licensors hereby grant to
BioLine an exclusive, worldwide, royalty-bearing license under Licensors’ rights
in the Licensor Technology and their interest in the Joint Technology solely to
develop, have developed, manufacture, have manufactured, use, market, offer for
sale, sell, have sold, export and import Licensed Products. For
purposes of this Section 5.1, the term “exclusive” means that, subject to
Section 6.5, Licensors shall not have any right to grant such licenses or rights
to any third party or engage in any of the foregoing, subject, however, to Licensors’ rights
to license TAU, BIU and members of the TAU Team and BIU Team to practice and
utilize such rights and licenses to conduct the Ramot Research and BIRAD
Research.
5.2 Sublicense.
5.2.1. Sublicense
Grant. BioLine shall be entitled to grant sublicenses or other
rights to third parties under the license granted pursuant to Section 5.1 on
terms and conditions in compliance and not inconsistent with the terms of this
Agreement (except that the royalty rates may be different than those set forth
in this Agreement). Such sublicenses shall be made for consideration
and in arm’s length transactions.
5.2.2. Sublicense
Agreements. Sublicenses shall only be granted pursuant to
written agreements, which shall be in compliance and not inconsistent with and
shall be subject and subordinate to the terms and conditions of this Agreement.
Each such sublicense agreement shall contain, among other things, provisions to
the following effect:
5.2.2.1. All provisions
necessary to ensure BioLine’s ability to perform its obligations under this
Agreement, including without limitation its obligations under Sections 6, 8.5
and 8.6;
5.2.2.2. In the event of
termination of the license (in whole or in part - e.g. termination in a
particular country) set forth in Section 5.1 above, any existing agreements that
contain a sublicense of, or other grant of right with respect to, Licensor
Technology or Joint 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, Licensors 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
Licensors which are not included in this Agreement; and
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
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5.2.2.3. The Sublicensee
shall not be entitled to sublicense its rights under such sublicense agreement,
except as follows:
5.2.2.3.1 the
Sublicensee may grant a sublicense to a third party solely to market, offer for
sale, sell, have sold, export and/or import Licensed Products in and to a
particular country for the purpose of effecting the distribution of Licensed
Products in such country; and
5.2.2.3.2 as part
of a co-development agreement between Sublicensee and a third party located in a
Far East Country pursuant to which such third party will participate in the
development of Licensed Products for Far East Countries, Sublicensee may grant
such third party (in addition to the sublicense described in Section 5.2.2.3.1)
a sublicense to develop and manufacture Licensed Products solely within one or
more Far East Countries. Such third party shall not be entitled to
further sublicense its rights under such sublicense agreement.
The
parties agree that in the event that (a) BioLine is in the final stages of
negotiations with a potential Sublicensee regarding the grant by BioLine of a
sublicense under BioLine's rights hereunder to such Sublicensee, and such
Sublicensee refuses to enter into such a sublicense agreement unless the
restrictions set forth in this sub-Section 5.2.2.3 are limited or removed and
(b) BioLine provides Licensors with a written request to amend or remove this
sub-Section 5.2.2.3 in order to enable BioLine to consummate the proposed
transaction which request shall include the reasoning for accepting such request
under the circumstances, Licensors shall not unreasonably withhold their
approval to make such amendment to this Agreement, which amendment shall be
contingent on the execution of the contemplated sublicense
agreement.
5.2.2.4. Any such
sublicense granted by a Sublicensee shall be pursuant to a sublicense agreement
that complies with the terms of this Section 5.2.
5.2.2.5. No sublicense
agreement may be assigned by Sublicensee without the prior written consent of
BioLine, except that Sublicensee may assign the sublicense agreement to an
Affiliate or to a successor in connection with the merger, consolidation, or
sale of all or substantially all of its assets or that portion of its business
to which the sublicense agreement relates; provided that any such assignee
agrees in writing to be bound by the terms of such sublicense
agreement.
5.2.2.6 Each Sublicensee shall
agree to indemnify Licensors to the same extent as BioLine agrees to indemnify
Licensors pursuant to Section 12 hereunder.
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5.2.3. Delivery of Sublicense
Agreement. BioLine shall furnish Licensors with a fully
executed copy of any such sublicense agreement, promptly after its execution and
shall ensure that any Sublicensee who further sublicenses its rights furnishes
Licensors, with a fully executed copy of any such sublicense agreement, promptly
after its execution.
5.2.4. Breach by
Sublicensee. BioLine undertakes to take all actions necessary
to enforce its rights under its agreements with Sublicensees and shall ensure
that Sublicensees which grant further sublicenses in accordance with Section
5.2.2.3 take all actions necessary to enforce their rights under such further
sublicense agreements. Any act or omission by a Sublicensee, which
would have constituted a breach of this Agreement had it been an act or omission
by BioLine, shall constitute a breach of this Agreement; provided, however, that any
such breach shall be subject to a cure period consistent with the terms of this
Agreement. BioLine
shall indemnify Licensors for, and hold them harmless from, any and all damages
or losses caused to Licensors as a result of any such breach by a
Sublicensee.
6.
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Development
and Commercialization.
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6.1. Diligence. BioLine
shall use all Commercially Reasonable Efforts, and/or shall cause its Affiliates
and/or Sublicensees to use their Commercially Reasonable Efforts, including
funding consistent with such efforts: (i) to develop Licensed Products in
accordance with the applicable Development Plan during the periods and within
the timetable specified therein, (ii) to introduce Licensed Products into the
commercial market, and (iii) to market Licensed Products following such
introduction into the market. Without limiting the foregoing, BioLine
and/or its Affiliates and/or Sublicensees shall fulfill the following
obligations:
6.1.1. BioLine, by
itself or through Affiliates or Sublicensees, shall meet the milestones set
forth in Exhibit 6.1.1 hereto; and
6.1.2. Licensee, by
itself or through Affiliates or Sublicensees, undertakes to employ Commercially
Reasonable Efforts, including funding consistent therewith, to carry out all
efficacy, pharmaceutical, safety, toxicological and clinical tests, trials and
studies and all other activities necessary in order to obtain Regulatory
Approval for the production, use and sale of Licensed Products in each country
in which Licensee, its Affiliates or Sublicensees intend to produce, use, offer
to sell and sell Licensed Products and in any case, BioLine shall use
Commercially Reasonable Efforts to obtain Regulatory Approval for the use and
sale of Licensed Products in the United States, the European Union and
Japan.
6.2. BioLine
shall be entitled, from time to time, to make such adjustments to the then
applicable Development Plan as BioLine believes, in its good faith judgment, are
needed in order to improve BioLine's ability to meet the milestones set forth in
Exhibit 6.1.1.
12
6.3. The
Principal Investigators, a BioLine representative and representatives of the
Licensors (the “Steering
Committee”) shall meet no less than once every six (6) months during the
term commencing with the Effective Date and ending upon the First Commercial
Sale of a Licensed Product, at locations and times to be mutually agreed upon by
the parties, (i) to review the progress being made under the Development Plan
and the progress being made in any other research and development activities
conducted by BioLine, its Affiliates and Sublicensees relating to Licensed
Products, (ii) to review and agree upon any necessary or desired revisions to
the then current Development Plan, (iii) to review the progress being made
towards fulfilling the milestones set forth in Section 6.1.1, and (iv) to
discuss intended efforts for fulfilling such milestones. For the
avoidance of doubt, the Steering 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 in respect of the Development Plan, and shall not have any
decision-making powers.
6.4. Within
sixty (60) days after the end of each calendar year, Licensee shall furnish
Licensors with a written report on the progress of its, its Affiliate’s and
Sublicensees’ efforts during the prior year to develop and commercialize
Licensed Products, including without limitation research and development
efforts, efforts to obtain Regulatory Approval and marketing
efforts.
6.5. Failure. If BioLine
breaches its obligations pursuant to Section 6.1, unless and to the extent such
delay is necessitated by regulatory agencies or by an event beyond the control
of BioLine, Ramot may notify BioLine in writing of BioLine’ failure and shall
allow BioLine [***] to cure its failure. BioLine’s failure to cure
such failure to Ramot’s reasonable satisfaction within such [***] period shall
constitute a material breach of this Agreement and Ramot shall have the right to
terminate this Agreement in accordance with Section 13.3.2.
6.6
Licensor Proposed Product.
6.6.1.
[***]
6.6.1
[***]
6.6.2.1. [***]
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
13
[***]
6.6.2.2. [***]
6.6.3.
[***]
7.
|
Consideration
for Grant of License
|
7.1. License Maintenance
Fee. BioLine shall pay Licensors an annual license maintenance
fee in the amount of $25,000 per year during the term of this Agreement, of
which [***] shall be paid to Ramot and [***] shall be paid to
BIRAD. The first such payment shall be made within fifteen (15) days
of the execution of this Agreement and the additional payments shall be made no
later than the first and each subsequent anniversary of this
Agreement.
7.2. Royalty
Payments. BioLine shall pay Licensors amounts equal to [***]
of all Net Sales. Such amounts shall be payable, on a Licensed
Product-by-Licensed Product and country-by-country basis, for the longer of: (a)
fifteen (15) years from the date of the First Commercial Sale of such Licensed
Product in such country; (b) until the last to expire of any patent included
within the Licensed Technology in such country; and (c) the expiration of
Licensed Product’s Orphan Drug status in such country.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
14
7.2.1
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.
7.2.2.
Third-Party Royalties.
7.2.2.1. In the event
that BioLine or an Affiliate of BioLine is legally required to make royalty
payments, at fair market terms after arms’ length negotiations, to one or more
third parties to obtain a Third Party License from such third party(ies) in
order to practice the Licensor Technology in a particular country, BioLine may
offset such third-party payments against the royalty payments that are due to
Licensors pursuant to Section 7.1 with respect to sales in such country; provided that royalty
payments under Section 7.1 to Licensors may not be reduced by a greater
percentage than the percent reduction for any third party; and provided further, that in no
event, shall the royalty payments to Licensors under Section 7.1 with respect to
such Licensed Product be reduced to less than an amount equal to [***] of all
Net Sales with respect to such Licensed Product in such country.
7.2.2.2. Notwithstanding
Section 7.2.2.1, in the event the royalties BioLine or its Affiliate are legally
required to pay for a Third Party License as described in Section 7.2.2.1 relate
to an Additional Ingredient included in a Combination Product, BioLine shall not
be entitled to reduce the royalty payments under Section 7.2.2.1.
7.3. Sublicense
Receipts. BioLine shall pay Licensors an amount equal to [***]
of all Sublicense Receipts.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
15
8.
|
Reports;
Payments; Records.
|
8.1. Net
Sales: Reports and Payments.
8.1.1. 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 Ramot 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;
(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 Licensors in U.S. dollars on Net Sales for the
applicable Calendar Quarter, together with the exchange rates used for
conversion; and
(e) a
calculation of any Sublicense Receipts for the applicable Calendar
Quarter.
If no
amounts are due to Licensors for any Calendar Quarter, the report shall so
state.
8.1.2. Payment. Concurrent
with the delivery of each report delivered pursuant to Section 8.1.1, BioLine
shall remit to Licensors all amounts due with respect to Net Sales for the
applicable Calendar Quarter, as follows: 75% (seventy-five percent) of such
amounts to Ramot and 25% (twenty-five percent) of such amounts to
BIRAD. For the avoidance of doubt, the foregoing allocation (i) has
been specifically agreed to as between Ramot and BIRAD, and (ii) any change
thereto shall only be accepted by BioLine if it is in writing and duly signed by
both Ramot and BIRAD.
8.2. Sublicense Receipts: Notification and
Payment. Concurrent with the delivery of each report delivered
pursuant to Section 8.1.1, BioLine shall remit to Licensors all amounts due with
respect to such Sublicense Receipts. Such amounts shall be paid as
follows: 75% (seventy-five percent) of such amounts to Ramot and 25%
(twenty-five percent) of such amounts to BIRAD. For the avoidance of
doubt, the foregoing allocation (i) has been specifically agreed to as between
Ramot and BIRAD, and (ii) any change thereto shall only be accepted by BioLine
if it is in writing and duly signed by both Ramot and BIRAD.
16
8.3. Payments in U.S.
Dollars. All payments due under this Agreement shall be
payable in United States dollars or in the currency in which they were
received. Conversion of foreign currency to U.S. dollars shall be
made at the conversion rate existing in the United States (as reported in the
Wall Street
Journal) on the last working day of the applicable Calendar
Quarter. Any expenses incurred in respect of exchange, collection, or
other charges, including transfer costs, shall be borne by BioLine and will not
be deducted from payments made hereunder.
8.4. Payments in Other
Currencies. If by law, regulation, or fiscal policy of a
particular country, conversion into United States dollars or transfer of funds
of a convertible currency to the United States is restricted or forbidden,
BioLine shall give Licensors prompt written notice of such restriction, which
notice shall satisfy the thirty-day payment deadlines described in Sections 8.1
and 8.2. In such case, BioLine shall pay any amounts due Licensors
through whatever lawful methods Licensors reasonably designate.
8.5. Records. Licensee
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 Licensors in relation to
such Licensed Products and all Sublicense Receipts received by BioLine and its
Affiliates, which records shall contain sufficient information to permit Ramot
to confirm the accuracy of any reports or notifications delivered to Licensors
under Sections 8.1 and 8.2. The relevant party shall retain such
records relating to a given Calendar Quarter for at least three (3) years after
the conclusion of that Calendar Quarter. During such three (3) year
period, Ramot shall have the right, at Licensors’ 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 Licensors or any
third party any information gained during the course of such inspection, except
that such accountant may disclose to Licensors 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 8.5 reveals an underpayment in excess of five
percent (5%) in any calendar year, the audited party shall bear the full cost of
such audit. Ramot may exercise its rights under this Section 8.5 only
once every year per audited party and only with reasonable prior notice to the
audited party. BioLine shall cause its Affiliates and Sublicensees to
fully comply with the terms of this Section 8.5.
8.6. Audited
Report. BioLine shall furnish Licensors, and shall cause its
Affiliates who make, use, market or sell Licensed Products to furnish Licensors,
within ninety (90) days after the end of each calendar year, commencing at the
end of the calendar year of the first sale of a Licensed Product, with a report,
certified by an independent certified public accountant, relating to royalties
and other payments due to Licensors pursuant to this Agreement in respect to the
previous calendar year and containing the same details as those specified in
Sections 8.1 and 8.2 in respect to the previous calendar year.
17
8.7. Late Payments. Any payments to
be paid under this Agreement that are not paid on or before the date such
payments are due under this Agreement shall bear interest at an annual interest,
compounded monthly, equal to three percent (3%) above the London Interbank Offer
Rate (LIBOR) as determined for each month on the last business day of that
month, assessed from the day payment was initially due until the date of
payment.
8.8. Payment
Method. Each payment due to Licensors under this Agreement
shall be made by wire transfer of funds to Licensors’ accounts in accordance
with written instructions provided by Licensors.
8.9. Withholding and Similar
Taxes. If applicable laws require that taxes be withheld from
any amounts due to Licensors 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 Licensors a statement including the
amount of tax withheld and justification therefor, and such other information as
may be necessary for tax credit purposes.
9.
|
Confidential
Information
|
9.1 Confidentiality.
9.1.1. Licensor Confidential
Information. BioLine agrees that, without the prior written
consent of Licensors, in each case, during the term of this Agreement, and for
five (5) years thereafter, 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 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. 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 Ramot, BIRAD, TAU, BIU, or any of their employees,
researchers or students 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 Ramot, BIRAD, TAU, BIU or any of their employees, researchers to
students, 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 Ramot, BIRAD, TAU or BIU with respect to such
information; or (iv) is independently developed by BioLine without the use of or
reference to the Licensor Confidential Information, as demonstrated by
documentary evidence.
18
9.1.2.
BioLine Confidential Information.
9.1.2.1. Licensors agree
that, without the prior written consent of BioLine, in each case, during the
term of this Agreement, and for five (5) years thereafter, they will keep
confidential, and not disclose or use BioLine Confidential Information (as
defined below) other than for the purposes of this
Agreement. Licensors shall treat such BioLine Confidential
Information with the same degree of confidentiality as they keep their own
confidential information, but in all events no less than a reasonable degree of
confidentiality. Licensors may disclose the BioLine Confidential
Information only to employees and consultants of Licensors or of their
Affiliates who have a “need to know” such information in order to enable
Licensors to exercise their rights or fulfill their 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 Section 6.2, 6.3
or 8 of this Agreement, whether in oral, written, graphic or machine-readable
form, except to the extent such information: (i) was known to Licensors at the
time it was disclosed, other than by previous disclosure by or on behalf of
BioLine as evidenced by Ramot’s or BIRAD’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 Ramot or BIRAD by a third party who is not
subject to obligations of confidentiality to BioLine with respect to such
information; or (iv) is independently developed by Ramot or BIRAD without the
use of or reference to the BioLine Confidential Information, as demonstrated by
documentary evidence.
9.1.2.2. Ramot shall
cause all members of the TAU Team to execute a team agreement in the form
attached hereto as Exhibit 9.1.2.2(a). BIRAD shall cause all members
of the BIU Team to execute a team agreement in the form attached hereto as
Exhibit 9.1.2.2(b).
9.1.3.
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 9.1.3, such party agrees, at its own expense, to seek confidential
treatment of portions of this Agreement or such terms, as may be reasonably
requested by the other party.
19
9.1.4. Publicity. Except as expressly
permitted under Section 9.1.3, no party will make any public announcement
regarding this Agreement without the prior written approval of the other
party.
9.2. Academic
Publications. Licensors shall have the right to allow the
Principal Investigators and other members of the Licensor Teams to publish the
Research Results, if any, in scientific publications or to present such results
at scientific symposia, provided that the following procedure is
followed:
9.2.1. Licensors shall
cause the members of the Licensor Teams to comply with standard academic
practice regarding authorship of scientific publications and recognition of
contribution of other parties in any publications relating to the Research
Results.
9.2.2. No later than
thirty (30) days prior to submission for publication of any scientific articles,
abstracts or papers concerning Research Results and prior to the presentation of
such results at any scientific symposia, Licensors shall send to BioLine a
written copy of the material to be so submitted or presented, and shall allow
BioLine to review such submission to determine whether the publication or
presentation contains subject matter for which patent protection should be
sought prior to publication or presentation for the preservation of Licensed
Patent Rights.
9.2.3. BioLine shall
provide its written comments with respect to such publication or presentation
within fourteen (14) days following its receipt of such written
material.
9.2.4. If BioLine, in
its written comments, identifies material for which patent protection should be
sought, then Licensors shall cause the publication or presentation of such
submission to be delayed for a further period of up to sixty (60) days from the
receipt of such written comments to enable the parties, through the parties’
patent counsel to make the necessary patent filings in accordance with Section
4, provided, however, that if such counsel determines in good faith that more
time is required the submission shall be delayed for an additional period of up
to thirty (30) days.
9.2.5. After compliance
with the foregoing procedures with respect to an academic, scientific or medical
publication and/or public presentation, members of the Licensor Teams shall not
have to resubmit any such information for re-approval should it be republished
or publicly disclosed in another form.
10.
|
Patent
Infringement.
|
10.1 Enforcement
of Patent Rights.
10.1.1. Notice. In the
event any party becomes aware of any possible or actual infringement or
unauthorized possession, knowledge or use of any Licensed Patent Rights
(collectively, an “Infringement”), that party shall promptly notify the other
parties and provide them with details regarding such
Infringement.
20
10.1.2. 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 Patent Rights. Should BioLine elect to bring suit
against an infringer and either Licensor is joined as party plaintiff in any
such suit, such Licensor shall have the right to approve the counsel selected by
BioLine to represent BioLine and such Licensor(s), such approval not to be
unreasonably withheld. The expenses of such suit or suits that
BioLine elects to bring, including any expenses of Licensors incurred in
conjunction with the prosecution of such suits or the settlement thereof, shall
be paid for entirely by BioLine and BioLine shall hold Licensors free, clear and
harmless from and against any and all costs of such litigation, including
attorney’s fees. BioLine shall not compromise or settle such
litigation without the prior written consent of Licensors, which consent shall
not be unreasonably withheld or delayed. In the event BioLine
exercises its right to xxx pursuant to this Section 10.1.2, 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
attorney’s fees, necessarily involved in the prosecution of any such
suit. If, after such reimbursement, any funds shall remain from said
recovery, then Licensors shall receive an amount equal to [***] of such funds
(75% of which shall be paid to Ramot and 25% of which shall be paid to BIRAD)
and the remaining [***] of such funds shall be retained by BioLine.
10.1.3. Suit by Ramot. If
BioLine does not take action in the prosecution, prevention, or termination of
any Infringement pursuant to Section 10.1.2 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 Ramot of the
existence of an Infringement, Licensors may elect to do so. Should
Licensors 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 Licensors to represent Licensors and BioLine, such approval
not to be unreasonably withheld. The expenses of such suit or suits that
Licensors elect 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 Licensors and Licensors shall hold BioLine free, clear
and harmless from and against any and all costs of such litigation, including
attorney’s fees. Licensors 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 Licensors exercise
their right to xxx pursuant to this Section 10.1.3, they shall first reimburse
themselves out of any sums recovered in such suit or in settlement thereof for
all costs and expenses of every kind and character, including reasonable
attorney’s fees, necessarily involved in the prosecution of any such
suit. If, after such reimbursement, any funds shall remain from said
recovery, then BioLine shall receive an amount equal to [***] of such funds and
the remaining [***] of such funds shall be retained by Licensors (of which 75%
shall be retained by Ramot and 25% shall be retained by BIRAD).
10.1.4. 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 10 by
the another party for Infringement.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
21
10.1.5. Cooperation. Each
party agrees to cooperate fully in any action under this Section 10 which is
controlled by another party, provided that the controlling party reimburses the
cooperating party promptly for any costs and expenses incurred by the
cooperating party in connection with providing such assistance.
10.1.6. Standing. If a
party lacks standing and another 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 a party determines that it is
necessary or desirable for another party to join any such suit, action or
proceeding, the other party shall execute all papers and perform such other acts
as may be reasonably required in the circumstances.
10.2 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.
11.
|
Warranties;
Limitation of Liability.
|
Representations and
Warranties. Licensors hereby represents and warrant that (i)
that they are the owners of the Licensor Patent Rights set forth in Exhibit
1.20; (ii) they have not granted any rights in or to Licensed Technology which
are inconsistent with the rights granted to BioLine under this Agreement; (iii)
they have the right to grant the license granted under this Agreement; (iv) they
will not transfer, assign, encumber, grant, sell, lease or otherwise dispose of
the Licensor Technology or their interest in the Joint Technology other than as
may be expressly permitted herein; and (v) they have no actual knowledge as of
the date hereof of any legal suit or proceeding by a third party against Ramot,
BIRAD, TAU or BIU contesting the ownership or validity of the Licensor Patent
Rights, or claiming that the practice of the Licensor Patent Rights in the
manner contemplated by this Agreement would infringe the rights of such third
party.
11.1. Compliance with
Law. BioLine warrants that it will comply with, and shall
ensure that its Affiliates and Sublicensees comply with, all local, state,
federal, and international laws and regulations relating to the development,
manufacture, use, and sale of Licensed Products.
11.2. No
Warranty.
11.2.1. Nothing in this
Agreement (including, without limitation, any exhibits or attachments hereto)
shall be construed as a warranty on the part of Licensors that any results or
inventions will be achieved in the Ramot Research or BIRAD
Research. Furthermore, Licensors make no warranties whatsoever as to
the commercial or scientific value of the Licensed
Technology. Licensors make no representation that the manufacture,
use or sale of the Licensed Technology or any Licensed Product, or any element
thereof, will not infringe the patent or proprietary rights of any third
party.
22
11.2.2. Except as
otherwise expressly provided in this Agreement, no party makes any warranty with
respect to any technology, patents, goods, services, rights or other subject
matter of this Agreement and hereby disclaims warranties of merchantability,
fitness for a particular purpose and noninfringement with respect to any and all
of the foregoing.
11.3. Limitation of
Liability. Notwithstanding the anything else in this Agreement
or otherwise, neither Licensors 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.
12.
|
Indemnification.
|
12.1 Indemnity. BioLine shall
indemnify, defend, and hold harmless Ramot, BIRAD, TAU, BIU, the Principal
Investigators, the other members of the Licensor Teams, and their respective
governors, 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
Licensors to BioLine under this Agreement (except in cases where, and
to the extent that, such claims, suits, actions, demands or judgments result
from gross negligence or willful misconduct on the part of any of the Licensor
Indemnitee).
12.2. Procedures. If any
Licensor Indemnitee receives notice of any Claim, such Licensor Indemnitee
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. Licensors 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.
23
12.3.
Insurance. BioLine shall maintain insurance that is
reasonably adequate to fulfill any potential obligation to the Licensor
Indemnitees consistent with industry standards. The Licensors shall
be listed as co-insured parties under any such insurance
policy(ies). BioLine shall provide Ramot, upon request, with written
evidence of such insurance.
13.
|
Term
and Termination.
|
13.1. Term. The term of
this Agreement shall commence on the Effective Date and, unless earlier
terminated as provided in this Section 13, shall continue in full force and
effect on until the expiration of all payment obligations pursuant to Section 7
for such Licensed Product.
13.2. Effect of
Expiration. Following the expiration of this Agreement
pursuant to Section 13.1 on a Licensed Product-by-Licensed Product and
country-by-country basis (and provided the Agreement has not been earlier
terminated pursuant to Section 13.3, in which case Section 13.4.1 shall apply):
(a) BioLine shall have a fully-paid up, nonexclusive, worldwide license (with
the right to grant sublicenses) under the Licensor Technology solely to develop,
have developed, manufacture, have manufactured, use, market, offer for sale,
sell, have sold, import, export, otherwise transfer physical possession of or
otherwise transfer title to Licensed Products; (b) Licensors shall be free to
use the Licensed Technology to develop, make and have made, use, offer to sell,
sell, have sold, import, export, otherwise transfer physical possession of or
otherwise transfer title to Licensed Products and to grant others licenses under
the Licensed Technology to do the same; and (c) each of BioLine and Licensors
shall have a fully-paid up, non-exclusive, worldwide license (with the right to
grant sublicenses) under the other party’s interest in the Joint Technology for
any and all purposes.
13.3.
Termination.
13.3.1. Termination Without
Cause. BioLine may terminate this Agreement upon sixty (60)
days prior written notice to Ramot, provided however, that if
BioLine terminates the Agreement prior to the end of the first nine (9) month
period of the Agreement, BioLine will not be obligated to fund the second year
of the Research Period; and provided further that if BioLine terminates the
Agreement following the end of such nine (9) month period but during the
Research Period, it will only be required to pay for the period preceding the
termination and the ninety (90) day period following such termination (in the
event that termination is to become effective on a date other than the last day
of a calendar quarter, BioLine shall pay the pro-rated amount of the research
funding for such quarter based on the number of days between the beginning of
such quarter and the date of termination).
24
13.3.2.
Termination for Default.
13.3.2.1 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 Ramot, Ramot may terminate this Agreement immediately upon written
notice to BioLine. In the event that Ramot or BIRAD 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
BioLine, BioLine may terminate this Agreement immediately upon written notice to
Licensors. Notwithstanding the foregoing, in the event that any
breach is not susceptible of cure within the stated period and the breaching
party uses diligent good faith efforts to cure such breach, the stated period
will be extended by an additional thirty (30) days.
13.3.2.2 In the event of
an uncured material breach by Ramot and/or BIRAD as described in the foregoing
paragraph, BioLine may elect not to terminate this Agreement but, instead, to
xxx Xxxxx and/or BIRAD, as the case may be, for damages arising from such
breach, provided
however, that in no event will BioLine seek damages against the breaching
party in any such action which exceed amounts actually paid to Licensors under
this Agreement.
13.3.3.
Bankruptcy.
13.3.3.1 Either BioLine
or Ramot 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.
13.3.3.2 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, Ramot shall not be
entitled to terminate this Agreement as contemplated under Section 13.3.3.1
during such period.
13.4.
Effect of Termination.
13.4.1. Termination of
Rights. Upon termination by BioLine pursuant to Sections
13.3.1, 13.3.2 or 13.3.3 hereof or by Ramot pursuant to Sections 6.4, 13.3.2 or
13.3.3 hereof (except in the circumstances set out in Section 13.3.3.2) : (a)
the rights and licenses granted to BioLine under Section 5 shall terminate; (b)
all rights in and to the Licensor Technology shall revert to Licensors and
BioLine shall not be entitled to make any further use whatsoever of the Licensor
Technology nor shall BioLine develop, make, have made, use, offer to sell, sell,
have sold, import, export, otherwise transfer physical possession of or
otherwise transfer title to Licensed Products developed in whole or in part
under the rights granted hereunder; and (c) any existing agreements that contain
a sublicense of the Licensed Technology shall terminate to the extent of such
sublicense;
25
provided, however, that, for
each Sublicensee, upon termination of the sublicense agreement with such
Sublicensee, Licensors 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, provided 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 Licensors
which are not included in this Agreement.
13.4.2. 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.
13.4.3. Transfer of Regulatory Filings and
Know How. In the event BioLine terminates this Agreement
pursuant to Section 13.3.1 or Ramot terminates this Agreement pursuant to
Section 6.4, 13.3.2 or 13.3.3 (except in the circumstances set out in Section
13.3.3.2), BioLine shall promptly deliver and assign to Licensors (a) all
documents and other materials filed by or on behalf of BioLine and its
Affiliates with Regulatory Agencies in furtherance of applications for
Regulatory Approval in the relevant country with respect to Licensed Products;
and (b) all intellectual property, inventions, conceptions, compositions,
materials, methods, processes, data, information, records, results, studies and
analyses, discovered or acquired by, or on behalf of BioLine and its Affiliates
which relate directly to actual or potential Licensed Products. The
Licensors, the TAU Team and the BIU Team shall be entitled to freely use and to
grant others the right to use all such materials, documents and know-how
delivered pursuant to this 13.4.3.
13.5. Survival. The
parties’ respective rights, obligations and duties under Sections 9, 11.3, 12,
13, 14.2 and 14.4, 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.
14.
|
Miscellaneous.
|
14.1. Entire
Agreement. This 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.
14.2. Publicity
Restrictions. Subject to Section 9.1.4, BioLine and its
Affiliates and Sublicensees shall not use the name of Ramot, BIRAD, TAU, BIU or
any of their governors, officers, faculty, students, employees, or agents, or
any adaptation of such names, in any promotional material or other public
announcement or disclosure relating to the subject matter of this Agreement or
in connection with the marketing or sale of any Licensed Products, without the
prior written consent of Licensors. Subject to Section 9.1.4, Ramot,
BIRAD, TAU, BIU shall not use the name of BioLine and its Affiliates and
Sublicensees or any of their employees, directors, stockholders and/or
representatives or any adaptation of such names, in any promotional material or
other public announcement or disclosure relating to the subject matter of this
Agreement, without the prior written consent of BioLine.
26
14.3. 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 14.3:
If
to BioLine:
|
|
19
Xxxxxx Xxxxxx
|
|
X.X.
Xxx 00000
|
|
Xxxxxxxxx 00000
|
|
Xxxxxx
|
|
Attn: CEO
|
|
Fax: 000-0-000-0000
|
|
With
a copy (which
|
Xxxxx
Xxxxx & Co., Law Offices
|
shall
not constitute
|
00
Xxxxxx Xxxxxx
|
notice)
to:
|
Xxxxxxxxx,
00000
|
Xxxxxx
|
|
Attn: Xxxxx
Xxxxxxxxx
|
|
Fax: 000-0-000-0000
|
|
If
to Ramot:
|
Ramot
at Tel Aviv University Ltd.
|
X.X.
Xxx 00000
|
|
Xxx
Xxxx 00000
|
|
Xxxxxx
|
|
Attn: CEO
|
|
Fax:
000-0-000-0000
|
|
If
to BIRAD:
|
Bar-Ilan
Research and Development Company Ltd.
|
Bar-Ilan
University
|
|
Ramat
Gan, 52900
|
|
Israel
|
|
Attn:
CEO
|
|
Fax:
000-0-0000000
|
Any
notice shall be deemed to have been received as follows: (i) by personal
delivery, upon receipt; (ii) by facsimile, 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. If notice is sent by facsimile,
a confirming copy of the same shall be sent by mail to the same
address.
27
14.4. 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 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, Israel.
14.5. 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.
14.6. Headings. Section
and subsection headings are inserted for convenience of reference only and do
not form a part of this Agreement.
14.7. Counterparts. This
Agreement may be executed simultaneously in two or more counterparts, each of
which shall be deemed an original.
14.8. Amendment;
Waiver. This Agreement may be amended, modified, superseded or
canceled, 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.
14.9. No Agency or
Partnership. 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.
14.10. 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.
14.11. Force
Majeure. Neither party will be responsible for delays
resulting from causes beyond the reasonable control of such party, including
without limitation fire, explosion, flood, war, strike, or riot, provided that
the nonperforming party uses commercially reasonable efforts to avoid or remove
such causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever such causes are removed.
28
14.12. 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.
14.13. 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, it is the intention
of the parties that the remainder of this Agreement shall not be
affected.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
29
IN WITNESS WHEREOF, the
parties have caused this Agreement to be executed by their duly authorized
representatives as of the date first written above.
Ramot
at Tel Aviv University Ltd.
|
||||
By:
|
/s/ Xxxxx X. Xxxxxxxx
|
By:
|
/s/ Xxxxxx Xxxxxx
|
|
Name:
|
Xxxxx X. Xxxxxxxx
|
Name:
|
Xxxxxx Xxxxxx
|
|
Title:
|
Chief Executive Officer
|
Title:
|
CEO
|
|
Bar-Ilan
Research and Development
|
||||
Company
Ltd.
|
||||
By:
|
/s/ Xxxxxxx Xxxxx
|
|||
Name:
|
Xxxxxxx Xxxxx
|
|||
Title:
|
CEO
|
We, the
undersigned, hereby confirm that we have read the Agreement, that its contents
are acceptable to us and that we will act in accordance with its
terms.
/s/ Xxxx Xxx-Ad
|
/s/ Xxx Xxxxxxxx
|
|
Xx.
Xxxx Xxx-Ad
|
Xx.
Xxx Xxxxxxxx
|
|
/s/ Xxxxxxx Xxxxxxx
|
/s/ Xxxxxxx Xxxxxxxx
|
|
Xxxxxxxxx
Xxxxxxx Xxxxxxx
|
Xxxxxxxxx
Xxxxxxx
Xxxxxxxx
|
30
Exhibit
1.4
BIRAD
Research Plan
Year 1
Objectives
Objective #
|
Description
|
End- point
|
1
|
[***]
|
[***]
|
2
|
[***]
|
[***]
|
3
|
[***]
|
[***]
|
4
|
[***]
|
[***]
|
5
|
[***]
|
[***]
|
Description of
objectives
1. [***]
2. [***].
3. [***]
4. [***]
5. [***]
Year 2
Commencing
January 1, 2005, the parties will meet to discuss and agree upon the BIRAD
Research Plan for the second year of the research period.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
31
Exhibit
1.11
Development
Plan
[***]
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
32
Exhibit
1.20(a)
License
Patent Rights
National Phase Applications,
submitted March 27, 2004:
Country
|
Ramot file
|
Attorney
|
ISRAEL
|
[***]
|
[***]
|
AUSTRALIA
|
[***]
|
[***]
|
EUROPE
|
[***]
|
[***]
|
JAPAN
|
[***]
|
[***]
|
CANADA
|
[***]
|
[***]
|
CHINA
|
[***]
|
[***]
|
SOUTH
KOREA
|
[***]
|
[***]
|
INDIA
|
[***]
|
[***]
|
MEXICO
|
[***]
|
[***]
|
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
33
Exhibit
1.21
Licensed
Product
A
compound having the general formula:
[***]
wherein,
[***]
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
34
Exhibit
1.31
Ramot
Research Plan
Year
1
Objectives
Objective
#
|
Description
|
End-
point
|
1
|
[***]
|
[***]
|
|
||
2
|
[***]
|
[***]
|
3
|
[***]
|
[***]
|
4
|
[***]
|
[***]
|
5
|
[***]
|
[***]
|
6
|
[***]
|
[***]
|
Description of
objectives
1. [***]
2. [***].
3. [***]
4. [***]
5. [***]
Year 2
Commencing
January 1, 2005, the parties will meet to discuss and agree upon the Ramot
Research Plan for the second year of the research period.
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
35
Exhibit
2.2.2
BIRAD
Payment Schedule
Due
Dates for Payment
|
$
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
36
Exhibit
4.3
List
of National Phase Countries
[***]
[***] Omitted pursuant to a confidential
treatment request. The confidential portion has been filed separately with the
SEC.
37
Exhibit
6.1.1
Milestones
[***]
38
Exhibit
9.1.2.2(a)
TAU
Team Agreement
April 15,
2004
Dear
Xxxxxxxxx Xxxxxxx Xxxxxxx (the "Principal Investigator")
Re: Team
Agreement
This
letter agreement (this "Letter") is addressed to you and the persons listed in
Exhibit A to this Letter (each a "Researcher" and collectively, the
"Researchers"). Exhibit A may be amended by the addition of new Researchers as
described below. You and the Researchers are referred to collectively in this
Letter as the "Team Members".
The Team
Members are or were faculty members , post-doctoral fellows, students or
technicians performing research at Felsenstein Medical Research Center of Tel
Aviv University ("FMRC"). In such capacity, they have performed research at FMRC
relating to conjugated anti-psychotic drugs and the use thereof (as further
described in Exhibit B to this Agreement, the "Project") and/or are members of a
team that will perform further research at FMRC relating to the Project under
the supervision of the Principal Investigator.
By
operation of law or under the terms of their employment or other relationships
with Clalit Health
Services, Tel Aviv University ("TAU") or Ramot, and according to agreements
between Clalit Health Services and TAU and between TAU and Ramot, all rights,
title and interest in and to any and all inventions and other
results arrived at by the Team Members as a result of their relationship with
TAU are owned by Ramot. This includes all intellectual property, inventions,
know-how, technology, methods, data and other results directly relating to the
Project arrived at prior to the date of this Agreement during the course of
research and development at FMRC (the "Existing Project
Technology").
Ramot and
BioLineRX Ltd. ("BioLine") have entered into a research and license agreement
(the "Research and License Agreement") pursuant to which: (1) Ramot granted
BioLine a license with respect to certain patent and other rights relating to
the Existing Project Technology, (2) BioLine agreed to fund further research
relating to the Project at FMRC by Team Members; and (3) Ramot agreed to cause
the performance of such research by Team Members and to grant BioLine a license
with respect to the results arrived at in the performance of such
research.
The
purpose of this Letter is to set forth the rights and obligations of the Team
Members with respect to the Project and the further research relating to the
Project to be performed by some or all of the Team Members. Please read this
Letter carefully and if you agree with its contents sign in the appropriate
place next to your name below.
Sponsored
Research.
(a) The
Principal Investigator agrees to supervise and cause the performance at FMRC of
further research relating to the Project in accordance with the research program
included in Exhibit C to this Letter (as may be amended from time to time by the
mutual agreement of Ramot and BioLine, after consultation with the Principal
Investigator) and the budget included in Exhibit C to this Letter (as may be
amended from time to time by the mutual agreement of Ramot and BioLine, after
consultation with the Principal Investigator). Such research is referred to in
this Letter as the "Sponsored Research."
39
(b) The
Principal Investigator will keep BioLine reasonably informed concerning the
Sponsored Research, its progress and its results.
2.
Intellectual Property Rights.
(a) Each
of the Team Members acknowledges , confirms and agrees that Ramot is and shall
be the sole owner of all rights , title and interest in and to any and all
Project Technology and any and all intellectual property rights relating to the
Project Technology . "Project Technology" means the Existing Project Technology
and any and all inventions , products, materials, methods, processes,
techniques, know-how, data, information, discoveries and other results of
whatever nature arrived at in the course of the performance of the Sponsored
Research, whether at FMRC or elsewhere.
(b) Each
of the Team Members agrees to sign and deliver to Ramot any documents, and to
take any actions , that Ramot believes are needed or desirable in order to best
confirm Ramot' s title in the Project Technology.
(c) The
Team Members acknowledge that all patent applications relating to Project
Technology, to the extent they cover inventions made by Team Members, will be
filed in the name of Ramot, except in cases where Ramot believes that it is
necessary that the patent applications be filed in the name of Team Members and
then assigned to Ramot . Each of the Team Members agrees, at Ramot's request ,
to assist Ramot to file and obtain, and if needed to enforce, any patent or
patent application relating to the Project Technology in any country requested
by Ramot. Such assistance may include signing, verifying and delivering to Ramot
such documents , and performing such other acts (including appearances as a
witness ), as Ramot may reasonably request for use in applying for , obtaining,
perfecting, evidencing, sustaining and enforcing such patents and patent
applications and confirming their assignment to Ramot.
(d) In
the event Ramot is unable for any reason, after reasonable effort, to secure a
Team Member's signature on any document needed in connection with the actions
specified in this clause 2, such Team Member hereby irrevocably designates and
appoints Ramot and its duly authorized officers and agents as such Team Member's
agent and attorney in fact, which appointment is coupled with an interest, to
act for and in such Team Member's behalf to sign, verify and file any such
documents and to do all other lawfully permitted acts to further the purposes of
this clause 2 with the same legal force and effect as if executed by such Team
Member.
3.
Confidentiality and Publications.
(a) Each
Team Member undertakes to keep confidential and not to disclose or use (other
than for the furtherance of the Project) any Project Technology or BioLine
Confidential Information to any person or entity other than a fellow Team
Member, an employee of Ramot, or an employee, officer or director of BioLine,
except and to the extent that s/he is instructed or authorized to do so by
Ramot. This obligation of confidentiality does not apply to any portion of the
Project Technology that is in the public domain (other than through the fault of
such Team Member), nor does it apply to information included in scientific
publications that have been approved by Ramot prior to publication. "BioLine
Confidential Information" means any scientific, technical, trade or business
information relating to the Sponsored Research designated as confidential or
which otherwise should reasonably be construed under the circumstances as being
confidential disclosed by or on behalf of BioLine to a Team Member, except to
the extent such information: (i) was known to such Team Member at the time it
was disclosed, other than by previous disclosure by or on behalf of BioLine, as
evidenced by such Team Member'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 Letter; (iii) is lawfully and in good faith made
available to the Team Member by a third party who is not subject to obligations
of confidentiality to BioLine or Ramot with respect to such information; or
(iv)is independently developed by the Team Member without the use of or
reference to BioLine Confidential Information, as demonstrated by documentary
evidence.
40
(b) In
general, Ramot will endeavor to assist the Team Members in facilitating
publications relating to Project Technology and Ramot agrees not to unreasonably
withhold its approval of publications, except to the extent described in this
paragraph. In order to permit Ramot to comply with its obligations to BioLine
and the opportunity to properly protect patent and proprietary rights relating
to information included in such proposed publications, the Team Members agree to
provide Ramot with a copy of each proposed publication at least forty (40) days
in advance of the contemplated submission for publication to permit Ramot to
review such submission to determine whether the publication or presentation
contains subject matter for which patent protection should be sought prior to
publication or presentation. Ramot will review, and shall allow BioLine to
review, such proposed publication. If Ramot informs the Principal Investigator
within thirty (30) days of the receipt of such proposed publication, that it
wishes to seek protection with respect to material included within such proposed
publication, then the Team Members will delay the submission of the publication
or presentation for a further period of up to sixty (60) days (or longer if
Ramot notifies the Team Members that such additional period is required in order
to make the necessary patent filings) to enable Ramot to make the necessary
patent filings.
(c) Each
Team Member's obligations under this clause 3 shall continue in full force
and
effect during the term such Team Member is involved with the Sponsored Research
and for a period
of seven (7) years after the termination of such Team Member's involvement with
the Sponsored
Research.
4.
Distributions.
(a) Those
of the Team Members who are inventors of technologies included in patents
relating to the Project Technology (together, the "Inventors") will be entitled,
together, to receive from the proceeds received by Ramot from the
commercialization of Project Technologies the amounts determined in accordance
with the rules and regulations in effect at TAU, from time to time, relating to
the allocation of the proceeds from the commercialization by Ramot of inventions
made by them. The total distributions received by all Team Members according to
this clause are referred to in this Agreement as the
"Distributions".
(b) The
Distributions shall be allocated among the Inventors in accordance with the
percentages set forth in Exhibit C hereto. The Team Members understand that this
allocation of the Distributions among the Inventors is based on the contribution
of each Inventor to the inventions included in the Existing
Technology.
(c) Each
of the Team Members agrees that if, in the Principal Investigator's judgment, a
change in the Sponsored Research, the composition of the research team or the
respective contributions of the Inventors to the Project Technology
being commercialized justifies a change in the allocation of the Distributions
among the Inventors, the Principal Investigator will decide, at his sole
discretion, on an amended allocation of the Distributions. Such change may
include: (i) additions of persons to the list of Inventors entitled to a share
of the Distributions; (ii) deletion of certain persons from the list of
Inventors entitled to Distributions; (iii) changes in the respective share of
the Distributions an Inventor is entitled to; and/or (iv) any other change
deemed by the Principal Investigator to be appropriate, in his absolute
discretion. (d) Ay change made pursuant to clause 4(c) will only affect
Distributions paid after the date of the relevant change. It will not affect
Distributions distributed to individual Inventors prior to the relevant
change.
41
(e) Each
of the Team Members agrees that, if a Team Member disputes a decision made by
the Principal Investigator pursuant to this clause 4, or if there is more than
one Principal Investigator and they are unable to reach agreement between them
regarding the allocation of Distributions among Inventors pursuant to this
clause 4, then the matter will be finally resolved by the Vice President and
Xxxx for Research of TAU followed by confirmation of such determination by the
President of TAU.
5.
No Other Consideration. Notwithstanding anything to the
contrary in the terms of employment of the Team Members, the Team Members agree
that they will not be entitled to any consideration or benefits of any nature in
connection with or arising out of the commercialization of Project Technology,
other than as specifically set forth in clause 4 above with respect to
Inventors.
6.
Taxes. Each Inventor will bear and pay any
taxes imposed on such Team Member with respect to his/her share of
Distributions. Ramot and TAU will be entitled to withhold, deduct or pay any
withholding taxes and/or any other deductions or payments that Ramot or TAU may
be required under law to withhold, deduct or pay with respect to any
Distributions received by any Team Member.
7.
Execution by New Team Members. The Principal Investigator undertakes to notify
Ramot and TAU immediately of any new faculty member, post-doctoral fellow,
student or other researcher who is to participate in the performance of the
Sponsored Research. After consultation with the Principal Investigator, Ramot
will decide whether such new researcher should sign this Letter as a Team
Member. If Ramot determines that such new researcher should sign this Letter,
the Principal Investigator will cause such new researcher to sign this Letter
prior to performing Sponsored Research.
42
If the
terms and provisions of this Letter are acceptable to you, please indicate your
acceptance
by
signing in the space indicated below (if you are the Principal Investigator) or
on Exhibit A (if
you are a
Researcher).
Sincerely,
Ramot
at Tel Aviv University Ltd.
|
Tel
Aviv University
|
|||
By:
|
By:
|
Name:
|
Name:
|
Title:
|
Title:
|
I have
read this Letter and I understand its contents. I hereby agree to and accept the
terms and conditions
of this Letter.
Principal
Investigator
43
Exhibit
9.1.2.2(b)
BIU
Team Agreement
April 15,
2004
Dear
Xxxxxxxxx Xxxxxxx Xxxxxxxx (the "Principal Investigator")
Re: Team Agreement Relating to
Project
This
letter agreement (this "Letter") is addressed to you and the persons listed in
Exhibit A to this Letter (each a "Researcher" and collectively, the
"Researchers"). Exhibit A may be amended by the addition of new Researchers as
described below. You and the Researchers are referred to collectively in this
Letter as the "Team Members".
The Team
Members are or were faculty members, post-doctoral fellows, students or
technicians performing research at Bar-Ilan University ("Bar-Ilan"). In such
capacity, they have performed research at Bar-Ilan relating to conjugated
anti-psychotic drugs and the use thereof (as further described in Exhibit B to
this Agreement, the "Project") and/or are members of a team that will perform
further research at Bar-Ilan relating to the Project under the supervision of
the Principal Investigator.
By
operation of law or under the terms of their employment or other relationships
with Bar-Ilan or Bar-Ilan Research and Development Company Ltd. ("BIRAD"), and
according to agreements between Bar-Ilan and BIRAD, all rights, title and
interest in and to any and all inventions and other results arrived at by the
Team Members as a result of their relationship with Bar-Ilan are owned by BIRAD.
This includes all intellectual property, inventions, know-how, technology,
methods, data and other results directly relating to the Project arrived at
prior to the date of this Agreement during the course of research and
development at Bar-Ilan (the "Existing Project Technology").
BIRAD,
Ramot at Tel Aviv University Ltd. ("Ramot") and BioLineRX Ltd. ("BioLine") have
entered into a research and license agreement (the "Research and License
Agreement") pursuant to which: (1) BIRAD granted BioLine a license with respect
to certain patent and other rights owned by BIRAD relating to the Existing
Project Technology , (2) BioLine agreed to fund further research relating to the
Project at Bar-Ilan by Team Members ; and (3) BIRAD agreed to cause the
performance of such research by Team Members and to grant BioLine a license with
respect to the results arrived at in the performance of such
research.
The
purpose of this Letter is to set forth the rights and obligations of the Team
Members with respect to the Project and the further research relating to the
Project to be performed by some or all of the Team Members. Please read this
Letter carefully and if you agree with its contents sign in the appropriate
place next to your name below.
44
1. Sponsored
Research.
(a) The
Principal Investigator agrees to supervise and cause the performance at Bar-Ilan
of further research relating to the Project in accordance with the research
program included in Exhibit C to this Letter (as may be amended from time to
time by the mutual agreement of BIRAD and BioLine, after consultation with the
Principal Investigator) and the budget included in Exhibit C to this Letter (as
may be amended from time to time by the mutual agreement of BIRAD and BioLine,
after consultation with the Principal Investigator ). Such research is referred
to in this Letter as the "Sponsored Research."
(b) The
Principal Investigator will keep BioLine reasonably informed concerning
the
Sponsored
Research, its progress and its results.
2.
Intellectual Property Rights.
(a) Each
of the Team Members acknowledges, confirms and agrees that BIRAD is and shall be
the sole owner of all rights, title and interest in and to any and all Project
Technology and any and all intellectual property rights relating to the Project
Technology. "Project Technology" means the Existing Project Technology and any
and all inventions, products, materials, methods, processes, techniques,
know-how, data, information, discoveries and other results of whatever nature
arrived at in the course of the performance of the Sponsored Research, whether
at Bar-Ilan or elsewhere.
(b) Each
of the Team Members agrees to sign and deliver to BIRAD any documents, and to
take any actions, that BIRAD believes are needed or desirable in order to best
confirm BIRAD's title in the Project Technology.
(c) The
Team Members acknowledge that all patent applications relating to Project
Technology, to the extent they cover inventions made by Team Members, will be
filed in the name of BIRAD, except in cases where BIRAD believes that it is
necessary that the patent applications be filed in the name of Team Members and
then assigned to BIRAD. Each of the Team Members agrees, at BIRAD's request, to
assist BIRAD to file and obtain, and if needed to enforce, any patent or patent
application relating to the Project Technology in any country requested by
BIRAD. Such assistance may include signing, verifying and delivering to BIRAD
such documents, and performing such other acts (including appearances as a
witness), as BIRAD may reasonably request for use in applying for, obtaining,
perfecting, evidencing, sustaining and enforcing such patents and patent
applications and confirming their assignment to BIRAD.
(d) In
the event BIRAD is unable for any reason, after reasonable effort, to secure a
Team Member's signature on any document needed in connection with the actions
specified in this clause 2, such Team Member hereby irrevocably designates and
appoints BIRAD and its duly authorized officers and agents as such Team Member's
agent and attorney in fact, which appointment is coupled with an interest, to
act for and in such Team Member's behalf to sign, verify and file any such
documents and to do all other lawfully permitted acts to further the purposes of
this clause 2 with the same legal force and effect as if executed by such Team
Member.
45
3.
Confidentiality and Publications.
(a) Each
Team Member undertakes to keep confidential and not to disclose or use (other
than for the furtherance of the Project) any Project Technology or BioLine
Confidential Information to any person or entity other than a fellow Team
Member, an employee of BIRAD, or an employee, officer or director of BioLine,
except and to the extent that s/he is instructed or authorized to do so by
BIRAD. This obligation of confidentiality does not apply to any portion of the
Project Technology that is in the public domain (other than through the fault of
such Team Member), nor does it apply to information included in scientific
publications that have been approved by BIRAD prior to publication. "BioLine
Confidential Information" means any scientific, technical, trade or business
information relating to the Sponsored Research designated as confidential or
which otherwise should reasonably be construed under the circumstances as being
confidential disclosed by or on behalf of BioLine to a Team Member, except to
the extent such information: (i) was known to such Team Member at the time it
was disclosed, other than by previous disclosure by or on behalf of BioLine, as
evidenced by such Team Member'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 Letter; (iii) is lawfully and in good faith made
available to the Team Member by a third party who is not subject to obligations
of confidentiality to BioLine or BIRAD with respect to such information; or (iv)
is independently developed by the Team Member without the use of or reference to
BioLine Confidential Information, as demonstrated by documentary
evidence.
(b) In
general, BIRAD will endeavor to assist the Team Members in facilitating
publications relating to Project Technology and BIRAD agrees not to unreasonably
withhold its approval of publications, except to the extent described in this
paragraph. In order to permit BIRAD to comply with its obligations to BioLine
and the opportunity to properly protect patent and proprietary rights relating
to information included in such proposed publications, the Team Members agree to
provide BIRAD with a copy of each proposed publication at least forty (40) days
in advance of the contemplated submission for publication to permit BIRAD to
review such submission to determine whether the publication or presentation
contains subject matter for which patent protection should be sought prior to
publication or presentation. BIRAD will review, and shall allow BioLine to
review, such proposed publication. If BIRAD informs the Principal Investigator
within thirty (30) days of the receipt of such proposed publication, that it
wishes to seek protection with respect to material included within such proposed
publication, then the Team Members will delay the submission of the publication
or presentation for a further period of up to sixty (60) days (or longer if
BIRAD notifies the Team Members that such additional period is required in order
to make the necessary patent filings) to enable BIRAD to make the necessary
patent filings.
(c) Each
Team Member's obligations under this clause 3 shall continue in full force and
effect during the term such Team Member is involved with the Sponsored Research
and for a period of seven (7) years after the termination of such Team Member's
involvement with the Sponsored Research.
4.
Distributions.
(a) Those
of the Team Members who are inventors of technologies included in patents
relating to the Project Technology (together, the "Inventors") will be entitled,
together, to receive from the proceeds received by BIRAD from the
commercialization of Project Technologies the amounts determined in accordance
with the rules and regulations in effect at Bar-Ilan, from time to time,
relating to the allocation of the proceeds from the commercialization by BIRAD
of inventions made by them. The total distributions received by all Team Members
according to this clause are referred to in this Agreement as the
"Distributions".
(b) The
Distributions shall be allocated among the Inventors in accordance with the
percentages
set forth in Exhibit C hereto. The Team Members understand that this allocation
of the
Distributions among the Inventors is based on the contribution of each Inventor
to the inventions
included in the Existing Technology.
46
(c) Each
of the Team Members agrees that if , in the Principal Investigator ' s judgment,
a change in the Sponsored Research; the composition of the research team or the
respective contributions of the Inventors to the Project Technology being
commercialized justifies a change in the allocation of the Distributions among
the Inventors , the Principal Investigator will decide, at his sole discretion ,
on an amended allocation of the Distributions . Such change may include: (i)
additions of persons to the list of inventors entitled to a share of the
Distributions; (ii) deletion of certain persons from the list of Inventors
entitled to Distributions ; (iii) changes in the respective share of the
Distributions an Inventor is entitled to; and/or (iv) any other change deemed by
the Principal Investigator to be appropriate, in his absolute
discretion.
(d) Any
change made pursuant to clause 4(c) will only affect Distributions paid after
the date of the relevant change. It will not affect Distributions distributed to
individual Inventors prior to the relevant change.
(e) Each
of the Team Members agrees that, if a Team Member disputes a decision made by
the Principal Investigator pursuant to this clause 4, or if there is more than
one Principal Investigator and they are unable to reach agreement between them
regarding the allocation of Distributions among Inventors pursuant to this
clause 4, then the matter will be finally resolved by the Vice President and
Xxxx for Research of Bar-Ilan followed by confirmation of such determination by
the President of Bar-Ilan.
5. No
Other Consideration. Notwithstanding anything to the contrary in the terms of
employment of the Team Members, the Team Members agree that they will not be
entitled to any consideration or benefits of any nature in connection with or
arising out of the commercialization of Project Technology, other than as
specifically set forth in clause 4 above with respect to Inventors.
6. Taxes.
Each Inventor will bear and pay any taxes imposed on such Team Member with
respect to his/her share of Distributions. BIRAD and Bar-Ilan will be entitled
to withhold, deduct or pay any withholding taxes and/or any other deductions or
payments that BIRAD or Bar-Ilan may be required under law to withhold, deduct or
pay with respect to any Distributions received by any Team Member.
7.
Execution by New Team Members. The Principal Investigator undertakes to notify
BIRAD and Bar-Ilan immediately of any new faculty member, post-doctoral fellow,
student or other researcher who is to participate in the performance of the
Sponsored Research. After consultation with the Principal Investigator, BIRAD
will decide whether such new researcher should, sign this Letter as a Team
Member. If BIRAD determines that such new researcher should sign this Letter,
the Principal Investigator will cause such new researcher to sign this Letter
prior to performing Sponsored Research.
47
If the
terms and provisions of this Letter are acceptable to you, please indicate your
acceptance by
signing in the space indicated below (if you are the Principal Investigator) or
on Exhibit A (if you are a
Researcher).
Sincerely,
Bar-Ilan
Research and Development
|
Bar-Ilan
University
|
|||
Company
Ltd.
|
||||
By:
|
By:
|
Name:
|
Name:
|
Title:
|
Title:
|
I have
read this Letter and I understand its contents. I hereby agree to and accept the
terms and conditions
of this Letter.
48