Exhibit 10.2

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

LICENSE AGREEMENT

(AP23573 in Medical Devices)

This License Agreement (this “Agreement”) is made effective as of January 26,
2005 (the “Effective Date”), by and between ARIAD Pharmaceuticals, Inc. and
ARIAD Gene Therapeutics, Inc., both corporations with a principal place of
business at 26 Landsdowne Street, Cambridge, MA 02139 (collectively, “ARIAD”),
and MEDINOL Ltd., a company with a principal place of business at Kiryat Atidim,
P.O. Box 58165, Tel Aviv, 61581, Israel (“MEDINOL”). ARIAD and MEDINOL are each
hereafter referred to individually as a “Party” and together as the “Parties.”

WHEREAS, ARIAD is the owner of, or otherwise controls, certain patents and
technology relating to AP23573 (as defined below);

WHEREAS, MEDINOL has expertise in developing and commercializing stents, which
can deliver drug products for the treatment of restenosis;

WHEREAS, MEDINOL desires to obtain the right from ARIAD to use AP23573 to
evaluate, develop and commercialize certain medical devices, including stents,
that will deliver AP23573;

WHEREAS, MEDINOL desires ARIAD to supply quantities of AP23573 to MEDINOL for
research, clinical and commercial use with certain medical devices, including
stents, that will deliver AP23573; and

WHEREAS, ARIAD desires to grant to MEDINOL rights to use AP23573 to evaluate,
develop and commercialize certain medical devices, including stents, that will
deliver AP23573 and to supply quantities of AP23573 to MEDINOL in connection
therewith on the terms and conditions set forth in this Agreement and the Supply
Agreement (as defined below).

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the Parties hereby agree as follows:

 

  1. DEFINITIONS

Whenever used in the Agreement with an initial capital letter, the terms defined
in this Article 1 shall have the meanings specified.

1.1 “Adverse Event” shall mean any untoward medical occurrence required to be
reported to any Regulatory Authority, including without limitation any

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

occurrence defined as a “serious adverse event” in applicable Regulatory
Authority regulations or guidelines (including 21 CFR §§312.32 and 314.80, and
European Standard EN540) in a patient who has been administered AP23573.

1.2 “Affiliate” shall mean any corporation, firm, limited liability company,
partnership or other entity that directly controls, is controlled by or is under
common control with a Party to this Agreement. For purposes of this Section 1.2,
“control” means ownership, directly or indirectly through one or more entities,
of fifty percent (50%) or more of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interests in the case of any other type of legal entity,
status as a general partner in any partnership, or any other arrangement whereby
a Party controls or has the right to control the Board of Directors or
equivalent governing body of a corporation or other entity.

1.3 “API” shall mean the active pharmaceutical ingredient of AP23573.

1.4 “AP23573” shall mean ARIAD’s proprietary compound designated “AP23573,”
described in [***] filed by ARIAD with the FDA.

1.5 “AP23573 Phase 1 Clinical Data” shall mean a narrative summary report
prepared by ARIAD of unaudited clinical data obtained by ARIAD for patients
enrolled in the AP23573 Phase 1 Clinical Trials as of the date which is three
weeks preceding the date of each such summary report. Each such narrative
summary report shall summarize each protocol, the number of enrolled patients
receiving each dosage level in accordance with each protocol, and the safety
information (which shall comprise all Adverse Events reported on draft data
listings and “serious adverse events” required to be reported to any Regulatory
Authority) obtained by ARIAD. For purposes of clarity, all AP23573 Phase 1
Clinical Data (i) is subject to change after audit, (ii) shall be treated as
Confidential Information of ARIAD, (iii) shall be used by MEDINOL solely for
internal purposes in performing its obligations and/or exercising its rights
under this Agreement and the Supply Agreement, and (iv) shall not be disclosed
by MEDINOL to any Third Party under any circumstances without ARIAD’s prior
written consent.

1.6 “AP23573 Phase 1 Clinical Trials” shall mean only the following studies of
AP23573: (a) [***] to be conducted in accordance with Protocol No. [***], and
(b) [***] to be conducted in accordance with Protocol No. [***].

1.7 “Authorized Distributor” shall mean a seller or distributor of MEDINOL
Licensed Products approved by ARIAD pursuant to Section 2.1.3.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

1.8 “CE Mark” shall mean the “Conformite Europeene” mark issued upon approval by
the European Union Regulatory Authority to market and sell MEDINOL Licensed
Products in the countries of the European Union.

1.9 “Change-in-Control” shall have the meaning set forth in Section 11.8.

1.10 “CMC Data” means the chemistry, manufacturing, and controls data set forth
in 21 CFR 314.50, as the same may be amended from time to time, or as otherwise
required by applicable law and regulations to be included in an NDA, or the
equivalent application to a Regulatory Authority for grant of marketing
authorization outside the United States, as such data may be amended or
supplemented from time to time. For purposes of clarity, CMC Data shall be
treated as Confidential Information for purposes of this Agreement.

1.11 “Confidential Information” shall mean (a) with respect to a Party (the
“Receiving Party”), all information (including without limitation, with respect
to ARIAD, all data from AP23573 Phase 1 Clinical Trials, the chemical structure
of AP23573 and, with respect to each Party, all Licensed Technology, CMC Data,
development plans and schedules, marketing and sales information, clinical and
pre-clinical data, information and results, specifications, and protocols),
which are disclosed by the other Party (the “Disclosing Party”) to the Receiving
Party hereunder or to any of its employees, consultants or Affiliates; and which
is designated as confidential information, prior to, during or immediately after
such disclosure. Confidential Information does not include information which
(i) as of the date of disclosure, is known to the Receiving Party or its
Affiliates, as demonstrated by written records, other than by virtue of a prior
confidential disclosure to such Party or its Affiliates; (ii) as of the date of
disclosure is in, or subsequently enters, the public domain, through no breach
of this Agreement by the Receiving Party; (iii) is obtained from a Third Party
having a lawful right to make such disclosure free from any obligation of
confidentiality to the Disclosing Party; or (iv) is independently developed by
or for the Receiving Party without reference to, or reliance upon, any
Confidential Information of the Disclosing Party as demonstrated by written
records.

1.12 “Control” or “Controlled” shall mean with respect to any Patent Rights or
Technology, the possession by a Party of the ability to grant a license or
sublicense of such Patent Rights or Technology, as provided for herein, without
violating the terms of any agreements between such Party and any Third Party and
without requiring such Party to make any contractual payment to any Third Party
in connection with such grant of rights or the exercise thereof by the grantee.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

1.13 “Current Good Laboratory Practices” or “cGLP” shall mean current good
laboratory practice and standards as described in Directive 2004/9/EC of the
European Parliament and of the Council of 11 February 2004 and in Directive
2004/10/EC of the European Parliament and of the Council of 11 February 2004 or
in 21 CFR Part 58, as amended, from time to time.

1.14 “Current Good Manufacturing Practices” or “cGMP” shall mean European
Community requirements for good manufacturing practice as set forth in
Commission Directives 91/356/EEC and 2003/94/EC, as amended, and guidance
documents issued pursuant to them, or as set forth in, Title 21 of the United
States Code of Federal Regulations, Parts 210 and 211, as amended, from time to
time.

1.15 “Drug Master File” or “DMF” shall mean a drug master file and any amendment
and supplements thereto, filed and maintained with a Regulatory Authority by or
on behalf of ARIAD, which shall contain, among other things, CMC Data and other
relevant information concerning AP23573.

1.16 “Excess API Cost,” as defined in the Supply Agreement, means, the
difference, if any, between (i) the purchase price per gram of API [***]
following expiration of the [***] notice period of a Refusal to Supply by ARIAD,
minus (ii) [***]amount equal to [***] Dollars (U.S. $[***]), subject to annual
adjustment for inflation, from the Effective Date to the date of purchase by
MEDINOL, using the United States Bureau of Labor Statistics Producer Price Index
for Pharmaceutical Preparation Manufacturing published at www.bls.gov. To
calculate the Excess API Cost, all payments made by MEDINOL for API in foreign
currency shall be converted into United States Dollars at the conversion rate
existing in the United States (as reported in The Wall Street Journal, Eastern
Edition, for purchasing United States Dollars) on the last business day of the
applicable calendar quarter in which the purchase of API took place.

1.17 “Exclusive Licensees” shall mean MEDINOL and up to two (2) additional Third
Parties who may be granted a license, under ARIAD’s interest in the Licensed
Patent Rights and Licensed Technology to develop, have developed, make, have
made, use, have used, sell, have sold, offer for sale, import, have imported,
export, have exported, distribute, market and promote Licensed Products for use
in the Licensed Field.

1.18 “FDA” shall mean the United States Food and Drug Administration and any
successor agency or authority thereto.

1.19 “First Commercial Sale” shall mean, on a country-by-country basis, the date
of the first arm’s length transaction, transfer or disposition for value to a

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

Third Party of a MEDINOL Licensed Product by or on behalf of MEDINOL or any
Affiliate of MEDINOL in such country, but specifically excluding any transfers
made in furtherance of clinical trials, research, or other such non-commercial
uses.

1.20 “First-In-Humans Clinical Trial” shall mean, with respect to a MEDINOL
Licensed Product, the first study in humans of the MEDINOL Licensed Product as
an investigational device in accordance with applicable rules and regulations of
the country or jurisdiction in the which the clinical trial is conducted.

1.21 “IDE” shall mean an investigational device exemption, as defined in Title
21 of the United States Code of Federal Regulations, Part 812 et seq., as
amended from time to time, filed or to be file with the FDA.

1.22 “IND” shall mean an investigational new drug application, as defined in
Title 21 of the United States Code of Federal Regulations, Part 312 et seq., as
amended from time to time, filed or to be filed with the FDA.

1.23 “Licensed Field” shall mean the [***] of any [***].

1.24 “Licensed Patent Rights” shall mean all Patent Rights that (i) are
Controlled by ARIAD as of the Effective Date, to the extent necessary to
develop, use, make, have made, import, have imported, export, have exported,
sell, have sold, offer to sell, distribute, market and promote MEDINOL Licensed
Products in the Licensed Field and/or (ii) become Controlled by ARIAD during the
License Term, to the extent necessary for MEDINOL to develop, use, make, have
made, import, have imported, export, have exported, sell, have sold, offer to
sell, distribute, market and promote MEDINOL Licensed Products in the Licensed
Field. The Licensed Patent Rights as of the Effective Date are listed in
Schedule A attached hereto and made a part hereof. During the Term, ARIAD shall
provide to MEDINOL an annual written update of Schedule A which includes any
additional patents and patent applications comprising Licensed Patents not
previously listed.

1.25 “Licensed Product” shall mean any Medical Device which delivers AP23573.

1.26 “Licensed Technology” shall mean and include all Technology, whether or not
patentable, including but not limited to formulations, techniques and materials,
that (i) is Controlled by ARIAD as of the Effective Date, to the extent
necessary for MEDINOL to develop, use, make, have made, import, have imported,
export, have exported, sell, have sold, offer to sell, distribute, market and
promote MEDINOL Licensed Products in the Licensed Field, and/or (ii) becomes
Controlled by ARIAD during the License Term, to the extent necessary for MEDINOL
to make and have made MEDINOL Licensed Products in the Licensed Field.

 

5

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

1.27 “License Term” shall mean, with respect to each MEDINOL Licensed Product,
the period commencing on the Effective Date and continuing, on a
country-by-country and product-by-product basis, until the expiration or
termination of the last Valid Claim covering the manufacture, sale, use or
importation of AP23573 in such country.

1.28 “Medical Device” shall mean any [***].

1.29 “MEDINOL-Gore Agreement” shall mean the Collaboration Agreement between
MEDINOL and W.L. Gore dated September 12, 2002.

1.30 “MEDINOL Licensed Product” shall mean any embodiment of a Licensed Product
manufactured by or exclusively for MEDINOL and sold by MEDINOL, W.L. Gore or
MEDINOL’s Authorized Distributors, for which all Patent Rights are reasonably
believed by MEDINOL to be owned or Controlled by MEDINOL, or for which MEDINOL
reasonably believes it otherwise has the right to practice all Patent Rights.
For avoidance of doubt, MEDINOL Licensed Product shall include any embodiment of
a Licensed Product manufactured by or exclusively for MEDINOL, but which is
bundled for sale by MEDINOL, W.L. Gore or MEDINOL’s Authorized Distributors with
any other product or products (each of which may or may not be a MEDINOL
Licensed Product); for example, a MEDINOL Licensed Product sold by W.L. Gore,
either as a single unit or bundled with other products manufactured by or
exclusively for W.L. Gore, pursuant to the MEDINOL-Gore Agreement).

1.31 “NDA” shall mean a New Drug Application filed with the FDA or any
equivalent successor application or entity seeking authorization to market
AP23573.

1.32 “Net Sales” shall mean the gross invoiced sales price for all MEDINOL
Licensed Products sold by MEDINOL, W.L. Gore or MEDINOL’s Authorized
Distributors, their respective Affiliates and the subdistributors of W.L. Gore
or MEDINOL’s Authorized Distributors to Third Parties throughout the world
during each calendar quarter, before the deduction of any promotional discounts,
promotions, royalties, taxes, duties, fees, charges or other expenses to such
seller and before any reimbursements made to its customers and after deduction
of other discounts to individual customers not in excess of [***]% for any
MEDINOL Licensed Product for any customer.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

1.33 “Patent Rights” shall mean the rights and interests in and to issued
patents and pending patent applications (including inventor’s certificates and
utility models) in any country or jurisdiction, including all provisionals,
substitutions, continuations, continuations in part, divisionals, supplementary
protection certificates, renewals, all letters patent granted thereon, and all
reissues, reexaminations, extensions, confirmations, revalidations,
registrations, patents of addition thereof, PCTs and foreign counterparts.

1.34 “Patented MEDINOL Licensed Product” shall mean a MEDINOL Licensed Product
manufactured or sold in a country in which there is a Valid Claim of a Licensed
Patent Right at the time of manufacture or sale.

1.35 “Permitted Assignee” shall mean any assignee assuming the rights and
obligations of a Party under this Agreement pursuant to a Change-in-Control.

1.36 “Pivotal Clinical Trial” shall mean, with respect to a MEDINOL Licensed
Product, a well-controlled study in humans designed to determine, taking into
account statistical considerations, the safety and efficacy of such MEDINOL
Licensed Product, which is designed to demonstrate whether such MEDINOL Licensed
Product is safe and effective for one or more indication(s) in the Licensed
Field.

1.37 “PMA” shall mean an application to obtain pre-market approval, as defined
in Title 21 of the United States Code of Federal Regulations, Part 814 et. seq.,
as amended from time to time, filed with the FDA.

1.38 “Registration Process” shall mean ARIAD’s manufacturing process for
manufacturing API under cGMP which is validated and reproducible to achieve
Regulatory Approval of the MEDINOL Licensed Product in the United States and the
European Union.

1.39 “Regulatory Approval” shall mean any and all approvals by applicable
Regulatory Authorities necessary to market and sell a MEDINOL Licensed Product
in any country or jurisdiction.

1.40 “Regulatory Authority” shall mean any applicable supranational, national,
federal, state or local regulatory agency, department, bureau or other
governmental entity of any country or jurisdiction (including the FDA in the
United States), having responsibility in such country or jurisdiction for any
Regulatory Approvals of any kind in such country or jurisdiction, and any
successor agency or authority thereto.

 

7

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

1.41 “Stent” shall mean a metal wire mesh tube that is placed, by means of a
catheter, at the site of a blockage within an artery [***] to keep the vessel
open after balloon angioplasty.

1.42 “Supply Agreement” shall mean that certain Supply Agreement, entered into
as of even date herewith between ARIAD and MEDINOL, in the form attached hereto
as Exhibit 3.3.

1.43 “Technology” shall mean and include any and all unpatented proprietary
ideas, inventions, discoveries, Confidential Information, biological materials,
data, results, formulae, designs, specifications, methods, processes,
formulations, techniques, ideas, know-how, technical information (including,
without limitation, structural and functional information), process information,
pre-clinical information, clinical information, and any and all proprietary
biological, chemical, pharmacological, toxicological, pre-clinical, clinical,
assay, control and manufacturing data and materials, and, in the case of
MEDINOL, any and all mechanical, mechanical design and material science data and
materials.

1.44 “Term” shall mean have the meaning set forth in Section 9.1.

1.45 “Third Party” shall mean any person or entity other than MEDINOL or ARIAD.

1.46 “Unpatented MEDINOL Licensed Product” shall mean a MEDINOL Licensed Product
that is neither manufactured nor sold in a country in which there is a Valid
Claim of a Licensed Patent Right at the time of manufacture or sale.

1.47 “Valid Claim” shall mean a claim in an issued, unexpired patent within the
Licensed Patent Rights that (a) has not been finally cancelled, withdrawn,
abandoned or rejected by any administrative agency or other body of competent
jurisdiction, (b) has not been revoked, held invalid, or declared unpatentable
or unenforceable in a decision of a court or other body of competent
jurisdiction that is unappealable or unappealed within the time allowed for
appeal, (c) has not been rendered unenforceable through disclaimer or otherwise,
and (d) is not lost through an interference proceeding.

1.48 [***].

1.49 “W.L. Gore” shall mean W.L. Gore and Associates.

 

8

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

  2. GRANT OF RIGHTS

2.1 License and Retained Rights.

2.1.1 Grant of License. Subject to the terms and conditions of this Agreement,
ARIAD hereby grants to MEDINOL a tri-exclusive, with up to two other Exclusive
Licensees, worldwide royalty-bearing license during the Term, with the right to
grant sublicenses solely to MEDINOL’s Affiliates, W.L. Gore, MEDINOL’s
Authorized Distributors and/or other sellers and distributors of MEDINOL
products who are not Affiliates of W.L. Gore or an Authorized Distributor and
who purchase MEDINOL products from W.L. Gore or an Authorized Distributor
(including in multi-tiered distribution channels), solely to enable such
Affiliates and/or W.L. Gore and Authorized Distributors and other such sellers
and distributors to market and sell MEDINOL Licensed Products, under ARIAD’s
interest in the Licensed Patent Rights and Licensed Technology, to develop, have
developed, make, have made, use, have used, sell, have sold, offer to sell,
import, have imported, export, have exported, distribute, market and promote
MEDINOL Licensed Products in the Licensed Field.

2.1.2 Retained Rights. Subject to the other terms of this Agreement, ARIAD
retains all rights to the Licensed Technology and the Licensed Patent Rights,
including without limitation, the right to:

(a) develop, have developed, make, have made, use, have used, sell, have sold,
offer for sale, import, have imported, export, have exported, distribute, market
or promote any product, except that ARIAD shall not have the right to use, have
used, sell, have sold, offer for sale, import, have imported, export or have
exported, distribute, market or promote any Licensed Product in the Licensed
Field;

(b) grant licenses to Affiliates and Third Parties under ARIAD’s interest in the
Licensed Patent Rights and Licensed Technology, except that ARIAD will not grant
more than two (2) tri-exclusive licenses to Exclusive Licensees, under ARIAD’s
interest in the Licensed Patent Rights and Licensed Technology, to develop, have
developed, make, have made, use, have used, sell, have sold, offer for sale,
import, have imported, export, have exported, distribute, market and promote
Licensed Products in the Licensed Field,

(c) make or have made and sell or supply AP23573 for any purpose, provided that
ARIAD will not use AP23573 in Licensed Products in the Licensed Field nor supply
AP23573 to any party for use in Licensed Products in the Licensed Field other
than to MEDINOL hereunder or under the Supply Agreement or to an Exclusive
Licensee licensed in accordance with clause (b) above; and

(d) otherwise develop and exploit Licensed Patent Rights and Licensed Technology
for any purpose other than Licensed Products for use in the Licensed Field.

 

9

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

No rights or licenses are granted hereunder (by implication, estoppel or
otherwise) except as expressly set forth herein. The restrictions and
limitations on ARIAD’s retained rights in clauses (a) and (b) of this
Section 2.1.2 shall, on a country by country basis, terminate and become void
upon the expiration or termination of the Licensed Term each such country.

2.1.3 Authorized Distributors. If MEDINOL wishes to appoint a seller or
distributor of MEDINOL Licensed Products other then W.L. Gore, it shall so
notify ARIAD and shall provide ARIAD with all material information regarding the
relationship and a copy of all relevant agreements (collectively, the
“Distributor Information”). No Third Party shall be appointed as a seller or
distributor of MEDINOL Licensed Products without written approval of ARIAD,
which shall not be unreasonably withheld. ARIAD shall respond to any request for
approval within ten (10) days of receipt of the Distributor Information from
MEDINOL. If ARIAD’s approval of any proposed seller or distributor is withheld,
ARIAD shall so notify MEDINOL in writing within such 10-day period, including an
explanation of the reasons therefor. Some examples (but not a complete list) of
reasons ARIAD may withhold its approval of a proposed seller or distributor
include ARIAD’s reasonable belief that such proposed seller or distributor has a
history of under performance, is competitive with ARIAD or its Affiliates, is
adverse to ARIAD or its Affiliates in a pending or threatened dispute or would
cause ARIAD or its Affiliates to be in breach under, or conflict with, any
agreement, decree, law, rule or regulation governing ARIAD’s business. MEDINOL
shall remain obligated for its performance under this Agreement notwithstanding
MEDINOL’s sublicense to, or appointment of, W.L. Gore or any Authorized
Distributor to sell or distribute MEDINOL License Products on MEDINOL’s behalf.

 

  3. DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS.

3.1 Development Obligations. ARIAD’s and MEDINOL’s obligations concerning the
development and commercialization of AP23573 and MEDINOL Licensed Products are
set forth in this Article 3.

3.1.1 ARIAD’s Obligations. During the Term, at ARIAD’s sole expense, ARIAD shall
use commercially reasonable efforts to:

(a) for so long as ARIAD and/or its pharmaceutical partners continue development
of AP23573 for use to treat cancer, take all actions necessary to continue
development and manufacture under cGMP of AP23573 in order to facilitate
MEDINOL’s efforts pursuant to Section 3.1.2;

 

10

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

(b) as mutually agreed, provide to MEDINOL, from time to time, such AP23573
Phase 1 Clinical Data to facilitate MEDINOL in meeting its obligations pursuant
to Section 3.1.2. MEDINOL shall maintain all such AP23573 Phase 1 Clinical Data
in confidence and shall not use or disclose it to any Third Party except as
expressly permitted under Section 3.4 of this Agreement.

(c) as soon as practicable following completion of its AP23573 Phase 1 Clinical
Trials, provide to MEDINOL a final audited report of all clinical data,
including all Adverse Events, obtained from patients enrolled in ARIAD’s AP23573
Phase 1 Clinical Trials. MEDINOL shall maintain the final audited report
disclosed to it pursuant to this Section 3.1.1(c) in confidence and shall not
use or disclose it to any Third Party except as expressly permitted under
Section 3.4 of this Agreement;

(d) take all actions necessary to file and maintain its U.S. DMF with respect to
API made using the Registration Process on a timetable to be mutually agreed
between ARIAD and MEDINOL;

(e) take all actions necessary, including completion of its ongoing AP23573
Phase 1 Clinical Trials, to file and maintain a European DMF with respect to API
made using the Registration Process on a timetable to be mutually agreed between
ARIAD and MEDINOL; and

(f) take all actions agreed upon by the Parties and necessary to seek marketing
approval for AP23573 in Japan on a timetable to be mutually agreed between ARIAD
and MEDINOL.

For purposes of clarity, it is acknowledged that (i) ARIAD’s obligation under
this Section 3.1.1 shall be limited to AP23573 as a drug, independent of any
Medical Device, and shall not apply to any MEDINOL Licensed Product, and
(ii) ARIAD’s obligations under this Section 3.1.1 to use commercially reasonable
efforts do not require ARIAD and/or its pharmaceutical partner to continue
development, manufacture and regulatory approval efforts with respect to AP23573
if, in ARIAD’s and/or its pharmaceutical partner’s reasonable commercial
judgment, it is not in its or their business interest to do so.

 

11

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

3.1.2 MEDINOL’s Obligations. During the Term, at MEDINOL’s sole expense, MEDINOL
shall use commercially reasonable efforts to:

(a) take all actions necessary to develop and manufacture MEDINOL Licensed
Product(s) under cGMP and to market (itself or through its Affiliates or W.L.
Gore or its Authorized Distributors) such MEDINOL Licensed Product(s) in the
United States, European Union and Japan in order to achieve the milestones and
cause ARIAD to receive the payments set forth in Section 4.4 as soon as
practicable;

(b) initiate First-In-Man Clinical Trials using a MEDINOL Licensed Product on a
timetable to be mutually agreed between ARIAD and MEDINOL;

(c) take all actions necessary, including the conduct of necessary clinical
trials, to file a PMA for a MEDINOL Licensed Product in the U.S. on a timetable
to be mutually agreed between ARIAD and MEDINOL;

(d) take all actions necessary, including the conduct of necessary clinical
trials, to file for CE Mark for a MEDINOL Licensed Product in Europe on a
timetable to be mutually agreed between ARIAD and MEDINOL; and

(e) take all actions necessary, including the conduct of necessary clinical
trials, to seek pricing and marketing approval for MEDINOL Licensed Products in
Japan on a timetable to be mutually agreed between ARIAD and MEDINOL.

MEDINOL’s obligations under this Section 3.1.2 do not require MEDINOL to
continue development, manufacture clinical development and regulatory work with
respect to MEDINOL Licensed Product(s) if, in MEDINOL’s reasonable commercial
judgment, it is not in MEDINOL’s business interest to do so.

3.1.3 Compliance with Laws and Regulations. In undertaking its respective
obligations pursuant to this Article 3, each of ARIAD and MEDINOL shall comply
with all applicable laws, regulations, ordinances and guidelines. Without
limiting the generality of the foregoing, with respect to the conduct of
clinical trials in humans sponsored by a Party, such Party (and its agents and
representatives) shall ensure compliance with, among other things, applicable
standards of good clinical practice of the FDA, ICHGCP guidelines and other
regulations of the FDA and other Regulatory Authorities governing the
performance of such clinical investigations.

3.2 Supply Agreement. Contemporaneously with the execution hereof, ARIAD and
MEDINOL shall enter into the Supply Agreement, pursuant to which ARIAD shall
supply, and MEDINOL shall purchase, API on the terms and conditions set forth on
Exhibit 3.3 attached hereto.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

3.3 Project Committee and Reporting.

3.3.1 Project Committee. Each Party shall designate an appropriate individual to
serve as its principal liaison (“Principal Liaison”). A Party’s Principal
Liaison shall serve as the principal point of contact for the other Party and
shall coordinate and manage the performance of that Party’s obligations under
this Agreement. The Principal Liaisons shall function as a Project Committee and
shall meet in person or by telephone, at a minimum, on a quarterly basis. For
purposes of the Project Committee operations, the parties’ understand and
acknowledge that ARIAD’s employees have and can contribute expertise in the area
of pharmaceutical product development, testing and commercialization and
MEDINOL’s employees have and can contribute expertise in the area of medical
device product development, testing and commercialization.

3.3.2 Committee Operations. The Project Committee shall establish procedures for
regular quarterly meetings at which it shall: (a) provide summary progress
reports and discuss and cooperate to resolve technical and regulatory issues
relating to the development and commercialization of MEDINOL Licensed Products
encountered by either Party, (b) discuss and help in the development of
strategies to commercialize MEDINOL Licensed Products worldwide, (c) provide
input for the development plans for each MEDINOL Licensed Product, including,
without limitation, assistance with the development of timelines for achievement
by each Party of the obligations specified in Sections 3.1.1 and 3.1.2 in order
to seek marketing approval for MEDINOL Licensed Products in the United States,
the European Union and Japan, and (d) discuss and implement procedures to
coordinate and manage each Party’s activities in meeting its respective
obligations in Sections 3.1.1 and 3.1.2. In addition to participation in such
quarterly meetings, ARIAD shall use reasonable efforts to provide technical and
regulatory assistance to MEDINOL, within its area of expertise and solely
related to AP23573, to assist MEDINOL to develop, manufacture and obtain
Regulatory Approvals to market MEDINOL Licensed Products. Such assistance shall
be organized through the Principal Liaisons of ARIAD and MEDINOL who shall act
as the principal contacts and project managers for development of MEDINOL
Licensed Products in their respective companies. All information shared at
Project Committee meetings shall be treated as Confidential Information of the
disclosing party and the recipient shall use such information only for purposes
expressly permitted under this Agreement. For sake of clarity, it is stressed
that no information exchanged under the mutual program or pursuant to this
Agreement will be shared by ARIAD with any of the other Exclusive Licensees
without the written consent of MEDINOL.

 

13

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

3.3.3 Regulatory Information. During the Term, the Parties shall share
information for clinical and regulatory purposes as follows:

3.3.4 Investigator Safety Letters. Each Party shall promptly (but in no event
later than 72 hours before expiration of the earliest deadline to provide notice
to clinical investigators pursuant to all relevant guidelines of Regulatory
Authorities governing the conduct of clinical trials worldwide) provide a copy
of all investigator safety letters generated by it or its Affiliates or
licensees in connection with worldwide clinical studies of products containing
AP23573 to the Principal Liaison of other Party. Upon receipt thereof, the Party
receiving such investigator safety letter shall (i) timely (in accordance with
all relevant guidelines of Regulatory Authorities) disseminate or cause to be
disseminated such investigator safety letters to each clinical investigator
conducting clinical trials in any patient population worldwide with any product
containing AP23573 on behalf of it or its Affiliates or licensees, and
(ii) within 24 hours thereafter, confirm in writing to the Principal Liaison of
the Party disclosing such investigator safety letter that it has complied with
its obligation in clause (i) of this sentence.

3.3.5 MEDINOL Data. Subject to applicable laws governing patient confidentiality
and to the extent necessary for ARIAD to comply with applicable statutes, laws,
regulations, ordinances and guidelines governing Regulatory Approval of AP23573,
MEDINOL shall provide to ARIAD: (a) in electronic database format, all safety
data (including Adverse Events) from its worldwide clinical trials relating to
MEDINOL Licensed Products, (b) copies of all investigator safety letters
provided by MEDINOL to its clinical investigators in connection with clinical
studies of MEDINOL Licensed Products, and (c) only to the extent reasonably
necessary for ARIAD to obtain Regulatory Approval of AP23573, summaries of
relevant data generated by MEDINOL in connection with its preclinical studies of
any product containing AP23573 (collectively, “MEDINOL Data”). MEDINOL’s Data
shall be treated as Confidential Information and ARIAD shall maintain such
MEDINOL Data disclosed to it pursuant to this Section 3.4.2 in confidence and
shall not use or disclose it to any Third Party other than to disclose, itself
or through its agent, such MEDINOL Data, after obtaining assurances that such
MEDINOL Data will be afforded confidential treatment by the recipient, to its
Exclusive Licensees, pharmaceutical partners or any Regulatory Authority solely
as required in order for such recipient to obtain or grant, as the case may be,
Regulatory Approval of a product containing AP23573.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

3.3.6 ARIAD Data. Subject to applicable laws governing patient confidentiality
and to the extent necessary for MEDINOL to comply with applicable statutes,
laws, regulations, ordinances and guidelines governing Regulatory Approval of
MEDINOL Licensed Products, ARIAD shall provide MEDINOL (i) the right to
cross-reference to all safety data (including Adverse Events) reported to the
FDA by ARIAD under its IND to obtain Regulatory Approval for AP23573,
(ii) copies of all investigator safety letters provided by ARIAD to its clinical
investigators in connection with clinical studies of AP23573, (iii) only to the
extent reasonably necessary for MEDINOL to obtain Regulatory Approval of any
MEDINOL Licensed Product, summaries of relevant data generated by ARIAD in
connection with its preclinical studies of AP23573, and (iv) summary reports of
all safety data (including Adverse Events) attributable to the use of AP23573
provided to ARIAD by any party granted a license pursuant to ARIAD’s retained
rights in Section 2.1.2 (together with ARIAD’s audited report referred to in
Section 3.1.1(b), “ARIAD Data”). ARIAD Data shall be treated as Confidential
Information and MEDINOL shall maintain such ARIAD Data disclosed to it pursuant
to this Section 3.4.3 in confidence and shall not use or disclose it to any
Third Party other than: (i) MEDINOL, itself or through its agent, may provide a
cross-reference to ARIAD Data reported to the FDA by ARIAD under its IND or
corresponding foreign country filing to obtain Regulatory Approval for AP23573
in any country or may disclose ARIAD Data in a written submission to any such
Regulatory Authority, in each case solely as required to obtain Regulatory
Approval of MEDINOL Licensed Products in the Licensed Field, but only after
obtaining prior written permission from ARIAD to make such disclosure which is
conditioned upon MEDINOL obtaining written assurances from the Regulatory
Authorities to whom the information is being disclosed that such ARIAD Data will
be afforded confidential treatment by such Regulatory Authority, and
(ii) MEDINOL, upon prior notice to ARIAD, may verbally disclose ARIAD Data in
any teleconference or meeting with any Regulatory Authority, in each case solely
as required to obtain Regulatory Approval of MEDINOL Licensed Products in the
Licensed Field, but only after obtaining prior written permission from ARIAD
which is conditioned upon affording appropriate ARIAD personnel the opportunity
participate in each such teleconference or meeting.

3.3.7 MEDINOL Licensed Product Reports. During the Term, in addition to the
requirements set forth in Sections 3.4.1 and 3.4.2, MEDINOL shall provide the
Project Committee with [***] written reports that summarize MEDINOL’s efforts to
develop and commercialize MEDINOL Licensed Products hereunder. In addition,
MEDINOL shall provide the Project Committee with prompt written notice of the
occurrence of the First Commercial Sale of any MEDINOL Licensed Product in each
country in which MEDINOL Licensed Products are introduced. ARIAD acknowledges
that all reports provided by MEDINOL pursuant to this Section 3.4.4 are MEDINOL
Confidential Information and shall use such information only for purposes
expressly permitted under this Agreement.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

3.3.8 ARIAD AP23573 Development Program Reports. During the Term, ARIAD shall
provide the Project Committee with [***] written reports that summarize ARIAD’s
efforts to obtain regulatory approval for AP23573 in any territory, and its
progress in arranging to supply MEDINOL with AP23573 on a timely basis according
to this Agreement and the Supply Agreement (in other words, ARIAD’s progress
with its manufacturing development program for AP23573). MEDINOL acknowledges
that all reports provided by ARIAD pursuant to this Section 3.4.5 are ARIAD
Confidential Information and shall use such information only for purposes
expressly permitted under this Agreement.

 

  4. PAYMENTS AND ROYALTIES

4.1 License Fee. As partial consideration for this Agreement, MEDINOL hereby
agrees to pay ARIAD, on the Effective Date, a non-refundable, non-creditable
upfront fee in the amount of Seven Hundred Fifty Thousand Dollars ($750,000).

4.2 [Intentionally omitted.]

4.3 Payment of Royalties; Royalty Rates. In further consideration of the grant
of the license granted under Section 2.1.1, and subject to the other terms of
this Agreement (including the remainder of this Section 4), commencing on the
date of the First Commercial Sale of each MEDINOL Licensed Product in each
country, MEDINOL shall pay to ARIAD royalties on Net Sales of MEDINOL Licensed
Products as follows: The royalty rate shall be: (a) with respect to all MEDINOL
Licensed Products [***] (i) [****] percent ([***]%) of Net Sales for the [***]
units of any such MEDINOL Licensed Products sold in each calendar year, and
(ii) [****] percent ([***]%) of Net Sales for [***] of any such MEDINOL Licensed
Product sold in each calendar year, and (b) with respect to all MEDINOL Licensed
Products [***]: (i) [***] percent ([***]%) of Net Sales for the first [***]
units of any such MEDINOL Licensed Products sold in each calendar year, and
(ii) [***] percent ([***]%) of Net Sales for [***] of any such MEDINOL Licensed
Product sold in each calendar year. In the event that, in any calendar quarter,
MEDINOL actually makes payments of Excess API Cost to purchase API from a Third
Party Approved Manufacturer to make or have MEDINOL Licensed Products, then
MEDINOL shall have the right to reduce royalties otherwise due ARIAD pursuant to
this Section 4.3, but only over the next [***] ([***]) consecutive quarters
following the calendar quarter in which such payment of Excess API Cost is made
by MEDINOL, by up to [***] percent ([***]%) of such Excess API Cost.
Notwithstanding the foregoing,

 

16

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

reductions for payments of Excess API Cost pursuant to this Section 4.3 shall in
no event reduce the royalty due ARIAD in any calendar quarter to less than [***]
percent ([***]%) of Net Sales of MEDINOL Licensed Products. The Royalty Payments
shall be due and payable (a) for Patented MEDINOL Licensed Products until the
expiration or termination of the last Valid Claim within the Licensed Patent
Rights in both the country where the MEDINOL Licensed Product is manufactured
and the country where the MEDINOL Licensed Product is sold and (b) for
Unpatented MEDINOL Licensed Products until [***] ([***]) years from the date of
first commercial sale of the Unpatented MEDINOL Licensed Product in each
country, as determined on a country-by-country and MEDINOL Licensed
Product-by-MEDINOL Licensed Product basis. For the avoidance of doubt, clause
(b) shall be applicable to Patented MEDINOL Licensed Products which become
Unpatented MEDINOL Licensed Product as a result of the expiration of patents for
the remainder of the [***] ([***]) year period.

4.4 Milestone Payments.

4.4.1 Payment. In further consideration of the licenses granted under
Section 2.1.1, and subject to the other terms and conditions of this Agreement,
MEDINOL shall make the non-refundable, non-creditable payments set forth in the
table below to ARIAD within thirty (30) days of the first achievement of each of
the following events by MEDINOL or its Affiliates or partners with respect to
(i) a MEDINOL Licensed Product [***], and (ii) each MEDINOL Licensed Product.
[***]. For purposes of clarity, it is expressly agreed that these milestone
payments will be payable only once for all MEDINOL Licensed Products [***] when
the first MEDINOL Licensed Product [***] reaches each milestone. MEDINOL
Licensed Products [***], which will trigger separate milestone payments
hereunder, means another [***].

 

Milestone

Number

 

Milestone

   Milestone
Payment  

1

 

Initiation of [***]

   $ [*** ] 

2

 

Initiation of [***]

   $ [*** ] 

3

 

Submission of an IDE for MEDINOL Licensed Product in the U.S.

   $ [*** ] 

4

 

Completion of [***]

   $ [*** ] 

5

 

Granting of [***]

   $ [*** ] 

6

 

Filing of [***]

   $ [*** ] 

7

 

Granting of [***]

   $ [*** ] 

8

 

Granting of [***]

   $ [*** ] 

9

 

[***]

   $ [*** ] 

10

 

[***]

   $ [*** ] 

 

17

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

4.4.2 Determination that Payments are Due. MEDINOL shall provide ARIAD with
prompt written notice upon its achievement of each of the milestones set forth
in Section 4.4.1. In the event that ARIAD believes any milestone payment is due
in spite of not having received notice from MEDINOL, it shall so notify MEDINOL
and shall provide to MEDINOL the data and information reasonably supporting its
belief that the conditions for payment have been achieved. If MEDINOL does not
provide reasonable evidence that such milestone has not been achieved within
forty five (45) days of receipt of the data and information from ARIAD, the
conditions for such milestone payment under Section 4.4.1 shall be deemed to
have been achieved.

4.5 Payment Terms.

4.5.1 Payment of Royalties and Milestones. Except as otherwise provided herein,
MEDINOL shall make any milestone, license or royalty payments owed to ARIAD
hereunder, in arrears, within sixty (60) days following the end of each calendar
quarter in which such payment accrues. For purposes of determining when a sale
of any MEDINOL Licensed Product occurs under this Agreement, royalties shall
accrue on the date of the [payment on] invoice to the purchaser of the MEDINOL
Licensed Product. Each royalty payment shall be accompanied by a report for each
country in which sales of MEDINOL Licensed Products occurred, and for which a
royalty payment is due, in the calendar quarter covered by such statement,
specifying: (i) the gross sales (if available) and Net Sales in each country’s
currency; (ii) the applicable royalty rate under this Agreement; (iii) the
royalties payable in US Dollars, including an accounting of deductions taken in
the calculation of Net Sales; (iv) the applicable exchange rate used to convert
from each country’s currency to United States Dollars under this Section 4.5. In
no event shall more than one royalty be due ARIAD for any unit of MEDINOL
Licensed Product sold by MEDINOL and/or its Affiliates or W.L. Gore, Authorized
Distributors or other sellers or distributors of MEDINOL Licensed Products
hereunder.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

4.5.2 Overdue Royalties. Subject to the other terms of this Agreement, royalties
not paid within the time period set forth in this Article 4 shall bear interest
at a rate of the lesser of either the maximum legally allowable interest rate or
[***] percent ([***]%) per month, from the due date until paid in full.

4.5.3 Accounting. All payments hereunder shall be made in the United States in
United States Dollars. 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, Eastern Edition, for purchasing United States Dollars) on
the last business day of the applicable calendar quarter in which the Net Sales
took place. If The Wall Street Journal ceases to be published, then the rate of
exchange to be used shall be that reported in such other business publication of
national circulation in the United States as the Parties reasonably agree. Each
Party shall deduct any taxes which the Party is obligated to pay and/or withhold
in its country on the payments due under this Agreement and pay them to the
proper authorities as required by applicable laws. Therefore, it is agreed and
understood that any amount to be paid under the terms of this Agreement is net
of any such tax, but the calculation of royalty according to Section 4.3 and
milestone payments according to Section 4.4 is calculated as the gross payment.
Each Party shall maintain official receipts of payment of any such taxes and
forward these receipts to the other Party within sixty (60) days of such payment
and shall provide reasonable assistance to the other Party in obtaining any
legally due credit or refund of such taxes.

4.5.4 Tax Withholding; Restrictions on Payment. All payments hereunder shall be
made free and clear of any taxes, duties, levies, fees or charges, except for
withholding taxes as set forth in Section 4.5.3. If by law, regulations or
fiscal policy of a particular country, remittance of royalties in United States
Dollars is restricted or forbidden, written notice thereof shall promptly be
given to ARIAD, and payment of the royalty shall be made by the deposit thereof
in local currency to the credit of ARIAD in a recognized banking institution
reasonably designated by ARIAD by written notice to MEDINOL. When, in any
country, the law or regulations prohibit both the transmittal and the deposit of
royalties on sales in such country, royalty payments shall be made in U.S.
Dollars from the United States for as long as such prohibition is in effect.

4.6 Records Retention; Review.

4.6.1 Royalty Record Retention. Commencing as of the date of First Commercial
Sale of the first MEDINOL Licensed Product, MEDINOL, W.L. Gore, the Authorized
Distributors and their Affiliates shall retain, for a minimum of three (3) years
from the end of the calendar year to which they pertain, complete and accurate

 

19

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

records of sales by MEDINOL, W.L. Gore, the Authorized Distributors or their
Affiliates, as the case may be, of each MEDINOL Licensed Product in sufficient
detail to allow the accuracy of the payments hereunder to be confirmed.

4.6.2 Review of Royalty Records. Subject to the other terms of this
Section 4.6.2, upon thirty (30) days’ prior written request from ARIAD no more
frequently than once each calendar year, at ARIAD’s expense (except as provided
in this Section 4.6.2 below), MEDINOL shall permit an independent certified
public accountant reasonably selected by ARIAD and reasonably acceptable to
MEDINOL to inspect (during regular business hours) the relevant records required
to be maintained by MEDINOL under this Section 4.6. In every case, the
accountant must have previously entered into a confidentiality agreement with
both Parties substantially similar to the provisions of Section 5 and limiting
the disclosure and use of such information by such accountant to authorized
representatives of the Parties and the purposes germane to this Section 4.6.
Results of any such review shall be binding on both Parties, absent manifest
error. Each Party agrees to treat the results of any such accountant’s review of
the other Party’s records under this Section 4.6 as Confidential Information of
the other Party subject to the terms of Section 5. If any review reveals a
deficiency in the calculation of royalties resulting from any underpayment by
MEDINOL, MEDINOL shall promptly pay ARIAD the amount remaining to be paid, and
if such underpayment is by [****] percent ([***]%) or more, MEDINOL shall pay
the reasonable out-of-pocket costs and expenses of the review.

4.6.3 Affiliates and Distributors. MEDINOL shall cause W.L. Gore and all
Authorized Distributors of MEDINOL Licensed Products and their Affiliates to
retain records relating to MEDINOL Licensed Products and permit ARIAD to inspect
such records in the same manner as set forth in this Section 4.6.

 

  5. TREATMENT OF CONFIDENTIAL INFORMATION

5.1 Confidential Obligations.

5.1.1 Each Party shall be deemed the owner of all right, title and interest,
including all intellectual property rights, in and to the Confidential
Information of that Party. ARIAD and MEDINOL each agree that, during the Term
and thereafter, it shall (a) keep confidential, and shall cause all of its
officers, employees, consultants, Third Party contractors and licensees and the
officers, employees, consultants, Third Party contractors and licensees of its
Affiliates to keep confidential, all Confidential Information of the other
Party, and (b) use, and shall cause all of its officers, employees, consultants,
Third Party contractors and licensees and the officers, employees, consultants,
Third Party contractors and licensees of its Affiliates to use, all Confidential

 

20

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

Information of the other Party solely for purposes expressly permitted under
this Agreement. Each Party shall take such action, and shall cause its
Affiliates to take such action, to preserve the confidentiality of each other’s
Confidential Information as it would customarily take to preserve the
confidentiality of its own Confidential Information, but no less than reasonable
action.

5.1.2 ARIAD and MEDINOL each agree that any disclosure of the other Party’s
Confidential Information to any officer, employee, consultant, Third Party
contractor or licensee of the other Party or any of its Affiliates (or W.L. Gore
or an Authorized Distributor in the case of MEDINOL) shall be made only to the
extent necessary to perform its obligations or exercise its rights under this
Agreement, shall be limited to the maximum extent possible consistent with such
obligations or rights and shall only be made to persons who are bound by written
confidentiality obligations to maintain the confidentiality thereof and not to
use such Confidential Information except as expressly permitted by this
Agreement. MEDINOL shall maintain all Confidential Information of ARIAD
comprising the structure of AP23573, all CMC Data and other chemistry data in a
secure file with access limited to MEDINOL’s regulatory personnel (and shall
maintain a log tracking personnel access to such data). Without limiting the
generality of the foregoing, MEDINOL shall cause W.L. Gore and each Authorized
Distributor to execute a written Confidentiality Agreement with ARIAD in form
and substance satisfactory to ARIAD. MEDINOL hereby guarantees full and complete
compliance by W.L. Gore and each Authorized Distributor with the terms of such
Confidentiality Agreement and shall be liable for any breach thereof by W.L.
Gore, any Authorized Distributor or any person or entity receiving Confidential
Information of ARIAD directly or indirectly from W.L. Gore.

5.1.3 Notwithstanding the provisions of Section 5.1.2, ARIAD and MEDINOL agree
not to disclose or transfer the other Party’s Confidential Information to any
Third Parties under any circumstances without the prior written approval from
the other Party (such approval not to be unreasonably withheld), except
(i) filing and prosecuting patent applications and maintaining patents which are
filed in accordance with Article 6 of this Agreement, except that MEDINOL may
not disclose the chemical structure of AP23573 or descriptive information
sufficient to determine the chemical structure of AP23573 in connection
therewith without ARIAD’s prior written consent, (ii) filing, prosecuting or
defending litigation in accordance with the provisions of Article 6, except that
MEDINOL may not voluntarily disclose the chemical structure of AP23573 or
descriptive information sufficient to determine the chemical structure of
AP23573 in connection therewith without ARIAD’s prior written consent, or
(iii) as required to obtain Regulatory Approval to market or sell AP23573 and
MEDINOL Licensed Products, (iv) as reasonably necessary to obtain the services
of any Third Party

 

21

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

contractor in connection with the preclinical or clinical development of MEDINOL
Licensed Products, except that MEDINOL may not disclose the chemical structure
of AP23573 without ARIAD’s prior written consent, (v) as permitted in the Supply
Agreement, or (vi) complying with court orders; provided, however, that if a
Party is required to make any such disclosure of the other Party’s Confidential
Information pursuant to any court order or discovery request, it will give
reasonable advance notice to the other Party of such disclosure requirement and
will use reasonable efforts to assist such other Party in efforts to limit
disclosure of such information to the maximum extent possible and to secure
confidential treatment of such information required to be disclosed.

5.1.4 Each Party, upon the request of the other Party, will return or destroy
all the Confidential Information disclosed or transferred to it by the other
Party pursuant to this Agreement, including all copies and extracts of documents
and all manifestations in whatever form, upon termination or expiration of this
Agreement; provided however, that one (1) copy of such Confidential Information
may be retained in a secure location solely for the purpose of establishing
compliance with this Agreement and/or if required by law or regulation.

5.1.5 The Parties acknowledge and agree that any breach or threatened breach of
the Article 5 will result in irreparable harm to the Party whose Confidential
Information is subject to such breach or threatened breach, for which remedies
at law will not be adequate. Each Party, as a disclosing Party, shall therefore
be entitled to seek injunctive relief in any court of competent jurisdiction in
addition to any other remedy at law or in equity in the event of a breach or
threatened breach of this Article.

5.2 Publication. Notwithstanding the confidentiality obligations set forth in
this Section 5, MEDINOL and its Affiliates and academic collaborators shall have
the right to publish (solely in recognized, peer-reviewed scientific journals)
or present the results of its clinical studies. In order to balance this right
with ARIAD’s proprietary interests, MEDINOL will submit for ARIAD’s review
manuscripts or other material intended for publication, abstracts, posters and
other disclosures (“Proposed Disclosures”) at least thirty (30) days prior to
the date of submission for publication or other disclosure. ARIAD will complete
its review within thirty (30) days of receipt of the Proposed Disclosure. Prior
to such publication or other disclosure, ARIAD shall have the right to review
and to request that MEDINOL delete any reference to ARIAD Confidential
Information (excluding the results of MEDINOL’s clinical studies). If not
delayed pursuant to the preceding sentence, at the end of the 30-day period,
MEDINOL will have the right to publish or present the disclosure as amended by
ARIAD.

 

22

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

5.3 Publicity. Neither Party may publicly disclose the existence or terms or any
other matter of fact regarding this Agreement without the prior written consent
of the other Party, which consent shall not be unreasonably withheld or delayed;
provided, however, that either Party may make such a disclosure (a) to the
extent required by law or by the requirements of any nationally recognized
securities exchange, quotation system or over-the-counter market on which such
Party has its securities listed or traded or intends to be listed or traded, or
(b) to any professional advisors, potential acquirers, investors, prospective
investors, lenders and other potential financing sources who are obligated to
keep such information confidential. In the event that such disclosure is
required as aforesaid in clause (a), the disclosing Party shall make reasonable
efforts to provide the other Party with notice beforehand and to coordinate with
the other Party with respect to the wording and timing of any such disclosure.
The Parties shall mutually agree to the form and timing of a press release with
respect to this transaction. Once such press release or any other written
statement is approved for disclosure by both Parties, either Party may make
subsequent public disclosure of the contents of such statement without the
further approval of the other Party.

5.4 Use of Name. Neither Party shall employ or use the name of the other Party
in any promotional materials or advertising without the prior express written
permission of the other Party.

5.5 Trademark. MEDINOL shall have the right to market the MEDINOL Licensed
Products under trademarks selected by MEDINOL. Any commercial use of AP23573 in
MEDINOL’s Licensed Products must reflect ARIAD’s then current product mark and
description.

 

  6. PROVISIONS CONCERNING THE FILING, PROSECUTION AND MAINTENANCE OF PATENT
RIGHTS; OWNERSHIP OF INVENTIONS

6.1 Patent Filing, Prosecution and Maintenance. Subject to the other terms of
this Section 6.1, ARIAD shall be responsible for preparing, filing, prosecuting,
obtaining and maintaining, at its sole cost, expense and discretion, and acting
through patent attorneys or agents of its choice, all Licensed Patent Rights in
each of the countries listed on Exhibit 6.1. MEDINOL represents that the
countries listed on Exhibit 6.1 comprise all of the markets wherein MEDINOL
intends to market and sell MEDINOL Licensed Products as of the Effective Date.
ARIAD (i) will provide MEDINOL with a copy of pending claims of the Licensed
Patent Rights that are relevant to the Licensed Field, and (ii) will keep
MEDINOL reasonably informed of the issuance or abandonment of such claims.

 

23

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

6.2 Notice of Infringement. If, during the License Term, either Party learns of
any actual, alleged or threatened infringement by a Third Party of any Licensed
Patent Rights in the Licensed Field under this Agreement, such Party shall
promptly notify the other Party and shall, to the extent it may lawfully do so,
provide such other Party with available evidence of such infringement.

6.3 Infringement of Patent Rights. ARIAD shall have the right (but not the
obligation), at its own expense and with legal counsel of its own choice, to
bring suit (or take other appropriate legal action) against any actual, alleged
or threatened infringement of the Licensed Patent Rights in the Licensed Field.
MEDINOL shall have the right, at its own expense, to be represented in any such
action by counsel of MEDINOL’s own choice; provided, however, that under no
circumstances shall the foregoing affect the right of ARIAD to control the suit
as described in the first sentence of this Section 6.3. If ARIAD brings any such
action or proceeding hereunder (i) MEDINOL agrees to be joined as party
plaintiff if necessary to prosecute such action or proceeding, and (ii) at
ARIAD’s expense, MEDINOL shall give ARIAD reasonable assistance and authority to
file and prosecute the suit, and (iii) ARIAD shall be permitted to settle any
such suit without the prior consent of MEDINOL. For the avoidance of doubt, it
is hereby expressly agreed that MEDINOL shall have the sole right (but not the
obligation) to take any action in respect of any actual, alleged or threatened
infringement of MEDINOL Patent Rights.

6.4 Ownership of Inventions.

6.4.1 Background IP. Subject to the rights and licenses expressly granted
herein, each Party shall retain all right, title and interest in and to all
inventions, discoveries and other intellectual property rights owned or
controlled by a Party, or which such Party otherwise has a right to use, prior
to the Effective Date.

6.4.2 Sole Inventions.

(a) Subject to the rights and licenses expressly granted herein, all right,
title and interest in and to all inventions, discoveries and other intellectual
property rights therein conceived or invented solely by personnel of a Party
without use of the Confidential Information or proprietary materials of the
other Party in connection with the performance of such Party’s rights and
obligations hereunder shall be owned solely by such Party (collectively, “Sole
IP”).

(b) MEDINOL shall solely own all right, title and interest in patent claims
filed by MEDINOL after the Effective Date which: (i) comprise inventions
conceived or invented solely by personnel of MEDINOL after the Effective Date
using

 

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Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

the Confidential Information of ARIAD as permitted by this Agreement, and
(ii) include the limitation of a Medical Device, and (iii) comprise a Medical
Device, a method of using a Medical Device in the Licensed Field or a method of
treatment using a Medical Device in the Licensed Field (collectively, “MEDINOL
Sole IP”).

(c) ARIAD shall solely own all right, title and interest in patent claims filed
by ARIAD after the Effective Date which: (i) comprise inventions conceived or
invented solely by personnel of ARIAD after the Effective Date using the
Confidential Information of MEDINOL as permitted by this Agreement, and (ii) do
not include the limitation of a Medical Device, and (iii) comprise the
composition of matter of a rapamycin analog, the use of a rapamycin analog or
methods of treatment using a rapamycin analog (collectively, “ARIAD Sole IP”).

6.4.3 Joint Inventions. Except as otherwise set forth in this Section 6.4, all
right, title and interest in and to all inventions, discoveries and other
intellectual property rights therein conceived or invented jointly by personnel
of ARIAD and MEDINOL or solely by personnel of a Party using the Confidential
Information or proprietary materials of the other Party in connection with the
performance of such Party’ rights and obligations hereunder shall be jointly
owned by ARIAD and MEDINOL (collectively, “Joint IP”). Except as expressly
provided in this Agreement, it is understood that neither Party shall have any
obligation to account to the other for profits, or to obtain any approval of the
other Party to license or exploit Joint IP, by reason of joint ownership
thereof.

6.4.4 Assignments. The Parties hereby agree to execute and deliver any and all
documents, including without limitation, any agreements relating to the
assignment of ownership rights, as the other Party may reasonably request to
give effect to the allocation of ownership rights set forth in this Section 6.4.

6.4.5 Licenses.

(a) MEDINOL hereby grants to ARIAD a non-exclusive, royalty-free, fully paid up,
sublicensable license under its interest in Joint IP to develop, have developed,
make, have made, use, have used, sell, have sold, offer to sell, import, have
imported, export, have exported, distribute, market and promote products for
sale and use outside the Licensed Field (and, to the extent ARIAD retains rights
in the Licensed Field pursuant to Section 2.1.1(b), also in the Licensed Field).
Further, in the event that MEDINOL files any patent application which discloses
the chemical structure of AP23573 or any analog of AP23573 or descriptive
information sufficient to determine the chemical structure of AP23573 or any
analog of AP23573 (“AP23573 Claims”), MEDINOL shall grant to ARIAD a
non-exclusive, royalty-free, fully paid up,

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

sublicensable license under its interest in AP23573 Claims (whether or not such
claims constitute MEDINOL Sole IP or Joint IP) to develop, have developed, make,
have made, use, have used, sell, have sold, offer to sell, import, have
imported, export, have exported, distribute, market and promote products.

(b) ARIAD hereby grants to MEDINOL a non-exclusive, royalty-free, fully paid up,
sublicensable license under its interest in ARIAD Sole IP and Joint IP to
develop, have developed, make, have made, use, have used, sell, have sold, offer
to sell, import, have imported, export, have exported, distribute, market and
promote MEDINOL License Products for sale and use in the Licensed Field.

 

  7. REPRESENTATIONS AND WARRANTIES

7.1 ARIAD Representations. ARIAD represents and warrants to MEDINOL that:

7.1.1 The execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all appropriate
ARIAD corporate action.

7.1.2 This Agreement is a legal and valid obligation binding upon ARIAD and
enforceable in accordance with its terms, and the execution, delivery and
performance of this Agreement by ARIAD does not conflict with any agreement,
instrument or understanding to which ARIAD is a party or by which it is bound.

7.1.3 ARIAD is the owner of, or has sufficient rights to, all of the Licensed
Patent Rights and the Licensed Technology to grant to MEDINOL the licenses
granted under Section 2.1.1. All Licensed Patent Rights are in full force and
effect and free of all liens, charges, encumbrances and security interests
except those placed or granted in the ordinary course of business. As of the
Effective Date, to the best knowledge of ARIAD, there are no actions or claims
threatened (in writing) or pending against ARIAD or its Affiliates in any court
with respect to the Licensed Patent Rights and the Licensed Technology.

7.1.4 As of the Effective Date, ARIAD intends to develop, make or have made and
supply AP23573 in accordance with this Agreement and the Supply Agreement.

7.2 MEDINOL Representations. MEDINOL represents and warrants to ARIAD that:

7.2.1 The execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all appropriate
MEDINOL corporate action.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

7.2.2 This Agreement is a legal and valid obligation binding upon MEDINOL and
enforceable in accordance with its terms, and the execution, delivery and
performance of this Agreement by MEDINOL does not conflict with any agreement,
instrument or understanding to which MEDINOL is a party of or by which it is
bound. MEDINOL further represents and warrants that it has no knowledge of any
information that would affect the validity of the Licensed Patent Rights.

7.2.3 As of the Effective Date, there are no actions or claims threatened (in
writing) or pending against MEDINOL or its Affiliates in any court with respect
to MEDINOL Licensed Products, except as set forth in Schedule 7.2.3.

7.2.4 As of the Effective Date, MEDINOL intends to develop manufacture, market
and sell MEDINOL Licensed Products in accordance with this Agreement and the
Supply Agreement.

7.3 No Warranties.

7.3.1 Nothing in this Agreement is or shall be construed as: (a) a warranty or
representation by either Party as to the validity or scope of any patent
application or patent licensed hereunder; or (b) a warranty or representation
that anything made, used, sold or otherwise disposed of under any license
granted pursuant to this Agreement is or will be free from infringement of
patents, copyrights, and other rights of Third Parties.

7.3.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER
OF THIS AGREEMENT AND HEREBY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR OF NON-INFRINGEMENT OF
ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES, OR ANY OTHER
EXPRESS OR IMPLIED WARRANTIES.

7.3.3 IN NO EVENT SHALL EITHER PARTY BE LIABLE UNDER OR AS A RESULT OF THIS
AGREEMENT FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, TREBLE,
PUNITIVE, EXEMPLARY

 

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Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

OR OTHER SIMILAR TYPES OF DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOSS OF
PROFITS OR BUSINESS OPPORTUNITY, INCURRED BY THE OTHER PARTY, WHETHER IN
CONTRACT OR TORT OR BASED ON A WARRANTY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH DAMAGES.

 

  8. INDEMNIFICATION AND INSURANCE

8.1 Indemnification.

8.1.1 MEDINOL Indemnity. MEDINOL shall at all times, during and after the Term,
indemnify, defend and hold harmless ARIAD, its Affiliates and their respective
directors, officers, employees, stockholders and agents and their respective
successors, heirs and assigns (the “ARIAD Indemnitees”) from and against any
liability, damage, loss or expense (including reasonable attorneys’ fees and
expenses of litigation) incurred by or imposed upon such ARIAD Indemnitees, or
any of them, in connection with any Third Party claims, suits, actions, demands
or judgments, including, without limitation, personal injury and product
liability matters, to the extent arising out of (i) any actions or omissions of
MEDINOL and its Affiliates in the development, testing, production, manufacture,
supply, promotion, import, sale or use by any person of any MEDINOL Licensed
Product (or any component thereof) manufactured or sold by MEDINOL or any
Affiliate under this Agreement, (ii) infringement of the intellectual property
rights of any Third Party through the manufacture, use or sale of MEDINOL
Licensed Products, except to the extent such infringement relates to the
manufacture, sale, or use of AP23573 generally, and not to its delivery by a
MEDINOL Licensed Product, (iii) any material breach of this Agreement by
MEDINOL, or (iv) gross negligence or willful misconduct on the part of MEDINOL
or any of its directors, officers and employees.

8.1.2 Indemnification Procedures. In the event that any Indemnitee is seeking
indemnification under Section 8.1 above from a Party (the “Indemnifying Party”),
the other Party shall notify the Indemnifying Party of such claim with respect
to such Indemnitee as soon as reasonably practicable after the Indemnitee
receives notice of the claim, and the Party (on behalf of itself and such
Indemnitee) shall permit the Indemnifying Party to assume direction and control
of the defense of the claim (including the right to settle the claim solely for
monetary consideration) and shall cooperate as requested (at the expense of the
Indemnifying

 

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Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

Party) in the defense of the claim; provided, however, that the Indemnifying
Party shall not agree to any settlement that adversely impacts the Indemnitee
without first seeking and receiving the Indemnitee’s prior written consent. The
indemnification obligations under Article 8 shall not apply to amounts paid in
settlement of any claim, demand, action or other proceeding if such settlement
is effected without the consent of the Indemnifying Party, which consent shall
not be withheld or delayed unreasonably. The Indemnitee, its employees and
agents, shall reasonably cooperate with the Indemnifying Party and its legal
representatives in the investigation of any claim, demand, action or other
proceeding covered by Section 8.1.

8.2 Insurance.

8.2.1 ARIAD. During the Term and for [***] ([***]) years thereafter, ARIAD shall
have and maintain in effect, at ARIAD’s sole cost, the following insurance
relating to ARIAD’s performance hereunder: (a) commercial general liability
Insurance for each occurrence of bodily injury and property damage, in an amount
of not less than [***] Dollars ($[***]), and (b) product liability insurance in
an amount of not less than [***] Dollars ($[***]).

8.2.2 MEDINOL. During the Term and for [****] ([***]) years thereafter, MEDINOL
shall have and maintain in effect, at MEDINOL’s sole cost, the following
insurance relating to MEDINOL’s performance hereunder: (a) commercial general
liability insurance for each occurrence of bodily injury and property damage, in
an amount of not less than [***] Dollars ($[***]), and (b) product liability
insurance in an amount of not less than [***] Dollars ($[***]).

8.2.3 Scope. The insurance required by this Section 8.3 shall cover all
performance under this Agreement by the applicable Party and its agents,
officers, directors, employees, and representatives.

8.2.4 Additional Insured. ARIAD shall have MEDINOL named as additional insured
under the above insurance policy obtained by ARIAD. MEDINOL shall have ARIAD
named as additional insured under the above insurance policy obtained by
MEDINOL. Such additional insured status shall be procured and evidenced by an
additional insured endorsement on the policy and certificate of insurance.

8.2.5 Certificates and Endorsements. Each Party shall furnish valid certificates
of insurance and endorsements to the other Party evidencing that the first Party
has obtained insurance coverage required under this Section 8.3.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

  9. TERM AND TERMINATION

9.1 Term; Expiration. The “Term” of this Agreement shall commence on the
Effective Date and unless earlier terminated in accordance with this Article 9
shall expire upon the later to occur of (i) the expiration of the final royalty
payment obligation under Section 4.3.1 above, or (ii) fifteen (15) years after
the First Commercial Sale of a MEDINOL Licensed Product. Upon the expiration of
the Term, MEDINOL shall have a fully paid-up, irrevocable license under the
Licensed Patent Rights and Licensed Technology, to develop, use, make, have
made, import, have imported, export, have exported, sell, have sold, offer to
sell, distribute, market and promote MEDINOL Licensed Products, for any and all
uses within the Licensed Field; and ARIAD shall provide to MEDINOL such
Confidential Information of ARIAD as may be reasonably necessary, but that is
not in MEDINOL’s possession as of the expiration of the Term, for MEDINOL to
make or have made MEDINOL Licensed Products. MEDINOL acknowledges that all such
Confidential Information provided by ARIAD pursuant to this Section 9.1 is ARIAD
Confidential Information and shall continue to be subject to the provisions of
Article 5 following expiration of the Term.

9.2 Termination for Breach. In addition to any other remedies available by law
or in equity, this Agreement may be terminated by either Party upon any material
breach by the other Party of any obligation of this Agreement or the Supply
Agreement, such termination to be effective thirty (30) days, in the case of
non-payment of any amount due, ninety (90) days, in the case of any other
curable material breach, and immediately, in the case of any non-curable
material breach, after receipt by the breaching Party of written notice of
termination from the non-breaching Party describing such material breach of this
Agreement and/or the Supply Agreement in reasonable detail. Notwithstanding the
foregoing, if such default or breach is curable and is cured or remedied or
shown to be non-existent within the aforesaid 30-day or 90-day, as the case may
be, period (the “Cure Period”), the notice of termination shall be automatically
withdrawn and of no legal force and effect; provided, that such Cure Period
shall be shortened, as appropriate, if such breach or default must be cured
within non-extendible time limits set forth by governmental entities (e.g.,
Regulatory Authorities, patent office, etc.). Any termination based upon notice
of termination describing a curable material breach shall be stayed, and the
Cure Period tolled, in the event that, during any Cure Period, the Party alleged
to have materially breached this Agreement shall have initiated dispute
resolution in accordance with Section 10.2 with respect to the alleged default,
which stay and tolling shall last until a final arbitral award is made.

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

9.3 Termination for Bankruptcy. In the event that either Party files for
protection under bankruptcy laws, makes an assignment for the benefit of
creditors, appoints or suffers appointment of a receiver or trustee over its
property, files a petition under any bankruptcy or insolvency act or has any
such petition filed against it which is not discharged within sixty (60) days of
the filing thereof, then the other Party may terminate this Agreement effective
immediately upon written notice to such Party.

9.4 Termination Without Cause.

9.4.1 MEDINOL may terminate this Agreement upon thirty days’ prior written
notice to ARIAD: (i) if MEDINOL reasonably concludes that no MEDINOL Licensed
Product will be safe for use in man, [***]

9.4.2 ARIAD may terminate this Agreement upon thirty days’ prior written notice
to MEDINOL pursuant to Section 3.1.1.

9.5 Effects of Termination. Upon termination of this Agreement under
Section 9.2, 9.3 or 9.4 and subject to Section 5.1.4, as of the effective date
of any such termination:

9.5.1 Termination by Reason of Material Breach or under Section 9.4. In the
event of a termination of this Agreement for material breach by either Party
(other than by reason of a breach by ARIAD described in Section 9.5.2), or
termination of this Agreement by MEDINOL pursuant to Section 9.4.1 above, all
relevant licenses and sublicenses granted by ARIAD to MEDINOL hereunder, ARIAD’S
covenants to MEDINOL in Article 2 and the Parties’ future obligations under
Article 3 and Sections 4.1 through 4.4, shall terminate automatically and
MEDINOL shall not be liable to make any further payments to ARIAD under this
Agreement (other than payments accrued before the date of termination).
Notwithstanding the foregoing, MEDINOL and its Affiliates shall have the right
to sell or otherwise dispose of all MEDINOL Licensed Products then on hand, with
royalties to be paid to ARIAD on all Net Sales of such MEDINOL Licensed Products
as provided for in this Agreement.

9.5.2 Termination by Reason of ARIAD’s Material Breach of Supply Agreement. In
the event of a termination of this Agreement for breach by ARIAD of the Supply
Agreement or termination of this Agreement by ARIAD pursuant to Section 9.4.2
above at any time following the earlier of initiation by MEDINOL of a Pivotal
Clinical Trial in the United States or the First Commercial Sale by MEDINOL of a
MEDINOL Licensed Product in any country: (a) all relevant licenses and
sublicenses

 

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Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

granted by ARIAD to MEDINOL hereunder shall remain in full force and effect,
(b) the Parties future obligations under Article 3 shall automatically
terminate, (c) MEDINOL shall have the right (i) without further consent required
by ARIAD, to access and refer to any and all filings made by ARIAD with
Regulatory Authorities and FDA solely in furtherance of MEDINOL’s interest in
developing and commercializing MEDINOL Licensed Product; and (ii) to disclose to
its Third Party manufacturers (with ARIAD providing introductions to appropriate
Third Party manufacturers to MEDINOL at MEDINOL’s request upon any termination
under this Section 9.5.2) under a confidentiality agreement containing
provisions no less stringent that those set forth in Article 5 such information
as is necessary to establish an alternate supply of AP23573 for use in MEDINOL
Licensed Products, (d) all of MEDINOL’s obligations pursuant to Section 3.6
shall survive such termination, and (e) MEDINOL and its Affiliates shall have
the right to develop, market and sell MEDINOL Licensed Products, with royalties
to be paid to ARIAD on all Net Sales of such MEDINOL Licensed Products as
provided for in this Agreement.

9.6 Remedies. Except as otherwise expressly set forth in this Agreement, the
termination provisions of this Section 9 are in addition to any other relief and
remedies available to either Party at law or equity; provided, however, that in
no event will MEDINOL be required to pay any amount beyond those payments by
MEDINOL pursuant to this Agreement that accrued prior to the date of
termination.

9.7 Surviving Provisions. Notwithstanding any provision herein to the contrary,
the rights and obligations of the Parties set forth in Article 4 (except
Section 4.4), 5, 8, 10 and 11, and Sections 1.10, 2.1.2, 6.3, 6.4 and 9.4 shall
survive the expiration or termination of the Term. Without limiting the
generality of the foregoing, MEDINOL shall have no obligation to make any
milestone payment to ARIAD that has not accrued prior to the effective date of
any termination of this Agreement, but shall remain liable for all such payment
obligations accruing prior to the effective date of such termination.

 

  10. DISPUTES

10.1 The Parties recognize that a bona fide dispute as to certain matters may
from time to time arise during the term of this Agreement which relates to
either Party’s rights and/or obligations hereunder. In the event of the
occurrence of such a dispute, either Party may, by written notice to the other
Party, have such dispute referred to their respective senior officials
designated below or their successors, for attempted resolution by good faith
negotiations within thirty (30) days after such notice is received. Said
designated senior officials are as follows:

 

For MEDINOL:           Chief Executive Officer For ARIAD: Chief Executive
Officer

 

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Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

In the event the designated senior officials are not able to resolve such
dispute within the thirty (30) day period, either Party may invoke the
provisions of Section 10.2.

10.2 Any dispute, controversy or claim initiated by either Party arising out of,
resulting from or relating to this Agreement, or the performance by either Party
of its obligations under this Agreement (other than bona fide Third Party
actions or proceedings filed or instituted in an action or proceeding by a Third
Party against a Party), whether before or after termination of this Agreement,
shall be finally resolved by binding arbitration. Whenever a Party shall decide
to institute arbitration proceedings, it shall give written notice to that
effect to the other Party. Any such arbitration shall be conducted under the
Commercial Arbitration Rules of the American Arbitration Association by a panel
of three arbitrators appointed in accordance with such rules. Any such
arbitration shall be held in Boston, Massachusetts. The method and manner of
discovery in any such arbitration proceeding shall be governed by the Federal
Rules of Civil Procedure and the local rules of the District Court for the
District of Massachusetts. The arbitrators shall have the authority to grant
injunctions and/or specific performance and to allocate between the Parties the
costs of arbitration in such equitable manner as they determine. Judgment upon
the award so rendered may be entered in any court having jurisdiction or
application may be made to such court for judicial acceptance of any award and
an order of enforcement, as the case may be. In no event shall a demand for
arbitration be made after the date when institution of a legal or equitable
proceeding based upon such claim, dispute or other matter in question would be
barred by the applicable statute of limitations. Notwithstanding the foregoing,
either Party shall have the right, without waiving any right or remedy available
to such Party under this Agreement or otherwise, to seek and obtain from any
court of competent jurisdiction any interim or provisional relief that is
necessary or desirable to protect the rights or property of such Party, pending
the selection of the arbitrators hereunder or pending the arbitrators’
determination of any dispute, controversy or claim hereunder.

 

  11. MISCELLANEOUS

11.1 Notification. All notices, requests and other communications hereunder
shall be in writing, shall be addressed to the receiving Party’s address set
forth below or to such other address as a Party may designate by notice
hereunder, and shall be either: (i) delivered by hand, (ii) made by facsimile
transmission (to be

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

followed with written fax confirmation), (iii) sent by private courier service
providing evidence of receipt, or (iv) sent by registered or certified mail,
return receipt requested, postage prepaid. The addresses and other contact
information for the Parties are as follows:

 

If to ARIAD: ARIAD Pharmaceuticals, Inc. ARIAD Gene Therapeutics, Inc. 26
Landsdowne Street Cambridge, MA 02139 Telephone: (617) 494-0400 Fax: (617)
225-2860 Attn.: Chief Legal Officer With a copy to: Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C. One Financial Center Boston, MA 02111 Phone: (617)
542-6000 Fax: (671) 542-2241 Attn.: Jeffrey M. Wiesen, Esq. If to MEDINOL:  
MEDINOL Inc. Kiryat Atidim P.O. Box 58165, Tel Aviv, 61581, Israel Tel:
972-3-767-9000 Fax: 972-3-648-2310 Attn.: Mr. Kobi Richter With a copy to: Doron
Cohen-David Cohen, Law Offices 14 Abba Hillel Silver Road Ramat Gan, Israel
52520 Phone: (972) 3-753-1000 Fax: (972) 3-753-1001 Attn: David Cohen, Adv.

All notices, requests and other communications hereunder shall be deemed to have
been given either (i) if by hand, at the time of the delivery thereof to the
receiving Party at the address of such Party set forth above, (ii) if made by
telecopy or facsimile transmission, at the time that receipt thereof has been
acknowledged by electronic confirmation or otherwise, unless not on a business
day on the receiving end, in which

 

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confidential treatment under Rule 406 of the Securities Act.

 

event such communication shall be deemed to have been given on the next business
day, (iii) if sent by private courier, on the third (3rd) business day following
the day such notice is delivered to the courier service, or (iv) if sent by
registered or certified mail, on the fifth (5th) business day following the day
such mailing is made (10th business day if sent internationally).

11.2 Language. This Agreement has been prepared in the English language and the
English language shall control its interpretation.

11.3 Governing Law. This Agreement will be construed, interpreted and applied in
accordance with the laws of the Commonwealth of Massachusetts (excluding its
body of law controlling conflicts of law).

11.4 Limitations. Except as set forth elsewhere in this Agreement, neither Party
grants to the other Party any right or license to any of its intellectual
property.

11.5 Entire Agreement. This Agreement and the Supply Agreement constitute the
entire agreement between the Parties with respect to the subject matter hereof
and thereof and supersede all prior representations, understandings and
agreements between the Parties with respect to the subject matter hereof and
thereof. No modification of this Agreement shall be effective unless in writing
with specific reference to this Agreement and signed by the Parties. In the
event of any conflict between this Agreement and the Supply Agreement, the terms
of this Agreement shall control.

11.6 Waiver. The terms or conditions of this Agreement may be waived only by a
written instrument executed by the Party waiving compliance. The failure of
either Party at any time or times to require performance of any provision hereof
shall in no manner affect its rights at a later time to enforce the same. No
waiver by either Party of any condition or term shall be deemed as a continuing
waiver of such condition or term or of another condition or term.

11.7 Headings. Section and Subsection headings are inserted for convenience of
reference only and do not form part of this Agreement.

11.8 Assignment. Neither this Agreement nor any right or obligation hereunder
may be assigned, delegated or otherwise transferred, in whole or part, by either
Party without the prior express written consent of the other; provided, however,
that (i) each of ARIAD Pharmaceuticals, Inc. or ARIAD Gene Therapeutics, Inc.
may, without the written consent of MEDINOL, assign this Agreement to its
Affiliates, or in

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

connection with the transfer or sale of all or substantially all of its assets
or business related to this Agreement, or in the event of its merger,
consolidation, change in control or similar transaction (collectively, “Change
in Control”), (ii) MEDINOL may, without ARIAD’s written consent, assign this
Agreement to its Affiliates, [***], or in a transaction involving Change in
Control. In the event of a Change in Control of ARIAD, ARIAD shall use
commercially reasonable efforts to cause its assignee to agree that, following
the effective date of such Change in Control, such assignee shall take
reasonable steps to segregate any part of its business which is developing,
manufacturing, using or selling Medical Devices which are directly competitive
with MEDINOL Licensed Products in the Licensed Field from those activities to be
performed by ARIAD after the effective date of such Change in Control pursuant
to this Agreement and the Supply Agreement. In the event of a Change in Control
of MEDINOL [***], MEDINOL shall cause its assignee to agree that, following the
effective date of such Change in Control or assignment, such assignee shall
segregate any part of its business which is developing, manufacturing, using or
selling rapamycin or a rapamycin analog delivered by stents which are directly
competitive with Licensed Patent Rights in the Licensed Field from those
activities to be performed by MEDINOL after the effective date of such Change in
Control or assignment pursuant to this Agreement and the Supply Agreement. As a
condition to assignment, any permitted assignee under this Section 11.8 shall
assume all obligations of its assignor under this Agreement in a separate
written agreement signed by the assignor and assignee. Any purported assignment
in violation of this Section 11.8 shall be void. The terms and conditions of
this Agreement shall be binding upon and inure to the benefit of the permitted
successors and assigns of the Parties.

11.9 Force Majeure. Neither Party shall be liable for failure of or delay in
performing obligations set forth in this Agreement, and neither shall be deemed
in breach of its obligations, if such failure or delay is due to natural
disasters or any causes beyond the reasonable control of such Party. In event of
such force majeure, the Party affected thereby shall use reasonable efforts to
cure or overcome the same and resume performance of its obligations hereunder.

11.10 Construction. 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 all Parties hereto
and not in favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement.

 

36

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

11.11 Severability. If any provision(s) of this Agreement are or become invalid,
are ruled illegal by any court of competent jurisdiction or are deemed
unenforceable under then current applicable law from time to time in effect
during the Term hereof, it is the intention of the Parties that the remainder of
this Agreement shall not be affected thereby provided that a Party’s rights
under this Agreement are not materially affected. The Parties hereto covenant
and agree to renegotiate any such term, covenant or application thereof in good
faith in order to provide a reasonably acceptable alternative to the term,
covenant or condition of this Agreement or the application thereof that is
invalid, illegal or unenforceable, it being the intent of the Parties that the
basic purposes of this Agreement are to be effectuated.

11.12 Further Assurances. Each Party agrees to execute, acknowledge and deliver
such further instructions, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

11.13 Independent Contractors. Notwithstanding any provision to the contrary
herein, the relationship of the Parties is that of independent contractor, and
nothing herein shall be construed to create a partnership, joint venture,
franchise, employment, or agency relationship between the Parties. Neither Party
shall have authority to enter into agreements of any kind on behalf of the other
Party, nor shall either Party have the power or authority to bind or obligate
the other Party in any manner.

11.14 Counterparts. This Agreement may be executed simultaneously in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

[Remainder of page intentionally left blank]

 

37

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representative in three (3) originals.

 

MEDINOL, INC. ARIAD PHARMACEUTICALS, INC. By:

/s/ Judith Richter

By:

/s/ Laurie A. Allen

Name: Laurie A. Allen Name: Judith Richter Title: Senior Vice President and
Chief Legal Officer Title: Chief Executive Officer ARIAD GENE THERAPEUTICS, INC.
By:

/s/ Harvey J. Berger, M.D.

Name: Harvey J. Berger, M.D. Title: Chairman and Chief Executive Officer

 

38

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

SCHEDULE A

LICENSED PATENT RIGHTS

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[***]

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[***]

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[***]

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[***]

 

39

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

EXHIBIT 3.3

SUPPLY AGREEMENT

[ATTACHED ON FOLLOWING PAGE]

 

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Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

 

EXHIBIT 6.1

Countries

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[***]

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[***]

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