Exhibit 10.1

EXECUTION VERSION

 

AMENDED AND RESTATED BUY-IN LICENSE AGREEMENT

 

between

 

ARIAD Pharmaceuticals, Inc.

 

and

 

ARIAD Pharmaceuticals (Europe) Sarl

 

and

 

Incyte Corporation (as guarantor)

 

 

 

   

 

 

TABLE OF CONTENTS

 

ARTICLE 1 – DEFINITIONS 2 ARTICLE 2 – GRANT OF LICENSES 18 ARTICLE 3 – RESERVED
TERRITORIES AND NON-COMPETITION 19 ARTICLE 4 – DEVELOPMENT AND COMMERCIALIZATION
COMMITTEES 23 ARTICLE 5 – DEVELOPMENT 25 ARTICLE 6 - EXCHANGE OF OTHER KNOW-HOW
31 ARTICLE 7 – PRICING AND REIMBURSEMENT 32 ARTICLE 8 – REGULATORY MATTERS 32
ARTICLE 9 – PHARMACOVIGILANCE 35 ARTICLE 10 – SUPPLY, FORECASTS AND ORDERING 37
ARTICLE 11 – SHIPMENT AND DELIVERY 39 ARTICLE 12 – MANUFACTURING OF THE PRODUCT
41 ARTICLE 13 – QUALITY ASSURANCE 43 ARTICLE 14 - RECALLS AND PRODUCT WITHDRAWAL
44 ARTICLE 15 – COMMERCIALIZATION OF THE PRODUCT 45 ARTICLE 16 – BUY-BACK OPTION
47 ARTICLE 17 – MEDICAL AFFAIRS ACTIVITIES 48 ARTICLE 18 – TRADEMARKS 49 ARTICLE
19 – CONSIDERATION AND PAYMENTS 51 ARTICLE 20 – REPRESENTATIONS AND WARRANTIES
56 ARTICLE 21 – COMPLIANCE WITH LAW; DATA PRIVACY; ANTI-BRIBERY AND
ANTI-CORRUPTION 59 ARTICLE 22 – INDEMNIFICATION, LIMITATIONS OF LIABILITY AND
INSURANCE 60 ARTICLE 23 – THE PATENTS 63 ARTICLE 24 – CONFIDENTIALITY 69 ARTICLE
25 – TERM 71 ARTICLE 26 – TERMINATION 71 ARTICLE 27 – FORCE MAJEURE 73 ARTICLE
28 – LAW TO GOVERN 74 ARTICLE 29 – DISPUTE RESOLUTION 74 ARTICLE 30 –
MISCELLANEOUS 75

 

appendices

APPENDIX 1.18 – ARIAD US TRADEMARKS

APPENDIX 1.21 – BCR-ABL INHIBITOR COMPOUND ASSAY

APPENDIX 1.35 – COMMERCIALIZATION PLAN

APPENDIX 1.40 – PONATINIB STRUCTURE

APPENDIX 1.62 – DISTRIBUTION AGREEMENTS

APPENDIX 1.128 – PATENTS

APPENDIX 1.134 – PRIMARY EFFICACY ENDPOINT

APPENDIX 1.138 – PROPOSED STUDIES

APPENDIX 1.161 – SUPERIORITY

APPENDIX 1.167 – TERRITORY

APPENDIX 1.175 – TRANSITION BACK ARRANGEMENTS

APPENDIX 17.3 – ISTs

APPENDIX 19.8.2 – OFFSET

APPENDIX 20 - DISCLOSURE SCHEDULES

APPENDIX 20.1.17 – POST-MARKETING REQUIREMENTS

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

THIS AMENDED AND RESTATED BUY-IN LICENSE AGREEMENT (“Agreement”) dated as of
June 1, 2016 (the “Effective Date”), between ARIAD Pharmaceuticals, Inc.,
(“ARIAD US”), a Delaware corporation and ARIAD Pharmaceuticals (Europe) Sarl,
(“ARIAD SWISSCO”), a Swiss limited liability company registered in Lausanne
(together, the “Parties” and, individually, each a “Party”) and Incyte
Corporation, a Delaware corporation (“Incyte Corporation”) solely in its
capacity as guarantor under Section 30.19. This Agreement only comes into effect
on the Effective Date (as defined below) and shall be of no force or effect if
there is no Closing (as defined below).

 

RECITALS

 

a.The Parties are engaged in the business of discovering, developing,
manufacturing and selling the Product (as defined below);

 

b.The Parties entered into a Buy-In License Agreement on August 7, 2012 (“Buy-In
License Agreement”), whereby ARIAD US granted to ARIAD SWISSCO a perpetual and
exclusive license to the Ponatinib Intangibles (as therein defined) for the
purposes of development and commercialization of the Product in certain
territories. The Parties also entered into a Development Cost Sharing Agreement
on August 7, 2012 (the “CSA Agreement”) pursuant to which they agreed to share
the costs and risks of further developing the Product.

 

c.ARIAD SWISSCO is an Affiliate of ARIAD Pharmaceuticals (Luxembourg) S.a.r.l.
(“ARIAD LUXCO”), a Luxembourg limited liability company registered in
Luxembourg. Pursuant to a Share Purchase Agreement (“Share Purchase Agreement”)
entered into on May 9, 2016 among ARIAD Pharmaceuticals (Cayman) L.P., a Cayman
Limited Partnership, ARIAD US (with respect to selected provisions only), Incyte
Europe S.a.r.l, an entity formed under the laws of Switzerland (“Incyte Europe”)
and Incyte Corporation (with respect to selected provisions only), Incyte Europe
will acquire the entire issued share capital in ARIAD LUXCO and, in connection
therewith, the parties thereto agreed that the Buy-in License Agreement would be
amended and restated on the terms of this Amended and Restated Buy-In License
Agreement. The CSA Agreement will terminate effective on the Effective Date and
the costs of development will now be on the terms set out in this Agreement.

 

d.The Parties entered into a Loan Agreement on August 7, 2012 (the “Loan
Agreement”) pursuant to which ARIAD US loaned the monies to ARIAD SWISSCO to
enable it to pay the consideration under the Buy-In License Agreement. In
consideration of ARIAD SWISSCO entering into this Agreement, ARIAD US has hereby
agreed to reduce all of the amount outstanding under the Loan Agreement and,
effective as of the Effective Date, the loan is no longer outstanding.

 

e.ARIAD SWISSCO wishes to continue to purchase the Product from ARIAD US for the
Territory, as further set forth herein.

 

f.The Parties agree that this preamble constitutes an integral part of this
Agreement and that all capitalized terms used in this preamble shall have the
respective meanings given above or in ARTICLE 1 or elsewhere in this Agreement.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  1

 

 

NOW, THEREFORE, in consideration of the above premises and the mutual promises
set forth below, the Parties hereby agree as follows:

 

ARTICLE 1 – DEFINITIONS

 

Capitalized terms used in this Agreement shall have the meanings specified below
or elsewhere herein.

 

1.1“Acquired Party” has the meaning set forth in Section 3.3.2.

 

1.2“Acquiring Party” has the meaning set forth in Section 3.3.2.

 

1.3“Adverse Ruling” has the meaning set forth in Section 26.1.

 

1.4“Affiliate” means any corporation or business entity that, whether now or in
the future, controls, is controlled by or is under common control with a Party.
For the purposes of this definition, the terms “controls”, “controlled by” and
“under common control with” as used with respect to any Party, means (i) to
possess (directly or indirectly) the power to direct the management or affairs
of a corporation or other business entity, whether through ownership of voting
securities or other equity rights or by contract relating to voting rights or
corporate governance or otherwise, or (ii) to own, directly or indirectly, more
than [***] of the outstanding voting securities or other ownership interest of
such corporation or other business entity. For purposes of this Agreement, as of
the Effective Date, ARIAD SWISSCO and ARIAD US are no longer Affiliates of one
another.

 

1.5“Agreement” has the meaning set forth in the Preamble.

 

1.6“Alliance Manager” has the meaning set forth in Section 4.6.

 

1.7“Ancillary Research” means research other than Basic Research, in the case of
ARIAD SWISSCO conducted under the licenses granted to ARIAD SWISSCO pursuant to
this Agreement and in the case of ARIAD US, comparable research conducted by
ARIAD US, other than in connection with a clinical trial under this Agreement.

 

1.8“Anti-Corruption Laws” means all Applicable Laws for the prevention of fraud,
kickbacks, bribery, corruption, racketeering, money laundering or terrorism,
including the FCPA, each, as amended from time to time.

 

1.9“API” means the Compound in the active pharmaceutical ingredient form set
forth in the Specifications.

 

1.10“Applicable Laws” means the applicable provisions of any and all national,
regional, state and local laws, treaties, statutes, rules, regulations,
administrative codes, and ordinances, and any and all directives, and orders or
administrative decisions of any governmental agency or authority (including
Regulatory Authorities) having jurisdiction over or related to the subject
matter in question, including Regulatory

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  2

 

 

Requirements, Regulatory Laws, Export Control Laws, and the FCPA and other
Anti-Corruption Laws, which are applicable to the subject matter of this
Agreement.

 

1.11“ARIAD LUXCO” has the meaning set forth in the Recitals.

 

1.12“ARIAD SWISSCO” has the meaning set forth in the Preamble.

 

1.13“ARIAD SWISSCO Improvements” means Know-how (for purposes of this definition
Know-how shall be the Know-how definition without clause (b) thereof and
references to ARIAD US therein shall be references to ARIAD SWISSCO) and any
associated Intellectual Property Rights arising after the Effective Date and
resulting from Development or Manufacturing activity conducted by ARIAD SWISSCO,
its Affiliates or Subcontractors but excluding Development Data.

 

1.14“ARIAD SWISSCO Trademarks” means any word, name, symbol, color, designation
or device or any combination thereof that functions as a source identifier,
including any trademark, trade dress, brand mark, service mark, trade name,
brand name, logo, business symbol or domain names, whether or not registered, to
be used by ARIAD SWISSCO or its Affiliates or its or their respective
Sublicensees (as an alternative to the ARIAD US Trademark) and any registrations
thereof or any pending applications relating thereto (excluding, in any event,
any trademarks, service marks, names or logos that include any corporate name or
logo of the Parties or their Affiliates). The ARIAD SWISSCO Trademarks exclude
the ARIAD US Trademarks.

 

1.15“ARIAD US” has the meaning set forth in the Preamble.

 

1.16“ARIAD US Improvements” means (i) Know How and any associated Intellectual
Property Rights arising after the Effective Date and resulting from Development
or Manufacturing activity conducted by ARIAD US, its Affiliates or
Subcontractors, but excluding Development Data ; and (ii) Know How and any
associated Intellectual Property Rights arising after the Effective Date and
resulting from the conduct of Basic Research by ARIAD US, its Affiliates or
Subcontractors; and (iii) any new technologies Controlled by ARIAD US or its
Affiliates and used by them in relation to Product during the Term.

 

1.17“ARIAD US Successor” has the meaning set forth in Section 16.1.

 

1.18“ARIAD US Trademarks” means any word, name, symbol, color, designation or
device or any combination thereof that functions as a source identifier,
including any trademark, trade dress, brand mark, service mark, trade name,
brand name, logo, business symbol or domain names, whether or not registered,
for the Product in the Territory used by ARIAD US for the Product in USA
including (a) the trademarks applications and registrations set forth in
Appendix 1.18 and (b) all registered and unregistered rights in such trademarks
set forth in Appendix 1.18, including all current and future registrations and
applications for registration of the same in the Territory and all renewals and
extensions thereto, in each case that are Controlled by ARIAD US or its
Affiliates.

 

1.19“Basic Research” means research on the Compound’s [***], [***], [***] and
all other research the objective of which is a product [***] from the Product.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  3

 

 

1.20“BCR-ABL” means the chromosomal translocation designated as t(9;22)(q34;q11)
in the International System for Human Cytogenetic Nomenclature (or a mutated or
modified form thereof).

 

1.21“BCR-ABL Inhibitor Compound” means any compound that inhibits BCR-ABL with
an [***] (measured as average [***] at an ATP concentration equal to the Km for
[***] in an enzyme assay when assayed [***] using the assay method set forth in
[***].

 

1.22“Breaching Party” has the meaning set forth in Section 26.1.

 

1.23“Business Day” means a day other than a Saturday or Sunday or any public
holiday in the United States or Switzerland or any other day on which banks are
required or authorized by Applicable Law to be closed in the United States or
Switzerland.

 

1.24“Business Entity” means any corporation, general or limited partnership,
trust, joint venture, unincorporated organization, limited liability entity or
other entity.

 

1.25“Buy-Back Option” has the meaning set forth in Section 16.1.

 

1.26“Buy-In License Agreement” has the meaning set forth in the Recitals.

 

1.27“CDA” means the Confidential Disclosure Agreement by and between ARIAD US
and Incyte Corporation dated January 19, 2016.

 

1.28“cGMP” means all Applicable Laws, guidance, directives, standards, practices
and procedures relating to the Manufacture of Compound or Product, including (i)
the U.S. Code of Federal Regulations and FDA’s guidance documents, and all
successor applicable regulations and guidance documents thereto, (ii) the
EUDRALEX Vol. 4 “Medicinals for Human and Veterinary Use: Good Manufacturing
Practice”, in particular Part II “Basic Requirements for Active Substances used
as Starting Materials” (03 October 2005), and applicable Annexes to Vol.4, and
(iii) the ICH (International Conference on Harmonisation of Technical
Requirements for the Registration of Pharmaceuticals for Human Use) guidelines,
including without limitation, ICH Q7A "ICH Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients.

 

1.29“Change of Control” means in respect of a Party the occurrence after the
Effective Date of any of the following: (i) the sale, conveyance or disposition,
in one or a series of related transactions, of all or substantially all of the
assets of such Party to a Third Party that is not an Affiliate of such Party
prior to such transaction or the first of such related transactions; (ii) the
consolidation, merger or other business combination of ARIAD US with or into any
other Business Entity, immediately following which the then-current stockholders
of the Party, as such, fail to own in the aggregate at least Majority Voting
Power of the surviving Party in such consolidation, merger or business
combination or of its ultimate publicly-traded parent Business Entity; or (iii)
a transaction or series of transactions in which any Person or “group” (as such
term is used in Sections 13(d) and 14(d) of the Exchange Act) acquires Majority
Voting Power of such Party (other than (a) a reincorporation or similar
corporate transaction in which each of such Party’s stockholders owns,
immediately thereafter, interests in

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  4

 

 

the new parent company in substantially the same percentage as such stockholder
owned in such Party immediately prior to such transaction, or (b) in connection
with a transaction described in (ii), which shall be governed by such (ii)), For
the Purposes of this definition “Majority Voting Power” means a majority of the
ordinary voting power in the election of directors or a majority of all the
outstanding voting securities of the resulting Business Entity or of the Party,
respectively.

 

1.30“Claim Notice” has the meaning set forth in Section 22.3.1.

 

1.31“Closing” has the meaning set forth in the Share Purchase Agreement.

 

1.32“CML” means chronic myeloid leukemia.

 

1.33“Combination Product” means a Product that is comprised of or contains
Compound as an active ingredient together with one (1) or more other active
ingredients and is sold either as a fixed dose or as separate doses in one (1)
product.

 

1.34“Commercialize” means all activities directed to importing (into, or within,
the Territory), exporting (to or within the Territory), storing, marketing,
promoting, selling, offering for sale and distributing the Product in the
Territory. “Commercializes,” “Commercialized,” “Commercialization” and other
forms of the word “Commercialize” shall have the correlative meaning. For
clarity, “Commercialize” excludes Manufacture.

 

1.35“Commercialization Plan” means (i) a [***] plan prepared by ARIAD SWISSCO
for the Product in the Field in the Territory setting out the Commercialization
[***],[***] and activities, in each case for the following calendar year; and
(ii) a [***] plan prepared by ARIAD US for the Product in the Field in the
Reserved Territory setting out the Commercialization [***],[***] and activities,
in each case for the following calendar year. The Commercialization Plan for
2016 is attached at [***], it being understood that the contents of future
Commercialization Plans shall be in accordance with this Section 1.35 without
regard to [***].

 

1.36“Commercially Reasonable Efforts” means, in respect of ARIAD SWISSCO, [***]
and in respect of ARIAD US, [***], in each case, to [***] and [***] a [***] such
party or [***], which [***] is [***] or [***] and is [***] taking into [***] and
other relevant factors.

 

1.37“Competitive Product” means any pharmaceutical product (other than a
Product, but including a generic version of the Product) that is a [***] other
than an Excluded Compound.

 

1.38“Compliance Event” has the meaning set forth in Section 21.5.

 

1.39“Composition Patent” means any Patent Controlled by ARIAD US or its
Affiliates in the Territory that contains a Valid Claim that covers the Product
and/or Compound.

 

1.40“Compound” means the active pharmaceutical ingredient known as ponatinib
having the structure set forth on Appendix 1.40, and any metabolite, salt,
ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form,
crystalline form, co-crystalline form, amorphous form, pro-drug (including ester
pro-drug) form,

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  5

 

 

racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form
of any of the foregoing, including crystalline ponatinib monohydrochloride.

 

1.41“Confidential Information” has the meaning set forth in Section 24.1.

 

1.42“Control” (including any variations such as “Controlled” and “Controlling”)
means, with respect to any item of Know-how, Regulatory Documentation, material,
Patent, or other Intellectual Property Right, the possession of the right,
whether directly or indirectly, and whether by ownership, license or otherwise
(other than by operation of the license granted under this Agreement), to grant
a license, sublicense or other right (including the right to reference
Regulatory Documentation) to or under such Know-how, Regulatory Documentation,
material, Patent, or other Intellectual Property Right as provided for herein
without violating the terms of any then-existing agreement with any Third Party;
provided, that Intellectual Property Rights of an acquirer of a Party or its
Affiliates in existence prior to the acquisition date, or developed after the
acquisition date solely by such acquirer without use of or reference to such
Party’s preexisting Know-how, Regulatory Documentation, material, Patent, or
other Intellectual Property Right and without contribution from employees of a
Party or its Affiliates other than the acquirer, shall not be deemed to be
“Controlled” by such Party or Affiliate.

 

1.43“Cost of Manufacture” means in relation to any aspect of the Manufacture
either (i) Direct Cost and Indirect Cost where the Party is undertaking the
manufacture; or (ii) Third Party Manufacturing Costs where a Party has appointed
a contract manufacturing organization or toll manufacturer.

 

1.44“CRO” means a contract research organization to which certain Development
services are contracted.

 

1.45“CSA Agreement” has the meaning set forth in the Recitals.

 

1.46“CSR” means a written clinical study report containing the results of an
Ongoing Study or other clinical study, as applicable.

 

1.47“CSR Payment” has the meaning set forth in Section 5.3.1.

 

1.48“Current Manufacturing Process” has the meaning set forth in Section 6.2.

 

1.49“Customer” means any entity or person that is authorized to purchase and
dispense or sell the Product in the Territory under Applicable Law.

 

1.50“Data Protection Laws” has the meaning set forth in Section 21.4.

 

1.51“Default Notice” has the meaning set forth in Section 26.1.

 

1.52“Defending Party” has the meaning set forth in Section 23.5.1.

 

1.53“Delivery” has the meaning set forth in Section 11.1.3.

 

1.54“Delivery Documents” means those documents specified and listed as such in
the Interim Quality Agreement

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  6

 

 

1.55“Development” and “Develop” means the conduct of Pre-clinical Research, test
method development and stability testing, process development, manufacturing
scale-up, qualification and validation, quality assurance/quality control, any
clinical studies carried out in relation to the Product leading to a Marketing
Authorization or an extension of such Marketing Authorization, including
Manufacturing in support thereof, statistical analysis and report writing, the
preparation and submission of Registrations, regulatory affairs with respect to
the foregoing and all other activities necessary or reasonably useful or
otherwise requested or required by a Regulatory Authority as a condition to or
in support of obtaining or maintaining a Registration. For clarity, Development
does not include Basic Research.

 

1.56“Development Costs” means the costs and expenses associated with Development
activities and shall include, unless stated otherwise, [***], [***] and [***].

 

1.57“Development Data” means data resulting from Development activity being
Pre-clinical Research or clinical studies.

 

1.58“Development Register” has the meaning set forth in Section 5.1.

 

1.59“Development Territory” means the Reserved Territory less [***].

 

1.60“Developing Party” means the Party conducting or proposing to conduct the
applicable clinical study itself or through its Affiliates, Sublicensees or
Third Parties.

 

1.61“Direct Costs” include direct labor costs, based on actual hours consumed by
personnel charged at an average hourly wage rate which is designed to
approximate actual cost for each employee’s position and direct labor fringe
benefit costs, including compensation expense (other than direct labor costs
already included), payroll taxes and benefits allocated based on a proportionate
percentage of direct labor costs charged to Development or Manufacture
(including Manufacturing Technology Transfer) of the Product (as the case may
be) in comparison to all development or manufacturing activity undertaken during
the period.

 

1.62“Distribution Agreements” means the existing Distribution Agreements entered
into as of the Effective Date in respect of the Commercialization of the Product
in the Territory, a list of which is set out in Appendix 1.62 to this Agreement
and any additional distribution agreements entered into by ARIAD SWISSCO or its
Affiliates in respect of the Commercialization of the Product during the Term.

 

1.63“Distribution Agreement Milestone Payments” means any and all outstanding
milestone payments [***] under Article 13.2 of the [***] between [***].

 

1.64“Drug Product” means Product in bulk finished (not labeled or packaged)
form.

 

1.65“Effective Date” has the meaning set forth in the Preamble.

 

1.66“Escalation Notice” has the meaning set forth in Section 5.6.

 

1.67“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended,
together with the rules and regulations promulgated thereunder.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  7

 

 

1.68“Excluded Compound” means a (i) [***] that is [***] or more potent on the
enzyme for that compound’s primary (biologically relevant) target compared to
BCR-ABL where the selectivity is assessed by the relative IC50s in enzyme assays
conducted at [***] ATP for each of the two kinases (i.e. BCR-ABL and the primary
target kinase of interest) or (ii) a BCR-ABL Inhibitor Compound that is more
potent with respect to a target other than BCR-ABL and is not being developed as
an inhibitor of BCR-ABL or for an indication for which there is an active
Development program ongoing with the Product or for which the Product is then
being Commercialized.

 

1.69“Export Control Laws” means all applicable U.S. laws and regulations
relating to (a) economic and trade sanctions and embargoes imposed by the Office
of Foreign Assets Control of the U.S. Department of Treasury or (b) the export
or re-export of commodities, technologies, or services, including the Export
Administration Act of 1979, 24 U.S.C. §§ 2401-2420, the International Emergency
Economic Powers Act, 50 U.S.C. §§ 1701-1706, the International Traffic in Arms
Regulations, 22 C.F.R. parts 120-130, the Trading with the Enemy Act, 50 U.S.C.
§§ 1 et. seq., the Arms Export Control Act, 22 U.S.C. §§ 2778 and 2779, and the
International Boycott Provisions of Section 999 of the U.S. Internal Revenue
Code of 1986 (as amended) or such equivalent laws of any other country.

 

1.70“FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. Section
78dd-1, et. seq.) as amended.

 

1.71“FDA” means the U.S. Food and Drug Administration.

 

1.72“Field” means the diagnosis, treatment and prevention of all diseases in
humans.

 

1.73“Final Manufacturing” means all activities occurring anywhere in the world
required to prepare the Product for commercial sale in the Territory, including
secondary packaging and labeling with the approved packaging and label for the
country in the Territory in which it is to be sold; stability or other testing;
quality control; and release of the Product for sale in the Territory.

 

1.74“First Commercial Sale” means the first sale to a Third Party of Product for
use or consumption by an end-user in the Field in a given country in the
Territory after all aspects of Registration have been obtained in such country.
A First Commercial Sale shall not include a sale of Product for use in clinical
trials, for research or for other non-commercial uses, or supply of Product as
part of a Named Patient Program or similar program.

 

1.75“Forecast” has the meaning set forth in Section 10.3.

 

1.76“Full Royalty Term” means, on a country-by-country basis within the
Territory, the period from the Effective Date expiring on the later of (i) the
expiry date (including the expiry of any patent term extensions, supplementary
protection certificates or pediatric extensions) of the Composition Patent in
such country or (ii) the expiration of any regulatory marketing exclusivity
period or other statutory designation that provides similar exclusivity for the
Commercialization of the Product in such country, or (iii) seven (7) years after
the date of First Commercial Sale in such country.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  8

 

 

1.77“Generic Product” means in any particular country any Third Party product
that contains Compound and either (i) for which equivalence with Product has
been demonstrated to the satisfaction of the Regulatory Authority in that
country or which can be substituted for Product by a dispenser or (ii) which is
approved in reliance, in whole or in part, on the prior approval (or on safety
or efficacy data submitted in support of the prior approval) of such Product as
determined by the applicable Regulatory Authority.

 

1.78“Global Product Positioning” has the meaning set forth in Section 15.3.

 

1.79“Global Study(ies)” means a multi-centre clinical trial carried out at
clinical research sites located both in the Territory and in the Development
Territory.

 

1.80“Global Third Party License” has the meaning set forth in Section 23.6.2(a).

 

1.81“Government Official” means (a) any officer or employee of a government or
any department, agency or instrumentality of a government; (b) any person acting
in an official capacity for or on behalf of a government or any department,
agency, or instrumentality of a government; (c) any officer or employee of a
company or business owned or controlled by a government; (d) any officer or
employee or person acting in an official capacity for or on behalf of a public
international organization or any department, agency, or instrumentality of such
public international organization such as the World Bank or United Nations; (e)
any political party or official thereof; and/or (f) any candidate for political
office.

 

1.82“Healthcare Professional” means any member of the medical, pharmacy or
nursing professions or any other person who in the course of his or her
professional activities may prescribe, administer or dispense to an end-user a
medicinal product.

 

1.83“IC50” means the half maximal inhibitory concentration.

 

1.84“Incyte Corporation” has the meaning set forth in the Preamble.

 

1.85“Incyte Europe” has the meaning set forth in the Recitals.

 

1.86“IND” means an investigational new drug application filed with, and accepted
by, the FDA prior to beginning clinical trials in humans in the US, or any
comparable application to and acceptance by the Regulatory Authority of a
country or group of countries other than the US including a request for
authorization of clinical trial to be conducted in the Territory made to EMA.

 

1.87“Indemnified Party” has the meaning set forth in Section 22.3.1.

 

1.88“Indemnifying Party” has the meaning set forth in Section 22.3.1.

 

1.89“Indirect Costs” include (i) within Development or Manufacture or
Manufacturing Technology Transfer (as the case may be), facility and occupancy
costs for development personnel, such cost to be allocated pro-rata to the
percent occupancy represented by development personnel on the overall facility
and (ii) the cost of allocable overhead, being an amount added to an item of
cost to reflect central or other overhead costs incurred by a Party being such
costs normally allocated by such

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  9

 

 

Party to its departments or project groups based on space occupied or headcount
or other activity based method, consistently applied in accordance with US GAAP.

 

1.90“Industry Guidelines” means voluntary industry codes or guidelines to which
a Party has publically stated it adheres as of the Effective Date, or
subsequently during the Term (as such codes or guidelines are revised from time
to time by their promulgating organization).

 

1.91“Inferiority” means the circumstance in relation to the results of the [***]
where [***] has been demonstrated to be [***] to either ponatinib dosing arm of
the study (according to the [***]).

 

1.92“Intellectual Property Rights” means all rights in, to and under patents,
trademarks, copyrights, databases, data, domain names, inventions, trade secrets
and confidential information, and all other intellectual or industrial property
and other analogous proprietary rights throughout the world.

 

1.93“Interim Quality Agreement” has the meaning set out in Section 13.1.

 

1.94“IST” means an investigator sponsored clinical trial.

 

1.95“JCC” has the meaning set forth in Section 4.4.

 

1.96“JSC” has the meaning set forth in Section 4.1.

 

1.97“Know-how” means all information regarding the Compound or Product,
including documentation, processes, data and other information, and further
including (a) all information on file with any competent Regulatory Authority in
support of a Marketing Authorization; and (b) ARIAD US Improvements, which
information and ARIAD US Improvements are Controlled by ARIAD US or its
Affiliates as of the Effective Date or at any time during the Term. Know-how
includes all unpatented Intellectual Property Rights licensed to ARIAD US
pursuant to a Global Third Party License.

 

1.98“Knowledge” shall mean, with respect to a fact or matter, that the
applicable Party’s [***] employee directly responsible for such fact or matter
is [***] of such fact or matter [***] with respect to such fact or matter of the
persons directly reporting to him or her.  “Known” has a correlative meaning.

 

1.99“Labeled Bottles” means Drug Product in labeled bottle form as set forth in
the Specifications.

 

1.100“Label Payment” has the meaning set forth in Section 5.3.1.

 

1.101“Latent Defect” means a Non-Conformance that is not discoverable or
actually discovered upon reasonable visual inspection performed pursuant to
Section 11.2.1, but that is discovered at a later time (e.g., a failure to
comply with the shelf-life set forth in the Specification that is identified as
a result of long-term stability studies conducted by ARIAD US or its Affiliates
or a Third Party authorized by ARIAD US or its Affiliates).

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  10

 

 

1.102“Liability” means any liability or obligation, whether known or unknown,
absolute or contingent, accrued or unaccrued, liquidated or unliquidated, due or
to become due.

 

1.103“Loan Agreement” has the meaning set forth in the Recitals.

 

1.104“Local Currencies” means the currency used in each of the respective
countries in the Territory.

 

1.105“Losses” has the meaning set forth in Section 22.1.

 

1.106“MAH” means the Marketing Authorization holder for the Product in each
country in the Territory.

 

1.107“Manufacture” means, as applicable, Final Manufacturing and the
manufacturing of the Product up to and including Drug Product in Unlabeled
Bottles or blister packages, and all activities related to such manufacturing of
Product, or any ingredient thereof, either directly or through a contract
manufacturer, including in-process and semi-finished Product testing, ongoing
stability tests and regulatory activities related to any of the foregoing.
“Manufactured” or “Manufacturing” and other forms of the word “Manufacture”
shall have correlative meaning.

 

1.108“Manufacturing Process” has the meaning set forth in Section 12.3.

 

1.109“Manufacturing Technology Transfer” has the meaning set forth in Section
6.2.

 

1.110“Marketing Authorization” means a marketing authorization for the Product
granted by the European Medicines Agency or by any other Regulatory Authority.

 

1.111“Named Patient Program” means a compassionate use, named patient use, or
similar program for the supply of the Product in the Field in the Territory
prior to obtainment of Registrations, to the extent permitted by and in
accordance with Applicable Laws.

 

1.112“Net Sales” means, with respect to a Product, the [***] by ARIAD SWISSCO,
its Affiliates or its Sublicensees for such Product in the Field in the
Territory to [***] (such [***], including, for the purposes of this definition,
the [***] under (x) the [***] and (y) any [***] where [***] is [***] of such
Product to [***], in each case of (x) or (y) which [***]), less the following
deductions relating to sales of the Product:

 

(a)[***] and/or other [***] and [***] with respect to such sales;

 

(b)[***];

 

(c)[***] or other [***] and paid with respect to the [***] of such Product
[***];

 

(d)the amount of [***] and amounts [***] by reason of [***];

 

(e)charges for [***] directly related to the [***], to the extent not already
deducted or excluded from the gross amount invoiced; and

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  11

 

 

(f)[***] payable to any [***];

 

(g)any other similar and customary deductions that are consistent with US GAAP
(not including bad debt).

 

Notwithstanding the foregoing, no [***], or any similar amount, however
designated, that is given or associated with the purchase by [***] of any
product or service in addition to the Products shall be [***] allocated to the
Product.

 

Such amounts invoiced and such deductions shall be determined from the books and
records of ARIAD SWISSCO and its Sublicensees maintained in accordance with US
GAAP, consistently applied throughout such party’s organization.

 

In the case of any sale of such Product for consideration other than (or in
addition to) cash, such as barter or countertrade, Net Sales shall be calculated
on the [***] of the [***] received.

 

In the case of a sale under a [***] by [***] to a [***] that is a [***] for
purposes of this definition of Net Sales, Net Sales will be based on the [***]
of Product; provided, however, that if the royalty payable based on such [***]
to ARIAD US is less than [***] of the royalty that would be applicable under
this Agreement if the Net Sales had been by [***] or [***], then any other
consideration received by [***] or [***] under such [***], such as upfront or
milestone payments (and not legitimate compensation for other services or
products) will be included in Net Sales on an equitable pro-rata basis.

 

If such Product is sold to any [***] together with other products or services,
the price of such Product, solely for purposes of the calculation of Net Sales,
shall be deemed to be no less than the price at which such Product would be
[***] to a [***] not also [***].

 

The Net Sales of any Combination Product:

 

(x)     for which the [***] and other [***] of such Combination Product are sold
separately by ARIAD SWISSCO, or any of its Affiliates or their Sublicensees, or
the relevant Third Party, in such country, then Net Sales for such Combination
Product in such country shall be calculated by multiplying [***] of such
Combination Product in such country by the fraction A/(A+B), where A is [***];

 

(y)     for which the other [***] in the Combination Product is/are not sold
separately by ARIAD SWISSCO or any of its Affiliates or their Sublicensees or
the relevant Third Party, in such country, then Net Sales for such Combination
Product in such country shall be calculated by multiplying [***] of such
Combination Product in such country by the fraction A/D, where A is the [***],
and D is the [***]; and

 

(z)     for which neither clause (x) nor clause (y) above is applicable, the
Parties shall determine Net Sales for such Combination Product in such country
by [***] based on the [***] and the [***] in the Combination Product.

 

1.113“New Indication” means any indication in the Field, being any disease,
condition or syndrome other than CML or Philadelphia chromosome positive ALL.
For clarity, new lines of therapy within an already approved indication or for
another subset of patients within an already approved indication (e.g.,
pediatric Ph+ ALL) would not qualify as a New Indication.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  12

 

 

1.114“Non-Breaching Party” has the meaning set forth in Section 26.1.

 

1.115“Non-Conformance” means a failure of the Product supplied hereunder to
comply with any of the Product warranties set forth in Section 20.1.5. For
clarity, a Latent Defect is an instance of Non-Conformance. The adjective
“Non-Conforming” shall have the correlative meaning. “Non-Conformance” does not
include damage caused to Products caused by actions of or on behalf of ARIAD
SWISSCO following Delivery by ARIAD US to ARIAD SWISSCO, including Manufacture,
where applicable.

 

1.116“Non-Developing Party” means the Party that is not the Developing Party.

 

1.117“Non-Inferiority” means the circumstance in relation to the results of the
[***] where neither [***] nor [***] has been demonstrated.

 

1.118“Notified Party” has the meaning set forth in Section 21.5.

 

1.119“Notifying Party” has the meaning set forth in Section 21.5.

 

1.120“Objection Notice” has the meaning set forth in Section 11.2.2.

 

1.121“OMNI Study” means the postmarketing observational study to evaluate the
incidence and risk factors for vascular occlusive events associated with
Iclusig®

 

1.122“Ongoing Studies” means the OPTIC Clinical Trial, OPTIC-2L Clinical Trial
and OMNI Study each of which were started prior to the Effective Date and are
scheduled to be completed after the Effective Date.

 

1.123“Ongoing Studies Budget” has the meaning set forth in Section 5.3.1

 

1.124“OPTIC Clinical Trial” means the Phase 2 dose-ranging OPTIC (Optimizing
Ponatinib Treatment in CML) trial being conducted by ARIAD US in respect of the
Product as at the Effective Date.

 

1.125“OPTIC 2L Clinical Trial” means the randomized Phase 3 OPTIC 2L (Optimizing
Ponatinib Treatment in CML, Second Line) trial versus nilotinib being conducted
by ARIAD US in respect of the Product as at the Effective Date.

 

1.126“Party” has the meaning set forth in the Preamble.

 

1.127“Payment” has the meaning set forth in Section 19.7.

 

1.128“Patents” means (a) all patents and patent applications that are Controlled
by ARIAD US or its Affiliates as of the Effective Date and at any time during
the Term that are necessary or useful (or, with respect to patent applications,
would be necessary or useful if such patent applications were to issue as
patents), a list of which as at the Effective Date is included in Appendix 1.128
hereto, or are licensed to ARIAD US pursuant to a Global Third Party License;
(b) all patents issuing from the applications in subsection (a); (c) any
additions, divisions, continuations, continuations-in-part, counterparts,
amendments, amalgamations, reissues and re-examinations of such applications or
patents; (d) any confirmation, importation and registration patents

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  13

 

 

thereof; and (e) any extensions and renewals of all such patents and patent
applications in whatever legal form and by whatever legal title they are
granted.

 

1.129“PDL Agreements” mean the (i) Revenue Interest Assignment Agreement between
ARIAD US and PDL BioPharma, Inc., dated July 28, 2015, and (ii) the Security
Agreement among ARIAD US, ARIAD Pharma Ltd. and PDL BioPharma, Inc., dated July
28, 2015, in each case as amended in connection with this Agreement. 

 

1.130“Pharmacovigilance Agreement” has the meaning set forth in Section 9.4.

 

1.131“Pre-clinical Research” means (i) research preparatory to the filing of an
IND to conduct clinical studies including studies on the toxicological,
pharmacological, metabolic or clinical aspects of the Product and testing
in-vivo in animal models in relation to a New Indication, a line extension of an
existing approved indication, or a Global Study or a Territory-specific study;
and (ii) research conducted in relation to a clinical study under this
Agreement. Pre-clinical Research excludes Basic Research.

 

1.132“Presentation” means each stock-keeping unit of Product differentiated by
dosage strength, bottle count, packaging presentation, and/or country-specific
labeling for the Product for which Marketing Authorization has been received in
a country in the Territory (e.g., a 60 count bottle of 15mg tablets labeled for
a specific country in the Territory).

 

1.133“Pricing and Reimbursement Approval” means any official, final, binding and
non-appealable determination of the reimbursable price of the Product in
accordance with Applicable Laws and approval by relevant Regulatory Authorities
pertaining to the reimbursement of the Product, as applicable in each country in
the Territory in which a Regulatory Authority approves or determines the price
and/or reimbursement of pharmaceutical products.

 

1.134“Primary Efficacy Endpoint” has the meaning set forth on Appendix 1.134.

 

1.135“Proceeding” means any (i) Third Party private action, claim or lawsuit
(including in arbitration) or (ii) governmental, judicial, administrative or
adversarial proceeding, hearing, probe or inquiry brought by any Third Party
public entity, including whistleblower complaints. Proceedings shall not include
any action, claim or lawsuit brought by one Party or its Affiliates against the
other Party or its Affiliates.

 

1.136“Product” means any pharmaceutical product containing Compound as an active
chemical entity in any and all forms, presentations, and dosages

 

1.137“Product Withdrawal” means removal of Product from the market in any
country on grounds of public health or safety resulting in discontinuation of
all or substantially all distribution of Product in such country. Product
Withdrawal does not include a Recall.

 

1.138“Proposed Studies” means the list of clinical studies proposed to be
undertaken by ARIAD US in the Territory and the Reserved Territory, the name,
protocol synopses for which are as set forth in Appendix 1.138.

 

1.139“Protected Personal Information” has the meaning set forth in Section 21.4.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  14

 

 

1.140“Quality Agreement” has the meaning set out in Section 13.1.

 

1.141“Raw Materials” means any raw materials, components, or other ingredients
required for the Manufacture of the Drug Product.

 

1.142“Recall” means a recall or retrieval of Product on grounds of
Non-Conformance, public health or safety which is limited as to lot(s) or
batch(es) of Product.

 

1.143“Reduced Royalty Term” has the meaning set forth in Section 19.2.2.

 

1.144“Registrations” means (a) Marketing Authorizations, (b) Pricing and
Reimbursement Approval, (c) receipt of any license required to import or export
Product(s), and (d) any other official license or approval which is legally
required to (i) Develop or Manufacture Compound or Product anywhere in the world
for purposes of Commercialization in the Field in the Territory or (ii)
Commercialize Product in the Field in the Territory (e.g., wholesale licenses).

 

1.145“Regulatory Authority” means the European Medicines Agency, FDA or any
other government agency that is a competent authority for the issuance of any of
the Registrations, or any part of them, throughout the Term.

 

1.146“Regulatory Documentation” means all letters, correspondence, applications
and other documents and information submitted to Regulatory Authorities or
received from Regulatory Authorities in writing, including in electronic format,
as well as any supporting documentation.

 

1.147“Regulatory Laws” means all laws, and all orders, determinations,
regulations, licenses and directions made or issued under such laws, in respect
of the Registrations, Manufacturing and Commercialization of the Product.

 

1.148“Regulatory Requirements” means all licenses, registrations, mandatory
standards, conditions, manufacturing principles, directions, orders and
determinations in force from time to time set out in the Regulatory Laws and all
other Applicable Laws that apply to the manufacture (including Manufacture),
supply, packaging, labeling and/or Commercialization of medicinal products.

 

1.149“Reserved Territory” shall have the meaning set forth in Section 3.1.

 

1.150“Royalty Term” means, with respect to a country in the Territory, the Full
Royalty Term and the Reduced Royalty Term, collectively.

 

1.151“Safety Improvement” means the circumstance in relation to the results of
the [***] where (i) [***]; but (ii) there is at least a [***] reduction in the
[***] in either ponatinib arm of the study compared to the rate set forth in
[***] for the Product as of the Effective Date (ie [***]).

 

1.152“Safety Information” has the meaning set forth in Section 9.5.

 

1.153“SEC” means the U.S. Securities and Exchange Commission or any successor
agency.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  15

 

 

1.154“Second Line CML” means the treatment of second line CML (post-imatinib)
based on demonstration of the Product’s [***] in the ongoing OPTIC 2L Clinical
Trial or any other study sponsored by either ARIAD US or ARIAD SWISSCO.

 

1.155“Segregate” means, with respect to a Competitive Product to use
Commercially Reasonable Efforts to segregate the Development, Manufacture, and
Commercialization activities relating to such Competitive Product from
Development, Manufacture, and Commercialization activities for Compounds or
Products under this Agreement, including using Commercially Reasonable Efforts
to ensure that: (i) no personnel involved in performing the Development,
Manufacture, or Commercialization of such Competitive Product have access to
non-public plans or non-public information relating to the Development,
Manufacture, or Commercialization of Compounds or Products or any other
Confidential Information of the applicable Party; and (ii) no personnel involved
in performing the Development, Manufacture, or Commercialization of Compounds or
Products have access to non-public plans or information relating to the
Development, Manufacture, or Commercialization of such Competitive Product;
provided, that, in either case of (i) or (ii), senior management personnel may
review and evaluate plans and information regarding the Development,
Manufacture, and Commercialization of such Competitive Product, solely in
connection with portfolio decision-making among product opportunities.

 

1.156“Senior Officer” means, (i) with respect to ARIAD US, its Chief Executive
Officer, and (ii) with respect to ARIAD SWISSCO, the Chief Executive Officer of
Incyte Corporation.

 

1.157“Specifications” means the specifications for the Product in Unlabeled
Bottle or API form, as applicable, as defined by the Parties and incorporated
into the Interim Quality Agreement and future Quality Agreements, together with
changes to such specifications made in accordance with Section 12.3.

 

1.158“Share Purchase Agreement” has the meaning set forth in the Recitals.

 

1.159“Sublicensee” means any Affiliate of ARIAD SWISSCO or Third Party appointed
by ARIAD SWISSCO as a sublicensee under this Agreement in accordance with the
terms of this Agreement.

 

1.160“Subcontractor” means a Third Party appointed by ARIAD SWISSCO, subject to
Section 2.3, to perform activities under this Agreement on behalf of ARIAD
SWISSCO. For clarity, a Subcontractor does not include a Sublicensee.

 

1.161“Superiority” has the meaning set forth on Appendix 1.161.

 

1.162“Supply Agreement” has the meaning set forth in Section 10.1.

 

1.163“Target Enrollment” has the meaning set forth in Section 5.3.2.

 

1.164“Taxes” has the meaning set forth in Section 19.7. The terms “Taxable” and
“Tax” have correlative meanings.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  16

 

 

1.165“Term” means the period beginning on the Effective Date and continuing
unless and until terminated in accordance with its terms.

 

1.166“Termination Notice” has the meaning set forth in Section 16.1.

 

1.167“Territory” means the area within the geographic boundaries as set forth in
Appendix 1.167. Appendix 1.167 sets forth the status of Product in the Territory
as of the Effective Date.

 

1.168“Territory-Only Third Party License” has the meaning set forth in Section
23.6.1.

 

1.169“Third Party” means any Person other than ARIAD US, ARIAD SWISSCO and their
respective Affiliates. For purposes of this definition, “Person” means any (i)
natural person, (ii) partnership, company, corporation or other form of business
organization or legal entity, and (iii) any governmental or administrative
entity.

 

1.170“Third Party Development Costs” mean within Development, the actual
invoiced amounts paid by a Party to a CRO, excluding recoverable taxes such as
VAT.

 

1.171“Third Party Infringement Claim” has the meaning set forth in Section
23.5.1.

 

1.172“Third Party License” has the meaning set forth in Section 23.5.6.

 

1.173“Third Party Manufacturing Costs” mean within or relating to Manufacture or
Manufacturing Technology Transfer, the actual invoiced amounts paid by a Party
to a contract manufacturing organization, excluding recoverable taxes such as
VAT.

 

1.174“Transaction” has the meaning set forth in Section 3.3.2.

 

1.175“Transition Back Arrangements” means the arrangements set out in Appendix
1.175.

 

1.176“Transitional Supply Arrangements” has the meaning set forth in Section
10.1.

 

1.177“Unlabeled Bottles” means Drug Product in unlabeled bottle form as set
forth in the Specifications.

 

1.178“US GAAP” means generally accepted accounting provisions in force in USA
from time to time.

 

1.179“Valid Claim” means a claim of an issued and unexpired Patent to the extent
such claim has not been revoked, held invalid or unenforceable by a patent
office, court or other governmental agency of competent jurisdiction in a final
order, from which no further appeal can be taken, and which claim has not been
disclaimed, denied or admitted to be invalid or unenforceable through reissue,
re-examination or disclaimer or otherwise.

 

1.180“Year-End Compensating Payment” has the meaning set forth in Appendix
19.8.2.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  17

 

 

ARTICLE 2 – GRANT OF LICENSES

 

2.1Grant of licenses.

 

2.1.1Subject to the terms and conditions of this Agreement, including any
reservation of ARIAD US’s rights expressly set forth herein, ARIAD US hereby
grants to ARIAD SWISSCO, and ARIAD SWISSCO hereby accepts, an exclusive (even as
to ARIAD US and its Affiliates, except in the case of clause (i) below),
perpetual, license under the Patents, the Know-how, the ARIAD US Trademarks and
any other Intellectual Property Rights of ARIAD US and its Affiliates in and to
the Compound or Product to (i) conduct Ancillary Research anywhere in the world,
(ii) Develop Product in the Territory (subject to ARIAD US’s rights to Develop
under Sections 5.3, 5.4 and 5.7) and, in connection with a Global Study, in the
Development Territory, (ii) Manufacture Product anywhere in the world for
purposes of Commercialization in the Field in the Territory, and (iv)
Commercialize Product in the Field in the Territory, in each case in accordance
with the terms of this Agreement.

 

2.1.2Subject to the terms and conditions of this Agreement, including any
reservation of ARIAD US’s rights expressly set forth herein (including payment
for use of Development Data as required under Sections 5.5, 5.7.3 and 5.9),
ARIAD US hereby grants to ARIAD SWISSCO, and ARIAD SWISSCO hereby accepts, an
exclusive (even as to ARIAD US and its Affiliates, except in the case of clause
(i) below) license and right of reference under the Registrations and all other
Regulatory Documentation that ARIAD US or its Affiliates may Control with
respect to the Compound or Product as necessary for ARIAD SWISSCO to (i) [***]
anywhere in the world, (ii) Develop Product in the Territory (subject to ARIAD
US’s rights to Develop under Sections 5.3, 5.4 and 5.7) and, in connection with
a Global Study, in the Development Territory, (iii) Manufacture Product anywhere
in the world for purposes of Commercialization in the Field in the Territory,
and (iv) Commercialize Product in the Field in the Territory. ARIAD US shall
sign, and shall cause its Affiliates to sign, any documents or instruments
requested by ARIAD SWISSCO in order to effectuate the foregoing grant and enable
ARIAD SWISSCO to exercise its rights under this Agreement.

 

2.1.3The licenses set forth in Section 2.1.1 and 2.1.2 shall be sublicensable
through multiple tiers by ARIAD SWISSCO without ARIAD US’s consent except where
the applicable Sublicense is to be granted in respect of the Commercialization
of the Product in all or substantially all of the countries within the
Territory, such consent not to be unreasonably withheld, conditioned or delayed
([***]). Prior to the grant of any such sublicense ARIAD SWISSCO shall give
ARIAD US not less than [***] of the intent to enter into such a sublicense, of
the identity of the proposed sublicensee and seeking consent and ARIAD US shall
have the right to grant or not grant such consent in its sole discretion;
provided, however, that if ARIAD US does not provide written notice that it does
not consent within [***] of receipt of notice from ARIAD SWISSCO, such consent
shall be deemed

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  18

 

 

given. ARIAD SWISSCO shall be liable for all acts or omissions of its
Sublicensees in connection with this Agreement. Any act or omission by any
Sublicensee that would constitute a breach of this Agreement if done, or omitted
to be done, by ARIAD SWISSCO, shall be deemed to be a breach of this Agreement
by ARIAD SWISSCO. Any Sublicense shall contain a provision that it shall be
assignable to ARIAD US in the event of termination of this Agreement.

 

2.2ARIAD US and its Affiliates agree that they shall not, and they shall not
appoint any Third Party (i) to [***] in the Territory other than pursuant to
Sections 5.3, 5.4 and 5.7) or in connection with a [***]; or (ii) [***] (other
than for purposes of supplying to ARIAD SWISSCO pursuant to this Agreement or
the Supply Agreement) anywhere in the world if it is intended for
Commercialization in the Territory or (iii) to [***] the [***] or Product in the
Territory or (iv) otherwise in contravention of the licenses set forth in
Section 2.1.1. Other than the Distribution Agreements, as at the Effective Date
no rights to develop, [***] or [***] the Product has been granted to Third
Parties for the Territory.

 

2.3ARIAD SWISSCO shall be entitled to engage Subcontractors with respect to the
performance of its rights under Section 2.1 without ARIAD US’ consent provided
that such sub-contract shall be assignable to ARIAD US in the event of
termination of this Agreement.

 

ARTICLE 3 – RESERVED TERRITORIES AND NON-COMPETITION

 

3.1Development of the Compound and/or Product for and Commercialization of the
Product in all countries other than those in the Territory (the “Reserved
Territory”) are reserved exclusively to ARIAD US or its Affiliates, or to Third
Parties appointed by ARIAD US or its Affiliates, as the case may be. In
consideration of the licenses granted to ARIAD SWISSCO by ARIAD US under Section
2.1, ARIAD SWISSCO shall refrain from [***] in the Reserved Territory and/or
(ii) [***] to Customers located in any country within the Reserved Territory or
to Third Parties with the knowledge that such Third Party may be intending to
sell the Product into the Reserved Territory. Without limiting the foregoing,
ARIAD SWISSCO shall use Commercially Reasonable Efforts to refrain from the
following activities solely with respect to the Product, except for permitted
activities under this Agreement:

 

(a)sales or marketing visits or details in the Reserved Territory;

 

(b)direct mail, including the sending of unsolicited e-mails, to persons or
entities located in the Reserved Territory;

 

(c)advertising in media, on the internet or other promotions, where such
advertising or promotion is specifically targeted at potential purchasers in the
Reserved Territory;

 

(d)online advertisements addressed to potential purchasers in the Reserved
Territory and other efforts specifically designed to be found by potential
purchasers in the Reserved Territory, including the use of in the Reserved
Territory based banners on Third Party websites and paying a search engine or

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  19

 

 

online advertisement provider to have advertisements or higher search rankings
displayed specifically to potential purchasers outside in the Reserved
Territory; and

 

(e)advertising or promotion in any form, or translation of ARIAD SWISSCO’s
website into a language other than an official language of any country forming
part of the Territory, that in each case ARIAD SWISSCO would not reasonably
carry out but for the likelihood that it will reach potential Customers in
countries in the Reserved Territory.

 

Notwithstanding the foregoing, if an activity is occurring as of the Effective
Date, it shall not be a breach of this Section 3.1 if it continues after the
Effective Date.

 

3.2For purposes of clarity, Development of the Compound and/or Product for and
Commercialization of the Product in the Territory are reserved exclusively to
ARIAD SWISSCO or its Affiliates, or to Third Parties appointed by ARIAD SWISSCO
or its Affiliates, as the case may be. ARIAD US shall refrain from (i) [***]
and/or (ii) [***] to Customers located in any country within the Territory or to
Third Parties [***]. Without limiting the foregoing, ARIAD US shall use
Commercially Reasonable Efforts to refrain from the following activities solely
with respect to the Compound and Product, except for permitted activities under
this Agreement:

 

(a)sales or marketing visits or details in the Territory;

 

(b)direct mail, including the sending of unsolicited e-mails, to persons or
entities located in the Territory;

 

(c)advertising in media, on the internet or other promotions, where such
advertising or promotion is specifically targeted at potential purchasers in the
Territory;

 

(d)online advertisements addressed to potential purchasers in the Territory and
other efforts specifically designed to be found by potential purchasers in the
Territory, including the use of in the Territory based banners on Third Party
websites and paying a search engine or online advertisement provider to have
advertisements or higher search rankings displayed specifically to potential
purchasers outside in the Territory; and

 

(e)advertising or promotion in any form, or translation of ARIAD US’ website
into a language other than an official language of any country forming part of
the Reserved Territory, that in each case ARIAD US would not reasonably carry
out but for the likelihood that it will reach potential Customers in countries
in the Territory.

 

3.3Competitive Product.

 

3.3.1As of the Effective Date and for [***] thereafter, neither Party nor its
Affiliates shall research (other than [***], which may be conducted worldwide),
develop, register, file for registration, manufacture, purchase, sell, promote,
distribute, commercialize or otherwise exploit any Competitive Product in the
Field anywhere in the Territory nor enable or

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  20

 

 

authorize any Third Party to do so. The foregoing shall not preclude either
Party from conducting research related to [***] that are not [***]; provided
that any such research shall not continue should such [***] become [***].

 

3.3.2Notwithstanding Section 3.3.1, if a Party or any of its Affiliates, either
as a result of a merger, acquisition, change of control or similar transaction
(including an acquisition of assets) (the “Transaction”) acquires (such Party
being referred to as the “Acquiring Party”) or is acquired (such Party being
referred to as the “Acquired Party”) by or otherwise merges with an entity that
owns, has a license to, or a right to distribute, a Competitive Product that
would otherwise result in a violation of Section 3.3.1, then the following shall
apply:

 

(a)The Acquiring Party shall (i) promptly, and in any event no later than [***]
following the date of the Transaction, notify the other Party in writing of the
Transaction and the Competitive Product, (ii) promptly [***] the Competitive
Product, and (iii) divest, or cause its relevant Affiliate to divest, all rights
(including distribution rights) to the Competitive Product in accordance with
this Section 3.3.2. The Acquiring Party shall promptly, and in any event no
later than [***] following the date of the Transaction, notify the other Party
that it or its Affiliate, as the case may be, intends to undertake good faith
efforts to divest the Competitive Product, such divestiture shall be completed
within [***] after the date of the Transaction and shall occur by (1) a
termination of or an outright sale or assignment to a Third Party of all of the
Acquiring Party’s or its Affiliate’s rights and interest in and to the
Competitive Product (including all rights under any contract, such as a license
or distribution agreement) or (2) an out license arrangement under which the
Acquiring Party and its Affiliates have no ongoing involvement in the
development or commercialization of the Competitive Product and derive no
material ongoing financial return following the effective date of divestiture
and no financial benefit tied to sales or success of the divested Competitive
Product. Should such divestiture not have occurred with respect to any country
in the Territory within such [***] period, and provided that the Acquiring Party
has been using good faith efforts to divest the owned Competitive Product in
such country during such [***] period, then the Acquiring Party shall
discontinue (and cause its Affiliates to discontinue) developing or
commercializing the Competitive Product (i.e., withdraw the Competitive Product
and/or the relevant marketing authorization and, to the extent applicable, cease
all promotion, marketing and other commercialization activities with respect to
the Competitive Product) in such country.

 

(b)If the Acquired Party is ARIAD US, it shall (i) promptly, and in any event no
later than [***] following the date of the Transaction, notify ARIAD SWISSCO in
writing of the Transaction and the Competitive Product, (ii) promptly [***] the
Competitive Product, and (iii) either (A) continue such [***] for the remainder
of the Term or (B) divest, or cause its relevant Affiliate to divest, all rights
(including

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  21

 

 

distribution rights) to the Competitive Product in the Territory. ARIAD US shall
promptly, and in any event no later than [***] following the date of the
Transaction, notify ARIAD SWISSCO that it or its Affiliate, as the case may be,
intends to (x) continue such [***] for the remainder of the Term or (y)
undertake good faith efforts to divest the Competitive Product, such divestiture
to be completed within [***] after the date of the Transaction and to occur by
(1) an outright sale or assignment to a Third Party of all of ARIAD US’s or its
Affiliate’s rights and interest in the Territory in and to the Competitive
Product (including all rights under any contract, such as a license or
distribution agreement), or (2) an out license arrangement.

 

(c)If the Acquired Party is ARIAD SWISSCO, it shall (i) promptly, and in any
event no later than [***] following the date of the Transaction, notify ARIAD US
in writing of the Transaction and the Competitive Product, (ii) promptly [***]
the Competitive Product, and (iii) divest, or cause its relevant Affiliate to
divest, all rights (including distribution rights) to either the Product or the
Competitive Product in the Territory. ARIAD SWISSCO shall promptly, and in any
event no later than [***] following the date of the Transaction, notify ARIAD US
that it or its Affiliate, as the case may be, intends to undertake good faith
efforts to divest either the Product or the Competitive Product, such
divestiture to be completed within [***] after the date of the Transaction and
to occur by (1) an outright sale or assignment to a Third Party of all of ARIAD
SWISSCO’s or its Affiliate’s rights and interest in the Territory in and to the
Product or the Competitive Product, as the case may be (including all rights
under any contract, such as a license or distribution agreement), or (2) an out
license arrangement.

  

3.4Nothing in this Agreement shall be construed as prohibiting either Party or
any of their respective Affiliates either themselves or through a Third Party
from developing or commercializing any Excluded Compound in any field anywhere
in the world.

 

3.5Nothing in this Agreement shall be construed as giving ARIAD SWISSCO any
right to use or otherwise exploit the Know-how, the Patents, the ARIAD US
Trademarks, ARIAD US’s other Intellectual Property Rights in the Compound or
Product and/or any other information received hereunder for purposes other than
to perform ARIAD SWISSCO’s obligations and exercise its rights under this
Agreement, including for purposes of meeting its responsibilities as the MAH in
the Territory, solely in accordance with the terms and conditions of this
Agreement. Except as expressly set forth in this Agreement, neither Party grants
to the other Party any right or license to any of its Intellectual Property
Rights.

 

3.6The Parties acknowledge and agree that the restrictions imposed on and
accepted by the Parties in this ARTICLE 3 are restrictions that each Party has
independently and unilaterally determined are necessary in order to protect such
Party’s Intellectual Property Rights and ensure such Party is able to
effectively commit and apply its skills, resources, networks and qualified
personnel so that the other Party may comply with and perform its obligations
under this Agreement.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  22

 

 

ARTICLE 4 – DEVELOPMENT AND COMMERCIALIZATION COMMITTEES

 

4.1Joint Steering Committee. The Parties shall, within [***] of the Effective
Date, establish a Joint Steering Committee (the “JSC”), comprised of three (3)
representatives of ARIAD US and three (3) representatives of ARIAD SWISSCO. The
JSC shall be co-chaired by a representative of each of ARIAD US and ARIAD
SWISSCO.

 

4.2General Responsibilities. The JSC shall coordinate and monitor progress of
the activities taking place under this Agreement.

 

4.3Development-Related Responsibilities. The JSC shall coordinate, liaise,
review and discuss matters related to the Development of the Product in the
Territory, the Reserved Territory and the Global Studies to be undertaken in
accordance with this Agreement. Without limitation to the generality of the
foregoing, it shall prepare and approve annual (or, if needed, more frequent)
updates and revisions to the Development Register, will discuss and attempt to
resolve disagreements escalated by any subcommittees or project teams that may
be set up from time to time to discuss any specific issues in relation to
Development and assume such other responsibilities as are set forth in this
Agreement, or as mutually agreed in writing by duly authorized representatives
of the Parties from time to time.

 

4.4Commercialization-related Responsibilities. The JSC shall establish a
subcommittee called Joint Commercialization Committee (“JCC”) to coordinate the
activities of the Parties in connection with Commercialization of the Product in
the Territory and the Reserved Territory in accordance with the terms of this
Agreement. Without limitation to the generality of the foregoing, the JSC will
discuss and attempt to resolve disagreements escalated by JCC and assume such
other responsibilities as are set forth in this Agreement with regard to
Commercialization, or as mutually agreed in writing by duly authorized
representatives of the Parties from time to time. For clarity, [***] shall be
[***], to [***] in the Territory, including the [***] Third Parties with respect
to the sale of the Product in the Territory and neither [***] shall have any
right to [***].

 

4.5Committee Administration.

 

4.5.1Subcommittees. The JSC may form subcommittees or project teams as it deems
appropriate to fulfill its responsibilities. The Parties intend to establish
joint pharmacovigilance (PV) and supply chain subcommittees or project teams as
soon as practicable after the Effective Date in order to facilitate discussions
and coordination of the Parties’ efforts and activities relating to Product PV
and manufacture, supply and quality assurance (including Manufacture) under this
Agreement. If a subcommittee or project team cannot reach agreement on any
matter within its remit, such matter shall be submitted to the JSC for
discussion and resolution prior to any further dispute resolution action being
taken.

 

4.5.2Changes to Representatives. A Party may change any one or more of its
representatives to the JSC or to a subcommittee or project team at any time upon
written notice to the other Party. The number of representatives

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  23

 

 

appointed by each Party to the JSC or to a subcommittee or project team may be
modified by mutual agreement of the Parties; provided, that at all times the
number of representatives from each Party shall be equal.

 

4.5.3Schedule and Minutes. The representatives of the JSC shall mutually agree
on the schedule for meetings, provided that there shall be at least one (1)
meeting per calendar quarter. Either Party may schedule an emergency meeting of
the JSC upon reasonable advance written notice to the other Party. A
representative of the Party hosting a meeting of the JSC shall serve as
secretary of that meeting. The secretary of the meeting shall prepare and
distribute to all members of the JSC: (a) agenda items at least [***] in advance
of the applicable meeting and (b) draft minutes of the meeting within [***]
following the meeting to allow adequate review and comment. Such minutes shall
provide a description in reasonable detail of the discussions held at the
meeting and a list of any actions, decisions or determinations approved by the
JSC. Minutes of the JSC meeting shall be approved or disapproved, and revised as
necessary, within [***] after their initial circulation in draft form. Minutes
for any subcommittees shall be prepared in the same manner and in accordance
with the same timelines. The final minutes of any subcommittee shall be provided
to the JSC.

 

4.5.4Location and Attendance. The location of JSC meetings shall alternate
between ARIAD US’s principal place of business and ARIAD SWISSCO’s principal
place of business, or as otherwise agreed by the Parties. The JSC may also meet
by means of telephone conference call or videoconference, provided that at least
one (1) meeting per calendar year shall be held in person. Each Party shall use
reasonable efforts to cause its representatives to attend JSC meetings. If a
Party’s representative to the JSC or any subcommittee is unable to attend a
meeting, such Party may designate an alternate to attend such meeting in place
of the absent representative. In addition, each Party may, at its discretion,
invite non-voting employees, and, with the consent of the other Party,
consultants or scientific advisors, to attend JSC meetings.

 

4.6Alliance Managers. Each Party shall appoint a business representative who
possesses a general understanding of the relevant technical, business and legal
issues to act as its Alliance Manager (each, an “Alliance Manager”).  The
Alliance Managers shall be responsible for creating and maintaining
collaborative, efficient and responsive communication within and between the
Parties, and for day-to-day management of operational matters other than matters
within the remit of the JSC. The Alliance Managers shall have no authority to
modify this Agreement or waive any non-compliance with its terms. Alliance
Managers may attend JSC and subcommittee meetings as observers.

 

4.7Decision Making Process.

 

4.7.1Development. For clarity, the veto rights set out in Sections 5.6 and 5.7.2
are to be exercised by the Parties but [***] pursuant to the first sentence of
Section 29.2 and are not subject to [***].

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  24

 

 

4.7.2Commercialization. In the event of any dispute relating to
Commercialization of the Product in a Party’s respective territory, the first
sentence of Section 29.2 shall apply. If [***] are not able to agree upon such
dispute, [***] shall have the final decision in relation to the Reserved
Territory and [***] shall have the final decision in relation to the Territory.

 

ARTICLE 5 – DEVELOPMENT

 

5.1Development Liaison. ARIAD US and ARIAD SWISSCO shall use good faith efforts
to coordinate and liaise, through the JSC, concerning continued Development of
the Product with respect to (i) Development being Global Studies, Ongoing
Studies and Proposed Studies and (ii) each Party’s separate plans for
Development in its respective territory. Each Party will disclose its
Development activities, Ancillary Research activities and Basic Research
activities, giving updates at each JSC meeting. The Proposed Studies and, if a
Party does not veto a clinical study under Sections 5.6 or 5.7.2, the clinical
studies the subject of (ii), in each case once initiated, shall be listed in a
Development register (“Development Register”) maintained by the JSC. The
Development Register shall be updated by the JSC as required to reflect changes
and additions to include all new clinical studies performed under this
Agreement. As of the Effective Date, the Development Register lists only the
Ongoing Studies.

 

5.2Registration of the Product in Territory. ARIAD SWISSCO shall, or shall
procure that its Sublicensees shall, [***], use Commercially Reasonable Efforts
to seek Registration of the Product in the Territory taking into account the
countries in which it has not obtained Registration as of the Effective Date. If
ARIAD US applies for a Marketing Authorization (or equivalent) of the Product in
the U.S. for a New Indication, ARIAD US will disclose full details at the JSC
and may request that ARIAD SWISSCO seek Registration of the Product for the New
Indication in the Territory using the Development Data provided by ARIAD US (if
not already available to ARIAD SWISSCO under the terms of this Agreement. ARIAD
SWISSCO will consider such request in good faith, including analyzing the
commercial viability of Commercializing the Product with the New Indication in
the Territory. ARIAD SWISSCO will share the results of this analysis with JSC.
ARIAD US will provide reasonable assistance as appropriate to and requested by
ARIAD SWISSCO as it conducts such analysis. The final decision regarding whether
to seek registration for such New Indication in the Territory, or at least some
countries of the Territory, shall be in [***] sole discretion.

 

5.3Ongoing Studies.

 

5.3.1ARIAD US shall be responsible for the conduct of the Ongoing Studies. For
clarity, if the Ongoing Studies are Global Studies they are not subject to
Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party
Development Costs incurred by ARIAD US in the Ongoing Studies, subject to a
maximum aggregate amount of US$7,000,000 for the period from the Effective Date
until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together,
the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual,
undisputed Third Party Development Costs quarterly within [***] of receipt of
ARIAD US’s

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  25

 

 

quarterly invoice and supporting evidence of the Third Party Development Costs
having been incurred. Payment shall be made into such bank account as ARIAD US
shall specify from time to time. For the period ending [***], no invoice shall
be in excess of [***] (provided that for [***] in which the Effective Date
occurs the invoice shall be for a pro-rated amount) and no invoice shall be
delivered before [***]. For clarity if a [***] invoice during the calendar year
ending [***] does not include the maximum of [***] any excess may be included in
a subsequent invoice for calendar year [***], provided however that no excess at
the end of the calendar year [***] may be rolled over to the calendar year
[***]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is
terminated prior to [***], then the maximum aggregate amount owed by ARIAD
SWISSCO with effect from the date of termination of the relevant Ongoing Study,
shall be [***] of the remaining Ongoing Studies Budget. If both the OPTIC
Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [***],
then no further amounts will be payable by ARIAD SWISSCO after the date of
termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical
Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD
US (i) [***] and (ii) [***] upon either (a) [***]; or (b) [***]. For clarity,
[***] will not be [***] in the event of [***]. For clarity, [***] will not be
[***]. For clarity, ARIAD US shall continue to control the conduct of the
Ongoing Studies and shall continue to be listed as the sponsor until completion.
ARIAD US will be responsible for collection and reporting of all serious adverse
events from these trials to the regulatory agencies in which the trials are
being conducted. No amounts will be due under this Section 5.3.1 and payable by
ARIAD SWISSCO if the Buy-Back Option has been exercised.

 

5.3.2In relation to the OPTIC Clinical Trial, ARIAD US shall pay to ARIAD
SWISSCO on calendar [***] basis an amount equal to (i) the number of patients
greater than [***] enrolled (the “Target Enrollment”) in the OPTIC Clinical
Trial in countries in the Territory in which the Product has a Marketing
Authorization multiplied by (ii) [***], multiplied by (iii) [***]. ARIAD US may
deduct [***] from the amount of such payment and pay the net amount to ARIAD
SWISSCO. Such payments shall be made within [***] after the end of each [***]
for amounts accrued in such [***]. If the OPTIC Clinical Study projected
enrollment of [***] subjects is changed, the Target Enrollment shall be adjusted
proportionally.

 

5.3.3ARIAD US shall provide to ARIAD SWISSCO within [***] of the end of each
calendar month, [***] for the Ongoing Studies (other than the Optic 2L Clinical
Trial, for which reports shall be provided quarterly) including the following
for such calendar month: [***]. In addition, ARIAD US shall within [***] of
receipt, provide ARIAD SWISSCO with copies of all (i) material communications
and safety reports to or from Regulatory Authorities and minutes from meetings
with Regulatory Authorities related to the Ongoing Studies and (ii) any related
material post-marketing requirements communications to or from Regulatory
Authorities. Subject to ARIAD SWISSCO making the applicable payments due to
ARIAD US

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  26

 

 

under Section 5.3.1 ARIAD SWISSCO shall have the right to use all Development
Data (including any needed right of reference) from the Ongoing Studies as
necessary or useful for Registration in the Territory.

 

5.3.4ARIAD US shall report the results of each of the Ongoing Studies to ARIAD
SWISSCO by sending a substantially complete draft of the CSR as soon as
practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within
[***] of database lock for the applicable study. ARIAD SWISSCO will provide
ARIAD US with any comments within [***] of its receipt of the draft of the final
CSR. ARIAD US shall consider in good faith such comments, but it shall be in the
sole discretion of ARIAD US whether to make changes to CSR Report to accommodate
ARIAD SWISSCO comments. If the final CSR for the OPTIC 2L Clinical Trial
demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall
submit a variation application to the Regulatory Authority to support the
approval of the Second Line CML indication within [***] of ARIAD SWISSCO’S
receipt of the final CSR.

 

5.3.5Should ARIAD US elect to discontinue one or more of the Ongoing Studies,
ARIAD US shall promptly, but in all cases prior to such discontinuance, notify
ARIAD SWISSCO of such decision.

 

5.4Proposed Studies. ARIAD US may in its sole discretion commence and conduct
the Proposed Studies and the provisions of Sections 5.6 or 5.7.2 shall not apply
to the Proposed Studies but otherwise all provisions of this ARTICLE 5 shall
apply as appropriate to a Proposed Study. ARIAD US shall submit for discussion
by the JSC the draft and final detailed budget, draft and final protocol and
overview of the clinical trial design prior to study initiation. ARIAD US shall
report the results of each of the Proposed Studies to ARIAD SWISSCO by sending a
substantially complete draft of the CSR as soon as practicable and a copy of the
draft of the final CSR to ARIAD SWISSCO within six (6) months of database lock
for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments
within fifteen (15) days of its receipt of the draft of the final CSR. ARIAD US
shall consider in good faith such comments but it shall be in the sole
discretion of ARIAD US whether to make changes to CSR Report to accommodate
ARIAD SWISSCO comments.

 

5.5Territory and Reserved Territory Specific Development. If ARIAD SWISSCO or
Sublicensee wishes to carry out Development activity comprising a clinical study
that is proposed to be conducted solely at clinical research sites in the
Territory, then ARIAD SWISSCO shall submit for consideration by the JSC the
proposed detailed budget, protocol and clinical trial design. If ARIAD US,
either itself or through an Affiliate wishes to carry out Development activity
comprising a clinical study that is proposed to be conducted solely at clinical
research sites in the Reserved Territory, then ARIAD US shall provide the JSC
with the proposed detailed budget, protocol and clinical trial design. Subject
to Section 5.6, both Parties shall be entitled to carry out such Development
activity and the provisions of Section 5.7.3 and 5.9 shall apply mutatis
mutandis to this Section 5.5.

 

5.6Territory and Reserved Territory Veto Right. In connection with any clinical
study proposed to be conducted by the Developing Party pursuant to Section 5.5,
the

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  27

 

 

Non-Developing Party shall have the right, by providing written notice to the
Developing Party of the grounds for such objections, to object to the study
taking place on the grounds that, in its reasonable opinion, the protocol design
is reasonably likely to create a safety risk or otherwise have a material
adverse impact on the Commercialization of the Product in the Non-Developing
Party’s territory. In the event of dispute on this subject, either Party shall
have the right to escalate the matter by written notice to the other Party
(“Escalation Notice”). The Senior Officers of both Parties shall use good faith
efforts to resolve any matter referred to them as soon as practicable. Any final
decision that the Senior Officers mutually agree to in writing shall be
conclusive and binding on the Parties. If the Senior Officers fail to resolve
the dispute, the decision of the Non-Developing Party shall be final on all
issues.

 

5.7Global Studies.

 

5.7.1If, after the Effective Date, either Party proposes to undertake a Global
Study, then it shall provide the JSC with the (i) proposed detailed budget,
protocol and clinical trial design, details of the sites and the key
investigators, (ii) a detailed breakdown and budget of the proposed Development
Costs and (iii) any other relevant information and plans relating to such study,
including template patient consent forms that are reasonably requested by the
other Party.

 

5.7.2Veto of Global Studies. In connection with any Global Study proposed to be
conducted by the Developing Party, the Non-Developing Party shall have the
right, by providing written notice to the Developing Party of the grounds for
such objection, to object to the study taking place on the grounds that, in its
reasonable opinion, the protocol design or conduct of the Global Study is
reasonably likely to create a safety risk or otherwise have a material adverse
impact on the Commercialization of the Product in the territory of the
Non-Developing Party. In the event of dispute on this subject, either Party may
refer the matter for escalation to the Senior Officers under the procedures in
Section 5.6. If the Senior Officers fail to resolve the dispute, the decision of
the Non-Developing Party shall be final on all issues.

 

5.7.3Subject to the veto right set out in Section 5.7.2, the Non-Developing
Party shall determine if it wishes to co-fund the Global Study by electing to
[***] and shall confirm such determination by notice in writing to the other
Party. The Developing Party shall be sponsor of any such co-funded Global Study.
Subject to the Pharmacovigilance Agreement, the Developing Party will be
responsible for ensuring the collection and reporting of all serious adverse
events from these trials to the regulatory agencies in countries and territories
in which the co-funded global trials are being conducted. In relation to such
Global Study, the Development Costs will be [***] ARIAD US and ARIAD SWISSCO.
Each Party shall have the right to the Development Data from such Global Study
as more particularly set out in Sections 5.11 and ARTICLE 6. No amounts under
this Section 5.7.3 will be due and payable by ARIAD SWISSCO if the Buy-Back
Option has been exercised.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  28

 

 

5.7.4Subject to the veto right set out in Section 5.7.2, if the Non-Developing
Party does not wish to co-fund pursuant to Section 5.7.3, the Developing Party
shall have the right to conduct the Global Study [***]. To the extent that the
study is being conducted in an on-label indication, the Developing Party shall
pay to the Non-Developing Party on calendar quarter basis an amount equal to (i)
[***], multiplied by (ii) [***], multiplied by (iii) [***]. If ARIAD US is the
Developing Party, it may deduct [***] from the amount of such payment and pay
the net amount to ARIAD SWISSCO. Such payments shall be made within [***] after
the end of each [***] for amounts accrued in such [***]. For purposes of
clarity, the payments under this Section 5.7.4 shall apply to any of the
Proposed Studies that are Global Studies.

 

5.8If either Party proceeds with a Global Study under Section 5.7.4, the
Developing Party shall, at least quarterly, provide to the Non-Developing Party
a detailed written report (which obligation may be satisfied by means of reports
prepared by or for the Developing Party for internal use) that includes the
then-current development status, the results achieved, the problems being
encountered, summary of material clinical data generated, Development Costs
incurred and other pertinent information relating to the Global Study. For each
Global Study, the Developing Party shall provide to the Non-Developing Party a
substantially complete draft of the CSR as soon as practicable and a draft of
the final CSR within [***] of database lock for the study. The Non-Developing
Party will provide the Developing Party with comments within [***] of its
receipt of the draft final CSR. The Developing Party shall consider in good
faith such comments but it shall be in the sole discretion of the Developing
Party whether to make changes to CSR Report to accommodate the Non-Developing
Party comments. The Developing Party shall send a copy of the final CSR of the
Global Study to the Non-Developing Party in the form of a written notice.

 

5.9The Non-Developing Party shall, at any time prior to [***] after the final
CSR of a Global Study is issued, have the right, by giving written notice to the
Developing Party exercising this right, to use the Development Data from such
Global Study in relation to Registration in its territory, provided that the
Non-Developing Party reimburses the Developing Party [***] of the Developing
Party’s Third Party Development Costs incurred in the conduct of such Global
Study to date and continues to pay directly, or reimburse to the Developing
Party on a [***] basis, [***] of the Third Party Development Costs paid for the
conduct of such Global Study. The Non-Developing Party shall have the right, at
reasonable times during business hours and upon reasonable notice to the
Developing Party to access the Developing Party’s books, records and accounts
for inspection and audit by the Non-Developing Party or its Affiliates or their
respective duly authorized representatives or by an independent auditor to be
nominated by the Non-Developing Party and reasonably acceptable to the
Developing Party, to ensure the accuracy of all reports and payments made
hereunder and in respect of all Development Costs. Such audit shall be covered
by confidentiality obligations of the auditor. No amounts under this Section 5.9
will be due and payable by ARIAD SWISSCO if the Buy-Back Option has been
exercised.

 

5.10Each Party hereby acknowledges and agrees that neither Party makes any
warranty, and nothing in this Agreement may or shall be construed as a warranty
by either

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  29

 

 

Party, that the Product will obtain Registrations in any or all of the countries
in or outside the Territory and neither Party shall have claims against the
other Party arising out of any delay or refusal by Regulatory Authorities to
issue Registrations or to issue Registrations that are acceptable to the Parties
in or outside the Territory.

 

5.11Each Party shall own all title right and interest in and to all Development
Data generated by them from Development activity in their respective territory
and in relation to Global Studies in relation to which they have been the
Developing Party. Access and the right to use Development Data for the other
Party is governed by this ARTICLE 5.

 

5.12ARIAD US shall own all ARIAD US Improvements and ARIAD SWISSCO shall own all
ARIAD SWISSCO Improvements. ARIAD SWISSCO is licensed to use ARIAD US
Improvements on the terms of the license set out in Section 2.1. Throughout the
Term, ARIAD US shall supply ARIAD SWISSCO with all ARIAD US Improvements that
are necessary or useful for ARIAD SWISSCO to Develop, use, Commercialize,
Manufacture Product in the Territory in accordance with this Agreement.
Notwithstanding the foregoing, nothing in this Agreement shall require ARIAD US
to develop additional Know-how or to obtain additional Know-how from Third
Parties. Subject to the terms and conditions of this Agreement, including
payment under Sections 5.7.3 and 5.9, ARIAD SWISSCO shall have the right to use,
cross-reference, file or incorporate by reference any Development Data disclosed
to ARIAD SWISSCO by or on behalf of ARIAD US or its Affiliates relating to the
Product for purposes of performing under this Agreement, including in order to
support any regulatory filings relating to the Product and in interactions with
any Regulatory Authority in connection with the development and Registration of
the Product in the Territory.

 

5.13ARIAD SWISSCO shall promptly disclose to ARIAD US all ARIAD SWISSCO
Improvements resulting from Development or Manufacturing activities conducted by
ARIAD SWISSCO or its Sublicensees or Subcontractors pursuant to this Agreement.
ARIAD US shall have a perpetual, irrevocable, exclusive license under the
Intellectual Property Rights covering such ARIAD SWISSCO Improvements and
Ancillary Research of ARIAD SWISSCO to use the same in any way whatsoever in the
Reserved Territory (subject to the other terms of this Agreement) [***] provided
always that in the case of ARIAD SWISSCO Improvements directly resulting from
studies conducted in the Territory by ARIAD SWISSCO or from Global Studies
conducted by them where ARIAD US has first paid to use the corresponding
Development Data.

 

5.14Each Party shall ensure that all necessary notifications are made and/or
necessary consents are obtained and/or agreements are entered into, under
applicable data protection or privacy regulations in its respective territory
such that all personal information obtained in the course of the conduct of
development activities under this Agreement by either Party, its respective
Affiliates or any Third Party subcontractor of such Party can be lawfully
processed including being transmitted to, and used by, the other Party and its
Affiliates for development work relating to the Compound and/or the Product as
provided for in this Agreement.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  30

 

 

ARTICLE 6 - EXCHANGE OF OTHER KNOW-HOW

 

6.1Subject to the terms and conditions of this Agreement, throughout the Term
and/or upon either Party’s reasonable request, each Party shall supply the other
in writing or by any other appropriate means at JSC meetings commercial and
medical affairs information and data relating to the Product to the extent it is
Controlled by the disclosing Party or its Affiliates, including relevant market
analyses and assessments of the competitive landscape for the Product, and,
subject to Applicable Laws, any patient or physician feedback relating to
Product. The receiving Party shall be free to use such information and data for
the purpose of its business and to disclose the same to its Affiliates and
distributors in the Territory (if ARIAD SWISSCO is the receiving Party) or in
the Reserved Territory (if ARIAD US is the receiving Party), provided that no
Confidential Information pertaining to the disclosing Party’s business shall be
disclosed by the receiving Party to such other distributors.

 

6.2Beginning immediately after the Effective Date, ARIAD US shall [***], effect
a [***] to ARIAD SWISSCO or its designee (which designee may be an Affiliate or
a Third Party manufacturer) of all Know-How and any other information regarding
Intellectual Property Rights of ARIAD US and its Affiliates relating to the
then-current process for the [***] and [***] (the “Current Manufacturing
Process”) and to implement the Current Manufacturing Process at facilities
designated by ARIAD SWISSCO (such transfer and implementation, as more fully
described in this Section 6.2, the “Manufacturing Technology Transfer”). ARIAD
US shall provide, and shall cause its Affiliates and Third Party manufacturers
to provide, [***] to enable ARIAD SWISSCO (or its Affiliate or designated Third
Party manufacturer, as applicable) to implement the Current Manufacturing
Process at the facilities designated by ARIAD SWISSCO. If requested by ARIAD
SWISSCO, such assistance shall include [***]. Without limitation to the
foregoing, in connection with each Manufacturing Technology Transfer, ARIAD US
shall, and shall cause its Affiliates and Third Party manufacturers to:

 

6.2.1make available to ARIAD SWISSCO (or its Affiliate or designated Third Party
manufacturer, as applicable) from time to time as ARIAD SWISSCO may request, all
[***] of ARIAD US and its Affiliates relating to the Current Manufacturing
Process, and all [***], that are reasonably necessary or useful to enable ARIAD
SWISSCO (or its Affiliate or designated Third Party manufacturer, as applicable)
to use and practice the Current Manufacturing Process;

 

6.2.2cause [***] to assist with the working up and use of the Current
Manufacturing Process and with the [***] to the extent reasonably necessary or
useful to enable ARIAD SWISSCO (or its Affiliate or designated Third Party
manufacturer, as applicable) to use and practice the Current Manufacturing
Process;

 

6.2.3Without limiting the generality of Section 6.2.2 above, cause appropriate
[***] and make available necessary [***], to support and execute the transfer of
all applicable analytical methods and the validation thereof (including, all
[***] of ARIAD US and its Affiliates relating to the Current Manufacturing
Process, [***]);

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  31

 

 

6.2.4take such steps as are reasonably necessary or useful to assist in [***]
with respect to the Manufacture of Product at the applicable facilities; and

 

6.2.5provide such other assistance as ARIAD SWISSCO (or its Affiliate or
designated Third Party manufacturer, as applicable) may reasonably request to
enable ARIAD SWISSCO (or its Affiliate or designated Third Party manufacturer,
as applicable) to use and practice the Current Manufacturing Process and
otherwise to Manufacture Product.

 

6.3Within [***] of the end of each [***] during the period of the [***] ARIAD US
shall report to ARIAD SWISSCO [***] incurred in such period, and shall invoice
ARIAD SWISSCO for the same. ARIAD SWISSCO shall pay each such invoice within
[***] of receipt of such invoice.

 

6.4Without limiting the foregoing, if ARIAD US or its Affiliates makes any
invention, discovery, or improvement relating to the Manufacture of Product
during the Term, ARIAD US shall, [***], promptly disclose such invention,
discovery, or improvement to ARIAD SWISSCO, and shall, at ARIAD SWISSCO’s
request, [***] with respect to such invention, discovery, or improvement in the
same manner as provided in Section 6.2. Neither Party will (nor cause its Third
Party Manufacturers to) implement any process improvement that may impact the
Specifications of the Product or the relevant sections of the Marketing
Authorization or that would require approval of any Regulatory Authority,
without the prior written approval of the other Party.

 

ARTICLE 7 – PRICING AND REIMBURSEMENT

 

7.1With respect to: (i) all countries within [***] and (ii) each country outside
[***] in the Territory if a Marketing Authorization of the Product has been
obtained in each such country in the Territory, ARIAD SWISSCO shall use
Commercially Reasonable Efforts to obtain Pricing and Reimbursement Approval in
such countries as soon as reasonably possible.

 

7.2In accordance with Applicable Law, the Parties shall discuss and exchange
information and documentation (including health economic data, analyses and
argumentation) to develop and support the pricing and reimbursement strategy for
the Product within the Territory. ARIAD SWISSCO shall provide ARIAD US with
periodic updates and, upon reasonable request, copies of material communications
with, and submissions to, pricing and reimbursement authorities with respect to
Products in the Field in the Territory. For clarity, ARIAD SWISSCO shall be
solely responsible for determining the actual selling price to Customers and all
other conditions of sale in the Territory.

 

ARTICLE 8 – REGULATORY MATTERS

 

8.1Marketing Authorizations.

 

8.1.1ARIAD SWISSCO shall oversee, monitor and coordinate all regulatory actions,
communications and filings with, and submissions to, Regulatory Authorities with
respect to Products in the Field in the Territory. ARIAD

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  32

 

 

US shall provide ARIAD SWISSCO with reasonable assistance, information, and
access to ARIAD US’s personnel, to support ARIAD SWISSCO’s or the relevant ARIAD
SWISSCO Sublicensees’ applications for Marketing Authorizations and other
interactions with Regulatory Authorities in the Territory relating to Product
and ARIAD SWISSCO shall reimburse ARIAD US for [***] in connection therewith.
Each Party shall use appropriately qualified personnel for such activities,
including personnel with local regulatory expertise. In accordance with its
responsibilities as the MAH in the Territory, ARIAD SWISSCO or the relevant
ARIAD SWISSCO Sublicensee shall act as the authorized contact for the Regulatory
Authorities in the Territory in connection with obtaining and maintaining
Marketing Authorizations (subject to ARIAD US’s involvement as provided in
Section 8.3), as well as in connection with the Development, Manufacturing (if
applicable) or Commercialization of the Product. [***].

 

8.1.2ARIAD US shall be responsible for maintaining the Company Core Data Sheet
(“CCDS”) / Company Core Safety Information (“CCSI”) / core Risk Management Plan
(“RMP”) for the Product.  In the event that a change to the CCDS/CCSI/RMP
necessitates a change to the local labeling in a country within the Territory,
ARIAD SWISSCO shall be responsible for developing a proposed revised draft
product label or package insert for each country in the Territory.  ARIAD US
shall provide ARIAD SWISSCO with information and reasonable access to ARIAD US’s
personnel, to support ARIAD SWISSCO’s changes to the Marketing Authorizations to
modify the revised draft labeling provided that ARIAD SWISSCO shall reimburse
ARIAD US for [***]. ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee
shall promptly submit a change to applicable Marketing Authorizations in the
Territory to modify the labeling.

 

8.2Subject to Section 4.7, ARIAD SWISSCO shall review and approve the
prescribing information, label and final packaging of the Product for the
Territory to be submitted in connection with applications for Marketing
Authorizations, and shall subsequently review and approve any modifications
thereto required by a Regulatory Authority or proposed by either Party. ARIAD
SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall prepare and submit the
relevant documentation related to Marketing Authorizations and other
Registrations in compliance with Applicable Laws.

 

8.3Each Party or its relevant Sublicensee or licensee (as applicable) shall
prepare for and conduct meetings with the local Regulatory Authorities for which
it is responsible in consultation with the other Party, and shall, to the extent
such meetings are reasonably likely to be material to the other Party’s rights
and obligations under this Agreement:

 

(a)notify the other Party in advance of such planned scheduled interactions with
Regulatory Authorities relating to the Product and invite the other Party to
attend such interactions, at the other Party’s cost, if permitted by the
Regulatory Authority;

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  33

 

 

(b)notify the other Party of such spontaneous interactions with the Regulatory
Authorities relating to the Product as soon as reasonably possible after the
interaction;

 

(c)prepare meeting minutes of such interactions with Regulatory Authorities and
circulate the same to the other Party, accompanied by a translation into English
if the original minutes are not in English; and

 

(d)address such questions and requests from the Regulatory Authorities relating
to the Product following consultation with the other Party.

 

8.4Without limiting the foregoing, in connection with regulatory activities for
which a Party has responsibility or authority under this Agreement, each Party
or its relevant Sublicensee or licensee (as applicable) shall (i) provide
advance copies to the other Party’s representatives on the JSC of any proposed
material submission to, or material communication with, any Regulatory Authority
to the extent they relate to the Marketing Authorization or otherwise to the
Product, and shall consider in good faith, and accommodate when reasonably
appropriate, any requests by the other Party’s JSC representatives to make any
modification thereto, and (ii) keep the other Party fully and promptly informed,
throughout the Term, about all material communications received from the local
[***] concerning the Product and/or the Compound, including providing the other
Party with a copy of all such material communications (without translation) no
later than [***] after receipt by ARIAD SWISSCO and with a copy thereof
translated into English as soon as practicable thereafter. Without prejudice to
full compliance by both Parties with any obligations established by Applicable
Laws of each country in the Territory, any and all material communications to
local Regulatory Authorities concerning the Product as described above shall be
submitted by the responsible Party only after the relevant contents have been
discussed with and approved by the JSC; provided, however, that the responsible
Party shall not be required to delay any communication with or regulatory
submission to any applicable Regulatory Authority in a manner that affects the
responsible Party’s ability to comply with Regulatory Requirements or Applicable
Laws. The responsible Party shall provide English translation of all material
documents relating to the Product to be submitted by the responsible Party or
its Sublicensees or licensees (as applicable) to, or that are received by
responsible Party or its Sublicensees or licensees (as applicable) from,
Regulatory Authorities in a language other than English. On a semi-annual basis,
each Party shall provide the other Party with an itemized list of (a) all
material written communications received from the local Regulatory Authorities
concerning the Product during the prior [***] and (b) all material documents and
written communications relating to the Product submitted by such Party or its
Sublicensees or licensees (as applicable) to any Regulatory Authority during the
prior [***]. Upon the request of a Party, the other Party shall provide the
requesting Party with copies of any such communications or documentation
itemized on such list, including where reasonably requested, English
translations of all material communications or documentation. For clarity, (1)
any communications with Regulatory Authorities or documents submitted to
Regulatory Authorities that relate to Product quality shall not be governed by
this Section 8.4 and shall be subject to the Quality Agreements, and (2) any
communications with Regulatory Authorities or documents and written
communications submitted to

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  34

 

 

Regulatory Authorities that relate to pharmacovigilance shall not be governed by
this Section 8.4 and shall be subject to ARTICLE 9 until the Pharmacovigilance
Agreement becomes effective and thereafter shall be subject to the
Pharmacovigilance Agreement.

 

8.5If any material alterations, modifications or amendments of this Agreement or
modification of the Product are required to comply with the request of any
Regulatory Authority as prerequisites for the continuation of the Marketing
Authorization or the grant or the continuation of the Registration of the
Product, or if the Marketing Authorization or Registrations are suspended or
withdrawn by any said Regulatory Authority, each Party shall notify the other
Party immediately and the Parties shall use Commercially Reasonable Efforts to
agree upon a reasonable and mutually acceptable resolution thereof.

 

8.6ARIAD US may retain a copy of, and have ongoing access to, the Marketing
Authorization for the Product granted by the European Medicines Agency existing
as at the Effective Date, together with the certificates of pharmaceutical
product and full dossier relating thereto (the “EMA MA”) and to all supplements,
amendments and revisions occurring after the Effective Date (“EMA MA Updates”),
provided that in the case of any supplement, amendment or revision that is made
as a result of Development for which ARIAD US is to pay costs pursuant to
Sections 5.5, 5.7.3 or 5.9, then ARIAD US shall only receive such EMA MA Updates
provided ARIAD US has made such payments under Section 5.5, 5.7.3 or 5.9 (as
applicable). Subject to the foregoing, ARIAD SWISSCO, on behalf of itself and
its Affiliates, hereby grants to ARIAD US and its Affiliates a right of
reference, with the right to grant further rights of reference to ARIAD US
licensees of rights to register and commercialize the Product in the Reserved
Territory, under suchEMA MA and any EMA MA Updates, in each case to enable ARIAD
US and its Affiliates to exercise its rights and perform its obligations under
this Agreement and to register and commercialize the Product in the Reserved
Territory.

 

ARTICLE 9 – PHARMACOVIGILANCE

 

9.1ARIAD US shall own and manage the global safety database for the Product and
ARIAD US or its Affiliates shall be responsible for the timely reporting of all
relevant adverse drug reactions/experiences, including those associated with
Product quality complaints, and aggregate safety data relating to the Product,
outside the Territory. ARIAD US shall provide ARIAD SWISSCO with extracts from
the global safety database upon request of ARIAD SWISSCO. Reconciliation between
the data contained in the ARIAD SWISSCO and ARIAD US safety databases shall be
conducted periodically in accordance with the separate Pharmacovigilance
Agreement. ARIAD SWISSCO will procure that the MAH in each country within the
Territory shall be responsible for the timely reporting of all relevant post
marketing adverse drug reactions/experiences, including those associated with
Product quality complaints, and aggregate safety data relating to the Product,
in accordance with local pharmacovigilance legislation within the Territory.
ARIAD SWISSCO will have the right to independently audit the global safety
database to ensure that their MAH obligations can be fulfilled.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  35

 

 

9.2ARIAD US shall be responsible for global medical surveillance, risk
management, global medical literature review and monitoring, and responses for
the Product to the appropriate Regulatory Authorities outside the Territory.
ARIAD US shall be responsible for the interpretation, in light of ARIAD US’s
global pharmacovigilance data, of adverse events in the Territory of which ARIAD
US becomes aware, including adverse events reported to ARIAD US by ARIAD SWISSCO
or the relevant ARIAD SWISSCO Sublicensee. ARIAD SWISSCO will procure that the
MAH in each country in the Territory shall be responsible for local medical
surveillance, risk management, medical literature review and monitoring within
such country of the Territory, and responses to the appropriate Regulatory
Authorities within the Territory. ARIAD SWISSCO will procure that the MAH in
each country in the Territory shall provide an English-translated copy of the
final responses to Regulatory Authorities to ARIAD US.

 

9.3ARIAD SWISSCO shall, and shall procure each MAH in each country in the
Territory, implement and execute local Product-specific risk management
activities, in collaboration with ARIAD US’s PV department, that are aligned
with ARIAD US’s global risk management strategies.

 

9.4Further details of the Parties’ respective pharmacovigilance obligations and
responsibilities (e.g., signal management, case processing and reporting,
aggregate reporting, risk management, health authority responses, safety data
exchange, etc.) shall be set forth in a pharmacovigilance agreement that will be
agreed to by the Parties (and their respective Affiliate(s), as appropriate)
within [***] after the Effective Date (as it may be amended from time to time,
the “Pharmacovigilance Agreement”). In the event of a conflict between the terms
of the Pharmacovigilance Agreement and the terms of this Agreement, the
provisions of this Agreement shall govern; provided, however, that the
Pharmacovigilance Agreement shall govern in respect of pharmacovigilance,
including safety and risk management, matters.

 

9.5Prior to executing the Pharmacovigilance Agreement, the Parties agree to work
together in good faith to coordinate activities regarding pharmacovigilance with
respect to the Product in accordance with this ARTICLE 9, including by
exchanging standard operating procedures and other information relevant to such
pharmacovigilance activities as mutually agreed by the Parties. ARIAD US shall
provide ARIAD SWISSCO with access to all pharmacovigilance related standard
operating procedures (local and global) required in Territory and ARIAD SWISSCO
shall procure that such standard operating procedures shall remain in place and
be used by ARIAD SWISSCO until ARIAD SWISSCO transitions all pharmacovigilance
standard operating procedures in accordance with the Pharmacovigilance
Agreement. Without limiting the foregoing, prior to executing the
Pharmacovigilance Agreement, in the event ARIAD SWISSCO or the relevant ARIAD
SWISSCO Sublicensee receives reports of adverse drug reactions/experiences or
safety data relating to the Product (“Safety Information”) ARIAD SWISSCO shall
send the Safety Information to ARIAD US on source documents, or other mutually
agreed format, via email or fax as soon as practicable, but, in any event, after
it receives the Safety Information, and, in the event ARIAD SWISSCO or a
Sublicensee receives any information concerning any investigation, inquiry or
other action by any Regulatory Authority concerning the safety of the Product,
ARIAD SWISSCO shall send such information to ARIAD US via email or

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  36

 

 

fax as soon as possible, but in any event, after ARIAD SWISSCO receives notice
of such regulatory request, inquiry or other action. Neither Party shall respond
to any Regulatory Authority request or inquiry relating to the safety of the
Product without discussing the issue with the other Party to the extent
reasonably feasible in context of relevant timelines applicable to such
responses and to the extent reasonably likely that such responses would impact
the Marketing Authorization or be materially relevant for the Regulatory
Authorities in the other Party’s Territory.

 

ARTICLE 10 – SUPPLY, FORECASTS AND ORDERING

 

10.1As soon as practicable but no later than [***] after the Effective Date, the
Parties shall, through a project team or subcommittee of the JSC, negotiate in
good faith and agree on the terms of (i) a definitive agreement pursuant to
which ARIAD US shall Manufacture and supply (or have Manufactured and supplied)
Product as API or Unlabeled Bottles to ARIAD SWISSCO or its Affiliates for Final
Manufacture as needed for Commercialization in the Territory (“Supply
Agreement”) and (ii) a related Quality Agreement. Pending finalization of the
Supply Agreement, the transitional supply of Product shall be made on the terms
set out in Sections 10.2 to and including ARTICLE 14 and the terms of the
Interim Quality Agreement in place (“Transitional Supply Arrangements”). The
terms of the Transitional Supply Arrangements shall form the basis for the
Supply Agreement and Quality Agreement.

 

10.2Product shall be supplied and may be ordered and Manufactured as follows:

 

10.2.1At any time during the Term until ARIAD SWISSCO commences [***], ARIAD US
will supply [***] of Product ordered by ARIAD SWISSCO pursuant to the terms of
this Agreement.

 

10.2.2At any time during the Term until ARIAD SWISSCO has [***], ARIAD US will
supply [***] ordered by ARIAD SWISSCO pursuant to the terms of this Agreement,
and ARIAD SWISSCO shall have the right to conduct Final Manufacturing of such
[***] for purposes of Commercialization in the Territory.

 

10.2.3Beginning on a date notified to ARIAD US by ARIAD SWISSCO once ARIAD
SWISSCO or its Subcontractor are ready to [***] ARIAD US shall supply [***]
ordered by ARIAD SWISSCO pursuant to the terms of this Agreement and ARIAD
SWISSCO shall have the right to conduct [***] for purposes of Commercialization
in the Territory.

 

10.3Within [***] after the Effective Date and in the [***] of each [***]
thereafter, ARIAD SWISSCO shall provide ARIAD US with a written [***] rolling
Forecast of its anticipated quarterly requirements for the Product ([***]) in
the Territory (each a “Forecast”). ARIAD US shall use Commercially Reasonable
Efforts to ensure sufficient manufacturing capacity and Raw Materials to meet
each Forecast. Each Forecast is a non-binding estimate for [***] and subject to
Section 10.4 is binding on both Parties for [***]. ARIAD US shall not be obliged
to Manufacture or supply ARIAD SWISSCO with quantities of the Product in excess
of the binding portion of the most recent Forecast.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  37

 

 

10.4Within [***] of issuance of each Forecast the Parties will ensure that
appropriate personnel of each of them responsible for manufacture and supply
will discuss proposed batch runs and Delivery dates, which shall be within [***]
in which the binding portion of the Forecast relates, and for the quantities of
Product set out in the binding portion of that Forecast. ARIAD SWISSCO shall
then promptly submit to ARIAD US and ARIAD US shall accept written purchase
orders reflecting the binding portion of the Forecast, in such form as the
Parties shall agree from time to time, specifying the quantities of Product
ordered and, the agreed delivery date for the order. ARIAD SWISSCO shall submit
each purchase order to ARIAD US in advance of the desired delivery date
specified in such purchase order, with [***] lead time. Any purchase orders for
Product submitted by ARIAD SWISSCO to ARIAD US shall reference this Agreement
and shall be governed exclusively by the terms contained herein. The Parties
hereby agree that the terms and conditions of this Agreement shall supersede any
term or condition in any order, confirmation or other document furnished by
ARIAD SWISSCO or ARIAD US that is in any way inconsistent with, or supplementary
to, the terms and conditions of this Agreement, unless expressly accepted in
writing by the other Party.

 

10.5When ARIAD US [***] for ARIAD SWISSCO, ARIAD US shall carry a [***]
sufficient to avoid [***] in the Territory in the event of [***]. In addition,
whether ARIAD US is [***] for ARIAD SWISSCO, ARIAD US shall, with effect from
the Effective Date, carry a safety stock of Product API allocated to the
Territory, in accordance with past practice but in any event equal to not less
than [***] projected requirement of [***] for ARIAD SWISSCO based on the most
recent [***] and discussions between the Parties. Unless otherwise agreed by the
Parties, such safety stock shall be [***] and identified as ARIAD SWISSCO [***].

 

10.6The price for the Manufacture of the Product shall be calculated as [***].
ARIAD US shall invoice ARIAD SWISSCO upon each Delivery of Product supplied
under this Agreement and ARIAD SWISSCO shall pay the undisputed amounts of such
invoice within [***] of receipt of such invoice. ARIAD US must include with each
invoice a detailed calculation of the invoiced amount including details of the
associated Direct Costs, Indirect Costs and any Third Party costs. ARIAD US
shall keep complete and accurate books, records and accounts in accordance with
all Applicable Laws and sound accounting practice covering all its Direct Costs,
Indirect Costs and any Third Party costs and as otherwise may be necessary for
the purpose of calculating all payments due to ARIAD US under this Section 10.6.
ARIAD SWISSCO shall have the right, throughout any period during which payments
are due under this under this Section 10.6 and for [***] thereafter, at
reasonable times during business hours and upon reasonable notice to ARIAD US,
to have ARIAD US’s books, records and accounts inspected and audited by one of
the four major accounting firms to be appointed by ARIAD SWISSCO and reasonably
acceptable to ARIAD US, to ensure the accuracy of all reports and payments made
hereunder and in respect of all [***]. Such audit shall be covered by
confidentiality obligations of the auditor. ARIAD US shall cooperate with the
independent auditor and make available all work papers and other information
related to the payments required under this Section 10.6 as reasonably requested
in connection.

 

10.7In the event of any [***] in the available supply of Product, ARIAD US shall
treat ARIAD SWISSCO’s demand [***] or [***] and, allocate manufacturing capacity
to

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  38

 

 

the respective demand on a [***]; provided, that the foregoing supply on a [***]
does not limit any other remedies ARIAD SWISSCO may have due to a failure to
supply under this Agreement or the Supply Agreement. ARIAD US shall promptly
provide a written plan of action stating in reasonable detail the root cause of
any [***] and proposed measures to remedy the [***] and the date such [***] is
expected to end. ARIAD US shall use Commercially Reasonable Efforts to minimize
the duration of any [***]; provided, that the foregoing efforts of ARIAD US do
not limit any remedies ARIAD SWISSCO may have due to a failure to supply under
this Agreement or the Supply Agreements.

 

ARTICLE 11 – SHIPMENT AND DELIVERY

 

11.1Delivery Terms.

 

11.1.1ARIAD SWISSCO shall be the importer of record for all Product supplied
under this Agreement. ARIAD SWISSCO shall be responsible for clearing the
Product through customs in the Territory [***]. At all times, ARIAD SWISSCO
shall maintain, [***], a valid import license for the Products, and shall be
responsible, [***], for all required documentation and communications with the
applicable customs office in connection therewith. ARIAD US shall provide
assistance with such documentation and communications upon ARIAD SWISSCO’s
reasonable request (e.g., by providing export documents or assisting with
documentation as the exporter of the Product.) In this Section 11.1, any
obligation on ARIAD SWISSCO may be performed by a Sub-licensee or Subcontractor.

 

11.1.2ARIAD US shall deliver the Product ordered by ARIAD SWISSCO in accordance
with the quantities and delivery dates specified in the applicable purchase
order. If ARIAD US fails to deliver at least [***] of the quantity ordered in a
given purchase order within [***] of the specified delivery date, ARIAD SWISSCO
shall only be required to pay for the quantity of Product Delivered and the
price for such Product shall be reduced by [***].

 

11.1.3Deliveries shall be made Ex Works (Incoterms 2010) at the location
specified in the Interim Quality Agreement or such other location as the Parties
may agree in writing (“Delivery”). Title and risk to the Product shall pass to
ARIAD SWISSCO upon Delivery.

 

11.2Acceptance and Rejection.

 

11.2.1Product Testing. No later than [***] prior to a scheduled Delivery ARIAD
US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such
review, unless within [***] of receipt of the Delivery Documents ARIAD SWISSCO
gives written notice of rejection of the Product to be delivered, stating the
reasons for such rejection, the Delivery shall proceed, and both Parties shall
organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall
visually inspect the shipment of the Product to identify any damage to the
external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof)
of the Product that is damaged by providing to ARIAD US reasonable evidence of
damage

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  39

 

 

within [***] after Delivery of such Product. If ARIAD SWISSCO does not so reject
any shipment (or portion thereof) of the Product within [***] of Delivery of
such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of
the Product; provided, however, that in the case of the Product having any
Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes
aware that a Product contains a Latent Defect and subsequently may reject such
Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of
such Product and shipping a representative sample of such Product or other
evidence of Non-Conformance to ARIAD US within [***] after becoming aware of
such Latent Defect, which notice shall include a description of the Latent
Defect.

 

11.2.2Replacement of Product and Dispute Procedure. If ARIAD SWISSCO rejects, in
accordance with Section 11.2.1 any proposed delivery or shipment (or portion
thereof) of the Product as Non-Conforming and ARIAD US disagrees that the
alleged Non-Conformance exists, ARIAD US shall so notify ARIAD SWISSCO in
writing (an “Objection Notice”) within [***] of receipt of ARIAD SWISSCO’s
notice of rejection and the following procedures shall apply: in the case of a
Latent Defect ARIAD US shall inspect the returned representative sample of
Product or other evidence of Non-Conformance and attempt to reach agreement with
ARIAD SWISSCO as to whether or not the Product is Non-Conforming. If ARIAD
SWISSCO and ARIAD US fail within [***] after delivery of the Objection Notice to
agree as to whether the Product is Non-Conforming, in the case of a Latent
Defect representative samples of the batch of the Product in question and their
reference samples shall be submitted to a mutually-acceptable, independent,
qualified Third Party laboratory or consultant for analysis or review to
determine whether there is a Non-Conformance. For clarity, this may include a
decision whether or not contamination is present. The results of such evaluation
shall be binding upon the Parties. The Parties initially shall [***] the cost of
such evaluation, except that the Party that is determined to have been incorrect
in its determination of whether the Product was or was not Non-Conforming shall
assume the responsibility for, and pay, the costs of any such evaluation and
reimburse the other Party for any amounts previously paid to the independent
laboratory or consultant in connection with that determination.

 

11.2.3Cost of Replacement of Rejected Product. If any delivery or shipment of
the Product is rejected by ARIAD SWISSCO following review of the Delivery
Documents or a visual inspection or any other alleged Non-Conformance, ARIAD
SWISSCO’s duty to pay all amounts payable to ARIAD US in respect of the rejected
Product shall be suspended. In the case of Latent Defect Non-Conformance if
there is a determination by the independent laboratory or consultant in support
of ARIAD US’s Objection Notice, or the Parties otherwise reach agreement that
the Product was not Non-Conforming, payment shall then be made by ARIAD SWISSCO
If only a portion of a shipment is rejected, ARIAD SWISSCO’s duty to pay

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  40

 

 

the amount allocable to the Non-Conforming portion only shall be suspended.

 

11.2.4Return of Rejected Product. If a shipment or partial shipment is rejected
by ARIAD SWISSCO pursuant to the provisions of Section 11.2.1 and (i) where
relevant, ARIAD US does not provide an Objection Notice within the [***] period
set forth in Section 11.2.2, (ii) the Parties agree that the Product is
Non-Conforming within the [***] period set forth in Section 11.2.2, or (iii)
there is a determination by the independent laboratory or consultant in support
of ARIAD SWISSCO’s allegation of Non-Conformance, ARIAD SWISSCO shall return to
ARIAD US at ARIAD US’s request and expense (or, at the election of ARIAD US,
destroy at ARIAD US’s cost and provide evidence of such destruction to ARIAD US)
any such rejected Product (provided that if the Product has been packaged by or
on behalf of ARIAD SWISSCO at the time of rejection, ARIAD SWISSCO shall not be
obliged to remove any packaging prior to its return). ARIAD US shall (i) credit
the original invoice in respect of the rejected Product and reimburse ARIAD
SWISSCO for any duties, freight, insurance, handling or other charges incurred
by ARIAD SWISSCO in respect of such rejected Product, and (ii) adjust the
invoice to ARIAD SWISSCO for the Product that was not rejected, payment of which
is due in accordance with the terms of the original invoice. Except as set forth
in ARTICLES 14 and 22, such credit or adjustment shall be ARIAD US’s sole
Liability, and ARIAD SWISSCO’s sole remedy, with respect to any rejected
Product.

 

11.2.5Supply of Replacement Product. During any rejection discussions, upon
ARIAD SWISSCO’s request, ARIAD US shall supply ARIAD SWISSCO with additional
Product, using expedited shipping at ARIAD US’s expense, which ARIAD SWISSCO
shall otherwise purchase on the same terms (adjusted for credit for
Non-Conforming Product) as the Product that is the subject of the rejection
discussions.

 

11.2.6Detection of Latent Defect by ARIAD US. If ARIAD US detects a Latent
Defect in any Product supplied to ARIAD SWISSCO, ARIAD US shall notify ARIAD
SWISSCO in writing, specifying the affected lots, and credit ARIAD SWISSCO for
the Non-Conforming Product as provided in Section 11.2.4.

 

11.2.7No Product Returns Policy. Except as expressly provided elsewhere in this
Section 11.2 or in ARTICLE 14, no Products supplied by or on behalf of ARIAD US
to ARIAD SWISSCO may be returned by ARIAD SWISSCO to ARIAD US after they have
been Delivered to ARIAD SWISSCO at the location designated under Section 11.1.3.

 

ARTICLE 12 – MANUFACTURING OF THE PRODUCT

 

12.1Manufacture of the Product. ARIAD US shall Manufacture or have Manufactured
the Labeled Bottles, Unlabeled Bottles and API in accordance with the
Specifications,

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  41

 

 

cGMP and Applicable Laws in the country of Manufacture and, to the extent
applicable, in the Territory.

 

12.2Packaging. ARIAD US shall package the Product in accordance with the
Specifications and requirements notified to it with sufficient advance notice by
ARIAD SWISSCO to comply with Applicable Laws.

 

12.3Changes to the Specifications or to the Manufacturing Process. If ARIAD US
proposes (a) a change to the Specifications or the Raw Materials, equipment
(other than changes for maintenance, repair, and like-for-like replacement) or
process used to Manufacture the Product, or (b) a change to the procedures or
facilities used to Manufacture the Product (collectively, the “Manufacturing
Process”) that, in the case of (a) or (b) would require approval of any
applicable Regulatory Authority in the Territory or would require an amendment
of any Marketing Authorization application or Registration, the prior written
approval of ARIAD SWISSCO is required before implementation of such change. If a
change to the Specifications, Raw Materials, equipment or Manufacturing Process
is required by one or more Regulatory Authorities or regulatory authorities
outside the Territory or shall be applied globally, including for the
manufacture of Products inside and outside the Territory, and if such change
would require approval of any Regulatory Authority in the Territory or an
amendment of any Marketing Authorization application or Registration, ARIAD US
shall provide ARIAD SWISSCO with all information needed to amend the Marketing
Authorization application or Registration and/or obtain the approval of the
Regulatory Authority, as applicable, and the Parties shall cooperate with each
other in obtaining any necessary modifications to any Registrations in the
Territory to allow such change to be implemented. If the proposed change is
required by a Regulatory Authority, then such notice shall include disclosure of
the Regulatory Authority request and relevant correspondence. If any change to
the Specifications, Raw Materials, equipment or Manufacturing Process is not
required by any Regulatory Authority outside the Territory and shall not be
applied globally and would require approval of any Regulatory Authority in the
Territory or an amendment of any Marketing Authorization application or
Registration, ARIAD US shall provide advanced written notice to ARIAD SWISSCO
and shall consult with ARIAD SWISSCO regarding the implementation of such
change. If the change is required by a Regulatory Authority inside the Territory
but not in any other part of the world, [***] of implementing such change. If
the change proposed by ARIAD US is required only by one or more regulatory
authorities outside the Territory, or is not required by any Regulatory
Authority, [***] of implementing such change. If the change is required by one
or more Regulatory Authorities inside the Territory and by one or more
regulatory authorities outside the Territory, [***]. For the avoidance of doubt,
[***] of implementing a change to the Specifications, Raw Materials, equipment
or Manufacturing Process if such change is mandated by a Regulatory Authority
inside the Territory, and [***] of implementing such a change that is not
mandated by any Regulatory Authority, including any such non-mandated change
that ARIAD SWISSCO approves and that requires an amendment of a Marketing
Authorization application or Registration or approval of a Regulatory Authority
in the Territory. For clarity, ARIAD US shall have the right, [***], to change
equipment for maintenance, repair, and like-for-like replacement, and to make
other changes that ARIAD US reasonably determines shall not require approval of
any Regulatory

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  42

 

 

Authority or affect the Marketing Authorization application(s) or
Registration(s) in the Territory, without notice to or consent of ARIAD SWISSCO.
Further for clarity, the Quality Agreements shall contain change control
procedures, and any changes made to the Specifications, Raw Materials, equipment
or Manufacturing Process shall be made in accordance with the Quality Agreements
and in compliance with cGMP and Applicable Laws.

 

12.4Final Manufacturing. Subject to Section 10.2.1, with effect from the
Effective Date, ARIAD SWISSCO shall be responsible for the Final Manufacturing
of all Product, including performing secondary packaging, labeling and providing
product inserts and final release and stability testing in accordance with the
Marketing Authorization and Regulatory Requirements in the country in the
Territory that is the intended market for such lot of Product, and in accordance
with all Applicable Laws.

 

12.5Inspections. At ARIAD SWISSCO’s request, ARIAD US will authorize ARIAD
SWISSCO or its representatives, during normal business hours (or at other times
for cause), to review documents including but not limited to: completed
manufacturing batch records, analytical results for product release and
stability, associated manufacturing standard operating procedures and other
standard operating procedures that are associated with maintenance of the
process, facility and personnel in accordance with cGMPs, and observe the
Manufacture of Product to confirm ARIAD US’s compliance with the terms of this
Agreement and the Quality Agreement. ARIAD US will notify ARIAD SWISSCO within
[***] of all contacts with Regulatory Authorities (written or verbal) related to
each Product. ARIAD US shall inform ARIAD SWISSCO of the result of any
regulatory inspection which directly affects the Manufacture of a Product,
including any notice of inspection, notice of violation or other similar notice
received by ARIAD US affecting Manufacturing, facility, testing, storage or
handling of a Product. In the event of an FDA inspection which directly involves
a Product, ARIAD SWISSCO shall be immediately informed of the issuance of the
Notice of Inspection (FDA Form 482). In the event that there are inspectional
observations (FDA Form 483), ARIAD SWISSCO shall be informed immediately and
shall have the opportunity to review and provide ARIAD US with comments to ARIAD
US’s response. ARIAD SWISSCO shall provide its comments to the response of these
observations within [***]. The contents of ARIAD US’s response shall be
determined by ARIAD US in its sole discretion. ARIAD US agrees to reasonably
cooperate with applicable Regulatory Authorities and shall permit reasonable
Product-specific inspections by such Regulatory Authorities.

 

ARTICLE 13 – QUALITY ASSURANCE

 

13.1Quality. The details of quality obligations and responsibilities of the
Parties, including responsibility for submissions of reports to Regulatory
Authorities, shall be set forth in one or more separate quality technical
agreements (each, a “Quality Agreement”). As of the Effective Date the Parties
will enter into an interim quality agreement in relation to the Transitional
Supply Arrangements (“Interim Quality Agreement”). The Parties shall negotiate
to agree a further Quality Agreement to be signed concurrently with the Supply
Agreement and, once executed, that Quality Agreement shall supersede and replace
the Interim Quality Agreement.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  43

 

 

ARTICLE 14 - RECALLS AND PRODUCT WITHDRAWAL

 

14.1Notice. Each Party shall make every reasonable effort to notify the other
Party promptly following the first Party’s determination that any event,
incident, or circumstance has occurred that may result in the need for a Product
Withdrawal anywhere in the world or a Recall anywhere in the world. Such Party
shall include in such notice the reasoning behind such determination, and any
supporting facts.

 

14.2Product Withdrawal. With respect to a Product Withdrawal within the
Territory, immediately after receipt of such notification, the JSC (or its
co-chairpersons) shall discuss and, unless the Product Withdrawal is mandated by
a Regulatory Authority, shall attempt to agree on whether to voluntarily
implement the Product Withdrawal within the Territory. If a Regulatory Authority
mandates that the Product Withdrawal within the Territory be implemented then
ARIAD SWISSCO, in consultation with ARIAD US, shall initiate the Product
Withdrawal within the Territory as and to the extent mandated by the Regulatory
Authority and in compliance with Applicable Laws. In the case of a Product
Withdrawal that is not mandated by Regulatory Authority, if the JSC (or its
co-chairpersons) fail(s) to agree within a reasonably appropriate time period
(depending upon the circumstances) whether to voluntarily implement or undertake
a Product Withdrawal within the Territory, then ARIAD SWISSCO and/or the MAH
shall have the right to make the determination whether or not to voluntarily
implement such Product Withdrawal within the Territory; provided that, to the
extent practicable prior to deciding to initiate a Product Withdrawal within the
Territory, ARIAD SWISSCO shall or shall procure that the relevant MAH shall
consider ARIAD US’s reasonable comments in good faith. ARIAD SWISSCO or its
Sublicensees shall carry out such Product Withdrawal activities in consultation
with ARIAD US, in a manner which enables the Parties to meet their respective
Regulatory Requirements as expeditiously as possible, and in compliance with all
Applicable Laws. In the event of a mandated or voluntary Product Withdrawal in
the Territory, the Parties will consider whether such action is necessary also
in the Reserved Territory. If either Party or the relevant MAH does not choose
to undertake a voluntary Product Withdrawal in its respective territory, despite
the other Party’s written recommendation that such Product Withdrawal should be
undertaken, then, notwithstanding anything to the contrary herein, such Party
shall indemnify and hold harmless the other Party from and against any Losses
that may arise or result thereafter from such Party’s failure to undertake such
Product Withdrawal following such written recommendation from the other Party
pursuant to the procedures set forth in Section 22.3.

 

14.3Recall. If a Regulatory Authority mandates that a Recall be implemented or
undertaken by ARIAD SWISSCO in the Territory or by ARIAD US in the Reserved
Territory, then ARIAD SWISSCO and/or the relevant Sublicensee, in consultation
with ARIAD US (in the case of Recalls in the Territory) or ARIAD US and/or the
relevant licensee, in consultation with ARIAD SWISSCO (in the case of Recalls in
the Reserved Territory), shall initiate the Recall as and to the extent mandated
by the Regulatory Authority and in compliance with Applicable Laws. With respect
to a Recall in the Territory that is not mandated by a Regulatory Authority, (i)
the Parties’ JSC co-chairs shall discuss and attempt to agree on whether to
voluntarily implement the Recall and (ii) if the Parties’ JSC co-chairs fail to
agree within a reasonably appropriate time period (depending upon the
circumstances), then ARIAD SWISSCO

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  44

 

 

shall have the right to make the determination whether or not to voluntarily
implement a Recall in the Territory and ARIAD US shall have the right to make
the determination whether or not to voluntarily implement a Recall in the
Reserved Territory.

 

14.4Expenses. [***], unless and to the extent the Recall or Product Withdrawal
is based on the fault of [***], including in relation to Manufacture in which
case such [***].

 

ARTICLE 15 – COMMERCIALIZATION OF THE PRODUCT

 

15.1Commercialization Plan. The Parties shall annually update their part of the
Commercialization Plan for the following Calendar Year before a mutually
agreeable date prior to December 31 in the preceding year. The JCC shall
consider and discuss the revised plans, and ARIAD SWISSCO shall consider in good
faith the input of ARIAD US on the ARIAD SWISSCO part of the Commercialization
Plan for the Territory. ARIAD SWISSCO shall use Commercially Reasonable Efforts
to implement its part of the then current Commercialization Plan.

 

15.2Commercialization Efforts. ARIAD SWISSCO shall either itself or through its
Affiliates, Sublicensees or Subcontractors, have the sole right to Commercialize
the Product [***] and in accordance with applicable cGMP and any other
Applicable Laws and Industry Guidelines in each country of the Territory. ARIAD
SWISSCO will conduct, as it deems appropriate, marketing and medical affairs
activities to support the Commercialization of the Product in the Territory.
ARIAD SWISSCO and its Affiliates will devote the following [***] to cover all
[***] of their [***] business as a whole for the Product, [***] (it being
understood that (a) such commercial costs will include a [***] of the Product
[***] based on the number of products they carry, (b) such medical affairs costs
will include costs only for [***] who support Product or work in CML or other
approved indications of Product, and (c) both [***] will exclude Third Party
costs that are not meaningfully related to the Product): [***] for calendar year
[***] and for each year thereafter until the earlier of (a) the expiration of
the Full Royalty Term in the last to expire country of the countries listed in
Appendix 1.167 Part B or (b) the launch of a Generic Product in any of [***],
the [***] will remain at [***] of Net Sales unless the Net Sales of Product by
ARIAD SWISSCO in the Territory in calendar year [***] or in any calendar year
thereafter is less than the Net Sales of Product by ARIAD SWISSCO in the
Territory in calendar year [***], in which case the percentage of Net Sales
applicable for such calendar shall be [***]. Notwithstanding the foregoing, the
[***] for each calendar year from calendar year [***] through the earlier of (i)
expiration of the Full Royalty Term in the last to expire country of the
countries listed in Appendix 1.167 Part B or (ii) the launch of a Generic
Product in any of [***] for each such calendar year. ARIAD SWISSCO will provide
ARIAD US within [***] of calendar year end, an annual report of its commercial
and medical expenses in support of Product, such report to contain the total
[***], and other such details that the Parties mutually agree.

 

15.3Promotion. The Parties shall meet on a periodic basis, through the JCC, to
(i) review and discuss the global Product communication strategy/brand
positioning (“Global Product Positioning”) for the Product (as proposed by ARIAD
US with input from

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  45

 

 

ARIAD SWISSCO as well as other Product partners globally) (ii) discuss marketing
strategies in their respective territories, (iii) discuss planned
marketing/promotional activities at international medical/scientific
meetings/conferences in either Party’s territories. ARIAD SWISSCO shall be
entitled to use all existing print marketing, advertising and promotional
materials, brand plan and strategy used in respect of the Product in the
Territory, and all training manuals currently used for ARIAD SWISSCO’s medical
science liaisons and sales representatives as at the Effective Date. Any new
materials shall be developed and prepared by ARIAD SWISSCO in its sole
discretion, provided that ARIAD SWISSCO shall consider Global Product
Positioning when preparing such materials and, upon written request by ARIAD US,
provide a courtesy copy of such materials to ARIAD US. ARIAD US shall provide a
courtesy copy of any new print marketing, advertising and promotional materials
that it may develop to ARIAD SWISSCO. Each Party shall have the right to
purchase stock of the other Party's print marketing, advertising and promotional
materials on mutually agreeable terms.

 

15.4Independent Contractor. ARIAD SWISSCO shall make clear in all dealings with
its actual and prospective Customers that it is selling the Product in its own
name and for its own account as an independent contractor and not as agent of
ARIAD US.

 

15.5Use of Internet.

 

15.5.1All of ARIAD SWISSCO’s internet marketing, advertising and promotional
materials concerning the Product, the ARIAD US Trademarks and/or ARIAD US shall
be developed and prepared by ARIAD SWISSCO in its sole discretion, provided that
ARIAD SWISSCO will consider Global Product Positioning when performing such
development.

 

15.5.2ARIAD US may grant to ARIAD SWISSCO the right to operate a website under a
domain name registered in the name of ARIAD US and relevant to or which contains
information about ARIAD US, the Product, and the Trademarks, subject to terms
and conditions of this Agreement.

 

15.5.3In the event that any Applicable Law or regulation in the Territory
requires the domain name of any website relevant to the Product, the Trademarks
and/or ARIAD US to be registered in the name of ARIAD SWISSCO or an Affiliate,
then any such domain name shall be registered in the name of ARIAD SWISSCO or
Affiliate as legally required. All such content shall be or shall become the
exclusive property of ARIAD US. Upon expiration or termination of the Agreement
ARIAD SWISSCO and its Affiliates agree to execute any and all further
documentation required to ensure that all such content and all copyright in such
content is owned by ARIAD US. To the extent permitted by Applicable Law, ARIAD
SWISSCO shall be required to assign to ARIAD US or its designee all domain name
registrations containing the name of the Compound, the Product, the ARIAD US
Trademarks or the name ARIAD US, or variants thereof, upon the expiration or
termination of this Agreement. Neither ARIAD SWISSCO nor its Affiliate may
assign or license any such domain name to any other Third Party.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  46

 

 

ARTICLE 16 – BUY-BACK OPTION

 

16.1If ARIAD US undergoes a Change of Control prior to six (6) years from the
Effective Date, ARIAD US’s successor (“ARIAD US Successor”) shall have the
right, within [***] of the effective date of the Change of Control to elect to
terminate this Agreement and all ancillary arrangements relating thereto earlier
than the expiry of the Term (the “Buy-Back Option”). ARIAD US Successor shall
exercise such Buy-Back Option by giving notice in writing (“Termination Notice”)
to ARIAD SWISSCO, specifying (i) the proposed date of early termination, which
(A) in the case of a Termination Notice prior to the second anniversary of the
Effective Date, shall be the third anniversary of the Effective Date, and (B) in
all other cases shall be the one-year anniversary of Termination Notice, in each
case such termination not to be effectuated later than seven (7) years after
Effective Date and (ii) whether payment option (A) or (B) set forth in Section
16.2 is elected. On the sixth (6th) anniversary of the Effective Date, the right
to give a Termination Notice in order to exercise the Buy-Back Option shall
expire and ARIAD US Successor shall have no right to terminate this License
Agreement and all ancillary arrangements relating thereto pursuant to this
ARTICLE 16.

 

16.2Upon exercise of the Buy-Back Option, ARIAD US Successor shall [***], pay to
ARIAD SWISSCO (i) an amount equal to the Purchase Price (as defined in the Share
Purchase Agreement) plus all milestone and Development Costs previously paid by
ARIAD SWISSCO to ARIAD US or ARIAD US Successor pursuant to this Agreement; and
(ii) at [***], either (A) an amount equal to [***] Net Sales of the Product of
ARIAD SWISSCO for the twelve (12) month period ending upon termination of this
Agreement and a payment of twenty-five percent (25%) of Net Sales of the Product
sold by ARIAD US Successor, its affiliates and sublicensees in the Territory
with effect from the date of termination of this Agreement; or (B) an amount
equal to [***] the Net Sales of the Product [***] in accordance with applicable
accounting standards for the twelve (12) month period ending upon termination of
this Agreement plus a payment of twenty percent (20%) of Net Sales of the
Product sold by ARIAD US Successor, its affiliates and sublicensees in the
Territory with effect from the date of termination of this Agreement. The
payments being a percent Net Sales shall be made during the Full Royalty Term,
and shall reduce to [***] of Net Sales thereafter for the Reduced Royalty Term.
Sections 19.2.3, 19.3, 19.5, 19.6, 19.7, 19.9, and 19.10 shall apply mutatis
mutandi to payments on Net Sales made pursuant to this Section 16.2 and to ARIAD
US Successor in connection therewith. Following exercise of the Buy-Back Option,
the payment obligations under this Section 16.2 shall survive any termination of
this Agreement and shall be binding upon ARIAD US and ARIAD US Successor.

 

16.3Following exercise of the Buy-Back Option the Transition Back Arrangements
will apply, and both Parties shall implement the same.

 

16.4If, within [***] after the exercise of the Buy-Back Option, ARIAD US
Successor determines to [***], ARIAD US Successor shall (and ARIAD US shall
ensure that ARIAD US Successor shall) so notify ARIAD SWISSCO in writing, and if
ARIAD SWISSCO desires to enter into negotiations with ARIAD US Successor with
respect to such [***], ARIAD SWISSCO shall so notify ARIAD US Successor in
writing within [***] of receipt of ARIAD US Successor’s written notice, and in
such case the

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  47

 

 

Parties shall enter into exclusive good faith negotiations with respect to such
[***]. If, notwithstanding such negotiations, the Parties are unable to reach a
definitive agreement within [***] after ARIAD US Successor’s receipt of ARIAD
SWISSCO’s written notice, then ARIAD US Successor shall be free to negotiate and
[***]. Notwithstanding anything to the contrary contained herein, in no event
shall the entering into [***] by ARIAD SWISSCO with ARIAD US Successor with
respect to such rights [***] affect in any manner any of the payments due to
ARIAD SWISSCO under this ARTICLE 16, unless mutually agreed by ARIAD SWISSCO and
ARIAD US Successor.

 

ARTICLE 17 – MEDICAL AFFAIRS ACTIVITIES

 

17.1ARIAD SWISSCO shall be solely responsible, [***], for medical affairs
activities in the Territory, including providing medical liaisons, medical
information and medical education programs and medical publications in the
Territory, and attending relevant medical or scientific meetings and congresses,
and shall allocate sufficient, appropriately qualified personnel and resources
to conduct such activities, as set forth herein. Each Party shall have the right
to purchase stock of the other Party’s medical education program materials and
medical publications on mutually agreeable terms.

 

17.2ARIAD SWISSCO will use Commercially Reasonable Efforts to ensure that its
Medical Affairs activities and communications are consistent with the Global
Product Positioning, and will consider in good faith comments and input from
ARIAD US to that effect. ARIAD SWISSCO shall appropriately disseminate medical
information relating to the Compound and the Product in accordance with
Applicable Laws and in a manner consistent with any medical affairs materials
provided by ARIAD US to ARIAD SWISSCO in writing, if any (provided such
materials provided by ARIAD US are compliant with Applicable Laws and Industry
Guidelines).

 

17.3ISTs - General: Subject to the exceptions below, each Party is responsible
for, at its expense, ISTs in its respective territory. The Parties shall review
and discuss, through a joint medical affairs team or other mutually agreed
process, each new proposal for an IST that a Party would like to support, and
consider in good faith inputs or comments from the other Party. Each Party may
then proceed with the IST subject to the other Party’s veto right in Sections
5.6 and 5.7.2.

 

Existing Contractual ISTs: Notwithstanding the generality of the foregoing but
subject to the remaining provisions of this Section, where ARIAD US has entered
into binding contractual arrangements prior to the Effective Date in respect of
the ISTs in the Territory listed in Part A of Appendix 17.3 (“Existing
Contractual ISTs”), ARIAD US shall [***]. If ARIAD US proposes to [***], the
Parties shall discuss in good faith whether they would [***] as may be agreed
between the Parties or whether [***], provided that, subject to the following,
ARIAD US shall [***] without the [***] of the Parties. Notwithstanding the
foregoing, ARIAD US shall be entitled to [***], by providing [***] to ARIAD
SWISSCO, on the grounds that, in ARIAD US's [***].

 

ISTs Under Discussion: In respect of ISTs in the Territory which ARIAD US has
considered but has not entered into binding contractual arrangements prior to
the Effective Date, a list of which is set out at Part B of

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  48

 

 

Appendix 17.3 (“Existing Non-Contractual ISTs”), the Parties shall discuss in
good faith whether they [***] as may be agreed between the Parties. In the event
that ARIAD SWISSCO does not wish to participate in a particular Existing
Non-Contractual IST [***], ARIAD US shall, [***]. Notwithstanding the foregoing,
ARIAD SWISSCO shall [***].

 

17.4ARIAD SWISSCO shall ensure that requests for information by Healthcare
Professionals are answered in an appropriate, accurate and lawful manner by
appropriately qualified personnel. Requests for information that are
inconsistent with the Marketing Authorization for the relevant country shall be
handled by the medical affairs personnel only.

 

17.5ARIAD SWISSCO’s medical personnel shall conduct periodic visits to clinical
trial sites and investigators participating in any Product clinical trials in
the Territory (including Global Studies, Proposed Studies and Ongoing Studies)
to support initiation and enrollment through the provision of appropriate
information and documentation and through issue escalation and coordination with
clinical research organizations involved in the conduct of such studies.

 

ARTICLE 18 – TRADEMARKS

 

18.1ARIAD SWISSCO shall use the ARIAD US Trademarks in relation to the
Development and Commercialization of the Products in the Territory. If in any
country of the Territory it is not legally possible or it is not commercially
practicable to use the ARIAD US Trademarks, ARIAD SWISSCO shall be allowed to
select and use ARIAD SWISSCO Trademarks. All details of the reasons for the need
to use ARIAD SWISSCO Trademarks and the ARIAD SWISSCO Trademarks proposed to be
used shall be disclosed to ARIAD US at JCC meetings, and ARIAD SWISSCO shall
make good faith efforts to take account of ARIAD US comments.

 

18.2ARIAD SWISSCO shall continue to have the right to sell inventory of Product
containing reference to ARIAD US corporate names and logos as follows. ARIAD
SWISSCO shall be permitted to sell any stock or inventory existing as of the
Effective Date without limitation. ARIAD SWISSCO shall: (i) as soon as
practicable after the Effective Date, and in any event by no later than the date
falling [***] following the Effective Date re-design the packaging and/or
labelling information on the Product which includes any ARIAD US corporate names
and logos, so that the design and/or labelling information for such stock or
packaging no longer includes any ARIAD US corporate names and logos; and (ii) as
soon as practicable following receipt of any necessary approval from the
applicable Regulatory Authorities cease the production and sale of any stock or
packaging bearing any ARIAD US corporate names and logos; except in each case if
the use of the ARIAD US corporate names and logos is required by a Regulatory
Authority or under Applicable Law.

 

18.3ARIAD SWISSCO shall use the ARIAD US Trademarks only and exclusively in
connection with and for the purpose of the Commercialization of the Product in
the Field in the Territory. ARIAD SWISSCO acknowledges that it shall not be
entitled to

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  49

 

 

any rights whatsoever in the ARIAD US Trademarks or ARIAD US’s corporate name or
logo except as required by a Regulatory Authority or under Applicable Law or as
is specifically granted pursuant to this Agreement.

 

18.4The ARIAD US Trademarks shall always be used together with the sign “R” or
the sign “TM” or such other customary symbol or legend that correctly identifies
the status of the ARIAD US Trademark (i.e., registered or unregistered) in the
Territory.

 

18.5Nothing contained in this Agreement shall be construed as giving ARIAD
SWISSCO the right to use any of the ARIAD US Trademarks or the name or logo of
ARIAD US outside the Territory or for any other product than the Product and
solely in the Field. ARIAD SWISSCO recognizes the exclusive ownership rights of
ARIAD US in and to the ARIAD US Trademarks and the name and logo of ARIAD US and
acknowledges that it shall not acquire any ownership or other rights in respect
of the ARIAD US Trademarks or the name or logo of ARIAD US and/or of the
goodwill associated therewith and that all such rights and goodwill are, and
shall at all times remain, vested in ARIAD US. ARIAD SWISSCO acknowledges and
agrees that all use of the ARIAD US Trademarks and the name and logo of ARIAD US
inures to and is for the benefit of ARIAD US. ARIAD SWISSCO shall, if requested
by ARIAD US, execute an assignment to ARIAD US of any and all rights that ARIAD
SWISSCO may acquire in respect of any of the ARIAD US Trademarks or the name or
logo of ARIAD US and/or of the goodwill associated therewith.

 

18.6ARIAD US shall use Commercially Reasonable Efforts to maintain the validity
of the ARIAD US Trademarks in the Territory throughout the Term, [***]. For
ARIAD US Trademarks currently used by ARIAD SWISSCO under this Agreement, ARIAD
SWISSCO agrees to provide any reasonable assistance in this effort [***],
provided, however, that [***] in connection with such assistance.

 

18.7ARIAD SWISSCO shall promptly notify ARIAD US with respect to any threatened,
potential or presumed counterfeits, copies, imitations, simulations of, or
infringements upon, the ARIAD US Trademarks or the name “ARIAD US” which comes
to its attention during any period where such marks or names are actively used
by ARIAD SWISSCO. ARIAD US shall decide on the steps to be taken after having
discussed such threatened, potential or presumed counterfeits, copies,
imitations, simulation and/or infringements with ARIAD SWISSCO. ARIAD SWISSCO
shall provide all reasonable assistance (with ARIAD SWISSCO bearing [***] solely
for the purpose of engaging any Third Party to assist in the performance of any
action contemplated by this Section 18.7) to ARIAD US in taking legal action, if
deemed necessary by ARIAD US, in its sole and absolute discretion, with respect
to such matters.

 

18.8ARIAD SWISSCO acknowledges that ARIAD US would have no adequate remedy under
this Agreement or at law in the event that ARIAD SWISSCO were to use the ARIAD
US Trademarks in a manner not authorized by this Agreement and that ARIAD US
would, in such circumstances, be entitled to specific performance, injunctive or
other equitable relief.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  50

 

 

ARTICLE 19 – CONSIDERATION AND PAYMENTS

 

19.1Milestone Payments.

 

19.1.1ARIAD SWISSCO shall pay ARIAD US the following non-refundable,
non-creditable milestone payments after the first achievement or occurrence of
the following by ARIAD SWISSCO, its Affiliates or Sublicensees:

 

Milestone Event   Payment Amount [***]   [***] [***]   [***] [***]   [***] [***]
  [***] [***]   [***] [***]   [***] [***]   [***]

 

19.1.2With the exception of the [***] milestones, each of the milestone payments
set out in Section 19.1.1 shall be payable only upon the first occurrence of the
applicable event, whenever it occurs. ARIAD SWISSCO shall report the occurrence
of each milestone event to ARIAD US within [***] of its occurrence. Upon
notification, ARIAD US shall invoice ARIAD SWISSCO for the amount of the
milestone. ARIAD SWISSCO shall pay the milestone invoice within [***] of receipt
of the invoice. Milestone payment to ARIAD US shall be made by wire transfer to
an account designated in writing by ARIAD US.

 

19.2Royalties.

 

19.2.1Full Royalty Term. Subject to the adjustments provided in this Section
19.2, Section 19.11 and ARIAD SWISSCO’s offset rights, ARIAD SWISSCO will pay to
ARIAD US during the Full Royalty Term as set forth below:

 

royalty = A+B+C+D+E, where:

 

A equals thirty-two percent (32%) of that portion of Net Sales of Product in the
Territory which, during the calendar year in question, is less than or equal to
[***];

 

B equals [***] of that portion of Net Sales of Product in the Territory which,
during the calendar year in question, is greater than [***] and less than or
equal to [***];

 

C equals [***] of that portion of Net Sales of Product in the Territory which,
during the calendar year in question, is greater than [***] and less than or
equal to [***];

 

D equals [***] of that portion of Net Sales of Product in the Territory which,
during the calendar year in question, is greater than [***] and less than or
equal to [***];

 

E equals fifty percent (50%) of that portion of Net Sales of Product in the
Territory which, during the calendar year in question, is greater than [***].

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  51

 

 

19.2.2Reduced Royalty Term. Subject to Section 19.11 and ARIAD SWISSCO’s offset
rights, ARIAD SWISSCO shall pay to ARIAD US a royalty of [***] of Net Sales in
each country in the Territory as to which the Full Royalty Term has expired.
Such royalty obligation shall begin in each country in the Territory on the day
after the Full Royalty Term has expired and continue until the [***] of such
expiration (the “Reduced Royalty Term”). Further for clarity, after the
expiration of the Reduced Royalty Term in each country in the Territory, no
further royalties shall be due with respect to Net Sales in such country and the
licenses granted to ARIAD SWISSCO hereunder shall become fully paid-up and
royalty-free with respect to such country for the remainder of the Term.

 

19.2.3Net Sales Reports and Royalty Payments

 

(a)[***] before the end of each calendar quarter (other than during the first
[***] after the Effective Date, when no such estimate shall be required), ARIAD
SWISSCO shall deliver to ARIAD US a report with estimated Net Sales made in such
quarter, including:

 

(i)Net Sales of Product in local currency, by country by Presentation, during
the quarter; and

 

(ii)all exchange rate conversions in accordance with Section 19.5..

 

The Parties, through a Transition Services Agreement as defined in the Share
Purchase Agreement, will agree upon an approach through which the foregoing
reports can be provided by ARIAD SWISSCO, whether through successful migration
to ARIAD SWISSCO or ARIAD US providing continued access to its reporting
systems.

 

(b)Within [***] after the end of each calendar quarter, ARIAD SWISSCO shall
deliver to ARIAD US a report setting out the details described in (a) and (b)
above with respect to actual Net Sales made in such calendar quarter.

 

(c)Promptly following receipt of the royalty report ARIAD US shall issue an
invoice for the royalties due and , ARIAD SWISSCO shall pay the invoiced royalty
within [***] of receipt of the invoice. Royalty payment to ARIAD US shall be
made by wire transfer to an account designated in writing by ARIAD US.

 

19.3ARIAD SWISSCO shall provide (a) such monthly sales reports as ARIAD US may
reasonably request in relation to the sales data and information reasonably
necessary to understand, the level of gross sales invoiced in the Territory and
(b) such quarterly sales reports as ARIAD US may reasonably request in relation
to the sales data and information reasonably necessary to understand, gross
sales invoiced and deductions taken in Sections 1.112(a) through 1.112(g) to
arrive at Net Sales in the Territory.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  52

 

 

19.4Distribution Agreement Milestone Payments. ARIAD SWISSCO shall, promptly,
upon receipt (and in any event within [***] of receipt) pay to ARIAD US [***] of
the Distribution Agreement Milestone Payments in [***]. ARIAD SWISSCO hereby
agrees to (i) use all Commercially Reasonable Efforts to enforce the provisions
of the relevant Distribution Agreement pursuant to which the Distribution
Agreement Milestone Payments are payable and collect payment thereof from the
relevant counterparty; and (ii) not [***] the relevant Distribution Agreement
pursuant to which the [***] or take any other steps that would [***] under this
Section 19.4 without ARIAD US’ prior written consent or without providing
compensation for such impact.

 

19.5Payment Currency and Exchange Rate. All amounts due under this Agreement
shall be paid in US dollars. The amount of Net Sales under Section 19.2 shall be
determined in Local Currency. The Net Sales amount shall be converted from Local
Currency into US dollars using the average interbank exchange rate for
conversion of one unit of Local Currency to one US dollar during the calendar
quarter prior to the payment due date. Exchange rates shall be as published by
OANDA.com “The Currency Site” under the heading “FxHistory: historical currency
exchange rates” at www.OANDA.com/convert/fxhistory. All payments under this
Agreement shall be made by bank wire transfer in immediately available funds to
a bank account designated in writing by the payee Party or by other means as
directed by the payee Party in writing.

 

19.6Interest. Payments made under this Agreement shall be considered to be made
as of the day on which there were sent. In the event that any payment due under
this Agreement is not made when due, the payment shall accrue simple interest
from the date due at a rate per annum equal to [***] above the [***] published
in the [***], (or, if the [***], ceases to publish such rates, such other
reputable financial news source as ARIAD US may select) in effect on the date of
the scheduled date of payment; provided that, in no event shall such rate exceed
the applicable maximum legal annual interest rate then in effect. The payment of
such interest shall not limit the payee Party from exercising any other rights
it may have as a consequence of the lateness of any payment. [***]. The payer
Party shall pay the interest together with the overdue amount.

 

19.7Tax Matters. Unless otherwise agreed in writing by the Parties or required
by Applicable Laws, all amounts payable by one Party to the other Party pursuant
to this Agreement (each a “Payment”) excludes all withholding, sales, use,
consumption, value-added, customs, excise and other taxes, duties or
governmental assessments (collectively, “Taxes”). The Parties shall use
commercially reasonable efforts to structure all Payments to minimize the
applicability of withholding taxes to the maximum extent consistent with
Applicable Laws. If any Payment is subject to a deduction or withholding of Tax
pursuant to Applicable Laws, the Parties shall use commercially reasonable
efforts to perform all acts (including by executing all appropriate documents)
so as to enable the payee Party to take advantage of any applicable double
taxation agreement or treaty or to otherwise secure any applicable exemption
from or reduction in withholding Taxes. In the event there is no applicable
double taxation (or other exemption) agreement or treaty, or if an applicable
double taxation (or other) agreement or treaty reduces but does not eliminate
such withholding Tax, the payer Party shall pay the applicable Tax to the

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  53

 

 

appropriate governmental authority, shall provide to the payee Party evidence of
such payment, and shall deduct the amount paid from the Payment due the payee
Party. If the payer Party has to pay applicable withholding tax because of a
failure by the payer Party to complete any procedural formalities necessary for
it to obtain authorization to make payments pursuant to this Agreement without
the obligation to make deduction or withholding, then the amount due from the
payer Party to ARIAD US shall be increased to an amount which (after making any
deduction for withholding in respect of taxes) leaves an amount equal to the
payment which payee Party would have received if no such deduction or
withholding had been required. Any withholding tax imposed on a payment from an
ARIAD SWISSCO Affiliate, Sublicensee or distributor in the Territory to ARIAD
SWISSCO is the responsibility of ARIAD SWISSCO.

 

19.8Payments and Adjustments.

 

19.8.1ARIAD SWISSCO shall be entitled to offset or otherwise withhold or adjust
any Payment due to ARIAD US under this Agreement and any actual tax payment made
to a tax authority under Section 9.7 (Tax Matters) of the Share Purchase
Agreement in view of claims that ARIAD SWISSCO may have.

 

19.8.2Within [***] after the end of each calendar year (except for the final
payment, which shall be made within [***] of the [***] of the Effective Date),
ARIAD US shall pay to ARIAD SWISSCO an amount equal to the Year-End Compensating
Payment as set forth on Appendix 19.8.2.

 

19.8.3Each Party shall make all payments due by it to the other Party under this
Agreement in accordance with the time periods set forth in this Agreement for
the applicable payment in full amount of such payment except (in the case of
payments under this Agreement other than those under Sections 19.1, 19.2 and
19.4) as may be disputed in good faith by such paying Party. Notice of the basis
for, and reasonable detail of, any such dispute shall be provided in writing
together with such payment, together with the identity of the designated finance
representative of such paying Party. The finance representatives of each Party
shall promptly, but no later than [***] after the receipt of such notice, in
order to attempt in good faith to resolve such dispute; provided, that, after
[***], such dispute shall be escalated to the Senior Officers under Section
29.2. If the Senior Officers are not able to resolve such dispute in accordance
with Section 29.2, upon the request of one of the Parties, such dispute shall be
submitted to an independent accounting firm in accordance with the general
procedures set forth in Section 19.9, or, absent such submission, either Party
may invoke the provisions of Section 29.3 with respect to such dispute.

 

19.9Books, records and accounts. Throughout the Royalty Term and for a period of
at least [***] thereafter, ARIAD SWISSCO shall keep complete and accurate books,
records and accounts in accordance with all Regulatory Laws and Regulatory
Requirements and sound accounting practice covering all its operations hereunder
and as may be necessary for the purpose of calculating all payments due to ARIAD
US under this ARTICLE 19 and the required expenditures under Section 15.2.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  54

 

 

ARIAD US shall have the right, throughout the Term and for a period of [***]
thereafter, at reasonable times during business hours and upon reasonable notice
to ARIAD SWISSCO, to have ARIAD SWISSCO’s books, records and accounts inspected
and audited by a reputable independent auditor employed by one of the four major
accounting firms to be appointed by ARIAD US and reasonably acceptable to ARIAD
SWISSCO, to ensure the accuracy of all reports and payments made hereunder and
in respect of all Development Costs and the expenditures made by ARIAD SWISSCO
and its Affiliates as required in Section 15.2. Such audit shall be covered by
confidentiality obligations of the auditor. Such inspection and audit may not be
(i) conducted for any calendar year more than [***] after the end of such year,
(ii) conducted more than once in any [***] period, or (iii) repeated for any
[***]. ARIAD SWISSCO shall cooperate with the independent auditor and make
available all work papers and other information related to this Agreement
reasonably requested in connection herewith (subject to written obligations of
confidentiality to ARIAD SWISSCO). For purposes of (a) payments under this
Agreement including Sections 5.3.1, 5.3.2, 5.7.3, 5.7.4, and 5.9 and calculation
of any Development Costs that one Party must pay to the other under this
Agreement, (b) the determination of the Cost of Manufacture, (c) calculation of
the Year-End Compensating Payment pursuant to Appendix 19.8.2, and (d)
calculation of manufacturing technology transfer costs, this Section 19.9 shall
apply mutatis mutandi to the applicable Party’s books, records and accounts and
for the applicable party to audit such books, records and accounts.

 

19.10Currency embargoes. If at any time currency embargoes or similar legal
restrictions in any country in the Territory prevent the prompt remittance of
any payments hereunder, ARIAD SWISSCO shall make such payments by depositing the
amount thereof in local currency to the account of ARIAD US in a bank or
depository in such country designated by ARIAD US.

 

19.11Generic Competition. In countries in the Territory where (i) a Generic
Product enters the market, the royalty rates set out in Section 19.2 above shall
be reduced by [***] during the Full Royalty Term and by [***] thereafter in such
country, (ii) the Generic Product(s) comprises more than [***] of the unit sales
of Product and Generic Products in such country, the royalty rates set out in
Section 19.2 above shall be reduced by [***] during the Full Royalty Term and by
[***] thereafter, and (iii) the Generic Product(s) comprises more than [***] of
the unit sales of Product and Generic Products in such country, the royalty
rates set out in Section 19.2 above shall be reduced to [***] during the Full
Royalty Term and by [***] thereafter. If such a Generic Product enters the
market prior to the expiration of the Composition Patent in such country and if
ARIAD US institutes an action or proceeding in accordance with Section 23.4 and
prevails in such action the applicable royalty rates set out in Section 19.2
would be reinstated until such other time as the foregoing provision applies.

 

19.12No amounts will be due and payable by ARIAD SWISSCO under Section 19.1 upon
the Buy-Back Option having been exercised pursuant to ARTICLE 16.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  55

 

 

ARTICLE 20 – REPRESENTATIONS AND WARRANTIES

 

20.1ARIAD US hereby represents and warrants to ARIAD SWISSCO as of the Effective
Date, and with respect to Sections 20.1.4, 20.1.5, 20.1.6, 20.1.7 and 20.1.17
only, throughout the Term, as follows:

 

20.1.1Organization. ARIAD US has been duly organized and is validly existing as
a corporation in good standing under the laws of the State of Delaware, USA.
ARIAD US has the corporate power and authority to enter into this Agreement and
to consummate the transactions contemplated by this Agreement.

 

20.1.2Authorization. The execution, delivery and performance of this Agreement,
and the consummation of the transactions contemplated by this Agreement, by
ARIAD US have been duly and validly authorized by all requisite corporate
actions. This Agreement constitutes a legal, valid and binding agreement of
ARIAD US, enforceable against ARIAD US in accordance with its terms.

 

20.1.3Execution. The persons executing this Agreement on behalf of ARIAD US are
duly authorized to do so and by so doing have bound ARIAD US to the terms and
conditions of this Agreement.

 

20.1.4No Inconsistent Obligations. Except as disclosed in the Disclosure
Schedules, the execution, delivery and performance by ARIAD US of this
Agreement, and the consummation of the transactions contemplated by this
Agreement, do not and shall not (i) contravene or conflict with the charter or
bylaws of ARIAD US or its Affiliates, as applicable, or (ii) conflict with,
constitute a default in any material respect under or give rise to any right of
termination or cancellation of, any agreement or instrument to which ARIAD US or
its Affiliates is a party that would have a material adverse effect on the
ability of ARIAD US or its Affiliates to perform its obligations hereunder. As
of the Effective Date, there is no action, suit, investigation or proceeding
pending against, or to the Knowledge of ARIAD US, threatened against or
affecting, ARIAD US or its Affiliates before any court, arbitrator or any
governmental authority, including Regulatory Authorities, which, if decided
against ARIAD US or its Affiliates, would have a material adverse effect on the
ability of ARIAD US or its Affiliates to perform their obligations hereunder.

 

20.1.5Product. Product Delivered hereunder shall:

 

(a)be Manufactured in all material respects in accordance with the Marketing
Authorization, the applicable Quality Agreements, all Applicable Laws and cGMPs;

 

(b)have the requisite shelf life on the date of Delivery as set forth in the
Specifications;

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  56

 

 

(c)conform to the Specifications at the time of Delivery until the expiry date
set forth on the label for the given lot of the Product; and

 

(d)at the time of Delivery, be free and clear of any lien or encumbrance.

 

20.1.6Right to Grant License. ARIAD US and its Affiliates are the sole and
exclusive owners of the Patents listed in Appendix 1.128 and the Know How, and
ARIAD US is entitled to grant the licenses to ARIAD SWISSCO specified in ARTICLE
2.

 

20.1.7Patent Validity and No Patent Challenge. To the Knowledge of ARIAD US, the
claims of the issued patents included in the Patents listed in Appendix 1.128
are not invalid and the issued patents included in the Patents listed in
Appendix 1.128 are not unenforceable in the Territory. No Third Party has
challenged in writing, or, to the Knowledge of ARIAD US, has threatened to
challenge, the enforceability or validity of any issued patents included in the
Patents listed in Appendix 1.128 or any claims therein, respectively in the
Territory through the institution of legal proceedings in a court or through
opposition, interference, reexamination, nullity or similar invalidity
proceedings before a patent office or any equivalent government agency in the
Territory. Appendix 1.128 represents all Patents that cover or disclose the
Compounds and Products as of the Effective Date.

 

20.1.8No ARIAD US Trademark Challenge. No Third Party has challenged in writing,
or, to the Knowledge of ARIAD US, has threatened to challenge, ARIAD US’s right
to use and license the ARIAD US Trademarks in the Territory.

 

20.1.9No Infringement by Third Parties. To the Knowledge of ARIAD US, no Third
Party is infringing the Patents in the Territory.

 

20.1.10No Claim that Development or Commercialization Infringes Third Party IP.
There are no claims asserted in writing, judgments, or settlements in effect
against, or amounts with respect thereto owed by, ARIAD US or any of its
Affiliates relating to the Patents in the Territory. No claim or litigation is
pending or, to the Knowledge of ARIAD US, threatened alleging that the
manufacture, use or sale of the Product in the Territory infringes or would
infringe any issued patent in the Territory. To ARIAD US’s Knowledge, the
Development, Manufacture, and Commercialization of Compounds or Products in the
Field in the Territory will not infringe or misappropriate the intellectual
property or proprietary rights of any Third Party in the Territory.

 

20.1.11Regulatory Documentation. The status of Marketing Authorizations in each
country or other jurisdiction in the Territory as of the Effective Date is
accurately reflected on Appendix 1.167 and each of them is in full force and
effect. To the Knowledge of ARIAD US, ARIAD US and its Affiliates have
generated, prepared, maintained, and retained all material records that are
required to be maintained or retained pursuant to and in accordance with

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  57

 

 

good laboratory practice and cGMP and Applicable Law, and all such information
is true, complete and correct. Neither ARIAD US nor its Affiliates have received
any written notice that any Regulatory Authority with jurisdiction in the
Territory over the Products has commenced or will commence any action: (i) to
suspend, revoke, not renew or materially amend any Marketing Authorization held
by ARIAD US or its Affiliates; or (ii) prohibit production, development,
marketing or sale of the Product in the Territory.

 

20.1.12Patent Prosecution. The Patents listed in Appendix 1.128 have been filed
and maintained, and are being diligently prosecuted, in the respective patent
offices where filed in the Territory in accordance with Applicable Laws. All
applicable and material fees due prior to the Effective Date in connection with
the prosecution and maintenance of the Patents listed in Appendix 1.128 in the
Territory have been paid.

 

20.1.13Compliance with Law. Except as disclosed in the Disclosure Schedules,
ARIAD US and its Affiliates and, to the Knowledge of ARIAD US, their respective
contractors and consultants, have complied in all material respects with
Applicable Laws in the Development, manufacture and Commercialization of the
Compound and Product in the Territory prior to the Effective Date.

 

20.1.14No Encumbrances. ARIAD US or its Affiliates Control the entire right,
title and interest in the Patents and the Know-How, free of any encumbrance,
lien, or claim of ownership by any Third Party, except its obligations to PDL
BioPharma, Inc. under the PDL Agreements.

 

20.1.15Employee Assignments. All current and former officers or employees of
ARIAD US or any of its Affiliates who are inventors of or have otherwise
contributed in a material manner to the creation or development of any Patents
or Know-How have (i) executed and delivered to ARIAD US or any such Affiliate an
assignment or other agreement regarding the protection of proprietary
information and the assignment to ARIAD US or any such Affiliate of any such
Patents or Know How; and (ii) to ARIAD US’s Knowledge, no current officer or
employee of ARIAD US or any of its Affiliates is in violation of any term of any
assignment or other agreement regarding the protection of Patents or Know-How or
of any employment contract or any other contractual obligation relating to the
relationship of any such Person with ARIAD US or any such Affiliate. ARIAD
SWISSCO has no obligation to contribute to any remuneration of any inventor
employed or previously employed by ARIAD US or any of its Affiliates in respect
of any such Patents and Know-How and discoveries and intellectual property
rights therein that are so assigned to ARIAD US or its Affiliate(s).

 

20.1.16No Debarment. Neither ARIAD US nor any of its Affiliates has been
debarred by the FDA, is not subject to any similar sanction of other Regulatory
Authorities in the Territory, and neither ARIAD US nor any of its Affiliates has
used, in any capacity, in connection with this Agreement or any ancillary
agreements (if any), any Person who either has been

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  58

 

 

debarred by such a Regulatory Authority, or is the subject of a conviction
described in Section 306 of the US Federal Food, Drug, and Cosmetic Act or
similar sanction of other Regulatory Authorities.

 

20.1.17Post-Marketing Requirements. Appendix 20.1.17 contains a true and
complete list of all post-marking requirements of all Regulatory Authorities
related to the Products. ARIAD US shall promptly notify ARIAD SWISSCO of any
changes in post-marketing requirements, ARIAD US and its Affiliates have and
during the Term, will comply with all such requirements.

 

For the purposes of this ARTICLE 20, Disclosure Schedules shall mean the
Disclosure Schedules set out in Appendix 20 to this Agreement.

 

ARTICLE 21 – COMPLIANCE WITH LAW; DATA PRIVACY; ANTI-BRIBERY AND ANTI-CORRUPTION

 

21.1Each Party shall obtain and keep current all licenses, certificates,
approvals and permits of whatever nature required under the Regulatory Laws and
the Regulatory Requirements for the fulfilment of such Party’s obligations under
this Agreement.

 

21.2In the performance of its obligations hereunder, each Party shall comply and
shall cause its Affiliates, employees and contractors involved in the
performance of this Agreement, and its Sublicensees and Subcontractors to comply
with all Applicable Laws, including Anti-Corruption Laws, and Industry
Guidelines, and, without limiting the foregoing, each Party shall comply, and
shall cause its Affiliates, Sublicensees, employees and Subcontractors involved
in Named Patient Program to comply with all Industry Guidelines and Applicable
Laws with respect to Named Patient Programs.

 

21.3Each Party shall certify to the other Party on an annual basis the
following:

 

(a)it has in effect and implements an appropriate Anti-Corruption policy;

 

(b)that training and training materials on such Anti-Corruption Policy
(including Anti-Corruption Laws) have been provided to all persons employed by
such Party who perform work under this Agreement and interact with Government
Officials or Healthcare Professionals in the normal course of their
responsibilities; and

 

(c)It has maintained true and accurate records necessary to demonstrate
compliance with the requirements of this Section 21.3.

 

21.4At times, either Party may provide the other Party with personal information
that falls under the protection of certain data security and privacy laws
(“Protected Personal Information”). Without limiting the generality of Section
21.1, each Party agrees to comply with all Applicable Laws relating to the use,
storage, collection or other processing of such Protected Personal Information
(“Data Protection Laws”). The Parties agree to use good-faith efforts to agree
upon and implement any security protocols and information handling guidelines
that their respective legal advisors

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  59

 

 

recommend in connection with the Parties’ compliance with such data security and
privacy laws.

 

21.5Notice of Compliance Events. Each Party agrees that if it learns of any
violation of Anti-Corruption Laws or any material violation of any Data
Protection Laws, Regulatory Laws or Export Control Laws by an employee or
Subcontractor (in the case of ARIAD SWISSCO) or contractor (in the case of ARIAD
US) that performs work under this Agreement (a “Compliance Event”), such Party
(the “Notifying Party”) shall promptly notify the other Party (the “Notified
Party”) in writing of such Compliance Event and the measures Notifying Party has
taken and intends to take to remedy such Compliance Event and to prevent its
recurrence. The Notified Party reserves the right to require the Notifying Party
to prohibit the employee, Subcontractor or contractor (as the case may be) from
performing any work related to this Agreement after due consultation with
Notifying Party.

 

ARTICLE 22 – INDEMNIFICATION, LIMITATIONS OF LIABILITY AND INSURANCE

 

22.1Upon the terms and conditions of this ARTICLE 22, ARIAD SWISSCO shall
defend, indemnify and hold ARIAD US and its Affiliates, and their respective
officers, directors and employees and agents, wholly free and harmless from and
against any and all liabilities, damages, losses, costs, taxes, expenses
(including reasonable attorneys’ fees and other expenses of litigation and
arbitration), claims, demands, suits, penalties, judgments or administrative and
judicial orders (collectively, “Losses”) relating to any Proceeding or
Proceeding threatened in writing to the extent arising out of or resulting from
(a) any failure by ARIAD SWISSCO to comply with any Applicable Laws; (b) the
performance (or failure to perform) by ARIAD SWISSCO, its Affiliates,
Sublicensees, Subcontractors, or its service providers or any of their
respective officers, directors, employees or agents of any of ARIAD SWISSCO’s
obligations under this Agreement (including the Manufacture of Product by ARIAD
SWISSCO, its Affiliates or its or their Third Party contract manufacturers); (c)
any negligent act or omission or willful misconduct of ARIAD SWISSCO, its
Affiliates, Sublicensees, Subcontractors, or its service providers, or any of
their respective officers, directors, employees or agents; (d) any breach by
ARIAD SWISSCO, its Affiliates, Sublicensees, Subcontractors, or service
providers, or any of their respective officers, directors, employees or agents,
of any of ARIAD SWISSCO’s representations, warranties, covenants or material
obligations contained in this Agreement; (e) the storage, sampling,
record-keeping or transfer of the Product by ARIAD SWISSCO, its Affiliates,
Sublicensees, Subcontractors, or its service providers, or any of their
respective officers, directors, employees or agents; and (f) failure of ARIAD
SWISSCO to undertake a voluntary Product Withdrawal in its respective territory,
despite the ARIAD US’s written recommendation that such Product Withdrawal
should be undertaken, except, in each of the foregoing cases, to the extent
ARIAD US has the obligation to indemnify for such Losses pursuant to Section
22.2.

 

22.2Upon the terms and conditions of this ARTICLE 22, ARIAD US shall defend,
indemnify and hold ARIAD SWISSCO and its Affiliates, and their respective
officers, directors and employees and agents, wholly free and harmless from and

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  60

 

 

against any and all Losses relating to any Proceeding or Proceeding threatened
in writing to the extent arising out or resulting from (a) any failure by ARIAD
US to comply with any Applicable Laws; (b) the performance (or failure to
perform) by ARIAD US, its Affiliates, subcontractors or its service providers,
or any of their respective officers, directors, employees or agents of any of
ARIAD US’s obligations under this Agreement (including the Manufacture of
Product by ARIAD US, its Affiliates or its or their Third Party contract
manufacturers); (c) any negligent act or omission or willful misconduct of ARIAD
US, its Affiliates, subcontractors or its service providers, or any of their
respective officers, directors, employees or agents; (d) any breach by ARIAD US,
its Affiliates, subcontractors or its service providers, or any of their
respective officers, directors, employees or agents of any of ARIAD US’s
representations, warranties, covenants or obligations contained in this
Agreement; (e) the storage, sampling, record-keeping or transfer of the Product
by ARIAD US, its Affiliates, subcontractors, or its service providers, or any of
their respective officers, directors, employees or agents; (f) the Development,
commercialization, Manufacture, final manufacture or other exploitation of the
Products or the Compounds anywhere in the world prior to the Effective Date or
after the Effective Date for the Reserved Territory; and (g) failure of ARIAD US
to undertake a voluntary Product Withdrawal in its respective territory, despite
the ARIAD SWISSCO’s written recommendation that such Product Withdrawal should
be undertaken, except for such activities conducted by or on behalf of ARIAD
SWISSCO or its Affiliates.

 

22.3Procedure. The following shall apply to all Proceedings subject to the
obligations set forth in Sections 22.1 and 22.2 above:

 

22.3.1A Party or its indemnified entity seeking indemnification pursuant to
Section 22.1 or Section 22.2 (an “Indemnified Party”) shall give to the Party
from whom such indemnification is sought (the “Indemnifying Party”) prompt
written notice (a “Claim Notice”) of the assertion of any claim, or the
commencement of any Proceeding for which the Indemnified Party believes the
Indemnifying Party may be liable under Section 22.1 or Section 22.2 of this
Agreement, as the case may be. The failure by any Indemnified Party so to notify
the Indemnifying Party shall not relieve the Indemnifying Party from Liability
under Section 22.1 or Section 22.2 of this Agreement, as the case may be, except
to the extent that the Indemnifying Party shall have been prejudiced in any
material respect as a result of such failure. A Claim Notice shall describe the
nature of the claim or Proceeding and shall indicate the amount of Losses
(estimated to the extent that the Losses in respect of any claim or Proceeding
are reasonably capable of being estimated); provided, however, that the failure
to estimate Losses (or the inaccuracy thereof) shall not affect the validity of
a Claim Notice or the amount of Losses to which the Indemnified Party may be
entitled.

 

22.3.2The Indemnifying Party shall have the right at its discretion to control
the defense of any claim or Proceeding and the right to settle or compromise any
such claim or Proceeding; provided that the prior written consent of the
Indemnified Party shall be required in connection with any settlement or
compromise unless such settlement, compromise, discharge or consent to

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  61

 

 

judgment (i) includes the delivery of a written release from all Liability in
respect of such claim or Proceeding, (ii) does not contain any admission or
statement suggesting any wrongdoing or Liability on behalf of the Indemnified
Party, and (iii) does not contain any equitable order, judgment or term which in
any manner affects, restrains or interferes with the business of the Indemnified
Party or any of its Affiliates. The Indemnifying Party shall exercise such right
by delivering written notice of its intent to undertake the defense of such
claim or Proceeding to the Indemnified Party within [***] after the receipt of a
Claim Notice. If the Indemnifying Party elects to control the defense of the
claim or Proceeding, then all expenses and legal fees of such defense shall be
borne by the Indemnifying Party. If the Indemnifying Party elects to control the
defense of the claim or Proceeding, then the Indemnified Party may participate
therein through counsel of its choice, but the cost of such counsel shall be
borne solely by the Indemnified Party. Only in the event that the Indemnifying
Party does not assume such defense within [***] after its receipt of a Claim
Notice or the Indemnifying Party notifies the Indemnified Party that it will not
assume such defense, the Indemnified Party may control the defense of such claim
or Proceeding at the Indemnifying Party’s cost and the Indemnified Party may
settle the claim or Proceeding on behalf of and for the account and risk of the
Indemnifying Party, who shall be bound by the result.

 

22.3.3The Indemnifying Party or the Indemnified Party, as the case may be, shall
at all times use commercially reasonable efforts to keep the Indemnifying Party
or the Indemnified Party, as the case may be, reasonably appraised of the status
of the defense of any matter the defense of which it is maintaining and to
cooperate in good faith with the Indemnifying Party or the Indemnified Party, as
the case may be, with respect to the defense of any such matter.

 

22.4EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE SUPPLY AGREEMENT OR THE
QUALITY AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY
KIND, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER
WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY, NON-INFRINGEMENT, COMMERCIAL POTENTIAL, CAPACITY OR FITNESS FOR
A PARTICULAR PURPOSE WITH RESPECT TO THE KNOW-HOW, THE PATENTS AND/OR THE
PRODUCT. NEITHER PARTY NOR ANY OF ITS RESPECTIVE EMPLOYEES OR REPRESENTATIVES IS
AUTHORIZED TO GIVE ANY WARRANTIES OR MAKE ANY REPRESENTATION ON BEHALF OF THE
OTHER PARTY.

 

22.5SUBJECT TO SECTION 22.6 AND EXCEPT AS EXPRESSLY SET FORTH IN SECTION 10.7,
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER OF THE PARTIES SHALL
BE LIABLE TO THE OTHER PARTY FOR INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY,
INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES ARISING OUT OF THIS

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  62

 

 

AGREEMENT, INCLUDING LOSS OF PROFITS OR REVENUES, REGARDLESS OF WHETHER SUCH
DAMAGES WERE FORESEEABLE OR NOT AND REGARDLESS OF ANY NOTICE OF SUCH DAMAGES OR
LOSSES.

 

22.6THE LIMITATIONS AND EXCLUSIONS OF LIABILITY SET FORTH IN SECTIONS 22.4 AND
22.5 SHALL NOT LIMIT OR RESTRICT: (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS
OF EITHER PARTY WITH RESPECT TO LOSSES AWARDED TO THIRD PARTY CLAIMANTS IN THIRD
PARTY PROCEEDINGS THAT ARE SUBJECT TO THE OBLIGATIONS IN SECTION 22.1 OR SECTION
22.2; OR (B) ANY LIABILITY THAT CANNOT BE LIMITED OR EXCLUDED UNDER APPLICABLE
LAW.

 

22.7Each Party agrees to procure and maintain in full force and effect during
the Term valid and collectible insurance policies in connection with its
activities as contemplated herein in amounts that are normal and customary in
the pharmaceutical industry generally for prudent companies similarly situated.
In particular, ARIAD SWISSCO’s coverage shall have limits of Liability which are
commercially reasonable in the Territory but shall be [***] per loss occurrence.
[***]. Each Party shall provide to the other Party upon such other Party’s
request a certificate evidencing the coverage required hereby and the amount
thereof. Each Party’s coverage shall be with a reputable insurance company and
shall have to be maintained for not less than [***] following expiration or
termination of this Agreement for any reason.

 

ARTICLE 23 – THE PATENTS

 

23.1Patent Marking. ARIAD SWISSCO acknowledges and agrees that any of the
Product Commercialized by it shall be marked with a notice of patent rights as
necessary or desirable, and legally possible, under Applicable Law to enable the
Patents to be enforced to the maximum extent permissible under Applicable Laws.

 

23.2Claims Relating to Patent Validity. ARIAD SWISSCO shall reasonably cooperate
with ARIAD US in connection with any claim, action, lawsuit, hearing, patent
office review or other Proceeding relating to the validity of the Patents in the
Territory, including by being joined as a necessary party to any such Proceeding
[***]. For clarity, any Proceeding attacking the validity of a Patent in
connection with an action under Section 23.4 (for example, an alleged
infringer’s attack on the validity of a Patent as a defense to an allegation of
infringement of such Patent) shall be dealt with pursuant to Section 23.4.

 

23.3Patent Prosecution and Maintenance.

 

23.3.1ARIAD US shall have the first right to prepare, file, prosecute (including
any reissues, re-examinations, post-grant proceedings, requests for patent term
extensions, supplementary protection certificates, interferences, and defense of
invalidation or opposition proceedings or of other challenges to validity or
enforceability) and maintain the Patents in the Territory, and shall keep ARIAD
SWISSCO informed regarding any such matters. ARIAD US shall consider in good
faith all comments, recommendations, analysis, and strategies provided by ARIAD
SWISSCO for patent

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  63

 

 

protection in the Territory. ARIAD SWISSCO shall provide reasonable assistance
in connection with any such prosecution and maintenance, including reasonably
cooperating with ARIAD US, as may be reasonably requested by ARIAD US from time
to time for the purpose of filing for and obtaining patent extensions and
supplementary or complementary protection certificates, if available, of the
Patents under the relevant Applicable Laws of the Territory. [***] shall be
responsible for any Patent prosecution and maintenance costs for the Territory
and shall reimburse [***] of [***]’s costs related to such Patent prosecution
and maintenance for the Territory within [***] of receipt of an invoice therefor
incurred in relation to its obligations under this Section 23.3.1.

 

23.3.2In the event that ARIAD US intends to cease to prosecute, or maintain a
Patent in a country in the Territory, ARIAD US shall provide reasonable prior
written notice to ARIAD SWISSCO of such intention (which notice shall, in any
event, be given no later than [***] prior to the next deadline for any action
that may be taken with respect to prosecution or maintenance of such ARIAD US
Patent in such country), and ARIAD SWISSCO shall thereupon have the option, in
its sole discretion, to assume the control and direction of the, prosecution and
maintenance of such Patent in such country. Upon ARIAD SWISSCO’s written
exercise of such option, ARIAD SWISSCO shall assume responsibility and full
control for the prosecution and maintenance of such patent in such country at
its own expense.

 

23.4Patent Enforcement.

 

23.4.1Each Party shall, within [***], inform the other Party in writing upon its
becoming aware of any potential infringement or misappropriation of any of the
Patents in the Territory. ARIAD SWISSCO shall provide reasonable assistance in
connection with any Proceedings to stop such infringement and/or recover damages
for such infringement in the Territory (including joining any action if
necessary), as may be reasonably requested by ARIAD US. ARIAD US shall have the
first right to control any such Proceedings and ARIAD SWISSCO shall reimburse
ARIAD US [***] of ARIAD US’s costs related to such Proceedings within [***] of
receipt of an invoice therefor incurred in relation to its obligations under
this Section. ARIAD SWISSCO shall also have the option to be represented by
counsel of its own choice to participate in the Proceedings in the Territory
[***]. For clarity, the foregoing option shall not relieve ARIAD SWISSCO’s
obligation to reimburse ARIAD US [***] of ARIAD US’s costs related to such
Proceedings.

 

23.4.2If ARIAD US does not institute an action or proceeding or take other
action to prevent or terminate such possible infringement in the Territory prior
to the earlier of (i) [***] following receipt of notice of such possible
infringement or (ii) in the case an injunction may be required, as soon as such
injunction is reasonably necessary, then ARIAD SWISSCO shall have the right to
institute an action or proceeding or take other appropriate action that it
believes is reasonably required to prevent or terminate such possible

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  64

 

 

infringement in the Territory, including possible infringement of the Patents in
the Territory if (and only if) such possible infringement involves the
development or commercialization of a product that contains the Compound, with
the reasonable assistance and cooperation of ARIAD US. In the event that ARIAD
SWISSCO institutes an action or proceeding or takes other appropriate action
that it believes is reasonably required to prevent or terminate such possible
infringement in the Territory, ARIAD SWISSCO reserves the right to have sole
control over such proceedings, subject to Section 23.4.4.

 

23.4.3In the event that ARIAD SWISSCO becomes aware of any challenge to the
validity of any Patent in a country in the Territory, ARIAD SWISSCO shall
provide reasonable prior written notice to ARIAD US of such challenge (which
notice shall, in any event, be given within [***] of ARIAD SWISSCO becoming
aware of such challenge), and ARIAD US shall thereupon have the option, in its
sole discretion, to assume the control and direction of any Proceedings in
relation to such Patent in such country.

 

23.4.4ARIAD SWISSCO shall not settle any action or Proceedings in a manner that
would have a material adverse effect on the rights or interests of ARIAD US or
its Affiliates without the prior written consent of the ARIAD US.

 

23.4.5Any recoveries from such Proceedings or amounts received by ARIAD US or
ARIAD SWISSCO from the settlement of the same shall be allocated as follows:
First, each Party shall be reimbursed for its direct, out-of-pocket expenses for
conducting, or cooperating with, such Proceeding, and second, the balance shall
be [***], provided that any recovery or settlement amount that includes
countries outside of the Territory shall be [***], acting reasonably and in good
faith, prior to such allocation between the Parties.

 

23.4.6ARIAD SWISSCO shall have no right to sue or institute an action or
proceeding or take other action to prevent infringement of any Patent other than
as set out in this Section 23.4.

 

23.5Infringement Claims by Third Parties.

 

23.5.1Each Party shall promptly notify the other Party in writing of any
allegation by a Third Party in the Territory that any Compound and/or Product
development, Commercialization (including import or export) or manufacturing
activities conducted by the Parties pursuant to this Agreement infringe or
misappropriate or may infringe or misappropriate the Intellectual Property
Rights in the Territory of such Third Party (a “Third Party Infringement
Claim”). The Parties shall discuss which Party shall defend the Third Party
Infringement Claim, and absent mutual agreement otherwise, each Party shall have
the right to control the defense of any such Third Party Infringement Claim
brought against it, by counsel of its own choice. If a Third Party Infringement
Claim is brought against one Party (the “Defending Party”) but not the other
Party, the non-Defending Party

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  65

 

 

shall have the right, at its own expense, to be represented in such Third Party
Infringement Claim by counsel of its own choice.

 

23.5.2Each Defending Party shall keep the other Party reasonably informed of all
material developments in connection with any Third Party Infringement Claim.
Each Defending Party agrees to provide the other Party with copies of all
pleadings filed in any suit or proceeding relating to such Third Party
Infringement Claim. The Defending Party may enter into a settlement or
compromise of any Third Party Infringement Claim, provided that, if such
settlement or compromise would admit Liability on the part of the non-Defending
Party or any of its Affiliates or would otherwise have a material adverse effect
on the rights or interests of the non-Defending Party or its Affiliates, the
Defending Party shall not enter into such settlement or compromise without the
prior written consent of the non-Defending Party.

 

23.5.3If a Third Party Infringement Claim is brought against both Parties, or
initially against one Party and the other Party is subsequently joined to the
Proceedings, all out-of-pocket expenses incurred by each Defending Party in
defending such Third Party Infringement Claim in the Territory (including
outside counsel fees), and all amounts payable by either Defending Party as a
judgment based on such Third Party Infringement Claim or in settlement of such
Third Party Infringement Claim (excluding payments pursuant to any Third Party
License, which is governed by Section 23.6), shall be paid for by the Parties as
follows: [***] by ARIAD SWISSCO and [***] by ARIAD US.

 

23.5.4If a Third Party Infringement Claim is brought against only one Defending
Party and the other Party is not subsequently joined to the Proceedings, all
out-of-pocket expenses incurred by such Defending Party in defending such Third
Party Infringement Claim in the Territory (including outside counsel fees), and
all amounts payable by such Defending Party as a judgment based on such Third
Party Infringement Claim or in settlement of such Third Party Infringement Claim
(excluding payments pursuant to any Third Party License, which is governed by
Section 23.6), shall be [***].

 

23.5.5Any recovery by a Party of any sanctions or other amounts awarded to such
Party against a Third Party asserting a Third Party Infringement Claim shall be
applied in the same manner as recoveries in an action as set forth in Section
23.4.5.

 

23.5.6If a Defending Party elects to enter into an agreement with a Third Party
to obtain a license under such Third Party’s Intellectual Property Rights
(“Third Party License”) in settlement of a Third Party Infringement Claim
asserted by such Third Party, the provisions of Section 23.6 shall apply.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  66

 

 

23.6Third Party Licenses.

 

23.6.1Territory-Only Third Party License.

 

(a)With respect to any Third Party License under which ARIAD SWISSCO is granted
rights relating to its exercise of its license grant under this Agreement and
which does not relate to the retained rights of ARIAD US with respect to the
Reserved Territory (“Territory-Only Third Party License”), the Parties (through
the JSC) shall discuss (1) whether such license is necessary or (2) or whether
such license is useful (but not necessary) and, in the case of this clause (2),
whether to obtain such Territory-Only Third Party License. A Territory-Only
Third Party License shall be considered necessary (and the JSC shall have no
discretion with regarding to such determination) if the intellectual property
included in such Third Party license covers the Compound or Product or the
Manufacture thereof in accordance with Section 6.4.

 

(b)If a Territory-Only Third Party License is necessary for ARIAD SWISSCO to
exercise its license grant under this Agreement, ARIAD SWISSCO shall have the
responsibility for negotiating such license and shall have the final
decision-making authority regarding the terms of such license, subject to
Section 23.6.3.

 

(c)If a Territory-Only Third Party License is useful (but not necessary) for
ARIAD SWISSCO to exercise its license grant under this Agreement, the JSC shall
determine (with neither Party having final decision-making authority) whether to
obtain such Territory-Only Third Party License and, if such a determination is
made to obtain such license, ARIAD SWISSCO shall have responsibility for
negotiating such license in accordance with terms agreed upon by the Parties. If
the Parties are unable to agree upon terms for a useful Territory-Only Third
Party License that the JSC has determined to obtain, ARIAD SWISSCO shall have
the final decision-making authority regarding the terms of such license, subject
to Section 23.6.3.

 

(d)In the event ARIAD SWISSCO enters into a Territory-Only Third Party License
(i) in accordance with Section 23.6.1(b) or (ii) in accordance with Section
23.6.1(c) in the event of a determination by the JSC to obtain such license,
ARIAD SWISSCO shall have the right to deduct [***] of all payments paid pursuant
to such Territory-Only Third Party License from the royalties payable to ARIAD
US pursuant to Section 19.2; provided, that in no event shall the royalty rate
otherwise payable to ARIAD US pursuant to Section 19.2.1 and Section 19.2.2 be
reduced by more than [***] in the aggregate; and provided further that, if, but
for the preceding proviso, the deduction under this Section 23.6.1(d) would have
reduced a royalty payment made by ARIAD SWISSCO to ARIAD US by more than [***],
then the amount of such deduction that exceeds [***] will be carried over

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  67

 

 

to subsequent royalty payments until the full amount that ARIAD SWISSCO would
have been entitled to deduct (absent the preceding proviso) is deducted.

 

(e)In the event ARIAD SWISSCO enters into a Territory-Only Third Party License
in accordance with Section 23.6.1(c) with absence of a determination by the JSC
to obtain such license, ARIAD SWISSCO shall have the sole responsibility for
making any payments due thereunder.

 

23.6.2Global Third Party License.

 

(a)With respect to any Third Party License to (i) Develop or Manufacture Product
in the Territory and the Reserved Territory, or (ii) Commercialize Product in
the Field in the Territory and the Reserved Territory (“Global Third Party
License”), the Parties (through the JSC) shall determine whether to obtain such
Global Third Party License and which Party will be responsible for negotiating
such license (it being agreed that if such Global Third Party License relates to
the US then ARIAD US shall be the Party responsible). If the Parties (through
the JSC) do not agree to obtain such Global Third Party License, cannot agree
upon the negotiating Party or cannot agree on the final form of such Global
Third Party License, ARIAD SWISSCO may enter into a Territory-Only Third Party
License pursuant to the terms of 23.6.1.

 

(b)If the Parties proceed with a Global Third Party License, ARIAD SWISSCO shall
be responsible for [***] of payments owed under such Global Third Party License
that are attributable to the Territory (and may deduct such amounts from the
royalties payable to ARIAD US pursuant to Section 19.2) and ARIAD US shall be
responsible for [***] of the payments attributable to the Territory and [***] of
the payments attributable to the Reserved Territory.

 

23.6.3For Territory-Only Third Party Licenses other than those for which ARIAD
SWISSCO has sole responsibility for payments, ARIAD SWISSCO shall keep ARIAD US
reasonably informed with respect to the negotiations and deal terms relating to
such license (including scope of the license and financial terms) and the ARIAD
SWISSCO shall consider in good faith any comments, recommendations or analysis
provided by ARIAD US. With respect to any Global Third Party License, the
negotiating Party shall keep the other Party reasonably informed with respect to
the negotiations and deal terms relating to such license (including scope of the
license and financial terms), provide the other Party a reasonable opportunity
to comment and consider in good faith all comments provided by the other Party
and shall secure the written consent of the other Party prior to executing such
Global Third Party License.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  68

 

 

ARTICLE 24 – CONFIDENTIALITY

 

24.1Each Party shall treat as strictly confidential any information, data and/or
document provided orally, visually, in writing or other form by or on behalf of
the other Party or its Affiliates hereunder and not generally known to the trade
and non-public information relating to the business of the disclosing Party or
its Affiliates (all hereinafter referred to as the “Confidential Information”),
and each receiving Party shall use the Confidential Information of the
disclosing Party solely for the purpose of and in accordance with this
Agreement. Each Party may disclose Confidential Information of the other Party
to its employees and agents and to the employees and agents of its Affiliates,
Sublicensees (in the case of ARIAD SWISSCO), Subcontractors (in the case of
ARIAD SWISSCO) and other Third Party contractors solely for purposes, and only
to the extent reasonably required, to facilitate the performance of such Party’s
rights or obligations under this Agreement, provided that each such employee and
agent and such Sublicensee, Subcontractor or other Third Party contractor, as
applicable, has confidentiality obligations with such receiving Party containing
provisions that protect the Confidential Information of the disclosing Party
that are materially equivalent to, or more protective than, the provisions of
this ARTICLE 24. In addition, ARIAD US and ARIAD SWISSCO each agrees that the
other Party may disclose its Confidential Information (a) to such other Party’s
legal and financial advisors, (b) as reasonably necessary in connection with an
actual or potential (i) debt or equity financing of such other Party, (ii)
merger, acquisition, consolidation, share exchange or other similar transaction
involving such Party and any Third Party, or (iii) prosecution, defense or
enforcement of any patent pursuant to ARTICLE 23 or of any litigation, (c) as
reasonably required in preparing Regulatory Documentation and obtaining
Registrations, (d) to comply with Applicable Law or any obligation in this
Agreement, (e) in communications with existing or bona fide prospective
acquirers, merger partners, lenders (including PDL BioPharma Inc. under the PDL
Agreements) or investors, and consultants and advisors in connection with
transactions or bona fide prospective transactions with the foregoing, in each
case on a “need-to-know” basis and under appropriate confidentiality provisions
substantially equivalent to those of this Agreement; provided, however, that the
receiving Party shall remain responsible for any violation of such
confidentiality provisions by any Third Party receiving such Confidential
Information; (f) to its Affiliates, Sublicensees or prospective Sublicensees,
Subcontractors or prospective Subcontractors (including Third Party
manufacturers), consultants, agents and advisors on a “need-to-know” basis in
order for the receiving Party to exercise its rights or fulfill its obligations
under this Agreement, each of whom prior to disclosure must be bound by
obligations of confidentiality and restrictions on use of such Confidential
Information that are no less restrictive than those set forth in this ARTICLE
24; provided, however, that, in each of the above situations, the receiving
Party shall remain responsible for any failure by any Person who receives
Confidential Information pursuant to this Section 24.1(f) to treat such
Confidential Information as required under this ARTICLE 24 and (g) for any other
purpose with the other Party’s written consent, not to be unreasonably withheld,
conditioned or delayed. Except as set forth in the two preceding sentences,
neither Party shall make Confidential Information of the other Party available
to any Third Party, or any of its Affiliates, except in accordance with Section
24.3 or to applicable government agencies as required by Applicable Laws, and in
this case (1) solely to the extent required by such Applicable Laws (based on

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  69

 

 

advice of legal counsel) and (2) only upon exercise of its reasonable efforts to
cause said agencies to maintain confidentiality thereof.

 

24.2Subject to any different arrangements agreed in writing by the Parties
pursuant to this Agreement, prior to the publication or presentation of any
information or data arising from any Development activity performed by a Party
or its Affiliates pursuant to ARTICLE 5, or other Development activities
performed hereunder, the Developing Party shall submit to the other Party a
summary of the proposed publication or presentation at least [***] prior to the
submission thereof for publication or presentation. The purposes for such prior
submission are: (i) to provide the non-Developing Party with the opportunity to
review and comment on the contents of the proposed publication or presentation;
and (ii) to identify any Confidential Information to be deleted from the
proposed publication or presentation. Any Confidential Information identified by
the non-Developing Party shall be deleted prior to publication or presentation.

 

24.3Notwithstanding expiration or termination of this Agreement for any reason,
the foregoing confidentiality and non-use obligations shall continue for a
period of [***] after expiration or termination of this Agreement.
Notwithstanding the foregoing, nothing contained in this ARTICLE 24 shall in any
way restrict or impair the right of either Party to use, disclose or otherwise
deal with Confidential Information of the disclosing Party, which the receiving
Party can demonstrate by competent written evidence:

 

24.3.1is or hereafter becomes part of the public domain through no act or
omission of the receiving Party, its employees, Affiliates, sublicensees and/or
subcontractors; or

 

24.3.2was in the lawful possession of the receiving Party prior to receipt of
the Confidential Information from the disclosing Party; or

 

24.3.3previously was, or at any time hereafter is, provided to the receiving
Party by a Third Party having the right to do so and which did not originate
directly or indirectly from the disclosing Party; or

 

24.3.4at the time of disclosure, was known by the receiving Party or an
Affiliate, sublicensee or subcontractor other than as a result of disclosure to
such party by the disclosing Party;

 

24.3.5or after disclosure was independently developed by the receiving Party, an
Affiliate, sublicensee or subcontractor without use of the Confidential
Information of the disclosing Party.

 

24.4The content of this Agreement shall constitute Confidential Information of
each Party and shall be treated by both Parties in accordance with the
provisions of this ARTICLE 24 and Section 30.9 (Public Statements).

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  70

 

 

ARTICLE 25 – TERM

 

25.1This Agreement comes into force at the Effective Date hereof and shall
remain in effect country by country of the Territory until the expiration of the
Royalty Term in such country, unless earlier terminated in accordance with the
terms of this Agreement.

 

ARTICLE 26 – TERMINATION

 

26.1Uncured Material Breach. If either Party (the “Non-Breaching Party”)
believes that the other Party (the “Breaching Party”) is in material breach of
any of its obligations under this Agreement, then the Non-Breaching Party may
deliver written notice of such material breach to the Breaching Party specifying
the nature of the breach (a “Default Notice”). The Breaching Party shall have
[***] (or [***] in the event of a payment breach) from the receipt of the
Default Notice to cure such breach or to dispute the allegation of breach;
provided that, if such breach (other than a payment breach) is capable of being
cured, but cannot be cured within such [***] period, and the Breaching Party
initiates actions to cure such breach within such period and thereafter
diligently pursues such actions, the Breaching Party shall have such additional
period as is reasonable to cure such breach, but in no event will such
additional period exceed [***]. If the Breaching Party fails to cure, and fails
to dispute, such breach within the applicable cure period, then the
Non-Breaching Party may pursue any or all available remedies at law or equity
but may not terminate this Agreement; provided, that, if such material breach
materially diminishes, or materially frustrates, the value of this Agreement
taken as a whole to the Non-Breaching Party, then the Non-Breaching Party shall
have the right to terminate this Agreement (1) if such material breach and
failure to cure is solely with respect to a particular country or countries,
such right to terminate this Agreement shall be solely with respect to such
country or countries, as applicable, or (2) if such material breach and failure
to cure is not solely with respect to a particular country or countries, such
right to terminate this Agreement shall be with respect to this Agreement in its
entirety. The Non-Breaching Party may effectuate such termination by giving the
Breaching Party written notice of termination, which termination shall be
effective immediately upon the Breaching Party’s receipt of such notice of
termination. If the Breaching Party disputes in good faith the existence or
materiality of a breach specified in a Default Notice or disputes any allegation
that the Breaching Party failed to cure or remedy such breach, and the Breaching
Party provides written notice of such dispute to the Non-Breaching Party within
the above applicable cure period, the matter shall be addressed under the
dispute resolution procedures in ARTICLE 29 (and during the pendency of such
dispute resolution, the Non-Breaching Party may not terminate this Agreement).
If, as a result of the application of such dispute resolution procedures, the
Breaching Party is determined to be in material breach of any provision of this
Agreement (an “Adverse Ruling”), and if the Breaching Party fails to complete
the actions specified by the Adverse Ruling to cure such material breach within
[***] after its receipt of such Adverse Ruling (or within [***] in the case of
an Adverse Ruling resulting from a payment breach), then, if such Adverse Ruling
specifies that such material breach materially diminishes, or materially
frustrates, the value of this Agreement taken as a whole to the Non-Breaching
Party, the Non-Breaching Party may terminate this Agreement with respect to such

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  71

 

 

particular country or countries, or with respect to this Agreement in its
entirety, as applicable in accordance with clauses (1) and (2) above, by giving
the Breaching Party written notice of termination, which termination shall be
effective immediately upon the Breaching Party’s receipt of such notice of
termination.

 

26.2Bankruptcy or Insolvency.

 

26.2.1Either Party shall have the right to terminate this Agreement immediately
upon written notice to the other Party, if such other Party or any of its
Affiliates (i) files a petition under any bankruptcy act or has any such
petition filed against it that is not discharged within [***] of the filing
thereof, (ii) makes an assignment for the benefit of creditors, or (iii)
appoints or suffers appointment of a receiver or trustee over substantially all
of its property that is not discharged within [***] after such filing.

 

26.2.2All licenses granted under or pursuant to this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy
Code or any analogous provisions in any other country or jurisdiction, licenses
of rights to “intellectual property” as defined under Section 101 of the U.S.
Bankruptcy Code. The Parties agree that ARIAD SWISSCO, as licensee of such
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code or any analogous provisions
in any other country or jurisdiction. The Parties further agree that, in the
event of the commencement of a bankruptcy proceeding by or against ARIAD US
under the U.S. Bankruptcy Code or any analogous provisions in any other country
or jurisdiction which proceeding is not terminated or withdrawn within [***]
after such commencement, ARIAD SWISSCO shall be entitled (unless ARIAD US elects
to continue to perform all of its obligations under this Agreement) to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property
necessary to exercise its license rights granted hereunder, which, if not
already in the ARIAD SWISSCO’s possession, shall be promptly delivered to it (i)
after [***] following any such commencement of a bankruptcy proceeding, upon
ARIAD SWISSCO’s written request therefor (unless ARIAD US elects to continue to
perform all of its obligations under this Agreement), or (ii) if not delivered
under subsection (i) above, following the rejection of this Agreement by or on
behalf of ARIAD US, upon written request therefor by ARIAD SWISSCO.

 

26.3Termination for Force Majeure. For the avoidance of doubt, this Agreement
also may be terminated as set forth in ARTICLE 27 (Force Majeure).

 

26.4Termination by ARIAD SWISSCO for Convenience. At any time after the three
(3) year anniversary of the Effective Date, ARIAD SWISSCO may terminate this
Agreement in its entirety, or on a country-by-country basis, for any or no
reason, upon twelve (12) months’ prior written notice to ARIAD US.

 

26.5Termination by ARIAD US. If ARIAD SWISSCO and its Affiliates fail to meet at
least [***] of the minimum expenditure obligations set forth in Section 15.2 in
each

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  72

 

 

of [***], and if ARIAD SWISSCO fails to exceed by at least [***] the minimum
expenditure obligations in each of the succeeding [***], then ARIAD US may
terminate this Agreement in its entirety upon [***] prior written notice to
ARIAD SWISSCO. Notwithstanding anything to the contrary in this Agreement, the
provisions of this Section 26.5 shall be the sole and exclusive remedy of ARIAD
US in this event.

 

26.6Effects of Termination and Expiration.

 

26.6.1Termination or expiration of this Agreement for any reason shall not
extinguish any existing claims either of the Parties may have for
indemnification pursuant to the terms and conditions of this Agreement, and
shall not preclude either of the Parties from pursuing any claim for
indemnification such Party otherwise may have pursuant to the terms and
conditions of this Agreement to the extent that the circumstances giving rise to
such claim arose prior to, on or after the date of termination or expiration of
this Agreement. Furthermore, the termination or expiration this Agreement shall
have no effect on a Party’s obligation to make any payment accruing prior to the
date of termination or expiration.

 

26.6.2Following expiration of the Royalty Term, the grants in Section 2.1 shall
become exclusive, fully-paid, royalty-free, perpetual and irrevocable.

 

26.6.3Upon termination of this entire Agreement by ARIAD US under Sections 26.1,
26.2, or 26.5 or by ARIAD SWISSCO under Section 26.4, or under ARTICLE 27 for
Force Majeure, the Transition Back Arrangements shall apply and shall be
implemented by the Parties.

 

26.6.4In the event of termination of this Agreement by ARIAD US under Section
26.1 in relation to a particular country or countries all rights granted to
ARIAD SWISSCO in relation to such country or countries shall terminate and ARIAD
SWISSCO shall cease any use and/or exploitation of the Registration with respect
to the Product in the terminated country or countries and shall promptly and
unconditionally transfer such Registration to ARIAD US or to ARIAD US’s nominee
or if not so assignable, permit ARIAD US or such nominee to cross-refer to such
Registration when applying for a new registration in their own name. ARIAD
SWISSCO shall cease Commercializing the Product in the terminated country or
countries, subject to a [***] sell off period.

 

26.6.5Upon the termination of this Agreement for any reason, ARIAD SWISSCO shall
have the right but not the obligation to sell all or a part of ARIAD SWISSCO’s
remaining stocks of the Product.

 

ARTICLE 27 – FORCE MAJEURE

 

27.1If the performance of this Agreement is prevented or restricted by
government action, war, fire, explosion, flood, strike, lockout, embargo,
epidemics, pandemics, quarantines, acts of terrorism, lockouts or other labor
disturbances, act of God, failures of common carriers, or any other similar
cause beyond the control of the

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  73

 

 

defaulting Party, or supply failures due to the foregoing or similar causes
beyond the control of the defaulting Party’s suppliers or contractors, the Party
so affected shall be released for the duration of the force majeure, or such
other period agreed between the Parties as being reasonable in all
circumstances, from its contractual obligations directly affected by the force
majeure, provided that the Party concerned shall:

 

(a)give prompt notice in writing to the other Party of the cause of force
majeure;

 

(b)use Commercially Reasonable Efforts to avoid or remove such cause of
non-performance; and

 

(c)continue the full performance of this Agreement as soon as such cause is
removed.

 

27.2The Parties shall take all reasonable steps to minimize the effects of force
majeure on the performance of this Agreement and shall, if necessary, agree upon
appropriate measures to be taken. Should the force majeure continue for more
than [***], then the Party not affected by such force majeure shall have the
right to terminate this Agreement immediately upon written notice to the
affected Party.

 

27.3Notwithstanding anything contained in this ARTICLE 27, obligations to pay
money are never excused by force majeure.

 

ARTICLE 28 – LAW TO GOVERN

 

28.1This Agreement shall be governed by and construed in accordance with the law
of the State of New York, United States of America, excluding any conflicts or
choice of law rule or principle that might otherwise make this Agreement subject
to the substantive law of another jurisdiction.

 

ARTICLE 29 – DISPUTE RESOLUTION

 

29.1Generally. The Parties recognize that disputes as to matters arising under
or relating to this Agreement or either Party’s rights and/or obligations
hereunder may arise from time to time. It is the objective of the Parties to
establish procedures to facilitate the resolution of such disputes in an
expedient manner by mutual cooperation and without resort to litigation. To
accomplish this objective, the Parties agree to follow the procedures set forth
in this ARTICLE 29 to resolve any such dispute if and when it arises.

 

29.2Escalation to Senior Officers. If an unresolved dispute as to matters
arising under or relating to this Agreement or either Party’s rights and/or
obligations hereunder arises (other than any dispute at the JSC which is subject
to the dispute resolution procedures set forth in Section 4.7, or any other
matter that is expressly subject to either Party’s final decision-making
authority or final approval as set forth elsewhere herein), either Party may
refer such dispute to the Senior Officers or their respective designees, who
shall meet in person or by telephone within [***] after such referral to attempt
in good faith to resolve such dispute and each Senior Officer may include a
relevant subject matter expert relevant to the dispute. If such matter cannot be

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  74

 

 

resolved by discussion of such officers within such [***] period (as may be
extended by mutual written agreement), such dispute shall be resolved in
accordance with Section 29.3. The Parties acknowledge that these discussions
between the Parties to resolve disputes are settlement discussions under
applicable rules of evidence and without prejudice to either Party’s legal
position.

 

29.3Jurisdiction. Any unresolved dispute that was the subject of Section 29.2
(and for which a Party does not have final decision making authority) shall be
brought exclusively in the federal courts of the United States of America
located in New York City, New York (and each party hereby consents to personal
jurisdiction and venue in, and agrees to service of process issued or authorized
by, such court); provided that either Party may seek injunctive relief from any
court of competent jurisdiction with respect to any claim for specific
performance or injunctive or other equitable relief as a remedy for a breach or
threatened breach of this Agreement and either Party may seek the enforcement of
any award of damages, in any court of competent jurisdiction.

 

ARTICLE 30 – MISCELLANEOUS

 

30.1Entire Agreement. Each schedule, exhibit or appendix hereto is integral to
this Agreement and is hereby incorporated herein. This Agreement supersedes all
prior agreements and understandings, including the CDA, the Buy-In License
Agreement, CSA Agreement, whether oral or written, made by either Party or
between the Parties and constitutes the entire Agreement of the Parties with
regard to the subject matter hereof. It shall not be considered extended,
cancelled or amended in any respect unless done so in writing and signed on
behalf of the Parties hereto. Information disclosed by either Party or its
Affiliates under the CDA shall be governed by the CDA until the Effective Date
of this Agreement, and shall be deemed to be Confidential Information of the
applicable Party disclosed hereunder and subject to the confidentiality
provisions of this Agreement from and including the Effective Date for the
duration set forth herein. If there is any conflict between any provision of the
main body of this Agreement and any provision set forth in a schedule, exhibit
or appendix hereto (each of which is hereby incorporated herein), the provision
set forth in the main body of this Agreement shall govern.

 

30.2Severability. The Parties hereby expressly state that neither Party intends
to violate any rule, law or regulation. If any provision of this Agreement is in
violation of any rule, law or regulation it shall be invalid and unenforceable,
without affecting the validity or enforceability of other provisions of this
Agreement. The Parties agree to renegotiate such provision in good faith and, to
the extent possible, to replace it with valid and enforceable provisions in such
a way as to reflect as nearly as possible the intent and purpose of the original
provision.

 

30.3Independent contractor status. The status of ARIAD US and ARIAD SWISSCO
under the business arrangement established by this Agreement is that of
independent contractors. When ARIAD SWISSCO acquires Products from ARIAD US or
ARIAD US’s nominee it shall Commercialize them to its Customers in its own name,
and for its own account. Neither Party has authority whatsoever to act as an
agent or representative of the other Party except as expressly set forth in this
Agreement, nor

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  75

 

 

any authority or power to contract in the name of or create any Liability
against or otherwise bind the other Party or its Affiliate in any way for any
purpose, nor shall ARIAD US or its Affiliate have such authority or power to so
bind ARIAD SWISSCO.

 

30.4Notices. Other than routine communications made through the JSC, its
subcommittees or project teams, or the Alliance Managers within the remit of
such committees or persons, as contemplated elsewhere herein, all reports,
notices, approvals and communications required or permitted to be made pursuant
to this Agreement by one Party to the other shall be validly given or made for
all purposes, in the absence of acknowledgement of receipt, on the date of
mailing if mailed by registered airmail or by international courier to the
addressee Party at the following addresses, respectively:

 

Notices to ARIAD US:

 

ARIAD US Pharmaceuticals, Inc.

26 Landsdowne Street

Cambridge, Massachusetts 02139-4234

USA

Attention: General Counsel

Tel: [***]

 

With copies (which shall be required but shall not itself constitute notice) to:

 

Baker & McKenzie LLP

100 New Bridge Street

London, EC4V 6JA

United Kingdom

Attention: J. Hobson

Tel: [***]

 

Notices to ARIAD SWISSCO:

 

ARIAD Pharmaceuticals (Europe) Sárl

Route de La Corniche 1

1066 Epalinges

Switzerland

Attention: Laurent Chardonne

Tel: [***]

 

With copies (which shall be required but shall not itself constitute notice) to:

 

Incyte Corporation

1801 Augustine Cut-Off

Wilmington, DE 19803

United States of America

Attention: General Counsel

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  76

 

 

Tel: [***]

 

and

 

Morgan, Lewis & Bockius LLP

502 Carnegie Center

Princeton, NJ 08540-6241

United States

Attention: Randall B. Sunberg

Tel: [***]

 

30.5Binding Effect. This Agreement shall inure to the benefit of, and be binding
upon, the respective successors of the Parties. For the avoidance of doubt,
subject to ARTICLE 16, the continued existence of this Agreement shall not be
affected in case of change of control of either Party.

 

30.6Waiver. The delay or failure of a Party to insist upon strict performance of
any of the terms and conditions of this Agreement by the other Party shall not
constitute a waiver of any of the provisions hereof and no waiver by a Party of
any of said terms and conditions shall be deemed to have been made unless
expressed in writing and signed by such waiving Party.

 

30.7Interpretation.

 

30.7.1The language of this Agreement is English. No translation into any other
language shall be taken into account in the interpretation of the Agreement
itself.

 

30.7.2The headings in this Agreement are inserted for convenience only and shall
not affect its construction.

 

30.7.3Where appropriate, the terms defined in this Agreement and denoting a
singular number only shall include the plural and vice versa. Unless otherwise
stated, references to days means calendar days, references to quarters means
calendar quarters beginning on the first of January, April, July and October and
references to years means calendar years beginning on January 1.

 

30.7.4The word “including” and similar words and phrases mean including without
limitation, whether or not expressly stated. The words “herein,” “hereof” and
“hereunder” and other words of similar import refer to this Agreement as a whole
and not to any particular Articles or other subdivision. References to the
singular include the plural. References to one gender include all genders.

 

30.7.5References to any law, regulation, statute or statutory provision includes
a reference to the law, regulation, statute or statutory provision as from time
to time amended, extended or re-enacted.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  77

 

 

30.8Assignment.

 

30.8.1This Agreement and the rights conferred upon a Party under this Agreement
cannot be transferred or assigned by a Party without the prior, written
authorization of the other Party, which authorization shall not be unreasonably
withheld, conditioned or delayed. Notwithstanding the foregoing, each Party may
make such transfer or assignment without the other Party’s consent to (i) its
Affiliates or (ii) to a successor of all or substantially all of the business to
which this Agreement relates, whether in a merger, sale of stock, sale of assets
or any other transaction, provided that written notice of the transfer or
assignment is provided to the other Party. With respect to an assignment to an
Affiliate, the assigning Party shall remain responsible for the performance by
such Affiliate of all of such Party’s rights and obligations hereunder.

 

30.8.2This Agreement shall be binding upon and inure to the benefit of the
Parties’ respective successors and permitted assigns.

 

30.9Public Statements.

 

30.9.1Subject to Section 30.9.2, neither Party shall make any public
announcement concerning this Agreement or the subject matter hereof without the
prior written consent of the other Party or as provided in the Share Purchase
Agreement. Once initial consent to a particular disclosure or public
announcement has been given and the disclosure or statement has been made
concerning particular subject matter, each Party may make any further public
statement concerning such subject matter so long as any such public statement is
accurate and not inconsistent with the prior public disclosures or public
statements approved by the other Party pursuant to this Section 30.9.1 and does
not reveal non-public information about the other Party, the Compound or the
Product.

 

30.9.2In the event that a Party is, based on the advice of the disclosing
Party’s counsel, required by Applicable Laws or the rules of a stock exchange on
which its securities are listed (or to which an application for listing has been
submitted) to make a public disclosure regarding this Agreement or its subject
matter (including the terms of this Agreement), such Party shall submit the
proposed disclosure (or proposed redacted copy of the Agreement, as applicable)
in writing to the other Party as far in advance as reasonably practicable (and
in no event less than [***] prior to the anticipated date of disclosure) so as
to provide a reasonable opportunity for the other Party to comment thereon.
Neither Party shall be obligated to obtain approval from the other Party with
respect to any filings made with the applicable securities exchange commission.
Neither Party shall be required to seek the permission of the other Party to
repeat any information regarding the terms of this Agreement or any amendment
thereto that has already been publicly disclosed by such Party, or by the other
Party, in accordance with the terms of this Agreement, provided such information
remains accurate as of such time and provided the frequency and form of such
disclosure are reasonable.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  78

 

 

30.9.3Except as expressly permitted in this Agreement or as required by
Applicable Law (or the regulations of applicable stock exchanges), neither Party
may use the other Party’s trademarks, service marks or trade names, or otherwise
refer to or identify that other Party in marketing or promotional materials,
press releases, statements to news media or other public announcements, without
the other Party’s prior written consent, which that other Party may grant or
withhold in its sole discretion.

 

30.10Expenses. Unless specifically and expressly provided for to the contrary in
this Agreement, a Party who has an obligation or right to take an action under
this Agreement shall be solely responsible for any and all expenses associated
with such action.

 

30.11Survival. The following Articles and Sections shall survive expiration or
termination of this Agreement for any reason: ARTICLE 1 (to the extent necessary
to give force to, or otherwise understand, surviving provisions), ARTICLE 16,
Sections 19.8, 19.9, 22.1, 22.2, 22.3, 22.4, 22.5, and 22.6, ARTICLE 24, Section
26.6, ARTICLE 28, ARTICLE 29 (with respect to any matters commenced prior to
expiration or termination), and Sections 30.1, 30.2, 30.4, 30.7, 30.11, 30.12,
30.13, 30.14, and 30.18.

 

30.12Waiver of Contra Proferentem Rule of Construction. Each Party has had the
opportunity to consult with counsel in connection with the review, drafting and
negotiation of this Agreement. Accordingly, the rule of construction that any
ambiguity in this Agreement shall be construed against the drafting Party shall
not apply.

 

30.13Remedies to be cumulative. Each Party’s remedies under this Agreement and
under the law are intended to be cumulative, and not mutually exclusive.

 

30.14Counterparts. The Parties may execute this Agreement in multiple
counterparts, each of which constitutes an original as against the Party that
signed it, and all of which together constitute one agreement. This Agreement is
effective upon delivery of one executed counterpart from each Party to the other
Parties. The signatures of all Parties need not appear on the same counterpart.
The delivery of signed counterparts by facsimile or email transmission that
includes a copy of the sending Party’s signature(s) is as effective as signing
and delivering the counterpart in person.

 

30.15Further Assurance. Each Party shall duly execute and deliver, or cause to
be duly executed and delivered, such further instruments and do and cause to be
done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.

 

30.16No Joint Venture. Nothing in this Agreement creates a joint venture or
partnership between the Parties. This Agreement does not authorize any Party (a)
to bind or commit, or to act as an agent, employee or legal representative of,
another Party, except as may be specifically set forth in other provisions of
this Agreement, or (b) to

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  79

 

 

have the power to control the activities and operations of another Party. The
Parties are independent contractors with respect to each other under this
Agreement. Each Party agrees not to hold itself out as having any authority or
relationship contrary to this Section 30.16.

 

30.17No Third Party Rights. Nothing expressed or referred to in this Agreement
will be construed to give any Third Party, other than the Parties to this
Agreement, any legal or equitable right, remedy or claim under or with respect
to this Agreement or any provision of this Agreement except such rights as may
inure to a successor or permitted assignee.

 

30.18Waiver of Jury Trial. EACH OF THE PARTIES KNOWINGLY, VOLUNTARILY AND
IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ALL RIGHT TO TRIAL
BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT,
TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR THE ACTIONS OF ANY PARTY TO THIS
AGREEMENT IN NEGOTIATION, EXECUTION AND DELIVERY, PERFORMANCE OR ENFORCEMENT OF
THIS AGREEMENT.

 

30.19Guaranty. Incyte Corporation hereby unconditionally and irrevocably
guarantees to ARIAD US the full and timely payment and discharge of all ARIAD
SWISSCO'S payment obligations under this Agreement, including pursuant to
Sections 5.3.1, 5.7.3, 5.9, 19.1, 19.2 and 19.4. This is a guarantee of payment,
and not of collection, and Incyte Corporation acknowledges and agrees that this
guarantee is absolute, full, unconditional and irrevocable, and no release or
extinguishment of the obligations or liabilities of ARIAD SWISSCO, whether by
decree in any bankruptcy proceeding or otherwise, shall affect the continuing
validity and enforceability of this guarantee, as well as any provision
requiring or contemplating payment by Incyte Corporation. Incyte Corporation's
guarantee under this Section 30.19 shall continue irrespective of (i) any lack
of validity or enforceability of this Agreement against ARIAD SWISSCO as a
result of any bankruptcy, insolvency, reorganization, moratorium or other
similar Laws affecting or relating to creditors’ rights generally, (ii) any
modification, amendment, consent, extension, waiver of or consent under this
Agreement that may be agreed to by ARIAD SWISSCO, (unless also agreed to by
ARIAD US and Incyte Corporation) or (iii) any change in the ownership of ARIAD
SWISSCO or any other Person, any merger or consolidation of ARIAD SWISSCO or any
other Person into or with any other Person, or any sale, lease or other transfer
of the assets of ARIAD SWISSCO or any other Person to any other Person. Incyte
Corporation hereby waives, for the benefit of ARIAD US and its successors, (A)
any right to require ARIAD US, as a condition of payment by Incyte Corporation,
to proceed against ARIAD SWISSCO or pursue any other remedy whatsoever
(provided, that, in the case of payments due by ARIAD SWISSCO under this
Agreement, ARIAD US shall have, where applicable, issued an invoice in
accordance with the terms of this Agreement and taken such other actions as are
specifically required by the terms of this Agreement to obtain payment and,
where applicable, waited the applicable payment period) and (B) to the fullest
extent permitted by Applicable Law, any defenses or benefits that may be derived
from or afforded by Applicable Law which limit the liability of or exonerate
guarantors or sureties, except to the extent that any

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  80

 

 

such defense would excuse the performance by ARIAD SWISSCO under the terms of
this Agreement. Subject to the foregoing, ARIAD US hereby agrees that Incyte
Corporation shall have all defenses to its obligations hereunder that would be
available to ARIAD SWISSCO under this Agreement.

 

[Remainder of page intentionally blank; signature page follows]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  81

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
in duplicate by their duly authorized officers as of the Effective Date.

 

For and on behalf of   For and on behalf of       ARIAD Pharmaceuticals, Inc.  
ARIAD Pharmaceuticals (Europe) Sarl       /s/ Manmeet S. Soni   /s/ Jonathan
Dickinson       Name: Manmeet S. Soni   Name:  Jonathan Dickinson       Title:
Executive Vice President, Chief   Title:   Manager           Financial Officer
and Treasurer           Solely in its capacity as guarantor under Section 30.19,
for and on behalf of           Incyte Corporation           /s/ Hervé Hoppenot  
        Name: Hervé Hoppenot           Title: President and CEO    

 

Signature Page to Amended and Restated Buy-In License Agreement

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.18

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.21

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.35

 

COMMERCIALIZATION PLAN

 

(see attached)

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.40

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.62

 

Distribution Agreements

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.128

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.134

 

PRIMARY EFFICACY ENDPOINT

 

The “Primary Efficacy Endpoint” means achieving the [***] by [***] defined
according to standard criteria as ≤[***]% of [***] to [***] on the [***],
measured by [***].  The primary analysis of the primary endpoint will be
performed using [***]. The study will be stratified by [***] at baseline (≥[***]
versus <[***]) and [***]) to compare the MMR rate by [***] between patients
receiving either dose level of ponatinib (initial dose: [***] or [***]) and
patients receiving nilotinib (initial dose: [***]) and will follow a testing
procedure to ensure an [***]. An efficacy interim analysis is planned after the
first [***] have at least [***] of [***].  To maintain an overall [***] of [***]
(2-sided), an [***] will be used which requires a [***]. Thus, with 2 treatment
comparisons significance will be declared for [***]. For each dose comparison,
if this boundary is not crossed at the time of the interim analysis, then the
primary analysis will be conducted [***] following the [***]. A [***] will be
used to adjust for comparisons of Cohorts A and B to Cohort C, with a dose
considered significant if the [***] is <[***].

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.138

 

Proposed Studies

 

(see attached)

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.161

 

SUPERIORITY

 

“Superiority” means ponatinib has demonstrated [***] to nilotinib where, for any
ponatinib arm the [***] is [***] at the interim or if both [***]. For each dose
comparison, if this boundary is not crossed at the time of the interim analysis,
then the primary analysis will be conducted [***] following the [***]. A [***]
will be used to adjust for comparisons of Cohorts A and B to Cohort C, with a
dose considered significant if the [***]. Additionally, both dose comparisons
will be considered significant if [***] are [***] for the tests of the primary
endpoint.  The primary analysis will be based on the [***]. A sensitivity
analysis of the primary endpoint will be performed on the [***], with patients
not [***] treated as [***].

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.167

 

Territory

 

Part A

 

European Union Countries   [***]       1.    Austria[***]   [***]
2.    Belgium[***]   33. Turkey 3.    Bulgaria   [***] 4.    Croatia   41.
Israel[***] 5.    Cyprus   [***] 6.    Czech Republic[***]   45. Norway[***]
7.    Denmark[***]   46. Russia 8.    Estonia   [***] 9.    Finland[***]   48.
Switzerland 10.  France[***]   [***] 11.  Germany[***]     12.  Greece    
13.  Hungary[***]     14.  Ireland[***]     15.  Italy[***]     16.  Latvia    
17.  Lithuania     18.  Luxembourg[***]     19.  Malta     20.  Netherlands[***]
    21.  Poland[***]     22.  Portugal[***]     23.  Romania[***]    
24.  Slovakia[***]     25.  Slovenia[***]     26.  Spain[***]    
27.  Sweden[***]     28.  United Kingdom (Scotland[***], Wales[***],
England[***] and Northern Ireland)    

 

[***]

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

[***]

 

Part B EU 16

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 1.175

 

TRANSITION BACK ARRANGEMENTS

 

1.Reversion

 

1.1All rights granted by ARIAD US to ARIAD SWISSCO hereunder including but not
limited to the license granted in Section 2.1 shall [***].

 

1.2Subject to and in accordance with the Transition Plan referred to in para 2
below, ARIAD SWISSCO shall [***] of (A) the ARIAD US [***], (B) the [***], (C)
[***], (D) the [***] (E) all [***], (F) all [***], (ii) where applicable, [***]
all [***].

 

1.3ARIAD SWISSCO and its Affiliates shall, subject to the Transition Plan,
[***].

 

1.4ARIAD SWISSCO shall [***] (i) the [***]; and (ii) [***] in accordance with
the Transition Plan. [***] will notify [***] of the [***] of [***] within [***].

 

1.5The [***] shall continue.

 

2.Transition Plan

 

2.1  The Parties shall use Commercially Reasonable Efforts to agree, in good
faith, a transition plan to transition (the "Transition"), from ARIAD SWISSCO to
ARIAD US and/or its designee, responsibility for Development, Commercialization
and Manufacturing activities (the "Transition Plan"). Such Transition Plan shall
include [***], including [***].

 

2. 2  The Transition Plan shall be for a period not exceeding [***] from the
date of termination of all or part of this Agreement, or any other shorter
period as the Parties may agree in writing.

 

3.Registrations and Documentation

 

3.1In accordance with Applicable Laws, ARIAD US and ARIAD SWISSCO shall, as soon
as is practicably possible after termination and in any event within [***] of
termination, take such reasonable actions as are necessary to [***].

 

3.2ARIAD US and ARIAD SWISSCO shall execute all necessary and appropriate
letters and applications to Regulatory Authorities (if any) to ensure that
ownership of the Registrations are transferred to ARIAD US as soon as
practicable.

 

3.3The date upon which Registration is registered in ARIAD US's name shall be
known as the “Transfer Date” in respect of a particular Registration.

 

3.4In the event that such a transfer is not possible under Applicable Laws,
ARIAD SWISSCO and ARIAD US shall each use Commercially Reasonable Efforts to
[***].

 

3.5From (i) [***], until (ii) [***], ARIAD SWISSCO shall [***] required to
[***].

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

4.Employees

 

4.1If, in the event of the termination of this Agreement by ARIAD SWISSCO
pursuant to Section 26.4 or 26.5, the Transition Back Arrangements are
implemented pursuant to this Agreement, it is [***] after the date of such
implementation of the Transition Plan:

 

1.   the Parties shall [***] to procure that any such [***]; and

 

2.   if the Parties are not able to procure that the [***] the [***] may [***]
including [***]; provided that the [***]. The [***] of this subparagraph (2)
shall only apply in the event that [***].

 

For the purposes of this Paragraph 4, "Transfer Regulations" means the Transfer
of Undertakings (Protection of Employment) Regulations 2006 and any other law
implementing in any jurisdiction the European Council Directive 2001/23/EC on
the approximation of laws of European member states relating to the safeguarding
of employees' rights in the event of transfers of undertakings, businesses or
parts of undertakings or businesses as amended or replaced from time to time or
any equivalent or analogous legislation or regulations in any other country
within the Territory.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 17.3

 

ISTs

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 19.8.2

 

YEAR-END COMPENSATING PAYMENT

 

1.     [***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 20

 

DISCLOSURE SCHEDULES

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.  

 

 

APPENDIX 20.1.17

 

[***]

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the
Securities and Exchange Commission pursuant to the Registrant’s application
requesting confidential
treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.