Exhibit 10.1

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

COMMERCIALIZATION AGREEMENT

 

This COMMERCIALIZATION AGREEMENT (“Agreement”), dated as of July 8, 2014
(“Effective Date”), is made between PARI PHARMA GMBH, a German corporation, with
a principal place of business at Moosstrasse 3, D-82319 Starnberg, Germany
(“PARI”), and INSMED INCORPORATED, a Delaware corporation, with a place of
business at 10 Finderne Avenue, Building 10, Suite F, Bridgewater, NJ 08807-3365
(“INSMED”).  PARI and INSMED are sometimes referred to herein individually as a
“Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, PARI is in the business of developing, manufacturing and
commercializing, among other things, drug inhalation devices and optimized
formulations used in the treatment of respiratory tract disorders.

 

WHEREAS, INSMED is in the business of developing and commercializing drugs for
various diseases and conditions, including without limitation the treatment of
respiratory tract disorders and infectious diseases.

 

WHEREAS, PARI and INSMED are parties to a certain license agreement effective as
of 25 April 25, 2008, as amended by Amendment No. 1 the 24th day of June 2009,
Assignment and Amendment No. 2 the 22nd day of December 2010, Amendment No. 3
the 6th day of March 2012, and Amendment No. 4 the 21st day of May 2012
(collectively the “License Agreement”).

 

WHEREAS, pursuant to Section 8.9 of the License Agreement, the Parties desire to
enter into this Agreement for PARI to manufacture and supply the Device (as
defined below) and Device Accessories (as defined below) for use with the INSMED
Product (as defined below).

 

NOW, THEREFORE, in consideration of the premises and direct and indirect
benefits to the Parties hereto and other consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereby agree as
follows:

 

ARTICLE I
DEFINITIONS

 

1.1                               “Affiliate” of a Party means any person or
entity that directly or indirectly owns or controls, is owned or controlled by
or is under common control with such Party, in each case, only for so long as
such control exists.  As used in this definition only, “control” of an entity
means beneficial ownership, directly or indirectly, of fifty percent (50%) or
more of the outstanding voting shares or securities or the ability otherwise to
elect or appoint a majority of the board of directors or other managing
authority of such entity.

 

1.2                               “Applicable Laws and Standards” means (a) all
applicable laws, ordinances, rules, orders, directives and regulations of any
and all supra-national, federal, state, provincial and local authorities and
agencies, including without limitation all laws and regulations of such
territories applicable to the maintenance of the manufacturing equipment and
facilities and the

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

manufacturing, transportation, storage, use, handling and disposal of medical
devices, components and of any hazardous materials, (b) applicable regulations
and guidelines of the FDA and other Regulatory Authorities and the ICH
guidelines; (c) as applicable to the particular activities performed, Good
Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices
promulgated by the FDA and other Regulatory Authorities or the ICH; and (d) all
applicable industry and trade standards, including the applicable standards of
the International Organization for Standardization (ISO).

 

1.3                               “Business Day” means a day other than a
Saturday or Sunday on which banking institutions in Berlin, Germany and New
York, United States of America, are open for business

 

1.4                               “Confidential Information” of a Party, means
the confidential or proprietary scientific, regulatory, clinical, technical or
business information, materials and technologies disclosed or learned under this
Agreement, whether in written, oral, electronic, photographic, magnetic or other
form.  For clarity, the Intellectual Property owned by a Party shall be deemed
the Confidential Information of such Party.  Confidential Information shall
exclude any information to the extent that the receiving Party can demonstrate
it:

 

(a)                                       is known by the receiving Party
without restriction at the time of receipt and not through a prior disclosure by
the disclosing Party;

 

(b)                                       is at the time of disclosure or
thereafter becomes published or otherwise part of the public domain through no
breach of this Agreement by the receiving Party;

 

(c)                                        is subsequently disclosed to the
receiving Party without restriction by a third party having the right to make
such a disclosure; or

 

(d)                                       is developed by the receiving Party
independent of and without access to Confidential Information received by it
from the disclosing Party hereunder.

 

1.5                               “Control” means, with respect to an item of
information or intellectual property rights, possession by such Party of the
power and authority, whether arising by ownership, license, or other
authorization, to disclose such item as required by this Agreement, and/or to
grant and authorize licenses or sublicenses under such items that are within the
scope granted to the other Party under this Agreement.

 

1.6                               “Cure Period” means the *** (***) Business Day
period following the date of issuance of a Notice of Failure Event.

 

1.7                               “Current Good Manufacturing Practices,” or
“cGMP” means all good manufacturing practices as promulgated by the Regulatory
Authority of the country where the Device is being sold, in the form of laws or
regulations or guidance documents, for the manufacturing of medical devices,
including 21 CFR § 820 — Quality System Regulation.

 

1.8                               “cGMP Manufacturing” means all processes and
activities typically engaged in by a person or entity in the pharmaceutical or
medical device industry for the cGMP manufacture

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

of a product or component thereof, including procuring raw materials,
manufacturing, quality control and assurance testing, cGMP record keeping,
packaging and labeling.

 

1.9                               “Data” means all data, data sets, test data,
pre-clinical and clinical trial data, technical and non-technical data, price
data (but excluding cost information and/or data), marketing data, sales data,
analyses, reports, regulatory filings and approvals and the information therein
or associated therewith (including drug master files and device master files,
supporting data, regulatory correspondence and meeting minutes) and rights to
reference the same. Each Party’s Data shall be deemed its Confidential
Information.

 

1.10                        “Device” means the eFlow® nebulizer system intended
to be branded as the ***™ Nebulizer System that has been optimized for the
INSMED Product as more specifically described in Exhibit A and any
Territory-Specific Appendix. For clarity, the Parties agree that the Device will
not include the ***™ functionality, i.e. a *** *** which *** of the *** to the
***.

 

1.11                        “Device Accessories” means those types of
accessories sold by PARI as of the Effective Date or during the Term for use
with Devices, which are not specific to the drug substance being delivered by
such Devices, including e.g. power adapters, carrying cases, face masks, and any
replacement parts associated with the foregoing. For the avoidance of doubt,
Device Accessories do not include an ***.

 

1.12                        “Device Specifications” means the characteristics,
processing, labeling, and packaging requirements and standards for the Device
and Device Accessories, as set forth in the applicable Territory Specific
Appendix.

 

1.13                        “Durable Components” means the ***, the AC power
supply and the *** of each Device.

 

1.14                        “***” shall have the meaning set forth in Exhibit I.

 

1.15                        “eFlow” means the nebulizer proprietary to PARI or
its Affiliates that is based on *** technology and includes the *** and ***.

 

1.16                        “EU” means the members states of the European Union,
as it may be constituted from time to time.

 

1.17                        “FDA” means the United States Food and Drug
Administration, or any successor thereto having the administrative authority to
regulate the marketing of medical devices and drugs in the United States.

 

1.18                        “First Commercial Sale” means the first commercial
sale of the INSMED Product subject to royalties under Article 6 of the License
Agreement, by or under authority of INSMED, its Affiliates and/or their
Sublicensees (as such term is defined in the License Agreement) in a country in
the INSMED Territory, after Marketing Approval in such country has been
obtained.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

1.19                        “Forecast” shall have the meaning set forth in
Section 6.2.

 

1.20                        “Initial Purchase Order” shall have the meaning set
forth in Section 6.3.

 

1.21                        “INSMED Field” means (a) the pulmonary
administration of INSMED Product for the treatment or prophylaxis in cystic
fibrosis (CF), bronchiectasis and/or Non-tuberculosis Mycobacteria infections,
and (b) any Secondary Indication (as defined in the License Agreement) that is
added to the Transave Field (as defined in the License Agreement) in accordance
with the provisions of Section 2.6 of the License Agreement.

 

1.22                        “INSMED Product” means INSMED’s proprietary amikacin
antibiotic based on INSMED’s proprietary sustained release liposomal technology
that is formulated for delivery via pulmonary administration exclusively for use
with the Device in the INSMED Field.

 

1.23                        “INSMED Territory” means the entire world.

 

1.24                        “Intellectual Property” means (a) any of the
following, whether existing now or in the future anywhere in the world: 
patents, inventor’s certificates, registrations and applications therefor,
including any provisionals, additions, divisionals, continuations,
substitutions, continuations-in-part, together with re-examinations, reissues,
renewals or extensions thereof and all foreign counterparts of any of the
foregoing (collectively, “Patent Rights”), and (b) all Data, ideas,
pharmaceutical, chemical and biological materials, products and compositions,
tests, assays, techniques, methods, procedures, and other information relating
to any of the foregoing, drawings, plans, designs, diagrams, sketches,
specifications or other documents containing such information or materials, and
business processes, price information, marketing information, sales information,
marketing plans and market research (collectively, “Know-How”).    It is
understood, however, that Know-How does not include information that falls
within exceptions of the definition of “Confidential Information” set forth in
Section 11.1 of the License Agreement. Intellectual Property includes all
enforcement rights.

 

1.25                        “Joint Steering Committee” shall have the meaning
set forth in Section 2.1(a).

 

1.26                        “MAA” means a fully completed marketing
authorization application, including a New Drug Application, (filed with the
FDA, if in the United States or to the counterpart of the FDA if outside the
United States), including all supporting documentation and Data required for
such application to be accepted for substantive review, filed with a Regulatory
Authority to seek Marketing Approval for a particular indication in a particular
country.  It is understood that MAA does not include applications for pricing or
reimbursement approval.

 

1.27                        “Manufacture” means all activities related to the
production, manufacture, processing, finishing, packaging, labelling, shipping
and holding of the PARI Products, including process development, process
qualification and validation, scale-up, pre-clinical, clinical and commercial
manufacture of the PARI Products, process improvements and optimization, product
characterization, quality assurance, quality control and release.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

1.28                        “Marketing Approval” means all approvals,
registrations or authorizations of any governmental entity that are necessary
for the sale of products in a regulatory jurisdiction excluding reimbursement
approvals.

 

1.29                        “Nebulizer Handset” means the eFlow® nebulizer
handset intended to be branded as the *** Nebulizer Handset that has been
optimized for the INSMED Product as set forth in more detail in Exhibit A.

 

1.30                        “New Drug Application” means a New Drug Application
filed pursuant to the requirements of the FDA, or the equivalent application or
filing in a country other than the United States.

 

1.31                        “PARI Competitor” shall have the meaning set forth
in Exhibit B.

 

1.32                        “PARI Intellectual Property” shall mean PARI Patents
and PARI Know-How.

 

1.33                        “PARI Know-How” shall mean all Know-How Controlled
by PARI or Affiliates as of the Effective Date or at any time during the Term
that relates to any of the PARI Product(s) or any component thereof and/or the
Manufacture or use of the PARI Products or any component thereof.

 

1.34                        “PARI Patents” shall mean the patents and patent
applications set forth on Exhibit C, which include all patents and patent
applications owned and Controlled by PARI or its Affiliates as of the Effective
Date or at any time during the Term, which claim or relate to any of the PARI
Product(s) or any component thereof and/or the Manufacture or use of the PARI
Products or any component thereof; and any divisionals, continuations,
substitutions, continuations-in-part, extensions, renewals or reissues of any of
the foregoing.  Upon request by INSMED, PARI shall provide update(s), if any, to
the list of patents and patent applications set forth on Exhibit C.

 

1.35                        “PARI Products” means, collectively, Devices, ***,
Nebulizer Handsets and Device Accessories.

 

1.36                        “Prices” shall have the meaning set forth in
Section 4.1.

 

1.37                        “Quality Agreements” shall have the meaning set
forth in Section 6.1.

 

1.38                        “Recall” means a recall, withdrawal, or field
correction of any product for any reason, or a dissemination of information
regarding such product due to a change in the labeling of such product.

 

1.39                        “Regulatory Approval” means approval by the
applicable Regulatory Authority of (x) the manufacture, use, importation,
packaging, labeling, marketing, pricing and sale of the PARI Product or (y) a
MAA, as applicable.

 

1.40                        “Regulatory Authority” means any regional, state,
national (e.g., the FDA), international, supra-national (e.g., the European
Commission, the Council of the European

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Union, or the EMA), or other governmental entity involved in regulation of or
the granting of Marketing Approval for the INSMED Product or PARI Products, as
applicable, or the development, manufacture, use or commercialization thereof
with jurisdiction over either Party.

 

1.41                        “Regulatory Requirements” means all applicable
requirements of the Regulatory Authorities relating to the sale, manufacture and
supply of any PARI Product or the INSMED Product, as applicable.

 

1.42                        “ROW” means all the countries in the INSMED
Territory excluding the United States and Canada.

 

1.43                        “Term” shall have the meaning set forth in
Section 12.1.

 

1.44                        “Territory-Specific Appendix” means each
sub-appendix attached to this Agreement under Appendix A summarizing the
applicable Device Specifications and the specific commercial terms for the
Manufacture and supply of PARI Products in one or more particular country(ies)
in the INSMED Territory.  From time to time, the Parties may agree to add the
INSMED Territory-Specific Appendices, or modify the INSMED Territory-Specific
Appendices applicable to one or more particular country(ies) to this Agreement. 
Such Territory-Specific Appendices may contain provisions, terms and conditions
that are exceptions to or different from this Agreement to address country
specific conditions, provided, both Parties have agreed thereto in writing.

 

1.45                        “Third Party” means any person or entity that is not
PARI, INSMED or any Affiliate of either PARI or INSMED.

 

1.46                        “Third Party License Agreement” means that agreement
entered into between the *** (“***”) and PARI dated ***, as amended.

 

1.47                        “United States” means the United States of America
and all of its territories and possessions.

 

ARTICLE II
GOVERNANCE; JOINT STEERING COMMITTEE

 

2.1                               Joint Steering Committee.

 

(a)                                       Membership.  The Parties hereby agree
to utilize the JSC (as defined in the License Agreement and established pursuant
to Section 2.3.1 of the License Agreement), to perform the additional
responsibilities set forth below.  As set forth in the License Agreement, the
JSC shall consist of three (3) representatives from each Party.  The
representatives of the JSC as of the Effective Date are set forth on Exhibit D
attached hereto.  Each Party shall designate one (1) of its representatives as
the co-chairperson of the JSC.  Each Party may replace its appointed JSC
representatives or co-chairperson at any time upon reasonable written notice to
the other Party.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

(b)                                       Responsibilities.  The
responsibilities of the JSC under this Agreement shall be:

 

(i)                                    to discuss INSMED’s worldwide strategy
for the commercialization of the INSMED Product;

 

(ii)                                to discuss the strategy for the sublicensing
and commercialization of the PARI Products with INSMED’s strategy set forth in
subsection (i) above;

 

(iii)                            to facilitate the exchange of information
between the Parties with respect to the activities hereunder;

 

(iv)                             to establish procedures for the efficient
sharing of information necessary for the supply of the PARI Products;

 

(v)                                 to share and discuss PARI’s performance
under this Agreement, including without limitation the quality of the PARI
Products supplied hereunder;

 

(vi)                             to share, discuss and coordinate between the
Parties to ensure that the overall market demand of PARI Products for use with
INSMED Product is met;

 

(vii)                         to create subcommittees as the JSC may find
necessary or desirable from time to time to coordinate specific activities
within the scope of the JSC’s responsibilities;

 

(viii)                     to review, discuss and decide the process for
establishing a call center for support and processing complaints regarding the
INSMED Product and PARI Products in the EU;

 

(ix)                             to review, discuss and implement appropriate
policies regarding social media related to the Parties activities contemplated
by this Agreement;

 

(x)                                 to oversee the activities of subcommittees
created under this Agreement; and

 

(xi)                             to perform such other functions as appropriate
to further the purposes of this Agreement as allocated to it in writing by the
Parties.

 

(c)                                        Guiding Principles.  The JSC shall
perform its responsibilities based on the principles of good faith, diligence,
prudence and good scientific and business judgment.  The JSC shall have only the
powers assigned expressly to it under this Article 2 and elsewhere in this
Agreement, and the JSC shall not have any power to amend, modify or waive
compliance under this Agreement. The Parties acknowledge and agree that if there
is any inconsistency between the JSC’s role and responsibilities under the
License Agreement and the role and responsibilities of the JSC under this
Agreement, in each case with respect to the manufacture and supply of PARI
Products, this Agreement shall control. In addition, the scope of the JSC’s role
and

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

responsibilities under this Agreement or the License Agreement shall not in any
way limit a Party’s rights under this Agreement, including any decisions
allocated to it hereunder.

 

(d)                                       JSC Meetings.  JSC meetings shall be
held as often as the Parties mutually agree are necessary but at least twice
every year (alternating each in-person meeting between a location selected by
PARI and a location selected by INSMED), or on another schedule agreed to by the
Parties. In person meetings may be waived and conference calls substituted as
agreed to by the JSC. With the consent of the representatives of each Party
serving on the JSC, other representatives of each Party may attend meetings as
non-voting observers (provided such non-voting observers have confidentiality
obligations to such Party that are at least as stringent as those set forth in
this Agreement).  Meetings of the JSC shall be effective only if at least one
(1) representative of each Party is present or participating.  Each Party shall
be responsible for all of its own expenses of participating in the JSC meetings.
The JSC will be chaired by a representative of INSMED.  The role of the
chairperson shall be to convene and preside at meetings of the JSC, but the
chairperson shall have no additional powers or rights beyond those held by the
other Committee representatives. Within *** (***) Business Days following each
JSC meeting, the chairperson shall prepare and deliver to the members of the JSC
the minutes of such meeting for review and approval by both Parties.  The
minutes shall reflect, without limitation, all material decisions made at such
meetings.  Such minutes will be deemed approved unless one or more members of
the JSC object to the accuracy of such minutes within *** (***) Business Days of
receipt thereof.

 

(e)                                        Void Decisions.  Notwithstanding
anything to the contrary in this Agreement, no decision by either Party would be
effective if such decision requires the other Party to breach any obligation or
agreement with a Third Party, or to perform any activities that are different or
greater in scope than those provided for specifically under this Agreement.

 

2.2                               Subcommittees.

 

(a)                                       Membership.  The JSC may establish
subcommittees to coordinate specific activities within the scope of the JSC’s
responsibilities.  Each such subcommittee shall consist of two
(2) representatives from each Party.  Each Party may replace its appointed
subcommittee representatives at any time upon reasonable written notice to the
other Party.  Each Party shall designate one (1) of its representatives as the
co-chairpersons of each subcommittee. The Parties will agree on the
responsibilities of a subcommittee before it will be established.

 

(b)                                       No Decision Making.  No subcommittee
shall have the authority to make any decisions on behalf of the Parties.

 

(c)                                        Subcommittee Meetings.  Other
representatives of each Party may attend meetings as nonvoting observers
(provided such nonvoting observers have confidentiality obligations to such
Party that are at least as stringent as those set forth in this Agreement). 
Meetings of the subcommittees shall be effective only if at least one
(1) representative of each Party is present or participating.  Each Party shall
be responsible for all of its own expenses of participating in the subcommittee
meetings.  Within *** (***) Business Days following each

 

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DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

subcommittee meeting, INSMED shall prepare and deliver to the members of the
subcommittee the minutes of such meeting for review and approval by both
Parties.

 

ARTICLE III
COMMERCIALIZATION

 

3.1                               Overview.  PARI shall be responsible for
Manufacturing and supplying PARI Products to INSMED, its Affiliates and
permitted Sublicensees (as such term is defined in the License Agreement) in the
INSMED Territory in compliance with the terms of this Agreement, including all
Applicable Laws and Standards, and for training the appropriate key INSMED
commercial team members who train general INSMED commercial team members. Unless
expressly provided otherwise and agreed to by the Parties in the
Territory-Specific Appendix, INSMED shall have the sole right to, in its sole
discretion, promote, advertise, and distribute INSMED Products, provided that
INSMED shall do so in compliance with all Applicable Laws and Standards.  The
Parties shall cooperate in good faith to fulfill their respective obligations
under this Agreement. Notwithstanding the foregoing, PARI must approve all PARI
Products related sections of promotional and/or advertising materials generated
for the INSMED Products prior to any use or dissemination of such materials;
provided that such approval shall not be unreasonably withheld or delayed, and
PARI’s failure to respond to a request for approval within *** (***) Business
Days will be deemed approval.  PARI shall not use or disseminate any promotional
and/or advertising materials for the Device, except that PARI shall be permitted
to do so as to Device Accessories and the *** (as a stand alone item), or, to
the extent not exclusively related to the INSMED Products, any other PARI
Products without INSMED’s prior written approval; provided that such approval
shall not be unreasonably withheld or delayed, and INSMED’s failure to respond
to a request for approval within *** (***) Business Days will be deemed
approval.  PARI agrees to comply with the following INSMED policies and
instructions to the extent applicable: (i) tracking expenditures in sufficient
detail, and providing such information in a timely manner and a form and format
required by INSMED so as to enable INSMED to comply with Applicable Laws,
including any state or federal “sunshine” reporting requirements applicable to
the INSMED Product; (ii) any policies regarding social media (which might
include, for example, disabling “comment” features) implemented by the JSC;
(iii) refrain from editing any promotional content (for the avoidance of doubt
promotional content shall not include any labelling or packaging of PARI
Products) relating to the INSMED Product other than as may be specifically
requested by INSMED and approved through INSMED’s promotional review process;
and (iv) submission of any proposed promotional content or scripts relating to
the INSMED Product sufficiently in advance of proposed use to permit INSMED time
to approve/reject/modify such data.

 

3.2                               Commercialization of PARI Products.  PARI
shall sell the PARI Products to INSMED or any Third Party designated by INSMED
(other than a PARI Competitor) as its representative in accordance with the
terms of this Agreement to be further distributed to end users for use with the
INSMED Product.

 

3.3                               Territory-Specific Appendixes.  Promptly after
INSMED submits a MAA for an INSMED Product in a particular country(ies), but in
any event no later than *** (***) days prior

 

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DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

to the earliest anticipated approval date by the appropriate Regulatory
Authority in a particular country(ies), the Parties shall agree on a
Territory-Specific Appendix setting forth the commercial terms governing such
country(ies), which shall contain the applicable Price for each territory in the
ROW (other than EU), the T-S Branding Strategy and any other material terms and
conditions that are specifically necessary to commence commercial sales of the
PARI Products and INSMED Product in such country(ies).  Such Territory-Specific
Appendixes shall then be attached to this Agreement and incorporated in this
Agreement.  Thereafter, the Parties may modify or supplement such
Territory-Specific Appendixes from time to time by written agreement; provided,
that PARI shall not withhold consent to any modification or supplement to a
Territory-Specific Appendix to the extent such modification or supplement is
required by the appropriate Regulatory Authority in the applicable country. If
the Parties are unable to agree on the terms of any Territory-Specific Appendix
(including any T-S Branding Strategy included therein) within *** (***) days
after either Party begins negotiations for such Territory-Specific Appendix,
then the provisions of Section 13.8 of this Agreement shall apply.

 

3.4                               Branding Generally.  Subject to applicable
Regulatory Requirements, the packaging, labeling and promotional materials for
both the PARI Products and the INSMED Products will be consistent with a
branding strategy to be agreed upon by the Parties and included as part of each
Territory-Specific Appendix (the “T-S Branding Strategy(ies)”).  Unless the
Parties agree otherwise under the applicable T-S Branding Strategy, each T-S
Branding Strategy shall contain the following elements:

 

(a)                                       PARI Product Branding.  PARI shall be
responsible for, and shall work together with INSMED in good faith in selecting
trademarks for use on or in connection with any PARI Product that is aligned
with PARI’s branding strategy for eFlow products.  PARI will label the packaging
for the Device and the packaging for the Nebulizer Handset of the Device.  As
determined by PARI (and reasonably acceptable to INSMED), packaging for the
Device will include the PARI word mark and/or logo and/or the PARI Pharma logo,
the eFlow® technology word mark and logo, a dedicated, unique brand name for the
Device, and the Drug Reference (as defined below).  The Nebulizer Handset
component of the Device will include the dedicated, unique brand name for the
Device and the Drug Reference.  The aerosol head component of the Device will
include only the dedicated, unique brand name for the Device.  Each of the above
Device components will have a distinct item number, and all such item numbers
will be identified on the packaging for the Device and the packaging for the
Nebulizer Handset.  For purposes of this Section 3.4, unless specified otherwise
by Regulatory Authorities, the “Drug Reference” means either (i) the generic
drug name associated with the INSMED Product, and/or (ii) INSMED’s trademark for
such INSMED Product, depending upon the status of INSMED’s branding for the
INSMED Product at the time of commercialization by the Parties as contemplated
herein.  Notwithstanding the foregoing, the Parties shall discuss the precise
forms of co-branding to accompany the Device and Nebulizer Handset and the
INSMED Products, including support or other promotional materials therefor, to
promote the use of the Device and Nebulizer Handset exclusively with the INSMED
Product and use of the INSMED Product in the INSMED Field exclusively with the
Device and Nebulizer Handset.  INSMED shall not modify PARI’s labeling in any
way (including by over-labeling).  Except as expressly set forth in this
Agreement (including, but not limited to Section 3.1), INSMED shall not use any
videos,

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

photographs or graphic depictions of the PARI Products without PARI’s prior
written approval; provided that such approval shall not be unreasonably withheld
or delayed, and PARI’s failure to respond to a request for approval within ***
(***) Business Days will be deemed approval.

 

(b)                                       INSMED Product Branding/PARI Product
Recognition.  INSMED shall be responsible for, and shall have sole discretion,
in selecting trademarks for the use on or in connection with any INSMED Product
and determining the packaging, labeling and branding of any INSMED Product;
provided, however, that, where it determines are appropriate, INSMED shall
provide recognition of the PARI Product approved by the applicable Regulatory
Authority for use with the INSMED Product.  In addition, subject to Regulatory
Requirements, INSMED agrees to include in the product labeling for the INSMED
Product the precise Device brand name and the Device item number(s) approved to
administer the INSMED Product. Except as expressly set forth in this Agreement,
PARI shall not use any videos, photographs or graphic depictions of the INSMED
Products without INSMED’s prior written approval; provided that such approval
shall not be unreasonably withheld or delayed, and INSMED’s failure to respond
to a request for approval within *** (***) Business Days will be deemed
approval.

 

(c)                                        PARI Supply Restriction.  PARI shall
not supply any Devices or any other product that is branded for use with any
INSMED Product to any Third Party for use with any product other than an INSMED
Product.

 

3.5                               Product Support.  PARI shall, at its own
expense, and in accordance with Applicable Law and Standards establish and
maintain product support capabilities for PARI Products consistent with the
terms to be set forth in any Territory-Specific Appendix, including without
limitation a call center or call centers and hotlines for patient support and
warranty claims for PARI Products to all patients using PARI Products in the
United States and Germany with toll-free access in the United States. Unless the
Territory-Specific Appendix for the United States expressly states
otherwise, INSMED will establish a call center for support in the United States
and there will be a warm transfer of telephone calls received by the INSMED call
center to PARI of all problems and complaints regarding the PARI Products. The
process for establishing a call center for support and processing complaints
regarding the INSMED Product and PARI Products in the EU will be reviewed,
discussed and decided by the JSC. PARI shall establish such patient support
capabilities for PARI Products prior to the first commercial sale of any INSMED
Product in the United States and Germany, pursuant to the specific requirements
in the applicable Territory-Specific Appendix and in compliance with any
requirements set forth in the Safety Data Exchange Agreement. For all other
countries PARI will establish an English speaking service support to communicate
with local distributors which will be available during normal business hours in
Germany.  Each Territory-Specific Appendix may set forth any additional product
support capabilities for PARI Products and for INSMED Products.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

ARTICLE IV
PAYMENTS

 

4.1                               Pricing.

 

(a)                                       Prices. PARI shall Manufacture and
sell the PARI Products at the prices (the “Prices”) set forth in Exhibit I. Each
Party acknowledges that the Prices were determined pursuant to an arms-length
transaction.

 

(b)                                       Distributors. Notwithstanding anything
to the contrary in this Agreement or the License Agreement, the Parties
acknowledge that PARI has established a network of distributors. If requested by
INSMED, INSMED and PARI will discuss in good faith the possibility of utilizing
that existing network on terms to be mutually agreed and as set forth in this
Agreement; provided that the foregoing shall not limit INSMED’s right or ability
to utilize distributors of its own choice.

 

(c)                                        ***. Notwithstanding anything to the
contrary in this Agreement, during the Term, PARI agrees to sell the Device to
INSMED in any country at the *** at which any *** is sold by *** or its ***, as
applicable, to a Third Party in the respective ***, taking into account *** for
the Device in transactions with ***, and in each case based on *** and ***.  For
purposes of the foregoing, “***” means any *** with a *** and *** used for the
same ***, or, if no *** is used for the same ***, for *** *** and *** and with a
*** (based on ***) and *** (as described in more detail in Exhibit A).

 

4.2                               Invoicing.  Except as otherwise set forth in
Article VI of this Agreement, PARI shall invoice INSMED when PARI *** the PARI
Products pursuant to the Initial Purchase Order or the Purchase Orders.  Subject
to the terms and conditions of this Agreement, INSMED shall pay all undisputed
invoices for the PARI Products delivered and accepted in accordance with
Section 7.4 within *** (***) calendar days after the acceptance of shipment and
receipt of the invoice.

 

4.3                               Payment.

 

(a)                                 Currency.  All references to “Dollars” or
“$” means the legal currency of the United States.  All references to “Euros” or
“€” means the legal currency of the Eurozone.  In the event any PARI Product is
ordered for delivery outside the United States or Canada, the currency for
payment shall be Euros.  With respect to the Prices for the United States and
Canada set forth in Section 4.1 above, if the exchange rate of Euros to Dollars,
based on the conversion rate reported by Reuters, Ltd. for the last Business Day
immediately preceding the applicable invoice date (the “Invoice Date Exchange
Rate”), is higher or lower than the mean exchange rate of the *** prior to the
Effective Date (the “Effective Date Exchange Rate”), as set forth on Exhibit E, 
by ***% or more, then the Price shall be adjusted as follows:

 

(i)                                    if the exchange rate has increased by
more than ***%:

 

the Price shall be equal to the sum of (X) the Price set forth in
Section 4.1(a)(i), (ii) or (iii), as applicable, plus (Y) the product of (A) the
Price set forth in Section 4.1(a)(i), (ii) or (iii), as applicable, multiplied
by (B) the amount equal to (x) the quotient of (a) the Invoice Date Exchange
Rate divided by (b) the Effective Date Exchange Rate, minus (y) ***.  By means
of example, if the Effective Date Exchange

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Rate is ***, the Price is $*** and the Invoice Date Exchange Rate is ***, then
the new Price will be computed as follows: $*** + ($*** x ((***/***) — ***))) =
$***.

 

(ii)                                if the exchange rate has decreased by more
than ***%:

 

the Price shall be an amount equal to the difference between (X) the Price set
forth in Section 4.1(a)(i), (ii) or (iii), as applicable, and (Y) the product of
(A) the Price set forth in Section 4.1(a)(i), (ii) or (iii), as applicable,
multiplied by (B) the amount equal to (x) *** minus (y) the amount equal to the
quotient of (a) the Invoice Date Exchange Rate divided by (b) the Effective Date
Exchange Rate.  By means of example, if the Effective Date Exchange Rate is ***,
the Price is $*** and the Invoice Date Exchange Rate is ***, then the new Price
will be computed as follows: $*** - ($*** x (*** - (***/***))) = $***.

 

(b)                                 Payment Type.  All payments pursuant to this
Agreement for the PARI Products shall be paid to the address listed on the
applicable invoice.

 

(c)                                  Withholding of Taxes.  INSMED may withhold
from payments due to PARI amounts for payment of any withholding tax that is
required by law to be paid to any taxing authority with respect to such
payments.  INSMED shall provide to PARI all necessary documents and
correspondence and written evidence to demonstrate the payment of such tax, and
shall also provide to PARI any other cooperation or assistance on a reasonable
basis as may be necessary to enable PARI to claim exemption from such
withholding taxes and to receive a full refund of such withholding tax or claim
a tax credit.

 

(d)                                 Late Payments.  Any payments or portions
thereof due hereunder which are not paid when due (unless disputed by INSMED in
good faith) shall bear interest equal to the prime rate as reported by the Chase
Manhattan Bank, New York, New York, on the date such payment is due, plus an
additional *** percent (***%) per year calculated on the number of days such
payment is delinquent or the maximum amount allowed by Applicable Laws and
Standards, whichever is lower.  This Section 4.3(d) shall not limit other
remedies available to PARI.

 

4.4                               Royalties.  INSMED shall pay PARI royalties
pursuant to Article 6 of the License Agreement in accordance with the terms of
the License Agreement, as amended pursuant to Section 12.1 of this Agreement.

 

ARTICLE V
REGULATORY

 

5.1                               Regulatory Assistance.

 

(a)                                 The Parties shall cooperate in good faith to
obtain any Regulatory Approvals for the use of PARI Products with INSMED
Products; provided, however, that as to ROW PARI shall be provided with
sufficient lead time and prior to requesting any such cooperation from
PARI, INSMED shall be committed to use commercially reasonable efforts to launch
the INSMED Products in the applicable country(ies).  PARI shall provide
regulatory and

 

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DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

technical information relating to the Manufacture and supply of PARI Products
and/or components thereof as reasonably requested by INSMED to the extent
required by a Regulatory Authority or that the Parties mutually agree will be
helpful for a filing with a Regulatory Authority.  Alternatively, if PARI
determines it is reasonably necessary to protect PARI Know-How related to eFlow
or the Manufacture of PARI Products and if permitted by the applicable
Regulatory Authority, PARI shall notify INSMED and make such information
available to Regulatory Authorities directly (e.g. via a master file for devices
or equivalent documents). INSMED shall provide regulatory and technical
information and Data relating to the INSMED Products as reasonably requested by
PARI to the extent required by a Regulatory Authority or that the Parties
mutually agree will be helpful for a filing with a Regulatory Authority or in
order for PARI to create its technical file of the CE documentation or similar
documents.  PARI shall cooperate with any inspection of its facilities
(including facilities of its Affiliates) by any Regulatory Authority relating to
the PARI Products.  INSMED shall cooperate with any inspection of its facilities
(including facilities of its Affiliates) by any Regulatory Authority relating to
the INSMED Products.  Each Party shall notify the other Party, as soon as
reasonably practicable but in any event within *** (***) Business Days via
telephone, followed by a notice in writing in the event any action is taken or
threatened by a Regulatory Authority relating to the PARI Products and the
INSMED Products, as applicable.

 

(b)                                       It is currently anticipated by the
Parties that, with respect to the United States, the Device regulatory path
shall not include a separate 510(k) submission to CDRH for clearance of the
Device.  Instead, the Parties currently anticipate proceeding with a single
marketing application for the combination product (Device and INSMED Product) in
the form of a New Drug Application for the INSMED Product, which single
marketing application will contain a Device module similar in format and content
to a 510(k) application.

 

5.2                               Reimbursement Assistance.  The Parties shall
cooperate in good faith to obtain any reimbursement approval for the use of the
Device with the INSMED Product (subject to the provisio set forth in the first
sentence of Section 5.1(a) above).  Each Party shall provide to the other
reasonable and accurate regulatory and technical information relating to the
PARI Products and/or components thereof or the INSMED Products and/or components
thereof, as applicable, as reasonably requested by a payor source (without
compromising confidentiality and in compliance with all applicable laws).

 

5.3                               Safety Data Exchange Agreement.  Within ***
(***) days after submission to a Regulatory Authority for Marketing Approval in
any given country of the INSMED Product, the Parties shall enter, with respect
to such country, into a safety data exchange agreement governing the safety data
exchange, adverse event reporting, patient support and management of patient
compliance relating to the Device, Device Accessories and INSMED Product (each a
“Safety Data Exchange Agreement”).

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

5.4                               Recall.

 

(a)                                 PARI Product.

 

(i)                                    Each Party shall promptly notify the
other Party in writing (which notice shall be provided within *** (***) hours)
if any Regulatory Authority or other governmental agency having jurisdiction
requests or orders it to conduct a Recall of any PARI Product, or with respect
to PARI, if PARI determines to undertake a Recall of any PARI Product
voluntarily.  Prior to the beginning of any such Recall, the Parties agree to
discuss the Recall process if practicable.  Promptly after being notified of
such Recall, but in no event later than may be required to permit such Party
conducting such Recall to meet applicable Regulatory Requirements, the other
Party shall provide the Party conducting such Recall with reasonable assistance
in connection with such Recall as requested by the Party conducting such Recall.

 

(ii)                                If PARI is required or determines to effect
any such Recall of the PARI Product, then PARI shall solely manage such Recall
and be responsible for (i) the cost of notifying end users; (ii) costs
associated with the collection and shipment from end users of the PARI
Product(s) subject to such Recall; and (iii) costs of replacing such PARI
Product(s), including the cost of shipping the replacement PARI Product(s) to
the affected end users.

 

(iii)                            In the event that the INSMED Product is
Recalled and such Recall does not result from a PARI Product or from PARI’s
breach of its obligations hereunder or the gross negligence or willful
misconduct of PARI or any of its Affiliates in its or their performance under
this Agreement or the Quality Agreement and as a consequence the FDA or other
Regulatory Authority also requires the Device be retrieved or recalled for any
reason, then INSMED will bear the costs (x) of notifying end users; (y) costs
associated with the collection and shipment from end users of the PARI
Product(s) subject to such Recall; and (z) costs of replacing such PARI
Product(s), including the cost of shipping the replacement PARI Product(s) to
the affected end users.

 

(b)                                       INSMED Product.  INSMED shall promptly
notify PARI in writing if any Regulatory Authority or other governmental agency
having jurisdiction requests or orders it to conduct a Recall of any INSMED
Product, or if it determines to undertake a Recall of any INSMED Product
voluntarily.  Prior to the beginning of any such Recall, the Parties agree to
discuss the Recall process if practicable.  INSMED shall solely manage such
Recall and be responsible for (i) the cost of notifying end users; (ii) costs
associated with the collection and shipment from end users of the INSMED Product
subject to such Recall; and (iii) costs of replacing such INSMED Product,
including the cost of shipping the replacement INSMED Product(s) to the affected
end users.  Notwithstanding anything to the contrary in this Section 5.4(b), to
the extent INSMED is required to effect any Recall of an INSMED Product and such
Recall results from a PARI Product or from PARI’s breach of its obligations
hereunder or the gross negligence or willful misconduct of PARI or any of its
Affiliates in its or their performance under this Agreement or the Quality
Agreement, PARI shall, to the extent resulting from the PARI Product or from
PARI’s or its Affiliates’ (as applicable) breach of its obligations hereunder,
or gross negligence or willful misconduct in its or their performance under this
Agreement or the Quality Agreement, bear the expense of repackaging any INSMED
Product that is still in INSMED’s or its Affiliates’ or their distributor’s
possession or control and replacing the PARI Products packaged with such INSMED
Products.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

5.5                               Deficiency Audits. INSMED shall have the right
at its own cost to inspect and audit, or cause to be inspected and audited, the
facilities, books and records of PARI which directly relate to (i) a Regulatory
Authority-identified deficiency, provided that such deficiency is related to
information or materials that PARI provided to INSMED; and/or (ii) a material
breach in PARI’s performance under this Agreement (each a “Deficiency”). INSMED
shall have the right at its own cost to inspect or audit, or caused to be
inspected or audited, any document, process, system, procedure, product or
material that has resulted in a Deficiency (a “Deficiency Audit”).

 

ARTICLE VI
MANUFACTURE AND SUPPLY OF PARI PRODUCTS

 

6.1                               Manufacture of PARI Products.  PARI shall
Manufacture all PARI Product(s) in accordance with this Agreement, the Quality
Agreements, the applicable Device Specifications and Applicable Laws and
Standards.  Within *** days from the Effective Date, the Parties will enter into
two substantially equivalent agreements (one to cover the US/Canada and the
other for the ROW) governing the change control processes, cGMP, quality system
regulations, other standards and procedures for manufacturing and supplying the
Device and the Device Accessories as required by Applicable Laws and Standards
and Regulatory Requirements customary for similar agreements (“Quality
Agreements”). Upon their execution, the Quality Agreements will be attached as
Exhibit F.  Any modification(s) to the Device Specifications that could:
(i) affect the Regulatory Approval of the Device or Device Accessories, as
applicable, or (ii) have a material adverse effect on the development of the
PARI Products and the manufacture thereof, including the quality, reliability,
robustness or user interface of the Device or which would otherwise have an
adverse effect on the INSMED Product when used with the Device or Device
Accessories, as applicable, shall be subject to the Parties’ written agreement
prior to their implementation provided, however, that if INSMED has not
responded to PARI in writing within *** (***) Business Days of receipt of PARI’s
notice regarding such modifications, then INSMED shall be deemed to have
approved such modifications. PARI shall promptly inform the JSC of any other
PARI Product modification(s) that could give rise to questions on the part of
end-users or others involved in Device distribution.

 

6.2                               Forecasts.  Subject to Section 6.3 with
respect to the Initial Forecast, after submission to a Regulatory Authority for
Marketing Approval of the INSMED Product in any given country but no less than
*** (***) months prior to the anticipated First Commercial Sale in such country
and thereafter on a quarterly basis during the Term, at least *** (***) days
before the end of each calendar quarter, INSMED shall provide PARI with its good
faith, reasonable written projections (broken down by Devices, *** and Nebulizer
Handsets) of the anticipated total market requirements of PARI Products for each
country in the INSMED Territory (“Forecast”), on a *** basis during the ***
(***)-*** period immediately following the calendar quarter in which such
projection is issued. The forecasted quantities of PARI Products set forth in
each Forecast are non-binding, good faith estimates provided solely to assist
PARI in its production planning.   All Forecasts shall be deemed INSMED
Confidential Information. PARI shall use commercially reasonable efforts to
commence scale-up activities to transition from clinical supply to commercial
supply based on INSMED’s Forecasts which shall be reasonably explained by INSMED
to PARI.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

6.3                               Initial Purchase Orders for PARI Products.  No
later than *** (***) days prior to the earliest anticipated approval date by the
Regulatory Authority of a MAA in any given country of the INSMED Product, INSMED
shall provide PARI with a PARI Product purchase order for a quantity of PARI
Products by item number (each an “Initial Purchase Order”).  PARI shall produce
sub-components for Devices and Nebulizer Handsets as specified in the Initial
Purchase Order. Such sub-components shall not be labeled with a trademark or
according to the branding strategy until INSMED and PARI will have mutually
agreed and confirmed in writing the labeling of the Devices and Nebulizer
Handsets. The shipment date of the Devices and Nebulizer Handsets covered by
such Initial Purchase Order shall allow PARI a lead time of *** (***) days from
the date of written agreement on the labeling of the Device and Nebulizer
Handset for completing the finished components.  Notwithstanding the above, if
requested in writing by INSMED as an amendment to the Initial Purchase Order,
PARI shall complete production and ship *** as requested in the amendment of the
PARI Products ordered in the Initial Purchase Order within *** (***) days of the
receipt of such amendment.  The amendment shall include the requested labeling
of the Device including the Nebulizer Handset, packaging, and instruction for
use. The remaining balance of the Initial Purchase Order shall be shipped within
*** (***) days from the date of written confirmation by INSMED on the labeling
of the Device and Nebulizer Handset.  For the avoidance of doubt, if INSMED
requests the production and shipment of *** of the PARI Products ordered in the
Initial Purchase Order before the date of written agreement on the labeling of
the Device and Nebulizer Handset, INSMED shall pay for such portion of the
Initial Purchase Order as set forth below regardless of whether the labeling of
the Device and Nebulizer Handset changes for any reason. Notwithstanding the
foregoing, if PARI needs to change the labeling upon request by INSMED or any
relevant Regulatory Authority, then INSMED shall promptly reimburse PARI for the
additional cost incurred by PARI and any resulting delay in shipment shall not
be deemed a breach of this Agreement and such late shipment shall not be
included to determine a Failure Event.  PARI shall store such PARI Products
until such time as PARI delivers such PARI Products on the dates and to the
locations to be provided by INSMED, to the extent allowed by applicable law, in
written instructions to PARI prior to the First Commercial Sale in the U.S. or
in the European Union, as applicable.  Notwithstanding Section 4.2 above, PARI
shall provide INSMED with an invoice for the PARI Products manufactured by PARI
pursuant to such Initial Purchase Order upon receipt and confirmation of the
Initial Purchase Order, and INSMED shall pay the invoice submitted by PARI for
the Initial Purchase Order within *** (***) calendar days after the date of
invoice.

 

6.4                               Subsequent Purchase Orders.

 

(a)                                 PARI shall supply PARI Products to INSMED in
accordance with the terms and conditions of this Agreement, and in accordance
with the purchase orders submitted to PARI by INSMED (the “Purchase Orders”). 
Each Purchase Order shall include item numbers and quantity, delivery
location(s), contact information and shipment date(s).  PARI shall ship the
quantity of PARI Products specified in each Purchase Order no less than ***
(***) days after the date and confirmation of such Purchase Order by PARI,
unless otherwise agreed to by PARI and INSMED; provided, however, that no such
Purchase Order shall have a shipment date prior to the *** day following the
date of receipt by PARI of the Initial Purchase Order.  PARI shall

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

accept all Purchase Orders for quantities of PARI Products that are set forth in
the most recent Forecast for the applicable time period, and PARI shall use
commercially reasonable efforts to accept and fill Purchase Orders placed by
INSMED that are *** of the forecasted quantities for such time period.  PARI
shall notify INSMED within *** (***) Business Days if it cannot meet the
requested shipment date for the ***; provided, however that failure by PARI to
fulfill such *** shall not be deemed a breach under this Agreement.

 

(b)                                 PARI’s sale of PARI Products hereunder shall
be subject to the terms and conditions of this Agreement and not to any terms
and conditions stated on any Purchase Order, PARI’s written acceptance of a
Purchase Order or other document not effectively amending this Agreement, except
insofar as such Purchase Order or other document establishes the quantity,
delivery date, specific shipping requirements and destination of shipment of
PARI Products ordered.  Any additional, inconsistent or different terms and
conditions contained in such other documents are hereby expressly rejected.

 

(c)                                  Rush orders for PARI Products requesting a
delivery date sooner than *** (***) days after the date of such Purchase Order
(other than the Initial Purchase Order) may incur additional charges.  Such
additional charges shall be equal to the actual cost incurred by PARI (over and
above non-rush order costs) due to such rush order.

 

6.5                               Continuity of Supply.  The Parties recognize
that continuity in the manufacture and supply of the PARI Products is critical
for patient care and for the commercial success of the PARI Products and the
INSMED Product(s).  The Parties have agreed on the following terms and
conditions in this Section 6.5 to minimize the risk of discontinuity in such
manufacture and/or supply.

 

(a)                                       Contingency Plan.  On or about ***
days prior to the earliest anticipated First Commercial Sale of the INSMED
Product, PARI will provide to INSMED its draft contingency plan for ensuring the
continuity of manufacture and supply of PARI Products in the event of a Supply
Interruption or other Failure Event (each as defined in Section 6.5(c)) (the
“Contingency Plan”).  INSMED shall have the opportunity to review and comment on
such draft Contingency Plan and the Parties shall finalize such Contingency Plan
by mutual written agreement (not to be unreasonably withheld).  As part of such
Contingency Plan, the Parties may discuss in the future the possibility for PARI
to use commercially reasonable efforts to negotiate in good faith and implement
a reasonably acceptable *** for the PARI Products, which may include a *** for
such PARI Products by PARI or its Affiliates, and any such discussions shall
also include the *** of *** and *** related to the implementation of such a ***.

 

(b)                                       Safety Stock.  For the purpose of
guarding against unexpected changes in market demand or unforeseen manufacturing
failures, delays and shortfalls, PARI agrees to maintain, at its own cost and
expense, safety stock of the Devices, *** and Nebulizer Handsets (the “Safety
Stock”), equal to *** (***) months supply as set forth in the most current
Forecast.  PARI shall have the Safety Stock in place beginning *** days after
the first Marketing Approval of the INSMED Product. PARI shall have the right to
freshen the Safety Stock from time to time by rotating such Safety Stock
provided that the minimum quantity of Safety Stock is not reduced

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

through such process.  In addition, an additional *** (***) months of safety
stock may be maintained by INSMED at its expense.

 

(c)                                        Back-up Manufacturer.

 

(i)                                    Notice of Supply Interruption.  In the
event of any interruption of PARI’s ability to supply Devices in accordance with
this Agreement for any reason, (a “Supply Interruption”), PARI shall promptly
notify INSMED.  Upon the occurrence of any Supply Interruption, the Parties will
meet immediately and discuss in good faith all appropriate actions to remedy and
cure the Supply Interruption.  PARI will use *** to cure the Supply Interruption
as soon as possible.  Upon the occurrence of a Supply Interruption, PARI shall
be permitted to use the Safety Stock to cure such Supply Interruption.  Promptly
following the event of a Supply Interruption, PARI shall prepare a plan to
address any deficiencies or cause(s) of such interruption, provide a draft of
the plan to INSMED (including a plan for filling up the Safety Stock if PARI
used the Safety Stock to cure the Supply Interruption or an otherwise
potentially incomplete Purchase Order) for review and agreement, and will
implement all reasonable comments from INSMED as soon as possible.

 

(ii)                                Failure Event.  The Parties acknowledge the
possibility that one or more of the following events (each, a “Failure Event”)
may occur:

 

(1)                                 PARI undergoes a voluntary or involuntary
dissolution;

 

(2)                                 PARI ceases to conduct business in the
normal course, becomes insolvent, files for bankruptcy, is subject to a
bankruptcy proceeding or otherwise becomes bankrupt, makes a general assignment
for the benefit of creditors, admits in writing its inability to pay its debts
as they are due, permits the appointment of a receiver for its business or
assets, avails itself of or becomes subject to any proceeding under any statute
of any governing authority relating to insolvency or the protection of rights of
creditors; or

 

(3)                                 PARI’s failure to supply at least ***
percent (***%) of all quantities of Devices, Nebulizer Handsets and *** (which,
for purposes of calculating a Failure Event under this subsection (3), shall be
calculated ***) set forth in all accumulated Purchase Orders (but only to the
extent each such Purchase Order is within the applicable forecasted amount) in
any *** (***) consecutive ***; provided that in order for a shortage in supply
to qualify under this subsection (3), the delivery date in the applicable
Purchase Order corresponding to such supply shortage must be at least *** (***)
days from the delivery date in any other Purchase Order for which a shortage in
supply occurred and is being applied towards a Failure Event under this
subsection (3); and provided further that PARI shall be permitted to use Safety
Stock to avoid an incomplete Purchase

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Order, in which case such Purchase Order shall be deemed complete and not be
counted towards the occurrence of a Failure Event.

 

(iii)                            Notification of Failure Event.  PARI shall
promptly notify INSMED in writing upon the occurrence of any Failure Event set
forth in subsection (1) or (2) in clause (ii) above. INSMED may notify PARI in
writing upon the occurrence of an event set forth in subsection (3) of clause
(ii) above (each such notice provided pursuant to this Section 6.4(c)(iii), a
“Notice of Failure Event”).

 

(iv)                             Cure.  If a Failure Event set forth in
Section 6.5(c)(ii)(3) occurs, PARI shall provide INSMED a written proposal which
includes: (1) a statement of the exact amount of Safety Stock and other PARI
Products available pro rata to INSMED, as applicable, remaining in PARI’s
inventory; (2) the current and expected (based on the Forecast) shipments for
PARI Products; and (3) PARI’s plans for remedying such Failure Event within the
Cure Period.  Such remedies may include, but are not limited to, PARI’s
implementation of the Contingency Plan, establishment of a new manufacturing
line at an alternate PARI facility or PARI establishing an agreement with a
Third Party to begin manufacturing.  INSMED will have *** (***) days to review
and give good faith consideration to PARI’s written proposal and, provide
comments to PARI’s proposal for cure.

 

(v)                                 Alternative Supplier.  If a Failure Event
set forth in Section 6.5(c)(ii)(1) or Section 6.5(c)(ii)(2) occurs or if PARI
fails to cure any Failure Event set forth in Section 6.5(c)(ii)(3) within the
Cure Period, then INSMED shall have the right to obtain PARI Products from an
alternate supplier of its choice other than a PARI Competitor (an “Alternative
Supplier”) and the further provisions of this Section 6.5(c)(v) shall apply.

 

(1)                                 PARI shall grant INSMED a limited,
non-exclusive right and license, with the right to grant sublicenses of INSMED’s
rights under the PARI Intellectual Property (in accordance with the terms and
conditions of this Agreement and the License Agreement, excluding the payment
terms for PARI Products under this Agreement), to make or have made the PARI
Products solely for use with the INSMED Product(s) in the INSMED Field in the
INSMED Territory (the “Back-Up License”). The Back-Up License shall survive any
termination of this Agreement by INSMED solely pursuant to Section 12.2(c) or
12.2(d) of this Agreement.

 

(2)                                 In the event INSMED requests that PARI
initiate the transfer of its Data to an Alternative Supplier to support the
Manufacture of PARI Products in accordance herewith, such Alternative Supplier
shall first enter into a reasonable non-disclosure/confidentiality rights
agreement with PARI to protect PARI’s Data, Confidential Information and PARI
Intellectual Property associated with such transfer and such transfer shall be
in accordance with the terms and conditions of this Agreement and the License
Agreement.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

(3)                                 Upon written notice from INSMED, PARI shall
promptly initiate and complete the transfer of the Data set forth below to
support the Manufacture of PARI Products pursuant to the Back-Up License at
PARI’s sole cost and expense to INSMED or INSMED’s Alternative Supplier in
accordance herewith, and provide related reasonable technical assistance
(including the availability of personnel) reasonably useful or necessary for
such Manufacture, including the right to review all records related to such
Manufacture upon reasonable advance written notice in accordance with Article X
of this Agreement:

 

(a) the complete Manufacture standard operating procedures (“SOPs”), including a
complete description of all PARI Intellectual Property, to the extent related to
the Manufacture of PARI Products;

 

(b) all technical reports and materials related to the Manufacture process
activities for the PARI Products, including all reports, documentation and other
materials generated, to the extent not previously delivered to INSMED (if any),
which at the time of such transfer are relevant to and would be required or
useful to Manufacture the PARI Products as set forth herein using the processes
as performed by PARI at such time;

 

(c) all regulatory filings relating to the Manufacture of the PARI Products,
including the materials comprising the PARI Products; and

 

(d) all necessary Chemistry, Manufacturing and Controls (“CMC”) section
documentation relating to the Manufacture of the PARI Products and required for
regulatory filings.

 

(vi)                             Notwithstanding anything set forth in this
Agreement or the License Agreement, in acknowledgment of PARI’s reasonable
concern over the protection of PARI Intellectual Property, INSMED shall not
(directly or indirectly) undertake, or cause to be undertaken by the Alternative
Supplier, the proprietary aspects of Manufacture of the PARI Products (including
without limitation the Device’s or Nebulizer Handset’s aerosol heads) in the
countries listed on Exhibit G hereto, except to the extent such country
currently listed no longer is listed on the TRIPS Priority Watch list.

 

(vii)                         If PARI regains the ability to manufacture and
supply PARI Products and INSMED reasonably determines in good faith that PARI
does have the ability to manufacture and supply PARI Products, then INSMED will
use its *** to transition back to PARI the Manufacture of the PARI Products
within a reasonable timeframe determined by INSMED in good faith after
consultation with PARI, such

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

timeframe not to exceed *** (***) days, provided that such maximum timeframe
shall be reasonably extended to the extent necessary to comply with any
necessary regulatory requirements or for INSMED to perform any ongoing clinical
development activities.

 

(viii)                     For clarity, INSMED shall remain responsible for its
royalty obligations in accordance with the terms of the License Agreement, as
amended pursuant to Section 12.1 of this Agreement. Notwithstanding anything to
the contrary contained herein, the Back-Up License and related rights set forth
in this Section 6.5(c) shall terminate concurrently with any termination of the
License Agreement by PARI under Section 15.2 of the License Agreement.

 

(ix)                             If INSMED and/or its Alternative Supplier
(directly or indirectly) modifies or improves any PARI Intellectual Property,
all such improvements and modifications, and all Intellectual Property rights
thereto, are and will be exclusively owned by PARI (and included within the
scope of the Back-Up License) and INSMED does hereby and will promptly (and
shall secure and cause its Alternative Supplier to promptly) transfer and assign
any and all such rights in such improvements and modifications to PARI without
further consideration at INSMED’s sole cost and expense.

 

6.6                               Relationship to the License Agreement.  The
provisions of this Agreement shall replace and supersede Section 8.9 and
Exhibit 8.9 of the License Agreement in their entirety.

 

ARTICLE VII
DELIVERY

 

7.1                               Delivery.  PARI shall deliver to INSMED all
PARI Products in conformance with each applicable Purchase Order.  PARI
recognizes that time is of the essence under this Agreement.  PARI shall report
to INSMED the occurrence of any event within or beyond its control which is
likely to affect delivery under this Agreement. All PARI Product so delivered
shall be accompanied by the following documentation, as applicable: (a) the
serial numbers of the delivered Devices or aerosol heads; (b) any documentation
required under this Agreement or the Quality Agreements, and (c) any
documentation that PARI customarily includes in shipments of such Device and/or
Device Accessories.

 

7.2                               Shipping; Risk of Loss.  All shipments for
PARI Products will be made (x) *** in *** (INCOTERMS 2010) by a common carrier
selected by PARI; and (y) in case of the United States and Canada, *** in ***
(INCOTERMS 2010) by a common carrier selected by INSMED, such selection to be
reasonably acceptable to PARI acting in good faith.

 

7.3                               Testing.  PARI shall test the orders of PARI
Product to be supplied to INSMED in accordance with the terms and conditions set
forth in the Quality Agreements.

 

7.4                               Acceptance.  INSMED shall have a period of ***
(***) Business Days from the date of receipt of any shipment of the PARI
Products to test for quality and visually inspect each

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

shipment for shortage in quantity or visible damages.  INSMED shall have the
right to reject all or a portion of a shipment for any visible damage, or
request for the shipment of additional units to the extent there is a shortage
in quantity.  If INSMED rejects a shipment, it shall notify PARI in writing
within such *** (***) Business Days, indicating the order number, date of
delivery and the nature of the Device defect. Upon PARI’s receipt of a rejection
from INSMED and PARI’s acceptance in good faith of such a rejection, PARI shall,
at the option of INSMED, replace the Device and/or Device Accessory or replace
the defective part or component, in each case at PARI’s sole expense.  Time
shall be of the essence in PARI’s replacement of such defective part or
component.  In the event INSMED does not so notify PARI of visible damage, a
shortage of PARI Products or a quality issue within *** (***) Business Days
after its receipt of any shipment thereof, INSMED shall be deemed to have
accepted such shipment and shall be obligated to make payment therefor as
provided in this Agreement.  Thereafter, INSMED may return any PARI Product only
pursuant to Section 8.3 below.

 

ARTICLE VIII
REPRESENTATIONS AND WARRANTIES

 

8.1                               Mutual Representations and Warranties.  Each
Party hereby represents and warrants to the other Party as follows:

 

(a)                                 Due Authorization.  Such Party has taken all
necessary action on its part to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder.

 

(b)                                 Enforcement of Obligations.   This Agreement
has been duly executed and delivered on behalf of such Party, and constitutes a
legal, valid, binding obligation, enforceable against such Party in accordance
with its terms.

 

(c)                                  No Conflict.  The execution and delivery of
this Agreement and the performance of such Party’s obligations hereunder do not
conflict with, or constitute a default or require any consent under, any
contractual obligation of such Party.

 

(d)                                 Each Party represents and warrants and
covenants that all relationships or arrangement between such Party and any
federal, state or local government (or an agency thereof)) or any elected or
appointed public official shall comply with all Applicable Laws and Standards,
including without limitation lobbying restrictions, conflicts of interest
requirements, and the Foreign Corrupt Practices Act.

 

8.2                               Representations and Warranties of PARI.  PARI
represents, warrants, and covenants to INSMED as follows:

 

(a)                                       PARI is not debarred pursuant to the
Federal Food, Drug and Cosmetic Act, excluded from a federal health care
program, or debarred from federal contracting, and PARI shall not use any
employee or consultant, in the United States, who has ever been so debarred or
excluded or is, to PARI’s knowledge (after reasonable inquiry), the subject of
such debarment or exclusion proceedings, or who has been convicted of or pled
nolo contendere to

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

any felony, or to any federal or state legal violation (including misdemeanors)
relating to prescription drug or device products or fraud, or convicted of any
other crime for which an entity or person could be so debarred or excluded
(including by the FDA under 21 U.S.C. § 335a (or subject to a similar sanction
of any other Regulatory Authority in the United States)).  PARI agrees that, if,
during the Term, all or part of the above statement ceases to be accurate,  PARI
shall immediately notify INSMED of such circumstance, and at INSMED’s option,
acting reasonably, this Agreement shall terminate automatically as of the first
date of such noncompliance);

 

(b)                                 PARI has not and shall not enter into any
agreement or arrangement with any other entity that could reasonably be expected
to prevent, in any material respect, or in any other negative way materially
interfere with, PARI’s ability to perform its obligations pursuant to this
Agreement, or that would prevent INSMED from exercising its rights under this
Agreement or the License Agreement;

 

(c)                                  PARI is a ISO-certified manufacturer
following ISO 13485, and PARI agrees to inform INSMED immediately regarding any
change in this status;

 

(d)                                 PARI agrees to inform INSMED immediately
regarding any change in its registration or status with the FDA or any other
Regulatory Authority;

 

(e)                                  PARI owns or otherwise Controls all
necessary rights to make, use, import, export, offer for sale and sell and
commercialize all Devices, *** and Nebulizer Handsets as contemplated under this
Agreement; and

 

(f)                                   PARI has not received any written notice
that any Regulatory Authority has commenced, or threatened to initiate, any
action to withdraw approval, place marketing or sale restrictions, or request
the recall of the PARI Products, or commenced, or threatened to initiate, any
action to enjoin or place restrictions on the production, sale, or marketing of
the PARI Products.

 

8.3                               Device Warranties.  PARI represents, warrants
and guarantees that each unit of PARI Products supplied by PARI under this
Agreement:

 

(a)                                 as of the time of first use, complies with
the terms of this Agreement and the applicable Device Specifications set forth
in the applicable Territory-Specific Appendix;

 

(b)                                 has been manufactured in compliance with
Applicable Laws and Standards;

 

(c)                                  has been manufactured in compliance with
the terms and conditions of the Quality Agreements;

 

(d)                                 with respect to the Durable Components of
each Device, will have no material defect in workmanship for a period of at
least *** (***) months from the date of receipt by an end user;

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

(e)                                  with respect to each Nebulizer Handset and
Device Accessory, will have no material defect in workmanship when the Nebulizer
Handset and Device Accessory is used by such end user for the first time,
provided such Nebulizer Handset and Device Accessory has been properly used and
maintained in accordance with any product user manual or the “Instructions for
Use” for the applicable Nebulizer Handset and Device Accessory;

 

(f)                                   is, upon shipment to INSMED, free and
clear of all security interests, liens and other encumbrances of any kind or
character;

 

(g)                                 to the knowledge of PARI, is not a product,
the manufacture, use or sale of which infringes any patent rights or other
intellectual property rights of any Third Party in the INSMED Field and subject
to the license and cross-license agreements mentioned in Exhibit C.

 

The foregoing warranties shall survive any inspection, delivery, acceptance, or
payment by INSMED, any subsequent sublicense or distribution to third parties by
INSMED, its Affiliates or its authorized agents, and shall be enforceable by
INSMED as well as its successors and permitted assigns for itself or the benefit
of any third party Sublicensee or distributor of the INSMED Product.

 

8.4                               Warranty Replacement.

 

(a)                                 Warranty to End Users.  The period and
requirement of the warranty set forth under Section 8.3(c) shall be included
with the Device.

 

(b)                                 PARI’s Responsibilities.  PARI shall be
solely responsible, at its cost, for any warranty claim that it accepts which
alleges that any PARI Product does not conform with any of the warranties
described under Sections 8.3, by replacing the non-conforming units.  INSMED
shall not be obligated to bear any costs, including transportation costs, in
connection with the replacement of such non-conforming units unless otherwise
defined in the Territory-Specific Appendix.  The Parties shall establish
appropriate timelines and procedures for responding to warranty calls in the
different countries within the INSMED Territory.  PARI shall have the right to
inspect defective Devices and/or Device Accessories to determine the validity of
warranty claims under this Section 8.4 or to comply with applicable Regulatory
Requirements.

 

8.5                               Warranty Limitations or Disclaimers.  THE
WARRANTIES, LIMITATIONS AND DISCLAIMERS DESCRIBED IN THIS ARTICLE 8 ARE
EXCLUSIVE AND SUPERSEDE ANY OTHER WARRANTY LIMITATIONS AND DISCLAIMERS GIVEN BY
PARI OR INSMED, WHETHER WRITTEN OR ORAL.  EXCEPT FOR THE EXPRESS WARRANTIES IN
SECTION 8.3, PARI MAKES NO WARRANTIES OF ANY KIND WITH RESPECT TO ANY PARI
PRODUCT, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE, FOR ANY
IMPLIED WARRANTIES ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING, OR
USAGE OF TRADE.  INSMED AND ITS DESIGNEES SHALL NOT MAKE ANY REPRESENTATION OR
WARRANTY ON BEHALF OF PARI THAT EXCEEDS THE EXPRESS WARRANTIES IN SECTION 8.3.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

8.6          Compliance with Laws.  Each Party certifies that it shall not
violate any Applicable Law, including but not limited to, the federal
anti-kickback statute, set forth at 42 U.S.C. sec. 1320a-7b(b), the Public
Contracts Anti-Kickback Act, 41 U.S.C. sec 50 et seq., any state anti-kickback
law, the Health Insurance Portability and Accountability Act (“HIPAA”), set
forth at 42 U.S.C. sec. 1320d-2, and the Foreign Corrupt Practices Act, set
forth at 15 U.S.C. sec. 78dd-1, et seq. Each Party certifies that it shall
cooperate with the other Party as required to comply with Applicable Laws,
including providing assistance with any disclosures required by Applicable Laws

 

ARTICLE IX
INTELLECTUAL PROPERTY

 

9.1          Trademark.

 

(a)           License and Authorization.

 

(i)            Subject to the terms and conditions set forth in this Agreement,
PARI hereby grants to INSMED and its designees, a non-exclusive,
non-transferable right and license to use PARI’s trademark(s) set forth on
Exhibit H attached hereto, in the INSMED Territory in connection with (w) the
PARI Products, (x) the INSMED Products offered by INSMED and its designees, and
(y) any advertising or promotional materials associated therewith, in the manner
mutually agreed to by the Parties pursuant to Section 3.4 of this Agreement, and
(z) packaging and prescribing information.  The license set forth herein shall
immediately terminate with respect to (w), (x), and (y), upon expiration or
sooner termination of this Agreement and with respect to (z), upon expiration or
sooner termination of the License Agreement.

 

(ii)           Subject to the terms and conditions set forth in this
Agreement, INSMED hereby grants to PARI a non-exclusive, non-transferable right
and license to use INSMED’s trademark(s) set forth on Exhibit H attached hereto,
in the INSMED Territory in connection with (x) the PARI Products and (y) any
advertising or promotional materials associated therewith, in the manner
mutually agreed to by the Parties pursuant to Section 3.4 of this Agreement, and
(z) packaging and prescribing information.  The license set forth herein shall
immediately terminate with respect to (x), and (y), upon expiration or sooner
termination of this Agreement and with respect to (z), upon expiration or sooner
termination of the License Agreement.

 

(b)           Notices.  Each of PARI and INSMED agree to use commercially
reasonable efforts to mark all materials, including packaging, advertising and
promotional materials, that incorporate the trademarks of the other Party hereto
that are licensed above in Section 9.1(a) with the symbol ™ or ®, as applicable,
and the following attribution notice: “[Insert applicable trademark from
Exhibit H] is a trademark of [insert applicable Party that owns the relevant
trademark]”.  In addition, each Party shall comply with any additional
requirements established by the other Party with respect to the use of its
trademarks.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

(c)           Ownership.  Each Party represents and warrants that it owns all
right, title and interest in and to its trademarks set forth in Exhibit H. 
Neither Party shall challenge, cause others to challenge or assist in any
challenge to the validity of the other Party’s trademarks, any registrations
thereof or the ownership thereof.  Each of INSMED and PARI shall be solely
responsible for taking such actions as it deems appropriate to obtain trademark,
service mark or copyright registration for its trademarks.  All uses of or
references to each Party’s trademarks shall inure to the benefit thereof, and
all rights with respect to such Party trademarks not specifically granted in
this Agreement shall be and are hereby reserved to such Party.

 

(d)           Infringement.  If either Party learns of any activity by a Third
Party which might constitute an infringement of the other Party’s rights in any
of its trademarks, or if any Third Party asserts that a Party’s use of the other
Party’s trademarks constitutes unauthorized use or infringement, such Party
shall so notify the other Party. The notifying Party shall make all reasonable
efforts to assist the other Party, at the other Party’s expense and request,
with any litigation concerning such trademarks, including providing such
evidence and/or expert assistance as the notifying Party may have within its
control.

 

(e)           Quality Control.  Each Party hereto acknowledges and agrees that
the other Party shall be entitled to monitor the use of its respective
trademarks pursuant to this Agreement.  If a Party determines that any of its
trademarks is not being used properly, it shall so notify the other Party in
writing or through the Joint Steering Committee and such other Party shall take
steps to: (i) reassure the notifying Party that the trademark usage is proper or
(ii) comply with any changes necessary to address the notifying Party’s
concerns.

 

ARTICLE X
CONFIDENTIALITY

 

10.1        Confidentiality and Non-Use Obligations.  Article 11 of the License
Agreement is hereby incorporated herein by reference and shall govern all
Confidential Information exchanged between the Parties under this Agreement.

 

10.2        Injunctive Relief.  The Parties expressly acknowledge and agree that
any breach or threatened breach of Article 9 or Article 10 may cause immediate
and irreparable harm which may not be adequately compensated by damages.  Each
Party therefore agrees that in the event of such breach or threatened breach and
in addition to any remedies available at law, the non-breaching Party shall have
the right to secure equitable and injunctive relief, without bond, in connection
with such a breach or threatened breach.

 

ARTICLE XI
INDEMNIFICATION

 

11.1        Indemnification of INSMED.  PARI shall at all times be responsible
for, and shall defend, indemnify and hold INSMED, its Affiliates, and their
respective directors, officers, employees, agents and representatives
(collectively, “INSMED Indemnitees”), harmless from and against any and all
losses, expenses, recoveries and damages, including reasonable legal expenses,
costs and attorneys’ fees (collectively “Losses”), arising out of Third

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Party claims, lawsuits, judgments, or proceedings of any kind or nature
(collectively, “Claims”) to the extent arising from: (i) any product liability
claim or lawsuit directly arising from the authorized use, design, manufacture
or function of a Devices, *** and/or Nebulizer Handsets; (ii) any claim of
infringement of any patent rights, trade secrets rights or other intellectual
property rights of a Third Party arising from the authorized use, design or
function of a Devices, *** and/or Nebulizer Handsets or manufacture by PARI
thereof; (iii) PARI’s failure to manufacture the PARI Products in accordance
with the applicable Device Specifications, Applicable Laws and Standards or the
terms of the Quality Agreement; (iv) PARI’s material breach of any
representation or warranty or covenant given in this Agreement by PARI; or
(v) any negligent conduct or willful misconduct by PARI in performance under
this Agreement; except, in each case to the extent that any Claim arises out of
or results from any negligent conduct or willful misconduct by INSMED or
INSMED’s material breach of any representation or warranty or covenant given in
this Agreement by INSMED. INSMED, at its expense, may participate in the defense
of any such claim or lawsuit.  The Parties acknowledge and agree that INSMED’s
indemnifications rights and PARI’s indemnification obligations under this
Section 11.1 shall control over Section 13.1 of the License Agreement with
respect to any Claims arising from activities performed under this Agreement and
nothing in this Section 11.1 shall permit a duplicative recovery by INSMED or
its Affiliates for any Losses for which indemnity is obtained hereunder and the
indemnification obligations of PARI under Section 13.1 of the License Agreement.

 

11.2        Indemnification of PARI.  INSMED shall at all times be responsible
for, and shall defend, indemnify and hold PARI, its Affiliates, and their
respective directors, officers, employees, agents and representatives
(collectively, “PARI Indemnitees”), harmless from and against any and all Losses
arising out of Third Party Claims to the extent arising from: (i) any product
liability claim or lawsuit directly arising from the INSMED Product; (ii) any
claim of infringement of any patent rights, trade secrets rights or other
intellectual property rights of a Third Party arising from the INSMED Product or
the manufacture thereof; (iii) INSMED’s material breach of any representation,
warranty or covenant given in this Agreement by INSMED; and (iv) any negligent
conduct or willful misconduct by INSMED in performance under this Agreement;
except, in each case to the extent that any Claim arises out of or results from
any negligent conduct or willful misconduct by PARI or PARI’s material breach of
any representation or warranty or covenant given in this Agreement by PARI. 
PARI, at its expense, may participate in the defense of any such claim or
lawsuit. The Parties acknowledge and agree that PARI’s indemnifications rights
and INSMED’s indemnification obligations under this Section 11.2 shall control
over Section 13.2 of the License Agreement with respect to any Claims arising
from activities performed under this Agreement and nothing in this Section 11.2
shall permit a duplicative recovery by PARI or its Affiliates for any Losses for
which indemnity is obtained hereunder and the indemnification obligations of
INSMED under Section 13.2 of the License Agreement.

 

11.3        Indemnification Procedures.  In the event of any claim that may be
subject to indemnification under this Article 11, the indemnified Party shall
(a) promptly notify the indemnifying Party of such claim; (b) at indemnifying
Party expense, reasonably cooperate with the indemnifying Party in the defense
of such claim; and (c) not settle any such claim without the

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

indemnifying Party’s written consent, which shall not be unreasonably withheld,
conditioned or delayed.  The indemnifying Party shall keep the indemnified Party
informed at all times as to the status of its efforts.  The indemnifying Party
shall not settle any such claim without the prior written consent of the
indemnified Party, which shall not be unreasonably withheld, conditioned or
delayed, unless (x) such settlement includes an unconditional release of the
indemnified Party from all liability arising out of such claim, (y) does not
contain any admission or statement suggesting any wrongdoing or liability on
behalf of the indemnified Party and (z) does not contain any equitable order,
judgment or term that in any manner affects, restrains or interferes with the
business of the indemnified Party.  The indemnified Party may participate in
proceedings relating to any indemnified claim with counsel of its own choosing
at its own expense.

 

11.4        Insurance.  During the Term and for a reasonable period of time
thereafter, each Party or its Affiliates shall maintain appropriate product
liability insurance with respect to any clinical trials, Manufacture,
development, sales, marketing, distribution and promotion activities performed
by such Party hereunder.  Each Party shall furnish the other Party, upon the
other Party’s request, with a certificate of insurance evidencing coverage under
the foregoing policies of insurance, along with any amendments and revisions
thereto.  PARI shall be (i) named as an additional insured on any such policies
maintained hereunder by INSMED, and (ii) also added by endorsement on such
policies.  With respect to the United States, INSMED shall be (i) named as an
additional insured on any such policy maintained hereunder by PARI’s Affiliate,
PRE Holding, Inc., and (ii) also added by endorsement on such policies of PRE
Holding, Inc.

 

11.5        Liability.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY UNDER
ANY CIRCUMSTANCES OR ANY LEGAL OR EQUITABLE THEORY, WHETHER IN CONTRACT, STRICT
LIABILITY OR OTHERWISE, FOR ANY INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL
DAMAGES OR DAMAGES FOR LOST PROFITS ARISING OUT OF OR RELATED TO THIS AGREEMENT,
EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.  THESE LIMITATIONS SHALL
APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED REMEDY.
THE LIMITATION OF THIS SECTION 11.5 SHALL NOT APPLY, HOWEVER, TO A PARTY’S
INDEMNIFICATION OBLIGATIONS FOR THIRD PARTY CLAIMS PURSUANT TO SECTION 11.1 OF
THIS AGREEMENT, OR TO A PARTY’S MATERIAL BREACH OF ITS OBLIGATIONS UNDER
ARTICLE 10.

 

ARTICLE XII
TERM

 

12.1        Term.  This Agreement shall become effective upon the Effective Date
and unless earlier terminated pursuant to Section 12.2 below shall remain in
full force and effect until fifteen (15) years from First Commercial Sale, (the
“Initial Term”); provided that INSMED may extend the Term of the Agreement for
an additional five (5) years by providing written notice thereof to PARI at
least one (1) year prior to the expiration of the Initial Term (the “Renewal
Term” and the Initial Term plus any Renewal Term, collectively the “Term”). The
Parties acknowledge and agree that if INSMED elects to extend the Term of the
Agreement for the Renewal Term, then INSMED shall be responsible for paying PARI
royalties on Net Sales of the

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Drug Product (as such terms are defined in the License Agreement) in accordance
with Article 6 of the License Agreement until expiration of the Renewal Term
(unless terminated earlier pursuant to Section 12.2 below).  In addition,
notwithstanding anything to the contrary in the License Agreement or this
Agreement, (x) the Royalty Term (as defined in the License Agreement) shall
automatically be extended for the entire duration of the Term of this Agreement,
and (y) the provisions of Article 6 of the License Agreement shall survive the
termination or expiration of the License Agreement if this Agreement remains in
effect after the expiration or termination of the License Agreement.

 

12.2        Termination.

 

(a)             For Convenience.  This Agreement may be terminated by INSMED at
any time upon prior written notice to PARI if INSMED terminates the License
Agreement in accordance with the provisions of Section 15.3 of the License
Agreement; provided, that INSMED shall provide PARI with written notice of its
intent to terminate this Agreement if PARI does not cure its default under the
License Agreement concurrent with the written notice of default provided to PARI
pursuant to Section 15.3 of the License Agreement.

 

(b)           By Mutual Agreement.  This Agreement may be terminated at any time
upon the mutual written agreement of the Parties.

 

(c)           For Insolvency.  This Agreement may be terminated by either Party
in the event the other Party files an application for commencement of
bankruptcy, civil rehabilitation, corporate reorganization, corporate
liquidation or special liquidation procedures, or any mailing of order or notice
of attachment or provisional attachment on any assets of such other Party, or
any other insolvency.

 

(d)           For Cause.  If a Party is in material breach of this Agreement,
then the non-breaching Party may deliver notice of such material breach to the
other Party.  For all material breaches other than a failure to make a payment
set forth in this Agreement, the breaching Party shall have *** (***) days to
cure such material breach from the receipt of the notice or to dispute.  With
respect to any failure to make a payment set forth in this Agreement, the
breaching Party shall have *** (***) days from the receipt of the notice to
dispute or cure such non-payment.  If the Party receiving notice of material
breach or failure to make a payment fails to cure, or fails to dispute, that
material breach or failure to make a payment within the applicable period set
forth above, then the non-breaching Party may terminate this Agreement
immediately on written notice of termination.

 

12.3        No Waiver.  The termination or expiration of this Agreement, as the
case may be, shall not act as a waiver of any breach of this Agreement and shall
not act as a release of either Party from any liability or obligation incurred
under this Agreement through the date of such termination or expiration,
including payments due PARI pursuant to this Agreement.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

12.4        Consequences of Expiration and Termination.

 

(a)           Supply Following Expiration.  At INSMED’s request, prior to the
expiration of this Agreement under Section 12.1 above, the parties shall meet
and discuss in good faith a new agreement, containing commercially reasonable,
arms-length terms, pursuant to which PARI and its Affiliates may make, have
made, import and export PARI Products to INSMED following the expiration of this
Agreement.

 

(b)           Reimbursement of Safety Stock.  If INSMED terminates this
Agreement pursuant to Section 12.2(a), then INSMED shall reimburse PARI no later
than *** (***) Business Days after the effective date of termination of this
Agreement for all reasonable costs related to the remaining Safety Stock, other
PARI Products manufactured and raw material / unfinished goods specific for the
Device by PARI pursuant to Purchase Orders submitted by INSMED in accordance
with this Agreement that, in each case, cannot be reallocated or reused by PARI
through PARI’s use of commercially reasonable efforts to do so. Any PARI
Products that INSMED reimburses PARI for pursuant to this Section 12.4(b) shall
be promptly delivered to INSMED in accordance with the provisions of
Section 7.2.

 

(c)           Rights in Bankruptcy.  All rights and licenses granted under this
Agreement are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the United States Bankruptcy Code, licenses of a right to
“intellectual property” as defined under Section 101(60) of the United States
Bankruptcy Code.  Each Party, as a licensee of such rights under this Agreement,
shall retain and may fully exercise all of its rights and elections under the
United States Bankruptcy Code in the event of the commencement of a bankruptcy
proceeding by or against the licensor Party under the United States Bankruptcy
Code, including without limitation the right to treat this Agreement or any
agreement supplementary to this Agreement as terminated or to retain its rights
under this Agreement or any agreement supplementary to this Agreement.  In the
event that the licensee Party elects to retain its rights under this Agreement
or any agreement supplementary to this Agreement, the licensor Party shall
provide to the licensee Party, within *** (***) calendar days after written
notice by the licensee Party to the licensor Party in accordance with
Section 13.1 of this Agreement, all intellectual property and all embodiments of
such intellectual property within the possession or Control of the licensor
Party.

 

(d)           Survival.  Sections 4.2, 4.3, 6.5(c)(v), 8.2, 8.3, 8.4, and 12.4,
and Articles 1, 10, 11 (with respect to any Claim that is attributable to any
cause that occurs under this Agreement prior to its expiration or termination,
as applicable) and 13 of this Agreement shall survive expiration or termination
of this Agreement for any reason.

 

ARTICLE XIII
MISCELLANEOUS

 

13.1        Notices.  All notices and other communications given hereunder shall
be in writing and shall be deemed to have been delivered and received (a) when
personally delivered, (b) on the *** (***) Business Day after which sent by
registered or certified mail, postage prepaid, return receipt requested, (c) on
the date on which transmitted by facsimile or other electronic means generating
a receipt evidencing a successful transmission (provided that, on that same
date, a copy of such notice is sent by registered or certified mail, postage
prepaid, return receipt requested), or (d) on the *** (***) Business Day after
the Business Day on which

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

deposited with a regulated public carrier (e.g., Federal Express) for overnight
delivery (receipt verified), freight prepaid, addressed to the Party for whom
intended at the mailing address or facsimile number set forth below, or such
other mailing address or facsimile number, notice of which is given in a manner
permitted by this Section 13.1:

 

If to PARI to:

 

 

 

 

 

 

PARI Pharma GmbH

 

 

Moosstrasse 3

 

 

D-82319 Starnberg, Germany

 

 

Attention: ***

 

 

Title: President

 

 

Telefax No.: ***

 

 

 

 

with a copy to:

 

 

 

 

 

McGuireWoods LLP

 

 

One James Center

 

 

901 East Cary Street

 

 

Richmond, Virginia 23219

 

 

Attention: ***

 

 

Telefax No.: ***

 

 

 

 

If to INSMED to:

 

 

 

 

 

Insmed Incorporated

 

 

10 Finderne Avenue, Building 10

 

 

Bridgewater, NJ  08807-3365

 

 

Attention: Chief Commercial Officer

 

 

Telefax No.: ***

 

 

 

 

with a copy to:

 

 

 

 

 

Insmed Incorporated

 

 

10 Finderne Avenue, Building 10

 

 

Bridgewater, NJ  08807-3365

 

 

Attention: General Counsel

 

 

Telefax No.: ***

 

 

Any Party may by such notice change the address to which notice or other
communications to it are to be delivered or mailed.

 

13.2        Force Majeure.  No failure or omission by either Party in the
performance of any obligation under this Agreement shall be deemed a breach of
this Agreement or create any liability if the same shall arise from any cause or
causes beyond the control of such Party including, but not limited to, the
following which, for the purposes of this Agreement, shall be

 

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DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

regarded as beyond the control of the Party in question: (a) any act or omission
of any government; (b) any future rule, regulation or order issued by any
governmental authority or by any officer, department, agency, or instrumentality
thereof which makes such performance impossible or commercially unreasonable; or
(c) any Act of God, fire, storm, flood, earthquake, accident, war, terrorism,
rebellion, insurrection, riot, invasion, strike, and lockout.

 

13.3        Relationship of the Parties.  In making and performing this
Agreement, the Parties are acting, and intend to be treated, as independent
entities and nothing contained in this Agreement shall be construed or implied
to create an agency, partnership, joint venture, or employer and employee
relationship between or among any of the Parties.  Except as otherwise provided
herein, no Party may make any representation, warranty or commitment, whether
express or implied, on behalf of or incur any charges or expenses for or in the
name of any other Party.  No Party shall be liable for the act of any other
party unless such act is expressly authorized in writing by such Party.

 

13.4        Choice of Language.  This Agreement, originally written in the
English language, shall be governed by the English language.  In the event any
dispute arises with respect to this Agreement, the meanings of all terms and
provisions of this Agreement shall be interpreted in their original English
form.  The governing language of all correspondence related to reporting,
negotiation, disputes, arbitration and notice requirements shall be the English
language.  The Parties shall bear their own expenses for having text or other
communications translated into the English language.

 

13.5        Waivers and Amendments.  This Agreement may be amended or modified,
and the terms and conditions hereof may be waived, only by a written instrument
signed by the Parties hereto or, in the case of a waiver, by the Party waiving
compliance.  No delay on the part of any Party in exercising any right, power or
privilege hereunder shall operate as a waiver thereof, nor shall any waiver on
the part of any Party of any right, power or privilege hereunder, nor any total
or partial exercise of any other right, power or privilege hereunder preclude
any other or further exercise thereof or the exercise of any other right, power
or privilege hereunder.  The rights and remedies herein provided are cumulative
and are not exclusive of other rights or remedies which any Party may otherwise
have.

 

13.6        Assignment.  This Agreement shall not be assignable by either Party
without the prior written consent of the other Party, which consent shall not be
unreasonably withheld, delayed or conditioned, except that without consent
either Party may assign or transfer the rights and obligations of this Agreement
to any Affiliate or to any successor in interest in connection with any merger,
consolidation, or sale of all or substantially all of the assets to which this
Agreement relates; provided, however, that (a) such assignment or transfer by
INSMED to a PARI Competitor shall require the prior written consent of PARI; and
(b) in the event of any such assignment or transfer by INSMED to *** or any of
its subsidiaries (“***”), (i) notwithstanding the provisions of
Section 6.5(c)(v), in the event *** is entitled to obtain supply of PARI
Products from an Alternative Supplier in accordance with Section 6.5(c)(v), PARI
shall grant the Back-Up License in accordance therewith (including in accordance
with the terms and conditions of this Agreement and the License Agreement) and
perform the technology transfer of the Data for Manufacture in accordance with
6.5(c)(v) to a Third Party reasonably acceptable to

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

*** and shall not be obligated to grant such Back-Up License or provide such
Data directly to ***.  This Agreement shall inure to the benefit of and be
binding upon the Parties hereto and their respective successors and permitted
assigns.  Any assignment in contravention of the foregoing shall be null and
void.  The Parties acknowledge and agree that, notwithstanding anything to the
contrary in the License Agreement, INSMED may also assign the License Agreement
to *** if this Agreement is assigned to *** in any instance permitted under this
Section 13.6.

 

13.7        Choice of Law. This Agreement is construed in accordance with, and
its performance is governed by, the laws of State of New York, excluding its or
any other jurisdiction’s choice of law principles.  In the event of any conflict
between US and foreign laws, regulations and rules, US laws, regulations and
rules shall govern.  The UN Convention on contracts for the International Sale
of Goods shall not apply to this Agreement. Any dispute arising hereunder shall
be brought exclusively in the state or federal courts located in the State of
New York in the division of Manhattan. The Parties hereby consent to the
exclusive jurisdiction and venue of such courts and waive any objections to the
jurisdiction and venue thereof.

 

13.8        Disputes. PARI and INSMED shall endeavor to resolve any claim or
controversy arising out of the threatened breach, breach, enforcement,
interpretation, termination or validity of this Agreement informally by good
faith negotiation between the senior executives, officers or management of PARI
and INSMED. Either Party may give the other Party written notice of any claim or
controversy not resolved in the normal course of business (the “Disputing Party
Notice”). Within *** (***) calendar days after the delivery of the Disputing
Party Notice, the receiving Party shall submit to the other Patty a written
response (the “Response”). The Disputing Party Notice and Response shall include
a statement of each Party’s position and a summary of the arguments supporting
that position. Within *** (***) days after the Disputing Party Notice, such
designated senior executives, officers or management of PARI and INSMED shall
meet at a mutually acceptable time and place and thereafter as often as they
reasonably deem necessary to attempt to resolve the claim or controversy. All
negotiations pursuant to this Section 13.8 are confidential and without
prejudice and shall be treated as compromise and settlement negotiations for
purposes of applicable rules of evidence. Any claim or controversy unresolved
after application of this Section 13.8 shall be subject to Section 13.7 of this
Agreement.

 

13.9        Entire Agreement.  This Agreement and the License Agreement contain
the entire understanding of the Parties hereto with respect to the subject
matter contained herein and supersede and cancel all prior agreements,
negotiations, correspondence, undertakings and communications among the Parties,
oral or written, with respect to such subject matter.  The License Agreement
shall remain in full force and effect except for those provisions that are
inconsistent with the terms and conditions under this Agreement, in which event
the terms and conditions under this Agreement shall control.

 

13.10      Severability.  Both Parties hereby expressly state that it is the
intention of neither Party to violate any law.  If any of the provisions of this
Agreement are held to be void or unenforceable, then such void or unenforceable
provisions shall be replaced by valid and

 

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DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

enforceable provisions which will achieve as far as possible the economic
business intentions of the Parties.

 

13.11      Section Headings.  The section headings contained in this Agreement
are for the purpose of convenience and are not intended to define or limit the
contents of such sections.

 

13.12      Further Assurances.  Upon the reasonable request of either Party, the
other Party shall execute any additional certificates or other documents that
may be reasonably necessary to fully implement this Agreement.

 

13.13      Counterparts.  This Agreement may be signed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.  This Agreement may be
executed in one or more counterparts, each of which shall be an original, but
taken together constituting one and the same instrument.  Execution of a
facsimile copy or in Adobe™ Portable Document Format (PDF) sent by electronic
mail shall have the same force and effect as execution of an original, and a
facsimile or PDF signature shall be deemed an original and valid signature.

 

[SIGNATURES APPEAR ON THE NEXT PAGE]

 

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DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

IN WITNESS WHEREOF, each Party hereto has executed or caused this Agreement to
be executed on its behalf as of the Effective Date.

 

 

 

PARI PHARMA GMBH

 

 

 

 

 

By:

/s/ Dr. Martin Knoch

 

 

Name:

Dr. Martin Knoch

 

 

Title:

President

 

 

 

 

 

INSMED INCORPORATED

 

 

 

 

 

By:

/s/ William H. Lewis

 

 

Name:

William H. Lewis

 

 

Title:

CEO & President

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT A

 

Device

 

The “Device” comprises of the following components:

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***

 

Specifications of the Device:

 

·                  *** ( ***): *** to ***

 

·                  *** (***):  ***

 

·                  ***: *** (***)

 

For clarity, Device does not mean: the ***, the ***, the *** or the ***.

 

Nebulizer Handset

 

The “Nebulizer Handset” comprises of the following components:

 

·                  ***

 

·                  ***

 

·                  ***

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT B

 

PARI Competitors

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

In the event of a merger, consolidation, sale of all or substantially all of the
assets or business or other change of control involving the above entities (the
“Original Competitors”), such Original Competitor listed above shall be replaced
with the successor thereof that is continuing to engage in the business of
developing and/or commercializing nebulizers.  However, if the merger or
acquisition partner had separate lines of business, divisions or operations
prior to such change of control, whether or not relating to nebulizers, the
merger or acquisition partner shall be deemed a PARI Competitor only to the
extent it is continuing the business of the Original Competitor, and not with
respect to any such separate lines of business, divisions or operations.

 

In addition, PARI Competitors shall include any subsidiary that is formed by the
Original Competitors, but shall not include any subsidiaries acquired by the
Original Competitors if such subsidiaries had separate lines of business,
divisions or operations prior to such acquisition, whether or not relating to
nebulizers.  However, PARI Competitors shall include such subsidiaries to the
extent such subsidiaries continue the lines of business, divisions or operations
of the Original Competitors relating to nebulizers.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT C

 

Patents

 

PARI Patents and Patent Applications

 

 

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

 

 

 

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

******

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

 

 

 

***

 

***

 

***

 

 

 

 

 

--------------------------------------------------------------------------------

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

 

 

 

***

 

***

 

***

 

 

 

 

***

 

***

 

***

 

 

 

 

***

 

***

 

***

 

 

 

 

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

 

 

 

***

 

***

 

***

 

 

 

 

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Additional Patents and Patent Applications from Insmed (with PARI Know How):

 

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Patents licensed from *** (***):

 

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

Application number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Patents licensed from ***:

 

***

 

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

Patents licensed from *** (non-exclusive):

 

***

 

Application
number

 

Publication number

 

Filing date

 

Patent number

 

Issue date

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT D

 

Initial Representatives of the JSC

 

Joint Steering Committee

 

PARI: *** and ***

 

INSMED:  *** and ***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT E

 

Effective Date Exchange Rate

 

*** EUR = *** USD

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT F

 

Quality Agreements

 

[To be agreed to by the Parties in writing and attached hereto after the
Effective Date as set forth in Section 6.1.]

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT G

 

TRIPS Priority Watch List

 

***

***

***

***

***

***

***

***

***

***

***

***

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT H

 

Trademarks

 

PARI Marks:

 

1.  ***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

INSMED Marks:

 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

GOODS

 

STATUS

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

GOODS

 

STATUS

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

GOODS

 

STATUS

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

GOODS

 

STATUS

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

GOODS

 

STATUS

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

 

 

 

 

 

 

 

 

***

 

***

 

***

 

***

 

***

 

--------------------------------------------------------------------------------

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.

 

EXHIBIT I

 

Price

 

1. Price

 

 

 

Prices for ***

 

Prices for
***

 

Prices for ***

 

 

 

 

 

 

 

 

 

for each unit of ***

 

$

 

****

 

 

 

 

 

******

 

 

 

 

 

 

 

 

 

 

 

 

for each unit of ***

 

$

 

*****

 

Euro   

*****

 

Euro   

*****

 

 

 

 

 

 

 

 

 

 

 

 

for each unit of *** (“***”)

 

$

 

****

 

Euro

****

 

 

******

 

 

--------------------------------------------------------------------------------

* Price includes ***** ***

******.

 

2. ***

 

A.            ***

 

B.            ***

 

--------------------------------------------------------------------------------