Exhibit 10.1

 

Portions of this exhibit have been omitted and filed separately with the
Secretary of the Securities and Exchange Commission (the “Commission”) pursuant
to an application for confidential treatment filed with the Commission pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Such
portions are marked as indicated below.

 

AMENDED AND RESTATED LICENSE AND

EXPANDED COLLABORATION AGREEMENT

 

THIS AMENDED AND RESTATED LICENSE AND EXPANDED COLLABORATION AGREEMENT (the
“Agreement”) is made as of the 17th day of July, 2012 (the “Restatement
Effective Date”) by and between Amicus Therapeutics, Inc., a Delaware
corporation having a place of business at 1 Cedar Brook Drive, Cranbury, New
Jersey, 08512 (“Amicus”) and Glaxo Group Limited, a company organized under the
laws of England and Wales with its registered office address at Glaxo Wellcome
House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, England (“GSK”).  Amicus
and GSK are each referred to herein by name or as a “Party” or, collectively, as
the “Parties”.

 

RECITALS

 

WHEREAS, Amicus has developed Compound (as defined below), and owns or controls,
solely or jointly with GSK, certain intellectual property rights related
thereto;

 

WHEREAS, the Parties previously entered into a certain License and Collaboration
Agreement dated October 28, 2010 (“Original Agreement”), pursuant to which
Amicus granted to GSK exclusive, worldwide, rights to Compounds and Products
(each as defined below) and pursuant to which Amicus and GSK have collaborated
and are collaborating on the Development of the Compound and Product;

 

WHEREAS, contemporaneously with the Original Agreement, the Parties entered into
a certain Stock Purchase Agreement dated October 28, 2010 (“Prior Equity
Agreement”), pursuant to which GSK purchased shares of common stock of Amicus;

 

WHEREAS, the Parties now desire to amend the Original Agreement and to restate
the Original Agreement in its entirety through this Agreement, to provide for,
among other matters, the reversion to Amicus of the rights for the
Commercialization of Compound and Products in the United States, including the
rights to Commercialize Co-Formulation Products in the United States, in
consideration of, among other things, the elimination of GSK’s outstanding
milestone and royalty payment obligations to Amicus under the Original Agreement
in connection with the Development and Commercialization of Compound and
Products outside of the United States; all on the terms and conditions set forth
in this Agreement; and

 

******                              - Material has been omitted and filed
separately with the Commission.

 

1

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

 

WHEREAS, contemporaneously with this Agreement, the Parties have executed a
Stock Purchase Agreement, pursuant to which GSK will purchase additional shares
of common stock of Amicus, as set forth in such Stock Purchase Agreement.

 

NOW, THEREFORE, in consideration of the mutual agreements contained herein and
other good and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties agree as follows:

 

I.                                        DEFINITIONS

 

Unless specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective meanings set
forth below:

 

1.1                               “011 Phase III Clinical Study” means the Phase
III Clinical Study sponsored, as of the Restated Effective Date, by GSK in the
United States and by Amicus outside of the United States, and identified by the
ClinicalTrials.gov Identifier NCT00925301.

 

1.2                               “012 Phase III Clinical Study” means the Phase
III Clinical Study sponsored, as of the Restated Effective Date, by GSK in the
United States and by Amicus outside of the United States, and identified by the
ClinicalTrials.gov Identifier NCT01218659.

 

1.3                               “2011 Carry-Forward Amount” means US$******.

 

1.4                               “AAA” has the meaning ascribed to that term in
Section 16.2.2.

 

1.5                               “Abandoning Party” has the meaning ascribed to
that term in Section 7.4.

 

1.6                               “Act” means the United States Food, Drug and
Cosmetic Act of 1938, as amended from time to time, and its implementing
regulations.

 

1.7                               “Affected Area” has the meaning ascribed to
that term in Section 14.2 (as applicable to Section 14.2) and in Section 14.3
(as applicable to Section 14.3).

 

1.8                               “Affiliate” means, with respect to any
specified Person, at any time, a Person that, directly or indirectly, through
one or more intermediaries, controls, or is controlled by, or is under common
control with, such specified Person at such time.  For purposes of this
definition and Section 1.33, “control,” when used with respect to any specified
Person, shall mean (a) the direct or indirect ownership of more than fifty
percent (50%) (or such lesser percentage which is the maximum allowed to be
owned by a foreign corporation in a particular jurisdiction) of the total voting
power of securities or other evidences of ownership interest in such Person or
(b) the power to direct or cause the direction of the management and policies of
such Person, directly or indirectly, whether through ownership of voting
securities, by contract or otherwise; and the terms “controlling” and
“controlled” have meanings correlative to the foregoing.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

2

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

 

1.9                               “Agreement” means this Amended and Restated
License and Expanded Collaboration Agreement, which pursuant to Section 16.8
below replaces the Original Agreement in its entirety as of the Restatement
Effective Date.

 

1.10                        “Alliance Manager” has the meaning ascribed to that
term in Section 4.2.2.

 

1.11                        “Amicus” has the meaning ascribed to that term in
the first paragraph of this Agreement.

 

1.12                        “Amicus Aggregate Existing Development Cost Cap”
means ******, which amount is equal to the aggregate of Amicus’ share of the
Development Costs specified in the Existing Development Plan for each of the
calendar years beginning with calendar year 2011 up to and including calendar
year 2015.

 

1.13                        “Amicus Annual Existing Development Cost Cap” means:
(a) for calendar year 2012, ****** (which amount is equal to twenty-five percent
(25%) of the total Development Costs for the calendar year 2012, as set forth in
the Existing Development Plan) plus the 2011 Carry-Forward Amount, for a total
of ******; (b) for calendar years 2013, 2014 and 2015 ******, and ******,
respectively (which amount is equal to forty percent (40%) of the total
Development Costs for the applicable calendar year, as set forth in the Existing
Development Plan), and (c) for each calendar year thereafter, if applicable,
****** (which amount is equal to forty percent (40%) of the total Development
Costs for calendar year 2015 as set forth in the Existing Development Plan), in
each case, as adjusted in accordance with Section 5.1.4(b).  For clarity, the
Amicus Annual Existing Cost Cap shall not apply to costs incurred by Amicus to
perform any Amicus Territory Required Activities.

 

1.14                        “Amicus Auditor” has the meaning ascribed to that
term in Section 3.9.

 

1.15                        “Amicus House Marks” has the meaning ascribed to
that term in Section 6.3.

 

1.16                        “Amicus Indemnitees” has the meaning ascribed to
that term in Section 15.1.

 

1.17                        “Amicus Intellectual Property” means Amicus Patents,
Amicus Know-How, and any and all copyrights that are Controlled by Amicus during
the Term and that pertain to the Compound and Products for the Territory.

 

1.18                        “Amicus Know-How” means all confidential Know-How
which (a) Amicus or its Affiliates Control as of the Effective Date; or
(b) subject to Sections 12.2 and 14.4(b), is Controlled by Amicus or its
Affiliates after the Effective Date and during the Term of this Agreement, and
that is developed or acquired by or on behalf of Amicus or its Affiliates
outside the Program and without the use of Program Improvements or
Co-Formulation Product IP; in each case (a) and (b), that is reasonably
necessary or actually used to Develop, Manufacture or Commercialize Products in
the Field for the Territory.  Notwithstanding the foregoing, Amicus Know-How
shall not include:

 

******                              - Material has been omitted and filed
separately with the Commission.

 

3

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

 

(i) information which is or becomes part of the public domain through no breach
of this Agreement by GSK; (ii) information which GSK can demonstrate by its
written records was known by GSK or its Affiliates prior to the disclosure
thereof by Amicus or its Affiliate; (iii) information which is independently
developed by GSK or its Affiliates outside of the Program, so long as such
development does not result from use of Amicus Know-How, and such independent
development can be demonstrated by written records; and (iv) information that
becomes available to GSK or its Affiliates on a non-confidential basis, whether
directly or indirectly, from a Third Party who is not bound by a confidentiality
obligation to Amicus or its Affiliates.

 

1.19                        “Amicus Patents” means: (a) all Patents Controlled
by Amicus or its Affiliates as of the Effective Date which are reasonably
necessary, or actually practiced, to Develop, Manufacture or Commercialize the
Compound or Products for use as a therapeutic agent, including without
limitation the Patents set forth on Schedule 7.2.1 hereto; and (b) subject to
Section 12.2, all Patents Controlled by Amicus or its Affiliates after the
Effective Date and during the Term of this Agreement that are reasonably
necessary, or actually practiced, to Develop, Manufacture or Commercialize the
Compound or Products in the Field for the Territory to the extent such Patents
claim inventions within the Amicus Know-How Controlled by Amicus or its
Affiliates as of the Effective Date.

 

1.20                        “Amicus Proprietary Chaperone Technology” means
Amicus’s proprietary technology used in connection with a small molecule drug
that selectively binds to the active site of a target enzyme resulting in enzyme
stabilization, improved trafficking, less aggregation, and/or increased activity
of the enzyme, including all associated Patents and Know-How Controlled by
Amicus in the Territory.

 

1.21                        “Amicus Prosecuted Patents” has the meaning ascribed
to that term in Section 7.2.2.

 

1.22                        “Amicus Protective Action” has the meaning ascribed
to that term in Section 8.2.

 

1.23                        “Amicus Reimbursement Trigger Event” has the meaning
ascribed to that term in Section 5.1.5(c).

 

1.24                        “Amicus Territory” means the United States.

 

1.25                        “Amicus Territory Required Activities Information”
has the meaning ascribed to that term in Section 5.1.5(c).

 

1.26                        “Amicus Territory Required Activities” means any
clinical trials, studies, or other activities, and any Post Marketing
Commitments, in each case that are required or requested by a Regulatory
Authority after the Restatement Effective Date in connection with obtaining or
maintaining Market Approval of a Product in the Amicus Territory and that are
determined in accordance with Section 5.1.5 to be specific to the Amicus
Territory.  For clarity, Amicus Territory Required Activities shall not include
those Development activities that are set forth in a

 

******                              - Material has been omitted and filed
separately with the Commission.

 

4

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

 

Development Plan and that are generally required in accordance with applicable
Laws to obtain Regulatory Approval for a Product in the Amicus Territory.

 

1.27                        “Amicus Wind-Down Period” has the meaning ascribed
to that term in Section 14.2.9.

 

1.28                        “Available JR051 Monotherapy Clinical Trial Data”
has the meaning ascribed to that term in Section 5.1.6(a).

 

1.29                        “Background License Agreements” means the
agreements, letters, and other documents listed in Schedule 1.29.

 

1.30                        “BLA” means a Biologics License Application (or
supplement thereto) as defined in the United States Public Health Service Act
and Food, Drug and Cosmetic Act and the regulations promulgated thereunder.

 

1.31                        “Business Day” means any day, other than a Saturday
or a Sunday, in which banks in New York, New York, United States and in London,
England are open for business, excluding any days on which GSK’s corporate
headquarters or Amicus’s corporate headquarters are closed.

 

1.32                        “Chairperson” has the meaning ascribed to that term
in Section 4.1.2.

 

1.33                        “Change of Control” means either:  (a) a sale of all
or substantially all of the assets of a Party in one or a series of integrated
transactions not in the ordinary course of business to a Third Party; or (b) the
acquisition of control (as defined in Section 1.8) of a Party by a Third Party
by means of any transaction or series of related transactions to which such
Party is a party (including, any stock acquisition, merger or consolidation);
******.  For clarity, a Change of Control would not include any transaction or
series of transactions in which the holders of voting securities of a Party
outstanding immediately prior to such transaction continue to retain (either by
such voting securities remaining outstanding or by such voting securities being
converted into voting securities of the surviving entity), as a result of shares
in the Party held by such holders prior to such transaction, fifty percent (50%)
or more of the total voting power represented by the voting securities of the
acquiring entity outstanding immediately after such transaction or series of
transactions.

 

1.34                        “Claim” means any action, appeal, petition, plea,
charge, complaint, suit, demand, litigation, arbitration, mediation, hearing,
inquiry, investigation, or similar event, occurrence, or proceeding.

 

1.35                        “Co-Administration Product” has the meaning ascribed
to that term in Section 1.45.

 

1.36                        “Co-Development Opt-Out Effective Date” has the
meaning ascribed to that term in Section 5.4.2.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

5

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

 

1.37                        “Co-Development Opt-Out Notice” has the meaning
ascribed to that term in Section 5.4.2.

 

1.38                        “Co-Development Opt-Out Right” has the meaning
ascribed to that term in Section 5.4.1.

 

1.39                        “Co-Development Opt-Out” has the meaning ascribed to
that term in Section 5.4.1.

 

1.40                        “Co-Formulation Development Plan” has the meaning
ascribed to that term in Section 5.1.1(b).

 

1.41                        “Co-Formulation MTA” means that certain materials
transfer agreement entered into between JCR and Amicus with the consent of, and
acknowledged by, GSK, dated as of ******, as may be amended.

 

1.42                        “Co-Formulation Product” means a pharmaceutical
preparation that incorporates the Compound formulated together with the
Co-Formulation Product ERT Enzyme.

 

1.43                        “Co-Formulation Product ERT Enzyme” means (a) JR051;
or ******.

 

1.44                        “Co-Formulation Product IP” means any and all
Know-How and Patents arising, during the period from the Effective Date to the
Restatement Effective Date under the Original Agreement or during the Term of
this Agreement, from the conduct of activities with respect to the Development
of a Co-Formulation Product under the Original Agreement or the Agreement,
including (a) the conduct of activities pursuant to the Co-Formulation MTA, or
(b) the conduct of activities pursuant to the Co-Formulation Development Plan;
in each case where such activities are conducted by or on behalf of Amicus, GSK,
their respective Affiliates or (sub)licensees, or by an agent designated by GSK
or Amicus to conduct such activities.  Notwithstanding the proviso in
Section1.108, as between Amicus and GSK, JCR shall be deemed an agent of GSK
with respect to all activities conducted by or on behalf of JCR in connection
with this Agreement and, as between Amicus and GSK, all such activities
conducted by JCR in connection with this Agreement shall be deemed to have been
conducted by GSK under this Agreement.  Co-Formulation Product IP expressly
excludes the: Amicus Intellectual Property, Amicus Proprietary Chaperone
Technology, GSK Background IP, Program Improvements, Program Patents and GSK
In-Licensed Background ERT IP.

 

1.45                        “Combination Therapy” means the use of the Compound
or a Product in combination with one or more other active ingredients.  Drug
delivery vehicles, adjuvants (except as expressly set forth in this definition
below) and excipients shall not be deemed to be “active ingredients”, and their
presence shall not be deemed to create a Combination Therapy.  Combination
Therapy includes, but is not limited to: (a) adjuvant use of the Compound or a
Product with an ERT; (b) co-administration of the Compound or a Product with an
ERT, regardless of the order or form in which the co-administration is performed
(“Co-Administration Product”); (c) a Co-Formulation Product; or

 

******                              - Material has been omitted and filed
separately with the Commission.

 

6

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

 

(d) subject Section 5.3.2 a pharmaceutical preparation that incorporates the
Compound formulated together with an ERT.

 

1.46                        “Commercialize” or “Commercialization” means
activities directed to obtaining pricing and reimbursement approvals for,
marketing, advertising, promoting, detailing, distributing, importing, or
selling a Product in the Field in the Territory and post-launch medical
education, planning, product support and medical efforts related to a Product in
the Field in the Territory.  For clarity, “Commercialize” and
“Commercialization” shall not include Development or Manufacturing.

 

1.47                        “Commercially Reasonable Efforts” means that level
of efforts and resources required to carry out a particular task or obligation
in an active and sustained manner, consistent with the usual practice followed
by a Party in the exercise of reasonable business discretion relating to other
pharmaceutical products owned by it, or to which it has exclusive rights, which
are of similar market potential and at a similar stage in development or product
life, taking into account issues of patent coverage, safety and efficacy,
scientific and product profile, the regulatory structure involved, and the
strategic value and profitability of the product (including, without limitation,
pricing and reimbursement status achieved).  A Party may not consider payments
required to be made hereunder when determining its Commercially Reasonable
Efforts with regards to a Product or its obligations under this Agreement.

 

1.48                        “Compound” means migalastat, as described in
Schedule 1.48, and includes (a) any compounds with alternative names but with
the same chemical structure as migalastat, and (b) any metabolites, prodrugs,
isomers and enantiomers (excluding the isomer/enantiomer “1-deoxynorjirimycin”
or “(2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol”), esters, salts,
hydrates, solvates, and polymorphs thereof, whether alone or in a mixture.

 

1.49                        “Confidential Information” means in the case of one
Party (the “disclosing Party”), that Party’s or its Affiliate’s (and, with
respect to GSK, including JCR’s) know-how and financial or other confidential or
proprietary information that is Controlled by that Party or its Affiliates and
made available (in whatever form and whether prior to, on, or after the
Effective Date) to the other Party (the “receiving Party”) in connection with
this Agreement or generated pursuant to this Agreement.  Notwithstanding the
foregoing, Confidential Information shall not include:

 

(a)                                 information which is or becomes part of the
public domain through no breach of this Agreement by the receiving Party or any
of its Affiliates;

 

(b)                                 information which the receiving Party can
demonstrate by its written records was known by the receiving Party or any of
its Affiliates prior to the disclosure thereof by the disclosing Party;

 

(c)                                  information which is independently
developed by the receiving Party or any of its Affiliates, so long as such
development does not result from use of Confidential

 

******                              - Material has been omitted and filed
separately with the Commission.

 

7

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

 

Information of the disclosing Party, and such independent development can be
demonstrated by written records of the receiving Party or any of its Affiliates;
and

 

(d)                                 information that becomes available to the
receiving Party or its Affiliates on a non-confidential basis, whether directly
or indirectly, from a Third Party who is not bound by a duty of confidentiality
to the disclosing Party.

 

1.50                        “Confidentiality Agreement” means the
Confidentiality Agreement between Amicus and GSK dated as of ****** and amended
as of ******.

 

1.51                        “Control” or “Controlled” means, with respect to any
compound, material, information, or intellectual property right, that a Party
owns or has a license to use, commercialize, manufacture, market, distribute or
sell, and has the ability to grant to the other Party a license or a sublicense
(as applicable under this Agreement) to such compound, material, information, or
intellectual property right as provided for herein without violating (i) the
terms of any agreement or other arrangements with any Third Party existing at
the time such Party would be first required hereunder to grant the other Party
such license or sublicense or (ii) any Law applicable to such license or
sublicense.

 

1.52                        “Cooperating Party” has the meaning ascribed to that
term in Section 11.2.2.

 

1.53                        “Current Good Manufacturing Practices” or “cGMP”
means the standards relating to manufacturing practices for fine chemicals,
intermediates, bulk products or finished pharmaceutical products: (a) detailed
in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211
and The Rules Governing Medicinal Products in the European Community, Volume IV
Good Manufacturing Practice for Medicinal Products, as each may be amended from
time to time; and/or (b) outside the United States and European Union,
promulgated by any Regulatory Authority having jurisdiction over the manufacture
of fine chemicals, intermediates, bulk products or finished pharmaceutical
products; and subject to any arrangements, additions or clarifications agreed to
from time to time by the Parties in a quality agreement.

 

1.54                        “Develop” or “Development” means all activities
related to (a) non-clinical and clinical research and drug development
(including preclinical testing and clinical trials) related to obtaining,
maintaining and/or expanding Marketing Approval (excluding pricing and
reimbursement approvals), (b) Post Marketing Commitments;(c) manufacturing
activities for the purposes of producing clinical supplies (or materials used in
preclinical testing or research), as well as test method development and
stability testing and process development and validation for a Product prior to
the first Marketing Approval of such Product (including manufacturing batches
for validation and registration purposes), formulation development, delivery
system development, quality assurance and quality control development for
clinical supplies, and (d) statistical analysis, regulatory affairs, and
activities directed towards obtaining Marketing Approval (excluding regulatory
activities directed to obtaining pricing and reimbursement approvals) and
clinical study regulatory activities

 

******                              - Material has been omitted and filed
separately with the Commission.

 

8

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

 

(excluding regulatory activities directed to pricing and reimbursement
approvals); in each case, with respect to the Products in the Field for the
Territory.  For clarity, “Develop” and “Development” shall not include
Manufacturing or Commercialization.

 

1.55                        “Developing Party” has the meaning ascribed to that
term in Section 5.3

 

1.56                        “Development Costs” has the meaning ascribed to that
term in Schedule 5.1.4.

 

1.57                        “Development Plan” means the Existing Development
Plan for the Development of a Monotherapy Product and for a Co-Administration
Product, and any amendments thereto in accordance with Section 5.1.4(b), and/or
the Co-Formulation Development Plan and any amendments thereto in accordance
with Section 5.1.4(b), as applicable.

 

1.58                        “disclosing Party” has the meaning ascribed to that
term in Section 1.49.

 

1.59                        “Discriminatory Conduct” has the meaning ascribed to
that term in Section 6.1.3(b).

 

1.60                        “Dispute” has the meaning ascribed to that term in
Section 16.2.1.

 

1.61                        “Effective Date” means October 28, 2010, the
effective date of the Original Agreement.

 

1.62                        “EMA” means the European Medicines Agency of the
European Union or any successor entity thereto having similar responsibilities
with respect to pharmaceutical products, such as the Products.

 

1.63                        “Equity Agreement” means the stock purchase
agreement attached hereto as Exhibit A.

 

1.64                        “ERT” means enzyme replacement therapy.

 

1.65                        “Escalation Notice” has the meaning ascribed to that
term in Section 4.1.5(a).

 

1.66                        “Excluded Item” has the meaning ascribed to that
term in Section 11.1.2.

 

1.67                        “Existing Development Plan” has the meaning ascribed
to that term in Section 5.1.1(a).

 

1.68                        “Expanded Major Market Country” means ******.

 

1.69                        “Ex-U.S. Commercialization Plan” means the strategic
plan for the marketing, promotion and other Commercialization activities for
Products in the GSK Territory, as prepared by GSK in accordance with GSK’s
normal and customary format and process for such plans, and which will include,
in reasonable scope and detail, plans for implementation of Commercialization

 

******                              - Material has been omitted and filed
separately with the Commission.

 

9

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

 

activities in the GSK Territory (consistent with the guidelines set forth in the
Global Commercialization Plan), and as amended from time to time by GSK during
the Term.

 

1.70                        “Ex-U.S. Commercialization Strategy” means the
marketing strategy for Products in the GSK Territory determined by GSK under the
global guidelines as set forth in the Global Commercialization Plan and reviewed
by the Joint Commercialization Subcommittee, including product positioning,
pricing, reimbursement, education programs, medical affairs, publications, sales
messages, marketing, and distribution, as such strategy may be amended by GSK
from time to time during the Term.

 

1.71                        “FDA” means the United States Food and Drug
Administration or any successor entity thereto having similar responsibilities
with respect to pharmaceutical products, such as the Products.

 

1.72                        “Field” means any and all uses or purposes,
including, without limitation, the treatment, palliation, and/or prevention and
diagnosis of any human or animal disease, disorder or condition, including use
of a Product in combination with ERT.

 

1.73                        “First Opt-Out Quarter” has the meaning ascribed to
such term in Section 5.4.2.

 

1.74                        “******” has the meaning ascribed to that term in
Section 5.1.4(b)(ii).

 

1.75                        “Force Majeure Event” has the meaning ascribed to
that term in Section 16.11.

 

1.76                        “******” has the meaning ascribed to that term in
Section 3.3.3(a).

 

1.77                        “FTE Costs” has the meaning ascribed to that term in
Schedule 5.1.4.

 

1.78                        “FTE Rate” has the meaning ascribed to that term in
Schedule 5.1.4.

 

1.79                        “FTE” has the meaning ascribed to that term in
Schedule 5.1.4.

 

1.80                        “GAAP” has the meaning ascribed to that term in
Section 1.137.

 

1.81                        “Generic Equivalent” means, as to a Terminated
Product that has received Regulatory Approval in a particular country in the
relevant Affected Area (as defined under Section 14.2 or 14.3, as applicable)
and is marketed and sold by a Party in such country, a non-innovator product
that: (A) (i) has obtained Regulatory Approval by means of an abbreviated NDA
filed pursuant to Section 505(j) of the Act which refers to the specific Product
at issue as the Reference Listed Drug (as defined in 21 C.F.R. 314.3(b) (as
amended)) in the United States, or an application similar to an abbreviated NDA
filed pursuant to Section 505(j) of the Act for any jurisdiction outside the
United States, in each case, without the requirement of any human clinical
efficacy trials; or (ii) has obtained Regulatory Approval by means of a BLA or
an NDA or a comparable procedure for

 

******                              - Material has been omitted and filed
separately with the Commission.

 

10

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

 

establishing bioequivalence or biosimilarity to such Terminated Product, in each
case, without the requirement of any human clinical efficacy trials; and (B) is
bioequivalent or bio-similar to such Terminated Product; and (C) is legally
marketed in such country by an entity other than such Party, its Affiliates or
Sublicensees.

 

1.82                        “Global Commercialization Plan” has the meaning
ascribed to that term in Section 6.1.

 

1.83                        “GSK” has the meaning ascribed to that term in the
first paragraph of this Agreement.

 

1.84                        “GSK Auditor” has the meaning ascribed to that term
in Section 3.8.

 

1.85                        “GSK Background IP” means all Patents and/or
Know-How which: (a) GSK or its Affiliates Controlled as of the Effective Date,
or (b) are developed by or on behalf of GSK or its Affiliates after the
Effective Date or acquired or otherwise Controlled by GSK or its Affiliates
after the Effective Date, in each case (a) or (b), outside the Program and
without the use of Program Improvements or Co-Formulation Product IP; or (c) any
manufacturing technology or manufacturing process intellectual property owned or
Controlled by GSK or its Affiliates as of the Restatement Effective Date, and
any improvements made thereto; excluding the GSK Monotherapy Product
Manufacturing Improvements.

 

1.86                        “GSK House Marks” has the meaning ascribed to that
term in Section 6.3.

 

1.87                        “GSK Indemnitees” has the meaning ascribed to that
term in Section 15.2.

 

1.88                        “GSK In-Licensed Background ERT IP” means all
Patents and Know-How to which GSK has acquired an exclusive license or other
rights from JCR pursuant to the GSK/JCR Master Agreement, including any
manufacturing technology or manufacturing process intellectual property owned or
Controlled by JCR as of the Restatement Effective Date, and any improvements or
modifications thereto.

 

1.89                        “GSK/JCR Master Agreement” means that certain Master
Agreement by and between JCR, GlaxoSmithKline K.K. and Glaxo Group Limited,
dated ******, and as amended, and including any addendums thereto (the “GSK/JCR
Agreement”).

 

1.90                        “GSK Monotherapy Product Manufacturing Improvements”
means any improvements or modifications made by or on behalf of GSK (i) after
the Effective Date and in the conduct of Development activities under the
Development Plan under the Original Agreement, to those certain manufacturing
processes for the Manufacture of Compound or Monotherapy Products that were
transferred to GSK in connection with the Manufacture technology transfer by
Amicus to GSK in accordance with Section 6.5.1 of the Original Agreement and
(ii) after the Restatement Date and in the conduct of Development activities
under the Existing Development Plan under this

 

******                              - Material has been omitted and filed
separately with the Commission.

 

11

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

 

Agreement to the manufacturing processes for the Manufacture of Compound or
Products (other than the Co-Formulation Products).

 

1.91                        “GSK Prosecuted Amicus Patents” has the meaning
ascribed to that term in Section 7.2.1.

 

1.92                        “GSK Prosecuted Improvement Patent” has the meaning
ascribed to that term in Section 7.6.1(b).

 

1.93                        “GSK Protective Action” has the meaning ascribed to
that term in Section 8.2.

 

1.94                        “GSK Reimbursement Trigger Event” has the meaning
ascribed to that term in Section 5.1.5(c).

 

1.95                        “GSK Terminated Product Royalty Term” has the
meaning ascribed to that term in Section 14.2.3(b)(i).

 

1.96                        “GSK Territory” means, subject to Section 14.4(a),
all countries and territories of the world, excluding the United States.

 

1.97                        “GSK Territory Required Activities” means any
clinical trials, studies, or other activities, and any Post Marketing
Commitments, in each case that are required or requested by a Regulatory
Authority after the Restatement Effective Date in connection with obtaining or
maintaining Market Approval of a Product in the GSK Territory and that are
determined in accordance with Section 5.1.5 to be specific to the GSK
Territory.  For clarity, GSK Territory Required Activities shall not include
those Development activities that are set forth in a Development Plan and that
are generally required in accordance with applicable Laws to obtain Regulatory
Approval for a Product in the GSK Territory.

 

1.98                        “GSK Territory Required Activities Information” has
the meaning ascribed to that term in Section 5.2.6(b).

 

1.99                        “GSK Trademark” has the meaning ascribed to that
term in Section 2.5.

 

1.100                 “GSK Wind-Down Period” has the meaning ascribed to that
term in Section 14.3.9.

 

1.101                 “Host Party” has the meaning ascribed to that term in
Section 5.2.2(a).

 

1.102                 “IFRS” has the meaning ascribed to that term in
Section 1.137.

 

1.103                 “IND” means any Investigational New Drug Application
(including any amendments thereto) filed with the FDA pursuant to 21 C.F.R. §312
before the commencement of clinical trials

 

******                              - Material has been omitted and filed
separately with the Commission.

 

12

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

 

of a Product, or any comparable filings (including clinical trial applications)
with any Regulatory Authority in any other jurisdiction.

 

1.104                 “Indemnitee” has the meaning ascribed to that term in
Section 15.3.

 

1.105                 “Indemnitor” has the meaning ascribed to that term in
Section 15.3.

 

1.106                 “Industry Guidelines” has the meaning ascribed to that
term in Section 10.1.3.

 

1.107                 “Initial Press Release” has the meaning ascribed to that
term in Section 11.2.1.

 

1.108                 “JCR” means JCR Pharmaceuticals, Co., Ltd, with a place of
business at 3-9 Kasuga-cho, Ashiya, Hyogo, 659-0021 Japan.  As between GSK and
Amicus, for the purpose of this Agreement, JCR shall be deemed a designated
agent of GSK, and all activities conducted by JCR under the Co-Formulation MTA,
a Co-Formulation Development Plan, or otherwise in connection with this
Agreement, shall be deemed to have been conducted by GSK under this Agreement;
provided, however that the foregoing shall not be construed to grant any rights
or licenses to Amicus under any intellectual property owned or Controlled by JCR
except as expressly set forth herein.

 

1.109                 “JCR Agreements” has the meaning ascribed to that term in
Section 9.3.10.

 

1.110                 “JDS” has the meaning ascribed to that term in
Section 4.2.3(a).

 

1.111                 “Joint Commercialization Subcommittee” has the meaning
ascribed to that term in Section 4.2.2(a).

 

1.112                 “Joint Development Subcommittee” has the meaning ascribed
to that term in Section 4.2.3.

 

1.113                 “Joint Patent Subcommittee” has the meaning ascribed to
that term in Section 4.2.1.

 

1.114                 “Joint Program Patent” has the meaning ascribed to that
term in Section 7.3.3.

 

1.115                 “Joint Steering Committee” or “JSC” has the meaning
ascribed to that term in Section 4.1.1.

 

1.116                 “JR051” means the JCR proprietary enzyme
alpha-Galactosidase that is internally referenced by GSK as JR051 and described
in Schedule 1.116 attached to this Agreement, including any derivatives or
modifications thereof or analogs thereto.

 

1.117                 “JR051 Monotherapy Clinical Trial Data” has the meaning
ascribed to that term in Section 5.1.6.

 

1.118                 “JR051 Opt-In Notice” has the meaning ascribed to that
term in Section 5.1.6(a).

 

******                              - Material has been omitted and filed
separately with the Commission.

 

13

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

 

1.119                 “JSC” has the meaning ascribed to that term in
Section 4.1.1.

 

1.120                 “Know-How” means any proprietary or confidential
technology, technical, scientific and medical information, methods of use,
processes, techniques, ideas, inventions (excluding any inventions disclosed in
any Patent or published Patent application), improvements, modifications,
know-how, practices, trade secrets, chemistry, manufacturing and control data,
quality control information and procedures, and pharmacological, toxicological
and preclinical and clinical test data and results and regulatory information
(including all documentation and correspondence submitted or required to be
submitted to a Regulatory Authority, or received from a Regulatory Authority, in
connection with a Marketing Approval in any country) and marketing, promotion
and other information and materials, all of the foregoing pertaining to the
Development, Manufacture and/or Commercialization of the Compound and/or
Products within the Field for the Territory, but excluding Patents associated
with any of the foregoing.

 

1.121                 “Launch” means, on a country-by-country and
Product-by-Product basis, the date of the first ****** (or one of its Affiliates
or sublicensees) in such country; provided that the Launch of a Product in a
country for a particular indication shall be deemed to occur upon the first
commercial sale of a Product with labeling for such indication.  Sales of a
Product for registration samples, compassionate use sales, named patient use and
the like, and inter-company transfers to Affiliates of a Party for resale will
not constitute a Launch.

 

1.122                 “Law” means all laws, statutes, regulations (including
securities laws, regulations or guidances), or governmental, regulatory, or
judicial orders or judgments in effect from time to time.

 

1.123                 “Liabilities” has the meaning ascribed to that term in
Section 15.1.

 

1.124                 “License” has the meaning ascribed to that term in
Section 2.1.

 

1.125                 “Licensed Amicus Technology” means, subject to
Section 12.2, all (a) Amicus Intellectual Property, (b) Program Improvements
developed solely or jointly by Amicus or its Affiliates from the Effective Date
and during the Term, (c) Program Patents in the Territory owned solely or
jointly by Amicus or its Affiliates, and (d) Amicus’s rights in and to the
Co-Formulation Product IP.  For the avoidance of doubt, the “Licensed Amicus
Technology” shall include Amicus Proprietary Chaperone Technology, but solely to
the extent such Amicus Proprietary Chaperone Technology is necessary for the
Development or Manufacture of Compound and/or Products in the Territory, or
Commercialization of Products in the GSK Territory.

 

1.126                 “MAA” means (a) a Marketing Authorization Application
filed with the EMA, seeking Regulatory Approval of a Product and all variations
thereto filed with the EMA; (b) an NDA or BLA submitted to the FDA in the United
States; or (c) a corresponding application for Regulatory Approval that has been
submitted to a Regulatory Authority in any other jurisdiction in the GSK
Territory.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

14

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

 

1.127                 “Major EU Country” means the ******, ******, ******,
****** or ******.

 

1.128                 “Major Market” means the ******, each ****** and ******.

 

1.129                 “Manufacture” or “Manufacturing” means all the activities
required for the production and supply of Compound and/or Product, including
without limitation, purchasing raw materials, quality control and assurance,
filing, finishing, labeling, packaging, qualified person release, holding,
shipping and storage and the tests and analyses conducted in connection
therewith.  For clarity, “Manufacture” and “Manufacturing” shall not include
Commercialization or Development.

 

1.130                 “Manufacturing Costs” means ******.

 

1.131                 “Marketing Approval” means all approvals, licenses,
registrations or authorizations of the Regulatory Authority in a country,
necessary for the manufacture, use, storage, import, marketing and sale of a
Product in such country.  For countries where governmental or other similar
approval of pricing and/or reimbursement is required for marketing in such
country, Marketing Approval shall not be deemed to occur until ******, as the
case may be, is obtained.  For clarity, however, it is understood that, as of
the Effective Date, Marketing Approval in the United States shall be deemed to
occur upon ******.  In the event that any such ****** of any governmental agency
in the United States is required at the time that a Party seeks Marketing
Approval for a Product in the United States, then Marketing Approval in the
United States shall not be deemed to occur until ******.  Notwithstanding the
foregoing, Marketing Approval shall be deemed to have occurred for a particular
indication for a Product in such jurisdiction upon the Launch of such Product in
such jurisdiction with labeling for such indication.

 

1.132                 “Milestone Payment” has the meaning ascribed to that term
in Section 3.3.3(a).

 

1.133                 “Milestone Per Share Price” has the meaning ascribed to
that term in Section 3.3.3(b).

 

1.134                 “Monotherapy Product” means a Product incorporating the
Compound as the sole active ingredient.

 

1.135                 “Mount Sinai Agreement” means that certain Amended and
Restated Agreement between Mount Sinai School of Medicine of New York University
and Amicus Therapeutics, Inc., dated October 31, 2008, and as amended.

 

1.136                 “NDA” means a New Drug Application or supplemental New
Drug Application as defined in Title 21 of the U.S. Code of Federal Regulations,
Section 314.50, et seq., which is submitted to the FDA in order to gain the
FDA’s approval to commercialize a pharmaceutical product in the United States
for the indications set forth in the New Drug Application or supplemental New
Drug Application.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

15

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

 

1.137                 “Net Sales” means the amount of gross sales of all
(i) Royalty-Bearing Co-Formulation Products sold by Amicus, its Affiliates or
Sublicensees or (ii) Products sold by GSK, its Affiliates, or Sublicensees or
(iii) Terminated Product(s) sold by a Party, its Affiliates, or Sublicensees in
the relevant Affected Area (as defined under Section 14.2 or 14.3, as
applicable) (each, as applicable, a “Selling Party”) to Third Parties less the
following amounts actually and reasonably incurred, allowed, paid or accrued as
reported by Amicus, its Affiliates or Sublicensees, as applicable, in its
financial statements prepared in accordance with generally accepted accounting
principles in the United States (“GAAP”), applied on a consistent basis, or by
GSK, its Affiliates or Sublicensees, as applicable, in its financial statements
prepared in accordance with the International Financial Reporting Standards
(“IFRS”), applied on a consistent basis:

 

(a)                                 quantity, trade and cash discounts actually
allowed or given;

 

(b)                                 discounts, replacements, credits or refunds
actually allowed for the return of rejected, outdated, damaged or returned
Products;

 

(c)                                  rebates, chargebacks and price adjustments
actually allowed or given;

 

(d)                                 sales or similar taxes (including duties or
other similar governmental charges or assessments) levied, or otherwise imposed
on the sale of the applicable Products to the customer (including VAT or other
governmental charges measured by the billing amount, when included in such
billing);

 

(e)                                  charges for freight, handling, postage,
transportation, insurance and other shipping charges; and

 

(f)                                   a reasonable provision for uncollectible
accounts not to exceed ****** percent (******) of gross amounts invoiced.

 

provided, however, that:

 

(i)                                     sales or transfers of Royalty-Bearing
Co-Formulation Products between or among Amicus, any Sublicensee or any
Affiliate of Amicus for resale, and sales or transfers of Products between or
among GSK, any Sublicensee or any Affiliates of GSK for resale, as the case may
be, shall be excluded from Net Sales calculations by Amicus or GSK, as
applicable; provided, however, that the subsequent resale to a Third Party shall
be included in Net Sales hereunder;

 

(ii)                                  if the applicable Product is sold or
transferred for consideration other than cash, the Net Sales from such sale or
transfer shall be deemed the then fair market value of such Product;

 

******                              - Material has been omitted and filed
separately with the Commission.

 

16

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

 

(iii)                               Products that are transferred or used
without charge in connection with any pre-clinical or clinical trials, or for
any testing, quality control, evaluation or other Development purposes, or
distributed as samples or charitable donations, shall be excluded from Net Sales
calculations for all purposes; and

 

(iv)                              sales or transfers of Products for
registration samples, compassionate use sales, named patient use and the like,
shall be excluded from Net Sales calculations for all purposes, unless the
Selling Party recognizes revenue with respect to any such sales or transfers in
which event such sales or transfers shall be included in Net Sales hereunder.

 

The Net Sales definition as applicable to Amicus may be amended upon written
notice from Amicus only to extent required to reflect changes to Amicus’
accounting rules that result from a merger, takeover, or change in applicable
Law. The Net Sales definition as applicable to GSK may be amended upon written
notice from GSK only to extent required to reflect changes to GSK’s accounting
rules that result from a merger, takeover, or change in applicable Law.

 

1.138                 “Non-Hosting Party” has the meaning ascribed to that term
in Section 5.2.2(a).

 

1.139                 “Original Agreement” has the meaning ascribed to that term
in the preambles of this Agreement.

 

1.140                 “Out-of-Pocket Expenses” means amounts paid to Third Party
vendors or contractors, for services or materials provided by them directly in
their performance of activities reflected in the applicable Development Plan, to
the extent such services or materials apply directly to a Product for the
Territory.  For clarity, Out-of-Pocket Expenses do not include payments for
salaries or benefits, facilities, utilities, general office or laboratory
supplies, insurance, information technology, and other general administrative
costs of a Party.

 

1.141                 “Overage” has the meaning ascribed to that term in
Section 5.1.4(a)(iv).

 

1.142                 “Party” or “Parties” has the meaning ascribed to that
term(s) in the first paragraph of this Agreement.

 

1.143                 “Patent” means any and all existing (as of the Effective
Date) and future patents and patent applications in any country or jurisdiction,
including but not limited to, any provisional applications, non-provisional
applications, PCT applications, re-issues, re-examinations, divisionals,
continuations, continuations-in-part, registrations, confirmations, validations,
re-validations, renewals, and extensions of term thereof (including
supplementary protection certificates and pediatric use extensions), including
utility, model, and design patents.

 

1.144                 “Patent Costs” means the reasonable fees and expenses paid
to outside legal counsel, and filing, maintenance and other out-of-pocket
expenses paid to Third Parties as incurred in connection with the prosecution
and maintenance of Patents.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

17

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

 

1.145                 “Per Share Price” has the meaning ascribed to that term in
Section 3.2.

 

1.146                 “Person” means any individual, corporation (including any
nonprofit corporation), general or limited partnership, limited liability
company, joint venture, estate, trust, association, organization, labor union,
government agency, Regulatory Authority, or other entity.

 

1.147                 “Pharmacological Chaperone” means a small molecule drug
that selectively binds to the active site of a target enzyme resulting in enzyme
stabilization, improved trafficking, less aggregation, and/or increased activity
of the enzyme.

 

1.148                 “Phase II Clinical Studies” means early controlled human
clinical studies conducted to obtain some preliminary data on the appropriate
dose range and effectiveness of a drug in a disease or condition under study, as
more fully defined in 21 C.F.R. §312.21(b) or its successor regulation, or the
equivalent in any country other than the United States.

 

1.149                 “Phase III Clinical Studies” means expanded and controlled
human clinical studies involving administration of a drug to sufficient numbers
of human patients with the goal of establishing that a drug is safe and
efficacious for its intended use, and to be considered as a pivotal study for
submission of an MAA, including, in the United States, a NDA or BLA as more
fully defined in 21 C.F.R. §312.21(c) or its successor regulation, and including
any such clinical study in any country other than the United States.

 

1.150                 “Phase IV Clinical Studies” means human clinical studies,
including marketing studies, epidemiological studies, modeling and
pharmaco-economic studies, investigator sponsored clinical trials and
post-marketing surveillance studies, in each case (i) that are required or
requested by a Regulatory Authority to be conducted for a Product after receipt
of Marketing Approval for such Product in such country, as a condition of or in
connection with obtaining and maintaining such Marketing Approval, (ii) subject
to Section 5.3, that a Party elects to conduct in connection with or to support
the TPP New Labeling for such Product within its respective Territory, or
(iii) subject to Section 5.3(a), that a Party elects to conduct in support of
medical affairs activities.

 

1.151                 “Post-Marketing Commitments” means Phase IV Clinical
Studies and other preclinical and clinical studies conducted after Marketing
Approval (such as, by way of example, carcinogenicity studies, preclinical
studies to establish pediatric or other dosing or safety studies, and
registries) that are required or requested by a Regulatory Authority to be
conducted after Marketing Approval, in connection with obtaining or maintaining
such Marketing Approval.

 

1.152                 “Prior Equity Agreement” has the meaning ascribed to that
term in the preambles of this Agreement.

 

1.153                 “Product” means, subject to Section 14.4(a), any
pharmaceutical preparation that incorporates Compound, whether or not as the
sole active ingredient, including any formulation thereof, such as intravenous,
transdermal, oral, or other dosage form.  For clarity, references in this

 

******                              - Material has been omitted and filed
separately with the Commission.

 

18

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

 

Agreement to a “Product” include a Monotherapy Product, Co-Administration
Product and/or Co-Formulation Product, as applicable.

 

1.154                 “Product Liability Claim” has the meaning ascribed to that
term in Section 15.4.1.

 

1.155                 “Program” means all activities directed to the
Development, Manufacture and/or Commercialization of Products for the Territory
performed after the Effective Date under the Original Agreement or after the
Restatement Effective Date under this Agreement by or on behalf of Amicus (or
its Affiliates or Sublicensees) and/or GSK (or its Affiliates or Sublicensees)
under this Agreement; provided, however, it is understood that all activities
(a) related to the Development of Products conducted either by Amicus or GSK
prior to the Effective Date, (b) pertaining to the Manufacture of JR051,
(c) conducted by Amicus or its Affiliates with respect to a Terminated
Product(s) in the Affected Area after a termination of this Agreement in such
country(ies) or with respect to such Product(s) either by Amicus pursuant to
Section 13.2 or by GSK pursuant to Section 13.3, or (d) conducted by GSK or its
Affiliates with respect to a Terminated Product(s) in the Affected Area after a
termination of this Agreement in such country(ies) or with respect to such
Product(s) by GSK pursuant to 13.2, or after exercise by Amicus of its Opt-Out
Right in accordance with Section 5.4; in each case, will be deemed to have been
conducted outside of the Program.

 

1.156                 “Program Improvements” means, collectively, (a) the GSK
Monotherapy Product Manufacturing Improvements, and (b) any and all Know-How,
and other information that is developed by or on behalf of GSK (or its
Affiliates or Sublicensees), or Amicus (or its Affiliates, or Sublicensees)
(subject to Sections 12.2 and 14.4(b)), or jointly by or on behalf of GSK and
Amicus or any of their respective Affiliates (subject to Sections 12.2 and
14.4(b)), after the Effective Date arising, during the period from the Effective
Date to the Restatement Effective Date under the Original Agreement or during
the Term of this Agreement, from the conduct of activities under the Original
Agreement or under this Agreement, in each case with respect to Products (other
than Co-Formulation Product(s)), including such activities conducted pursuant to
(i) the Development Plan under the Original Agreement, (ii) the Existing
Development Plan, including any modifications or amendments thereto, under this
Agreement or (iii) any Amicus Territory Required Activities with respect to any
Product (other than a Co-Formulation Product) or GSK Territory Required
Activities with respect to any Product (other than a Co-Formulation Product),
including all inventions, Know-How, and all other intellectual property rights
relating to any of the foregoing; provided, however, that Program Improvements
will not include Amicus Intellectual Property, GSK Background IP, GSK
In-Licensed Background ERT IP, or Co-Formulation Product IP; and provided
further that, Program Improvements shall not include: (a) information which is
or becomes part of the public domain through no breach of this Agreement by GSK
or Amicus or their respective Affiliates; (b) information which GSK can
demonstrate by its written records was known by GSK or its Affiliates prior to
the Effective Date excluding any information received by GSK under the terms of
the Confidentiality Agreement; and (c) information which is independently
developed by GSK or Amicus or their respective Affiliates outside of the
Program, and such independent development can be demonstrated by written
records.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

19

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

 

1.157                 “Program Patent” means a Patent or Patent application
disclosing and claiming a Program Improvement.

 

1.158                 “Proof of Concept” has the meaning ascribed to that term
in Section 3.3.3(a).

 

1.159                 “Quarter” means a calendar quarter consisting of any of
the three-month periods ending on March 31, June 30, September 30 and
December 31 in any particular year.

 

1.160                 “receiving Party” has the meaning ascribed to that term in
Section 1.49.

 

1.161                 “Regulatory Approval” means: (a) in the United States,
written notice of Marketing Approval by the FDA based on approval of an NDA or
BLA, as applicable, and (b) in any country of the GSK Territory, written notice
of required Marketing Approval ******, such acceptance not to be unreasonably
withheld) by the Regulatory Authority having jurisdiction in such country;
provided that with respect to countries in the European Union, written notice of
a centralized Marketing Approval from the European Medicines Agency shall
constitute written notice with respect to each and every such country.

 

1.162                 “Regulatory Assignment” has the meaning ascribed to that
term in Section 5.2.1(b).

 

1.163                 “Regulatory Authority” means the agency, if any, of the
national government of any country with which a pharmaceutical or biological
therapeutic product must be registered or by which a pharmaceutical or
biological therapeutic product must be approved prior to its manufacture, use,
or sale in such country, provided that with respect to countries in the European
Union, the European Medicines Agency shall constitute such an agency with
respect to each and every such country in addition to any agency of a national
government of such country.

 

1.164                 “Requesting Party” has the meaning ascribed to that term
in Section 11.2.2.

 

1.165                 “Required Activities Opt-In Notice” has the meaning
ascribed to that term in Section 5.1.5(c).

 

1.166                 “Required Changes” has the meaning ascribed to that term
in Section 6.5.6.

 

1.167                 “Restatement Effective Date” has the meaning ascribed to
that term in the first paragraph of this Agreement.

 

1.168                 “Royalty-Bearing Co-Formulation Product” means a
Co-Formulation Product in which the ERT enzyme is JR051.

 

1.169                 “Rules” has the meaning ascribed to that term in
Section 16.2.2.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

20

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

 

1.170                 “Safety Data Exchange Agreement” has the meaning ascribed
to that term in Section 5.2.6(a).

 

1.171                 “Safety Issue” means any unexpected or untoward adverse
event related to a Product that is reported to a Party by a patient or
physician, or about which a Party becomes aware, which event raises a question
about patient safety or the efficacy of such Product and which event a Party
considers to be serious enough to contemplate taking a prompt affirmative action
with respect to such Product.

 

1.172                 “Second Opt-Out Right” has the meaning ascribed to that
term in Section 5.1.4(b)(ii).

 

1.173                 “Selling Party” has the meaning ascribed to that term in
Section 1.137.

 

1.174                 “Senior Executives” has the meaning ascribed to that term
in Section 4.1.5(a).

 

1.175                 “Specifications” has the meaning ascribed to that term in
Section 6.5.6.

 

1.176                 ******.

 

1.177                 “Subcommittee” has the meaning ascribed to that term in
Section 4.2.

 

1.178                 “Sublicensee” means a Third Party to whom GSK or Amicus,
as applicable, has granted a right to make, have made, use, sell, market,
distribute and/or promote a Product in the GSK Territory or Amicus Territory, as
applicable; and “Sublicense” shall mean an agreement or arrangement between GSK
and a Sublicensee, or between Amicus and a Sublicensee, as applicable, granting
such rights.  As used in this Agreement, “Sublicensee” shall not include a
wholesaler, or reseller of Product who does not market such Product.

 

1.179                 “Supply Agreement” has the meaning ascribed to that term
in Section 6.5.5.

 

1.180                 “Supply Transition Plan” has the meaning ascribed to that
term in Section 6.5.1.

 

1.181                 “Target Product Profile” means a voluntary format for
discussions between a sponsor and FDA that may be used throughout the drug
development process to pursue new indications or other substantial changes in
labeling.

 

1.182                 “Term” has the meaning ascribed to that term in
Section 13.1.

 

1.183                 “Terminated Product(s)” has the meaning ascribed to that
term in Section 14.2 (as applicable to Section 14.2) and Section 14.3 (as
applicable to Section 14.3).

 

1.184                 “Territory” means, subject to Section 14.4(a), all
countries and territories in the world.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

21

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

 

1.185                 “Third Party” means any Person other than Amicus or GSK or
an Affiliate of Amicus or GSK.

 

1.186                 “Third Party Claim” has the meaning ascribed to that term
in Section 15.1.

 

1.187                 “Third Party Enzyme IP” has the meaning ascribed to that
term in Section 10.3.3.

 

1.188                 “Total Co-Formulation Development Cost Cap” means ******
(which amount is equal to ****** of the total Development Costs specified in the
Co-Formulation Development Plan attached to this Agreement as Schedule 5.1B for
each of the calendar years beginning with calendar year 2012 up to and including
calendar year 2020).

 

1.189                 “Total Program Development Costs in the Existing
Development Plan” means the aggregate Development Costs for the Development of
the Compound and Products specified in the Existing Development Plan for each of
the calendar years beginning with calendar year 2011 up to and including
calendar year 2015.

 

1.190                 “TPP New Labeling” has the meaning ascribed to that term
in Section 5.3.

 

1.191                 “Trademarks” means (a) trademarks, service marks, logos,
trade dress and trade names, and domain names indicating the source of goods or
services, and other indicia of commercial source or origin (whether registered,
common law, statutory or otherwise), (b) all registrations and applications to
register the foregoing anywhere in the world, (c) all goodwill associated
therewith, and (d) all rights in and to any of the foregoing.

 

1.192                 “Trademark License Agreement” means an agreement in the
form attached hereto as Exhibit C.

 

1.193                 “Treaty” has the meaning ascribed to that term in
Section 3.10.

 

1.194                 “United States” or “U.S.” means the United States,
including Puerto Rico and the other territories and possessions of the United
States.

 

1.195                 “US Buy-Out Option Price” has the meaning ascribed to that
term in Section 12.1.4.

 

1.196                 “US Buy-Out Option” has the meaning ascribed to that term
in Section 12.1.

 

1.197                 “U.S. Commercialization Plan” means the strategic plan for
the marketing, promotion and other Commercialization activities for Products in
the Amicus Territory, as prepared by Amicus in accordance with Amicus’ normal
and customary format and process for such plans, and which will include, in
reasonable scope and detail, plans for implementation of Commercialization
activities in the Amicus Territory (consistent with the guidelines set forth in
the Global Commercialization Plan), and as amended from time to time by Amicus
during the Term.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

22

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

 

1.198                 “U.S. Commercialization Strategy” means the marketing
strategy for Products in the Amicus Territory determined by Amicus under the
global guidelines as set forth in the Global Commercialization Plan and reviewed
by the Joint Commercialization Subcommittee, including product positioning,
pricing, reimbursement, education programs, medical affairs, publications, sales
messages, marketing, and distribution, as such strategy may be amended by Amicus
from time to time during the Term.

 

1.199                 “Valid Claim” means a claim of an issued, unexpired Amicus
Patent or a Program Patent (other than a Formulation Patent or a Method of
Manufacture Patent) covering i) Compound; or ii) method of use of the Compound
or a Product (******) which: (a) has not been revoked or held unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, which decision is not appealable or has not been appealed within
the time allowed for appeal; (b) has not been disclaimed, denied or admitted to
be invalid or unenforceable through reissue, re-examination or disclaimer or
otherwise; or (c) has not lapsed, been cancelled or abandoned, or been dedicated
to the public.  For purposes of this Section 1.199, a “Formulation Patent” means
a Patent primarily directed to an invention which is a formulation of Compound
and one (1) or more excipients, and a “Method of Manufacture Patent” means a
Patent primarily directed to an invention which is a method of manufacture of
Compound or Product.

 

1.200                 Construction.  For purposes of this Agreement: (a) words
in the singular shall be held to include the plural and vice versa as the
context requires; (b) the word “including” and “include” shall be deemed to be
followed by the phrase “without limitation” or like expression unless otherwise
specified; (c) the terms “hereof,” “herein,” “herewith,” and “hereunder,” and
words of similar import shall, unless otherwise stated, be construed to refer to
this Agreement as a whole and not to any particular provision of this Agreement;
(d) the word “will” shall be construed to have the same meaning and effect as
the word “shall”; and (e) all references to “Section,” “Article,” “Schedule” and
“Exhibit,” unless otherwise specified, are intended to refer to a Section,
Article, Schedule or Exhibit of or to this Agreement.

 

II.                                   LICENSES

 

2.1                               License Grant to GSK from Amicus.

 

2.1.1                          Subject to the terms and conditions of this
Agreement, Amicus hereby grants to GSK the following licenses, with the right to
grant sublicenses in accordance with Section 2.2, under the Licensed Amicus
Technology: (i) a co-exclusive license (co-exclusive with Amicus) to Develop
Products in the Field in the Territory in accordance with Article V, (ii) an
exclusive license (exclusive even as to Amicus) to make, have made and otherwise
Manufacture Compound and Products in the Field and anywhere in the Territory for
the GSK Territory in accordance with Article VI; (iii) an exclusive license
(exclusive even as to Amicus) to make, have made and otherwise Manufacture
Co-Formulation Products in the Field and anywhere in the Territory for the
Amicus Territory in accordance with Article VI; (iv) an exclusive license
(subject to Section 6.5.3)

 

******                              - Material has been omitted and filed
separately with the Commission.

 

23

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

 

to Manufacture Compound and Products for use in connection with Development
activities as set forth in Section 6.5.4; and (v) an exclusive license
(exclusive even as to Amicus) to use, sell, offer for sale, import and otherwise
Commercialize Products in the Field in the GSK Territory (collectively, the
“License”).  For clarity, nothing set forth in this Section 2.1.1 shall be
construed to restrict Amicus’ licenses and rights granted hereunder to make and
have made and otherwise Manufacture Products (other than Co-Formulation
Products) anywhere in the Territory for the Amicus Territory in accordance with
Article VI, or to use, sell, offer for sale, import and otherwise Commercialize
Products in the Field in the Amicus Territory.

 

2.1.2                          Subject to Sections 5.3.2 and 10.4, and subject
to the exclusive rights of Amicus under this Agreement with respect to Products
in the Field in the Amicus Territory, Amicus hereby grants to GSK a worldwide,
non-exclusive, fully paid-up, royalty-free, right and license, with the right to
grant sublicenses, under Amicus’ and its Affiliates’ rights in the Program
Patents and the Patents within the Co-Formulation Product IP to make, have made,
use, sell, offer for sale, and import products, and to otherwise practice and
exploit the Program Improvements and Co-Formulation Product IP claimed in such
Program Patents and Patents within the Co-Formulation Product IP.

 

2.2                               Sublicensees.  GSK shall have the right to
grant sublicenses to its current and future Affiliates (solely for so long as
such entity remains an Affiliate) or to a Third Party, without the prior written
consent of Amicus, under and within the scope of the licenses granted to GSK in
Section 2.1.1(ii), (iii), (iv) and (v).  GSK shall have the right to grant
sublicenses under and within the scope of the license granted to GSK in
Section 2.1.1(i): (i) without the prior written consent of Amicus, to its
current and future Affiliates solely for so long as such entity remains an
Affiliate; (ii)without the prior written consent of Amicus to a Third Party
******; (iii) without the prior written consent of Amicus to a Third Party in
******; and (iv) subject to 2.2(iii), only with the prior written consent of
Amicus (which consent shall not be unreasonably withheld) ******.  In any event,
GSK shall ensure that each of its Sublicensees is bound by a written agreement
containing provisions at least as protective of the Compound, the Products and
Amicus as this Agreement; and GSK shall remain responsible to Amicus for all
activities of its Affiliates and Sublicensees to the same extent as if such
activities had been undertaken by GSK itself.  Promptly following the execution
of each Sublicense, GSK shall provide Amicus with a redacted copy of such
Sublicense (redacted solely to the extent necessary to prevent the disclosure of
Third Party confidential information and not redacting any terms or information
that are necessary for Amicus to determine GSK’s compliance with the provisions
of this Agreement with respect to the grant of such Sublicense); provided,
however, that GSK’s obligation to provide a redacted copy of any Sublicense
granted by GSK to a Sublicensee shall not apply with respect to Sublicenses
granted to a Third Party in accordance with this Section 2.2 in connection with
******.

 

2.3                               Reversion of Rights.  It is understood that,
as of the Effective Date, pursuant to the Original Agreement (including
Sections 2.1 and 2.2 thereof), Amicus granted to GSK certain licenses and rights
to use, sell, offer for sale, import and otherwise Develop, Manufacture and

 

******                              - Material has been omitted and filed
separately with the Commission.

 

24

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

 

Commercialize the Compound and Products in the Territory (as defined in the
Original Agreement).  As of the Restatement Effective Date, all such licenses
and rights granted by Amicus to GSK shall terminate and the Agreement shall
supersede and replace the Original Agreement as set forth in Section 16.8; it
being understood that the licenses granted to each Party under Article 2 of the
Original Agreement shall be deemed to apply to the activities conducted by a
Party between the Effective Date and the Restatement Effective Date.

 

2.4                               License Grant from GSK.

 

2.4.1                          Subject to the terms and conditions of this
Agreement, GSK hereby grants to Amicus the following licenses, with the right to
grant sublicenses in accordance with this Section 2.4.1 below, under all Program
Improvements and Program Patents:  (i) a co-exclusive license (co-exclusive with
GSK) to Develop Products in the Field and in the Territory in accordance with
Article V, (ii) subject to GSK’s rights and obligations to Manufacture Products
for Development activities as set forth in Article 6.5.4, an exclusive license
(exclusive even as to GSK) to make and have made and otherwise Manufacture
Compound and Products (other than Co-Formulation Products) in the Field and
anywhere in the Territory for the Amicus Territory in accordance with VI; and
(iii) an exclusive license (exclusive even as to GSK) to use, sell, offer for
sale, import and otherwise Commercialize Products in the Field in the Amicus
Territory.  For clarity, nothing set forth in this Section 2.4.1. shall be
construed to restrict GSK’s licenses and rights granted hereunder to make, have
made and otherwise Manufacture Products anywhere in the Territory for the GSK
Territory in accordance with Article VI, or to use, sell, offer for sale, import
and otherwise Commercialize Products in the Field in the GSK Territory.  Amicus
shall have the right to grant sublicenses to its current and future Affiliates
(solely for so long as such entity remains an Affiliate) or to a Third Party,
without the prior written consent of GSK, under and within the scope of the
licenses granted to Amicus pursuant to Section 2.4.1(ii) and (iii).  Amicus
shall have the right to grant sublicenses (i) without the prior written consent
of GSK to its current and future Affiliates solely for so long as such entity
remains an Affiliate; (ii) without the prior written consent of GSK to a ******;
and (iii) subject to 2.4(ii), only with the prior written consent of GSK (which
consent shall not be unreasonably withheld), to ******.  With respect to each
such Sublicense granted by Amicus pursuant to this Section 2.4.1, Amicus shall
ensure that each of its Third Party Sublicensees is bound by a written agreement
containing provisions at least as protective of the Compound, the Products and
GSK as this Agreement; and Amicus shall remain responsible to GSK for all
activities of its Affiliates and Sublicensees to the same extent as if such
activities had been undertaken by Amicus itself.  Promptly following the
execution of each Sublicense with a Third Party, Amicus shall provide GSK with a
redacted copy of such Sublicense with a Third Party (redacted solely to the
extent necessary to prevent the disclosure of Third Party confidential
information and not redacting any terms or information that are necessary for
GSK to determine Amicus’ compliance with the provisions of this Agreement with
respect to the grant of such Sublicense); provided, however, that Amicus’
obligation to provide a redacted copy of any Sublicense granted by Amicus to a
Sublicensee shall not apply with respect to Sublicenses granted to a Third Party
in connection with Manufacturing activities with respect to Products (other than
Co-Formulation Products) for the

 

******                              - Material has been omitted and filed
separately with the Commission.

 

25

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

 

Amicus Territory or Commercialization activities with respect to Product(s) for
the Amicus Territory.

 

2.4.2                          Co-Formulation Product IP.

 

(a)                                 Subject to the terms and conditions of this
Agreement, GSK hereby grants to Amicus the following licenses, with the right to
grant sublicenses in accordance with this Section 2.4.2(a) below, under the
Co-Formulation Product IP: (i) a co-exclusive license (co-exclusive with GSK) to
Develop Co-Formulation Products in the Field in the Territory in accordance with
Article V, and (ii) an exclusive license (exclusive even as to GSK) to use,
sell, offer for sale, import and otherwise Commercialize Co-Formulation Products
in the Field in the Amicus Territory.  For the avoidance of doubt, nothing set
forth herein shall be construed to restrict GSK’s licenses and rights granted
hereunder to Manufacture the Co-Formulation Products in the Field in the
Territory for the GSK Territory and for the Amicus Territory in accordance with
Article VI, or to Commercialize Co-Formulation Products in the Field in the GSK
Territory.  Nothing set forth herein shall be construed to grant to Amicus any
rights under the Co-Formulation Product IP to Manufacture Co-Formulation
Products.  Amicus shall have the right to grant sublicenses under the licenses
granted to Amicus in Section 2.4.2(a)(i) to an Affiliate (solely for so long as
such entity remains an Affiliate) without the prior written consent of GSK, and
to a Third Party only with the prior written consent of GSK (which consent shall
not be unreasonably withheld).  Amicus shall have the right to grant sublicenses
to an Affiliate (solely for so long as such entity remains an Affiliate) or
Third Party, in each case, without the consent of GSK, under and within the
scope of the foregoing licenses granted to Amicus in Section 2.4.2(a)(ii).  All
Sublicenses granted by Amicus pursuant to this Section 2.4.2(a) shall be subject
to the following: Amicus shall ensure that each of the Third Parties to which
Amicus has granted a Sublicense in accordance with this Section 2.4.2(a) is
bound by a written agreement containing provisions at least as protective of the
Compound, the Products and GSK as this Agreement; and Amicus shall remain
responsible to GSK for all activities of its Affiliates and Sublicensees to the
same extent as if such activities had been undertaken by Amicus itself. 
Promptly following the execution of each sublicense with a Third Party, Amicus
shall provide GSK with a redacted copy of such Sublicense with a Third Party
(redacted solely to the extent necessary to prevent the disclosure of Third
Party confidential information and not redacting any terms or information that
are necessary for GSK to determine Amicus’ compliance with the provisions of
this Agreement with respect to the grant of such sublicense); provided, however,
that Amicus’ obligation to provide a redacted copy of any Sublicense granted by
Amicus to a Sublicensee shall not apply with respect to Sublicenses granted to a
Third Party in connection with Commercialization activities with respect to
Co-Formulation Product(s) for the Amicus Territory.

 

(b)                                 Without limiting the right and licenses
granted under Sections 2.4.1, 2.4.2(a) or 2.4.3, GSK hereby irrevocably
covenants from and after the Restatement Effective Date and, subject to
Section 14.3.1(a), during the Term that ******.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

26

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

 

2.4.3                          Subject to Sections 5.3.2 and 10.4, and subject
to the exclusive rights granted to GSK under this Agreement with respect to the
Products in the Field in the GSK Territory and, subject to Section 14.3.11, as
applicable, with respect to the Co-Formulation Product, the exclusive
Manufacturing rights granted to GSK in the Territory, GSK hereby grants to
Amicus a worldwide, non-exclusive, fully paid-up, royalty-free, right and
license, with the right to grant sublicenses, (a) under GSK’s and its
Affiliates’ rights in the Program Patents to make, have made, use, sell, offer
for sale, and import products, and to otherwise practice and exploit the Program
Improvements and (b) under GSK’s and its Affiliates’ rights in the Patents
within the Co-Formulation Product IP to make and have made (other than JR051 or
Co-Formulation Product in which the ERT enzyme is JR051), use, sell, offer for
sale and import products (other than JR051), and to otherwise practice and
exploit the Patents within the Co-Formulation Product IP claimed in such Program
Patents and/or Patents within the Co-Formulation Product IP.

 

2.5                               GSK Trademarks.  For all Trademarks Controlled
by GSK or any of its Affiliates during the Term that the Joint Commercial
Subcommittee determines should be used on or in connection with Products for the
Amicus Territory in accordance with Section 6.3.1 (each, a “GSK Trademark”), GSK
shall grant to Amicus a license in accordance with the terms of the Trademark
License Agreement, a form of which is attached hereto as Exhibit C, to use the
GSK Trademark(s) solely in connection with Amicus’s right to (i) Develop
Compound and Products in the Field in the Territory as provided in Article V,
(ii) Manufacture Compound or Products in the Field anywhere in the Territory for
the Amicus Territory in accordance with Article VI, and (iii) use, sell, offer
for sale, distribute, promote and otherwise Commercialize Products in the Field
in the Amicus Territory.  Such license under the GSK Trademarks shall include
the right to use the GSK Trademark(s), other than GSK House Marks, as part of a
domain name.

 

2.6                               No Implied Licenses.  Except as expressly set
forth in this Agreement or in a Trademark License Agreement, neither Party shall
acquire any licenses or other intellectual property right or interest, by
implication or otherwise, in any Know-How disclosed to it under this Agreement
or under any Patents Controlled by the other Party or its Affiliates.  Without
limiting the foregoing, nothing herein shall be deemed to grant to GSK a right
or license to any active pharmaceutical ingredient other than the Compound, and
nothing herein shall be deemed to grant to Amicus a right or license under any
of GSK’s, its Affiliates’ or JCR’s rights in or to any enzyme used as an ERT
that is owned or Controlled by GSK, its Affiliates, or JCR, except as expressly
set forth herein with respect to use of JR051 solely in a Co-Formulation
Product.

 

III.                              CONSIDERATION

 

3.1                               [Reserved]

 

3.2                               Equity Investment.  Pursuant to the terms of
the Equity Agreement, Amicus will sell to GSK, and GSK will purchase from
Amicus, Two Million Nine Hundred Forty-Nine Thousand Five Hundred Eight-One
(2,949,581) shares of Common Stock of Amicus, at a per share price equal

 

******                              - Material has been omitted and filed
separately with the Commission.

 

27

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

 

to the greater of (a) ******, or (b) ****** (the “Per Share Price”).  The Equity
Agreement shall be executed by the Parties on even date herewith, with GSK’s
payment to Amicus for such Common Stock payable within ten (10) Business days
after the effective date of the Equity Agreement.

 

3.3                               Milestone Payments.

 

3.3.1                          GSK Milestone Payment.  Subject to Section 3.10
with respect to payment of taxes, GSK will pay to Amicus Three Million Five
Hundred Thousand Dollars (US$3,500,000) following the completion of the last
patient’s six (6) month visit in the 011 Phase III Clinical Study.  Such amount
shall be paid by GSK to Amicus no later than sixty (60) days following the
receipt of an invoice therefor from Amicus as provided in Section 3.6.  GSK
shall notify Amicus in writing promptly, but in no event later than ten
(10) days, after the achievement of such milestone event, and no invoice for
payment of a milestone shall be sent by Amicus to GSK as provided herein prior
to Amicus’s reasonable determination that such milestone event has been
achieved.

 

3.3.2                          GSK’s Milestone Obligations under the Original
Agreement.  The Parties acknowledge and agree that GSK’s milestone payment
obligations to Amicus as set forth in the Original Agreement shall be, as of the
Restatement Effective Date, null and void and no longer in effect and that, as
of the Restatement Effective Date, GSK’s sole milestone obligation to Amicus
shall be as set forth in this Agreement.

 

3.3.3                          Amicus Milestone Payments.

 

(a)                                 Subject to Section 3.10 with respect to
payment of taxes, Amicus shall pay to GSK the milestone payments set forth below
(each, a “Milestone Payment”), following the first achievement of each of the
corresponding milestone events by Amicus, its Affiliate or Sublicensee or GSK,
its Affiliates, or Sublicensee, as applicable, no later than sixty (60) days
following the receipt of an invoice therefor from GSK as provided in
Section 3.5.2.  Any Milestone Payments set forth below and payable by Amicus
shall be paid ******.  Amicus shall notify GSK in writing promptly, but in no
event later than ten (10) days, after the achievement of such milestone event,
and no invoice for payment of a milestone shall be sent by GSK to Amicus as
provided herein prior to GSK’s reasonable determination that the corresponding
milestone event has been achieved.  Each of the following Milestone Payments
shall be payable only once, regardless of how many times a Product achieves each
milestone event and no milestones shall be paid by Amicus for milestone events
that are not achieved.  Notwithstanding the foregoing, with respect to the
Milestone Payments regarding a Royalty-Bearing Co-Formulation Product (i.e.,
Milestone Payments #1, #2, #3, #4, #5, and #8), GSK shall notify Amicus in
writing promptly after the achievement of the corresponding milestone event, and
no invoice for payment of a milestone shall be sent by GSK to Amicus as provided
herein prior to Amicus’ receipt of written evidence of ******, which reflects
that the amount of the corresponding Milestone Payment ******.  In any event,
Milestone Payments regarding a Royalty-Bearing Co-Formulation Product shall be
payable by Amicus only to the extent ******.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

28

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

 

Filing and Approval Milestone Event

 

Milestone Payment
(US Dollars ($) or
Japanese Yen (¥), as
designated below)
(Form of Payment)

 

1. ****** **

 

******

 

2. ****** **

 

******

 

3. ****** **

 

******

 

4. ****** **

 

******

 

5. ****** **

 

******

 

6. ******

 

******

 

7. ******

 

******

 

8. ****** **

 

******

 

9. ******

 

******

 

 

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

**  ******.

 

For purposes of this Section 3.3.3(a), “Achievement of Proof of Concept” means
******.

 

(b)                                 Notwithstanding anything to the contrary in
Section 3.6, with respect to any of the Milestone Payments due under
Section 3.3.3(a) that are eligible for payment, in whole or in part, in equity
as specified in the milestone table set forth in Section 3.3.3(a), Amicus shall
pay all or a portion of any such Milestone Payments, as applicable, (i) first,
by ****** and, in such an event, GSK shall ******.

 

3.3.4                          Co-Formulation Product Post-Launch Milestones. 
If a Co-Formulation Product is Launched in the Amicus Territory and Amicus, its
Affiliate or Sublicensee is selling a Co-Formulation Product in the Amicus
Territory as of the occurrence of the applicable post-launch milestone set out
in the table below, then Amicus shall pay to GSK the amount set forth below
following the first occurrence of the corresponding post-launch milestone as set
out below.  Each of the milestone payments set out below shall be payable only
once and no milestones shall be paid by Amicus if the milestone event does not
occur in accordance with this Section 3.3.4:

 

******                              - Material has been omitted and filed
separately with the Commission.

 

29

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

 

Co-Formulation Product Post-Launch Milestones:

 

Milestone Payment
(in US Dollars Cash)

 

******

 

$

******

 

******

 

$

******

 

 

3.4                               Royalties.

 

3.4.1                          Royalties on Royalty-Bearing Co-Formulation
Products in the Amicus Territory.  In addition to (and not in lieu of) the
milestone payments to be made by Amicus as set forth in Section 3.3, and subject
to Sections 3.4.2 and 14.2.3(b)(iv)(b), commencing on the date of Launch of a
Royalty-Bearing Co-Formulation Product in the Amicus Territory and during the
Term, Amicus shall pay to GSK a ****** royalty on Net Sales of Royalty-Bearing
Co-Formulation Products by Amicus, its Affiliates and Sublicensees in the Amicus
Territory in accordance with Section 3.7 below.  Notwithstanding the foregoing,
royalty payments pursuant to this Section 3.4.1 shall be payable by Amicus
******, which shall not be greater than ****** percent (******) of Net Sales of
Royalty-Bearing Co-Formulation Products, and no amounts shall be paid for any
other amounts of royalty payments made from ******.

 

3.4.2                          Except as provided in this Section 3.4 with
respect to a Royalty-Bearing Co-Formulation Product, the Parties acknowledge and
agree that no royalties are payable by Amicus to GSK under this Agreement with
respect to the sale or other Commercialization in the Amicus Territory of any
Product.  Further, it is understood that the only royalties or other amounts
payable by Amicus to GSK with respect to the Development or Commercialization of
Products are as set forth in this Article III, Article VIII, or Article XV, or
in Sections 5.1 or 6.5 below, and Amicus shall have no other obligations to pay
to GSK any amounts payable by GSK to an Affiliate or by GSK or its Affiliates to
a Third Party as a result of the Development, Manufacture or Commercialization
of Products in the Field for the Amicus Territory.  Except as provided in
Section 3.4.3(a)(ii), the Parties acknowledge and agree that no royalties are
payable by GSK to Amicus under this Agreement with respect to the Development,
Manufacture or Commercialization of Products in the Field for the GSK
Territory.  For clarity, nothing in this Section 3.4.2 shall be deemed to limit
a Party’s payment obligations pursuant to Section 5.4 below or, following an
applicable termination of this Agreement, pursuant to Article XIV below.

 

3.4.3                          Third Party Obligations.

 

(a)                                 Third Party Payments.

 

(i)                                     Amicus shall be solely responsible for
payment of any and all royalties and other payments (including but not limited
to fees, upfront payments, milestone payments and royalties) owed by Amicus to a
Third Party for the Development or Manufacture of all

 

******                              - Material has been omitted and filed
separately with the Commission.

 

30

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

 

Products in the Territory or for the Commercialization of all Products in the
Amicus Territory pursuant to any Background License Agreements that are in
effect as of the Effective Date of the Agreement.

 

(ii)                                  Subject to Section 14.3.3(b)(iv)(b), GSK
shall be solely responsible for, and shall reimburse Amicus as set forth in
Section 3.7 for any and all payments as set forth on the attached Schedule 3.4.3
(and as may be modified in accordance with Section 3.4.3(b) below) that are owed
by Amicus to the Mount Sinai School of Medicine of New York pursuant to the
Mount Sinai Agreement as a result of the Manufacture or Commercialization of
Products in the Field for the GSK Territory.  Such payments shall be made by GSK
to Amicus for the period of time during which GSK, its Affiliates and/or
Sublicensees have rights to Manufacture and/or Commercialize Products in the GSK
Territory and such amounts are payable to Mount Sinai School of Medicine of New
York University under the Mount Sinai Agreement as a result of Manufacture or
Commercialization of Products in the Field for the GSK Territory.

 

(b)                                 In the event that Amicus intends to modify
any of the terms of a Background License Agreement pertaining to (i) the amounts
payable under such Background License Agreement by reason of the Development,
sale or other Commercialization of Products in the GSK Territory, (ii) the term
for which royalties with respect to sales of Products in the GSK Territory are
payable, or (iii) the scope of any rights or obligations granted to GSK under
this Agreement, Amicus shall provide notice of such intent to GSK within a
reasonable period of time (but in no event longer than five (5) Business days)
prior to making any such modifications.  If such modifications would increase
any amounts payable by reason of the Development, sale or other
Commercialization of Products in the GSK Territory or the term for which
royalties with respect to sales of Products in the GSK Territory are payable or
otherwise materially and adversely modify the scope of any rights or obligations
granted to GSK under this Agreement, Amicus shall not proceed to so modify any
such Background License Agreement without the prior consent and approval of GSK
(such approval not to be unreasonably withheld).

 

(c)                                  GSK shall be solely responsible for payment
of any and all amounts, including upfront payments, license fees, milestones and
royalties, owed to any Third Party under any agreement with a Third Party with
respect to the Third Party Enzyme IP that are negotiated and obtained by GSK in
accordance with Section 10.3.3.

 

3.5                               Method of Payment.

 

3.5.1                          Unless otherwise agreed by the Parties, all
amounts owed by a Party to another Party under this Agreement and payable in
cash shall be paid in U.S. dollars, by bank wire transfer in immediately
available funds to an account designated in an invoice from the Party to which
such payments are due, which invoice should include bank details, the contact
name for any issue resolution and be marked for the attention of the Alliance
Manager of the Party to whom such

 

******                              - Material has been omitted and filed
separately with the Commission.

 

31

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

 

payment is due.  All amounts owed by GSK to Amicus hereunder shall be paid by an
entity resident in the United Kingdom from a bank account located in the United
Kingdom.

 

3.5.2                          Unless otherwise expressly stated herein, all
payments made by one Party to the other pursuant to this Agreement shall be made
within sixty (60) days following receipt by such Party of an invoice from the
other Party for such amounts; provided that in the case of any payments made by
Amicus pursuant to Section 3.4.1, such payments shall be made within sixty (60)
days following receipt by Amicus of an invoice and written evidence of payment
****** of such corresponding royalty payments owed under ****** in accordance
with Section 3.7.

 

3.6                               Foreign Exchange.  Unless otherwise agreed by
the Parties, all payments to be made by either Party to the other Party under
this Agreement shall be made in United States dollars.  In the case of any
amounts payable or receivable in a foreign currency, the Parties shall use the
spot exchange rate sourced from Bloomberg/Reuters.

 

3.7                               Reports and Royalty Payment.  Commencing with
the first Quarter in which the first Launch of a Royalty-Bearing Co-Formulation
Product in the Amicus Territory occurs, and for each Quarter thereafter for so
long as Amicus owes a royalty to GSK under Section 3.4, Amicus shall, within
****** after the end of the applicable Quarter, submit to GSK, together with
Amicus’ payment for the royalties due for each Quarter, a written report showing
the actual Net Sales and the royalties payable in accordance with Section 3.4 in
each case in U.S. dollars.  Such report shall be in the format reasonably
requested by GSK, including any such information regarding the Net Sales of
Royalty-Bearing Co-Formulation Products in the Amicus Territory and calculation
of such royalties as may be requested by GSK to comply with its obligations
under the GSK/JCR Master Agreement. ******, GSK shall issue an invoice to Amicus
for reimbursement of such amounts together with ****** in accordance with
Section 3.4.1.  Similarly, commencing with the first Quarter in which the first
Launch of a Product in the GSK Territory occurs, and for each Quarter thereafter
during the Term, GSK shall, within ****** after the end of the applicable
Quarter, submit to Amicus, together with GSK’s payment for the royalties due for
each Quarter, a written report showing the Net Sales of Products and any
royalties payable by GSK pursuant to Section 3.4.3(a)(ii) and/or Section 5.4 and
14.2, as applicable.  Such reports shall be in the format reasonably requested
by Amicus and shall include equivalent information to that provided by Amicus in
the reports provided by Amicus to GSK pursuant to this Section 3.7 and such
other information regarding the Net Sales of Products in the GSK Territory and
calculation of such royalties as may be requested by Amicus to comply with its
obligations under any Background License Agreement.

 

3.8                               GSK Records.  GSK will keep, and will require
any Affiliates and Sublicensees to keep, for three (3) years from the end of the
Quarter to which they pertain, or such longer period as may be required by
applicable Law, complete and accurate books of account and records, including
with respect to Development Costs and amounts spent on research and Development
in accordance with this Agreement, as well as with respect to sales of Products
in the GSK Territory, in sufficient detail to allow amounts payable to Amicus
hereunder to be determined accurately.  Amicus will have

 

******                              - Material has been omitted and filed
separately with the Commission.

 

32

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

 

the right during such three (3) year period to appoint an independent certified
public accountant reasonably acceptable to GSK (the “Amicus Auditor”) to inspect
those books or records of GSK for the purpose of determining the applicable
amounts payable to Amicus pursuant to this Agreement.  Upon not less than sixty
(60) days’ prior written notice from Amicus, GSK will make such books and
records and the books and records of its Affiliates available (including any
sales reports received from its Sublicensees selling Products in the GSK
Territory) for inspection by such Amicus Auditor during regular business hours
at such place or places where such records are customarily kept, for the sole
purpose of verifying the amounts payable hereunder.  The Amicus Auditor will
disclose to Amicus only the amount and accuracy of payments reported and
actually paid or otherwise payable under this Agreement.  The Amicus Auditor
will send a copy of the report to GSK at the same time it is sent to Amicus. 
******. Notwithstanding the foregoing, in the event that Amicus demonstrates
sufficient cause, giving due consideration to each of the Parties’ resources, to
support the conduct of an additional inspection pursuant to this Section 3.9
within the same calendar year, the Parties shall discuss in good faith whether
to require such additional inspection to take place; provided that GSK may not
unreasonably withhold its consent to such an inspection.  The Amicus Auditor
shall be obligated to execute a reasonable confidentiality agreement prior to
commencing any such inspection.  Inspections conducted under this Section 3.8
shall be at the expense of Amicus; provided, however, that if the designated
auditor discovers an underpayment to Amicus of ****** or more for any period
covered by the inspection between the payments GSK has made under this Agreement
and the payments actually owed to Amicus under this Agreement, then GSK will
bear all reasonable costs and expenses associated with such audit and any
amounts underpaid by GSK that are established shall be paid by GSK to Amicus,
together with interest on such underpaid amounts at the rate set forth in
Section 16.12.  Amicus agrees to treat all information learned in the course of
any audit or inspection as Confidential Information of GSK.

 

3.9                               Amicus Records.  Amicus will keep, and will
require its Affiliates and Sublicensees to keep, for three (3) years from the
end of the Quarter to which they pertain, or such longer period as may be
required by applicable Law, complete and accurate books of account and records,
including with respect to Development Costs and amounts spent on research and
Development undertaken in accordance with this Agreement, as well as with
respect to Net Sales of Royalty-Bearing Co-Formulation Products, in sufficient
detail to allow amounts payable to GSK hereunder to be determined accurately. 
GSK will have the right during such three (3) year period to appoint an
independent certified public accountant reasonably acceptable to Amicus (the
“GSK Auditor”) to inspect those books or records of Amicus for the purpose of
determining the applicable amounts payable to GSK pursuant to this Agreement. 
Upon not less than sixty (60) days’ prior written notice from GSK, Amicus will
make such books and records and the books and records of its Affiliates
available (including any sales reports received from its Sublicensees selling
Royalty-Bearing Co-Formulation Products in the Amicus Territory) for inspection
by such GSK Auditor during regular business hours, at such place or places where
such records are customarily kept, for the sole purpose of verifying the amounts
payable hereunder.  The GSK Auditor will disclose to GSK only the amount and
accuracy of payments reported and actually paid or otherwise payable under this
Agreement.  The GSK Auditor will send a copy of the report to Amicus at the same
time it is sent to

 

******                              - Material has been omitted and filed
separately with the Commission.

 

33

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

 

GSK.  ******.  Notwithstanding the foregoing, in the event that GSK demonstrates
sufficient cause, giving due consideration to each of the Parties’ resources, to
support the conduct of an additional inspection pursuant to this Section 3.9
within the same calendar year, the Parties shall discuss in good faith whether
to require such additional inspection to take place; provided that Amicus may
not unreasonably withhold its consent to such an inspection.  The GSK Auditor
shall be obligated to execute a reasonable confidentiality agreement prior to
commencing any such inspection.  Inspections conducted under this Section 3.9
shall be at the expense of GSK; provided, however, that if the designated
auditor establishes an underpayment to GSK of ****** or more for any period
covered by the inspection between the payments Amicus has made under this
Agreement and the payments actually owed to GSK under this Agreement for a
period covered by the inspection, then Amicus will bear all reasonable costs and
expenses associated with such audit and any amounts underpaid by Amicus that are
established shall be paid by Amicus to GSK, together with interest on such
underpaid amounts at the rate set forth in Section 16.12.  GSK agrees to treat
all information learned in the course of any audit or inspection as Confidential
Information of Amicus.

 

3.10                        Taxes.

 

3.10.1                   Amicus warrants that Amicus is a resident for tax
purposes of the United States of America and that Amicus is entitled to relief
from United Kingdom income tax under the terms of the double tax agreement
between the United Kingdom and the United States of America (the “Treaty”). 
Amicus shall notify GSK immediately in writing in the event that Amicus ceases
to be entitled to such relief.

 

3.10.2                   GSK shall cooperate with Amicus in obtaining formal
certification of Amicus’s entitlement to relief under the Treaty.  Amicus agrees
to indemnify and hold harmless GSK against any loss, damage, expense or
liability arising in any way from a breach of the above warranties or any future
claim by a United Kingdom tax authority alleging that GSK was not entitled to
deduct withholding tax on such payments at source at the Treaty rate.  The
royalty and other payments under this Agreement shall not be reduced by any
taxes required to be withheld by any taxing authority outside of the United
Kingdom.

 

3.10.3                   If GSK assigns this Agreement to an Affiliate and GSK
or its Affiliate becomes liable to withhold any taxes from payments under this
Agreement, then GSK or its Affiliate shall pay to Amicus the full amount of any
payment required to be paid, unreduced by any withholding tax and shall pay any
amount owed to the relevant tax authority; provided, however, that to the extent
Amicus is able to obtain credit for any taxes withheld against Amicus’ tax
liability and actually realizes a reduction in its tax liability as a result of
the utilization of such credit, Amicus shall refund to GSK the amount of such
net tax savings, as determined in the reasonable discretion of Amicus.

 

3.10.4                   All sums payable under this Agreement are exclusive of
value added tax and any other sales taxes.  The Parties agree that, where
appropriate, the Parties shall provide each other

 

******                              - Material has been omitted and filed
separately with the Commission.

 

34

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

 

with a valid tax invoice, and against such invoice, the Parties shall pay the
amount of any such tax to the other Party.  Should such amounts of tax be
refunded subsequently by the fiscal authorities, the Party receiving the refund
shall immediately notify the other Party and refund these monies within thirty
(30) days of receipt of such funds.

 

IV.                               GOVERNANCE

 

4.1                               Joint Steering Committee.

 

4.1.1                          Existing JSC.  Amicus and GSK shall continue to
use the joint steering committee (the “Joint Steering Committee” or “JSC”) that
was formed under the Original Agreement to oversee the Development and
Commercialization of Products, and to review and coordinate the Development of
the Products in the Field in the Territory, subject to the terms and conditions
of Articles V and VI herein.

 

4.1.2                          Membership.  The Joint Steering Committee will be
composed of six (6) representatives: three (3) representatives nominated by
Amicus and three (3) representatives nominated by GSK.  Each such representative
on the Joint Steering Committee shall be a senior executive or other member of
senior management (or their designees who shall have the necessary authority to
make decisions as such senior executives or other members of senior management,
as applicable) of the respective Party or an Affiliate of such Party, and in
each case such representatives shall have significant experience and
responsibility for oversight of Products and shall be empowered by the Party
whom they represent to make decisions that are binding upon such Party with
respect to the Development, Manufacture and/or Commercialization, as applicable,
of the Product.  Each Party may also have its Alliance Manager attend Joint
Steering Committee meetings as non-voting participants.  GSK and Amicus will
each be entitled to replace its representatives on the Joint Steering Committee
in its sole discretion at any time during the Term with representatives of
similar experience and level of responsibility.  The Joint Steering Committee
shall be chaired by a GSK representative (the “Chairperson”), and the
Chairperson shall be responsible for, among other similar tasks as necessary,
(a) calling and managing the conduct of meetings, (b) preparing and issuing
minutes of each such meeting within thirty (30) days thereafter, and
(c) preparing and circulating an agenda for the upcoming meeting, but shall have
no final decision-making authority.  For clarity, the Chairperson shall include
in the upcoming agenda any items reasonably requested by any other JSC
representative.  With the consent of the other Party (such consent not to be
unreasonably withheld), other employees or consultants of GSK or Amicus or their
respective Affiliates may attend Joint Steering Committee meetings to present
information or participate in discussions on an ad hoc basis as non-voting
participants or observers.  The Parties shall cause their respective members on
the Joint Steering Committee to act in good faith in carrying out their
activities on the Joint Steering Committee.

 

4.1.3                          Duties of the Joint Steering Committee.  The
Joint Steering Committee will:

 

******                              - Material has been omitted and filed
separately with the Commission.

 

35

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

 

(a)                                 Review and approve the Development Plans
(and the associated budgets for Development Costs included therein) on an annual
basis, including any amendments and updates thereto;

 

(b)                                 Oversee the implementation of the
Development Plans by the Parties and each Party’s progress towards completion of
the activities allocated to such Party under the Development Plans;

 

(c)                                  Review and approve changes to the
Development Plans;

 

(d)                                 Review and if applicable in accordance with
Section 5.1.1(c), approve any necessary amendments to the Development Plans to
include Phase IV Clinical Studies, Post-Marketing Commitments, Amicus Territory
Required Activities, or GSK Territory Required Activities, if applicable;

 

(e)                                  Review and approve changes to the Global
Commercialization Plan;

 

(f)                                   Oversee the coordination of global
Commercialization activities of Products in the Field and in the Territory
during the Term consistent with the Global Commercialization Plan;

 

(g)                                  Oversee the global Development activities,
including all filings and interactions with Regulatory Authorities with respect
to obtaining Marketing Approvals for Products in the Amicus Territory and in the
Expanded Major Market countries in the GSK Territory;

 

(h)                                 Designate a Trademark(s) for use on each
Product in the Territory;

 

(i)                                     Subject to Section 11.2, oversee
strategy for publications and presentations of clinical trial results and other
scientific information; and

 

(j)                                    Decide any disputes elevated to the Joint
Steering Committee from a Subcommittee in accordance with Section 4.1.5,
including any such disputes elevated to the Joint Steering Committee from the
Joint Commercialization Subcommittee in accordance with Section 4.2.2 and from
the Joint Development Subcommittee in accordance with Section 4.2.3; and

 

(k)                                 Perform such other duties as are
specifically assigned to the JSC in this Agreement or otherwise agreed to in
writing by the Parties.

 

4.1.4                          Committee Meetings.  The Joint Steering Committee
shall meet at least once per Quarter, or more or less often as otherwise agreed
to by the Parties.  Joint Steering Committee meetings may be conducted by
telephone, video-conference or in person as agreed to by the Parties.  Unless
otherwise agreed by the Parties, all in-person meetings for the Joint Steering
Committee shall be held on an alternating basis between Amicus’ facilities and
GSK’s facilities.  Each Party shall

 

******                              - Material has been omitted and filed
separately with the Commission.

 

36

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

 

bear its own personnel and travel costs and expenses relating to Joint Steering
Committee or Subcommittee meetings, and such expenses shall not be included in
Development Costs.

 

4.1.5                          Decision-Making.  Decisions of the Joint Steering
Committee shall be made by unanimous vote, with each Party having (1) vote and
with at least one (1) representative from each Party participating in any vote. 
Each Party will use reasonable efforts to achieve consensus on the Joint
Steering Committee.  In the event that the Joint Steering Committee fails to
reach unanimous agreement with respect to a particular matter within its
authority within thirty (30) days of the date such matter was first presented to
the Joint Steering Committee, then such matter shall be resolved, as follows:

 

(a)                                 Disputes Related to Development and
Regulatory Issues.  Either Party may, by written notice to the other Party (an
“Escalation Notice”), refer such disputes regarding Development of a Product in
the Territory or regulatory issues relating to a Product in the Territory to the
Chief Executive Officer of Amicus (or his/her designee) and the GSK Head of Rare
Diseases Business Unit (or his/her designee) (the “Senior Executives”).  The
Parties’ respective Senior Executives shall meet promptly, but in any event
within thirty (30) days following the referral of such matter to the Senior
Executives, and shall negotiate in good faith to resolve such matter.  If the
Senior Executives are unable to resolve such dispute within ten (10) days
following the initial meeting of such Senior Executives, then, except as
expressly set forth in Section 4.1.5(a), (i), (ii) or (iii) below, the dispute
shall be resolved by the GSK Chairman for Research and Development, and such
decision by the GSK Chairman of Research and Development shall become the final
decision of the JSC with respect to the dispute specified in the applicable
Escalation Notice.

 

(i)                                     With respect to any such dispute related
to the initiation, design, content or conduct of any Amicus Territory Required
Activities, if the Senior Executives are unable to resolve such dispute, such
dispute will not be resolved by the GSK Chairman for Research and Development,
but rather shall be resolved by the Chief Executive Officer of Amicus and such
decision by the Chief Executive Officer of Amicus shall become the final
decision of the JSC with respect to the dispute; and

 

(ii)                                  With respect to any such dispute related
to the initiation, design, content or conduct of any GSK Territory Required
Activities, if the Senior Executives are unable to resolve such dispute, such
dispute will not be resolved by the GSK Chairman for Research and Development,
but rather such dispute shall be resolved by the GSK Head of Rare Diseases
Business Unit (or his or her designee) and such decision by the GSK Head of Rare
Diseases Business Unit (or his or her designee) shall become the final decision
of the JSC with respect to the dispute; and

 

(iii)                               With respect to any such dispute related to
amendments to be made to the Co-Formulation Development Plan in accordance with
Section 5.1.1(c) below that could result in the amount of Development Costs that
Amicus is required to fund pursuant to

 

******                              - Material has been omitted and filed
separately with the Commission.

 

37

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

 

Section 5.1.4(a)(iv) below to exceed the Total Co-Formulation Development Cost
Cap, such dispute shall not be resolved by the GSK Chairman of Research and
Development and shall be resolved in accordance with Section 5.1.4(b)(ii) below.

 

(b)                                 Disputes Related to Manufacturing.  With
respect to any dispute related to the Manufacturing of a Product, each Party
shall have final decision-making authority to the extent the matter pertains to
the Manufacturing of a Product for such Party’s territory (i.e., GSK shall have
final decision making authority to the extent the matter pertains to
Manufacturing of Products for, by, or on behalf of GSK for use or sale in the
GSK Territory and Amicus shall have final decision making authority to the
extent the matter pertains to Manufacturing of Products for, by, or on behalf of
Amicus for use or sale in the Amicus Territory), without the need to further
escalate such dispute.

 

(c)                                  Disputes Related to Commercialization of
Product.  With respect to any dispute related to the Commercialization of a
Product, each Party shall have final decision making authority to the extent the
matter pertains to the Commercialization of a Product in such Party’s respective
Territory (i.e., GSK shall have final decision making authority to the extent
the matter pertains to Commercialization of Products in the GSK Territory and
Amicus shall have final decision making authority to the extent the matter
pertains to Commercialization of Products in the Amicus Territory), without the
need to further escalate such dispute; provided that each Party shall exercise
its final-decision making authority with respect to matters pertaining to
Commercialization in its respective Territory in a manner that is consistent
with the Global Commercialization Plan.  In addition, with respect to any
dispute relating to the Global Commercialization Plan, including any changes
thereto, neither Party shall have final decision making authority if the Parties
are unable to mutually agree in accordance with Section 6.1.

 

4.2                               Subcommittees.  From time to time, the Joint
Steering Committee may establish subcommittees to oversee particular projects or
activities within the scope of authority of the Joint Steering Committee, as it
deems necessary or advisable (each, a “Subcommittee”).  Unless otherwise set
forth in the Agreement, each Subcommittee shall consist of such number of
representatives of each Party as the Joint Steering Committee determines is
appropriate from time to time.  Each Subcommittee shall meet with such frequency
as the Joint Steering Committee shall determine.  Each Subcommittee shall
operate by unanimous vote in all decisions, with each Party having one (1) vote
and with at least one (1) representative from each Party participating in such
vote.  If, with respect to a matter that is subject to a Subcommittee’s
decision-making authority, the Subcommittee cannot reach unanimity, except with
respect to the Joint Patent Subcommittee, the matter shall be immediately
referred to the Joint Steering Committee, which shall resolve such matter in
accordance with Section 4.1.5.

 

4.2.1                          Joint Patent Subcommittee.  Amicus and GSK shall
continue to use the joint Patent Subcommittee (“Joint Patent Subcommittee”) that
was formed under the Original Agreement to oversee the Patent issues pertaining
to the Compound and Products.  The Joint Patent

 

******                              - Material has been omitted and filed
separately with the Commission.

 

38

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

 

Subcommittee will be composed of one (1) representative (or such other number of
representatives as the Parties may agree) from each of the Parties.  The Joint
Patent Subcommittee will serve as the forum to review and discuss and decide, in
the first instance, all matters relating to Patents and Know-How included in
Amicus Intellectual Property, Program Improvements and Program Patents, and
Co-Formulation Product IP.  The Joint Patent Subcommittee shall select Patent
counsel to file and prosecute Patent applications included in Amicus
Intellectual Property, or constituting Program Patents, and constituting
Co-Formulation Product IP and will promptly report all discussions and decisions
to the Joint Steering Committee.  The Joint Patent Subcommittee shall operate by
unanimous vote in all decisions, with each Party having one (1) vote and with at
least one (1) representative from each Party participating in such vote.  If the
Joint Patent Subcommittee is unable to agree on any matter considered by the
Joint Patent Subcommittee within ten (10) days after first considering such
matter, it shall seek the opinion of mutually acceptable outside counsel (such
opinion to be provided within ten (10) days of instruction) and, if the Joint
Patent Subcommittee is still unable to agree following receipt of such outside
counsel’s opinion, such matter shall be referred to the Senior Executives for
resolution.  If, after referral to the Senior Executives, notwithstanding
anything to the contrary in Section 4.1.5, the matter has not been resolved, the
Senior Executive of GSK shall make the final decision within ten (10) days of
being referred such matter (which decision shall become the decision of the
Joint Patent Subcommittee and the JSC, and the Senior Executive of Amicus, not
GSK, shall make the final decision with respect to any dispute pertaining to a
Patent for which Amicus has responsibility for the prosecution and maintenance
of such Patent pursuant to Section 7.2, 7.3, or 7.6 below (which decision shall
become the decision of the Joint Patent Subcommittee and the JSC).  At the
discretion and upon unanimous consent of the Joint Patent Subcommittee, any of
the ten (10) day time limits in this Section 4.2.1 may be shortened.

 

4.2.2                          Joint Commercialization Subcommittee.

 

(a)                                 Formation.  Promptly after the Restatement
Effective Date, the Parties will form a joint commercialization Subcommittee
(“Joint Commercialization Subcommittee”) to oversee, coordinate and review the
conduct of the Commercialization and marketing activities for Products in the
GSK Territory and Amicus Territory in accordance with the Global
Commercialization Plan.  The Joint Commercialization Subcommittee will be
composed of at least two (2) representative(s) (or such other number of
representatives as the Parties may agree) from each of the Parties.  The Joint
Commercialization Subcommittee shall provide regular updates to the JSC as
provided in Section 4.2.2(c) to ensure that the JSC is informed of all
activities conducted by, and decisions made by, the Joint Commercialization
Subcommittee.

 

(b)                                 Duties.  The Joint Commercialization
Subcommittee will:

 

(i)                                     Develop the Global Commercialization
Plan for the Parties’ mutual agreement in accordance with Section 6.1 and the
Global Commercialization Plan guidelines attached hereto as Schedule 6.1;

 

******                              - Material has been omitted and filed
separately with the Commission.

 

39

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

 

(ii)                                  Subject to Section 6.1, oversee,
coordinate and implement the Global Commercialization Plan during the Term,
including reviewing any and all changes thereto;

 

(iii)                               Designate and approve GSK Trademark(s) to be
used by each Party in connection with the Products in the Territory;

 

(iv)                              Oversee and coordinate the Commercialization
activities in accordance with the Global Commercialization Plan for Products in
the Field and in the GSK Territory and the Amicus Territory during the Term;

 

(v)                                 Review the Ex-U.S. Commercialization Plan,
Ex-U.S. Commercialization Strategy, U.S. Commercialization Plan and U.S.
Commercialization Strategy, including any amendments and updates thereto and the
implementation of the Ex-U.S. Commercialization Plan and Ex-U.S.
Commercialization Strategy by GSK, its Affiliates and Sublicensees and of the
U.S. Commercialization Plan and U.S. Commercialization Strategy by Amicus, its
Affiliates and Sublicensees, in each case with the goal to ensure that such
Commercialization Plans and Commercialization Strategies are consistent with the
guidelines and principles set forth in the Global Commercialization Plan;

 

(vi)                              Provide a forum for the Parties to exchange
information and coordinate their respective activities as set forth in this
Agreement with respect to matters pertaining to the Commercialization for
Products in the GSK Territory and the Amicus Territory, as applicable; and

 

(vii)                           Perform such other duties as are specifically
assigned to the Joint Commercialization Subcommittee in this Agreement or
delegated to the Joint Commercialization Subcommittee by the JSC.

 

(c)                                                          Decision-Making;
Reports.  It is understood and agreed that the Joint Commercialization
Subcommittee shall function primarily to facilitate coordination of global
Commercialization activities of the Parties with respect to all Product(s)
Commercialized in the Territory hereunder.  The Joint Commercialization
Subcommittee shall provide quarterly summary updates to the JSC with respect to
activities conducted by the Joint Commercialization Subcommittee hereunder. 
Except with respect to decisions made by the Joint Commercialization
Subcommittee with respect to the matters set forth in Section 4.2.2(b)(iii),
which shall be fully and finally determined by the GSK representatives on the
Joint Commercialization Subcommittee without escalation to the JSC and without
being submitted for resolution in accordance with Section 16.2.3, any and all
disputes at the JCS level shall be referred to the JSC as provided in
Section 4.2 above.  Any disputes of the JSC with respect to any such matters
shall be determined in accordance with Section 4.1.5(c).

 

******                              - Material has been omitted and filed
separately with the Commission.

 

40

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

 

4.2.3                          Joint Development Subcommittee.

 

(a)                                 Formation.  Amicus and GSK shall continue to
work through the current medicine development team for global development of the
Product(s) and such medicine development team as modified herein shall be, as of
the Restatement Effective Date, deemed the Joint Development Subcommittee
(“JDS”).  In addition, the Joint Steering Committee may elect, upon
recommendation of the JDS if necessary, to divide the Joint Development
Subcommittee into two (2) or more Joint Development Subcommittees, each with the
responsibility for a specific Product under this Agreement.  The Joint
Development Subcommittee shall be chaired by a GSK representative, who shall be
responsible for, among other similar tasks, (a) calling and managing the conduct
of meetings, (b) preparing and issuing minutes of each such meeting within
thirty (30) days thereafter and (c) preparing and circulating an agenda for the
upcoming meeting, but shall not have any final decision making authority.  The
chairperson of the JDS shall include in the upcoming agenda any items reasonably
requested by any other JDS member.  The total number of representatives on the
JDS shall be (13) representatives.  Each Party will designate six (6) of its
representatives on the JDS, and GSK shall designate a seventh (7th)
representative to serve as Chairperson of the JDS Either Party may invite
additional employees of such Party to attend certain JDS meetings as appropriate
on an ad hoc basis as non-voting observers, subject to the confidentiality
provisions of Article XI.  In addition, with respect to Joint Development
Subcommittee meetings regarding the Development of the Co-Formulation Product
and/or activities pursuant to the Co-Formulation Development Plan, GSK may elect
for designated individuals from JCR to attend and participate in such Joint
Development Subcommittee meetings, solely in the capacity of designated GSK
agents.  The Joint Development Subcommittee shall have global oversight and
shall review and approve the global activities and Development Plans for
Development of all Product(s) in the Territory, subject to the terms and
conditions set forth in this Article IV and in Article V.  The Joint Development
Subcommittee shall provide regular updates to the JSC as provided in
Section 4.2.3(c) to ensure that the JSC is informed of all activities conducted
by, and decisions made by, the Joint Development Subcommittee.

 

(b)                                 Duties.  The Joint Development Subcommittee
will:

 

(i)                                     Subject to Section 5.1.1(a) and (b),
develop and discuss the Development Plans for all activities to be conducted in
the Territory with respect to each Product;

 

(ii)                                  Subject to Section 5.1.1(c), review and
approve any and all changes to the Development Plans in the GSK Territory and in
the Amicus Territory;

 

(iii)                               Coordinate and oversee any and all
Development activities for Products in the GSK Territory and in the Amicus
Territory;

 

(iv)                              Oversee the budget for the conduct of
activities under each Development Plan;

 

******                              - Material has been omitted and filed
separately with the Commission.

 

41

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

 

(v)                                 Subject to Section 5.1.5, coordinate and
oversee all Post-Marketing Commitment activities and coordinate all Amicus
Territory Required Activities and GSK Territory Required Activities;

 

(vi)                              Subject to Section 5.3, determine, coordinate
and oversee strategy for establishing and expanding labeling of the Products in
the Amicus Territory or GSK Territory, as applicable,

 

(vii)                           Subject to Section 11.2, oversee strategy for
publications and presentations of clinical trial results and other scientific
information;

 

(viii)                        Subject to Section 6.5.4, determine and coordinate
amounts of clinical supply of Compound and Product(s) required by each Party for
the conduct of activities pursuant to the Development Plan(s); and

 

(ix)                              Perform such other duties as are specifically
assigned to the Joint Development Subcommittee in this Agreement or delegated to
the Joint Development Subcommittee by the JSC.

 

(c)                                  Decision-making; Reports.  Decisions of the
Joint Development Subcommittee shall be made by unanimous vote, with each of
Amicus and GSK having one (1) vote and with at least one (1) representative from
each Party participating in any vote.  The Joint Development Subcommittee shall
provide quarterly summary updates to the JSC with respect to activities
conducted by the Joint Development Subcommittee hereunder.  It is understood and
agreed that all disputes at the JDS level shall be referred to the JSC as
provided in Section 4.2 above.  Any disputes of the JSC with respect to any such
matters shall be determined in accordance with Section 4.1.5(a).

 

4.3                               Alliance Managers.  Each Party has appointed a
representative (“Alliance Manager”) to facilitate communications between the
Parties and to act as a liaison between the Parties with respect to such matters
as the Parties may mutually agree in order to maximize the efficiency of the
collaboration.  Unless replaced by a Party in accordance with this Section 4.3,
each Party’s Alliance Manager as of the Restatement Effective Date shall
continue as such Party’s Alliance Manager for the collaboration.  Each Alliance
Manager shall be permitted to attend meetings of the JSC, JDS, and JCS as a
nonvoting observer, subject to the confidentiality provisions of Article XI. 
Each Party may replace its Alliance Manager with an alternative representative
at any time with prior written notice to the other Party.

 

4.4                               General Communications.  Each Party shall keep
the other Party informed, by way of updates to the Joint Steering Committee at
its meetings and as otherwise specified in this Agreement, or as reasonably
requested by the other Party, as to its progress and activities relating to the
Development of the Products in the Territory (including with respect to
regulatory matters and meetings with Regulatory Authorities in such Party’s
territory), and the Commercialization of the

 

******                              - Material has been omitted and filed
separately with the Commission.

 

42

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

 

Products in such Party’s respective territory (i.e., in the case of GSK, the GSK
Territory and in the case of Amicus, the Amicus Territory).  In connection
therewith, Amicus and GSK shall provide each other through the Joint Steering
Committee, the Joint Development Subcommittee, and the Joint Commercialization
Committee with such information regarding such progress and activities under the
Development Plan and/or the U.S. Commercialization Plan or Ex-U.S.
Commercialization Plan, or otherwise relating to Products, as the other Party
may request from time to time.

 

4.5                               Scope of Governance.  Notwithstanding the
creation of the Joint Steering Committee, or any Subcommittee (including the
Joint Patent Subcommittee, Joint Development Subcommittee and Joint
Commercialization Subcommittee), each Party shall retain the rights, powers and
discretion granted to it hereunder, and neither the Joint Steering Committee nor
any Subcommittee shall be delegated or vested with rights, powers or discretion,
unless such delegation or vesting is expressly provided herein, or the Parties
expressly so agree in writing.  Neither the Joint Steering Committee, nor any
Subcommittee, will have the power to amend or modify, or waive compliance with,
this Agreement, and no decision of the Joint Steering Committee, or any Party
exercising a deciding vote as provided in Section 4.1.5, Section 4.2.1 or
Section 4.2.2(b), as applicable, shall be in contravention of any terms and
conditions of this Agreement or shall result in any obligations (including any
obligation to incur or assume any financial or other commitment, including
without limitation allocation of additional FTEs to the Program) being imposed
on Amicus or its Affiliates, or GSK or its Affiliates, except as otherwise
expressly set forth herein, without the express prior written consent of Amicus
or GSK, as applicable.  It is understood and agreed that issues to be formally
decided by the Joint Steering Committee or a particular Subcommittee are only
those specific issues that are expressly provided in this Agreement to be
decided by the Joint Steering Committee or such Subcommittee.

 

V.                                    PRODUCT DEVELOPMENT AND REGULATORY
ACTIVITIES

 

5.1                               Product Development.  Subject to
Section 4.1.3(a) through (d) and (g) and Section 4.1.5, the Joint Steering
Committee will oversee Development of the Products in the Territory in
accordance with the then-current Development Plans (including the associated
budgets).  Oversight and, subject to Section 4.1.5(a), decision-making authority
with respect to all Development activities for the Product(s) in the Territory,
shall be the responsibility of the Joint Development Subcommittee.  In addition,
the Joint Development Subcommittee, subject to Section 5.5.2, shall oversee and
conduct all global patient advocacy activities and, subject to Section 5.5.1,
shall coordinate medical affairs activities.

 

5.1.1                          Development Plans.

 

(a)                                 Existing Development Plan.  It is understood
that during the period of time from the Effective Date and through the
Restatement Effective Date, the Parties have conducted Development activities
pursuant to a development plan and corresponding budget under the Original
Agreement for a Monotherapy Product and a Co-Administration Product in the Field
in the Territory

 

******                              - Material has been omitted and filed
separately with the Commission.

 

43

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

 

(the “Existing Development Plan”).  The Existing Development Plan in effect as
of the Restatement Effective Date is attached to this Agreement as
Schedule 5.1.  As of the Restatement Effective Date, the Existing Development
Plan shall continue in effect with respect to the Parties’ global Development of
any Products (other than Co-Formulation Products) in the Territory and shall
continue to govern the Development activities with respect to the existing
Monotherapy Product and Co-Administration Product under this Agreement for all
purposes.  The Existing Development Plan may be amended from time to time by the
Joint Development Subcommittee and the JSC in accordance with Section 5.1.1(c)
below.  Without limiting this Section 5.1.1(a) and except as set forth in
Section 5.1.5, it is understood that the Existing Development Plan will at all
times provide for Amicus and for GSK to have an active role in the Development
activities for the Development of all Products (other than Co-Formulation
Products) in the Field.

 

(b)                                 Co-Formulation Development Plan.  A
preliminary Co-Formulation Development Plan and associated preliminary budget
for the Development of Co-Formulation Products for intravenous and subcutaneous
deliveries in the Field in the Territory is attached to this Agreement as
Schedule 5.1B and sets out separately the Development activities for a
Co-Formulation Product to be conducted by each Party following the Restatement
Effective Date and a budget for such activities (the “Co-Formulation Development
Plan”).  The Co-Formulation Development Plan shall be deemed to be a Development
Plan under this Agreement for all purposes, and may be amended by the Joint
Development Subcommittee and the JSC in accordance with Section 5.1.1(c) below. 
In addition, unless expressly agreed in writing by the Joint Development
Subcommittee, the Co-Formulation Development Plan shall include the use of JR051
as the Co-Formulation Product ERT Enzyme. Without limiting this
Section 5.1.1(b), it is understood that the Co-Formulation Development Plan will
at all times provide for Amicus and for GSK to have an active role in the
Development activities for the Development of Co-Formulation Products in the
Field.

 

(c)                                  Amendments.  Subject to Section 4.1.3(a)
through (d) and (g), Section 4.2.3(b)(ii), and Section 5.1.4, the Joint Steering
Committee shall review each of the Existing Development Plan(s) and the
Co-Formulation Development Plan on an ongoing basis and no less frequently than
once each calendar year and shall amend each of the then-current Existing
Development Plan(s) and the then-current Co-Formulation Development Plan(s),
based upon amendments made by the Joint Development Subcommittee pursuant to
Section 4.2.3(b) during such calendar year and proposals made to the JSC by the
Joint Development Subcommittee pursuant to Section 4.2.3(b), as necessary to
include a reasonably detailed written plan of the Joint Development
Subcommittee’s then-current estimate of the Development activities with respect
to the applicable Product(s) (and associated budget) ****** of the period
covered by such plan and an outline of Development activities with respect to
the applicable Product(s) (and the associated budget for such Development
activities) ******.  Subject to Sections 4.1.5(a) and 5.1.4, the JSC shall agree
upon any amendments to be made to each Development Plan, including any changes
to the budget or timelines for each such Development Plan, ******, provided that
the JSC shall, to the extent possible, ******.  Notwithstanding the foregoing,
the JSC shall agree upon any extensions to the

 

******                              - Material has been omitted and filed
separately with the Commission.

 

44

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

 

timelines in each Development Plan that result directly from (i) material
changes to any activities pertaining to the goals specified in such Development
Plan that are required or reasonably requested by the FDA or other Regulatory
Authority in a Major Market, such that if not performed, is likely, in the
reasonable judgment of the JSC, to jeopardize the receipt of Marketing Approval
of a Product in any such Major Market or (ii) other factors beyond a Party’s
reasonable control.  The preliminary agreed-upon annual allocation of Amicus and
GSK FTEs with respect to the conduct of the Development activities in the Field
and in the Territory for Monotherapy Products and Co-Administration Products is
set forth in Schedule 5.1.1(c), attached hereto and incorporated herein by
reference.  The preliminary agreed-upon annual allocation of Amicus and GSK FTEs
with respect to the conduct of the Development activities for Co-Formulation
Product(s) in the Field and in the Territory shall be set forth in the
applicable Co-Formulation Development Plan(s).  Unless otherwise mutually agreed
by the Parties in writing, in the event that the JDS and/or JSC modify an
Existing Development Plan or a Co-Formulation Development Plan, as applicable,
such that the total allocated Amicus FTEs for a given calendar year are reduced
by ****** or more under such Existing Development Plan or Co-Formulation
Development Plan, as applicable, the JDS and/or JSC, as applicable, shall
provide Amicus with a ****** advanced written notice of such reduction in the
allocation of Amicus FTEs prior to the implementation of such reduction.  The
Parties agree that the priority for Development activities under the
then-current Existing Development Plan(s) shall be the Development activities
for the Monotherapy Products in the Field and in the Territory.  Notwithstanding
the foregoing, at all times during the conduct of activities under the
applicable Development Plan, each Party shall commit at least the minimum FTE
resources allocated to such Party for the conduct of the applicable activities
pursuant to such Development Plan.  If the Joint Development Subcommittee and/or
the JSC, as applicable, is unable to agree upon any changes to be made to a
Development Plan, including the budget included therein (subject to
Section 5.1.4 below), then, until such time as a revised Development Plan is
approved by the JSC, or established pursuant to Section 4.1.5(a) above: (1) the
then-current Development Plan shall continue to govern the Parties’ respective
Development activities with respect to the applicable Products under this
Agreement; and (2) each Party shall be permitted to conduct and/or commence
Development activities allocated to such Party in such preceding Development
Plan and incur Development Costs consistent with such preceding Development
Plan, which Development Costs shall be shared by the Parties in accordance with
Sections 5.1.4 and 5.1.5 below and Schedule 5.1.4.

 

5.1.2                          Conduct of Development Activities.  Each Party
shall conduct those activities allocated to such Party under the Development
Plans in compliance in all material respects in accordance with good scientific
and clinical practices, and Laws applicable in the country in which such
activities are conducted.

 

5.1.3                          Diligence.  Each Party shall use Commercially
Reasonable Efforts to carry out all clinical Development and other activities
allocated to such Party in the Development Plans attached to this Agreement as
Schedules 5.1A and 5.1B.  Following the Restatement Effective Date and with
oversight by the Joint Development Subcommittee and the Joint Steering
Committee, each of Amicus and GSK shall continue to conduct the activities
allocated to Amicus or GSK, as

 

******                              - Material has been omitted and filed
separately with the Commission.

 

45

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

 

applicable, including the conduct of the existing 011 Phase III Clinical Study,
the 012 Phase III Clinical Study, the 013 Clinical Study, the 014 Clinical
Study, and the 015 Clinical Study; in each case as set forth in the Existing
Development Plan, and as amended.  Except as otherwise mutually agreed in
writing by the Parties, such efforts by each Party shall include, but shall not
be limited to, use of Commercially Reasonable Efforts: (a) to achieve the
specific overall Development goals as set forth in the applicable Development
Plan for each Product; and (b) to achieve such Development goals in accordance
with the timelines specified in the applicable Development Plan.  In addition,
Amicus shall use its Commercially Reasonable Efforts to obtain Regulatory
Approval for at least ****** Monotherapy Product and ****** Co-Formulation
Product in the Field in the Amicus Territory.

 

5.1.4                          Allocation of Funding of Development Plans. 
Subject to the terms and conditions of this Agreement (including Sections 5.1.5
and 5.4 below), Amicus and GSK shall share in the Development Costs to jointly
fund the Development of Monotherapy Products and Co-Administration Products for
the Territory pursuant to the Existing Development Plan, and Co-Formulation
Products for the Territory pursuant to the Co-Formulation Development Plan as
follows and in accordance with the provisions of Schedule 5.1.4, excluding the
Amicus Territory Required Activities and the GSK Territory Required Activities.

 

(a)                                 Existing Development Plan for the
Monotherapy Product and Co-Administration Product.

 

(i)                                     Subject to Section 5.1.4(a)(iv), from
the Restatement Effective Date through and until December 31, 2012, Amicus shall
fund an amount equal to twenty-five percent (25%) of the Development Costs as
set forth in the then-current Existing Development Plan, in each case incurred
in the conduct of Development activities under and in accordance with such
Development Plan; provided that Amicus shall not be obligated to fund more than
an amount equal to the Amicus Existing Annual Cost Cap for calendar year 2012. 
GSK shall fund the remaining Development Costs incurred in the conduct of
activities during such period pursuant to the then-current Existing Development
Plan for the calendar year 2012.

 

(ii)                                  Except as provided in Section 5.1.5 below
and subject to Section 5.1.4(a)(iv), from January 1, 2013 and for each calendar
year (or part thereof) thereafter until the Amicus Aggregate Existing
Development Cost Cap is reached, Amicus shall fund on an annual basis forty
percent (40%) of the Development Costs incurred under and in accordance with the
then-current Existing Development Plan during each calendar year of such period;
provided that Amicus shall not be obligated to fund more than an amount equal to
the Amicus Annual Existing Development Cost Cap for each such calendar year, and
GSK shall fund the remaining Development Costs incurred in the conduct of
Development activities pursuant to the Existing Development Plan for each such
calendar year.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

46

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

 

(iii)                               To the extent that, for any calendar year
commencing with calendar year 2013, Amicus has been required pursuant to
Section 5.1.4(a)(ii) above to fund an amount of Development Costs less than the
applicable Amicus Annual Existing Development Cost Cap for the applicable
calendar year due to the actual amount of Development Costs for such calendar
year being less than the amount of Development Costs budgeted in the
then-current Existing Development Plan for such calendar year, then the
difference between the applicable Amicus Annual Existing Development Cost Cap
for such calendar year and the share of the Development Costs incurred under
such Existing Development Plan for such calendar year actually required to be
paid by Amicus pursuant to Section 5.1.4(a)(ii) above shall be carried forward
into the next calendar year and added to the applicable Amicus Annual Existing
Development Cost Cap for that subsequent calendar year and each subsequent year
thereafter until such “carry-forward” amounts are exhausted.

 

(iv)                              If the total Development Costs incurred under
and in accordance with the Existing Development Plan exceed the Total Program
Development Costs in the Existing Development Plan by ******, Amicus shall be
responsible for ****** of such additional Development Costs that are between
****** and ****** of the Total Program Development Costs in the Existing
Development Plan (such additional Development Costs, the “Overage”), and GSK
shall be responsible for all other Development Costs that exceed the Total
Program Development Costs in the Existing Development Plan.  Amicus shall pay
its ****** share of the Overage on a quarterly basis in accordance with the
provisions of Schedule 5.1.4 until such amount is paid in full.  For purposes of
illustration only: if the total Development Costs incurred under and in
accordance with the Existing Development Plan equals ****** and the Total
Program Development Costs in the Existing Development Plan equals ******, then
Amicus would be responsible for ****** of ******, which would equal ******.

 

(b)                                 Co-Formulation Development Plan.

 

(i)                                     Subject to Section 5.1.4(b)(ii) and
Section 5.1.5, from the Restatement Effective Date through and until
December 31, 2012, and for each calendar year (or part thereof) thereafter,
Amicus shall fund forty percent (40%) of the actual Development Costs incurred
in the conduct of Development activities under and in accordance with the
then-current Co-Formulation Development Plan for each such calendar year, and
GSK shall fund the remaining sixty percent (60%) of the actual Development Costs
incurred in the conduct of Development activities pursuant to the Co-Formulation
Development Plan for each such calendar year.

 

(ii)                                  If any amendments to be made to the
Co-Formulation Development Plan by the Joint Development Subcommittee pursuant
to Section 4.2.3(b)(ii), or by the JSC in accordance with Section 4.1.3 and
Section 5.1.1(c) above, based upon proposals made to the JSC by the Joint
Development Subcommittee pursuant to Section 4.2.3(b), would result in the
amount of Development Costs incurred under and in accordance with the amended
Co-Formulation Development Plan to meet or exceed the Total Co-Formulation
Development Cost Cap, then the

 

******                              - Material has been omitted and filed
separately with the Commission.

 

47

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

 

Joint Development Subcommittee shall ******.  Until such time as an amended
Co-Formulation Development Plan is established pursuant to this
Section 5.1.4(b)(ii): (1) the then-current Co-Formulation Development Plan shall
continue to govern the Parties’ respective Development activities with respect
to the Co-Formulation Product under this Agreement; and (2) each Party shall be
permitted to conduct and/or commence Development activities allocated to such
Party in such preceding Co-Formulation Development Plan and incur Development
Costs consistent with such preceding Co-Formulation Development Plan, which
Development Costs shall be shared by the Parties in accordance with this
Section 5.1.4 above and Section 5.1.5 below and Schedule 5.1.4.

 

5.1.5                          Determination of Amicus Territory Required
Activities and GSK Territory Required Activities; Opt-In Notice.

 

(a)                                 ******.

 

(b)                                 ******.

 

(c)                                  Amicus or GSK, as applicable, shall provide
regular summary updates and reports of all then-existing data and information
generated by such Party in the conduct of such Amicus Territory Required
Activities or GSK Territory Required Activities, as applicable (such summary
reports and updates to be provided with at least the frequency with which such
reports are provided by each Party to the Joint Development Subcommittee), and
shall make all data, results, information and analysis with respect to such
activities available to the other Party in accordance with the terms of
Section 5.2.3.  If, at any time after the initiation of such activities, ******.

 

(i)             Within ****** from the receipt of an invoice:

 

a)                                     ******

 

b)                                     ******

 

5.1.6                          ******.

 

(a)                                 ******

 

(b)                                 ******

 

5.1.7                          Use of Clinical Trial Data.  Subject to
Section 2.1, Amicus shall make available to GSK, and GSK shall have complete
access to, at no charge to GSK, all clinical trial data and all additional data
resulting from any clinical trials performed by Amicus, its Affiliates,
Sublicensees or licensees with respect to the Products in the Territory,
including without limitation all such clinical trial data and all additional
data resulting from the conduct of any Amicus Territory Required Activities or
TTP New Labeling activities.  Subject to Sections 5.1.4, 5.1.5, and 5.3, GSK
shall be free to use all such data and information, as necessary or as required,
to support the

 

******                              - Material has been omitted and filed
separately with the Commission.

 

48

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

 

Development and Manufacture of the Compound and Products under the applicable
Development Plan and the Commercialization of the Products in the GSK Territory,
including in connection with any safety assessments, safety reports, or annual
reports required to be filed with the relevant Regulatory Authority with respect
to the Products in the GSK Territory, in each case accordance with the terms and
conditions of this Agreement.  Likewise, subject to Section 2.4, GSK shall make
available to Amicus, and Amicus shall have complete access to, at no charge to
Amicus, all clinical trial data and all additional data resulting from any
clinical trials performed by GSK, its Affiliates, or Sublicensees with respect
to the Products in the Territory, including without limitation all such clinical
trial data and all additional data resulting from the conduct of any GSK
Territory Required Activities or TTP New Labeling activities.  Subject to
Sections 5.1.4, 5.1.5, and 5.3, Amicus shall be free to use all such data and
information, as necessary or as required, to support the Development and
Manufacture of the Compound and Products under the applicable Development Plan
and the Commercialization of the Products in the Amicus Territory, including in
connection with any safety assessments, safety reports, or annual reports
required to be filed with the relevant Regulatory Authority with respect to the
Products in the Amicus Territory, in each case in accordance with the terms and
conditions of this Agreement.  For the avoidance of doubt, the foregoing
obligation of GSK shall not include ******.  For the avoidance of doubt, the
Licensed Amicus Technology shall include any and all data resulting from any
clinical trials performed by Amicus, its Affiliates, its Sublicensee and its
licensees in the Territory with respect to the Products (excluding data
resulting from any clinical trials performed with respect to products other than
the Products that relate to the Amicus Proprietary Chaperone Technology), to the
extent that Amicus has the right to grant to GSK access to such data from its
Sublicensees and licensees.  In the event that Amicus does not have the right to
grant to GSK access to such data from such Sublicensees or licensees, then
Amicus shall use all reasonable efforts to obtain the right, at no cost to GSK,
to sublicense to GSK, or otherwise obtain the right for GSK to access and make
any other use of any such clinical trial data within the scope of the License
and otherwise in accordance with the terms and conditions of this Agreement;
provided that in no event shall Amicus be obligated to undertake additional
payment obligations to such Sublicensees or licensees in order to obtain such
rights for GSK, unless GSK agrees to reimburse Amicus for such additional
payment obligations with respect to the grant of rights to GSK for such clinical
trial data.  Similarly, the licenses granted by GSK to Amicus in Section 2.4
herein shall be deemed to include a license to any and all data resulting from
any clinical trials performed by GSK, its Affiliates, its Sublicensees and its
licensees in the Territory with respect to the Products (******), in each case
to the extent that GSK has the right to grant to Amicus access to such data from
such Sublicensees or licensees.  In the event that GSK does not have the right
to grant to Amicus access to such data from such Sublicensees or licensees, then
GSK shall use all reasonable efforts to obtain the right, at no cost to Amicus,
to sublicense to Amicus, or otherwise obtain the right for Amicus to access and
make any other use of any such clinical trial data within the scope of the
licenses granted to Amicus in Section 2.4 and otherwise in accordance with the
terms and conditions of this Agreement; provided that in no event shall GSK be
obligated to undertake additional payment obligations to such Sublicensees or
licensees in order to obtain such rights for Amicus, unless Amicus agrees to
reimburse GSK for such additional payment obligations with respect to the grant
of rights to Amicus for such clinical trial data.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

49

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

 

5.2                               Regulatory Matters.

 

5.2.1                          Assignment of, and Responsibility for, Regulatory
Filings.  Amicus and GSK acknowledge that following the Effective Date, Amicus
transferred and assigned to GSK ownership of all Marketing Approvals and other
agreed upon filings (if applicable) with Regulatory Authorities for the Products
in the Territory existing as of the Effective Date.

 

(a)                                 As of the Restatement Effective Date, GSK
shall own and shall have the sole responsibility, as overseen by the Joint
Steering Committee and Joint Development Subcommittee during the Development of
Products, to hold and maintain all Marketing Approvals and other filings with
Regulatory Authorities for the Products in the GSK Territory during the Term;
provided, however, that Amicus shall continue to hold and maintain the IND
filings for the existing 011 Phase III Clinical Study, the 012 Phase III
Clinical Study, the 013 Clinical Study, and the 205 Clinical Study in the GSK
Territory and will continue, in collaboration with GSK and as requested by the
Joint Development Subcommittee, to submit any necessary clinical study protocol
amendments for such clinical studies, as necessary, in each case until the
completion of the relevant clinical study , after which Amicus shall assign and
transfer such IND filing for such completed clinical study to GSK in accordance
with reasonable a timeline and process to be agreed between the Parties.  GSK
will be solely responsible for submitting to, and obtaining INDs, MAAs and/or
Marketing Approvals (including pricing or reimbursement approvals) from, the
applicable Regulatory Authorities in connection with the Development,
Manufacture, use, and Commercialization of the Products in the GSK Territory as
overseen by the Joint Steering Committee and Joint Development Subcommittee. 
GSK shall also be responsible for filing and maintaining any regulatory filings
required to be submitted to the relevant Regulatory Authority with respect to
the Products in the GSK Territory, including any annual reports with respect to
Products in the GSK Territory, and for obtaining any export approvals required
by a relevant Regulatory Authority to import or export Compound or Products to
any country within the GSK Territory or the Amicus Territory.  All such
activities shall be conducted via the Joint Steering Committee and Joint
Development Subcommittee in accordance with the applicable Development Plan, and
in accordance with the terms of this Article V.

 

(b)                                 Following the Restatement Effective Date:

 

(i)                                     With respect to the Monotherapy Product,
subject to the oversight of the Joint Steering Committee and Joint Development
Subcommittee, GSK shall hold and maintain the IND for the Monotherapy Product
filed with the Regulatory Authorities in the Amicus Territory as of the
Restatement Effective Date and, until the assignment and transfer of the NDA for
the Monotherapy Products in the Amicus Territory to Amicus as set forth in this
Section 5.2.1(b)(i), GSK shall continue to lead the liaison with, and manage,
all interactions with Regulatory Authorities in the Amicus Territory with
respect to the Monotherapy Products in accordance with Section 5.2.2(a).  GSK
shall further prepare and submit to the FDA, subject to the oversight of the
Joint Steering Committee and Joint Development Subcommittee, the first NDA for a

 

******                              - Material has been omitted and filed
separately with the Commission.

 

50

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

 

Monotherapy Product in the Amicus Territory, and upon the earlier of (a) ******,
or (b) ******, GSK shall promptly assign to Amicus ownership of all existing
regulatory filings (including the IND and NDA for the Monotherapy Products, and
the orphan product designation, in the Amicus Territory) for the Monotherapy
Products in the Amicus Territory and transfer to Amicus the NDA, and the orphan
product designation, for the Monotherapy Products in the Amicus Territory, and
GSK shall, within ****** thereafter or such shorter period of time to be
mutually agreed by the Parties, transfer to Amicus the IND, NDA and orphan
product designation for the Monotherapy Products in the Amicus Territory in
accordance with a transition plan to be determined and overseen by the Joint
Development Subcommittee; ******.  Following the assignment and transfer of the
NDA for the Monotherapy Products in the Amicus Territory to Amicus as set forth
in this Section 5.2.1(b)(i), Amicus shall own and shall have the sole
responsibility, as overseen by the Joint Steering Committee and Joint
Development Subcommittee during the Development of the Products, for submitting
and obtaining INDs, MAAs and/or Marketing Approvals (including pricing or
reimbursement approvals) from the applicable Regulatory Authorities in
connection with the Development, Manufacture, use, and Commercialization of the
Monotherapy Products in the Amicus Territory and shall lead the liaison with,
and manage, all interactions with Regulatory Authorities in the Amicus Territory
with respect to the Monotherapy Products as set forth in and subject to
Section 5.2.2(a), including responsibility for responding to any inquires of the
Regulatory Authority with respect to any such regulatory filings, including the
NDA for the Monotherapy Products in the Amicus Territory, and including holding
any requested of required advisory committee meetings with respect thereto, in
each case subject to the reasonable input and participation of GSK as set forth
in Section 5.2.2(a); and Amicus shall own and shall have the sole
responsibility, as overseen by the Joint Steering Committee and Joint
Development Subcommittee during the Development of the Monotherapy Products, to
hold and maintain all Marketing Approvals and other filings and submissions with
Regulatory Authorities for the Monotherapy Products in the Amicus Territory.

 

(ii)                                  Except as set forth in Section 5.2.1(b)(i)
with respect to the Monotherapy Product, following the Restatement Effective
Date and subject to Section 5.2.2 and the terms of this Agreement, Amicus shall
be solely responsible for submitting to and obtaining from the applicable
Regulatory Authorities in the Amicus Territory any new INDs, MAAs and/or
Marketing Approvals in connection with activities for the Development,
Manufacture (as permitted under this Agreement and the Supply Agreement), use,
and Commercialization of the Products in the Amicus Territory, as overseen by
the Joint Steering Committee and Joint Development Subcommittee and consistent
with the then-current Development Plan for such Product.  Amicus shall also be
responsible for filing and any maintaining any regulatory filings required to be
submitted to the relevant Regulatory Authority with respect to the Products in
the Amicus Territory, including any annual reports with respect to Products in
the Amicus Territory, and for obtaining any export approvals required by a
relevant Regulatory Authority for Amicus to import or export Products into or
out of the Amicus Territory.  All such activities shall be conducted via the
Joint Steering Committee and Joint Development Subcommittee in accordance with
the applicable Development Plan, and in accordance with the terms of this
Article V.

 

******                              - Material has been omitted and filed
separately with the Commission.

 

51

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

 

5.2.2         Regulatory Cooperation.

 

(a)           From and after the Restatement Effective Date, GSK shall lead the
liaison with, and manage, all interactions with Regulatory Authorities in the
GSK Territory in relation to Products during the Term of the Agreement, in each
case subject to the reasonable input and participation of Amicus as set forth in
this Section 5.2.2(a) below.  From and after the Effective Date and until the
assignment of the NDA for the Monotherapy Products in the Amicus Territory to
Amicus as set forth in Section 5.2.1(b)(i), GSK shall lead the liaison with, and
manage, all interactions with Regulatory Authorities in the Amicus Territory in
relation to the Monotherapy Product.  Subject to Section 4.1.5 and 5.2.1(b)(i),
******.  In any event, the following provisions shall apply to each Party with
respect to its respective territory (i.e., in the case of Amicus, the Amicus
Territory and in the case of GSK, the GSK Territory) and shall also apply to GSK
with respect to the Monotherapy Product in the entire Territory until the
assignment and transfer of the NDA for the Monotherapy Product in the Amicus
Territory to Amicus as set forth in Section 5.2.1(b)(i), after which such
provisions shall only apply to GSK, with respect to the Monotherapy Product, in
the GSK Territory:  Each Party shall keep the other Party, via the Joint
Development Subcommittee and the Joint Steering Committee informed with respect
to all interactions with Regulatory Authorities in the United States or Expanded
Major Markets in such Party’s respective Territory, including without limitation
providing a copy of all material correspondence and proposed responses to any
material communications from such Regulatory Authorities to the other Party, and
will reasonably consider in good faith the comments of such other Party with
respect to such activities.  Each Party will also provide reasonable cooperation
and assistance to the other Party, as reasonably requested by the other Party,
in the event that such other Party must respond to questions from Regulatory
Authorities in such other Party’s Territory concerning Development or
Manufacturing activities conducted by or on behalf of a Party with respect to
the Products.  Each Party (the “Non-Hosting Party”) shall have the right to have
up to ****** representatives in attendance at all meetings of the other Party
(the “Host Party”) with Regulatory Agencies in the United States or Expanded
Major Markets in the other Party’s respective Territory (i.e., with respect to
Amicus, the United States, and with respect to GSK, each Major EU Country,
****** and ******), and up to ****** representatives in attendance at all
advisory board or advisory committee meetings and discussions held by the Host
Party regarding the Products; provided that if a Regulatory Authority limits the
number of representatives in attendance at such meeting, then the Host Party
shall have the right to have up to ****** representatives in attendance before
the Non-Hosting Party shall have the right to have up to ****** representatives
in attendance, unless the limit is ****** representatives or less in total, in
which case, the Non-Hosting Party shall have the right to have one (1)
representative in attendance at such meeting.  For clarity, prior to the
assignment of the NDA for the Monotherapy Products in the Amicus Territory to
Amicus as set forth in Section 5.2.1(b)(i): (i) GSK shall also continue to lead
the liaison with, and manage, all interactions with Regulatory Authorities in
the United States with respect to such filings; and (ii) GSK shall (A) keep
Amicus and the Joint Development Subcommittee informed with respect to all
interactions with Regulatory Authorities in the United States with respect to
the preparation and filing of the first NDA for a Monotherapy Product in the
United States, and (B) use reasonable

 

******       - Material has been omitted and filed separately with the
Commission.

 

52

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

 

efforts in good faith to incorporate any comments of Amicus with respect to the
preparation and filing such NDA in the United States.

 

(b)           Each Party will promptly provide the other Party and to the Joint
Development Subcommittee with copies of, or electronic access to, all documents
and correspondence received from, or submitted to, a Regulatory Authority in the
Amicus Territory and in each Expanded Major Market in the GSK Territory, as
applicable, related to a Product, including any notices of, or requests for, any
substantive meetings with a Regulatory Authority in the Amicus Territory and in
a Expanded Major Market country in the GSK Territory, as applicable, relating to
a Product.

 

5.2.3         Exchange of Data and Know-How; Reports.

 

(a)           During the Term, each Party shall provide to the other Party
promptly upon the request of such Party (but not more frequently than ******)
and at no cost or expense to such other Party (other than as provided under
Sections 5.1.4, 5.1.5 and 5.3), all of such Party’s Know-How within the Program
Improvements and Co-Formulation Product IP arising during the conduct of
activities pursuant to a Development Plan (or the Co-Formulation MTA) that is
necessary or materially useful for the other Party to Develop and Manufacture
Compound and Products, and Commercialize the Products in each Party’s respective
Territory, to the extent that such Know-How has not previously been provided to
such other Party.  Each Party shall provide all such Know-How in electronic form
to the extent the same exists in electronic form, and shall provide copies as
reasonably requested and an opportunity for the requesting Party or its designee
to inspect (and copy) all other materials comprising such Know-How (including
for example, original patient report forms and other original source data).  The
Parties will cooperate and reasonably agree upon formats and procedures to
facilitate the orderly and efficient exchange of such Know-How during the Term.

 

(b)           Reports.  Each Party shall provide quarterly reports to the JSC
and reports (at least quarterly or more frequently as requested) to the Joint
Development Subcommittee in reasonable detail of all data and information
generated or obtained in the course of such Party’s performance of activities
with respect to the Product(s) under the applicable Development Plans in each
Party’s respective Territory.  Without limiting the foregoing, GSK shall provide
in its reports under this Section 5.2.3(b) summary updates of any material
Development activities and material regulatory filings and regulatory
communications associated with any submissions of MAAs or other approvals for
Products outside the Expanded Major Markets in the GSK Territory.

 

5.2.4         Sharing of Regulatory Filings.  Without limiting Section 5.1.6 or
Section 5.2.3 above, each Party shall permit the other Party access to and a
right to reference and use in association with exercising its rights and
performing its obligations under this Agreement, all of such Party’s, and its
Affiliates’ and, to the extent it has the right to do so, its licensees’ and
Sublicensees’ data, regulatory filings and regulatory communications associated
with any submissions of MAAs or other approvals for Products (a) in the case of
either Party, in each Major

 

******       - Material has been omitted and filed separately with the
Commission.

 

53

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

 

Market or Expanded Major Market, as applicable, in such Party’s respective
territory or (b) in the case of GSK, upon Amicus’ request, in a country outside
the Expanded Major Market in the GSK Territory.

 

5.2.5         Clinical Trial Register.  Notwithstanding anything in this
Agreement to the contrary, GSK shall have the right to publish in its clinical
trial register the results or summaries of the results of all clinical trials
for the Products conducted by either Party, their Affiliates, licensees and
Sublicensees (subject to Sections 5.2.4 and 11.5) in the Territory pursuant to
this Agreement.  Likewise, Amicus shall have the right to publish in its
clinical trial register the results or summaries of the results of all clinical
trials for the Products conducted by either Party, their Affiliates, licensees
and Sublicensees (subject to Sections 5.2.4 and 11.5) in the Territory pursuant
to this Agreement to the extent that such results or summaries of the results of
such clinical trial has been published by GSK in the GSK clinical trial register
and the results or summaries of the results of such clinical trial published by
Amicus in its clinical trial registry is identical to that published by GSK.  In
the event that GSK has no published results or summaries of the results of a
clinical trial for a Product(s) on its clinical trial registry and Amicus
desires to publish in its clinical trial register the results or summaries of
the such clinical trial for a Product, Amicus shall notify GSK in writing and
Amicus and GSK will coordinate and agree upon a single version of such clinical
trial results or summaries to be included on the clinical trial register of both
Parties.

 

5.2.6         Adverse Event Reporting.

 

(a)           Initial Safety Data Exchange Agreement.  The Parties acknowledge
that certain Safety Data Exchange Agreement, effective as of September 15, 2011
by and between the Parties, which was entered into pursuant to the terms of
Section 5.2.6(a) of the Original Agreement.

 

(b)           Adverse Event Reporting.  From and after the Restatement Effective
Date, as between the Parties:  (i)  GSK shall be responsible for the timely
reporting of all Product quality complaints, adverse drug
reactions/experiences/events, Product complaints and safety data relating to the
Compound and Products to appropriate Regulatory Authorities in the GSK Territory
in accordance with the applicable Laws of the relevant countries and Regulatory
Authorities in the GSK Territory; and (ii) Amicus shall be responsible for the
timely reporting of all Product quality complaints, adverse drug
reactions/experiences/events, Product complaints and safety data relating to the
Compound and Products to appropriate Regulatory Authorities in the Amicus
Territory in accordance with the applicable Laws and Regulatory Authorities in
the Amicus Territory.

 

(c)           Safety Data Exchange Agreement.  Within a reasonable period of
time after the Restatement Effective Date, the Parties shall enter into a new
Safety Data Exchange Agreement, that will supersede the Safety Data Exchange
Agreement described in Section 5.2.6(a) above, on terms no less stringent than
those required by ICH guidelines, including:  (i) providing detailed procedures
regarding the maintenance of core safety information and the exchange of safety

 

******       - Material has been omitted and filed separately with the
Commission.

 

54

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

 

data relating to the Compound and Products in the GSK Territory and/or the
Amicus Territory within appropriate timeframes and in an appropriate format to
enable each Party to meet both expedited and periodic regulatory reporting
requirements; and (ii) ensuring compliance with the reporting requirements of
all applicable Regulatory Authorities on a worldwide basis for the reporting of
safety data in accordance with standards stipulated in the ICH guidelines, and
all applicable regulatory and legal requirements regarding the management of
safety data (the “Safety Data Exchange Agreement”).

 

(d)           Global Safety Database.  As between the Parties:  GSK shall
maintain a unified worldwide global safety database with respect to Products in
the GSK Territory and the Amicus Territory.

 

5.3          New Labeling for Products.

 

5.3.1         In the event that either Party (the “Developing Party”) desires to
conduct clinical trials in order to amend the labeling for a Product in its
respective territory to ******, in order to ****** and the JSC determines not to
include such clinical trials in the relevant Development Plan, the Developing
Party shall have the right, at its own expense, to conduct such clinical trials
pertaining to ****** outside the relevant Development Plan solely for the
Developing Party’s respective territory; ******.  It is further understood that
any Development and Commercialization activities with respect to the ****** by
Amicus pursuant to this Section 5.3 shall not be subject to ******; provided
that ******.

 

5.3.2         For the avoidance of doubt, and except for the activities
involving a Compound that a Party is permitted to conduct pursuant to clauses
(A) and (B) of Section 10.4, neither Party shall have the right to conduct any
activities with respect to Compound or Product(s) in the Territory, or to
initiate activities with respect to a Combination Therapy Product that includes
Compound co-formulated to an ERT enzyme that is not a Co-Formulation Product ERT
Enzyme, except as set forth in this Agreement without the express written
consent of the JSC and inclusion of such additional activities with respect to
Compound or Product(s) in a relevant Development Plan under, and subject to the
terms of, this Agreement.

 

5.4          Termination of Amicus’ Co-Development Right for Product.

 

5.4.1         Amicus may, in its sole discretion, elect to terminate its right,
on a Product-by-Product basis, to co-Develop a Product with GSK pursuant to
Section 5.1 and to share Development Costs incurred in the Development of such
Product pursuant to Sections 5.1.4 and 5.1.5 and Schedule 5.1.4 (such option,
the “Co-Development Opt-Out Right”); provided that Amicus may only elect to
exercise its Co-Development Opt-Out Right with respect to the Co-Formulation
Product(s) under the following circumstances:

 

(a)           ******

 

******       - Material has been omitted and filed separately with the
Commission.

 

55

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

 

(b)           ******

 

(c)           ******

 

5.4.2         Exercise of Co-Development Opt-Out.  Amicus may exercise its
Co-Development Opt-Out Right set forth in Section 5.4.1(a) in accordance with
the procedures set forth in Section 5.1.4(b)(ii).  Amicus may otherwise exercise
its Co-Development Opt-Out Right by providing written notice to GSK of its
desire to terminate its right with respect to a particular Product (any such
notice, as well as any notice delivered by Amicus to GSK pursuant to Section
5.1.4(b)(ii) exercising Amicus’ First Opt-Out Right or Second Opt-Out Right,
each a “Co-Development Opt-Out Notice”) at least ****** prior to the beginning
of the first Quarter in which Amicus wishes such Co-Development Opt-Out to take
effect (“First Opt-Out Quarter”).  Upon delivery of the Co-Development Opt-Out
Notice, Amicus’ Co-Development rights with respect to such Product pursuant to
Section 5.1, and Amicus’ obligations to pay Development Costs incurred in the
Development of such Product pursuant to Sections 5.1.4 and 5.1.5 and Schedule
5.1.4, shall terminate as of the first day of the First Opt-Out Quarter (the
“Co-Development Opt-Out Effective Date”).

 

5.4.3         Effects of Exercise of Opt-Out Right.  In the event that Amicus
exercises its Co-Development Opt-Out Right as set forth in this Section 5.4,
then from the first day of the First Opt-Out Quarter and thereafter during the
Term, the terms of Section 14.2 and 14.4 shall apply, mutatis mutandis, with
respect to the Product(s) for which Amicus exercised its Co-Development Opt-Out
Right, such that each reference to the Terminated Product(s) shall be deemed a
reference to the Product(s) for which Amicus exercised its Co-Development
Opt-Out Right.

 

5.5          Medical Affairs; Patient Advocacy.

 

5.5.1         Medical Affairs.  Medical affairs activities of each Party in
their respective Territory shall be overseen by the Joint Development
Subcommittee; it being understood that GSK shall be solely responsible for and
shall control medical affairs activities with respect to Products in the GSK
Territory and Amicus shall be solely responsible for and shall control medical
affairs activities with respect to Products in the Amicus Territory.  For the
avoidance of doubt, any decisions of a Party with respect to the conduct of
medical affairs activities for a Product in such Party’s Territory shall be
final and shall not be subject to the terms of Sections 4.2.3(c), 4.1.5(a) or
16.2.

 

5.5.2         Patient Advocacy.  The Joint Development Subcommittee shall be
responsible for the oversight and control of the conduct of all global patient
advocacy activities with respect to the Products in the Territory, including
sponsorship of, and presentations and other disclosures made to, patient
advocacy groups by a Party with respect to the Products in the Territory;
provided, however, that (i) GSK shall be responsible for and control the conduct
of all patient advocacy activities with respect to the Products that relate
solely to the GSK Territory (including

 

******       - Material has been omitted and filed separately with the
Commission.

 

56

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

 

activities conducted in the GSK Territory with respect to a patient advocacy
group located solely in the GSK Territory) and (ii) Amicus shall be responsible
for and control the conduct of all patient advocacy activities with respect to
the Products that relate solely to the Amicus Territory (including activities
conducted in the Amicus Territory with respect to a patient advocacy group
located solely in the Amicus Territory).  For the avoidance of doubt, any
decisions of a Party with respect to the conduct of patient advocacy activities
with respect to the Products that relate solely to such Party’s respective
territory (including such Party’s determination that such activities relate
solely to such Party’s respective territory) shall be final and shall not be
subject to the terms of Sections 4.2.3(c), 4.1.5(a) or 16.2.

 

VI.          COMMERCIALIZATION; MANUFACTURING AND SUPPLY

 

6.1          Commercialization Plan.  The Parties will discuss, through the
Joint Commercialization Subcommittee, the Commercialization of the Products as
provided in Section 4.2.2(b) and this Article VI and will agree upon a global
commercialization plan (the “Global Commercialization Plan”), which will form
the guiding principles for Commercialization activities for the Products in the
Amicus Territory and the GSK Territory.  An initial draft of the guiding
principles to be used by the Joint Commercialization Subcommittee in developing
the Global Commercialization Plan is attached hereto as Schedule 6.1.  Promptly
after the Restatement Effective Date, and in any event within ****** prior to
the first projected Launch of a Product in the Territory, the Joint
Commercialization Subcommittee shall develop and the Parties shall mutually
agree upon a Global Commercialization Plan in accordance with the Global
Commercialization Plan guiding principles set forth on Schedule 6.1. 
Thereafter, the Joint Commercialization Subcommittee will review and make any
necessary mutually-agreed upon changes to the then-current Global
Commercialization Plan and will provide quarterly updates to the JSC with
respect thereto in accordance with Section 4.2.2(c).  The development of the
Global Commercialization Plan and any changes thereto must be made by mutual
agreement of the Parties, and neither Party shall have final decision making
authority with respect to the Global Commercialization Plan.  In the event that
the JCS disagrees with respect to any proposed changes to the Global
Commercialization Plan, such dispute shall be submitted for review by the JSC at
the next regularly scheduled JSC meeting.  If the Parties via the JSC are unable
to mutually agree on such disputed proposed changes to the then-current Global
Commercialization Plan, the then-current Global Commercialization Plan shall
remain unmodified and such disagreement shall not be subject to further
escalation or to dispute resolution in accordance with Section 4.1.5 or Section
16.2.  The Parties will coordinate Commercialization activities in their
respective territories, including coordination of marketing and branding
activities, via the Joint Commercialization Subcommittee.  Notwithstanding the
foregoing, pursuant to Section 4.1.5(c), each Party shall have final
decision-making authority with respect to Commercialization of Products in its
respective territory pursuant to this Agreement, provided that each Party shall
exercise its final decision-making authority in its respective territory in a
manner that is consistent with the Global Commercialization Plan.

 

******       - Material has been omitted and filed separately with the
Commission.

 

57

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

 

6.1.1         For the GSK Territory.  Prior to the anticipated Launch of the
first Product in a ******, GSK shall prepare the Ex-U.S. Commercialization Plan,
which shall include without limitation the Ex-U.S. Commercialization Strategy,
and shall provide such Ex-U.S. Commercialization Plan to the Joint
Commercialization Subcommittee.  GSK, not less frequently than ******, will
provide to the Joint Commercialization Subcommittee summary updates to the
Ex-U.S. Commercialization Plan and summary updates of Commercialization
activities undertaken by GSK and its Affiliates and Sublicensees pursuant to the
Ex-U.S. Commercialization Plan ******.  In addition, GSK will update the Joint
Commercialization Subcommittee on a rolling basis during the Joint
Commercialization Subcommittee’s meetings with respect to activities conducted
pursuant to the then-current Ex-U.S. Commercialization Plan ******.  GSK shall
carry out all marketing, promotion and other Commercialization activities of the
Products in the GSK Territory in accordance with the then-current Ex-U.S.
Commercialization Plan.

 

6.1.2         For the Amicus Territory.  Prior to the anticipated Launch of the
first Product in the Amicus Territory, Amicus shall prepare the U.S.
Commercialization Plan, which shall include without limitation the U.S.
Commercialization Strategy, and shall provide such U.S. Commercialization Plan
to the Joint Commercialization Subcommittee.  Amicus, not less frequently than
******, will provide to the Joint Commercialization Subcommittee summary updates
to the U.S. Commercialization Plan and summary updates of Commercialization
activities undertaken by Amicus and its Affiliates and permitted sublicensees
pursuant to the U.S. Commercialization Plan ******.  In addition, Amicus will
update the Joint Commercialization Subcommittee on a rolling basis during the
Joint Commercialization Subcommittee’s meetings with respect to activities
conducted pursuant to the then-current U.S. Commercialization Plan ******. 
Amicus shall carry out all marketing, promotion and other Commercialization
activities of the Products in the Amicus Territory in accordance with the
then-current U.S. Commercialization Plan.

 

6.1.3         GSK’s Responsibilities.  GSK shall have, in GSK’s sole discretion
and at its sole expense, the exclusive right to Manufacture or have
Manufactured, on behalf of GSK, or its Affiliates or Sublicensees, Compounds and
Products for the GSK Territory, and the exclusive right, subject to Section
6.5.4, to Manufacture Co-Formulation Products for supply to Amicus for the
Amicus Territory.  In addition, GSK shall have, in GSK’s sole discretion and at
its sole expense, the exclusive right to distribute, market, provide sales force
support for, and to promote and otherwise take all actions determined by GSK to
be necessary to Commercialize Products in the Field in the GSK Territory,
including, without limitation, the exclusive right and responsibility for the
following in the GSK Territory:

 

(a)           determining pricing for Products in the GSK Territory and
negotiating with relevant governmental authorities and agencies and MCOs to
establish pricing and reimbursement for Products in the GSK Territory;

 

(b)           managed care contracting for Products in the GSK Territory, if
applicable, provided that GSK shall not engage in any Discriminatory Conduct
with respect to

 

******       - Material has been omitted and filed separately with the
Commission.

 

58

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

 

managed care contracting or otherwise relating to the Products.  For the
purposes of this Section 6.1.3(b), “Discriminatory Conduct” shall be deemed to
occur if a Party or its Affiliate discounts the price of or positions a Product
in its managed care contracting or otherwise to benefit or increase the sales of
other products of such Party or its Affiliate;

 

(c)           receiving, accepting and filling orders for Products from
customers in the GSK Territory;

 

(d)           distributing Products to customers in the GSK Territory;

 

(e)           controlling invoicing, order processing and collecting accounts
receivable for sales of Products in the GSK Territory;

 

(f)            recording sales of Products in the GSK Territory in its books of
account for sales;

 

(g)           conducting disease awareness and medical education programs in the
GSK Territory; and

 

(h)           any and all other Commercialization activities, in GSK’s
discretion and consistent with the Global Commercialization Plan, related to the
Products in the GSK Territory.

 

6.1.4         Amicus’s Responsibilities.  Amicus shall have, in Amicus’ sole
discretion and at its sole expense, the exclusive right to Manufacture or have
Manufactured, on behalf of Amicus or its Affiliates or sublicensees, Monotherapy
Products and Co-Administration Products for the Amicus Territory, subject to
GSK’s rights and obligations to Manufacture Products for Development activities
as set forth in Section 6.5.4.  In addition, Amicus shall have, in Amicus’ sole
discretion and at its sole expense, and, using its Commercially Reasonable
Efforts with respect to Co-Formulation Products only, the exclusive right to
distribute, market, provide sales force support for, and to promote and
otherwise take all actions determined by Amicus to be necessary to
Commercialize, Products in the Field in the Amicus Territory, including, without
limitation, the exclusive right and responsibility for the following in the
Amicus Territory:

 

(a)           determining pricing for Products in the Amicus Territory and
negotiating with relevant governmental authorities and agencies and MCOs to
establish pricing and reimbursement for Products in the Amicus Territory;

 

(b)           managed care contracting for Products in the Amicus Territory,
provided that Amicus shall not engage in any Discriminatory Conduct with respect
to managed care (including, Medicare) contracting or otherwise relating to the
Products;

 

(c)           receiving, accepting and filling orders for Products from
customers in the Amicus Territory;

 

******       - Material has been omitted and filed separately with the
Commission.

 

59

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

 

(d)           distributing Products to customers in the Amicus Territory;

 

(e)           controlling invoicing, order processing and collecting accounts
receivable for sales of Products in the Amicus Territory;

 

(f)            recording sales of Products in the Amicus Territory in its books
of account for sales;

 

(g)           conducting disease awareness and medical education programs in the
Amicus Territory; and

 

(h)           any and all other Commercialization activities, in Amicus’s
discretion and consistent with the Global Commercialization Plan, related to the
Products in the Amicus Territory.

 

6.2          Promotional Materials.  The final determination of the content,
quantity, and method of distribution of any promotional materials for the
Compound or Products for each Party’s respective territory shall be the sole
responsibility of such Party, provided that all such promotional materials shall
be consistent with guidelines set forth in the Global Commercialization Plan. 
Subject to Section 6.3, each Party shall own all right, title and interest in
and to all such promotional materials for the Compound or Products for each
Party’s respective territory created during the Term of the Agreement, including
any intellectual property rights therein or attendant thereto, excluding any
Trademark(s) and the House Marks of the other Party.

 

6.3          Use of Trademarks and House Marks.

 

6.3.1         The Joint Commercialization Subcommittee will determine, and the
Joint Steering Committee will confirm, which GSK Trademark or GSK Trademarks
will be used in marketing Products in the GSK Territory and the Amicus
Territory, with the goal of identifying a global GSK Trademark for each Product
that may be used in the Amicus Territory and throughout the GSK Territory.  In
the event that a GSK Trademark selected by the Joint Commercialization
Subcommittee and Joint Steering Committee is not registerable in the Amicus
Territory or throughout the GSK Territory, or is not approved by the applicable
Regulatory Authorities for a Product in a country in the Territory, the Joint
Commercialization Subcommittee shall have the right to select (subject to
approval by the Joint Steering Committee) an alternative GSK Trademark for use
in connection with such Product in such country, it being understood that the
Parties shall mutually agree upon the pool of alternative GSK Trademarks for
such purposes.  Neither Party shall have the right to select and use a Trademark
or a GSK Trademark in connection with a Product without the prior written
consent and approval of the Joint Commercialization Subcommittee and the Joint
Steering Committee.  All packaging and package inserts for Product in the GSK
Territory will include the GSK brand name and logo or other identifying markings
of GSK or its Affiliates (collectively, the “GSK House Marks”), and all
packaging and package inserts for Product in the Amicus Territory will include
the Amicus brand name and logo, or other identifying markings of

 

******       - Material has been omitted and filed separately with the
Commission.

 

60

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

 

Amicus (collectively “Amicus House Marks”) in reasonable size and prominence as
allowed by applicable Law.

 

6.4          Product Recalls.  Subject to Article XV, GSK will have the
responsibility for initiating and conducting any total or partial recall or
market withdrawal of a Product in the GSK Territory (whether voluntary or not)
and Amicus will have the responsibility for initiating and conducting any total
or partial recall or market withdrawal of a Product in the Amicus Territory
(whether voluntary or not); provided that, prior to initiating a recall of a
Product pursuant to this Section 6.4, the Party proposing such recall shall
notify the other Party in writing (such notification to be within twenty-four
(24) hours in the event of a recall for safety or toxicity reasons), and shall
consider in good faith any reasonable comments provided promptly by the other
Party with respect to the initiation and/or conduct of such recall.  The Parties
will cooperate with and assist each other in effecting such recall or market
withdrawal, including making available to the other Party, upon request, all
pertinent records.  Except as otherwise agreed by the Parties in writing and
subject to Article XV, all costs associated with any total or partial recall or
market withdrawal of a Product in each Party’s respective territory shall be
borne by the Party responsible for initiating and conducting such recall in the
applicable territory pursuant to the first sentence of this Section 6.4;
provided that, to the extent that such total or partial recall or market
withdrawal is a result of the other Party’s (or such other Party’s Third Party
manufacturer’s) gross negligence or failure to comply with the terms of this
Agreement (or in the case of GSK, the Supply Agreement (when executed)), all
such costs shall be borne by the other Party.

 

6.5          Manufacturing Responsibilities.

 

6.5.1         The Parties acknowledge and agree that, pursuant to Section 6.5.1,
Schedule 6.5.1, and the Supply Transition Plan, in each case as set forth in the
Original Agreement, Amicus transitioned responsibility for the Manufacture and
supply of the Compound and Products in the Territory to GSK.  Further, following
the Effective Date, GSK has developed the GSK Monotherapy Product Manufacturing
Improvements as set forth in the attached Schedule 6.5.1.  Following the
Restatement Effective Date, GSK and Amicus shall agree upon a timeline and
transition plan as necessary (the “Supply Transition Plan”) pursuant to which
Amicus shall transfer to GSK or the designated Third Party CMO(s) currently used
by the Parties for Manufacturing under this Agreement as of the Restatement
Effective Date, and GSK shall transfer to Amicus or designated Third Party
CMO(s) currently used by the Parties for Manufacturing under this Agreement as
of the Restatement Effective Date, as applicable, the information (including
such information generated by Amicus’ or GSK’s, as applicable, Third Party
manufacturer(s)), as set forth in the attached Schedule 6.5.1.  The Supply
Transition Plan shall provide for reasonable assistance to establish and
validate the Manufacture and supply process at a location designated by Amicus,
or by GSK, as applicable.  During the Term, GSK shall transfer to Amicus any
additional GSK Monotherapy Product Manufacturing Improvements and Amicus shall
transfer to GSK any Amicus Licensed Technology related to improvements to the
manufacturing processes for the Manufacture

 

******       - Material has been omitted and filed separately with the
Commission.

 

61

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

 

of Compound or Products (other than the Co-Formulation Products), in each case,
in accordance with Section 5.2.3.

 

6.5.2         GSK shall have the exclusive right to Manufacture Compound and
Products in the Territory for Commercialization of such Products in the Field in
the GSK Territory.  In addition, GSK shall have the exclusive right and
responsibility to Manufacture Co-Formulation Products in the Territory for
Commercialization of such Co-Formulation Products in the Field in the GSK
Territory and for supply of such Co-Formulation Products to Amicus for
Commercialization of such Products in the Field in the Amicus Territory.  The
foregoing rights shall include, without limitation, the right to Manufacture all
batches of drug substance and drug product (including any such batches of drug
substance or drug product planned for use to support registration and validation
of Product).  GSK shall have the right, in accordance with the terms of this
Agreement, to appoint one or more Third Parties to Manufacture Compound and
Products for any of the foregoing purposes.  For the avoidance of doubt, GSK
shall have the ultimate decision-making authority over the use of Third Parties
in its manufacturing supply chain.

 

6.5.3         Amicus shall have the exclusive right to Manufacture Compound and
Products (other than Co-Formulation Products) in the Territory for
Commercialization of such Products in the Field in the Amicus Territory,
including, without limitation, the right to Manufacture all batches of drug
substance and drug product (including any such batches of drug substance or drug
product planned for use to support registration and validation of such
Products), and shall have the right, in accordance with the terms of this
Agreement, to appoint one or more Third Parties to Manufacture Compound and
Products (other than Co-Formulation Products) for such purposes.  Amicus shall
have the right to Manufacture Compound and Products (other than Co-Formulation
Products) in the Territory for Development of such Products in the Field in the
Amicus Territory; provided, however, Amicus shall first obtain its, its
Affiliates’ and Sublicensees’ requirements to conduct the Development activities
allocated to Amicus, its Affiliates or Sublicensees under the then-current
Existing Development Plan from GSK to the extent such quantities are made
available to Amicus in accordance with Section 6.5.4 below.  For the avoidance
of doubt, Amicus shall have the ultimate decision making authority over the use
of Third Parties in its manufacturing supply chain for Compound and Products
(other than Co-Formulation Products).

 

6.5.4         Clinical Supply by GSK to Amicus.  GSK agrees to make available,
and supply to Amicus, its Affiliates, and its and its Affiliates’ Sublicensees,
and to GSK, its Affiliates, and its and its Affiliates’ Sublicensees, such
quantities of the Compound and Products that are necessary or reasonably useful,
as determined by the Joint Development Committee, for Amicus and for GSK to
conduct and complete the Development activities allocated to Amicus and/or its
Affiliates or Sublicensees or GSK and/or its Affiliates or Sublicensee, as
applicable, under and in accordance with the then-current Development Plans. 
******.  For clarity, ******.  The Parties shall collaborate, via the Joint
Development Subcommittee, to appropriately forecast the supply amounts of
Compound and Products necessary for Amicus and for GSK to conduct and complete
the Development activities allocated to Amicus and/or its Affiliates or
Sublicensees or GSK and/or its

 

******       - Material has been omitted and filed separately with the
Commission.

 

62

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

 

Affiliates or Sublicensee, as applicable, under and in accordance with the
then-current Development Plans; and with respect to supply amounts of
Co-Formulation Products, the Parties shall collaborate, via the Joint
Development Committee, to appropriately forecast to GSK, on a two-year rolling
basis, the amount of the Co-Formulation Product ERT Enzyme that is anticipated
to be necessary to conduct and complete the Development activities under and in
accordance with the then-current Co-Formulation Development Plan.  Other than as
expressly set forth in this Section 6.5.4, each Party shall be solely
responsible for obtaining the supply of Compound for use in connection with the
conduct of activities allocated to such Party under the applicable Development
Plan.

 

6.5.5         Commercial Supply of Co-Formulation Product.  Upon request by
Amicus, GSK shall supply Amicus with Co-Formulation Product, for
Commercialization in the Amicus Territory, at a price equal to GSK’s
Manufacturing Costs.  The Parties shall enter into a separate supply agreement
(the “Supply Agreement”), within ****** following a request by either Party to
do so, covering the foregoing commercial supply of Co-Formulation Product by GSK
to Amicus, which shall include certain minimum order requirements, an obligation
to ******, and which shall reflect such other terms and conditions as are
reasonable and customary for pharmaceutical supply arrangements.  ******.

 

6.5.6         Supply of Compound and Product.  Any quantities of Compound or
Products (other than Co-Formulation Products) to be supplied by GSK to Amicus
pursuant to Section 6.5.4 will meet applicable Compound or Product
specifications.  The specifications for the Compound and Products (other than
the Co-Formulation Product) as of the Effective Date are attached hereto as
Schedule 6.5.6.  The specifications for the Co-Formulation Product ERT Enzyme
shall be agreed upon by the Parties in advance of the conduct of Manufacturing
activities for the supply of such Co-Formulation Product ERT Enzyme for use in
connection with Co-Formulation Product(s).  Each Party shall appoint a
representative as a primary point of contact for discussions between the Parties
regarding Manufacturing activities and Compound and/or Product specifications
under this Agreement.  Any quantities of Co-Formulation Products to be supplied
by GSK to Amicus pursuant to Section 6.5.4 and/or Section 6.5.5 will meet
applicable Co-Formulation Product specifications as mutually agreed upon by the
Parties (such Co-Formulation Product specifications together with the Compound
and Product specifications set forth on Schedule 6.5.5, the “Specifications”). 
Neither Party shall make any changes to the Specifications without the other
Party’s prior written approval; unless such changes are requested or required by
a Regulatory Authority or applicable Laws (“Required Changes”), in which case,
GSK may amend the applicable Specifications for the Co-Formulation Product and,
upon reasonable prior written notice to Amicus, for any Compound or Products to
be supplied by GSK pursuant to Section 6.5.4, and Amicus may amend the
applicable Specifications for Compound and Products (other than Co-Formulation
Products) for which Amicus is responsible; in each case in order to comply with
such Required Changes and provide notice thereof to the other Party; ******.  In
addition, all quantities of Compound and Products supplied by GSK to Amicus
pursuant to this Section 6.5 will not be misbranded or adulterated.  All such
Compound and Products supplied by GSK to Amicus pursuant to this Section 6.5
will be manufactured in accordance with cGMPs; provided, however, that GSK may
supply to Amicus

 

******       - Material has been omitted and filed separately with the
Commission.

 

63

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

 

Compound or Products not manufactured in accordance with cGMP if specifically
intended for non-human testing activities allocated to Amicus under the
applicable Development Plan and as agreed to in writing in advance by Amicus.

 

6.5.7         Remaining Supply of Clinical Trial materials.  In the event that,
following the conclusion of the Development activities by the Parties in the
Territory under this Agreement, additional supply of Compound or Products exists
that have not been otherwise allocated to Development activities by a Party and
for which the shelf-life has not yet expired, the Parties shall discuss
allocation of such additional supply to a Party for use in connection with
Commercialization of the applicable Product in such Party’s Territory, subject
to agreement by the Parties on the appropriate payment terms for such additional
supplies, such payment terms to be consistent with the terms for the cost of
commercial supply of Compound and/or Product as set forth in Section 6.5.5.

 

6.6          Commercial Transition.  Following the Restatement Effective Date,
GSK and Amicus shall agree upon a timeline and transition plan in accordance
with Schedule 6.6 attached hereto as necessary to effect a smooth and orderly
transition of the Commercialization of the Products for the Amicus Territory
(the “Commercial Transition Plan”) pursuant to which GSK shall transfer to
Amicus Commercialization activities for the Amicus Territory and provide
reasonable assistance with respect such Commercialization transfer in accordance
with the Commercial Transition Plan.

 

VII.         OWNERSHIP AND INTELLECTUAL PROPERTY

 

7.1          Ownership.  Subject to any license or other rights granted to GSK
pursuant to the terms of this Agreement, as between the Parties, Amicus will own
or Control the Amicus Intellectual Property, Amicus Confidential Information,
Amicus Know-How, and Amicus House Mark owned or Controlled by Amicus in the
Territory as of the Effective Date.  Subject to any license or other rights
granted to Amicus pursuant to the terms of this Agreement, GSK will own the GSK
Confidential Information, GSK Background IP, GSK In-Licensed Background ERT IP,
GSK Trademarks, and GSK House Marks owned or Controlled by GSK in the Territory
as of the Effective Date or, with respect to the GSK Trademarks and the GSK
In-Licensed Background ERT IP, during the Term.  GSK shall own any Trademarks
that are created or designated by the Parties for use on a Product in the
Territory after the Effective Date.

 

7.2          Patent Applications on Licensed Amicus Technology.

 

7.2.1         GSK Control of Prosecution.  Subject to any restrictions Amicus
may have under any Third Party agreement covering the Amicus Patents included in
the Licensed Amicus Technology (including the Background License Agreements) and
subject to Section 7.2.1(a) below, GSK will assume control of, and will bear the
Patent Costs associated with, prosecuting and maintaining such Patents in the
Territory included in the Amicus Patents as of the Effective Date, or which may
be filed in any country of the Territory after the Effective Date, to the extent
the same are directed to the Compound or a Product, and/or Manufacturing and/or
use thereof, in the Field in the

 

******       - Material has been omitted and filed separately with the
Commission.

 

64

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

 

Territory, excluding those Amicus Prosecuted Patents described below in Section
7.2.2 (such Patents, excluding the Amicus Prosecuted Patents, are referred to
below as the “GSK Prosecuted Amicus Patents”).  A list of the GSK Prosecuted
Amicus Patents, as of the Restatement Effective Date, is set forth on Schedule
7.2.1 attached hereto.  Amicus shall have the right, at its own cost and
expense, to reasonably assist GSK in connection with the filing, prosecution and
maintenance of any GSK Prosecuted Amicus Patents in the Territory.  GSK shall
use diligent efforts consistent with those normally employed by GSK in the
course of business to prosecute and maintain the GSK Prosecuted Amicus Patents
described in this Section 7.2.1 and GSK will, in a timely manner, solicit
Amicus’ comments regarding the prosecution and maintenance of such GSK
Prosecuted Amicus Patents and review of the nature and text of any such Patent
application and prosecution matters related thereto, including any
correspondence between GSK and any government intellectual property or Patent
authorities, agencies or other government bodies, in reasonably sufficient time
prior to filing thereof, and GSK shall give due consideration to Amicus’
reasonable amendments to such correspondence.  Without prejudice to Section
7.2.4 in the event that GSK intends to disregard any of Amicus’ amendments, GSK
shall set up a meeting between Amicus’ and GSK’s respective patent counsels to
provide explanations therefor.

 

(a)           Amicus will control, and will bear the Patent Costs associated
with, prosecuting and maintaining each GSK Prosecuted Amicus Patent in the
Amicus Territory after such Patent has been issued, including but not limited to
re-examination, re-issue, post-grant review, inter partes post-grant review and
supplementary examination.  GSK shall have the right, at its own cost and
expense, to reasonably assist Amicus in connection with the prosecution or
maintenance of such GSK Prosecuted Amicus Patent after such Patent has been
issued in the Amicus Territory.  Amicus will keep GSK reasonably informed with
respect to such prosecution and maintenance via the Joint Patent Subcommittee
and will, in a timely manner, solicit GSK’s comments regarding such prosecution
and maintenance, including any comments of GSK with respect to any
correspondence between Amicus and any government intellectual property or Patent
authorities, agencies or other government bodies, in reasonably sufficient time
prior to filing thereof, and Amicus will give due consideration to GSK’s
reasonable comments and amendments.  Without prejudice to Section 7.2.4, ******.

 

7.2.2         Amicus Prosecuted Patents.  Amicus will control, and will bear the
Patent Costs associated with, prosecuting and maintaining the Amicus Patents
identified on Schedule 7.2.2 (together with future Patents claiming priority
thereto, the “Amicus Prosecuted Patents”).  GSK shall have the right, at its own
cost and expense, to reasonably assist Amicus in connection with the filing,
prosecution and maintenance of any such Amicus Prosecuted Patents in the
Territory.  Amicus shall use diligent efforts consistent with those normally
employed by Amicus in the course of business to prosecute and maintain the
Amicus Prosecuted Patents and Amicus will, in a timely manner, solicit GSK’s
comments regarding the prosecution and maintenance of such Amicus Prosecuted
Patents and review of the nature and text of any such Patent application and
prosecution matters related thereto, including any correspondence between Amicus
and any government intellectual property or Patent authorities, agencies or
other government bodies, in reasonably sufficient time prior to filing

 

******       - Material has been omitted and filed separately with the
Commission.

 

65

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

 

thereof, and Amicus will give due consideration to GSK’s reasonable comments and
amendments.  Without prejudice to Section 7.2.4, ******.

 

7.2.3         Segregation of Patent Applications.  In the event that any Amicus
Patent contains claims to the Compound and/or Products (i.e., is a GSK
Prosecuted Amicus Patent) as well as the Amicus Proprietary Chaperone Technology
more broadly or any other compound or product owned or controlled by Amicus, the
Parties shall cooperate in good faith to segregate such Patents to allow Amicus
to control the prosecution and maintenance of Patent applications and Patents
pertaining to subject matter other than the Compound and/or Products.  A list of
such Segregated Patents as of the Restatement Effective Date is set forth on
Schedule 7.2.3 hereto.

 

7.2.4         Additional Matters.  Any disagreements under this Section 7.2
shall be referred to the Joint Patent Subcommittee for resolution as provided in
Section 4.2.1. For purposes of this Article VII, “prosecution and maintenance”
(including variations such as “prosecute and maintain”) means, with respect to a
Patent, the preparing, filing, maintenance and prosecution of such Patent, as
well as the conduct of interferences, oppositions, re-examination, re-issues and
other similar proceedings.

 

7.3          Program Improvements; Co-Formulation Product IP.

 

7.3.1         To the extent that a Program Improvement or Co-Formulation Product
IP is developed by or on behalf of one Party, that Party will promptly disclose
such Program Improvement or Co-Formulation Product IP to the Joint Patent
Subcommittee in writing with all relevant data supporting such Program
Improvement or Co-Formulation Product IP, as applicable.

 

7.3.2         Each Party will, subject to the terms of Section 7.4, be sole
owner of Program Improvements and Co-Formulation Product IP invented solely by
its employees and agents and the employees and agents of its respective
Affiliates and will do and procure all necessary acts, and obtain all necessary
assignments or other instruments as may be required to confer such sole
ownership on said Party.  With respect to such solely-invented Program
Improvements and Co-Formulation Product IP, the Party owning such Program
Improvement or Co-Formulation Product IP, as applicable, will own any
applications for Patent with respect thereto and any Patents issued on such
applications, unless such rights are assigned to the other Party pursuant to
Section 7.4.

 

7.3.3         The Parties will be the joint owners of Program Improvements and
Co-Formulation Product IP invented jointly by the employees and agents of the
Parties or the employees and agents of their respective Affiliates and any
Program Patents covering such jointly invented Program Improvements or Patents
covering such jointly invented Co-Formulation Product IP, applicable (each a
“Joint Program Patent”).  Each Party will do and procure all necessary acts, and
obtain all necessary assignments or other instruments as may be required to
confer such joint ownership on the Parties.

 

******       - Material has been omitted and filed separately with the
Commission.

 

66

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

 

7.3.4         Inventorship under this Agreement shall be determined in
accordance with the patent laws of the United States.

 

7.4          Abandonment of Patents and Applications.  In the event that GSK
decides not to file, continue to prosecute or maintain a GSK Prosecuted Patent
that falls under Section 7.2, or either Party decides not to file, maintain a
Patent or to abandon a Patent application or issued Patent that falls under
Section 7.3 (in either case, the “Abandoning Party”), such Abandoning Party will
give written notice to the other Party at least ****** prior to any public
disclosure, allowing such application to go abandoned, or prior to not taking a
necessary step to maintain such Patent, and the other Party will have the option
of taking over the prosecution or maintenance of such application or Patent at
its sole expense.  If the other Party elects to take over the filing,
prosecution or maintenance of such application or Patent pursuant to this
Section 7.4, the Abandoning Party or Party giving permission will assign all its
right, title and interest in such application or Patent to the other Party,
subject to the Abandoning Party or Party giving permission retaining a
non-exclusive, perpetual, irrevocable, sublicensable, fully-paid-up license from
the other Party to such Patent or Patent application.  The Party taking over
prosecution, or maintenance will, in a timely manner, solicit the Abandoning
Party’s comments in prosecution matters related to such applications, including
any correspondence between the Abandoning Party and any government intellectual
property or Patent authorities, agencies or other government bodies, in
reasonably sufficient time prior to filing thereof, and shall give due
consideration to the Abandoning Party’s comments.  Any disagreements hereunder
shall be referred to the Joint Patent Subcommittee for resolution as provided in
Section 4.2.1.

 

7.5          Cooperation.  Each Party will cooperate, and will require its
employees, Affiliates, consultants, and subcontractors to cooperate, and will
use its reasonable efforts to require its agents to cooperate, with all
reasonable requests of the other Party for assistance in preparation and
prosecution and maintenance of any applications for Patent and any Patent
issuing therefrom and any applications for Trademark for use with a Product and
any registration issuing therefrom that is owned by the requesting Party
hereunder.  GSK shall be solely responsible for any and all costs associated
with the GSK Trademarks and GSK House Marks, including any Trademarks owned by
GSK pursuant to Section 7.1 herein.  Amicus shall be solely responsible for any
and all costs associated with the Amicus House Marks.

 

7.6          Patent Filing Procedures for Patents relating to Program
Improvements; Co-Formulation Product IP.

 

7.6.1         Program Improvement and Co-Formulation Product IP relating to
Compound or Product.

 

(a)           GSK will determine whether or not to file a Patent application
covering a Program Improvement or Co-Formulation Product IP relating to Compound
or a Product in the Territory.  If GSK elects to file such an application,
subject to Section 7.6.1(b), GSK will bear

 

******       - Material has been omitted and filed separately with the
Commission.

 

67

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

 

the Patent Costs of prosecuting and maintaining any Patents that issue thereon
and will control the prosecution of such application; however, Amicus shall have
the right, at its own cost and expense, to reasonably assist GSK in connection
with the filing, prosecution and maintenance of any Patent applications filed
under this Section 7.6.1(a).  GSK shall use diligent efforts consistent with
those normally employed by GSK in the course of business to prosecute and
maintain any such Patent application or Patent described in this Section
7.6.1(a) and GSK will, in a timely manner, solicit Amicus’ comments and review
of the nature and text of any such application and prosecution and maintenance
matters related thereto, including any correspondence between GSK and any
government intellectual property or Patent authorities, agencies, or other
government bodies, in reasonably sufficient time prior to filing thereof, and
GSK shall give due consideration to Amicus’ reasonable amendments to such
correspondence.  ******.  Any remaining disagreements hereunder, including
filing, prosecution and maintenance decisions or strategies and/or any disputes
by Amicus regarding GSK’s determination to disregard any of Amicus’ proposed
amendments provided with respect to an application for Patent or Patent
described in this Section 7.6.1(a), shall be referred to the Joint Patent
Subcommittee for resolution as provided in Section 4.2.1.  If GSK elects not to
file an application for Patent in any country in the Territory covering any such
Program Improvement or Co-Formulation Product IP (unless GSK elects to maintain
such Co-Formulation Product IP as a trade secret), GSK shall give Amicus notice
thereof at least ****** prior to causing in any way such Program Improvement or
Co-Formulation Product IP to become unpatentable through disclosure, sale, or
otherwise, and Amicus shall thereafter have the right, at its sole expense, to
prosecute and maintain such Patent application in any such country.  Any
disagreements hereunder shall be referred to the Joint Patent Subcommittee for
resolution as provided in Section 4.2.1.

 

(b)           If GSK elects to file an application for Patent in any country in
the Territory covering any such Program Improvement or Co-Formulation Product IP
in accordance with Section 7.6.1(a) (each a “GSK Prosecuted Improvement
Patent”), Amicus will control, and will bear the Patent Costs associated with,
prosecuting and maintaining each GSK Prosecuted Improvement Patent in the Amicus
Territory after such Patent has been issued, including but not limited to
re-examination, re-issue, post-grant review, inter partes post-grant review and
supplementary examination.  GSK shall have the right, at its own cost and
expense, to reasonably assist Amicus in connection with the prosecution or
maintenance of such GSK Prosecuted Improvement Patent after such Patent has been
issued in the Amicus Territory.  Amicus will keep GSK reasonably informed with
respect to such prosecution and maintenance via the Joint Patent Subcommittee
and will, in a timely manner, solicit GSK’s comments regarding such prosecution
and maintenance, including any comments of GSK with respect to any
correspondence between Amicus and any government intellectual property or Patent
authorities, agencies or other government bodies, in reasonably sufficient time
prior to filing thereof, and Amicus will give due consideration to GSK’s
reasonable comments and amendments.  Without prejudice to Section 7.2.4, ******.

 

******       - Material has been omitted and filed separately with the
Commission.

 

68

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

 

7.6.2         Program Improvement or Co-Formulation Product IP not relating to
Compound or Product.

 

(a)           If a Program Improvement or Co-Formulation Product IP does not
relate to Compound or Product, then Amicus will determine whether or not to file
a Patent application in any country on such Program Improvement or
Co-Formulation Product IP.  If Amicus elects to file such an application, Amicus
will bear the Patent Costs of prosecuting and maintaining any Patents that issue
thereon and will control the prosecution of such application; however, GSK shall
have the right, at its own cost and expense, to reasonably assist Amicus in
connection with the filing, prosecution and maintenance of any Patent
applications filed under this Section 7.6.2(a).  Amicus shall use diligent
efforts consistent with those normally employed by Amicus in the course of
business to prosecute and maintain any such Patent application or Patent
described in this Section 7.6.2(a) and Amicus will, in a timely manner, solicit
GSK’s comments and review of the nature and text of any such application and
prosecution and maintenance matters related thereto, including any
correspondence between Amicus and any government intellectual property or Patent
authorities, agencies, or other government bodies, in reasonably sufficient time
prior to filing thereof, and Amicus shall give due consideration to GSK’s
reasonable amendments to such correspondence.  ******.  Any remaining
disagreements hereunder, including filing, prosecution and maintenance decisions
or strategies, shall be referred to the Joint Patent Subcommittee for resolution
as provided in Section 4.2.1; and

 

(b)           If Amicus elects not to file an application for Patent in any
country in the Territory covering any such Program Improvement or Co-Formulation
Product IP, Amicus shall give GSK notice thereof at least sixty (60) days prior
to causing in any way such Program Improvement or Co-Formulation Product IP to
become unpatentable through disclosure, sale, or otherwise, and GSK shall
thereafter have the right, at its sole expense, to prosecute and maintain such
Patent application in any such country.  Any disagreements hereunder shall be
referred to the Joint Patent Subcommittee for resolution as provided in Section
4.2.1.

 

7.7          Orange Book Listing; Patent Term Restoration and Supplemental
Protection Certificates.

 

7.7.1         Obligations.  After consultation with GSK via the Joint Patent
Subcommittee and giving due consideration to any comments and recommendations of
GSK, ******.  Prior to such listings, the Parties will meet, through the Joint
Patent Subcommittee, to evaluate and identify all applicable Patent rights, and
subject to any restrictions Amicus may have under third party agreements
covering the Amicus Patents included in the Licensed Amicus Technology
(including the Background License Agreements), GSK will have the right to
review, where reasonable, original records relating to any invention for which
Patent rights are being considered for any such listing.  ******. In addition,
subject to any restrictions Amicus may have under third party agreements
covering the Amicus Patents included in the Licensed Amicus Technology
(including the Background License Agreements), ******.  Subject to any
restrictions Amicus may have under third party agreements covering the Amicus
Patents included in the Licensed Amicus Technology (including the Background
License Agreements), ******.  The Parties will cooperate with each other in
gaining Patent term extension where applicable to Products.  Upon either Party’s
reasonable

 

******       - Material has been omitted and filed separately with the
Commission.

 

69

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

 

request, the other Party shall timely provide any documentation or other
assistance required in order to obtain such Patent term extensions, subject to
any restrictions either Party may have under third party agreements covering the
applicable Patent (including the Background License Agreements).

 

7.8          Trademark Filing Procedures.  During the Term of this Agreement,
******.

 

VIII.       ENFORCEMENT AND DEFENSE OF INTELLECTUAL PROPERTY

 

8.1          Notices.  Each Party will advise the Joint Steering Committee and
the Joint Patent Subcommittee promptly upon its becoming aware of: (a) any
unlicensed activities which such Party believes may be an actual or impending
infringement of any Patent or other proprietary right owned or applied for by it
or the other Party included in the Amicus Patents, or Program Patents, or
Patents included in the Co-Formulation Product IP, by a Product, or the
Development, Manufacture, use, importation, or sale thereof; (b) any attack on
or appeal of the grant of any Patent owned or applied for by it or the other
Party to the extent containing claims to the Compound or a Product or the
Development, Manufacture, use, or sale thereof; (c) any application for Patent
by, or the grant of a Patent to, a Third Party in respect of rights which may be
related to the Compound or a Product so as to potentially materially affect the
Development, Manufacture, use, importation, or sale thereof; (d) any application
made for a compulsory license under any Patent owned or applied for by it or the
other Party and covering the Compound or a Product or the Development,
Manufacture, use, importation, or sale thereof in the Territory; or (e) any
application for Patent by, or the grant of a Patent to, a Third Party in respect
of rights which may claim the same subject matter as, or conflict with, any
Patent owned or applied for by it or the other Party containing claims to the
Compound or a Product, or the Development, Manufacture, use, importation, or
sale thereof.

 

8.2          Control of Actions.

 

8.2.1         Subject to any restrictions Amicus may have under a Third Party
agreement covering the Amicus Patents included in the Licensed Amicus Technology
(including the Background License Agreements), GSK will determine whether or not
to take whatever legal or other action is required in response to activities in
the GSK Territory requiring notice under Section 8.1, 8.1 or 8.1 to the extent
such activities specifically relate to Compound or a Product (“GSK Protective
Action”).  If GSK determines that such GSK Protective Action is warranted, in
its sole discretion after reasonable consultation with Amicus via the Joint
Patent Subcommittee, then, subject to any restrictions Amicus may have under a
Third Party agreement covering the Amicus Patents included in the Licensed
Amicus Technology (including the Background License Agreements), GSK shall, at
GSK’s expense, have the right to commence, prosecute and control such GSK
Protective Action, including the settlement thereof and the granting of any
licenses or sublicense within the scope of the License granted to GSK under any
Amicus Patents, Program Patents or Patents within the Co-Formulation Product IP
licensed to GSK hereunder.  Amicus will cooperate with GSK in such action,
including being joined as a Party to such action if such joinder is necessary
for standing.

 

******       - Material has been omitted and filed separately with the
Commission.

 

70

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

 

8.2.2         Amicus will determine whether or not to take whatever legal or
other action is required in response to activities in the Amicus Territory
requiring notice under Section 8.1, 8.1 or 8.1 to the extent such activities
specifically relate to Compound or a Product (“Amicus Protective Action”).  If
Amicus determines that such Amicus Protective Action is warranted, in its sole
discretion after reasonable consultation with GSK via the Joint Patent
Subcommittee, then Amicus shall, at Amicus’ expense, have the right to commence,
prosecute and control such Amicus Protective Action, including the settlement
thereof and the granting of any licenses or sublicense within the scope of the
licenses granted to Amicus pursuant to Section 2.4 in the Amicus Territory under
any Program Patents or Patents within the Co-Formulation Product IP licensed to
Amicus hereunder.  GSK will cooperate with Amicus in such action, including
being joined as a Party to such action if such joinder is necessary for
standing.

 

8.2.3         In the event that the Parties determine that legal or other action
is required in response to activities both in the Amicus Territory and GSK
Territory, the Parties shall meet via the Joint Patent Subcommittee and shall
coordinate such activities within their respective territories, including review
and coordination of legal filings, strategy, and related issues in advance of
taking such actions.

 

8.2.4         Each Party may be represented by counsel of its own selection at
its own expense in a GSK Protective Action or Amicus Protective Action, as
applicable.  Any recovery obtained as a result of such GSK Protective Action and
attributable to activities in the GSK Territory, whether by judgment, award,
decree, or settlement, will, after reimbursement of the Parties for their
reasonable costs and expenses associated with such GSK Protective Action, will
be shared as follows:  ******.  Any recovery obtained as a result of such Amicus
Protective Action and attributable to activities in the Amicus Territory,
whether by judgment, award, decree, or settlement, will, after reimbursement of
the Parties for their reasonable costs and expenses associated with such Amicus
Protective Action, be shared as follows:  ******.  To the extent such recovery
is insufficient to reimburse the Parties’ associated reasonable costs and
expenses fully, then a Party’s share of such recovery will be the product of the
total amount recovered with that Party’s reasonable costs and expenses divided
by the sum of both Parties’ reasonable costs and expenses.  The Party
responsible pursuant to Section 7.2, 7.3 or 7.6 above, as applicable for
prosecution and maintenance of the relevant Patent described in Section 8.1 and
Section 8.1 shall determine whether or not to take whatever legal or other
action is required with respect to the activities described in Section 8.1 and
Section 8.1.  For the avoidance of doubt, Amicus will determine and control any
legal or other action in response to activities equivalent to those described in
Section 8.1, Section 8.1 and Section 8.1 that do not specifically relate to
Compound or Product.

 

8.3          Trademark Infringement.  Notice regarding potential infringement of
and control of any Protective Action relating to any GSK Trademark in any
country of the Territory related to the Compound or a Product or the
Development, Manufacture, use, importation, or sale thereof in the Territory
will be addressed in accordance with the applicable Trademark License Agreement.

 

******       - Material has been omitted and filed separately with the
Commission.

 

71

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

 

8.4          Third Party Claims. GSK and Amicus will each promptly notify the
Joint Steering Committee and the Joint Patent Subcommittee of any Claim by a
Third Party against GSK or Amicus, or any Affiliate or sublicensee of Amicus or
GSK, alleging infringement of such Third Party’s intellectual property rights as
a result of the Development, Manufacture, marketing, sale, importation, or use
of the Compound or a Product in any country.  As directed by the Joint Steering
Committee, the Parties will cooperate and use Commercially Reasonable Efforts to
resolve such claimed infringement.  Notwithstanding the foregoing, as between
the Parties: (a) GSK shall be entitled, at its own expense, to lead in the
defense of any such Claim by a Third Party against GSK or its Affiliates or
sublicensees and shall select its counsel, and Amicus shall have the right to
participate in such action, and to select its own counsel at its own expense;
and (b) Amicus shall be entitled, at its own expense, to lead in the defense of
any such Claim by a Third Party against Amicus or its Affiliates or sublicensees
and shall select its counsel, and GSK shall have the right to participate in
such action, and to select its own counsel at its own expense.  If it appears
reasonably likely that the claimed infringement will give rise to a Claim for
indemnification hereunder, then the Party against whom such Claim for
indemnification would be made will have the first right to defend against such
Claim in accordance with Article XV.

 

IX.          REPRESENTATIONS AND WARRANTIES

 

9.1          Representations and Warranties of Both Parties.  Amicus and GSK
each hereby represent and warrant to the other, as of the Restatement Effective
Date, as follows:

 

9.1.1         It is a corporation, duly organized, validly existing and in good
standing under the laws of the jurisdiction of its incorporation and has all
requisite power and authority, corporate or otherwise, to conduct its business
as now being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement.

 

9.1.2         No consent, approval, order or authorization of, or registration,
declaration or filing with, any governmental agency is required to be obtained
or made by or with respect to such Party in connection with its execution,
delivery and performance of this Agreement.

 

9.1.3         The execution, delivery and performance by it of this Agreement
and the transactions contemplated thereby have been duly authorized by all
necessary corporate action and stockholder action and will not (i) violate any
applicable Laws or (ii) result in a breach of or constitute a default under any
material agreement, mortgage, lease, license, permit or other instrument or
obligation to which it is a party or by which it or its properties may be bound
or affected.

 

9.2          Representations and Warranties of Amicus.  Amicus hereby represents
and warrants to GSK, as of the Restatement Effective Date (unless otherwise
specifically limited to the Effective Date), as follows:

 

******       - Material has been omitted and filed separately with the
Commission.

 

72

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

 

9.2.1         It has the full right, power and authority to enter into this
Agreement and to grant the License to GSK.

 

9.2.2         Except as otherwise may have been disclosed by Amicus to GSK prior
the Restatement Effective Date, Amicus has received no notice that (a) the
manufacture, sale, importation or use of the Compound within the Field as
contemplated hereby infringes any Third Party rights, and (b) the Amicus Patents
(to the extent representing issued Patents) are invalid or unenforceable.

 

9.2.3         To Amicus’ knowledge, as of the Effective Date, there are no
errors in the inventorship set forth in any of the Patent applications
comprising Amicus Patents.

 

9.2.4         Except as provided or limited in Article II, as of the Effective
Date, the Amicus Intellectual Property constitutes all intellectual property
that is Controlled by Amicus and used in the Development and/or Manufacture of
the Compound, and Amicus does not Control any additional Patents, Know-How or
information that are necessary for GSK to Develop, Manufacture and Commercialize
the Compound.

 

9.2.5         To Amicus’ knowledge, as of the Effective Date, no Third Party
Controls any Patent that is necessary for GSK to Develop, Manufacture and
Commercialize the Compound as such activities are currently conducted or
currently proposed to be conducted in the Amicus Territory or the GSK Territory.

 

9.2.6         It has not previously granted any right, license or interest in or
to the Amicus Patents, or any portion thereof, that is in conflict with the
rights or licenses granted to GSK under this Agreement.

 

9.2.7         As of the Effective Date and, to Amicus’ knowledge as of the
Restatement Effective Date, there are no investigations, inquiries, actions or
other proceedings pending before any Regulatory Authority with respect to the
Compound, and Amicus has not received written notice threatening any such
investigation, inquiry, action or other proceeding.

 

9.2.8         As of the Effective Date, the Development of the Compound by or on
behalf of Amicus has been conducted in compliance in all material respects with
all applicable Laws; and, as of the Restatement Effective Date, neither Amicus
nor to Amicus’ knowledge, its Third Party contractors, have received any written
notice which has led Amicus to believe that any of the Regulatory Approvals
relating to the Compound or a Product developed by Amicus are not currently in
good standing with the FDA or EMA and Amicus has no knowledge that any of its
Third Party contractors has developed Compound or a Product in a manner that
does not comply in all material respects with all applicable Laws.

 

9.2.9         Other than the Background License Agreements, as of the Effective
Date, there are no other agreements to which Amicus is a party or, to Amicus’
knowledge, as of the

 

******       - Material has been omitted and filed separately with the
Commission.

 

73

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

 

Restatement Effective Date, that would prevent Amicus from performing its
obligations under this Agreement or GSK from exercising the rights under the
Amicus Intellectual Property under and in accordance with the License.

 

9.2.10      To its knowledge, there is no pending or threatened product
liability action in relation to the Compound, and it is not aware of any grounds
for any such product liability action.

 

9.2.11      The Development of the Co-Formulation Product(s) by or on behalf of
Amicus (and excluding any such Development by or on behalf of GSK) has been, to
the knowledge of Amicus, conducted in compliance in all material respects with
all applicable Laws; and Amicus has no knowledge that any of its Affiliates or
Third Party collaborators or contractors has developed the Co-Formulation
Product(s) in a manner that does not comply in all material respects with all
applicable Laws.

 

9.2.12      Amicus has all material permits, licenses, franchises,
authorizations, orders and approvals of, and has made all filings, applications
and registrations with, governmental entities that are required in order to
permit Amicus to own or lease properties and assets and to carry on its business
as presently conducted that are material to Amicus.  Amicus has complied and is
in compliance in all material respects with all statutes, laws, regulations,
rules, judgments, orders and decrees of all governmental entities applicable to
it that pertain to its business, including but not limited to compliance with
the U.S. Foreign Corrupt Practices Act of 1977 (FCPA) (15 U.S.C. §§ 78dd-1, et
seq.) and any applicable similar laws in foreign jurisdictions in which Amicus
is currently, or has previously, conducted its business or is currently, or has
previously, conducted clinical trials.  Amicus has not received any notice from
a governmental entity alleging noncompliance with any such applicable statutes,
laws, regulations, rules, judgments, orders and decrees, and, to the knowledge
of Amicus, Amicus is not under investigation with respect to, or threatened to
be charged, with any material violation of any applicable statutes, laws,
regulations, rules, judgments, orders or decrees of any governmental entities.

 

9.3          Representations and Warranties of GSK.  GSK hereby represents and
warrants to Amicus, as of the Restatement Effective Date, as follows:

 

9.3.1         It has the full right, power and authority to enter into this
Agreement and to grant the licenses to Amicus as purported to be granted
pursuant to this Agreement.

 

9.3.2         It has all necessary rights from JCR and sufficient legal or
beneficial title in the Co-Formulation Product IP and the GSK In-Licensed
Background ERT IP to grant to Amicus the rights and licenses as purported to be
granted pursuant to this Agreement.

 

9.3.3         It has not previously granted any right, license or interest in or
to the Co-Formulation Product IP or GSK In-Licensed Background ERT IP that is in
conflict with the rights or licenses granted to Amicus under this Agreement.

 

******       - Material has been omitted and filed separately with the
Commission.

 

74

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

 

9.3.4         Except as otherwise may have been disclosed by GSK to Amicus prior
the Restatement Effective Date, ******.

 

9.3.5         To GSK’s knowledge, ******.

 

9.3.6         As of the Restatement Effective Date, GSK has acquired, by
assignment or license, from JCR and included in the licenses granted to Amicus
under Article II herein all JCR intellectual property that is necessary for
Amicus to conduct the Development activities allocated to Amicus under the
Co-Formulation Development Plan for the Development of a Co-Formulation Product
and/or to exercise Amicus’ rights to Commercialize a Co-Formulation Product as
set forth herein.

 

9.3.7         To GSK’s knowledge, there are no investigations, inquiries,
actions or other proceedings pending before any Regulatory Authority in the
Amicus Territory with respect to the Co-Formulation Product(s), including JR051,
as JR051 exists as of the Restatement Effective Date, and GSK has not received
written notice threatening any such investigation, inquiry, action or other
proceeding.

 

9.3.8         The Development of the Co-Formulation Product(s), including JR051,
as JR051 exists as of the Restatement Effective Date, by or on behalf of GSK
(and excluding any such Development by or on behalf of Amicus) has been, to the
knowledge of GSK, conducted in compliance in all material respects with all
applicable Laws; and GSK has no knowledge that any of its Affiliates or Third
Party collaborators or contractors has developed the Co-Formulation Product(s),
including JR051, as JR051 exists as of the Restatement Effective Date, in a
manner that does not comply in all material respects with all applicable Laws.

 

9.3.9         There are no other agreements to which GSK is a party or, to GSK’s
knowledge, that would prevent GSK from performing its obligations under this
Agreement or Amicus from exercising the rights under and in accordance with the
licenses granted by GSK to Amicus herein.

 

9.3.10      ******.

 

9.3.11      ******.

 

9.3.12      ******.

 

******.

 

9.4          Mutual Limitations on Warranties.  OTHER THAN THE REPRESENTATIONS
AND WARRANTIES MADE BY THE PARTIES PURSUANT TO SECTIONS 9.1 AND 9.2, THE PARTIES
DISCLAIM ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES WHETHER EXPRESS OR
IMPLIED, INCLUDING ANY REPRESENTATIONS OR

 

******       - Material has been omitted and filed separately with the
Commission.

 

75

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

 

WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR
PURPOSE OR ANY REPRESENTATIONS OR WARRANTY ARISING FROM COURSE OF DEALING OR
USAGE OF TRADE.

 

X.            COVENANTS

 

10.1        Conduct of Activities.

 

10.1.1      Throughout the Term, Amicus and GSK will comply in all material
respects with all applicable Laws, including all applicable anti-bribery and
anti-corruption Laws, concerning the Development, Manufacture, and
Commercialization of the Compound or Products.

 

10.1.2      Neither Amicus nor GSK, nor any of their respective employees,
consultants, agents or representatives who shall be undertaking any activities
related to this Agreement or the subject matter thereof, shall have been
debarred or shall be the subject of debarment or other disciplinary proceedings
by the FDA or any Regulatory Authority in the Territory.

 

10.1.3      Amicus covenants that, as of the Restatement Effective Date, Amicus
shall conduct all sales, marketing, medical affairs, and other activities
allocated to Amicus hereunder in the Amicus Territory: (i) in compliance with
all applicable Laws; (ii) consistent with applicable Industry Guidelines; and
(iii) in compliance with Amicus’ then-current compliance systems, policies,
processes and procedures.  For purposes of this Section 10.1.3, “Industry
Guidelines” shall mean ******.

 

10.2        Background License Agreements.

 

10.2.1      It is understood that certain Patents and Know-How included within
the Amicus Intellectual Property have been in-licensed pursuant to the
Background License Agreements and that the obligations of Amicus and the rights
of GSK under this Agreement shall be subject to, and limited by, the Background
License Agreements.

 

10.2.2      It is further understood that each Background License Agreement may
require that particular provisions be incorporated into a sublicense granted
thereunder.  The text of any such provisions in the Background License
Agreements is set out on Schedule 10.2 attached hereto and shall be deemed
incorporated by reference into this Agreement.  GSK agrees to be bound by the
provisions set out on Schedule 10.2 to the extent applicable to GSK in its
capacity as a sublicensee under each Background License Agreement and, to the
extent required by any Background License Agreement, the relevant Third Party
licensor shall be deemed to be a third party beneficiary of this Agreement for
the purposes of enforcing such Third Party licensor’s rights against GSK in its
capacity as a sublicensee under the applicable Background License Agreement.  In
addition, GSK, in its capacity as a sublicensee under each Background License
Agreement, agrees to comply with the obligations applicable to sublicensees
under such agreement, as set forth on Schedule 10.2.

 

******       - Material has been omitted and filed separately with the
Commission.

 

76

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

 

10.2.3      Except as the Parties may otherwise mutually agree or as provided in
Section 3.4.3(b), Amicus shall not amend, without the prior written consent of
GSK (such consent not to be unreasonably withheld or delayed), or voluntarily
terminate, its rights under any Background License Agreement in any manner that
would materially and adversely affect GSK’s rights and licenses under this
Agreement.  Amicus shall promptly notify GSK of any notice of breach delivered
by it, or any termination or amendment of any of the Background License
Agreements solely if such notice of breach, termination, or amendment materially
and adversely affects GSK’s rights and licenses under this Agreement.

 

10.3        ******; Third Party Obligations.

 

10.3.1      All activities performed by JCR under this Agreement shall be deemed
to be activities conducted by GSK and GSK shall remain responsible to Amicus for
all activities of JCR under this Agreement to the same extent as if such
activities had been undertaken by GSK itself.

 

10.3.2      ******.

 

10.3.3      GSK covenants that, in the event that GSK determines in good faith
that any Third Party intellectual property rights are necessary in order to
Develop, Manufacture or Commercialize the JR051 as a component of a
Co-Formulation Product(s) (collectively, the “Third Party Enzyme IP”), then GSK
shall be ******; it being understood that such Third Party rights shall be
deemed to be included within Co-Formulation Product IP and subject to the terms
and conditions of this Agreement accordingly.

 

10.4        Non-Compete.  ******.

 

XI.          CONFIDENTIAL INFORMATION

 

11.1        Confidentiality.

 

11.1.1      During the Term and for five (5) years thereafter, each Party will
keep, and cause its Affiliates and sublicensees, if any, to keep confidential
all Confidential Information of the other Party, and neither Party, nor any of
its Affiliates or sublicensees, if any, will use or disclose the Confidential
Information of the other Party except as expressly permitted in this Agreement. 
The Parties acknowledge that Confidential Information may have been disclosed by
either Party or its Affiliates to the other Party or its Affiliates pursuant to
the Confidentiality Agreement.  All information disclosed pursuant to the
Confidentiality Agreement will be deemed Confidential Information of the
disclosing Party within the meaning of this Agreement and subject to the terms
hereof.

 

11.1.2      The fact that a particular item of information is not or has ceased
to be Confidential Information by virtue of one or more of the exclusions
specified in the definition of Confidential Information (the “Excluded Item”)
shall not relieve the Party who obtained or received

 

******       - Material has been omitted and filed separately with the
Commission.

 

77

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

 

the Excluded Item from that Party’s obligation of confidentiality and non-use
(a) as to any other item of Confidential Information of the other Party or (b)
as to the relationship of the Excluded Item to any other item of Confidential
Information of the other Party.

 

11.1.3      Each Party hereby acknowledges that the Confidential Information of
the other Party is highly valuable, proprietary, and confidential and that any
use or disclosure of the other Party’s Confidential Information, including any
disclosures made to any Person or governmental agency in connection with the
conduct of a clinical study pursuant to a Development Plan, will be made only to
the extent reasonably necessary to carry out such Party’s responsibilities or
exercise the rights granted to, or reserved by it, under this Agreement.  Any
disclosure of the other Party’s Confidential Information shall be made to an
officer, employee, agent, or permitted sublicensee or contractor of a Party or
any of its Affiliates only if such officer, employee, agent, or permitted
sublicensee is informed of the confidential nature thereof and shall have agreed
to hold such information in confidence and not to use such Confidential
Information under confidentiality provisions at least as stringent as those
provided in this Agreement, and each Party shall be responsible for any breach
of such obligation of confidentiality by its or its Affiliates officers,
employees, agents, permitted sublicensees and/or contractors.

 

11.1.4      The Parties agree that the obligations of this Section 11.1 are
necessary and reasonable in order to protect the Parties’ respective businesses,
and that monetary damages alone may be inadequate to compensate a Party for any
breach by the other Party or any of its Affiliates or their respective officers,
employees, or agents of its covenants and agreements set forth herein.  The
Parties agree that any breach or threatened breach of this Section 11.1 may
cause irreparable injury to the injured Party for which damages may not be an
adequate remedy and that, in addition to any other remedies that may be
available, in Law and equity or otherwise, such Party will be entitled to seek
equitable relief against the breach or threatened breach of the provisions of
this Section 11.1.

 

11.2        Disclosure of Terms; Public Announcements.

 

11.2.1      Press Release.  Notwithstanding Section 11.3 below, the Parties have
agreed on an initial press release of the transaction contemplated by this
Agreement which is attached hereto as Exhibit B (the “Initial Press Release”). 
The Initial Press Release may be issued or used by each Party individually or by
the Parties jointly on or after the Restatement Effective Date.  Thereafter,
each Party may disclose the information contained in such press release without
need for further approval by the other.

 

11.2.2      Further Publicity.  The Parties acknowledge the importance of
supporting each other’s efforts to publicly disclose results and significant
development regarding the Products in the Amicus Territory and/or the GSK
Territory and other activities in connection with this Agreement that reflect
information that is not otherwise permitted to be disclosed under this Article
XI, beyond what is required by Law, and each Party may make such public
disclosures from time to time, subject to the terms set forth below in this
Section 11.2.2. and Section 11.5, after good

 

******       - Material has been omitted and filed separately with the
Commission.

 

78

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

 

faith consultation with the other Party; provided that if such public
disclosures relate to clinical Development of a Product and are to be made by a
Party prior to the earliest of (i) ******, or (ii) ******; then each Party may
make such public disclosures only with the approval of the other Party, which
approval shall not be unreasonably withheld.  Such disclosures may include, with
respect to such activities in such Party’s Territory, the achievement of
milestones, significant events in the Development or regulatory process and/or
the Launch of a Product in a Major Market in such Party’s Territory.  When a
Party (the “Requesting Party”) elects to make any such public disclosure under
this Section 11.2.2, it will give the other Party (the “Cooperating Party”) at
least six (6) Business days notice to review and comment on such statement, and
in any event the Cooperating Party shall work diligently and reasonably
regarding its review and provision of comments on the text of any proposed
disclosure in an expeditious manner.  The principles to be observed in such
disclosures shall be accuracy, compliance with applicable Law and regulatory
guidance documents, reasonable sensitivity to potential negative reactions of
the FDA (and its foreign counterparts), adherence to each Party’s internal
guidelines and policies, and the need to keep investors informed regarding the
Requesting Party’s business.

 

11.3        Confidential Terms; Required Disclosure.  Each Party agrees not to
disclose to any Third Party the terms of this Agreement without the prior
written consent of the other Party hereto, except each Party may disclose the
terms of this Agreement to its advisors (including financial advisors, attorneys
and accountants), actual or potential acquisition partners or private investors,
and others on a need to know basis, in each case under appropriate
confidentiality provisions substantially equivalent to those in this Agreement. 
A Party will be entitled to disclose the terms of this Agreement and/or
Confidential Information of the disclosing Party where such disclosure is
reasonably necessary to prosecute or defend any litigation or otherwise enforce
its rights pursuant to this Agreement, or where demand for such disclosure is
made on such Party or otherwise required pursuant to: (i) a valid order of a
court or other governmental body or (ii) any other applicable Law; provided that
if such Party, as the receiving Party, intends to make such disclosure or
receives such demand, to the extent it may legally do so, the receiving Party
shall give the disclosing Party prompt notice thereof to enable the disclosing
Party to seek a protective order or other appropriate remedy concerning any such
disclosure.  The receiving Party will co-operate with the disclosing Party at
the disclosing Party’s expense in connection with the disclosing Party’s efforts
to obtain any such order or other remedy.  If any such order or other remedy
does not fully preclude disclosure, the receiving Party will make such
disclosure only to the extent that such disclosure is legally required and
subject to confidentiality, to the extent available.  Notwithstanding the
foregoing, the Parties agree to work together to prepare a redacted version of
this Agreement to be filed by Amicus with the United States Securities Exchange
Commission.

 

11.4        Clinical Trial Register.  Either Party shall have the right to
publish in its clinical trial register the results or summaries of the results
of all clinical trials for the Compound or Products, solely in accordance with
the terms set forth in Section 5.2.5 herein.

 

******       - Material has been omitted and filed separately with the
Commission.

 

79

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

 

11.5        Publications.  Except as otherwise expressly set forth herein and
excluding publications made pursuant to Section 5.2.5 and Section 11.4, each
Party shall have the right to publish manuscripts, abstracts, or other articles
in scientific journals, or to make any public presentations with respect
thereto, pertaining to a Product in the Territory, as follows:  (a) prior to the
earliest of (i) ******, or (ii) ******, neither Party shall have the right to
publish any manuscripts, abstracts, or other articles in scientific journals, or
to make any public presentations with respect thereto, without first obtaining
the prior written consent of the other Party, which consent shall not be
unreasonably withheld, and (b) regardless of whether a Party must obtain the
prior written consent of the other Party before making a publication or
presentation in accordance with this Section 11.5, neither Party shall publish
any manuscripts, abstracts, or other articles in any scientific journals, nor
make any public presentations with respect thereto, pertaining to any Product in
the Territory without first following the procedures as set forth below in this
Section 11.5 for review of such manuscript, abstract, article, or text of such
public presentation by the other Party.  In the event that either Party desires
to make a publication or presentation pursuant to this Section 11.5, such Party
shall provide a copy of the proposed manuscript (including abstracts, or
presentation to a journal, editor, meeting, seminar or other third party) or
proposed presentation to the other Party for its review and comments ******
prior to submission of such proposed manuscript for publication and shall
reasonably consider all comments of the other Party with respect thereto.  The
non-publishing Party shall confirm receipt of such proposed manuscript. If,
during the ****** specified above the non-publishing Party notifies the other
Party that a proposed manuscript contains patentable subject matter which
requires protection, the non-publishing Party may require the delay of the
publication for a period of time not to exceed ******, for any abstract
submitted to a conference) for the purpose of allowing the pursuit of such
protection; the object being to prevent either the endangerment of applications
for the protection of intellectual property rights by premature publications
detrimental to their novelty or the disclosure of Confidential Information.  The
publishing Party shall delete from the proposed manuscript prior to submission
all Confidential Information of the non-publishing Party that the non-publishing
Party identifies in good faith and requests to be deleted.  If no prior written
consent of the non-publishing Party is required as set forth above and no
response is received from the non-publishing Party within ******, as applicable)
of the date the proposed manuscript was submitted to the non-publishing Party,
it may be conclusively presumed that the publication may proceed without delay;
provided, however, that if the publishing Party does not receive confirmation of
receipt of the proposed manuscript from the non-publishing Party prior to the
expiration of such ******, as applicable), then the publishing Party shall use
its reasonable efforts (prior to the expiration of such ******, as applicable)
to confirm with the non-publishing Party that such proposed manuscript was
received for review by the non-publishing Party.  Notwithstanding the foregoing,
but without limiting either Party’s rights under Section 11.3, in the event that
a Party believes in good faith that it is obligated or appropriate to disclose
any information pertaining to the safety of a Product, then such Party shall
immediately notify the other Party and the Senior Executives of each Party shall
meet within five (5) days thereafter to discuss disclosure of such information. 
In the event that the Senior Executives are unable to agree upon whether or not
to disclose such information within three (3) days after such meeting, then the
matter shall be referred

 

******       - Material has been omitted and filed separately with the
Commission.

 

80

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

 

to the Joint Steering Committee, which shall meet shall meet as expeditiously as
possible to fully and finally resolve the dispute.

 

XII.        CHANGE OF CONTROL

 

12.1        Change of Control of Amicus.  In the event of a Change of Control of
Amicus during the Term, subject to Section 12.1.5 below, GSK shall have a right
to acquire an exclusive license to the Compound and Products in the Amicus
Territory, in accordance with terms and conditions of this Article 12 (the “US
Buy-Out Option”).

 

12.1.1      ******.

 

12.1.2      ******.

 

12.1.3      ******.

 

12.1.4      ******.

 

12.1.5      ******.

 

12.1.6      The only obligations of GSK and Amicus under this Section 12.1 are
as expressly stated herein, and there are no further implied obligations
relating to the matters contemplated herein.  Without limiting the foregoing,
except as expressly provided in Sections 12.1.1 and 12.1.2 above, Amicus shall
have no obligation ******.

 

12.2        Amicus Intellectual Property.  Notwithstanding any provision of this
Agreement to the contrary, in the event of a Change of Control of Amicus, the
scope of the Licensed Amicus Technology (including the Amicus Patents, Amicus
Know-How and other Licensed Amicus Technology) and the Compound and Products and
the rights and licenses granted to GSK with respect to the Compound and Products
under this Agreement, shall not include, and nothing herein shall be construed
to include, any of the Patents, Know-How or other intellectual property or
subject matter that: (a) was owned or Controlled by the acquiring entity or its
Affiliates prior to the closing of such Change of Control of Amicus; or (b) any
intellectual property rights that the acquiring entity or any of its Affiliates
develops following a Change of Control of Amicus independently, outside of the
conduct of any activities under this Agreement, without using any of the (A)
Licensed Amicus Technology, or (B) any of the GSK Background IP or GSK
In-Licensed Background ERT IP; provided that:

 

12.2.1      Such acquiring entity’s and its Affiliates’ rights with respect to
the Co-Formulation Product IP and Program Improvements, including any
improvements made thereto by such acquiring entity or its Affiliates included
therein, shall also be subject to the terms of Section 10.4; and

 

12.2.2      if, in the period from the date on which the closing of such Change
of Control occurs and during the Term, the acquiring entity or any of its
Affiliates make any inventions (and file applications for and obtain Patents
claiming such inventions) as a result of such acquiring entity

 

******       - Material has been omitted and filed separately with the
Commission.

 

81

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

 

or its Affiliates using, pursuant to the license granted from GSK to Amicus in
Section 2.1.2, any Program Patents or Patents included in the Co-Formulation
Product IP and such inventions of such acquiring entity or its Affiliates are
dominated by the Program Patents or Patents included in the Co-Formulation
Product IP, then such inventions of the acquiring entity and its Affiliates and
any Patents claiming such inventions shall be deemed to be licensed to GSK
pursuant to Section 2.1.1 above.

 

12.3        Other Matters.  For the avoidance of doubt, except as set out in
this Article XII, a Change of Control of Amicus shall not otherwise affect the
rights or obligations of the Parties with respect to the Compound and Products
in the Amicus Territory or the GSK Territory under this Agreement, and shall not
be deemed to modify or expand the scope of either Party’s rights under Article
II above.

 

12.4        Disputes.  Any dispute regarding this Article XII of the Agreement
shall be resolved in accordance with the dispute resolution procedures set forth
in Section 16.2 of the Agreement.

 

XIII.       TERM AND TERMINATION

 

13.1        Term.  This Agreement shall commence on the Restatement Effective
Date, and unless terminated earlier as provided in this Article 12.1, shall
continue in full force and effect so long as a Party is Commercializing a
Product pursuant to this Agreement (the “Term”).

 

13.2        Termination for Material Breach.

 

13.2.1      In the event that Amicus is in material default or material breach
of any of its obligations hereunder, and Amicus fails to remedy such default or
breach within a period of ****** after written notice thereof was provided to
Amicus by GSK, GSK may terminate this Agreement, by written notice to Amicus, as
follows:

 

(a)           in its entirety, (i) if Amicus is in material breach or material
default of its obligations under ****** or under ******; or (ii) pursuant to
******, if Amicus fails to perform its obligations under ****** or Section
10.1.1 (******) (it being understood that the ******cure period specified above
shall not apply in the case of such termination pursuant to ******); or

 

(b)           solely with respect to the affected Product, if: (i) Amicus is in
material breach or material default of its payment obligations under ******,
******, ******, with respect to such Product; or (ii) Amicus fails to conduct
the Development activities allocated to Amicus under and in accordance with this
Agreement and the relevant Development Plan for a Product, including a material
breach or material default to bear Amicus’ share of the Development Costs under
a particular Development Plan in accordance with Section 5.1.4 and Schedule
5.1.4, (iii) Amicus fails to make payments as required in accordance with
Section 6.5 or the applicable Supply Agreement with respect to such Product(s),
or (iv) Amicus is in material breach of any of the representations or

 

******       - Material has been omitted and filed separately with the
Commission.

 

82

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

 

warranties in Section 9.2 and such breach of such representations and warranties
have a material, adverse effect on the rights or obligations of GSK hereunder.

 

13.2.2      In the event that GSK is in material default or material breach of
any of its obligations hereunder, and fails to remedy such default or breach
within a period of ****** after written notice thereof was provided to GSK by
Amicus, Amicus may terminate this Agreement, by written notice to GSK, as
follows:

 

(a)           in its entirety, if: (i) GSK is in material breach or material
default of its obligations hereunder as a result of activities conducted ******;
or (ii) pursuant to Section 15.7.2, if ****** in each case with respect to the
conduct of Development activities with respect to a Product(s) (it being
understood that the ninety (90) day cure period specified above shall not apply
in the case of such termination in accordance with ******);

 

(b)           solely with respect to the affected Product (i.e., ******), if GSK
fails to conduct the Development activities allocated to GSK under and in
accordance with this Agreement and the relevant Development Plan for a Product,
including a material breach or material default to bear GSK’s share of the
Development Costs under a particular Development Plan in accordance with Section
5.1.4 and Schedule 5.1.4;

 

(c)           solely with respect to the Co-Formulation Product (i.e., in all
countries of the Territory), if (i) GSK is in material breach or material
default of its obligations pursuant to ****** as a result of GSK ******; or (ii)
GSK is in breach of any of the representations or warranties in Section 9.3 and
such breach of such representations and warranties have a material, adverse
effect on the rights or obligations of Amicus hereunder, or any of the covenants
in ******, ****** or ******;

 

(d)           solely with respect to a particular Expanded Major Market Country,
if GSK is in material breach or material default of its obligations under ******
in such Expanded Major Market Country;

 

(e)           to the extent such default or breach pertains to a particular
Product(s) in a particular Expanded Major Market Country(ies), then on an
affected Product-by-affected Product basis in each affected Expanded Major
Market Country(ies) in which GSK is in such material breach or material default.

 

Any termination by a Party pursuant to this Section 13.2 shall become effective
at the end of the applicable ****** cure period unless the breaching Party has
cured any such breach or default prior to the expiration of such ****** period.

 

13.3        Termination for Convenience.  GSK may terminate this Agreement in
its entirety, or on a Product-by-Product basis, or an Expanded Major Market
Country-by-Expanded Major Market Country basis, for any reason whatsoever, upon
****** prior written notice to Amicus; provided that

 

******       - Material has been omitted and filed separately with the
Commission.

 

83

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

 

GSK shall not have the right to terminate this Agreement with respect to the
Monotherapy Product in the Amicus Territory pursuant to this Section 13.3 prior
to earlier of: (i) ******, or (ii) the ****** anniversary of the Restatement
Effective Date; provided, however, that in the event of (A) a material change in
the applicable Law or applicable regulatory guidance in the GSK Territory with
respect to the applicable Product(s), that results in, or that is probable to
result in, the inability of GSK to obtain Marketing Approval for a Monotherapy
Product in any Expanded Major Market Country within the GSK Territory, or (B)
the occurrence of a material Safety Event with respect to the Monotherapy
Product, the foregoing restriction with respect to termination of this Agreement
by GSK pursuant to this Section 13.2 with respect to the Monotherapy Product
shall no longer apply and GSK shall have the right to exercise its termination
right upon ****** written notice as set forth above in this Section 13.3.

 

13.4        Bankruptcy.  Either Party may terminate this Agreement in its
entirety at any time during the Term by giving written notice to the other Party
if the other Party files in any court or agency pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or
for reorganization or for an arrangement or for the appointment of a receiver or
trustee of the Party or of its assets, or if the other Party is served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition will not be dismissed within ****** after the filing thereof, or if the
other Party makes a general assignment for the benefit of creditors.

 

13.5        By Mutual Consent.  The Parties may terminate this Agreement in its
entirety or on a Product-by-Product or country-by-country basis at any time and
for any reason during the Term upon their mutual written agreement.

 

XIV.       EFFECTS OF TERMINATION

 

14.1        Accrued Obligations.  The expiration or termination of this
Agreement for any reason shall not release either Party from any liability that,
at the time of such expiration or termination, has already accrued to the other
Party or that it is attributable to a period prior to such expiration or
termination, nor will any termination of this Agreement preclude either Party
from pursuing any and all rights and remedies it may have under this Agreement,
or at law or in equity, with respect to breach of this Agreement.

 

14.2        Rights upon Termination by GSK for Amicus Breach; Exercise by Amicus
of its Opt-Out Rights.  If GSK terminates this Agreement pursuant to Section
13.2, either in its entirety or with respect to a particular Product(s), or if
Amicus exercises its Co-Development Opt-Out Right pursuant to Section 5.4 with
respect to a particular Product(s) (including, for clarity, if Amicus exercises
its First Opt-Out Right or Second Opt-Out Right pursuant to Section 5.1.4(b)(ii)
with respect to a Co-Formulation Product), then the provisions of this Section
14.2 shall apply.  As used in this Section 14.2 below, “Affected Area” shall
mean the Amicus Territory and “Terminated Product(s)” shall mean the Compound
and all Products in the case of termination of this Agreement in its entirety,
or the terminated Product(s) in the case of termination of this Agreement with
respect

 

******       - Material has been omitted and filed separately with the
Commission.

 

84

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

 

to such Product(s), or if Amicus exercises its Co-Development Opt-Out Right, the
Product(s) for which Amicus has exercised such Co-Development Opt-Out Right.

 

14.2.1      Licenses.

 

(a)           Effective upon such termination or the Co-Development Opt-Out
Effective Date,  as applicable, and solely with respect to each of the
Terminated Product(s), the License in Section 2.1.1 shall terminate and shall be
replaced with the following:  Amicus hereby grants to GSK an exclusive, ******
and license, with the right to grant sublicenses, under all Licensed Amicus
Technology, to make, have made, use, sell, offer for sale, and import such
Terminated Product(s) in the Field and in the Territory.  For clarity, the
License in Section 2.1.1 shall not be amended or modified by this Section
14.2.1(a) for any non-Terminated Product and shall continue in effect in
accordance with its terms with respect to each non-Terminated Product
(including, for clarity, and if applicable, with respect to each Product for
which Amicus has not exercised its Opt-Out right).  The license granted by
Amicus to GSK in Section 2.1.2 shall also survive any such termination.

 

(b)           Effective upon such termination or the Co-Development Opt-Out
Effective Date, and solely with respect to each of the Terminated Product(s),
the rights and licenses granted by GSK to Amicus pursuant to Section 2.4.1 and,
if applicable, Section 2.4.2 above shall terminate; provided that Amicus shall
continue to have a non-exclusive license under the relevant intellectual
property described in such sections for the purposes of permitting Amicus to
comply with its obligations under this Section 14.2 for the applicable periods
described under this Section 14.2 below.  ******.

 

14.2.2      Assumption of Development and Commercialization Activities for
Terminated Product(s).  With respect to each of the Terminated Product(s),
following the effective date of any such termination or the Co-Development
Opt-Out Effective Date, as applicable, and in each case, in accordance with the
terms of this Section 14.2, ******.

 

14.2.3      Payment Obligations.  Subject to Sections 14.1 and 14.2.4, all of
Amicus’ payment obligations under Section 3.3, Section 3.4 and Section 5.1 with
respect to the Terminated Product(s) shall terminate effective as of the
effective date of such termination or the Co-Develoment Opt-Out Effective Date,
as applicable, and thereafter, GSK shall make the following payments to Amicus
with respect to the Terminated Product(s), as follows:

 

(a)           Milestones Payments:  GSK will pay to Amicus the milestone
payments set out below following the first achievement by GSK, its Affiliate or
Sublicensee of each of the corresponding milestone events that are achieved
after the effective date of such termination or the Co-Development Opt-Out
Effective Date, as applicable, such milestone payment to be made by GSK no later
than ****** following the receipt of an invoice from Amicus therefor.  GSK shall
notify Amicus in writing promptly, but in no event later than ****** after the
first achievement of

 

******       - Material has been omitted and filed separately with the
Commission.

 

85

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

 

each of the following milestone events, and no invoice for payment of a
milestone shall be sent by Amicus to GSK as provided herein prior to Amicus’s
reasonable determination that the corresponding milestone event has been
achieved.  Each of the following milestone payments shall be payable only once
with respect to the first Terminated Product (other than a Co-Formulation
Product) to achieve such milestone event, regardless of the number of times such
Terminated Product or any other Terminated Product achieves the milestone event,
and no milestones shall be paid by GSK for milestone events that are not
achieved after the effective date of such termination or the Co-Development
Opt-Out Effective Date, as applicable.  For clarity, no milestone payments shall
be made with respect to a Terminated Product that is a Co-Formulation Product.

 

Filing and Approval Milestone Event

 

Milestone Payment

 

1. ******

 

$

******

 

2. ******

 

$

******

 

3. ******

 

$

******

 

 

Sales Performance Milestones

 

Milestone Payment

 

4. ******

 

$

******

 

5. ******

 

$

******

 

 

For purposes of Milestone 4 and Milestone 5 in the table set forth above and the
calculation of the royalty tiers in the table set forth in Sections
14.2.3(b)(i)(a) below, if the Terminated Product(s) is a Product(s) other than a
Co-Formulation Product, the Net Sales of all such Terminated Products in the
United States ******.

 

(b)           Royalties.

 

(i)        Subject to Section 14.2.3(b)(ii), (iii), (iv) and (v) below, from and
after (A) the effective date of such termination or the Co-Development Opt-Out
Effective Date, as applicable, or (B) the date of Launch of the applicable
Terminated Product, whichever of (A) or (B) is the later to occur, GSK shall pay
to Amicus royalties as set forth in clause a) or b) of this Section
14.2.3(b)(i), as applicable, based on the Net Sales of the applicable Terminated
Product(s) in the Affected Area during a particular calendar year, on a
Terminated Product-by-Terminated Product basis, for the longer of (x) ******,
(y) ******, or (z) ****** (the “GSK Terminated Product Royalty Term”).  Upon the
expiration of the GSK Terminated Product Royalty Term for a particular
Terminated Product and GSK’s obligations under Sections 3.4.3(b) and
14.2.3(b)(iv)b), GSK’s license with respect to such Terminated Product as set
forth in Section 14.2.1 shall become a royalty-free, fully paid-up license.

 

******       - Material has been omitted and filed separately with the
Commission.

 

86

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

 

a)            With respect to a Terminated Product that is a Product other than
a Co-Formulation Product:

 

Net Sales of the Terminated Product in the United States in a
particular calendar year

 

Royalty

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

 

b)            With respect to a Terminated Product that is a Co-Formulation
Product:

 

Net Sales of the Terminated Product in the United States in a particular
calendar year

 

Royalty

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

 

(ii)       ******.

 

(iii)      Generic Equivalent.  During the GSK Terminated Product Royalty Term,
on a Terminated Product-by-Terminated Product basis, if the cumulative unit
volume of Generic Equivalent(s) sold by Third Parties in the Affected Area are
equal to or greater than ****** of the combined unit volume of the applicable
Terminated Product and such Generic Equivalent(s) for all indications in the
aggregate in the Affected Area in any calendar quarter determined by the number
of prescriptions given for such Terminated Product and such Generic
Equivalent(s), in the aggregate during such calendar quarter in the Affected
Area (as measured by a Scott Levin Associates audit or other mechanism mutually
agreed by the Parties), then the royalty rates applicable to Net Sales of such
Terminated Product in the Affected Area shall be ****** of the applicable
royalty rates specified above in clause a) or b) of Section 14.2.3(b)(i), as
applicable, with respect to Net Sales of such Terminated Product for so long as
such competition exists, and such reduced royalty shall be paid by GSK for the
shorter of ****** from the date upon which GSK’s

 

******       - Material has been omitted and filed separately with the
Commission.

 

87

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

 

royalty obligations were reduced pursuant to this Section 14.2.3(b)(iii) as a
result of the sales of such Generic Equivalent(s) in the Affected Area, or
****** from the date of the first Launch of such Terminated Product in the
Affected Area, after which time, and subject to GSK’s obligations under Sections
3.4.3(b) and 14.2.3(b)(iv)b), GSK’s license with respect to such Terminated
Product as set forth in Section 14.2.1 shall become a fully paid-up,
royalty-free right and license.

 

(iv)     Third Party Payments.

 

a)            During the GSK Terminated Product Royalty Term for a particular
Terminated Product, any milestones, royalties and/or other license payments
actually paid to a Third Party by GSK, its Affiliates, or Sublicensees under a
written license agreement covering intellectual property in the Affected Area
which, following a reasonable evaluation in accordance with normal business
practice, GSK determines is necessary to enable GSK to Develop, Manufacture or,
use, import, offer for sale, sell or otherwise Commercialize such Terminated
Product in the Affected Area in accordance with this Agreement such that, absent
such Third Party license the Development, Manufacture or Commercialization of
such Terminated Product in the Affected Area would infringe such Third Party
intellectual property, then such payments shall be creditable by GSK against
royalties payable to Amicus under this Section 14.2.3(b); provided that the
royalties due by GSK to Amicus with respect to such Terminated Product in any
Quarter shall not be so reduced by more than ****** of the royalties that would
otherwise be payable by GSK to Amicus with respect to such Terminated Product
for such Quarter; provided further that GSK can credit the remainder of such
amounts paid to such Third Party against future royalties payable to Amicus by
GSK.

 

b)            The obligations of GSK under Section 3.4.3(a)(ii) shall survive
any such termination by GSK or any exercise by Amicus of its Co-Development
Opt-Out Right, and shall continue in effect in accordance with its terms
following such termination or the Co-Development Opt-Out Effective Date, as
applicable, and in addition, from and after the effective date of such
termination or the Co-Development Opt-Out Effective Date, as applicable, the
obligations of GSK under Section 3.4.3(a)(ii) shall automatically expand to
include payments owed by Amicus pursuant to the Mount Sinai Agreement as a
result of the Manufacture or Commercialization of the Terminated Product(s) in
the Affected Area.  In addition, in accordance with Section 14.2 above, from and
after of the date of termination of this Agreement by GSK with respect to the
Co-Formulation Product, or the date of the Co-Development Opt-Out Effective Date
with respect to a Co-Formulation Product, as applicable, ******.

 

(v)      If (A) GSK terminates this Agreement in its entirety or with with
respect to a Product, in each case, pursuant to Section 13.2 or (B) Amicus
exercises its Co-Development Opt-Out Right pursuant to Section 5.4 with respect
to the Co-Formulation Product (and not, for clarity, if Amicus exercises its
Co-Development Opt-Out Right pursuant to Section 5.4 with respect to any Product
other than the Co-Formulation Product), GSK may off-set Amicus’ share
(determined in accordance with Section 5.1.5) of any documented Development
Costs (calculated in

 

******       - Material has been omitted and filed separately with the
Commission.

 

88

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

 

the same manner as specified in Schedule 5.1.5) that GSK incurs directly as a
result of the assumption, and the conduct of any Development activities
allocated to Amicus under the relevant Development Plan for the Terminated
Product(s) in effect as of the date of any such termination or the relevant
Co-Development Opt-Out Effective Date, as applicable, that are assumed by GSK
following such effective date of termination or such Co-Development Opt-Out
Effective Date, as applicable, against any milestone or royalty payments owed by
GSK to Amicus pursuant to Section 14.2.3(a) or (b).

 

(vi)     Solely in the case that Amicus exercises its Co-Development Opt-Out
Right pursuant to Section 5.4 with respect to any Product other than the
Co-Formulation Product (and not for clarity GSK if terminates this Agreement
pursuant to Section 13.2 or if Amicus exercises its Co-Development Opt-Out Right
pursuant to Section 5.4 with respect to the Co-Formulation Product), prior to
any reduction that may be taken pursuant to Section 14.2.3(b)(ii) or (iii)
above, ******.

 

(vii)    For purposes of this Section 14.2, “Valid Claim” shall have the meaning
given to such term in Section 1.199 above; it being understood that, for
purposes of this Section 14.2, references to a “Product” in Section 1.199 shall
be deemed to refer to the applicable Terminated Product(s).

 

(viii)   Commencing with the first Quarter in which Net Sales of a Terminated
Product(s) for which GSK owes a royalty to Amicus in accordance with Section
14.2.3(b) and for each Quarter thereafter in which GSK, or any of its Affiliates
or Sublicensees sell a Terminated Product(s), GSK shall, within ****** after the
end of the applicable Quarter, submit to Amicus, together with GSK’s payment for
the royalties due for each Quarter, a written report showing the Net Sales of
Terminated Products, and any royalties payable by GSK pursuant to Section
14.2.3(b).  Such reports shall be in the format reasonably requested by Amicus
and shall include such information regarding the Net Sales of such Terminated
Products and calculation of such royalties as may be reasonably requested by
Amicus, including to permit Amicus to comply with its obligations under any
Background License Agreement.

 

14.2.4      Development.  In the event that, on the date of notice of such
termination or the date of the relevant Co-Development Opt-Out Notice, as
applicable, Amicus is conducting any ongoing clinical trials of any Terminated
Product(s) in the Affected Area, to the extent and as requested by GSK, Amicus
will promptly transition such ongoing clinical trial(s) to GSK or its designee
following the effective date of termination or the date of such Co-Development
Opt-Out Notice.  During the shorter of (a) the period in which Amicus is
performing transition activities in accordance with this Section 14.2.4, or (b)
for ****** following the effective date of such termination or the
Co-Development Opt-Out Effective Date, as applicable, Amicus will remain
responsible for Amicus’ share under Sections 5.1.4 and 5.1.5 of (i) any
Development Costs incurred in the continued conduct of such ongoing clinical
trials and (ii) any Out-of-Pocket Expenses incurred

 

******       - Material has been omitted and filed separately with the
Commission.

 

89

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

 

by Amicus or GSK to transition any such ongoing clinical trials (or portion
thereof) to GSK or its designee, as requested by GSK.

 

14.2.5      Committees.  For the avoidance of doubt, upon termination by GSK of
this Agreement in its entirety pursuant to Section 13.2 or if Amicus exercises
its Co-Development Opt-Out Right pursuant to Section 5.4 with respect to all
Products, the Joint Steering Committee and all Subcommittees (other than the
Joint Patent Subcommittee) shall cease to exist and, subject to this Section
14.2.5 below, all obligations of the Joint Steering Committee and such
Subcommittees shall vest exclusively in GSK, including the right to make a final
decision on matters originally within the scope of responsibilities of the Joint
Steering Committee, or any relevant Subcommittee, as applicable, subject to
Section 4.4.  Notwithstanding the foregoing, GSK shall not have the right to
terminate and dissolve the Joint Patent Subcommittee, and the Joint Patent
Subcommittee shall continue in effect with the responsibilities described in,
and decisions made in accordance with, Section 4.2.1 until the last Patent
application included within the Licensed Amicus Technology or Program Patents or
Co-Formulation Product IP Controlled by Amicus has been granted or rejected in a
final, unappealable decision by the relevant governmental authority after which
GSK may terminate and dissolve the Joint Patent Subcommittee, and all
obligations of the Joint Patent Subcommittee shall vest exclusively in GSK,
including the right to make a final decision on matters originally within the
scope of responsibilities of the Joint Patent Subcommittee, except that Amicus,
not GSK, shall have the right to make the final decision with respect to any
matter pertaining to (a) an Amicus Prosecuted Patent or (b) a Program Patent or
Patent within the Co-Formulation Product IP, in either case, Controlled by
Amicus.  For the avoidance of doubt, in the event that GSK terminates the
Agreement pursuant to Section 13.2 with respect to a particular Product, but
does not terminate the Agreement in its entirety, or if Amicus exercises its
Co-Development Opt-Out Right pursuant to Section 5.4 with respect to a
particular Product, but not all Products, as applicable, then the JSC and all
Subcommittees (other than the Joint Patent Subcommittee) shall continue solely
with respect to the Products with respect to which this Agreement has not been
terminated and the Joint Patent Subcommittee shall continue with respect to both
the Terminated Product(s) and any Product(s) with respect to which this
Agreement has not been terminated or with respect to which Amicus has not
exercised its Co-Development Opt-Out Right, as applicable.

 

14.2.6      Additional Matters.

 

(a)           Subject to Section 14.2.5, from and after any termination of this
Agreement by GSK pursuant to Section 13.2 or the Co-Development Opt-Out
Effective Date, as applicable, all of the Parties rights and obligations under
Articles VII and VIII with respect to the Licensed Amicus Technology, Program
Patents, Program Improvements, and Co-Formulation Product IP shall survive.

 

(b)           From and after the termination of this Agreement by GSK pursuant
to Section 13.2 with respect to one or more Products, but not this Agreement in
its entirety, or from and after Amicus’ exercise of its Co-Development Opt-Out
Right with respect to one or more Products,

 

******       - Material has been omitted and filed separately with the
Commission.

 

90

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

 

but not all Products, all of the Parties’ rights and obligations with respect to
the Development and Commercialization activities for any and all non-terminated
Products shall survive unchanged and continue in full force and effect.

 

14.2.7      Non-Compete.  From and after any termination of this Agreement by
GSK pursuant to Section 13.2 or Amicus’ exercise of its Co-Development Opt-Out
Right pursuant to Section 5.4, as applicable, ******.

 

14.2.8      Transition.  Without limiting the foregoing, following such
termination of this Agreement pursuant to Section 13.2, or the Co-Development
Opt-Out Effective Date, as applicable, Amicus shall use Commercially Reasonable
Efforts to cooperate with GSK and/or its designee to effect a smooth and orderly
transition of any Development activities with respect to the Terminated
Product(s) that were, prior to such termination or Co-Development Opt-Out
Effective Date, as applicable, allocated to Amicus under the applicable
Development Plan, and to effect a smooth and orderly transition of any
Commercialization activities with respect to such Terminated Product(s)
conducted by Amicus prior to such termination.

 

14.2.9      Commercialization.  Solely in the case of a termination of this
Agreement by GSK pursuant to Section 13.2, to avoid disruption of supply of any
Terminated Product(s) to patients if termination occurs after the Launch of a
Terminated Product(s) in the Affected Area, Amicus, its Affiliates and
Sublicensees shall continue to sell the Terminated Product(s) in the Affected
Area in accordance with the terms and conditions of this Agreement, for up to
****** or such shorter period of time as requested by GSK as provided below,
after the effective date of any such termination of this Agreement with respect
to any such Terminated Product(s) (“Amicus Wind-Down Period”); provided that GSK
may terminate the Amicus Wind-Down Period in the Affected Area upon ******
written notice to Amicus; provided further that (i) Amicus shall not be
obligated to promote the sale of such Terminated Products in the Affected Area
during the Amicus Wind-Down Period; and (ii) if the Terminated Product is a
Co-Formulation Product, then GSK shall continue to supply Amicus with its (and
its Affiliates’ and sublicensees’) reasonable requirements of such Terminated
Product for such purposes.  Within ****** following the expiration of the Amicus
Wind-Down Period, Amicus shall notify GSK of any quantities of the Terminated
Product(s) remaining in Amicus’ or its Affiliates’ inventory and GSK shall have
the option, upon notice to Amicus, to repurchase any such quantities of the
Terminated Product(s) from Amicus at a price equal to Amicus’ Manufacturing
Costs.  If GSK so elects to purchase any remaining quantities of the Terminated
Product(s) from Amicus as set forth herein, Amicus will transfer to GSK such
quantities of inventory of the Terminated Product(s).

 

14.2.10    Regulatory Filings.  Following termination of this Agreement by GSK
pursuant to Section 13.2, or the date of the Co-Development Opt-Out Notice, as
applicable, and at GSK’s written election, Amicus will assign and transfer (or
cause to be assigned and transferred) to GSK or its designee (or to the extent
not so assignable, Amicus shall take all reasonable action to make available to
GSK or its designee the benefits of) all regulatory submissions and filings and

 

******       - Material has been omitted and filed separately with the
Commission.

 

91

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

 

marketing approvals (including all INDs, MAAs and Marketing Approvals)
Controlled by Amicus pertaining solely to the Terminated Product(s) in the
Affected Area.  In each case, unless otherwise required by any applicable Law,
Amicus shall use all reasonable efforts to make such foregoing assignment (or
availability), within ****** after the effective date of any such termination or
the Co-Development Opt-Out Effective Date, , as applicable, (or, with respect to
any such regulatory filings pertaining to an Ongoing Trial that Amicus is
continuing to conduct pursuant to Section 14.2.4 above, within ****** after the
completion of such Ongoing Trial), provided, however, that in the event that
Amicus is unable to make such assignment or to make such regulatory filings
available to GSK within ****** after the effective date of any such termination
(or the completion of such Ongoing Trial, as applicable) or the Co-Development
Opt-Out Effective Date, as applicable, due to factors beyond Amicus’ reasonable
control, then Amicus shall so notify GSK (including the reason for any such
delay) prior to the expiration of such ****** period and the Parties shall
mutually agree (such agreement not to be unreasonably withheld by either Party)
an appropriate extension to such ****** period.

 

14.3        Rights upon Termination by Amicus for GSK Breach; or Termination by
GSK for Convenience.  If (a) Amicus terminates this Agreement in its entirety,
or terminates with Agreement with respect to a particular Product(s) or with
respect to a particular Product in one or more Expanded Major Market
Country(ies), in each case, pursuant to Section 13.2 or (b) if GSK terminates
this Agreement in its entirety or terminates this Agreement with respect to a
particular Product(s), or terminates an Expanded Major Market Country, in each
case pursuant to Section 13.3, then the provisions of this Section 14.3 shall
apply.  As used in this Section 14.3 below: “Terminated Product(s)” shall mean
the Compound and all Products in the case of termination of this Agreement in
its entirety, or the terminated Product(s) in the case of termination of this
Agreement with respect to such Product(s); and “Affected Area” shall mean all
countries within the GSK Territory if this Agreement is terminated in its
entirety or with respect to a particular Product(s), or the specific terminated
Expanded Major Market Country(ies) in the case of termination of this Agreement
with respect to such Expanded Major Market Country(ies).

 

14.3.1      Licenses.

 

(a)           The licenses granted by GSK to Amicus pursuant to Sections 2.4 and
2.5 above shall survive such termination, except that from and after such
termination such licenses and rights shall also be expanded as follows: (i) if
this Agreement is terminated in its entirety for all Products or with respect to
a particular Product, the license and rights in clause (i) of Section 2.4.1 and,
if applicable, clause (i) of Section 2.4.2 shall convert to an exclusive
license, with the right to grant sublicenses, to Develop the Terminated
Product(s) in the Field in the Territory; (ii) the license and rights granted by
GSK to Amicus in clause (ii) of Section 2.4.1 shall expand to include the right
to make and have made and otherwise Manufacture a Terminated Product (other than
a Co-Formulation Product) for the purpose of use, sale and/or other
Commercialization in the Amicus Territory and/or the Affected Area and (ii) the
license and rights granted by GSK to Amicus in clause (iii) of Section 2.4.1
and, if applicable, clause (ii) of Section 2.4.2 shall convert to an

 

******       - Material has been omitted and filed separately with the
Commission.

 

92

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

 

exclusive (even as to GSK) license, with the right to grant sublicenses, to use,
sell, offer for sale, import and otherwise Commercialize the relevant
Termination Product(s) in the Field in the Amicus Territory and/or the Affected
Area.  Further, Section 2.4.2(b) shall survive and shall be deemed to be amended
as follows:  the words “and/or the Affected Area” shall be deemed to be added
after each reference to “the Amicus Territory” in Section 2.4.2(b).

 

(b)           Following the effective date of termination, the License granted
by Amicus to GSK under the Licensed Amicus Technology, solely with respect to
the Terminated Product(s) in the Affected Area, shall convert to a non-exclusive
license and shall be limited to the use of the Licensed Amicus Technology: (i)
for the purposes of permitting GSK to comply with its obligations under this
Section 14.3 for the applicable periods described under this Section 14.3 below;
and (ii) to make and/or have made the Terminated Product(s) in the Affected Area
solely for use and sale (A) by GSK, its Affiliates or Sublicensees within the
GSK Territory, excluding the Affected Area, or (B) if the Terminated Product is
a Co-Formulation Product, for supply to Amicus pursuant to Section 6.5.4 and/or,
if applicable, Section 6.5.5 and the Supply Agreement, unless or until this
Agreement is terminated in its entirety.  Except as provided in the preceding
sentence for the applicable periods described in such sentence, the License, and
all of GSK’s rights, under the Licensed Amicus Technology with respect to the
Terminated Product(s) in the Affected Area shall terminate and shall
automatically revert to Amicus upon any such termination of this Agreement.

 

14.3.2      Assumption of Development and Commercialization Activities for
Terminated Product(s) in the relevant terminated Expanded Major Market
Country(ies).  With respect to each of the Terminated Product(s) in the Affected
Area, following the effective date of any such termination and in each case, in
accordance with this Section 14.3, ******.

 

14.3.3      Payment Obligations.  Subject to Sections 14.1 and 14.3.4, all of
GSK’s payment obligations under Section 5.1 with respect to the Terminated
Product(s) shall terminate effective as of the effective date of any such
termination by Amicus, and thereafter, Amicus shall make the following payments
to GSK with respect to the Terminated Product(s)

 

(a)           Milestones Payments:  Following the effective date of any such
termination by Amicus pursuant to Section 13.2 or by GSK pursuant to Section
13.3, Amicus will make milestone payments to GSK with respect to each Terminated
Product and the Affected Area, as set forth in this Section 14.3.3(a).  Amicus
will pay to GSK the milestone payments set out below following the first
achievement by Amicus, its Affiliate or Sublicensee of each of the corresponding
milestone events that are achieved after the effective date of such termination,
such milestone payment to be made by Amicus to GSK no later than ******
following the receipt of an invoice from GSK therefor.  Amicus shall notify GSK
in writing promptly, but in no event later than ****** after the first
achievement of each of the following milestone events, and no invoice for
payment of a milestone shall be sent by GSK to Amicus as provided herein prior
to GSK’s reasonable determination that the corresponding milestone event has
been achieved.  Each of the following milestone payments shall be payable only
once with respect to the first Terminated Product (other

 

******       - Material has been omitted and filed separately with the
Commission.

 

93

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

 

than a Co-Formulation Product) to achieve such milestone event, regardless of
the number of times such Terminated Product or any other Terminated Product(s)
achieves the milestone event, and no milestones shall be paid or payable by
Amicus for milestone events that are not achieved after the effective date of
such termination. For clarity, no milestone payments shall be made with respect
to a Terminated Product that is a Co-Formulation Product.

 

Filing and Approval Milestone Event

 

Milestone Payment

 

1.******

 

******

 

2.******

 

******

 

3.******

 

******

 

 

Sales Performance Milestones

 

Milestone Payment

 

4.******

 

******

 

5.******

 

******

 

 

For purposes of Milestone 4 and Milestone 5 in the table set forth above and the
calculation of the royalty tiers in the table set forth in Sections 14.3.3
(b)(i)(a) below, if the Terminated Product(s) is a Product(s) other than a
Co-Formulation Product, the Net Sales of all such Terminated Products in the
applicable Expanded Major Market Country ******.

 

(b)           Royalties.

 

(i)        Following the effective date of any such termination by Amicus
pursuant to Section 13.2, and subject to Section 14.3.3(b)(ii), (iii), (iv) and
(v) below, from and after the effective date of such termination or the date of
Launch of the applicable Terminated Product in the Affected Area, whichever is
later, Amicus shall pay to GSK royalties as set forth in clause a) or b) of this
Section 14.3.3(b)(i), as applicable, based on the Net Sales of the applicable
Terminated Product(s) in the relevant Affected Area during a particular calendar
year, on a Terminated Product-by-Terminated Product basis, and
country-by-country basis, for the longer of (x) ******, (y) ******, or (z)
****** (the “Amicus Terminated Product Royalty Term”).  Upon the expiration of
the Amicus Terminated Product Royalty Term for a particular Terminated Product,
and subject to Section 14.3.3(b)(iv)(b) below if the Terminated Product is a
Royalty-Bearing Co-Formulation Product, Amicus’ license with respect to such
Terminated Product as set forth in Section 14.3.1 shall become a royalty-free,
fully paid-up license.

 

a)            With respect to a Terminated Product other than a Co-Formulation
Product:

 

******       - Material has been omitted and filed separately with the
Commission.

 

94

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

 

Net Sales of Terminated Product in an Expanded Major Market
Country in the Affected Area in a particular calendar year

 

Royalty

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

 

b)            With respect to a Terminated Product that is a Co-Formulation
Product:

 

Net Sales of Terminated Product in an Expanded Major Market
Country in the Affected Area in a particular calendar year

 

Royalty

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

******

 

 

(ii)       If, at any time during the applicable Amicus Terminated Product
Royalty Term, the only Valid Claim covering the relevant Terminated Product in
the applicable country of the Affected Area is a Valid Claim of a Joint Program
Patent, then the royalty rate for such Terminated Product during the applicable
period shall be reduced by ****** of the applicable royalty rates set forth in
the table above; it being understood that if during such Amicus Terminated
Product Royalty Term, such Terminated Product becomes covered by any other Valid
Claim in the Affected Area, the applicable royalty rate shall be the full rate
set forth in the table above.

 

(iii)      Generic Equivalent.  During the Amicus Terminated Product Royalty
Term, on a Terminated Product-by-Terminated Product and country-by-country
basis, if the cumulative unit volume of Generic Equivalent(s) sold by Third
Parties in the applicable country of the Affected Area are equal to or greater
than ****** of the combined unit volume of the applicable Terminated Product and
such Generic Equivalent(s) for all indications in the aggregate in such country
in the Affected Area in any calendar quarter determined by the number of
prescriptions given for the Terminated Product and such Generic Equivalent(s),
in the aggregate during such calendar quarter in such country in the Affected
Area (as measured by a Scott Levin Associates audit

 

******       - Material has been omitted and filed separately with the
Commission.

 

95

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

 

or other mechanism mutually agreed by the Parties), then the royalty rates
applicable to Net Sales of the Terminated Product in such country in the
Affected Area shall be ****** of the royalty rates specified above in clause a)
or b) of Section 14.3.3(b)(i), as applicable, with respect to the Net Sales of
such Terminated Product in such country in the Affected Area for so long as such
competition exists, and such reduced royalty shall be paid by Amicus for the
shorter of ****** from the date upon which Amicus’ royalty obligations were
reduced pursuant to this Section 14.3.3(b)(iii) as a result of the sales of such
Generic Equivalent(s) in such country in the Affected Area, or ****** from the
date of the first Launch of the Terminated Product in such country in the
Affected Area, after which time, and subject to Section 14.3.3(b)(iv)b) if the
Terminated Product is a Royalty Bearing Co-Formulation Product, Amicus’ license
rights with respect to such Terminated Product as set forth in Section 14.3.1
shall become a fully paid-up and royalty-free.

 

(iv)     Third Party Payments.

 

a)            During the Amicus Terminated Product Royalty Term for a particular
Terminated Product, any milestones, royalties and/or other license payments
actually paid to a Third Party by Amicus, its Affiliates, or Sublicensees under
a written license agreement covering intellectual property in the Affected Area
which, following a reasonable evaluation in accordance with normal business
practice, Amicus determines is necessary to enable Amicus to Develop,
Manufacture or, use, import, offer for sale, sell or otherwise Commercialize
such Terminated Product in the Affected Area in accordance with this Agreement
such that, absent such Third Party license the Development, Manufacture or
Commercialization of such Terminated Product in the Affected Area would infringe
such Third Party intellectual property, then such payments shall be creditable
by Amicus against royalties payable to GSK under this Section 14.3; provided
that the royalties due by Amicus to GSK with respect to such Terminated Product
in any Quarter shall not be so reduced by more than ****** of the royalties that
would otherwise be payable by Amicus to GSK with respect to such Terminated
Product for such Quarter; provided further that Amicus can credit the remainder
of such amounts paid to such Third Party against future royalties payable to GSK
by Amicus.

 

b)            The obligations of GSK under Section 3.4.3(a)(ii) shall terminate
solely with respect to the Terminated Product(s) in the Affected Area upon the
effective date of termination and thereafter Amicus shall be responsible for any
payments owed by Amicus pursuant to the Mount Sinai Agreement as a result of the
Manufacture or Commercialization of such Terminated Product(s) in the Affected
Area. Only if the Terminated Product is a Royalty-Bearing Co-Formulation
Product, the obligations of Amicus, and the rights of GSK, under Section 3.4.1
shall survive any such termination and, from and after the effective date of
such termination, shall automatically expand to include payment of a ******
royalty on Net Sales of such Terminated Product constituting a Royalty-Bearing
Co-Formulation Product as owed by GSK pursuant to the GSK/JCR Master Agreement
as a result of Net Sales of such Terminated Product constituting a
Royalty-Bearing Co-Formulation Product in the Affected Area.

 

******       - Material has been omitted and filed separately with the
Commission.

 

96

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

 

(v)      Amicus may off-set GSK’s share (determined in accordance with Section
5.1.5) of any documented Development Costs (calculated in the same manner as
specified in Schedule 5.1.5) that Amicus incurs directly as a result of the
assumption, and the conduct of any Development activities in the Affected Area
allocated to GSK under the relevant Development Plan for the Terminated
Product(s) in effect as of the date of any such termination that are assumed by
Amicus following such effective date of termination against any milestone or
royalty payments owed by Amicus to GSK pursuant to Section 14.3.3(a) or (b).

 

(vi)     Commencing with the first Quarter in which Net Sales of a Terminated
Product(s) for which Amicus owes a royalty to GSK in accordance with Section
14.3.3(b) and for each Quarter thereafter during the Term, Amicus shall, within
****** after the end of the applicable Quarter, submit to GSK, together with
Amicus’ payment for the royalties due for each Quarter, a written report showing
the Net Sales of Terminated Products and any royalties payable by Amicus
pursuant to Section 14.3.3(b).  Such reports shall be in the format reasonably
requested by GSK and shall include such information regarding the Net Sales of
Products and calculation of such royalties as may be reasonably requested by
GSK.

 

(vii)    For purposes of this Section 14.3, “Valid Claim” shall have the meaning
given to such term in Section 1.199 above, it being understood that for purposes
of this Section 14.3, references to a “Product” in Section 1.199 shall be deemed
to refer to the applicable Terminated Product.

 

14.3.4      Development.  In the event that, on the date of notice of such
termination, there are any ongoing clinical trials of any Terminated Product(s)
in the Affected Area (or, if the Affected Area is less than the entire world,
any ongoing clinical trials of any Terminated Product(s) that are specifically
directed to the requirements of an Expanded Major Market Country or other
country within the Affected Area), to the extent and as requested by Amicus,
following the effective date of termination, GSK will promptly transition to
Amicus or its designee such ongoing clinical trials.  During the shorter of (a)
the period in which GSK is performing transition activities in accordance with
this Section 14.3.4, or (b) for ****** following the effective date of such
termination, GSK will remain responsible for GSK’s share under Sections 5.1.4
and 5.1.5 of (i) any Development Costs incurred in the continued conduct of such
ongoing clinical trials and (ii) any Out-of-Pocket Expenses incurred by GSK or
Amicus to transition any such ongoing clinical trials (or portion thereof) to
Amicus or its designee, as requested by Amicus.

 

14.3.5      Committees.  For the avoidance of doubt, upon termination of this
Agreement in its entirety by Amicus pursuant to Section 13.2 or by GSK pursuant
to Section 13.3, as applicable, the Joint Steering Committee and all
Subcommittees (other than the Joint Patent Subcommittee) shall cease to exist
and, subject to this Section 14.3.5 below, all obligations of the Joint Steering
Committee and such Subcommittees shall vest exclusively in Amicus, including the
right to make a final decision on matters originally within the scope of
responsibilities of the Joint Steering Committee or the relevant Subcommittee,
as applicable, subject to Section 4.4.  Notwithstanding the

 

******       - Material has been omitted and filed separately with the
Commission.

 

97

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

 

foregoing, Amicus shall not have the right to terminate and dissolve the Joint
Patent Subcommittee, and the Joint Patent Subcommittee shall continue in effect
with the responsibilities described in, and decisions made in accordance with,
Section 4.2.1 until the last Patent application included within the Licensed
Amicus Technology or Program Patents or Co-Formulation Product IP Controlled by
GSK has been granted or rejected in a final, unappealable decision by the
relevant governmental authority after which Amicus may terminate and dissolve
the Joint Patent Subcommittee, and all obligations of the Joint Patent
Subcommittee shall vest exclusively in Amicus, including the right to make a
final decision on matters originally within the scope of responsibilities of the
Joint Patent Subcommittee.  For the avoidance of doubt, in the event that this
Agreement is terminated with respect to a particular Product and/or with respect
to a particular Expanded Major Market Country(ies), but the Agreement is not
terminated in its entirety, then the JSC and all Subcommittees (other than the
Joint Patent Subcommittee) shall continue solely with respect to the Products
and countries with respect to which this Agreement has not been terminated and
the Joint Patent Subcommittee shall continue with respect to both the Terminated
Product(s) and any Product(s) with respect to which this Agreement has not been
terminated.

 

14.3.6      Additional Matters.

 

(a)           Subject to Section 14.3.5, from and after any termination of this
Agreement by Amicus pursuant to Section 13.2, all of the Parties rights and
obligations under Articles VII and VIII with respect to the Licensed Amicus
Technology, Program Patents, Program Improvements, and Co-Formulation Product IP
shall survive .

 

(b)           From and after any termination of this Agreement by Amicus
pursuant to Section 13.2 with respect to one or more Product(s) or one or more
Expanded Major Market Country(ies), but not this Agreement in its entirety, all
of the Parties’ rights and obligations with respect to the Development and
Commercialization activities for any and all non-terminated Products and
non-terminated Expanded Major Market Countries and other countries within the
Territory shall survive unchanged and in full force and effect.

 

14.3.7      Non-Compete.  From and after any termination of this Agreement by
Amicus pursuant to Section 13.2 or by GSK pursuant to Section 13.3, ******.

 

14.3.8      Transition.  Without limiting the foregoing, following such
termination of this Agreement, GSK shall use Commercially Reasonable Efforts to
cooperate with Amicus and/or its designee to effect a smooth and orderly
transition of the Development activities with respect to the Terminated
Product(s) in the Affected Area that were, prior to such termination, allocated
to GSK under the applicable Development Plan, and to effect a smooth and orderly
transition of all Commercialization activities with respect to such Terminated
Product(s) for the Affected Area conducted by or under the authority of GSK
prior to such termination.

 

******       - Material has been omitted and filed separately with the
Commission.

 

98

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

 

14.3.9      Commercialization.  To avoid disruption of supply of any Terminated
Product(s) to patients if termination occurs after the Launch of a Terminated
Product(s) in the relevant Affected Area, GSK, its Affiliates and Sublicensees
shall continue to sell the Terminated Product(s) in the relevant Affected Area,
in accordance with the terms and conditions of this Agreement, for up to ******
or such shorter period of time as requested by Amicus as provided below, after
the effective date of any such termination of any such Terminated Product(s)
(“GSK Wind-Down Period”); provided that Amicus may terminate the GSK Wind-Down
Period in any country of the relevant Affected Area upon ****** written notice
to GSK; provided further that GSK shall not be obligated to promote the sale of
Terminated Products in the Affected Area during the GSK Wind-Down Period. 
Subject to the foregoing obligations of GSK, during the GSK Wind-Down Period,
GSK may transfer any remaining inventory of Terminated Product(s) from the
Affected Area to a country within the GSK Territory for which GSK’s rights with
respect to such Product(s) have not been terminated.  Within ****** following
the expiration of the GSK Wind-Down Period, GSK shall notify Amicus of any
quantities of Terminated Product(s) for the Affected Area remaining in GSK’s or
its Affiliates’ inventory and Amicus shall have the option, upon notice to GSK,
to repurchase any such quantities of the Terminated Product(s) from GSK at a
price equal to GSK’s Manufacturing Costs.  If Amicus so elects to purchase any
remaining quantities of Terminated Product(s) from GSK as set forth herein, GSK
will transfer to Amicus such quantities of inventory of Terminated Products.  If
Amicus does not elect to purchase any such remaining quantities of inventory of
Terminated Products, GSK may transfer any such remaining inventory of Terminated
Product(s) to a country within the GSK Territory for which GSK’s rights with
respect to such Product(s) have not been terminated.

 

14.3.10    Regulatory Filings.  Following termination of this Agreement by
Amicus pursuant to Section 13.2 or by GSK pursuant to Section 13.3, at Amicus’
written election, which shall be exercised by written notice to GSK, GSK will
assign and transfer (or cause to be assigned and transferred) to Amicus or its
designee (or to the extent not so assignable, GSK shall take all reasonable
action to make available to Amicus or its designee) the benefits of all
regulatory submissions and filings and marketing approvals (including all INDs,
MAAs and Marketing Approvals) related to the Compound or the Terminated
Product(s) in the Affected Area, including such regulatory submissions and
registrations made or owned by GSK’s Affiliates and Sublicensees; provided that
GSK may retain a copy of all such regulatory submissions and filing and
marketing approvals and shall retain a right of reference to all such regulatory
submissions, filings, and marketing approvals, for use in connection with the
non-Terminated Product(s) and in the non-terminated countries of the GSK
Territory.  In each case, unless otherwise required by any applicable Law, GSK
shall use all reasonable efforts to make such foregoing assignment (or
availability), within ****** after the effective date of any such termination
(or, with respect to any such regulatory filings pertaining to an Ongoing Trial
that GSK is continuing to conduct pursuant to Section 14.3.4 above, within
****** after the completion of such Ongoing Trial), provided, however, that in
the event that GSK is unable to make such assignment or to make such regulatory
filings available to Amicus within ****** after the effective date of any such
termination (or the completion of such Ongoing Trial, as applicable) due to
factors beyond GSK’s reasonable control,

 

******       - Material has been omitted and filed separately with the
Commission.

 

99

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

 

then GSK shall so notify Amicus and (including the reason for any such delay)
prior to the expiration of such ****** period and the Parties shall mutually
agree (such agreement not to be unreasonably withheld by either Party) an
appropriate extension to such ****** period.

 

14.3.11    Supply.  ******.

 

14.3.12    Sublicensees.  Any contracts with Sublicensees with respect to a
Terminated Product in the Affected Area engaged by GSK, other than GSK’s
Affiliates and JCR, shall be assigned to Amicus, solely to the extent such
contracts related to the Terminated Product in the Affected Area and to the
extent GSK has the right to do so and Amicus so requests.  In the event such
assignment is not requested by Amicus or GSK does not have the right to do so,
then the rights of such Sublicensees with respect to the Terminated Product in
the Affected Area shall terminate upon termination of GSK’s rights with respect
to the applicable Terminated Product(s) in the Affected Area.  GSK shall ensure
that its Affiliates and such Sublicensees (if not assigned to Amicus pursuant to
this Section 14.3.12) shall transition all Terminated Products in the Affected
Area back to Amicus in the manner set forth in this Section 14.3 as if such
Affiliate or Sublicensee were named herein.

 

14.4        Termination solely with respect to a Product(s) or country(ies). 
Upon termination of this Agreement by GSK pursuant to Section 13.2 or 13.3 or by
Amicus pursuant to Section 13.2 with respect to a Terminated Product(s) and/or
the Affected Area only or if Amicus exercises its Co-Development Opt-Out Right
pursuant to Section 5.4 with respect to a particular Product(s), the Parties’
rights and obligations under the Agreement shall terminate with respect such
Terminated Product(s) and/or the Affected Area and shall survive with respect to
all other Products in the Parties’ respective territories, subject to the
following provisions:

 

(a)           Each country of the Affected Area shall cease to be a country
within the Territory and the definition of “Territory” in Section 1.184 shall be
deemed to be amended accordingly and all references to a Major Market shall be
deemed to be references to a “Major Market within the Territory”; similarly,
each country of the Affected Area shall cease to be a country within the GSK
Territory and the definition of “GSK Territory” in Section 1.96 shall be deemed
amended accordingly; similarly, each Terminated Product shall cease to be a
Product covered by this Agreement and the definition of “Product” in Section
1.153 shall be deemed amended accordingly;

 

(b)           Notwithstanding any other provision of this Agreement, including
the definition of “Amicus Know-How” in Section 1.18 and Sections 2.1, 5.1.7 and
5.2.3, in the event of termination by Amicus pursuant to Section 13.2 or by GSK
pursuant to Section 13.3, Amicus shall not have any obligation to make available
to GSK any data or other Know-How with respect to a Terminated Product generated
by or on behalf of Amicus, its Affiliates and/or (sub)licensees solely for the
Affected Area following any such termination of such Product and GSK shall have
no rights to, and neither the License, nor the license granted by Amicus to GSK
pursuant to Section 2.1.2, shall include, any such data or Know-How. 
Notwithstanding any other provision of this Agreement,

 

******       - Material has been omitted and filed separately with the
Commission.

 

100

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

 

including the Sections 2.4, 5.1.7 and 5.2.3, in the event of termination by GSK
pursuant to Section 13.2 or exercise by Amicus of its Co-Development Opt-Out
Right pursuant to Section 5.4, GSK shall not have any obligation to make
available to Amicus any data or other Know-How with respect to a Terminated
Product, in each case that is generated by or on behalf of GSK, its Affiliates
and/or (sub)licensees solely for the Affected Area following any such
termination of this Agreement with respect to such Product or the Co-Development
Opt-Out Effective Date, and Amicus shall have no rights to, and the licenses set
forth in Section 2.4 shall not include, any such data or Know-How.

 

(c)           As between the Parties, Parties shall promptly negotiate and
implement any appropriate amendments to the safety data exchange agreement
described in Section 5.2.6(a) as customary and necessary under such
circumstances to clearly define each Party’s role with respect to
pharmacovigilance and adverse event reporting in the Territory following such
termination; and

 

(d)           The Parties rights and obligations under Section 7.1 shall
survive; and, upon termination of this Agreement by Amicus pursuant to Section
13.2 or by GSK pursuant to 13.3, in each case in its entirety or only with
respect to the Co-Formulation Product, as applicable, GSK’s rights and
obligations under Article VII regarding the prosecution and maintenance of all
GSK Prosecuted Amicus Patents and Program Patents and Patents within the
Co-Formulation Product IP in the Affected Area to the extent pertaining to the
Terminated Products shall terminate from and after the date of any such
termination and all such Patents shall be deemed to be Amicus Prosecuted
Patents; provided, however, that Amicus will, in a timely manner, solicit GSK’s
comments regarding the prosecution and maintenance of such Amicus Patents and
Program Patents and Patents within the Co-Formulation Product IP and review of
the nature and text of any such Patent application and prosecution matters
related thereto, including any correspondence between Amicus and any government
intellectual property or Patent authorities, agencies or other government
bodies, in reasonably sufficient time prior to filing thereof, and Amicus will
give due consideration to GSK’s reasonable comments and amendments.

 

14.5        Rights upon Termination for Bankruptcy.  Notwithstanding the
bankruptcy of Amicus, or the impairment of performance by Amicus of its
obligations under this Agreement as a result of bankruptcy or insolvency of
Amicus as described in Section 13.4, upon the termination of this Agreement by
GSK pursuant to Section 13.4, GSK will be entitled to retain all rights and
licenses granted to GSK by Amicus under this Agreement.  All rights and licenses
granted under or pursuant to this Agreement by Amicus to GSK are, and will
otherwise be deemed to be, for purposes of Article 365(n) of the Bankruptcy
Code, licenses of rights to “intellectual property” as defined under Article
101(52) of the Bankruptcy Code.  The Parties agree that GSK, as a licensee of
such rights under this Agreement, will retain and may fully exercise all of its
rights and elections under the Bankruptcy Code.  The Parties further agree that,
in the event of the commencement of a bankruptcy proceeding by or against Amicus
under the Bankruptcy Code, GSK will be entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property, and same, if not already in its
possession, will be

 

******       - Material has been omitted and filed separately with the
Commission.

 

101

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

 

promptly delivered to GSK (i) upon any such commencement of a bankruptcy
proceeding upon written request therefore by GSK, unless Amicus elects to
continue to perform all of its obligations under this Agreement, or (ii) if not
delivered under (i) above, upon the rejection of this Agreement by or on behalf
of Amicus upon written request therefore by GSK.  The provisions of this Section
14.5 shall apply mutatis mutandis to Amicus in the event of any bankruptcy or
insolvency of GSK as described in Section 13.4.

 

14.6        Return of Materials.  No later than ****** after the expiration or
termination of this Agreement in its entirety, each Party shall return or cause
to be returned to the other Party (or, at such other Party’s request, destroy
and certify such destruction) all Confidential Information received from the
other Party and all copies thereof that are in such Party’s possession, as well
as all biological or chemical materials delivered or provided by the other
Party; provided, however, that each Party may retain one (1) copy of such
Confidential Information received from the other Party for record purposes. 
Notwithstanding the foregoing, to the extent that a Party has a continuing
license pursuant to Section 14.2 or Section 14.3 above, as applicable, after
such termination of this Agreement, such Party may retain the Confidential
Information of the other Party and use such Confidential Information solely to
the extent necessary and for the purpose of the continued practice of such
license and in such event, notwithstanding Section 11.1 above, such Party’s
obligations under Article XI above, shall continue for so long as such Party
continues to practice such license.

 

14.7        Survival.  Upon the expiration or termination of this Agreement in
its entirety, all rights and obligations of the Parties under this Agreement
shall terminate except as expressly set forth under this Article XIV and those
described in the following provisions (which such provisions shall survive for
the term specified therein and, if no such term is specified, then
indefinitely): Article XVI and Sections 3.5, 3.6, 3.7 (except as otherwise
expressly set forth under this Article XIV), 3.8, 3.9, 3.10, 6.4, 10.2.2 (only
with respect to either (i) a termination of this Agreement in its entirety by
GSK for Amicus’s breach pursuant to Section 13.2 or (ii) if Amicus exercises its
Co-Development Opt-Out Right pursuant to Section 5.4 with respect to all
Products), 11.1, 11.3, 15.1, 15.2, 15.3, 15.4, 15.6.

 

XV.         INDEMNIFICATION AND LIMITATION OF LIABILITY

 

15.1        Indemnification of Amicus.

 

15.1.1      GSK shall indemnify and hold harmless each of Amicus, its Affiliates
and the directors, officers, stockholders and employees of such entities and the
successors and assigns of any of the foregoing (the “Amicus Indemnitees”), from
and against any and all (i) liabilities, damages, penalties, fines, costs,
expenses (including, reasonable attorneys’ fees and other expenses of
litigation) (“Liabilities”) from any claims, actions, suits or proceedings
brought by a Third Party (a “Third Party Claim”) incurred by any Amicus
Indemnitee, to the extent arising from, or occurring as a result of:  (a)
activities relating to the Development or use of any Compound and Products by
GSK, its Affiliates, Sublicensees, or subcontractors in the Territory, and
relating to the

 

******       - Material has been omitted and filed separately with the
Commission.

 

102

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

 

Commercialization of any Compound and Products by GSK, its Affiliates,
Sublicensees, or subcontractors in the GSK Territory; (b) any material breach of
any representations, warranties or covenants by GSK in Articles 8.1 and X above;
(c) activities relating to the Manufacture of any Compound or Products by GSK,
its Affiliates, Sublicensees, or subcontractors for distribution in the GSK
Territory or the Amicus Territory; and/or (d) ******; in each case except to the
extent such Third Party Claims fall within the scope of Amicus’ indemnification
obligations set forth in Section 15.2 below or result from the gross negligence
or intentional misconduct of a Amicus Indemnitee.  For the avoidance of doubt,
Product Liability Claims are not subject to this Section 15.1 and are governed
by the provisions of Section 15.4 below.

 

15.2        Indemnification of GSK.  Amicus shall indemnify and hold harmless
each of GSK, its Affiliates and Sublicensees and the directors, officers and
employees of GSK, its Affiliates and Sublicensees and the successors and assigns
of any of the foregoing (the “GSK Indemnitees”), from and against any and all
Liabilities from any Third Party Claims incurred by any GSK Indemnitee, to the
extent arising from, or occurring as a result of (a) activities relating to the
Development or use of any Compound and Products by Amicus, its Affiliates,
sublicensees or subcontractors in the Territory, and relating to
Commercialization of any Compound and Products by Amicus, its Affiliates,
sublicensees or subcontractors in the Amicus Territory; (b) any material breach
of any representations, warranties or covenants by Amicus in Article 8.1 and X
above; or (c) activities relating to the Manufacture of any Compound or Products
(other than the Co-Formulation Product) by Amicus, its Affiliates, sublicensees,
or subcontractors; in each case except to the extent such Third Party Claims (i)
fall within the scope of GSK’s indemnification obligations set forth in Section
15.1 above or (ii) result from the gross negligence or intentional misconduct of
an GSK Indemnitee.  For the avoidance of doubt, Product Liability Claims are not
subject to this Section 15.2 and are governed by the provisions of Section 15.4
below.

 

15.3        Procedure.  A Party that intends to claim indemnification under this
Article XV (the “Indemnitee”) shall promptly notify the other Party (the
“Indemnitor”) in writing of the assertion or the commencement of Third Party
Claim and will provide the Indemnitor such information with respect thereto that
the Indemnitor may reasonably request.  The Indemnitor shall be entitled to
control and appoint lead counsel for such defense, in each case at its expense. 
If the Indemnitor shall assume the control of the defense of any Third Party
Claim in accordance with the provisions of this Section 15.3, the Indemnitor
shall obtain the prior consent of the Indemnitee (which shall not be
unreasonably withheld) before entering into any settlement of such Third Party
Claim.  The failure to deliver written notice to the Indemnitor within a
reasonable time after the commencement of any action with respect to a Third
Party Claim shall not relieve the Indemnitor of its obligations under this
Article XV unless the delay or failure is prejudicial to its ability to defend
such action.  The Indemnitee under this Section 15.3 shall cooperate fully with
the Indemnitor and its legal representatives in the investigation of any action
with respect to a Third Party Claim covered by this indemnification.

 

******       - Material has been omitted and filed separately with the
Commission.

 

103

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

 

15.4        Product Liability.

 

15.4.1                   Each Party shall notify the other Party as promptly as
practicable if any Third Party Claim is commenced or threatened against such
Party alleging product liability, product defect, design, packaging or labeling
defect, failure to warn or any similar action relating to the use or safety of
Compound and Products (a “Product Liability Claim”).  For clarity, a Product
Liability Claim will not be deemed to include any Third Party Claims relating to
a Manufacturing defect of Compound and Products and Sections 15.1 and 15.2 shall
apply to any such Third Party Claims.

 

15.4.2                   To the extent that either the GSK Indemnitees or the
Amicus Indemnitees incur, suffer, or are faced with any Product Liability Claims
with respect to a Product, then ******.

 

15.4.3                   GSK shall have the right to control and appoint lead
counsel for the defense of any such Product Liability Claims in the GSK
Territory and to settle any such Product Liability Claims, in its discretion,
provided that GSK shall reasonably consult with and consider the input of Amicus
with respect to such matters.  Amicus shall have the right to control and
appoint lead counsel for the defense of any such Product Liability Claims in the
Amicus Territory and to settle any such Product Liability Claims, in its
discretion, provided that Amicus shall reasonably consult with and consider the
input of GSK with respect to such matters

 

15.5                        Insurance.  In addition to its duty to indemnify,
each Party will procure product liability insurance in commercially reasonable
amounts in view of its activities.  Alternatively, either Party may establish a
program of self insurance for the same risks.  In either event, as reasonably
requested in writing by the other Party not more than once every twelve (12)
months, each Party will supply the other Party with evidence of such coverage
during the time any Product is being Developed, Manufactured or Commercialized
by such Party or any of its Affiliates, sublicensees, designees or agents.

 

15.6                        Disclaimer of Consequential Damages.  IN NO EVENT
WILL EITHER AMICUS OR GSK BE LIABLE TO THE OTHER FOR ANY SPECIAL, INDIRECT,
CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES ARISING UNDER OR AS A RESULT OF
THIS AGREEMENT (OR THE TERMINATION HEREOF) INCLUDING, BUT NOT LIMITED TO, THE
LOSS OF PROSPECTIVE PROFITS OR ANTICIPATED SALES.

 

15.7                        Anti-Bribery and Anti-Corruption.

 

15.7.1                   Amicus acknowledges that it has received and read GSK’s
‘Prevention of Corruption — Third Party Guidelines’ (attached at Exhibit D and
incorporated herein by reference).  Each Party agrees to perform its obligations
under the Agreement in accordance with the applicable anti-corruption laws of
the territory in which such Party conducts business with the other Party as set
forth therein.

 

15.7.2                   Each Party shall be entitled to exercise its
termination right under and in accordance with the terms of Section 13.2 to
terminate this Agreement pursuant to Section 13.2 above immediately on written
notice to the other Party, if the other Party fails to perform its

 

******                           - Material has been omitted and filed
separately with the Commission.

 

104

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

 

obligations in accordance with Section 15.7.1 or 10.1.1 (to the extent such
failure to perform solely relates to a violation of applicable anti-bribery and
anti-corruption laws as set forth therein).  Neither Party shall have a claim
against the other Party for compensation for any loss of whatever nature by
virtue of the termination of this Agreement in accordance with this
Section 15.7.  To the extent (and only to the extent) that the laws of the
territory provide for any such compensation to be paid to a Party upon the
termination of this Agreement, each Party hereby expressly agrees (to the extent
possible under the laws of the territory) to waive or to repay to the other
Party any such compensation or indemnity.  For the avoidance of doubt, it is
understood that nothing in this Section 15.7.2 shall be deemed to limit a
Party’s obligations to pay the applicable milestones, royalties and other
amounts set forth in Article XIV following any termination of this agreement in
accordance with this Section 15.7.

 

XVI.                     MISCELLANEOUS

 

16.1                        Governing Law.  For all matters other than the scope
and validity of Patents, this Agreement shall be deemed to have been made in the
State of Delaware and its form, execution, validity, construction and effect
shall be determined in accordance with the laws of the State of Delaware,
without giving effect to the principles of conflicts of law thereof and the
Parties agree to the personal jurisdiction of and venue in any federal or state
court located in Delaware.  The application of the United Nations Convention for
Contracts for the International Sales of Goods is hereby expressly excluded.

 

16.2                        Dispute Resolution.

 

16.2.1                   The Parties agree that with respect to any disputes
arising with respect to the interpretation, breach, enforcement, termination or
validity of this Agreement (for the purposes of this Section 16.2, each a
“Dispute”), the Dispute shall first be presented to the Chief Executive Officer
of Amicus and the GSK Chairman of Research and Development, or their respective
designees for resolution.  If the Amicus Chief Executive Officer and GSK
Chairman or Research and Development, or their respective designees, cannot
resolve the Dispute within ****** of the request to do so, either Party may
initiate arbitration proceedings with respect thereto as provided in
Section 16.2.2 below.  Prior to the establishment of an arbitration tribunal,
Amicus and GSK shall each have the right to apply to any court of competent
jurisdiction for appropriate interim or provisional relief, as necessary to
protect the rights or property of that Party.

 

16.2.2                   Any Dispute shall be finally resolved by arbitration in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association (“AAA”) then in effect (the “Rules”), except as modified herein. 
The place of arbitration shall be Wilmington, Delaware.  If the amount in
controversy ******, there shall be one (1) neutral and impartial arbitrator who
shall be agreed upon by the Parties within twenty (20) days of receipt by
respondent of a copy of the demand for arbitration.  If the amount in
controversy ******, there shall be three (3) arbitrators, of whom each Party
shall appoint one (1) within thirty (30) days of the receipt by the respondent
of the

 

******                           - Material has been omitted and filed
separately with the Commission.

 

105

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

 

demand for arbitration.  The two (2) arbitrators so appointed shall select a
third (3rd) arbitrator as the chair of the arbitral tribunal within thirty (30)
days of the appointment of the second arbitrator.  If any arbitrator is not
appointed within the time limit provided herein, such arbitrator shall be
appointed by the AAA in accordance with the listing, striking, and ranking
procedures in the Rules.  Any arbitrator appointed by the AAA shall be an
attorney with no less than fifteen (15) years of experience with commercial
cases and an experienced arbitrator, who shall, if practicable, have substantial
experience with transactions or disputes related to the field of pharmaceutical
products and/or, if applicable, intellectual property.

 

16.2.3                   In the case of any Dispute which may be submitted to
arbitration hereunder, the procedures of this Section 16.2.3 shall apply. 
Arbitration with respect to all such Disputes shall be a “baseball” type
arbitration, meaning that, following all permitted discovery and in accordance
with procedures otherwise determined by the arbitrator, each Party shall prepare
and submit to the arbitrator and the other Party a written report setting forth
its final position with respect to the substance of the dispute, and each party
may submit a revised report and position within 15 (fifteen) days of receiving
the other party’s report.  The arbitrator shall then select one of the Party’s
positions as his or her final decision and shall not have authority to render
any substantive decision other than to so select the position of either GSK or
Amicus.  The Parties and the arbitrator shall use all reasonable efforts to
complete any such arbitration with respect to a Dispute within ninety (90) days.

 

16.2.4                   The arbitral tribunal is not empowered to award damages
in excess of compensatory damages, and each Party hereby irrevocably waives any
right to recover punitive, exemplary, multiple or similar damages with respect
to any Dispute.  Any arbitration proceedings, decision, or award rendered
hereunder and the validity, effect, and interpretation of this arbitration
provision shall be governed by the Federal Arbitration Act, 9 U.S.C. §1 et seq. 
The decision of the arbitral tribunal shall be in writing and, if applicable,
shall state the findings of fact and conclusions of law on which it is based. 
The decision of the arbitral tribunal shall be final and binding upon the
Parties regarding the applicable Dispute presented to the arbitral tribunal. 
Judgment upon the decision of the arbitral tribunal may be entered in any court
having jurisdiction.  The arbitration proceedings and the decision of the
arbitral tribunal shall not be made public without the joint consent of the
Parties and each Party shall maintain the confidentiality of such proceedings
and decision unless each Party otherwise agrees in writing; provided that either
Party may make such disclosures as are permitted for Confidential Information of
the other Party under Article XI above.  The Parties agree that they shall share
equally the cost of the arbitration filing and hearing fees, and the cost of the
arbitral tribunal and administrative fees of the AAA.  Each Party shall bear its
own costs and attorneys’ and witnesses’ fees and associated costs and expenses. 
The arbitral tribunal shall have full authority to grant provisional remedies
and to direct the Parties to request that any court modify or vacate any
temporary or preliminary relief issued by such court.

 

16.2.5                   The Parties hereby submit to the exclusive jurisdiction
of the federal and state courts located in Delaware for the purpose of an order
to compel arbitration, for preliminary relief in aid of arbitration, or for a
preliminary injunction to maintain the status quo or prevent irreparable

 

******                           - Material has been omitted and filed
separately with the Commission.

 

106

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

 

harm prior to the appointment of the arbitrators, and to the non-exclusive
jurisdiction of such courts for the enforcement of any award issued hereunder. 
The Parties hereby agree to accept service of process pursuant to the notice
provisions of this Agreement.

 

16.3                        Assignment and Binding Effect.

 

16.3.1                   This Agreement may not be assigned, by operation of law
or otherwise, by either Party without the prior written consent of the other,
except as otherwise permitted under this Section 16.3:

 

(a)                                 Amicus may assign this Agreement to an
Affiliate or to a Third Party without such prior written consent as part of a
merger, consolidation, sale, or transfer of all or substantially all its assets,
but only if the assignee has or simultaneously acquires all of the necessary
rights and other assets to perform Amicus’s obligations under this Agreement;
provided, however, a Change of Control event of Amicus shall be subject to the
terms set forth in Article XII.

 

(b)                                 GSK may assign this Agreement to any
Affiliate without the prior written consent of Amicus. GSK may also assign this
Agreement to a Third Party as part of a merger, consolidation, sale, or transfer
of all or substantially all its assets, without the prior written consent of
Amicus, but only if the assignee has or simultaneously acquires all of the
necessary rights and other assets to perform GSK’s obligations under this
Agreement.

 

16.3.2                   No assignment under this Section 16.3 shall be
effective unless the intended assignee executes and delivers to the Party which
is not the assignor a writing whereby the assignee expressly undertakes to
perform and comply with all of its assignor’s obligations hereunder. 
Notwithstanding such undertaking, such assignor shall continue to be primarily
liable for such assignee’s performance hereof and compliance herewith.

 

16.3.3                   Any assignment in violation of this Section 16.3 shall
be void and of no effect.

 

16.3.4                   This Agreement, and the rights and obligations of the
Parties herein contained, shall be binding upon, and shall inure to the benefit
of, the Parties and their respective legal representatives, successors and
permitted assigns.

 

16.4                        Independent Contractor Status.  The relationship of
the Parties is that of independent contractors.  Nothing in this Agreement will
be construed to constitute, create, give effect or otherwise imply a joint
venture, agency, partnership or other formal business organization or any
employer/employee relationship of any kind between the Parties.

 

16.5                        Notices.  All notices, requests and other
communications required or permitted to be given hereunder or with respect
hereto will be in writing and in English, and may be given by (i) personal
service, (ii) registered first-class mail, postage prepaid, return receipt
requested,

 

******                           - Material has been omitted and filed
separately with the Commission.

 

107

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

 

(iii) express delivery service, charges prepaid, or (iv) facsimile (complete
transmission verified and a copy promptly sent by another permissible method of
providing notice described in clauses (i), (ii) or (iii) above) and in each case
addressed to the other Party at the address for such Party as set forth below,
and shall be effective upon receipt in the case of clauses (i), (iii) or
(iv) above, and five days after mailing in the case of clause (ii) above.

 

If to GSK:

Glaxo Group Limited

 

Great West Road

 

Brentford, Middlesex

 

United Kingdom

 

TW8 9GS

 

Facsimile: +44 (020) 804 76904

 

Attention: Company Secretary

 

 

With a copy to:

GlaxoSmithKline

 

980 Great West Road

 

Brentford, Middlesex, TW8 9GS

 

Facsimile: +44 (0) (208) 046-0641

 

Attention: Marc Dunoyer

 

President, GSK Rare Diseases

 

 

 

And

 

 

 

GlaxoSmithKline

 

2301 Renaissance Boulevard

 

Mail Code RN0220

 

King of Prussia, PA 19406

 

Facsimile: (610) 787-7084

 

Attention: Vice President and Associate General Counsel, Legal Operations —
Business Development Transactions

 

 

If to Amicus:

Amicus Therapeutics, Inc.

 

1 Cedar Brook Drive

 

Cranbury, New Jersey 08512

 

Attention: John F. Crowley

 

Chairman and Chief Executive Officer

 

Facsimile: +1 (609) 662-2001

 

******                           - Material has been omitted and filed
separately with the Commission.

 

108

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

 

With a copy to:

Wilson Sonsini Goodrich & Rosati

 

650 Page Mill Road

 

Palo Alto CA 94304-1050

 

Attention: Kenneth A. Clark, Esq.

 

Facsimile: +1 (650) 493-6811

 

The address of either Party set forth above may be changed from time to time by
written notice in the manner prescribed herein from the Party requesting the
change.

 

16.6                        Further Assurances.  The Parties will execute and
deliver any further or additional instruments or documents and perform any acts
which may be reasonably necessary in order to effectuate and carry out the
purposes of this Agreement.

 

16.7                        Waivers.  The waiver by either Party of a default or
a breach of any provision of this Agreement by the other Party will not operate
or be construed to operate as a waiver of any subsequent default or breach.  The
continued performance by either Party with knowledge of the existence of a
default or breach will not operate or be construed to operate as a waiver of any
default or breach.  Any waiver by a Party of a particular provision or right
will be in writing, will be as to a particular matter and, if applicable, for a
particular period of time and will be signed by such Party.

 

16.8                        Effect of Restatement; Entire Agreement.  From and
after the Restatement Effective Date, this Agreement (including the Exhibits and
Schedules hereto), the Prior Equity Agreement, the Equity Agreement, the
Trademark License Agreement (to be entered into in accordance with Section 2.5)
and the Pharmacovigilance Agreement (including as amended or replaced in
accordance with Section 5.2.6(c)) (in each case, if and when executed by the
Parties) constitute the entire agreement between the Parties with respect to the
subject matter hereof, and supersede and replace all prior agreements and
negotiations with respect to such subject matter from and after the Restatement
Effective Date, including the Original Agreement (other than with respect to the
Equity Agreement attached as Exhibit A to the Original Agreement which such
agreement shall continue in effect in accordance with its terms following the
Restatement Effective Date).

 

16.9                        Severability.  If any provision in this Agreement is
deemed to be, or becomes, invalid, illegal, void or unenforceable under
applicable Laws, then: (i) it will be deleted with respect to the applicable
jurisdiction(s) to which such Law pertains and the validity, legality and
enforceability of the remaining provisions of this Agreement shall not be
impaired or affected in any way, and (ii) the Parties will use Commercially
Reasonable Efforts to substitute for the invalid, illegal or unenforceable
provision a valid, legal and enforceable provision which conforms as nearly as
possible with the original intent of the Parties.  In the event a Party seeks to
avoid a provision of this Agreement by asserting that such provision is invalid,
illegal or otherwise unenforceable, the other Party shall have the right to
terminate this Agreement upon sixty (60) days’ prior written notice to the
asserting Party, unless such assertion is eliminated and the effect of such
assertion cured within such sixty (60) day period.  Any termination in
accordance with the foregoing shall be deemed a

 

******                           - Material has been omitted and filed
separately with the Commission.

 

109

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

 

termination of this Agreement in its entirety pursuant to Section 13.3 if the
Party who made the assertion was GSK, and shall be deemed a termination of this
Agreement in its entirety under Section 13.2 by reason of a breach by Amicus, if
Amicus is the Party who made such assertion.

 

16.10                 Counterparts.  This Agreement may be executed in more than
one counterpart, each of which shall be deemed to be an original but all of
which taken together shall be deemed a single instrument.  A facsimile
transmission of the signed Agreement will be legal and binding on both Parties.

 

16.11                 Force Majeure.  Neither Party to this Agreement will be
liable for failure or delay in the performance of any of its obligations
hereunder (other than the failure to pay monies owed), if such failure or delay
is due to acts of God, earthquakes, fires, strikes, acts of war (whether
declared or not), terrorism, civil unrest, or intervention of any governmental
authority or any other event or occurrence beyond the reasonable control of such
Party (a “Force Majeure Event”), but any such delay or failure will be remedied
by such Party as soon as practicable after the removal of the cause of such
failure or delay.  Upon the occurrence of Force Majeure Event, the Party failing
or delaying performance will promptly notify the other Party in writing, setting
forth the nature of the occurrence, its expected duration and how such Party’s
performance is affected, and the Party failing or delaying performance will use
its Commercially Reasonable Efforts to avoid or remove the causes of
non-performance and shall continue performance with the utmost dispatch whenever
such causes are removed.

 

16.12                 Interest on Late Payments.  If any Party fails to pay in
full on or before the date due any royalty, fee or other amount that is required
to be paid to the other Party under this Agreement, the paying Party will also
pay to the other Party (or its designee) interest at a rate equal to:  (i) the
prime rate as reported by Citibank N.A., plus ******; or (ii) if lower, the
maximum rate permitted by law; calculated on the number of days such payment is
delinquent, compounded annually and computed on the basis of a three hundred
sixty five (365) day year.

 

16.13                 Cumulative Remedies.  Unless otherwise set forth in this
Agreement, all rights and remedies of the Parties, including all rights to
payment, rights of termination, rights to injunctive relief, and other rights
provided under this Agreement, shall be cumulative and in addition to all other
remedies provided for in this Agreement, in law, and in equity.

 

16.14                 Amendment.  This Agreement may not be amended,
supplemented or otherwise modified except by an instrument in writing signed by
both Parties that specifically refers to this Agreement.

 

16.15                 Headings and References.  All section headings contained
in this Agreement are for convenience of reference only and will not affect the
meaning or interpretation of this Agreement.

 

16.16                 No Strict Construction.  This Agreement has been prepared
jointly and will not be strictly construed against either Party.

 

******                           - Material has been omitted and filed
separately with the Commission.

 

110

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

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

******                           - Material has been omitted and filed
separately with the Commission.

 

111

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

 

IN WITNESS WHEREOF, the Parties hereto, intending to be legally bound hereby,
have caused this Amended and Restated License and Expanded Collaboration
Agreement to be executed by their duly authorized representatives.

 

 

AMICUS THERAPEUTICS, INC.

 

GLAXO GROUP LIMITED

 

 

 

 

 

 

 

 

By:

/s/ John F. Crowley

 

By:

/s/ Paul Williamson

 

 

 

 

 

Name:

John F. Crowley

 

Name:

Paul Williamson

 

 

 

 

 

Title:

Chairman and CEO

 

Title:

Corporate Director

 

 

 

 

 

Date:

July 17, 2012

 

Date:

July 17, 2012

 

******      - Material has been omitted and filed separately with the
Commission.

 

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

 

EXHIBIT A

 

STOCK PURCHASE AGREEMENT

 

(See Exhibit 10.2 to Quarterly Report on Form 10-Q filed on November 5, 2012)

 

******              - Material has been omitted and filed separately with the
Commission.

 

 

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

 

EXHIBIT B

 

INITIAL PRESS RELEASE

 

(See attached.)

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

[g201171ke17i001.jpg]

[g201171ke17i002.jpg]

 

[g201171ke17i003.jpg]

 

Amicus Therapeutics and GlaxoSmithKline Expand Fabry Disease Collaboration

 

Companies Jointly to Develop Proprietary Enzyme Replacement Therapy (ERT) for
Fabry Disease Co-Formulated with Migalastat HCl Chaperone

 

Fabry Products to be Commercialized by Amicus in U.S. and by GSK ex-U.S.

 

GSK to Increase Ownership in Amicus to 19.9% with $18.6

Million Investment in Common Stock Priced at $6.30 per share

 

CRANBURY, NJ, US & LONDON, UK, July 17, 2012 — Amicus Therapeutics (Nasdaq:
FOLD) and Glaxo Group Limited (GSK) today announced an expansion of their
collaboration to develop and commercialize the investigational pharmacological
chaperone migalastat HCl for Fabry disease.

 

The expanded alliance comprises three components:

 

·                  Co-development of all current and future formulations of
migalastat HCl for Fabry disease, including a co-formulation of migalastat HCl
with GSK/JCR Pharmaceutical’s investigational enzyme replacement therapy (ERT)
for Fabry disease;

·                  Commercialization arrangements for all future Fabry products.
Amicus will have commercial rights to all Fabry products in the United States
and GSK will commercialize all products in the rest of world; and

·                  Increased GSK ownership in Amicus with $18.6 million
investment in common stock priced at $6.30 per share, bringing GSK’s total
ownership stake in Amicus to 19.9%.

 

“We have strengthened our relationship with Amicus through the expanded Fabry
collaboration and additional equity investment in the Company,” said Marc
Dunoyer, Global Head of GSK Rare Diseases and a member of the GSK Corporate
Executive Team. “Amicus has a very successful track record as our development
partner, long-standing relationships with the Fabry community and we look
forward to their leadership in the U.S. commercialization of now several
potential new medicines for patients with Fabry disease. This is an important
step in our strategic vision, allowing us to undertake and fund an enlarged
scientific program with a view to turning molecules into medicines for rare
diseases faster and more effectively than ever before.”

 

The global Fabry collaboration combines Amicus’ U.S. presence, pharmacological
chaperone development expertise, and established relationships in the rare and
orphan disease community with GSK’s global rare disease unit and worldwide
regulatory, commercial, and manufacturing capabilities. Amicus and GSK are now
committed to the parallel development of three different uses of migalastat HCl
for Fabry disease:

 

******                           - Material has been omitted and filed
separately with the Commission.

 

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

 

·                  Migalastat HCl monotherapy in Phase 3: Phase 3 global
registration studies (Study 011 and Study 012) are currently underway in
patients with genetic mutations that are amenable to chaperone monotherapy.
Results from Study 011 are anticipated in the third quarter of 2012 to support a
New Drug Application submission to the U.S. Food and Drug Administration (FDA).
If approved, Amicus will be responsible for the U.S. commercial launch.

 

·                  Migalastat HCl co-administered with ERT in Phase 2: A Phase 2
study of migalastat HCl co-administered with ERT for Fabry disease (Study 013)
is currently ongoing. In January 2012, Amicus announced positive preliminary
results from Study 013.

 

·                  Migalastat HCl co-formulated with a proprietary preclinical
ERT: Amicus and GSK, in collaboration with Japan-based JCR Pharmaceuticals, are
developing migalastat HCl co-formulated with a proprietary recombinant human
alpha-Gal A enzyme (JR-051). This ERT was developed by JCR and licensed to GSK
for all markets outside Japan. Preclinical studies conducted by Amicus, GSK and
JCR suggest that this chaperone-ERT co-formulation may provide greater alpha-Gal
A enzyme uptake into tissue uptake and markedly reduced levels of GL-3 in Fabry
disease-relevant tissues compared to recombinant enzyme alone. Amicus and GSK
believe that this co-formulated chaperone-ERT for Fabry disease has the
potential to enter clinical studies in 2013. Further details of this program and
preclinical results will be presented on today’s conference call and webcast.

 

John F. Crowley, Chairman and Chief Executive Officer of Amicus said, “GSK has
added significant value to the Fabry program through its global scale and
capabilities as well as the dedicated focus of GSK Rare Diseases. Through our
expanded agreement, GSK is increasing its investment in the Fabry development
program and Amicus is transforming into a commercial-stage biopharmaceutical
company within the U.S. Amicus is leveraging this chaperone-ERT platform to
advance migalastat HCl in multiple potential uses for patients with Fabry
disease.”

 

Expanded Amicus-GSK Collaboration for Fabry Disease: Key Highlights

 

·                  Amicus will commercialize all formulations of migalastat HCl
in the U.S., while GSK will commercialize in the rest of the world.

 

·                  Amicus and GSK will continue to share research and
development costs for all formulations of migalastat HCl, with Amicus funding
25% and GSK funding 75% of these costs for monotherapy and co-administration
during the remainder of 2012. Amicus and GSK will be responsible for 40% and 60%
of these costs, respectively, for co-formulation immediately and for all
formulations in 2013 and beyond.

 

·                  GSK will make an $18.6 million equity investment in Amicus by
purchasing 2,949,581 shares common stock at $6.30 per share, a 7% premium over
the 15 day average closing sale price of Amicus’s common stock as reported by
Nasdaq, bringing GSK’s total ownership stake in Amicus to 19.9%.

 

·                  Amicus will receive a $3.5 million cash payment from GSK this
quarter to reflect Amicus’ achievement of a clinical development milestone
during the second quarter 2012.

 

·                  GSK will be eligible to receive U.S. regulatory approval and
product launch milestones totaling $20 million for migalastat HCl monotherapy
and chaperone-ERT co-administration.

 

·                  GSK will be eligible to receive additional regulatory and
time-based milestone payments totaling up to $35 million within 7 years
following the launch of a co-formulation product. Amicus will also be

 

******              - Material has been omitted and filed separately with the
Commission.

 

2

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

 

 responsible for certain additional pass-through milestone payments and
single-digit royalties on the net U.S. sales of the co-formulated chaperone-ERT
product that GSK must pay to a Third Party.

 

Conference Call and Webcast

 

Amicus Therapeutics will host a conference call and webcast today, July 17, 2012
at 5:00 P.M. ET to discuss the expanded agreement with GSK and provide
additional details surrounding the new chaperone-ERT co-formulation. Interested
participants and investors may access the live conference call by dialing
877-303-5859 (U.S./Canada) or 678-224-7784 (international).

 

An audio webcast can also be accessed via the Investors section of the Amicus
Therapeutics corporate web site at http://www.amicustherapeutics.com, and will
be archived for 30 days. Web participants are encouraged to go to the Web site
15 minutes prior to the start of the call to register, download and install any
necessary software.

 

A telephonic replay of the call will be available for seven days beginning at
8 p.m. ET today. Access numbers for this replay are 855-859-2056 (U.S./Canada)
and 404-537-3406 (international); participant code 11288561.

 

About Fabry Disease

 

Fabry disease is an inherited lysosomal storage disease that is currently
estimated to affect approximately 5,000 to 10,000 people worldwide. Fabry
Disease is caused by deficiency of an enzyme called alpha-galactosidase A
(alpha-Gal A). The role of alpha-Gal A within the body is to break down a
complex lipid called globotriaosylceramide (GL-3). Reduced or absent levels of
alpha-Gal A activity leads to the accumulation of GL-3 in the affected tissues,
including the central nervous system, heart, kidneys, and skin. This
accumulation of GL-3 is believed to cause the various symptoms of Fabry disease,
including pain, kidney failure, and increased risk of heart disorders and
stroke.

 

About Amicus Therapeutics

 

Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the
forefront of developing therapies for rare diseases. The Company is developing
orally-administered, small molecule drugs called pharmacological chaperones, a
novel, first-in-class approach to treating a broad range of human genetic
diseases. Amicus’ late-stage programs for lysosomal storage disorders include
migalastat HCl monotherapy in Phase 3 for Fabry disease; migalastat HCl
co-administered with enzyme replacement therapy (ERT) in Phase 2 for Fabry
disease; and AT2220 co-administered with ERT in Phase 2 for Pompe disease.

 

About GlaxoSmithKline

 

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further information
please visit www.gsk.com

 

******              - Material has been omitted and filed separately with the
Commission.

 

3

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

 

Amicus Forward-Looking Statements

 

This press release contains, and the accompanying conference call will contain,
“forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995 relating to preclinical and clinical development
of Amicus’ candidate drug products, the timing and reporting of results from
preclinical studies and clinical trials evaluating Amicus’ candidate drug
products, the projected cash position for the Company, and business development
and other transactional opportunities. Words such as, but not limited to, “look
forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,”
“targets,” “likely,” “will,” “would,” “should” and “could,” and similar
expressions or words identify forward-looking statements. Such forward-looking
statements are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. The inclusion of forward-looking
statements should not be regarded as a representation by Amicus that any of its
plans will be achieved. Any or all of the forward-looking statements in this
press release may turn out to be wrong. They can be affected by inaccurate
assumptions Amicus might make or by known or unknown risks and uncertainties.
For example, with respect to statements regarding the goals, progress, timing
and outcomes of discussions with regulatory authorities and the potential goals,
progress, timing and results of preclinical studies and clinical trials, actual
results may differ materially from those set forth in this release due to the
risks and uncertainties inherent in the business of Amicus, including, without
limitation: the potential that results of clinical or pre-clinical studies
indicate that the product candidates are unsafe or ineffective; the potential
that it may be difficult to enroll patients in our clinical trials; the
potential that regulatory authorities may not grant or may delay approval for
our product candidates; the potential that preclinical and clinical studies
could be delayed because we identify serious side effects or other safety
issues; the potential that we will need additional funding to complete all of
our studies and, our dependence on third parties in the conduct of our clinical
studies. Further, the results of earlier preclinical studies and/or clinical
trials may not be predictive of future results. With respect to statements
regarding projections of the Company’s cash position, actual results may differ
based on market factors and the Company’s ability to execute its operational and
budget plans. In addition, all forward looking statements are subject to other
risks detailed in our Annual Report on Form 10-K for the year ended December 31,
2011. You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary statement, and
Amicus undertakes no obligation to revise or update this news release to reflect
events or circumstances after the date hereof. This caution is made under the
safe harbor provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995.

 

GlaxoSmithKline cautionary statement regarding forward-looking statements

 

Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK’ s operations are
described under ‘Risk Factors’ in the ‘Financial review & risk section’ in the
company’ s Annual Report 2011 included as exhibit 15.2 to the company’s Annual
Report on Form 20-F for 2011.

 

Amicus Contact:

 

Investors/Media: Sara Pellegrino (609) 662-5044 / spellegrino@amicusrx.com

 

Media: Dan Budwick (973) 271-6085 / dan@purecommunicationsinc.com

 

GlaxoSmithKline Contacts:

 

 

 

 

 

UK Media enquiries:

David Mawdsley

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Janet Morgan

(020) 8047 5502

 

David Daley

(020) 8047 5502

 

******      - Material has been omitted and filed separately with the
Commission.

 

4

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

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

 

 

 

European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543

 

Gary Davies

(020) 8047 5503

 

Ziba Shamsi

(020) 8047 3289

 

 

 

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

 

Jeff McLaughlin

(215) 751 7002

 

FOLD-G

 

******              - Material has been omitted and filed separately with the
Commission.

 

5

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

 

EXHIBIT C

 

TRADEMARK LICENSE AGREEMENT

 

THIS TRADEMARK LICENSE AGREEMENT (“Agreement”) is made as of the      day of
      , 20     (the “Effective Date”) by and between Glaxo Group Limited, a
company organized under the laws of England and Wales with its registered office
at Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, England
(“Licensor”), as licensor, and Amicus Therapeutics, Inc., a Delaware corporation
having a place of business at 6 Cedar Brook Drive, Cranbury, New Jersey, 08512
(“Licensee”), as licensee.  Licensee and Licensor are sometimes collectively
referred to herein as the “Parties” and separately as a “Party.”

 

WHEREAS, pursuant to that certain Amended and Restated License and Expanded
Collaboration Agreement by and between Licensee and Licensor, dated as of the
17th day of July, 2012 (the “License and Collaboration Agreement”), Licensor
agreed to license to Licensee certain trademarks in the Territory as set forth
on Exhibit A attached hereto, including all common law rights to such trademarks
(the “Licensed Marks”) in the United States (the “Territory”);

 

WHEREAS, Licensor is willing to grant, and Licensee is willing to receive, a
license to use the Licensed Marks in connection with Licensee’s right to Develop
Compound and Products in the Territory, and to Manufacture Compound and Products
and Commercialize Products (as those terms are defined in the License and
Collaboration Agreement) in the Amicus Territory pursuant to the terms and
conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants, agreements and
stipulations set forth herein and in the License and Collaboration Agreement,
the receipt and legal sufficiency of which are hereby mutually acknowledged,
Licensor and Licensee hereby agree as follows:

 

1.                   DEFINITIONS.  Capitalized terms not otherwise defined in
this Agreement shall have the meaning set forth in the License and Collaboration
Agreement.

 

2.              GRANT OF LICENSE.

 

2.1.         During the Term of this Agreement, and pursuant to the terms and
conditions contained herein, Licensor hereby grants to Licensee and its
Affiliates, and Licensee and its Affiliates hereby accept, a non-exclusive,
royalty-free license, including the right to grant sublicenses as provided in
Section 2.3 below, to use the Licensed Marks in the Territory solely in
connection with Licensee’s right to:

 

2.1.1.       Develop Compound and Product in the Field in the Territory as
provided in Article V of the License and Collaboration Agreement;

 

2.1.2.       Manufacture Compound or Product in the Field in the Territory
accordance with Section 6.5 of the License and Collaboration Agreement; and

 

******                           - Material has been omitted and filed
separately with the Commission.

 

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

 

2.1.3.       use, sell, offer for sale, distribute, promote and otherwise
Commercialize Products in the Field in the Amicus Territory in accordance with
the terms of the License and Collaboration Agreement.

 

2.2.         Licensee shall have the right to use the Licensed Marks (excluding
GSK House Marks) as part of a domain name, subject to Licensor’s prior written
approval and provided that Licensee remains responsible for all costs associated
with development and operation of the associated website.

 

2.3.         Licensee shall have the right to grant sublicenses under this
Agreement solely as and to the extent Licensee is permitted to grant sublicenses
to any of its Affiliates (solely for so long as such entity remains an
Affiliate) and to Third Parties, in each case, under and in accordance with
Section 2.4.1 of the License and Collaboration Agreement.  In any event,
Licensee shall ensure that each of its Third Party Sublicensees is bound by a
written agreement containing provisions at least as protective of the Licensed
Marks and Licensor as this Agreement; and Licensee shall remain responsible to
Licensor for all activities of its Affiliates and Sublicensees in connection
with the Licensed Marks to the same extent as if such activities had been
undertaken by Licensee itself.

 

3.              USE OF THE LICENSED MARKS

 

3.1.                            Upon reasonable advance written request,
Licensee agrees to submit to Licensor samples of the Product (to the extent
Manufactured by Licensee or its designee) and samples of packaging of the
Product displaying the Licensed Marks for Licensor’s inspection.  If Licensor
reasonably determines that Licensee has failed to maintain a level of quality
consistent with those normally employed by the Licensor in the use of the
Licensor’s Trademarks, then Licensor may request that Licensee take reasonable
steps to remedy any such deficiencies and Licensee agrees to take commercially
reasonable actions to comply with such requests, and in any event, Licensee
shall not use or distribute Product or any packaging for the Product displaying
the Licensed Marks until it has complied with such requests.

 

3.2.                            Licensee and its Affiliates and Sublicensees
shall comply with all applicable laws and regulations pertaining to the
Commercialization of Products bearing the Licensed Marks, to the extent that
Licensee shall perform any such Commercialization activities under the License
and Collaboration Agreement.

 

4.              MAINTENANCE OF LICENSED MARKS.

 

4.1.                            Licensor shall prepare, file, prosecute and
maintain trademark applications and registrations for the Licensed Marks used on
or in connection with Product in the Territory.  All costs and expenses
(including but not limited to attorneys’ fees and expenses and official fees) of
preparing, filing, prosecuting and maintaining the Licensed Marks shall be borne
by Licensor.

 

******              - Material has been omitted and filed separately with the
Commission.

 

2

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

 

4.2.                            Licensor shall not (i) abandon any rights in the
Licensed Marks in the Territory, (ii) abandon or allow any pending application
for the Licensed Marks to lapse in the Territory, or (iii) permit any active
registration for the Licensed Marks to lapse, expire or be cancelled in the
Territory, without first notifying Licensee.

 

5.              TERM.  This Agreement shall be effective commencing on the
Effective Date and shall continue perpetually unless terminated as set forth in
Section 6 below.

 

6.              TERMINATION.

 

6.1.                            This Agreement shall terminate automatically,
without notice or any further action hereunder by either Party: (a) in its
entirety upon the expiration of the License and Collaboration Agreement in its
entirety or upon the expiration of the Amicus Wind-Down Period, following a
termination of the License and Collaboration Agreement in its entirety by GSK
pursuant to Section 13.2 thereof, or by either Party pursuant to Section 13.4 of
the License and Collaboration Agreement; or (b) if the License and Collaboration
Agreement is terminated by GSK pursuant to Section 13.2 with respect to a
Product (but not terminated in its entirety, i.e. with respect to all Products),
then this Agreement shall terminate with respect to the particular Licensed Mark
and particular country(ies) licensed for use in connection with the Terminated
Product in the relevant Affected Area upon the expiration of the applicable
Amicus Wind-Down Period following the termination of the License and
Collaboration Agreement by GSK pursuant to Section 13.2 with respect to the
Product with which such Licensed Mark is used in the Territory.

 

6.2.                            The Parties may terminate this Agreement in its
entirety or on a Licensed Mark-by-Licensed Mark basis at any time and for any
reason during the Term upon their mutual written agreement; provided that the
Parties shall agree to terminate this Agreement, in its entirety, or on a
Licensed Mark-by-Licensed Mark basis, as applicable, if the JSC determines that
such Licensed Mark(s) shall no longer be used with respect to a Product in the
Territory.

 

6.3.                            Subject to and in accordance with Section 14.2
of the License and Collaboration Agreement, Licensee agrees, with respect to all
Licensed Marks upon termination or expiration of this Agreement in its entirety,
or, if the License and Collaboration Agreement is terminated with respect to a
Terminated Product and/or a particular country(ies), but not in its entirety,
then solely with respect to such Licensed Marks that are licensed with respect
to the Terminated Product(s) in such country(ies): (i) to discontinue
immediately following the expiration of the Amicus Wind-Down Period, and to
cause all of Licensee’s Affiliates and any Sublicensees of Licensee thereof to
discontinue immediately, the use of such Licensed Marks; (ii) to return to
Licensor, upon Licensor’s request, or to destroy all tangible embodiments (other
than packaging containing Product) of any such Licensed Marks;  (iii) to

 

******              - Material has been omitted and filed separately with the
Commission.

 

3

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

 

furnish Licensor with certification and evidence of destruction of such items or
materials bearing the Licensed Marks, if such items or materials are destroyed
by Licensee at Licensor’s request; and (iv) to reasonably work with Licensor to
facilitate the proper possession, transfer and/or destruction of packaging
containing Product and such Licensed Marks in accordance with the License and
Collaboration Agreement.

 

7.              OWNERSHIP.  Licensor represents and warrants, and Licensee
acknowledges, that the Licensed Marks are the sole and exclusive property of
Licensor or its Affiliates in the Territory and all goodwill accrued through use
of the Licensed Marks shall be deemed to be the absolute property of Licensor or
its Affiliates. Licensee further acknowledges that nothing in this Agreement
confers upon Licensee any right of ownership in and to the Licensed Marks. 
Licensee agrees to reasonably cooperate with Licensor to execute, deliver, and
otherwise provide to Licensor all information and documents reasonably requested
for the purpose of establishing, registering, evidencing or defending Licensor’s
complete and exclusive ownership of all rights, titles, and interests of every
kind and nature whatsoever in and to the Licensed Marks.  Licensee agrees not to
register, use or authorize the use of any trademark or designation confusingly
similar to the Licensed Marks, and Licensee agrees not to challenge Licensor’s
or its Affiliates’ ownership of the Licensed Marks.

 

8.              ASSIGNMENTS.  Neither this Agreement, nor any of the rights or
obligations of a Party may be directly or indirectly assigned, sold, delegated
or otherwise disposed of by a Party except in connection with such Party’s
assignment of, and to the same assignee as, the License and Collaboration
Agreement in accordance with Section 16.3 of the License and Collaboration
Agreement.

 

8.1.                            No assignment under this Section 8 shall be
effective unless the intended assignee executes and delivers to the Party which
is not the assignor a writing whereby the assignee expressly undertakes to
perform and comply with all of its assignor’s obligations hereunder. 
Notwithstanding such undertaking, such assignor shall continue to be primarily
liable for such assignee’s performance hereof and compliance herewith.

 

8.2.                            Any assignment in violation of this Section 8
shall be void and of no effect.

 

8.3.                            This Agreement, and the rights and obligations
of the Parties herein contained, shall be binding upon, and shall inure to the
benefit of, the Parties and their respective legal representatives, successors
and permitted assigns.

 

9.              AMENDMENTS.  No waiver, amendment or modification of any
provision hereof or of any right or remedy hereunder shall be effective unless
in writing and signed by the Party against whom such waiver, amendment or
modification is sought to be enforced.

 

10.       COUNTERPARTS.  This Agreement may be executed in any number of
counterparts, each of which shall be deemed to be an original, but all of which
together shall constitute but one and the

 

******              - Material has been omitted and filed separately with the
Commission.

 

4

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

 

same instrument.  Delivery of an executed counterpart signature page of this
Agreement by facsimile or other electronic transmission shall be as effective as
delivery of a manually executed signature page.

 

11.       APPLICABLE LAW AND DISPUTE RESOLUTION.  This Agreement shall be
governed by, interpreted and construed, and all claims and disputes, whether in
tort, contract or otherwise be resolved in accordance with the substantive laws
of the State of Delaware without reference to any rules of conflict of laws. 
Any and all disputes under this Agreement shall be resolved in accordance with
Section 16.2 of the License and Collaboration Agreement.

 

12.       FURTHER ASSURANCES.  Each of Party shall, at any time or from time to
time after the Effective Date, at the request and expense of the other Party,
execute and deliver to the other Party all such instruments and documents or
further assurances as the other Party may reasonably request in order to give
effect to the transactions contemplated by this Agreement, including but not
limited to Licensee’s request for Licensor’s cooperation to record or register
this Agreement with any applicable governmental entity.

 

13.       REPRESENTATIONS AND WARRANTIES.  Each Party represents and warrants
that (i) this Agreement has been duly and validly executed and delivered by such
Party and constitutes a legal and binding obligation of such Party, enforceable
against it in accordance with its terms, and (ii) it has all necessary right,
power and authority to execute and perform its obligations under this Agreement
and to grant the rights granted herein.  Licensor further represents and
warrants that it is the owner of all right, title, and interest in and to the
Licensed Marks and that the execution, delivery, and performance of its
obligations under this Agreement will not conflict with or violate any agreement
or other obligation of Licensor or binding upon Licensor’s assets, including but
not limited to the Licensed Marks.

 

14.       SEVERABILITY.  If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any present or future law, and if the
rights or obligations of either Party under this Agreement will not be
materially and adversely affected thereby, (a) such provision will be fully
severable, (b) this Agreement will be construed and enforced as if such illegal,
invalid or unenforceable provision had never comprised a part hereof, (c) the
remaining provisions of this Agreement will remain in full force and effect and
will not be affected by the illegal, invalid or unenforceable provision or by
its severance herefrom, and (d) in lieu of such illegal, invalid or
unenforceable provision, there will be added automatically as a part of this
Agreement a legal, valid and enforceable provision as similar to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties.

 

15.       WAIVER.  No waiver by any Party in one or more instances of any of the
provisions of this Agreement or the breach thereof shall establish a precedent
for any other instance with respect to that or any other provision. 
Furthermore, in case of waiver of a particular provision, all other provisions
of this Agreement will continue in full force and effect.

 

******              - Material has been omitted and filed separately with the
Commission.

 

5

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

 

16.       INTEGRATION.  This Agreement (including Exhibits hereto), and the
License and Collaboration Agreement, embodies the entire agreement of the
Parties hereto with respect to the subject matter hereof and supersedes any and
all prior agreements with respect thereto.

 

[Remainder of page intentionally left blank]

 

******              - Material has been omitted and filed separately with the
Commission.

 

6

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

 

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

 

 

AMICUS THERAPEUTICS, INC.

 

 

 

 

 

By:

 

 

 

Name:

 

 

 

Title:

 

 

 

 

 

GLAXO GROUP LIMITED

 

 

 

 

 

By:

 

 

 

Name:

 

 

 

Title:

 

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

EXHIBIT A

 

TO TRADEMARK LICENSE AGREEMENT

 

LICENSED MARKS

 

Mark

 

Registration/Application No.

 

Territory/Country

CONECTRIC

 

Reg. No. 3961746

 

US

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

EXHIBIT D

 

PREVENTION OF CORRUPTION — THIRD PARTY GUIDELINES

 

The GSK Anti-Bribery and Corruption Policy (POL-GSK-007) requires compliance
with the highest ethical standards and all anti-corruption laws applicable in
the countries in which GSK (whether through a third party or otherwise) conducts
business.  POL-GSK-007 requires all GSK employees and any third party acting for
or on behalf of GSK to ensure that all dealings with third parties, both in the
private and government sectors, are carried out in compliance with all relevant
laws and regulations and with the standards of integrity required for all GSK
business.  GSK values integrity and transparency and has zero tolerance for
corrupt activities of any kind, whether committed by GSK employees, officers, or
third-parties acting for or on behalf of the GSK.

 

Corrupt Payments — GSK employees and any third party acting for or on behalf of
GSK, shall not, directly or indirectly, promise, authorise, ratify or offer to
make or make any “payments” of “anything of value” (as defined in the glossary
section) to any individual (or at the request of any individual) including a
“government official” (as defined in the glossary section) for the improper
purpose of influencing or inducing or as a reward for any act, omission or
decision to secure an improper advantage or to improperly assist the company in
obtaining or retaining business.

 

Government Officials — Although GSK´s policy prohibits payments by GSK or third
parties acting for or on its behalf to any individual, private or public, as a
“quid pro quo” for business, due to the existence of specific anticorruption
laws in the countries where we operate, this policy is particularly applicable
to “payments” of “anything of value” (as defined in the glossary section), or at
the request of, “government officials” (as defined in the glossary section).

 

Facilitating Payments — For the avoidance of doubt, facilitating payments
(otherwise known as “greasing payments” and defined as payments to an individual
to secure or expedite the performance of a routine government action by
government officials) are no exception to the general rule and therefore
prohibited.

 

GLOSSARY

 

The terms defined herein should be construed broadly to give effect to the
letter and spirit of the ABAC Policy.  GSK is committed to the highest ethical
standards of business dealings and any acts that create the appearance of
promising, offering, giving or authorising payments prohibited by this policy
will not be tolerated.

 

Anything of Value: this term includes cash or cash equivalents, gifts, services,
employment offers, loans, travel expenses, entertainment, political
contributions, charitable donations, subsidies, per diem payments, sponsorships,
honoraria or provision of any other asset, even if nominal in value.

 

Payments: this term refers to and includes any direct or indirect offers to pay,
promises to pay, authorisations of or payments of anything of value.

 

Government Official shall mean:

 

·                  Any officer or employee of a government or any department,
agency or instrument of a government;

 

·                  Any person acting in an official capacity for or on behalf of
a government or any department, agency, or instrument of a government;

 

·                  Any officer or employee of a company or business owned in
whole or part by a government;

 

·                  Any officer or employee of a public international
organisation such as the World Bank or United Nations;

 

·                  Any officer or employee of a political party or any person
acting in an official capacity on behalf of a political party; and/or

 

·                  Any candidate for political office.

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

EXHIBIT E

 

******

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 1.29

 

BACKGROUND LICENSE AGREEMENTS

 

1)                                     ******

 

2)                                     ******

 

3)                                     Amended and Restated Agreement between
Mount Sinai School of Medicine of New York University and Amicus
Therapeutics, Inc., dated October 31, 2008.

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 1.48

 

DESCRIPTION OF COMPOUND

 

United States Adopted Name: migalastat

 

Other Chemical Names:

 

1)                                     1-deoxygalactonojirimycin

 

2)                                    
(2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol

 

Chemical Structure:

 

[g201171ke19i001.jpg]

 

MOLECULAR FORMULA:  C6H13NO4

 

MOLECULAR WEIGHT:  163.17

 

CAS REGISTRY NUMBER:  108147-54-2

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 1.116

 

JR051

 

******

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 3.4.3

 

THIRD PARTY PAYMENTS OWED

 

As of the Effective Date, pursuant to Amended and Restated Agreement between
Mount Sinai School of Medicine of New York University (“MSSM”) and Amicus
Therapeutics, Inc., dated October 31, 2008 (“MSSM License”) royalties are
payable by Amicus to MSSM at the rates specified below and otherwise in
accordance with the terms of the MSSM License:

 

·                                          ****** and

 

·                                          ******.

 

Capitalized terms used in this Schedule 3.4.3 and not defined in the Amended and
Restated License and Collaboration Agreement to which this Schedule 3.4.3 is
attached have the meanings given to such terms in the MSSM License, a copy of
which has been provided by Amicus to GSK prior to the Effective Date.

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 5.1A

 

EXISTING DEVELOPMENT PLAN

 

******

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 5.1B

 

CO-FORMULATION DEVELOPMENT PLAN

 

******

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 5.1.4

 

DEVELOPMENT COST SHARING

 

******

 

******              - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 6.1

 

GLOBAL COMMERCIAL PLAN

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 6.5.1

 

TECHNOLOGY TRANSFER REQUIREMENTS

 

Technology Transfer Requirements

 

Note:  GSK’s responsibility with regard to items in this document are restricted
to materials and data generated by GSK since the execution of the Original
Agreement.

 

Contacts

 

1.              Name, address, phone, FAX, and e-mail address of key technical
contacts for each Party and all third parties involved in process development,
manufacture, analysis, or release.

 

Materials

 

2.              Allocated portion of drug substance inventory of, and
intermediates, along with their batch histories, batch records and analytical
results (to the extent such histories, records and analytical results can be
reproduced and transferred from the site of the contract manufacturer).

 

3.              Drug substance primary reference standard and any reports
describing its characterization and assignment of purity.

 

4.              Working references standards for drug substance, intermediates
and impurities along with any report on their comparability, characterization,
or assignment of purity.

 

5.              Allocation of drug product inventory, with CoA, shelf life,
input drug substance and other details

 

API  (chemical synthesis)

 

6.              An updated schematic of the chemical synthesis, including
typical yields for each stage.

 

7.              Copies of detailed complete manufacturing instructions for all
stages and operations of the API chemical synthesis processes on the largest
scale to date, including all in-process analytical tests and methods. To be
transferred upon completion of DS validation work and analytical test
method/validation work and reporting of the same.

 

8.              Available documented process knowledge established through
development and commercial supply. To be transferred upon completion of DS
validation work and analytical test method/validation work and reporting of the
same.

 

9.              Process validation protocols and reports when available

 

10.       Cleaning method and validation reports for each stage of the chemical
processes.

 

******                           - Material has been omitted and filed
separately with the Commission.

 

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

 

11.       For all key raw materials, a table of suppliers, ordering lead times,
and buying specifications, including detailed specifications of any components
to the extent access to such information is provided to Amicus or GSK by the
contract manufacturer.

 

12.       A summary report describing the history of chemical synthesis process
development, changes and their reason, and optimization of the processes.

 

13.       Report on the Genotoxic Risk Assessment of the manufacturing process

 

Analytical

 

14.       A report summarizing available data describing the physical properties
of the drug substance, including MW, solubility, pKa, etc as applicable.

 

15.       The Drug Substance Stability Report, including all data and methods.

 

16.       Current specifications for drug substance and starting materials,
including justification for the specifications.

 

17.       All analytical methods and validation reports employed for analysis of
the starting and key raw materials

 

18.       A complete drug substance batch history table, including lot number,
amount, Certificates of Analyses, and use or intended use (particularly for
safety assessment or clinical studies).

 

19.       A statement or certificate of available API inventory is free from
TSEs/BSEs.

 

20.       All analytical methods employed for analysis of the drug substance
used in safety assessment and clinical trial supplies. This should include
methods/limits of detection/limits of quantification for heavy metals and low
level potential genotoxic impurities if such analysis is performed.

 

21.       A table listing all impurities (by Retention Time of the major,
Relative Retention Time and {% (a/a) or (w/w)} of all impurities present in the
drug substance used in safety assessment studies and in the clinical trial
supplies.

 

22.       A table or report describing drug substance impurities including
critical and typical levels, probable origins, and methods for control,
particularly for any known or potential highly-toxic or mutagenic impurities or
degradants.

 

23.       A report summarizing effort to characterize drug substance impurities.

 

24.       A report summarizing the history of analytical methods development.

 

25.       A table of isolated intermediate acceptance criteria or buying
specifications, and their analytical methods (including purity profile),
including limits for any potentially mutagenic or highly toxic impurities.

 

26.       Recommended storage conditions for the drug substance and
intermediates suitable for international shipping.

 

27.       Any shipping studies data for drug substance and intermediates
including container specifications used for storage and shipping.

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Drug Product: Formulation and Manufacturing

 

28.       Full analytical data on all batches of drug substance that have been
converted to drug product.

 

29.       Reports on and details of pre-formulation studies

 

30.       Reports on and details of development pharmaceutics, including all
formulation approaches considered and evaluated

 

31.       Any analytical methods developed or modified subsequent to formulation
development, method validation and drug product specifications.

 

32.       Results of any drug-excipient compatibility studies that have been
conducted if applicable.

 

33.       The Drug Product Stability Report, including all data and methods

 

34.       Details of the manufacturing process

 

35.       Full manufacturing records to the extent access to such information is
provided to Amicus or GSK by the contract manufacturer ******

 

36.       Process validation protocols and reports when available

 

37.       Statement or certificate that the drug product capsules do not contain
TSEs/BSEs.

 

38.       Formulation and process details of toxicology formulations and
approaches including crystal form of input drug substance

 

39.       Any shipping studies or data for drug product, including container
specifications used for storage and shipping.

 

40.       Details on commercial pack development

 

Regulatory

 

41.       All CMC regulatory documentation including the NDA and IND, including
agency questions and responses, especially those related to any aspect of
primary drug substance manufacture, analysis, batch histories, impurity
profiles, or stability.

 

42.       Any regulatory data to support international shipment or shaking of
drug substance or process materials.

 

43.                                Any drug substance process data or reports
needed to support regulatory filings.

 

44.       Any new GSK audit reports of ******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Environmental, Health and Safety

 

45.       Any worker safety information on the drug substance, formulation,
reagents/excipients, including toxicity (including exposure limits, where
known), thermal, gaseous or other hazards.

 

·                                          MSDS (where applicable)

 

·                                          Occupational exposure limits or
exposure guidelines (where defined).

 

·                                          Occupational Hygiene monitoring and
analytical methods (where available)

 

46.       A report summarizing any environmental process safety assessment for
the API process, including

 

·                                          Environmental fate and effects data
(e.g., aquatic toxicity, biodegradability, bioaccumulation potential) for
API/materials/excipients.

 

·                                          Chemical hazard data for the process
used to manufacture drug substance (e.g., material stability, hazardous
incompatibilities, etc.)

 

Intellectual Property

 

·                                          Reference to any Amicus intellectual
property (e.g. patents, patent applications) covering the drug substance,
intermediates, or synthetic processes.

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 6.5.4

 

API AND DRUG PRODUCT SPECIFICATIONS

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 6.6

 

COMMERCIAL TRANSITION PLAN

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 7.2.1

 

GSK PROSECUTED AMICUS PATENTS

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 7.2.2

 

AMICUS PROSECUTED PATENTS

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 7.2.3

 

PATENT APPLICATIONS TO BE SEGREGATED PER SECTION 7.2.3

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 10.2

 

BACKGROUND LICENSE AGREEMENT PROVISIONS

 

1.                                      MSSM LICENSE

 

Pursuant to Section 2.d. of the MSSM License, GSK agrees: (i) to be bound by,
and comply with, Sections 6 (Confidential Information), 9 (Liability and
Indemnification) and 10 (Security for Indemnification) of the MSSM License
(substituting “GSK” for “AMICUS” in such provisions), the text of which is
included below and incorporated herein by reference, to the extent applicable to
GSK in its capacity as sublicensee; and (ii) that MSSM is an intended third
party beneficiary of the Agreement for purposes of enforcing such
indemnification and insurance provisions.

 

Pursuant to Section 2.c. of the MSSM License, GSK agrees: (a) the sublicense
granted by Amicus to GSK under the MSSM License shall be subject and subordinate
to the terms and conditions of the MSSM License; (b) such sublicense shall
expire automatically on the termination of the MSSM License; (c) such sublicense
shall not be assignable, in whole or in part; provided, however, that GSK may,
with written notice to MSSM, assign the sublicense in connection with a merger
or acquisition of GSK or the sale by the sublicensee of substantially all of its
assets; (d) GSK shall be entitled to grant further sublicenses, provided that
GSK complies with the obligations of Amicus under Section 2.c., Section 2.d. and
all other provisions of MSSM License relating to the grant of sublicenses by
Amicus under the MSSM License; and (e) both during the term of such sublicense
and thereafter GSK shall be bound by a secrecy obligation similar to that
imposed on Amicus in Section 6 of the MSSM License, and that GSK shall bind its
employees and agents, both during the terms of their employment and thereafter,
with a similar undertaking of secrecy.  In addition, GSK, in its capacity as a
sublicensee under the MSSM License, specifically agrees to comply with the audit
rights applicable to sublicensees and the obligation to maintain books and
records to enable the determination of the amounts payable by Amicus, as a
result of the activities of GSK in its capacity as a sublicensee under the MSSM
License.

 

Provisions Extracted from MSSM License:

 

Capitalized terms in the following provisions of the MSSM License, but not
defined therein, shall have the meanings given to such terms in the MSSM
License.

 

“6.                                Confidential Information.

 

a.                                      In the course of research to be
performed under this Agreement, it will be necessary for each party to disclose
“Confidential Information” to the other.  For purposes of this Agreement,
“Confidential Information” is defined as all information, data and know-how
disclosed by one party (the “Disclosing Party”) to the other (the “Receiving
Party”), either embodied in tangible materials (including writings, drawings,
graphs, charts, photographs, recordings, structures, technical and other
information) marked “Confidential” or, if initially disclosed orally, which is
reduced to writing marked “Confidential” within 21 days after initial oral
disclosure, other than that information which is,

 

i)                                         known by the Receiving Party at the
time of its receipt, and not through a prior disclosure by

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

the Disclosing Party, as documented by the Receiving Party’s business records;
or

 

ii)                                      at the time of disclosure, or
thereafter becomes, published or otherwise part of the public domain without
breach of this Agreement by the Receiving Party; or

 

iii)                                   obtained from a third party who has the
legal right to make such disclosure and without any confidentiality obligation
to the Disclosing Party; or

 

iv)                                  independently developed by the Receiving
Party without the use of Confidential Information received from the Disclosing
Party and such independent development can be documented by the Receiving Party;
or

 

v)                                     disclosed to governmental or other
regulatory agencies in order to obtain patents, provided that such disclosure
may be made only to the extent reasonably necessary to obtain such patents or
authorizations, and further provided that any such patent applications shall be
filed in accordance with the terms of this Agreement; or

 

vi)                                  required by law, regulation, rule, act or
order of any governmental authority to be disclosed.

 

b.                                      The Receiving Party agrees that at all
times and notwithstanding any termination, expiration, or cancellation
hereunder, it will hold the Confidential Information of the Disclosing Party in
strict confidence, will use all reasonable safeguards to prevent unauthorized
disclosure by its employees and agents.  Notwithstanding the foregoing, the
parties recognize that industry standards with respect to the treatment of
Confidential Information may not be appropriate in an academic setting. 
However, MSSM agrees to retain Confidential Information of AMICUS in the same
manner and with the same level of confidentiality as MSSM retains its own
Confidential Information.

 

c.                                       The Receiving Party will maintain
reasonable procedures to prevent accidental or other loss, including
unauthorized publication of any Confidential Information of the Disclosing
Party.  The Receiving Party will promptly notify the Disclosing Party in the
event of any loss or unauthorized disclosure of the Confidential Information.

 

d.                                      Upon termination or expiration of this
Agreement, and upon written request, the Receiving Party will promptly return to
the Disclosing Party all documents or other tangible materials representing
Confidential Information and all copies thereof.

 

e.                                       The Receiving Party will immediately
notify the Disclosing Party in writing, if it is requested by a court order, a
governmental agency, or any other entity to disclose Confidential Information in
the Receiving Party’s possession.  The Disclosing Party will have an opportunity
to intervene by seeking a protective order or other similar order, in order to
limit or prevent disclosure of the Confidential Information.  The Receiving
Party will disclose only the minimum Confidential Information required to be
disclosed in order to comply, whether or not a protective order or other similar
order is obtained by the Disclosing Party.”

 

“9.                                Liability and Indemnification.

 

a.                                      AMICUS shall indemnify, defend and hold
harmless MSSM and its trustees, officers, directors, medical and professional
staff, employees, students and agents and their respective

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

successors, heirs and assigns (the “Indemnitees”), against any liability,
damage, loss or expense (including reasonable attorneys’ fees and expenses of
litigation) incurred by or imposed upon the Indemnitees or any one of them in
connection with any claims, suits, actions, demands or judgments: (i) arising
out of the production, manufacture, sale, use in commerce or in human clinical
trials, lease, or promotion by AMICUS or by a licensee, Affiliate or agent of
AMICUS of any Licensed Product, process or service relating to, or developed
pursuant to, this Agreement, or (ii) arising out of any other activities to be
carried out pursuant to this Agreement.

 

b.                                      AMICUS’ indemnification under subsection
a(i), above, shall apply to any liability, damage, loss or expense whether or
not it is attributable to the negligent activities of the Indemnitees.  AMICUS’
indemnification under subsection a(ii) above, shall not apply to any liability,
damage, toss or expense to the extent that it is attributable to the negligence,
gross negligence or intentional misconduct of the Indemnitees.

 

c.                                       AMICUS shall, at its own expense,
provide attorneys reasonably acceptable to MSSM to defend against any actions
brought or filed against any party indemnified hereunder with respect to the
subject of indemnity contained herein, whether or not such actions are
rightfully brought.

 

d.                                      EXCEPT AS PROVIDED IN THIS SECTION 9,
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INCIDENTAL, CONSEQUENTIAL,
SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES.

 

10.                               Security for Indemnification.

 

a.                                      At such time as any Licensed Product is
being commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by AMICUS or by a sub-licensee, Affiliate or agent of
AMICUS and to the extent that it is available on commercially reasonable terms,
AMICUS shall at its sole cost and expense, procure and maintain policies of
comprehensive general liability insurance in amounts not less than ****** per
incident and ****** annual aggregate and naming the indemnitees as additional
insureds.  Such comprehensive general liability insurance shall provide
(i) product liability coverage and (ii) broad form contractual liability
coverage for AMICUS’ indemnification under Section 9 of this Agreement.  The
minimum amounts of insurance coverage required under this Section 10 shall not
be construed as a limit of AMICUS’ liability with respect to its indemnification
under Section 9 of this Agreement.

 

b.                                      AMICUS shall provide MSSM with written
evidence of such insurance upon request of MSSM. AMICUS shall provide MSSM with
written notice at least 60 days prior to the cancellation, non-renewal or
material change in such insurance; if AMICUS does not obtain replacement
insurance providing comparable coverage within such 60 day period effective
immediately upon notice to AMICUS, MSSM shall have the right to terminate this
Agreement effective at the end of such 60 day period without notice or any
additional waiting periods.

 

c.                                       AMICUS shall maintain such
comprehensive general liability insurance beyond the expiration or termination
of this Agreement during: (i) the period that any product, process or service,
relating to, or developed pursuant to, this Agreement is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by AMICUS or by a licensee, Affiliate or agent of AMICUS and (ii) a
reasonable period after the period referred to in (c)(i) above

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

which in no event shall be less than seven years.”

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 12.1A

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 12.1B

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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

 

Schedule 14.2.3

 

CALCULATION OF ROYALTY RATE REDUCTION

 

******

 

******                 - Material has been omitted and filed separately with the
Commission.

 

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