Exhibit 10.46

 

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.

 

SECOND RESTATED AGREEMENT

 

This SECOND RESTATED AGREEMENT (the “Agreement”) is made as of the 19th day of
November, 2013 (the “Second Restated 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 980 Great West Road, Brentford, Middlesex,TW8 9GS, England (“GSK”). 
Amicus and GSK are each referred to herein by name or as a “Party” or,
collectively, as the “Parties”.

 

RECITALS

 

WHEREAS, the Parties previously entered into a certain License and Collaboration
Agreement (“Original Agreement”) dated October 28, 2010 (the “Original Effective
Date”), pursuant to which Amicus granted to GSK exclusive, worldwide, rights to
Compounds and Products (each as defined below);

 

WHEREAS, on July 17, 2012 (the “First Restated Effective Date”), the Parties
amended and restated the Original Agreement in its entirety to provide for,
among other matters, the reversion to Amicus of the rights for the
Commercialization of Compound and Products in the United States (the “First
Restated Agreement”);

 

WHEREAS, in connection with both the Original Agreement and with the First
Restated Agreement, GSK acquired shares of common stock of Amicus; and

 

WHEREAS, the Parties now desire for GSK to return all of the worldwide rights to
the Compound and Products to Amicus, on the terms and conditions as set forth
herein.

 

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.  Capitalized terms used but not defined herein shall have the
meaning ascribed to such terms in the First Restated Agreement:

 

1.1                               “AAA” has the meaning ascribed to that term in
Section 14.2.2.

 

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

 

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1.2                               “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 1.2, “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.

 

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

 

1.4                               “Amicus Indemnitees” has the meaning ascribed
to that term in Section 12.3.

 

1.5                               “Amicus Product Royalty Term” has the meaning
ascribed to that term in Section 7.1(b)(ii).

 

1.6                               “API” has the meaning ascribed to that term in
Section 1.48.

 

1.7                               “Assigned Agreements” has the meaning ascribed
to that term in Section 4.4, a list of which, as of the Second Restated
Effective Date, is set forth in the attached Exhibit B.

 

1.8                               “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’ corporate headquarters are closed.

 

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

 

1.10                        “Co-Administration Product” means a product
consisting of co-administration of the Compound or a Product with an enzyme
replacement therapy (including without limitation JR051), regardless of the
order or form in which the co-administration is performed.

 

1.11                        “Co-Formulation Development Plan” means the
development plan and associated budget for the Development of Co-Formulation
Products for intravenous and subcutaneous deliveries in the Field in the
Territory, as attached to the First Restated Agreement as Schedule 5.1B, as such
development plan and associated budget have been amended in accordance with the
First Restated Agreement and in the form in which such development plan and
associated budget exist as of the Second Restated Effective Date.

 

1.12                        “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.

 

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

 

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1.13                        “Co-Formulation Product” means a pharmaceutical
preparation that incorporates the Compound formulated together with JR051.

 

1.14                        “Co-Formulation Product IP” means any and all
Know-How and Patents arising, during the period from the Original Effective Date
until the Second Restated Effective Date of this Agreement, from the conduct of
activities with respect to the Development of a Co-Formulation Product under the
Original Agreement or the First Restated 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.  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 the First Restated Agreement and, as between Amicus and GSK, all
such activities conducted by JCR in connection with the First Restated Agreement
shall be deemed to have been conducted by GSK under the First Restated
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.

 

1.15                        “Co-Formulation Transition Supply Period” has the
meaning ascribed to that term in Section 6.3.

 

1.16                        “Collaboration Claims” has the meaning ascribed to
that term in Section 2.3(b).

 

1.17                        “Commercialize,” “Commercialized” or
“Commercialization” means activities directed to obtaining pricing and
reimbursement approvals for a Product in the Field and in the Territory;
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 and in the Territory.  For clarity, “Commercialize,” “Commercialized,”
and “Commercialization” shall not include Development or Manufacturing.

 

1.18                        “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 its 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.

 

1.19                        “Compound” means migalastat, as described in
Schedule 1.48 of the First Restated Agreement, 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.

 

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

 

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1.20                        “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 Original
Effective Date) to the other Party (the “receiving Party”) in connection with or
generated pursuant to the Original Agreement, First Restated Agreement or this
Agreement.  Confidential Information expressly includes the terms of this
Agreement, which shall be deemed Confidential Information of both Parties. 
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 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.

 

1.21                        “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.

 

1.22                        “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 (excluding regulatory activities directed
to pricing and reimbursement approvals); in each case, with

 

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

 

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respect to the Products in the Field for the Territory.  For clarity, “Develop”
and “Development” shall not include Manufacturing or Commercialization.

 

1.23                        “Dispute” has the meaning ascribed to that term in
Section 14.2.1.

 

1.24                        “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.

 

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

 

1.26                        “Expanded Major Market Country” means ******

 

1.27                        “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.

 

1.28                        “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 enzyme replacement therapy.

 

1.29                        “Force Majeure Event” has the meaning ascribed to
that term in Section 14.11.

 

1.30                        “FTE” means a full-time equivalent person from an
employee of a Party or one of its Affiliates assigned to perform specific work,
as set forth in Section 3.3.

 

1.31                        “GAAP” has the meaning ascribed to that term in
Section 1.60.

 

1.32                        “Generic Equivalent” means, as to a Product that has
received Regulatory Approval in a particular country in the Territory 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 establishing bioequivalence or
biosimilarity to or interchangeability with such Product, in each case, without
the requirement of any human clinical efficacy trials other than to establish
biosimilarity or interchangeability; and (B) is bioequivalent or bio-similar to,
or interchangeable with, such Product; and (C) is legally marketed in such
country by an entity other than such Party, its Affiliates or Sublicensees.

 

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

 

1.34                        “GSK Auditor” has the meaning ascribed to that term
in Section 9.4.

 

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

 

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1.35                        “GSK Background IP” means all Patents and/or
Know-How which: (a) GSK or its Affiliates Controlled as of the Original
Effective Date, or (b) were developed by or on behalf of GSK or its Affiliates
after the Original Effective Date or acquired or otherwise Controlled by GSK or
its Affiliates after the Original 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 First Restated Effective Date, and any improvements made thereto; excluding
the GSK Monotherapy Product Manufacturing Improvements.  For the avoidance of
doubt, GSK Background IP expressly excludes any intellectual property rights
related to the GSK Route B Manufacturing Process, which are outside of the scope
of this Agreement.

 

1.36                        “GSK House Marks” means the GSK brand name, logo,
and other identifying markings of GSK or its Affiliates.

 

1.37                        “GSK Indemnitees” has the meaning ascribed to that
term in Section 12.4.2.

 

1.38                        “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 Second Restated Effective Date, and any improvements
or modifications thereto.

 

1.39                        “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.

 

1.40                        “GSK Monotherapy Product Manufacturing Improvements”
means any improvements or modifications made by or on behalf of GSK (i) after
the Original 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 First Restated Effective Date and in the conduct of
Development activities under the Existing Development Plan under the First
Restated Agreement to the manufacturing processes for the Manufacture of
Compound or Products (other than the Co-Formulation Products).  For the
avoidance of doubt, GSK Monotherapy Product Manufacturing Improvements
specifically excludes the GSK Route B Manufacturing Process.

 

1.41                        “GSK Route B Manufacturing Process” means the
fermentation process developed by GSK from the wild-type Streptomyces sp. BTA
530 to produce migalastat.  The commercial sourcing for Route B is fully within
GSK’s primary network and outside of the scope of the Original Agreement, First
Restated Agreement, or this Agreement.

 

1.42                        “GSK Trademark” means a Trademark that was
Controlled by GSK or any of its Affiliates during the term of the First Restated
Agreement that the Joint Commercialization

 

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

 

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Subcommittee determined should be used on or in connection with Products.  As of
the Second Restated Effective Date, there are no GSK Trademarks.

 

1.43                        “GSK Transferred Activities” has the meaning
ascribed to that term in Section 3.1.

 

1.44                        “GSK Transferred Patents” means all Patents owned,
solely or jointly, by GSK or its Affiliate included in the Program Improvements,
Program Patents and Co-Formulation Product IP.

 

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

 

1.46                        “Indemnitee” has the meaning ascribed to that term
in Section 12.4.3.

 

1.47                        “Indemnitor” has the meaning ascribed to that term
in Section 12.4.3.

 

1.48                        “Inventory” shall mean all active pharmaceutical
ingredient (“API”) and drug product for the Products and intermediates used in
the synthesis of the Compound that is owned or Controlled by GSK or its
Affiliates on the Second Restated Effective Date that have been procured for the
Program, excluding any of the foregoing that was manufactured by GSK using the
GSK Route B Manufacturing Process.  A schedule of the Inventory for each Product
by location, batch and lot number with the relevant expiration dates as of the
Second Restated Effective Date is attached hereto as Schedule 1.48.

 

1.49                        “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 the First Restated 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 the First Restated Agreement, shall be deemed to have been
conducted by GSK under the First Restated 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.

 

1.50                        “Joint Program Patent” means (i) any Program Patents
covering jointly invented Program Improvements and (ii) Patents covering jointly
invented Co-Formulation Product IP.

 

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

 

1.52                        “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

 

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

 

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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.

 

1.53                        “Launch” means, on a country-by-country and
Product-by-Product basis, the date of the first ****** by Amicus, its
Affiliates, Sublicensees, or successors-in-interest 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 Amicus for resale will not constitute a Launch.

 

1.54                        “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.

 

1.55                        “Liabilities” means liabilities, damages, penalties,
fines, costs, fees and expenses, (including, reasonable attorneys’ fees and
other expenses of litigation).

 

1.56                        “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 Territory.

 

1.57                        “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.

 

1.58                        “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 ******.

 

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

 

1.60                        “Net Sales” means the amount of gross sales of all
Products sold by Amicus, its Affiliates or Sublicensees (each, 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”), as
applied by the Selling Party on a consistent basis:

 

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

 

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(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 Products between or among Amicus, any
Sublicensee or any Affiliate of Amicus for resale shall be excluded from Net
Sales calculations by Amicus; 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;

 

(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.

 

1.61                        “Non-Compete Territory” means ******.

 

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

 

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1.63                        “Patent” means any and all existing (as of the
Second Restated 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.

 

1.64                        “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.

 

1.65                        “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.

 

1.66                        “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.

 

1.67                        “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.

 

1.68                        “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)  that a
Party elects to conduct in connection with or to support the TPP New Labeling
for such Product in the Territory, or (iii) that a Party elects to conduct in
support of medical affairs activities.

 

1.69                        “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.

 

1.70                        “Product” means 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 Agreement to a “Product”

 

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include a Monotherapy Product, Co-Administration Product and/or Co-Formulation
Product, as applicable.

 

1.71                        “Program” means all activities directed to the
Development, Manufacture and/or Commercialization of Products for the Territory
performed after the Original Effective Date, during the period from the Original
Effective Date to the First Restated Effective Date, and during the period from
the First Restated Effective Date to the Second Restated Effective Date, by or
on behalf of Amicus (or its Affiliates or Sublicensees) and/or GSK (or its
Affiliates or sublicensees) under the Original Agreement or the First Restated
Agreement, as applicable; provided, however, it is understood that all
activities that are (a) related to the Development of Products conducted either
by Amicus or GSK prior to the Original Effective Date, or (b) related to the
Manufacture of JR051, or (c) related to the GSK Route B Manufacturing Process,
will be deemed to have been conducted outside of the Program.

 

1.72                        “Program Improvements” means, collectively, (a) the
GSK Monotherapy Product Manufacturing Improvements, and (b) any and all
Know-How, and other information that was developed by or on behalf of GSK (or
its Affiliates or sublicensees), or Amicus (or its Affiliates, or Sublicensees),
or jointly by or on behalf of GSK and Amicus or any of their respective
Affiliates after the Original Effective Date, during the period from the
Original Effective Date to the First Restated Effective Date, or during the
period from the First Restated Effective Date to the Second Restated Effective
Date, from the conduct of activities under the applicable Development Plan under
the Original Agreement or the First Restated Agreement, as applicable, in each
case with respect to any Products (but expressly excluding JR051 individually
and JR051 as part of any Co-Formulation Product(s)), including all inventions,
Know-How, and all other intellectual property rights arising in the conduct of
such activities; provided, however, that Program Improvements will not include
Amicus Intellectual Property, GSK Background IP, GSK In-Licensed Background ERT
IP, Co-Formulation Product IP, or GSK Route B Manufacturing Processes; 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 Original Effective Date excluding any information received by GSK
under the terms of the Confidentiality Agreement; and (c) information which was
independently developed by GSK or Amicus or their respective Affiliates outside
of the Program, and such independent development can be demonstrated by written
records.

 

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

 

1.74                        “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.

 

1.75                        “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 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

 

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Approval from the European Medicines Agency shall constitute written notice with
respect to each and every such country.

 

1.76                        “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.

 

1.77                        “Rules” has the meaning ascribed to that term in
Section 14.2.2.

 

1.78                        “Selling Party” has the meaning ascribed to that
term in Section 1.60.

 

1.79                        “Sublicensee” means a Third Party to whom Amicus has
granted a right to make, have made, use, sell, market, distribute and/or promote
a Product in the Territory.  As used in this Agreement, “Sublicensee” shall not
include a wholesaler, or reseller of Product who does not market such Product.

 

1.80                        “Term” means the period commencing on the Second
Restated Effective Date until the Products are no longer Commercialized pursuant
to this Agreement.

 

1.81                        “Territory” means all countries and territories in
the world.

 

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

 

1.83                        “Third Party Claim” has the meaning ascribed to that
term in Section 12.3.

 

1.84                        “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.

 

1.85                        “Transition Plan” has the meaning ascribed to that
term in Section 3.1.

 

1.86                        “Treaty” has the meaning ascribed to that term in
Section 9.5.1.

 

1.87                        “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 1.73, a “Formulation

 

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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.

 

1.88                        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.                                   TERMINATION OF COLLABORATION AGREEMENT;
MUTUAL RELEASE

 

2.1                               Termination of Collaboration Agreement.  As of
the Second Restated Effective Date, except as certain provisions of the First
Restated Agreement are expressly referenced and incorporated herein, the First
Restated Agreement is terminated in its entirety, including all rights and
licenses granted thereunder and any and all obligations thereunder, including,
but not limited to those incurred prior to, as of or subsequent to the Second
Restated Effective Date, and no rights or obligations of the First Restated
Agreement shall survive such termination.  For the avoidance of doubt, this
Section 2.1 of this Agreement supersedes Section 14 of the First Restated
Agreement (including Section 14.7 of the First Restated Agreement) and sets
forth the Parties’ entire understanding and agreement as to the effect of this
termination of the First Restated Agreement and reversion of rights to Amicus.

 

2.2                               Termination of Safety Data Exchange
Agreement.  Effective as of the date of the completion of the transfer of the
regulatory filings from GSK to Amicus in accordance with Section 3.2 and the
Transition Plan, the Safety Data Exchange Agreement by and between Amicus and
GSK, dated September 15, 2011, as amended, shall be terminated.

 

2.3                               Mutual Release.  Effective as of the Second
Restated Effective Date:

 

(a)                                 No Party shall have any further obligation
or shall have any right or benefit under the First Restated Agreement, and all
rights and obligations of the Parties under the First Restated Agreement are
hereby fully, finally and forever discharged.

 

(b)                                 Except as specified under Section 2.5, each
of Amicus and GSK, for itself, and its respective successors and assigns, and
its Affiliates, and each of their respective current and former trustees,
officers, directors, employees, agents, attorneys and representatives, does
hereby irrevocably, unconditionally, fully, finally and forever waive, release,
remise, acquit and discharge the other Party, together with its respective
successors and assigns, and its Affiliates, and each of their respective current
and former trustees, officers, directors, employees, agents, attorneys, and
representatives, from any and all manner of obligations, covenants, promises,
undertakings, claims,

 

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counterclaims, rights, demands, actions, suits, causes of action, debts, costs,
expenses, attorney’s fees, damages, losses and liabilities, of whatsoever
character, nature and kind, whether known or unknown, contingent or
non-contingent, suspected or otherwise, which either Party may have or claim to
have against the other Party or the other Persons identified above, in the past,
now or at any time in the future, based in whole or in part upon, arising out
of, in connection with or relating to the Compounds, Products, or the Original
Agreement or First Restated Agreement (collectively, “Collaboration Claims”).

 

2.4                               Estoppel.  Effective as of the Second Restated
Effective Date, each of the Parties covenants and agrees that it has released
the other Party pursuant to Section 2.3 with regard to the Collaboration Claims,
and the Parties are forever estopped from instituting any lawsuit, arbitration
or administrative proceeding against any Person herein released or asserting any
Collaboration Claim of any nature against any Person herein released with
respect to such Collaboration Claims.

 

2.5                               Limitation.  Each of the Parties acknowledges
and agrees that, for the avoidance of any doubt, the foregoing mutual release
and the term “Collaboration Claims” does not and shall not include, and does not
and shall not extend to, any obligations, covenants, promises, undertakings,
claims, counterclaims, rights, demands, actions, suits, causes of action, debts,
costs, expenses, attorney’s fees, damages, losses and liabilities, of whatsoever
character, nature and kind, whether known or unknown, contingent or
non-contingent, suspected or otherwise, based in whole or in part upon, arising
out of, in connection with or relating to this Agreement.

 

III.                              TRANSITION PLAN; RETURN OF INFORMATION AND
MATERIALS

 

3.1                               Transition Plan.  In connection with the
termination of the First Restated Agreement and reversion of rights to Amicus,
GSK will use its Commercially Reasonable Efforts to effect a smooth and orderly
transition of the activities of the Program that were conducted by or under the
authority of GSK as of the Second Restated Effective Date to Amicus (the “GSK
Transferred Activities”).  The transition plan governing the transition of such
activities from GSK to Amicus in connection with this Agreement is attached
hereto as Exhibit A, incorporated herein by reference (the “Transition Plan”). 
GSK shall use its Commercially Reasonable Efforts to perform the activities and
provide the deliverables set forth in the Transition Plan in accordance with the
timelines set forth therein, and Amicus agrees to use its Commercially
Reasonable Efforts to cooperate with GSK with respect to such transition
activities.  In addition, for a period of ninety (90) days following the Second
Restated Effective Date, GSK will also remain available to provide to Amicus
such assistance, free of charge and excluding any obligations for GSK to provide
in-person assistance, as Amicus reasonably requests from time to time to assist
Amicus in understanding and implementing the information and materials provided
by GSK under the Transition Plan.  Following the Second Restated Effective Date,
and for a period of thirty (30) days thereafter, the Parties may amend the
Transition Plan in writing by mutual agreement, or otherwise agree to include in
or remove from Exhibit B contracts to be assigned to Amicus or terminated by GSK
in accordance with the provisions of Section 4.4; provided that Amicus shall not
be required to accept assignment of such contracts until Amicus has agreed in
writing, in its discretion, whether to accept such assignment after reviewing a
true and complete copy of such contract (which may be redacted to exclude any
confidential terms unless consent to disclose is provided by the counterparty to
such contract).

 

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3.2                               Transfer of Regulatory Filings.  Following the
Second Restated Effective Date and in accordance with the Transition Plan, 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 reasonable
actions to make available to Amicus or its designee the benefits of) all
regulatory submissions and filings (including all INDs and MAAs), and all
modules prepared for such regulatory submissions and filings, related to the
Compound and the Products in the Territory, including such regulatory
submissions and registrations made or owned by GSK or its Affiliates.

 

3.3                               Consulting Services.  For a period of one
(1) year from the Second Restated Effective Date, GSK will provide to Amicus on
a contractual basis up to three (3) FTE-equivalents to consult with Amicus and
to provide certain clinical, regulatory, and CMC expertise to ensure a smooth
and orderly transition of the rights hereunder back to Amicus.  GSK will be
responsible for the FTE rate for such FTE equivalents, and Amicus will be
responsible for reasonable incidental costs and expenses, including reasonable
travel costs and per diem travel allowances, incurred as a result of providing
such consulting services to Amicus.  Within a reasonable period of time
following the Second Restated Effective Date of this Agreement, Amicus and GSK
shall negotiate in good faith and enter into a definitive consulting agreement
to govern the scope of activities and to include other usual and customary
provisions regarding the terms and conditions of such consultancy.

 

3.4                               Return of Confidential Information.  No later
than thirty (30) days after the Second Restated Effective Date, 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 and subject to Article XI
herein, Amicus may retain the Confidential Information of GSK provided to Amicus
under the Original Agreement or First Restated Agreement and may use such
Confidential Information of GSK solely to the extent necessary and for the
purpose of exercising its rights and performing its obligations under this
Agreement, including the continued practice of the licenses granted to Amicus
under Article IV herein.

 

IV.                               LICENSES

 

4.1                               License Grant from GSK.

 

4.1.1                          Subject to the terms and conditions of this
Agreement, GSK hereby grants to Amicus an exclusive license (exclusive even as
to GSK) under all of GSK’s rights in the Program Improvements, Program Patents,
and Co-Formulation Product IP, with the right to grant sublicenses: (i) to
Develop the Compound and Products, (ii) to make, have made, and otherwise
Manufacture Compound and Products (excluding such rights with respect to JR051
individually or for use as part of a Co-Formulation Product), and (iii) to use,
sell, offer for sale, import and otherwise Commercialize the Compound and
Products, in each case in the Field and in the Territory.  For the avoidance of
doubt, nothing set forth herein shall be construed to grant to Amicus any rights
under the Co-Formulation Product IP or under any other intellectual property
rights owned or controlled by GSK as of the Second Restated Effective Date to
make, have made, or otherwise Manufacture JR051

 

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individually or for use as part of a Co-Formulation Product or construed to
grant to Amicus any rights or licenses to make, have made, use, sell, offer for
sale, import or otherwise Develop, Manufacture, or Commercialize JR051 other
than as part of a Co-Formulation Product as set forth herein.  To the extent
that Amicus determines such licenses may be necessary, Amicus shall have the
sole responsibility, at Amicus’ sole cost and expense, to seek such a license
from JCR Pharmaceuticals, Co. Ltd.

 

4.1.2                          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 in the Field and in
the Territory and (b) under GSK’s and its Affiliates’ rights in the Patents
within the Co-Formulation Product IP to make and have made (excluding JR051),
use, sell, offer for sale and import products (excluding 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.  For the avoidance of doubt, the licenses granted from GSK to Amicus
hereunder expressly exclude the right to make or have made JR051 individually or
for use as part of a Co-Formulation Product and expressly exclude any rights
with respect to JR051 other than as part of a Co-Formulation Product as set
forth herein.

 

4.2                               Without limiting the right and licenses
granted under Sections 4.1 and 4.3, GSK hereby irrevocably covenants from and
after the Second Restated Effective Date that it shall not, and shall cause its
Affiliates not, and during the Co-Formulation Transition Supply Period, shall
use its reasonable efforts to cause JCR not to bring any actions, suits or
claims, or cause, authorize or assist any other Third Party to bring any
actions, suits or claims, against (i) Amicus or its Affiliates or
(Sub)licensees, or (ii) their respective manufacturers, importers, distributors,
wholesalers, and resellers (in the case of each of the foregoing, to the extent
that such parties are acting on Amicus’ behalf under this Agreement), or
(iii) Amicus or its Affiliates’ or Sublicensees’ customers; in each case,
alleging that the Development and/or use, sale, offer for sale, importation or
other Commercialization of the Co-Formulation Products in the Field in the
Territory infringes or misappropriates or otherwise violates any Know-How that
covers or is included in, or Patents that claim and, in each case, that are
Controlled by GSK or any of its Affiliates, such Development and/or the use,
sale, offer for sale, importation or other Commercialization activities with
respect to the Co-Formulation Products.  For the avoidance of doubt, the
foregoing covenants set forth in this Section 4.2 shall not apply with respect
to any Development, Manufacture, use, sale, offer for sale, importation or other
Commercialization of JR051 by or on behalf of any of the parties set forth in
parts (i), (ii) or (iii) above when used as a monotherapy, biosimilar, or in
connection with any other product that is not a Co-Formulation Product.

 

4.3                               Trademarks.  The Parties acknowledge and agree
that as of the Second Restated Effective Date, a definitive trademark has not
been selected by the JSC for use in connection with any of the Products under
the Program, and that the Parties have not entered into any trademark licenses
with respect to any such marks.  No licenses or rights are granted hereunder to
Amicus with respect to any GSK House Marks and, as of the Second Restated
Effective Date, there are no GSK Trademarks.

 

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4.4                               Assigned Agreements.  The list of material
Third Party contracts to which GSK or its Affiliates is a party with respect to
the Compound or Products, including use of such Compound or Products in the
conduct of a clinical trial, as of the Second Restated Effective Date is set
forth on Exhibit B, attached hereto (the “Assigned Agreements”).  To the extent
that GSK has a right to do so, and GSK shall use Commercially Reasonable Efforts
to obtain such right to do so, GSK will provide true and complete copies of the
Assigned Agreements to Amicus within a reasonable period of time after the
Second Restated Effective Date.  Amicus may request that GSK assign its rights
in such Assigned Agreements to Amicus on or after the Second Restated Effective
Date and, to the extent that GSK has a right to make such assignment and solely
to the extent that such Assigned Agreement relates solely to Compound or
Products, GSK will assign, and hereby assigns, to Amicus, and Amicus will
assume, and hereby assumes, all of GSK’s rights and obligations under such
Assigned Agreement, including all claims for damages by reason of past, present
or future breach of such Assigned Agreement; provided, however, that Amicus
shall not assume and shall not be liable for any obligations or liabilities of
any nature whatsoever of GSK, whether known or unknown, accrued or not accrued,
fixed or contingent, arising prior to the effective date of assignment of such
Assigned Agreement.  In the event such assignment is not requested by Amicus
within thirty (30) days following Amicus’ receipt of a true and complete copy of
an Assigned Agreement, or GSK does not have the right to make such assignment
(after GSK has used Commercially Reasonable Efforts to obtain such right to
assign by requesting consent of the counterparty to such Assigned Agreement),
then GSK will terminate such Assigned Agreement to the extent such Assigned
Agreement relates to Compound or Products.  In addition, GSK shall promptly
provide notice of termination and terminate any contract to which GSK or its
Affiliates is a party with respect to the Compound or Products that is not
otherwise listed in Exhibit B (as may be amended by the Parties in accordance
with Section 3.1) solely to the extent such contract relates to Compound or
Products (“Terminated Agreements”).  Upon termination of an Assigned Agreement
or termination of a Terminated Agreement, GSK shall ensure that its Affiliates
and Third Parties with whom GSK or its Affiliates have contracted under such
Assigned Agreement (if not assigned to Amicus pursuant to this Section 4.4) or
such Terminated Agreement shall transition all Products back to Amicus in the
manner set forth herein as if such Affiliate or other Third Party were named
herein.

 

4.5                               No Implied Licenses.  Except as expressly set
forth in this 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.  It is expressly understood and agreed that
the licenses granted by GSK to Amicus in this Article IV shall not include
(i) the right to make, have made, or otherwise Manufacture JR051, (ii) any
licenses with respect to JR051 other than as component of a Co-Formulation
Product as expressly set forth herein, or (iii) any rights or licenses related
to the GSK Route B Manufacturing Process.

 

V.                                    COMMITTEES; FUTURE PATENT RIGHTS

 

5.1                               Committees; Joint Patent Subcommittee. 
Effective upon the Second Restated Effective Date of this Agreement, the Joint
Steering Committee and all Subcommittees (other than the Joint Patent
Subcommittee) shall cease to exist and 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

 

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Committee or the relevant Subcommittee, as applicable.  Notwithstanding the
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 of the First Restated Agreement with respect to all matters
relating to Patents included in Amicus Intellectual Property, Program
Improvements, Program Patents and Co-Formulation Product IP; provided that
Amicus shall make the final decision with respect to any dispute of the Joint
Patent Subcommittee.  Following the Second Restated Effective Date and in
accordance with the Transition Plan, GSK shall transfer to Amicus control of the
prosecution and enforcement of such Patents, including transferring to Amicus
all prosecution history files and other documents related thereto, 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 and the right to
enforce such Patents with respect to infringing activities and defend
declaratory judgment actions related thereto.  Amicus shall assume
responsibility for all Patent Costs relating to Patents included in Amicus
Intellectual Property, Program Improvements, Program Patents and Co-Formulation
Product IP as of the Second Restated Effective Date of this Agreement; provided
that GSK shall bear any costs incurred in transferring prosecution control of
such Patents to Amicus.  At Amicus’ reasonable request, GSK shall reasonably
cooperate and assist Amicus by making any necessary filings as required for the
prosecution and maintenance of such Patents; provided that Amicus shall
reimburse GSK for any reasonable out-of-pocket costs incurred by GSK in such
cooperation or assistance.  Except as expressly provided in this Agreement, it
is understood that neither Party shall have any obligation to obtain any
approval of nor pay a share of the proceeds to the other Party to practice,
enforce, license, assign or otherwise exploit any Joint Program Patent, and each
Party hereby waives any right it may have under the Laws of any country to
require such approval or sharing.

 

5.2                               Assignment.  Without limiting Section 5.1, as
of the Second Restated Effective Date, GSK shall assign and transfer, and hereby
assigns and transfers, to Amicus all right, title and interest in and to the GSK
Transferred Patents.  Concurrently with the execution of this Agreement, GSK
shall execute and deliver to Amicus the patent assignment agreement set forth as
Exhibit C, attached hereto.  Upon assignment of the GSK Transferred Patents, all
Confidential Information of the GSK Transferred Patents (excluding specific
references to JR051 to the extent such references are not and have not become
part of the public domain through no breach of this Agreement) shall be treated
as Amicus-only Confidential Information under this Agreement, notwithstanding
the exceptions to the definition of Confidential Information under clauses
(b) and (c).

 

5.3                               Further Patent Application.  To the extent
that any inventions arose prior to the Second Restated Effective Date and during
the course of the conduct of the Program that but for the reversion of rights
under this Agreement would have been included in the Program Patents or Patents
included within the Co-Formulation Product IP, but which, as of the Second
Restated Effective Date, had not yet been the subject of a patent application,
such invention shall be included within the GSK Transferred Patents and assigned
and transferred to Amicus pursuant to Section 5.2 above; provided, however, that
Amicus will consult with GSK regarding inventorship for any patent applications
claiming such invention.  Any such patents which are granted from such patent
applications shall, as of the date of issuance, be included as a Program Patent
or Patent included within the Co-Formulation Product IP, as applicable,
hereunder.

 

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VI.                               TRANSFER OF DEVELOPMENT AND COMMERCIALIZATION
ACTIVITIES; SUPPLY

 

6.1                               Assumption of Development and
Commercialization Activities.  As of the Second Restated Effective Date, Amicus
shall assume, at Amicus’ sole cost and expense, the conduct of all Development
activities allocated to either Amicus or to GSK under the applicable
then-current Development Plan and all Commercialization activities for each and
every Product in the Territory.  Except as expressly set forth in this
Agreement, as of the Second Restated Effective Date, GSK shall have no further
rights or obligations to Develop or Commercialize the Compound or any Products
in the Territory and shall have no obligation to share in any costs or expenses
incurred in the performance of activities to Develop, Manufacture, and/or
Commercialize the Compound or Products in the Territory.  For clarity, this
Section 6.1 does not apply to Development or Commercialization activities
conducted by a Third Party pursuant to and in accordance with an Assigned
Agreement, and Amicus shall assume the conduct of such activities in accordance
with the terms and conditions of such Assigned Agreement on the date of
assignment of such Assigned Agreement from GSK to Amicus in accordance with
Section 4.4.

 

6.2                               On-going Development Activities.  Within a
reasonable period of time after the Second Restated Effective Date and in
accordance with the Transition Plan, 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
Product(s) that were, prior to the Second Restated Effective Date, allocated to
GSK under the applicable Development Plan, after which time GSK shall have no
further obligations with respect to the conduct of any such Development
activities.  Without limiting the foregoing, Amicus or its designee, at Amicus’
cost and expense, shall assume all of the activities and subject to Section 4.4,
contractual obligations of GSK with respect to all Program costs, including
without limitation costs and expenses for the ongoing clinical trials set forth
in Exhibit D attached hereto.  Following the transition of such ongoing clinical
trials to Amicus as set forth herein, GSK shall have no further obligations with
respect to the conduct of any activities related to any such clinical trials. 
For the avoidance of doubt, except as expressly provided otherwise under
Section 8.1, effective as of the Second Restated Effective Date, Amicus shall
assume responsibility for all costs and expenses and all payments due in
relation to any and all such activities and subject to Section 4.4, under
contractual obligations of GSK with respect to such ongoing clinical trials that
were initiated and executed by GSK prior to the Second Restated Effective Date,
and GSK shall have no obligations in relation to any payments due with respect
thereto after the Second Restated Effective Date.

 

6.3                               Transition Supply.  .  Beginning on the Second
Restated Effective Date and for a period of the shorter of (i) twelve (12)
months thereafter, or (ii) the date upon which Amicus has obtained its own
supply commitment from JCR for the supply of JR051, GSK will supply to Amicus,
either itself or from a Third Party, JR051 (the “Co-Formulation Transition
Supply Period”).  During the Co-Formulation Transition Supply Period, GSK shall
supply JR051 to Amicus, at a price of ¥ 90M per 2000L batch plus an allocation
of the costs of GSK FTEs of USD$312,000 per 2000L batch), such quantity of JR051
to be agreed in writing in advance, such amounts to be consistent with the
current amounts and timelines set forth in the research plan for the
Co-Formulation Development Plan during such period of time.  At Amicus’ request,
GSK will fill and finish (including testing for stability) such quantity of
JR051 into Co-Formulation Product in

 

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

 

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finished form as further set forth in the Transition Plan; provided that Amicus
will reimburse GSK for GSK’s costs and expenses to provide such fill and finish
services, which will not include a mark-up.  Immediately after the Second
Restated Effective Date and during the Co-Formulation Transition Supply Period,
GSK will use reasonable efforts to either (A) transition to Amicus its
arrangement with any Third Party contractor (including JCR) for the supply of
JR051 for use in a Co-Formulation Product or (B) facilitate discussions between
JCR or any such other Third Party contractor and Amicus to allow Amicus to
obtain from JCR or other Third Party contractor a supply agreement for the
supply of JR051 for use in a Co-Formulation Product.  Without limiting the
foregoing, within a reasonable period of time following the Second Restated
Effective Date of this Agreement, the Parties will negotiate and enter into an
appropriate supply agreement(s) on customary and reasonable terms, including
representations and warranties and indemnification, for the transition supply of
JR051, and at Amicus’ request, the fill and finish of the transition supply of
JR051 into Co-Formulation Product, set forth in this Section 6.3.  In addition,
GSK shall supply to Amicus the Co-Formulation Product to be re-worked in the JCR
Murotani plant in finished form in accordance with the Transition Plan set forth
in Exhibit A, attached hereto.

 

6.4                               Inventory.  On the Second Restated Effective
Date all right, title and interest in and to the Inventory in the possession of
GSK or its Affiliates shall pass to Amicus.  Within a reasonable period of time
after the Second Restated Effective Date, GSK shall deliver to Amicus all
quantities of Inventory in GSK’s or its Affiliates’ possession to a location
designated by Amicus using a carrier selected by and paid for by Amicus, Ex
Works (Incoterms 2010) in accordance with the Transition Plan.  Prior to
delivery of such Inventory, GSK and its Affiliates, as applicable, will store
and handle all Inventory in the same manner and using the same degree of care in
which such Inventory was stored and handled immediately prior to the Second
Restated Effective Date.  GSK shall not use, sell, transfer or otherwise dispose
of the Inventory except as otherwise permitted under this Section 6.4, and
Amicus shall reimburse GSK for direct costs and expenses related to such storage
and handling incurred by GSK or its Affiliates, as applicable, from and after
the Second Restated Effective Date.  Prior to the transfer of Inventory to
Amicus, GSK and Amicus shall enter into customary documents, including an
appropriate bill of sale, if required for the shipment of Inventory to Amicus. 
All Inventory provided hereunder shall be provided “AS IS” without warranty or
representations of any kind, provided however, that all transfers of Inventory
under this Section 6.4 will include the original certificates of analysis
generated for such Inventory.  Amicus acknowledges and agrees that such
certificates of analysis include relevant data regarding the Inventory at or
around the date of manufacture and, therefore, may not be reflective of the
current status of the Inventory when transferred (given the passage of time from
manufacture).  For clarity, this Section 6.4 does not apply to Inventory held in
the possession of a Third Party pursuant to and in accordance with an Assigned
Agreement, and all right, title and interest in and to such Inventory shall pass
to Amicus in accordance with the terms and conditions of such Assigned Agreement
on the date of assignment of such Assigned Agreement from GSK to Amicus in
accordance with Section 4.4.

 

VII.                          PAYMENTS BY AMICUS

 

7.1                               Payment Obligations.  Except as expressly set
forth in this Agreement, as of the Second Restated Effective Date, all of GSK’s
payment obligations under the First Restated Agreement, including without
limitation any and all Development costs for the Monotherapy

 

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

 

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Product, Co-Administration Products, and Co-Formulation Products, shall
terminate and thereafter, Amicus shall make the following payments to GSK with
respect to such Products:

 

(a)                                 Milestones Payments:  Following the Second
Restated Effective Date, Amicus will make milestone payments to GSK with respect
to each Product in the Expanded Major Market Countries as set forth below. 
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 Second Restated Effective Date,
such milestone payment to be made by Amicus to GSK no later than sixty (60) days
following the receipt of an invoice from GSK therefor.  Amicus shall notify GSK
in writing promptly, but in no event later than ten (10) calendar days 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 Product (other than a Co-Formulation Product) to
achieve such milestone event, regardless of the number of times such Product or
any other Product achieves the milestone event, and no milestones shall be paid
or payable by Amicus for milestone events that are not achieved after the Second
Restated Effective Date.  ******.

 

Milestones:  For Monotherapy Products and Co-Administration Products:

 

Approval Milestone Event

 

Milestone Payment

1.

******

 

******

2.

******

 

******

 

Sales Performance Milestones

 

Milestone Payment

3.

******

 

******

4.

******

 

******

 

For purposes of Milestone 3 and Milestone 4 in the table set forth above and the
calculation of the royalty tiers in the table set forth in
Section 7.1(b)(i)(a) below, if the Product(s) is a Product(s) other than a
Co-Formulation Product, the Net Sales of all such Products in the applicable
Expanded Major Market Country shall be included in determining whether such
Milestone has been achieved and/or the applicable royalty tier.  Without
limiting the foregoing, by way of example only, if both the Monotherapy Product
and the Co-Administration Product are Products under this Section 7.1, Net Sales
of both such Products in the applicable Expanded Major Market Country shall be
used in calculating whether Milestone 3 or Milestone 4 in the table set forth
above have been achieved.

 

(b)                                 Royalties.

 

(i)             Following the Second Restated Effective Date, from and after the
date of Launch of the applicable Product in an Expanded Major Market Country,
Amicus shall pay to GSK royalties as set forth in clause a) or b) of this
Section 7.1(b)(i), as applicable, based on

 

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

 

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the Net Sales of the applicable Product(s) during a particular calendar year, on
a Product-by- Product basis, and country-by-country basis, for the longer of
****** (the “Amicus Product Royalty Term”).  Upon the expiration of the Amicus
Product Royalty Term for a particular Product, and subject to
Section 7.1(b)(iv)(c) below regarding Co-Formulation Products, Amicus’ license
with respect to such Product as set forth in Article IV shall become a
royalty-free, fully paid-up license.  Notwithstanding the foregoing, nothing set
forth herein shall be construed or interpreted to grant to Amicus a
royalty-free, fully-paid up license for any Co-Formulation Product(s) that
include JR051 as a component of such Co-Formulation Product.

 

a)                                     With respect to Monotherapy Products and
Co-Administration Products:

 

Net Sales of Product in an Expanded Major Market Country in a
particular calendar year

 

Royalty

******

 

******

******

 

******

******

 

******

******

 

******

 

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

 

Net Sales of Product in an Expanded Major Market Country in a
particular calendar year

 

Royalty

******

 

******

******

 

******

******

 

******

******

 

******

 

(ii)          ******.

 

(iii)       ******. Notwithstanding the foregoing, nothing set forth herein
shall be construed or interpreted to grant to Amicus a royalty-free, fully-paid
up license for any intellectual property rights that are owned or Controlled by
GSK or if Affiliates with respect solely to JR051.

 

(iv)      Third Party Payments.

 

a)                                     ******.

 

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

 

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b)                                     The obligations of GSK with respect to
any payments due to Mount Sinai pursuant to the Mount Sinai Agreement as a
result of the Manufacture or Commercialization of any Product(s) shall terminate
as of the Second Restated Effective Date and thereafter Amicus shall be solely
and exclusively responsible for any and all payments that may be due to Mount
Sinai pursuant to the Mount Sinai Agreement with respect to the Compounds and/or
Products.

 

c)                                      ******. For the avoidance of doubt, such
payments due to JCR pursuant to this Section 7.1(b)(iv)(c) shall not be
creditable under Section 7.1(b)(iv)(a) against royalties otherwise owed to GSK.

 

(c)                                  Other than as expressly provided for in
this Agreement, 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 VII, 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 Territory.

 

VIII.                     PAYMENTS BY GSK

 

8.1                               Within ten (10) Business Days following the
Second Restated Effective Date, GSK will pay to Amicus a one-time,
non-refundable payment of one million, nine hundred thousand US dollars
($1,900,000) in immediately available funds by wire transfer to the bank account
details as specified by Amicus in writing in advance as a one-time settlement of
all Development Costs forecasted to be paid by GSK for Development activities
between 19 November 2013 and 31 December 2013 under the terms of the First
Restated Agreement.  With respect to any Development Costs for Development
activities that have been incurred prior to 19 November 2013 under the terms of
the First Restated Agreement, the Parties will share such Development Costs in
accordance with the provisions, which provisions are incorporated herein by
reference, for sharing Development Costs in Section 5.1.4 of the First Restated
Agreement and for reconciliation and payment in Schedule 5.1.4 of the First
Restated Agreement.

 

IX.                              PAYMENT TERMS; REPORTS

 

9.1                               Method of Payment.

 

9.1.1                          Except as expressly set forth herein, 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 and the contact name for any
issue resolution.  All amounts owed by Amicus to GSK hereunder shall be paid by
an entity resident in the United States from a bank account located in the
United States.

 

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

 

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9.1.2                          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.

 

9.2                               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.

 

9.3                               Reports and Royalty Payment.  Commencing with
the first Quarter in which the first Launch of a Product occurs, and for each
Quarter thereafter for so long as Amicus owes a royalty to GSK under
Section 7.1(b), Amicus shall, within ****** after the end of the applicable
Quarter, submit to GSK, together with Amicus’ payment for the royalties due
under Section 7.1(b) for each Quarter, a written report showing the actual Net
Sales and the royalties due, 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 such Products and calculation of such royalties. 
Amicus will also provide to GSK, on a quarterly basis following the Launch of a
Co-Formulation Product, a report showing any royalties due to JCR under
Section 7.1(b)(iv)(c), together with payment of any royalties due.

 

9.4                               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
with respect to Net Sales of 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 Products in the 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 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
hereto 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 hereunder 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

 

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

 

24

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GSK, together with interest on such underpaid amounts at the rate set forth in
Section 14.12.  GSK agrees to treat all information learned in the course of any
audit or inspection as Confidential Information of Amicus.

 

9.5                               Taxes.

 

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

 

9.5.2                          The Parties shall cooperate in obtaining formal
certification of GSK’s entitlement to relief under the Treaty.  GSK agrees to
indemnify and hold harmless Amicus 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 States tax authority alleging that Amicus 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
States.

 

9.5.3                          All sums payable under this Agreement shall be
exclusive of value added tax and any other sales taxes.  It is understood,
however, that no such taxes apply under current Law to payments hereunder.  To
the extent any such taxes apply, the Parties agree that, where appropriate, the
Parties shall provide each other 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.

 

X.                                   NON-COMPETE

 

10.1                        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.

 

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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 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                        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

 

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

 

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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.

 

11.3                        Publications.  Following the Second Restated
Effective Date, Amicus 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, subject to the
following:

 

11.3.1                   With respect to any presentations, publications,
abstracts, or conferences regarding the subject matter of the Nov. 2013 World
Congress Abstract on which Nick France (GSK) is listed as an author, Amicus
shall provide to GSK such proposed manuscript (including abstracts, or
presentation to a journal, editor, meeting, seminar or other third party) or
proposed presentation for GSK’s review and comments at least forty-five (45)
days (or fourteen (14) days for any abstract submitted to a conference or
presentation to be made at a conference) prior to submission of such proposed
manuscript for publication and shall reasonably consider all comments of GSK
with respect thereto.  GSK shall confirm receipt of such proposed manuscript.
Amicus shall delete from the proposed manuscript prior to submission all
Confidential Information of GSK that GSK identifies in good faith and requests
to be deleted.  Amicus shall not publish or present any manuscripts described in
this Section 11.3.1 without the prior written consent of GSK, not to be
unreasonably withheld.

 

11.3.2                   The foregoing shall not prohibit or prevent GSK from
publishing any GSK-only Confidential Information, or Amicus from publishing any
Amicus-only Confidential Information, in each case without the prior written
consent of the other Party.

 

11.3.3                   For the avoidance of doubt and notwithstanding the
foregoing, GSK shall have the right to publish the results of any work
undertaken under the Program with respect to Fabry Disease generally, any work
conducted by GSK with respect to technology advancements, and any results of any
non-product specific work conducted by GSK, its Affiliates, or collaboration
partners, in any case, that does not include any Amicus-only Confidential
Information.

 

11.4                        Press Release.  The Parties have agreed upon a joint
press release regarding the subject matter of this Agreement, attached hereto as
Exhibit F, and incorporated herein by reference.  In addition, the Parties agree
to cooperate and agree on the content of any presentations to be made by Amicus
with respect to the subject matter of such press release, including any
presentations, publications, or future press releases that Amicus may make with
respect to the subject matter of this Agreement.

 

XII.                         REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION AND
LIMITATION OF LIABILITY

 

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

 

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

 

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12.1.1                   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.

 

12.1.2                   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.

 

12.1.3                   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.

 

12.2                        Representations and Warranties of GSK.  GSK hereby
represents and warrants to Amicus, as of the Second Restated Effective Date, as
follows:

 

12.2.1                   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.  No rights from JCR (including any GSK
In-Licensed Background ERT IP) are necessary to grant to Amicus the rights and
licenses as purported to be granted pursuant to this Agreement.

 

12.2.2                   It has not previously granted any right, license or
interest in or to the Co-Formulation Product IP that is in conflict with the
rights or licenses granted to Amicus under this Agreement.  Except as otherwise
may have been disclosed by GSK to Amicus prior the Second Restated Effective
Date, GSK has not received written notice from any Third Party that (a) the
manufacture, sale, importation or use of JR051, as JR051 exists as of the Second
Restated Effective Date, as incorporated into a Co-Formulation Product as
contemplated immediately prior to the Second Restated Effective Date, infringes
or misappropriates any Third Party rights.

 

12.2.3                   As of the Second Restated Effective Date, GSK has a
license from JCR to provide to Amicus the supply of JR051 or JR051 as
incorporated into a Co-Formulation Product as set forth herein.

 

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

 

12.2.5                   The Development of the Co-Formulation Product(s),
including JR051, as JR051 exists as of the Second Restated 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

 

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

 

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its Affiliates or Third Party collaborators or contractors has developed the
Co-Formulation Product(s), including JR051, as JR051 exists as of the Second
Restated Effective Date, in a manner that does not comply in all material
respects with all applicable Laws.

 

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

 

12.2.7                   None of the information disclosed or statements made by
GSK in connection with the First Restated Agreement or this Agreement relating
to JR051, as JR051 exists as of the First Restated Effective Date or Second
Restated Effective Date, respectively, and/or to GSK’s relationship with JCR as
it relates to GSK’s right to supply to Amicus JR051 or JR051 as incorporated
into a Co-Formulation Product as set forth herein, contain any untrue statement
of a material fact or omitted to state any material fact that would adversely
affect Amicus’ rights and licenses under this Agreement or, to GSK’s knowledge,
would be material to Amicus’ decision to enter into this Agreement and to
undertake the commitments and obligations set forth herein.

 

12.2.8                   To GSK’s knowledge as of the Second Restated Effective
Date, no material data or other material information exists concerning JR051, as
JR051 exists as of the Second Restated Effective Date, that has not been
disclosed by GSK to Amicus and that would adversely affect Amicus’ rights and
licenses under this Agreement or, to GSK’s knowledge, would be material to
Amicus’ decision to enter into this Agreement and to undertake the commitments
and obligations set forth herein.

 

12.3                        Mutual Limitations on Warranties.  OTHER THAN THE
REPRESENTATIONS AND WARRANTIES MADE BY THE PARTIES PURSUANT TO SECTIONS 12.1 AND
12.2, THE PARTIES DISCLAIM ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES
WHETHER EXPRESS OR IMPLIED, INCLUDING ANY REPRESENTATIONS OR 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.

 

12.4                        Indemnification.

 

12.4.1              Indemnification of Amicus.  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 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 as of or prior to the Second
Restated Effective Date; (b) any material breach of any representations,
warranties by GSK in Sections 12.1 and 12.2 above; and/or (c) to the extent that
such Third Party Claims include a claim that JR051 in the form supplied by GSK
to Amicus pursuant to this Agreement or the First Restated Agreement, when used
by Amicus or GSK or their respective Affiliates or Sublicensees in a
Co-Formulation Product(s), infringes or misappropriates such Third Party’s
intellectual property rights; in each case except to the extent such Third Party
Claims fall within the scope of Amicus’ indemnification obligations set forth in

 

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Section 12.4.2 below or result from the gross negligence or intentional
misconduct of an Amicus Indemnitee.

 

12.4.2                   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 (i) 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 Territory; or (b) 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 12.3 above or (ii) result from the gross negligence or intentional
misconduct of an GSK Indemnitee.

 

12.4.3                   Procedure.  A Party that intends to claim
indemnification under this Article XII (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 12.4.3, 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 XII unless the delay or failure is
prejudicial to its ability to defend such action.  The Indemnitee under this
Section 12.4.3 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.

 

12.5                        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; PROVIDED HOWEVER THAT NOTHING
IN THIS SECTION 12.5 SHALL BE DEEMED TO LIMIT THE INDEMNIFICATION OBLIGATIONS OF
EITHER PARTY UNDER SECTIONS 12.1 THROUGH 12.3 ABOVE TO THE EXTENT A THIRD PARTY
RECOVERS ANY SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES
FROM AN INDEMNITEE.

 

XIII.                    EQUITY INVESTMENT

 

13.1                        Potential Equity Investment.  In the event that
Amicus raises a strategic private placement equity round with Third Party
investors concurrently with the execution of this

 

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Agreement, or raises a public financing round or a private placement equity
round at any time during the period of time beginning on the Second Restated
Effective Date and closing ninety (90) days thereafter, GSK agrees to
participate in such financing round and to purchase pro-rata shares (up to and
capped at three million dollars ($3.0M) of new Amicus equity to GSK, provided
GSK’s ownership of Amicus does not exceed, and would not upon the close of such
additional equity round exceed, 19.9%) at the price of the next round of Amicus
strategic equity, which, if such equity purchase is part of a private placement
would be at a discount to the market price on the date of the equity
transaction; provided in each case that such share offer to GSK is offered on
terms no worse than on par with other investors participating in the proposed
strategic equity round, except that GSK shall have no obligation to agree to a
vote-along provision, and provided further that such proposed equity round is
raised and closes within ninety (90) days of the Second Restated Effective Date
of this Agreement.  GSK’s obligation to participate in any such equity round
raised by Amicus will lapse after ninety (90) days if Amicus does not raise such
equity round during this time.  In no event will GSK’s lock-up period under such
purchase of Amicus shares in connection with such strategic equity round exceed
six (6) months.

 

XIV.                     MISCELLANEOUS

 

14.1                        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.

 

14.2                        Dispute Resolution.

 

14.2.1                   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 14.2, 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 of Research and Development, or their respective designees, cannot
resolve the Dispute within thirty (30) days of the request to do so, either
Party may initiate arbitration proceedings with respect thereto as provided in
Section 14.2.2 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.

 

14.2.2                   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 is $50 million or less, 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 is more than $50 million, there shall be three (3) arbitrators, of
whom each Party shall appoint one (1) within thirty (30) days of the receipt

 

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by the respondent of the 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.

 

14.2.3                   In the case of any Dispute which may be submitted to
arbitration hereunder, the procedures of this Section 14.2.3 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.

 

14.2.4                   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.

 

14.2.5                   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 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.

 

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14.3                        Assignment and Binding Effect.

 

14.3.1                   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 14.3:

 

(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’ obligations under this Agreement.

 

(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.

 

14.3.2                   No assignment under this Section 14.3 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.

 

14.3.3                   Any assignment in violation of this Section 14.3 shall
be void and of no effect.

 

14.3.4                   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.

 

14.4                        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.

 

14.5                        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, (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

 

 

980 Great West Road

 

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Brentford, London

 

 

TW8 9GS

 

 

United Kingdom

 

 

Facsimile: +44 (020) 804 76904

 

 

Attention: Company Secretary

 

 

 

With a copy to:

 

GlaxoSmithKline

 

 

980 Great West Road

 

 

Brentford, London

 

 

TW8 9GS

 

 

United Kingdom

 

 

Facsimile: +44 (0) (208) 046-0641

 

 

Attention: Head, 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

 

 

 

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.

 

14.6                        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.

 

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14.7                        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.

 

14.8                        Entire Agreement.  From and after the Second
Restated Effective Date, this Agreement constitutes 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 Second Restated Effective Date, including the First Restated
Agreement except as certain provisions of the First Restated Agreement are
expressly referenced and incorporated herein.

 

14.9                        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.

 

14.10                 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.

 

14.11                 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.

 

14.12                 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 two percent (2%) per year; 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.

 

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14.13                 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.

 

14.14                 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.

 

14.15                 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.

 

14.16                 No Strict Construction.  This Agreement has been prepared
jointly and will not be strictly construed against either Party.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

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IN WITNESS WHEREOF, the Parties hereto, intending to be legally bound hereby,
have caused this Second Restated Agreement to be executed by their duly
authorized representatives.

 

AMICUS THERAPEUTICS, INC.

 

GLAXO GROUP LIMITED

 

 

 

 

 

 

 

 

 

 

By:

/s/ John F. Crowley

 

By:

/s/ Balbir Kelly-Bisia

 

 

 

 

 

Name:

John F. Crowley

 

Name:

Balbir Kelly-Bisia

 

 

 

 

 

Title:

Chairman & CEO

 

Title:

Corporate Director

 

 

 

 

 

Date:

November 19, 2013

 

Date:

November 19, 2013

 

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Schedule 1.48

 

Inventory

 

******

 

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1

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Exhibit A

 

Transition Plan

 

******

 

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

 

2

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Exhibit B

 

Assigned Agreements

 

1.              Task Order by and between PPD Development Inc. and
GlaxoSmithKline LLC, effective from January 1, 2011 until December 31, 2014, and
incorporating by reference the terms of the January 2011 Master Agreement
between PPD Development Inc. and GlaxoSmithKline LLC.

 

2.              Master Agreement by and between Celerion, Inc. and
GlaxoSmithKline LLC, effective 28, January 2009.

 

3.              Master Services Agreement for the Provision of Pharmaceutical
Support Services by and between GlaxoSmithKline LLC and Almac Group Limited,
effective 21 June 2012.

 

4.              Pharmaceutical Development Services Agreement by and between
Carbogen AMCIS AG and GlaxoSmithKline Research and Development Ltd., effective
June 16, 2011.

 

5.              Pharmaceutical Development Services Agreement by and between
Carbogen AMCIS AG and GlaxoSmithKline Research and Development Ltd., effective
September 28, 2011.

 

6.              Contract Manufacture Agreement for Active Pharmaceutical
Ingredient of Medicinal Product Migalastat HCL, by and between Carbogen AMCIS AG
and GlaxoSmithKline Export Ltd., effective December 14, 2011.

 

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Exhibit C

 

Patent Assignment Agreement

 

THIS PATENT ASSIGNMENT AGREEMENT (this “Patent Assignment”) is made and entered
into as of November 19, 2013 (“Patent Assignment Effective Date”) between Amicus
Therapeutics, Inc., a Delaware corporation having a place of business at 1 Cedar
Brook Drive, Cranbury, New Jersey, 08512 (“Amicus” or “Assignee”), and Glaxo
Group Limited, a company organized under the laws of England and Wales with its
registered office address at 980 Great West Road, Brentford, Middlesex,TW8 9GS,
England (“GSK” or “Assignor”).

 

BACKGROUND

 

A.            Assignor and Assignee are parties to that certain Second Restated
Agreement (“Second Restated Agreement”), dated as of November 19, 2013 (“Second
Restated Effective Date”), pursuant to which Assignor and Assignee have agreed
to terminate the First Restated Agreement, as set forth in, and subject to the
terms and conditions of, the Second Restated Agreement, to provide for, among
other matters, the reversion all of the worldwide rights to the Compound and
Products to Amicus.  Capitalized terms used herein and not otherwise defined
herein shall have the meanings respectively ascribed to such capitalized terms
in the Second Restated Agreement; and

 

B.            Pursuant to Section 5.2 of the Second Restated Agreement, Assignor
and Assignee have agreed that Assignor shall assign to Assignee and Assignee
shall acquire all right, title and interest in and to the GSK Transferred
Patents.

 

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

 

1              Assignment.  Assignor hereby perpetually, irrevocably and
unconditionally assigns, transfers, conveys and sets over to Assignee and its
successors, assigns and other legal representatives all of Assignor’s rights,
titles and interests in and to the GSK Transferred Patents and the inventions
disclosed therein, together with all additions, divisions, continuations,
continuations-in-part, substitutions, reissues, re-examinations, extensions,
registrations, patent term extensions, supplemental protection certificates and
renewals of any of the foregoing (collectively, the “Transferred Patents”), for
Assignee’s own use and enjoyment, and for the use and enjoyment of Assignee’s
successors, assigns or other legal representatives, as fully and entirely as the
same would have been held and enjoyed by Assignor if this assignment had not
been made, together with all income, royalties or payments due or payable as of
the Patent Assignment Effective Date or thereafter, including, without
limitation, all claims for damages by reason of past, present or future
infringement of the Transferred Patents, with the right to sue for and collect
the same for Assignee’s own use and enjoyment and for the use and enjoyment of
its successors, assigns or other legal representatives.

 

2              Terms of the Second Restated Agreement.  Nothing herein will, or
will be deemed to, modify or otherwise affect any provisions of the Second
Restated Agreement or affect or modify any of the rights or obligations of the
parties under the Second Restated Agreement.  In

 

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the event of any conflict or inconsistency between the terms of the Second
Restated Agreement and the terms hereof, the terms of the Second Restated
Agreement shall govern.

 

3              Further Actions.  Assignor agrees to execute such documents,
render such assistance, and take such other action as Assignee may reasonably
request, to apply for, register, perfect, confirm, and protect Assignee’s rights
in the Transferred Patents, including, without limitation, the execution and
delivery of any and all affidavits, declarations, oaths, samples, exhibits, and
other documentation as may be reasonably required in connection with
(a) preparation and prosecution of any application for patent protection
relating to any of the Transferred Patents that Assignee may deem appropriate
that may be secured under the laws now or hereafter in effect in the United
States or any foreign countries; (b) prosecution or defense of any cancellation,
revocation, opposition, infringement or other proceedings that may arise in
connection with any of the Transferred Patents, including, without limitation,
testifying as to any facts relating to the Transferred Patents or this Patent
Assignment; (c) enforcement of Assignee’s rights in any Transferred Patents; and
(d) implementation, perfection and/or recording of this Patent Assignment. 
Without limiting the foregoing, Assignor shall execute the Patent Assignment for
Recordal attached hereto as Exhibit A upon execution of this Patent Assignment.

 

4              Power of Attorney.  Assignor agrees that if Assignee is unable
because of Assignor’s unavailability, dissolution or incapacity, or for any
other reason, to secure Assignor’s signature on any assignments, applications or
other documents or filings pertaining to any or all of the Transferred Patents,
then Assignor hereby irrevocably designates and appoints Assignee and its duly
authorized officers and agents as Assignor’s agents and attorneys-in-fact, to
act for and on Assignor’s behalf and stead to execute and file any and all such
assignments, applications and other documents or filings and to do all other
lawfully permitted acts with respect thereto with the same legal force and
effect as if executed by such Assignor.

 

5              Authorization.  Assignor authorizes and requests the United
States Commissioner of Patents and Trademarks and any other applicable
government authority to record Assignee as the assignee and owner of the
Transferred Patents, and issue any and all registrations or patents thereon to
Assignee, as assignee of the entire right, title and interest in, to and under
the same, for the sole use and enjoyment of Assignee and its successors, assigns
or other legal representatives.

 

6              Miscellaneous.  This Patent Assignment and all questions
regarding its validity or interpretation, or the breach or performance of this
Patent Assignment, shall be governed by, and construed and enforced in
accordance with, the laws of the State of Delaware, without reference to
conflict of law principles.  No amendment or modification of any provision of
this Patent Assignment shall be effective unless in writing signed by a duly
authorized representative of each party hereto.  This Patent Assignment will
bind and inure to the benefit of Assignor and Assignee and their respective
successors and assigns.  This Patent Assignment may be executed in any number of
counterparts, each of which shall be deemed an original, and all of which
together shall constitute one and the same instrument.

 

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

 

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IN WITNESS WHEREOF, the parties have executed this Patent Assignment as of the
date first set forth above.

 

AMICUS THERAPEUTICS, INC.

 

BY:

/s/ Kenneth Peist

 

 

 

 

NAME:

Kenneth Peist

 

 

 

 

TITLE:

Vice President, Legal & IP

 

 

 

 

GLAXO GROUP LIMITED

 

BY:

/s/ Balbir Kelly-Bisia

 

 

 

 

NAME:

Balbir Kelly-Bisia

 

 

 

 

TITLE:

Corporate Director

 

 

 

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

 

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EXHIBIT A

 

Patent Assignment for Recordal

 

THIS PATENT ASSIGNMENT AGREEMENT (this “Patent Assignment”) is made and entered
into as of November 19th, 2013 (“Patent Assignment Effective Date”) between
Amicus Therapeutics, Inc., a Delaware corporation having a place of business at
1 Cedar Brook Drive, Cranbury, New Jersey, 08512 (“Amicus” or “Assignee”), and
Glaxo Group Limited, a company organized under the laws of England and Wales
with its registered office address at 980 Great West Road, Brentford,
Middlesex,TW8 9GS, England (“GSK” or “Assignor”).

 

WHEREAS, Assignor is the joint owner, by assignment, of issued letters patents
and applications for letters patents listed on Schedule 1 attached hereto and
the inventions disclosed therein (collectively, the “Patents and Patent
Applications”); and

 

WHEREAS, Assignor has agreed to assign all right, title and interest in and to
the Patents and Patent Applications to the Assignee.

 

NOW, THEREFORE, in consideration of good and sufficient consideration, the
receipt of which is hereby acknowledged, Assignor has assigned, transferred and
conveyed, and does hereby assign, transfer and convey all right, title and
interest (a) in and to the Patents and Patent Applications, including the right
to claim priority to said Patents and Patent Applications; (b) in and to any and
all applications filed and any and all patent(s) granted on said Patents and
Patent Applications in the United States, in any foreign country, or under the
International Convention for the Protection of Industrial Property or any
international convention, agreement, protocol, or treaty, including each and
every application filed and any and all patent(s) granted on any application
which is a divisional, substitution, continuation, or continuation-in-part of
any of said Patents and Patent Applications; and (c) in and to each and every
reissue, reexamination, or extensions of any of said Patents and Patent
Applications, the same to be held and enjoyed by the said Assignees, for their
own use and the use of their successors, legal representatives and assigns, to
the full end of the term or terms for which letters patent or patents, may be
granted, as fully and entirely as the same would have been held and enjoyed by
the Assignors, had this assignment not been made.

 

AND Assignor does hereby assign, transfer, and convey to the Assignee its
successors, legal representatives and assigns, all of Assignor’s claims for
damages and all of Assignor’s remedies arising out of any violation of the
rights assigned hereby that may have accrued prior to the date of assignment to
Assignee, or may accrue hereafter, including, but not limited to, the right to
sue for, collect, and retain damages for past infringements of the above letters
patents before or after issuance.

 

AND Assignor hereby authorizes and requests the Commissioner of Patents and
Trademarks and any other applicable government authority to issue any and all
letters patent or patents resulting from said applications and any
continuations, continuations-in-part, divisionals and reissues thereof to
Assignee, as Assignee of the entire right, title and interest, and hereby
covenants that it has full right to convey the entire right, title and interest
herein assigned, and that it has not executed, and will not execute, any
agreements inconsistent herewith.

 

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

 

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IN WITNESS WHEREOF the Assignor has executed this Patent Assignment as of the
date first set forth above.

 

GLAXO GROUP LIMITED

 

 

 

BY:

/s/ Paul Williamson

 

 

 

 

NAME:

Paul Williamson

 

 

 

 

TITLE:

Corporate Director

 

 

ACKNOWLEDGEMENT

 

State of       England

)

 

 

 

)

SS:

 

 

County of             London

)

 

On this the    5th       day
of    December                                     ,              2013,                 Paul
Williamson       personally appeared before me, to me known to be the person
named in and who executed the above Patent Assignment on behalf of the
corporation named herein, and acknowledged that s/he executed it in such
representative capacity for the uses and the purposes therein mentioned.

 

SEAL

/s/ Charles Ekeng Henshaw

 

 

 

NOTARY PUBLIC

 

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

 

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SCHEDULE 1

 

GSK Transferred Patents

 

United States Patent Application No. 61/672566

 

International Patent Application No. PCT/US2013/050721

 

Taiwanese Patent Application No. 102125649

 

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

 

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Exhibit D

 

Ongoing Clinical Trials as of Second Restated Effective Date

 

Lead
Company

 

Amicus Study #

 

eTrack Identifier #

 

Abbreviated Title

Amicus

 

AT1001-011

 

MGM116016

 

Migalastat vs Pbo in Fabry disease (study011)

Amicus

 

AT1001-012

 

MGM116017

 

Fabry disease (Study 012) Migalastat vs. ERT

GSK

 

NA

 

MGM116041

 

OLE phs 3 Long-term Safety Study of Migalastat

Amicus

 

FAB-CL-205

 

MGM116045

 

Migalastat Phase 2 Extension (study 205) NB only study report outstanding

GSK

 

NA

 

MGM116188

 

Compassionate Use of Migalastat HCl

Amicus

 

AT1001-013

 

116430

 

DDI (ERT+Migalastat in fabry pts) (013 study) NB only study report outstanding

 

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

 

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Exhibit E

 

JCR Payments

 

******

 

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

 

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Exhibit F

 

Amicus Therapeutics and GSK Announce Revised Fabry Agreement

 

Amicus Acquired Full Rights to Global Drug Development, Regulatory and
Commercial Activities for migalastat HCl

 

GSK Retains Interest through Additional Equity Investment in Amicus, and Future
Milestones and Royalties

 

Conference Call Today at 5:00pm ET

 

CRANBURY, NJ, US & LONDON, UK, November 20, 2013 — Amicus Therapeutics (Nasdaq:
FOLD) and GlaxoSmithKline (GSK) today announced that Amicus has obtained global
rights to develop and commercialize the investigational pharmacological
chaperone migalastat HCl as a monotherapy and in combination with enzyme
replacement therapy (ERT) for Fabry disease.

 

Key Highlights of Revised or Changed Agreement:

 

·                  Amicus will have sole rights to the global drug development,
regulatory and commercial activities for the next-generation Fabry ERT
(migalastat HCl co-formulated with ERT) as well as migalastat HCl monotherapy

·                  GSK will be eligible for future regulatory and commercial
milestone payments, as well as royalty payments.

·                  GSK will further invest $3 million in Amicus through an
equity investment in a concurrent private placement in public equity (PIPE)
transaction..

 

Under the terms of the revised agreement, there is no upfront payment from
Amicus to GSK. For the next-generation Fabry ERT GSK is eligible to receive
single-digit royalties on net sales in eight major markets outside the U.S. For
migalastat HCl monotherapy, GSK is eligible to receive post-approval and
sales-based milestones as well as tiered royalties in the mid-teens in eight
major markets outside the U.S. The terms of the restated agreement replace the
prior agreement in its entirety. Under the prior agreement entered into in
July 2012, Amicus and GSK were co-developing migalastat HCl globally and GSK had
rights to commercialize migalastat HCl outside the United States.

 

Moncef Slaoui, chairman GSK R&D commented, “With internal expertise and
established relationships within the rare disease community, we believe Amicus
is well positioned to maintain momentum of the programs, maximizing their
potential for success, which we hope will provide benefit to patients living
with Fabry disease. GSK will continue to support Amicus through our equity
investment and share in the future value of migalastat HCl as the Fabry program
meets certain regulatory and sales

 

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

 

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milestones.”

 

John F. Crowley, Chairman and Chief Executive Officer of Amicus
Therapeutics, Inc. stated, “This transaction is very important for Amicus and
for our future. It delivers what we believe to be immediate and significant
value to our shareholders while allowing us to maintain a strong relationship
with GSK, our largest shareholder. GSK has been an excellent active development
partner for us on these programs for three years. With this transaction we are
gaining worldwide rights to our first proprietary next generation co-formulated
product, as well as migalastat HCl monotherapy. We look forward to advancing
these programs to major milestones into 2014.”

 

About Migalastat HCl

 

Migalastat HCl is an investigational pharmacological chaperone in development as
a monotherapy and in combination with ERT for the treatment of Fabry disease. As
a monotherapy, migalastat HCl is designed to bind to and stabilize, or
“chaperone” a patient’s own alpha-galactosidase A (alpha-Gal A) enzyme in those
with genetic mutations that are amenable to this chaperone in a cell-based
assay. For patients currently receiving ERT for Fabry disease, migalastat HCl in
combination with ERT may improve ERT outcomes by keeping the infused alpha-Gal A
enzyme in its properly folded and active form.

 

Amicus Solo Conference Call and Webcast

 

Amicus Therapeutics will host a conference call and audio webcast today,
November 19, 2013 at 8:30 a.m. ET to review financial results and provide a
corporate update. Interested participants and investors may access the
conference call at 5:00 p.m. ET 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.amicusrx.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 8:00 p.m. ET today. Access numbers for this replay are 855-859-2056
(U.S./Canada) and 404-537-3406 (international); participant code 115896.

 

About Amicus Therapeutics

 

Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the
forefront of therapies for rare and orphan diseases. The Company is developing
novel, first-in-class treatments for a broad range of human genetic diseases,
with a focus on delivering new benefits to individuals with lysosomal storage
diseases. Amicus’ lead programs include the small molecule pharmacological
chaperones migalastat HCl as a monotherapy and in combination with enzyme
replacement therapy (ERT) for Fabry disease; and AT2220 (duvoglustat HCl) in
combination with ERT 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

 

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, and the

 

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

 

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projected cash position for the Company. Words such as, but not limited to,
“look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,”
“potential,” “plan,” “targets,” “likely,” “may,” “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, 2012. 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

 

GSK enquiries:

 

 

 

 

 

 

 

 

 

 

 

 

 

UK Media enquiries:

 

David Mawdsley

 

+44 (0) 20 8047 5502

 

(London)

 

 

 

 

 

 

 

 

 

Simon Steel

 

+44 (0) 20 8047 5502

 

(London)

 

 

 

 

 

 

 

 

 

David Daley

 

+44 (0) 20 8047 5502

 

(London)

 

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

 

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Catherine Hartley

 

+44 (0) 20 8047 5502

 

(London)

 

 

 

 

 

 

 

US Media enquiries:

 

Stephen Rea

 

+1 215 751 4394

 

(Philadelphia)

 

 

 

 

 

 

 

 

 

Melinda Stubbee

 

+1 919 483 2510

 

(North Carolina)

 

 

 

 

 

 

 

 

 

Mary Anne Rhyne

 

+1 919 483 0492

 

(North Carolina)

 

 

 

 

 

 

 

 

 

Sarah Alspach

 

+1 202 715 1048

 

(Washington, DC)

 

 

 

 

 

 

 

 

 

Jennifer Armstrong

 

+1 215 751 5664

 

(Philadelphia)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Analyst/Investor enquiries:

 

Sally Jackson

 

+44 20 8047 5543

 

(London)

 

 

 

 

 

 

 

 

 

Kirsty Collins (SRI & CG)

 

+44 20 8047 5534

 

(London)

 

 

 

 

 

 

 

 

 

Tom Curry

 

+ 1 215 751 5419

 

(Philadelphia)

 

 

 

 

 

 

 

 

 

Gary Davies

 

+ 44 (0) 20 8047 5503

 

(London)

 

 

 

 

 

 

 

 

 

James Dodwell

 

+ 44 (0) 20 8047 2406

 

(London)

 

 

 

 

 

 

 

 

 

Jeff McLaughlin

 

+ 1 215 751 7002

 

(Philadelphia)

 

 

 

 

 

 

 

 

 

Ziba Shamsi

 

+ 44 (0) 20 8047 3289

 

(London)

 

 

 

 

 

 

 

 

 

Lucy Singah

 

+44 (0) 20 8047 2248

 

(London)

 

GSK Cautionary statement regarding forward-looking statementsGSK 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 Item
3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2012.

 

FOLD-G

 

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

 

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