Exhibit 10.30
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.
LICENSE AND COLLABORATION AGREEMENT
THIS LICENSE AND COLLABORATION AGREEMENT (the “Agreement”) is made as of the
28th day of October, 2010 (the “Effective Date”) by and between Amicus
Therapeutics, Inc., a Delaware corporation having a place of business at 6 Cedar
Brook Drive, Cranbury, New Jersey, 08512 (“Amicus”) and Glaxo Group Limited, a
company organized under the laws of England and Wales with its registered office
address at Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,
England (“GSK”). Amicus and GSK are each referred to herein by name or as a
“Party” or, collectively, as the “Parties”.
RECITALS
WHEREAS, Amicus is developing Compound (as defined below), and owns or controls
certain regulatory filings and intellectual property related thereto;
WHEREAS, GSK desires to collaborate with Amicus on the Development of Compound
and to obtain exclusive rights to Commercialize Products in the Field in the
Territory (each as hereinafter defined) as set forth in this Agreement;
WHEREAS, Amicus desires to collaborate with GSK on the Development of the
Compound and Products in the Field in the Territory as set forth in this
Agreement; and
WHEREAS, Amicus further desires that GSK exclusively Commercialize Compound and
Product(s) in the Field in the Territory, as set forth in this Agreement.
WHEREAS, contemporaneously with the execution of this Agreement, the Parties
have executed an Equity Agreement under which GSK shall purchase common stock of
Amicus, as set forth in such Equity Agreement.
NOW, THEREFORE, in consideration of the mutual agreements contained herein and
other good and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties agree as follows:
I. DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms,
whether used in the singular or plural, shall have the respective meanings set
forth below:
1.1 “011 Phase III Clinical Study” means the Phase III Clinical Study sponsored
by Amicus and identified by the ClinicalTrials.gov Identifier NCT00925301.
 

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1.2 “012 Phase III Clinical Study” means the Phase III Clinical Study sponsored
by Amicus and identified by the ClinicalTrials.gov Identifier NCT01218659.
1.3 “AAA” has the meaning ascribed to that term in Section 16.2.2.
1.4 “Abandoning Party” has the meaning ascribed to that term in Section 7.4.
1.5 “Acceptance of Filing” has the meaning ascribed to that term in
Section 3.3.2.
1.6 “Act” means the United States Food, Drug and Cosmetic Act of 1938, as
amended from time to time, and its implementing regulations.
1.7 “Actual Payment Report” has the meaning ascribed to that term in
Section 3.8.
1.8 “Affected Area” has the meaning ascribed to that term in Section 14.2.
1.9 “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 1.27,
“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.
1.10 “Agreement” has the meaning ascribed to that term in the first paragraph of
this Agreement.
1.11 “Alliance Manager” has the meaning ascribed to that term in Section 4.3.
1.12 “Amicus” has the meaning ascribed to that term in the first paragraph of
this Agreement.
1.13 “Amicus Aggregate Development Cost Cap” means ******, which amount is equal
to the aggregate of Amicus’ share of the Development Costs specified in the
Initial Development Plan for each of the calendar years beginning with calendar
year 2011 up to and including calendar year 2015.
 

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1.14 “Amicus Annual Cost Cap” means: (a) for calendar year 2010, ****** (which
amount represents the aggregate of one hundred percent (100%) of Amicus’s
Development Costs for calendar year 2010 as set forth in the Initial Development
Plan ******; (b) for calendar year 2011, ****** (which amount is equal to fifty
percent (50%) of the total Development Costs for calendar year 2011 as set forth
in the Initial Development Plan); (c) for calendar years 2012, 2013, 2014 and
2015, respectively, ******, ******, ****** and ******, respectively (which
amount is equal to twenty-five percent (25%) of the total Development Costs for
the applicable calendar year, as set forth in the Initial Development Plan); and
(d) for calendar year 2016 and each calendar year thereafter, if applicable,
****** (which amount is equal to twenty-five percent (25%) of the total
Development Costs for calendar year 2015 as set forth in the Initial Development
Plan); in each case, as adjusted in accordance with Section 5.1.5(d) below.
1.15 “Amicus Auditor” has the meaning ascribed to that term in Section 3.9.
1.16 “Amicus House Marks” has the meaning ascribed to that term in Section 6.3.
1.17 “Amicus Indemnitees” has the meaning ascribed to that term in Section 15.1.
1.18 “Amicus Intellectual Property” means Amicus Patents, Amicus Know-How, and
any and all copyrights pertaining to the Compound and Product for the Territory
that are Controlled by Amicus during the Term.
1.19 “Amicus Know-How” means all confidential Know-How which (i) Amicus or its
Affiliates Control as of the Effective Date, or (ii) subject to Section 12.3 and
Section 14.3.10(b), is Controlled by Amicus or its Affiliates after the
Effective Date during the Term of this Agreement and developed or acquired by or
on behalf of Amicus or its Affiliates outside the Program and without the use of
Program Improvements; in each case, that is reasonably necessary or actually
used to Develop, Manufacture or Commercialize Products in the Field for the
Territory. Notwithstanding the foregoing, Amicus Know-How shall not include:
(a) information which is or becomes part of the public domain through no breach
of this Agreement by GSK; (b) information which GSK can demonstrate by its
written records was known by GSK or its Affiliates prior to the disclosure
thereof by Amicus or its Affiliate; (c) information which is independently
developed by GSK or its Affiliates outside of the Program, so long as such
development does not result from use of Amicus Know-How, and such independent
development can be demonstrated by written records; and (d) information that
becomes available to GSK or its Affiliates on a non-confidential basis, whether
directly or indirectly, from a Third Party who is not bound by a confidentiality
obligation to Amicus or its Affiliates.
1.20 “Amicus Patents” means: (i) all Patents Controlled by Amicus or its
Affiliates as of the Effective Date which are reasonably necessary, or actually
practiced, to Develop, Manufacture or Commercialize the Compound or Product for
use as a therapeutic agent, including without limitation the Patents set forth
on Schedule 7.2.1 hereto; and (ii) subject to Section 12.3, all Patents
Controlled by Amicus or its Affiliates in the Territory during the Term of this
Agreement that are reasonably necessary, or actually practiced to Develop,
Manufacture or Commercialize the Compound or Product in the Territory or to the
extent claiming inventions within the Amicus Know-How Controlled by Amicus or
its Affiliates as of the Effective Date.
 

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1.21 “Amicus Proprietary Chaperone Technology” means Amicus’ proprietary
technology used in connection with a small molecule drug that selectively binds
to the active site of a target enzyme resulting in enzyme stabilization,
improved trafficking, less aggregation, and/or increased activity of the enzyme,
including all associated Patents and Know-How Controlled by Amicus in the
Territory.
1.22 “Amicus Prosecuted Patents” has the meaning ascribed to that term in
Section 7.2.2.
1.23 “Amicus Terminated Product Trademark” has the meaning ascribed to that term
in Section 14.2.2.
1.24 “Amicus Trademark” has the meaning ascribed to that term in Section 2.4.
1.25 “Background License Agreements” means the agreements, letters, and other
documents listed in Schedule 1.25.
1.26 “Calendar Year Net Sales” means the total Net Sales of all Products sold in
the specified country or countries of the Territory in a particular calendar
year.
1.27 “Change of Control” means either: (a) a sale of all or substantially all of
the assets of a Party in one or a series of integrated transactions not in the
ordinary course of business to a Third Party; (b) the acquisition of control (as
defined in Section 1.9) of a Party by a Third Party by means of any transaction
or series of related transactions to which such Party is a party (including, any
stock acquisition, merger or consolidation); or (c) the acquisition by a Major
Pharmaceutical Company of ****** percent ****** or more of the total issued
capital stock of a Party and the right to direct or cause the direction of the
management and polices of such Party, directly or indirectly, whether through
ownership of voting securities, by contract, or otherwise; ******. For clarity,
a Change of Control would not include any transaction or series of transactions
in which the holders of voting securities of a Party outstanding immediately
prior to such transaction continue to retain (either by such voting securities
remaining outstanding or by such voting securities being converted into voting
securities of the surviving entity), as a result of shares in the Party held by
such holders prior to such transaction, fifty percent (50%) or more of the total
voting power represented by the voting securities of the acquiring entity
outstanding immediately after such transaction or series of transactions.
1.28 “Claim” means any action, appeal, petition, plea, charge, complaint, suit,
demand, litigation, arbitration, mediation, hearing, inquiry, investigation, or
similar event, occurrence, or proceeding.
1.29 “Co-Development Opt-Out” has the meaning ascribed to that term in
Section 13.6.
 

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1.30 “Co-Development Opt-Out Notice” has the meaning ascribed to that term in
Section 13.6.
1.31 “Combination Therapy” means the use of the Compound or Product in
combination with one or more other active ingredients. Drug delivery vehicles,
adjuvants, and excipients shall not be deemed to be “active ingredients”, and
their presence shall not be deemed to create a Combination Therapy. Combination
Therapy includes, but is not limited to: (i) adjuvant use of the Compound or
Product with an ERT; (ii) co-administration of the Compound or Product with an
ERT, regardless of the order or form in which the co-administration is
performed; or (iii) formulation of the Compound or Product and an ERT.
1.32 “Commercialize” or “Commercialization” means activities directed to
obtaining pricing and reimbursement approvals for, marketing, advertising,
promoting, detailing, distributing, importing, or selling a Product in the Field
in the Territory, and education, planning, product support and medical efforts
related to a Product in the Field in the Territory.
1.33 “Commercially Reasonable Efforts” means that level of efforts and resources
required to carry out a particular task or obligation in an active and sustained
manner, consistent with the usual practice followed by a Party in the exercise
of reasonable business discretion relating to other pharmaceutical products
owned by it, or to which it has exclusive rights, which are of similar market
potential and at a similar stage in development or product life, taking into
account issues of patent coverage, safety and efficacy, scientific and product
profile, the regulatory structure involved, and the strategic value and
profitability of the product (including, without limitation, pricing and
reimbursement status achieved). A Party may not consider payments required to be
made hereunder when determining its Commercially Reasonable Efforts with regards
to the Product or its obligations under this Agreement.
1.34 “Compound” means migalastat, as described in Schedule 1.34, and includes
(i) any compounds with alternative names but with the same chemical structure as
Migalastat, and (ii) 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, whether alone or in a mixture.3
1.35 “Confidential Information” means in the case of one Party (the “disclosing
Party”), that Party’s or its Affiliate’s know-how and financial or other
confidential or proprietary information that is Controlled by that Party or its
Affiliates and made available (in whatever form and whether prior to, on, or
after the Effective Date) to the other Party (the “receiving Party”) in
connection with this Agreement or generated pursuant to this Agreement.
Notwithstanding the foregoing, Confidential Information shall not include:
(a) information which is or becomes part of the public domain through no breach
of this Agreement by the receiving Party or any of its Affiliates;
(b) information which the receiving Party can demonstrate by its written records
was known by the receiving Party or any of its Affiliates prior to the
disclosure thereof by the disclosing Party;
 

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(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.
1.36 “Confidentiality Agreement” means the Confidentiality Agreement between
Amicus and GSK dated as of ****** and amended as of ******.
1.37 “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.
1.38 “Cooperating Party” has the meaning ascribed to that term in
Section 11.2.2.
1.39 “Develop” or “Development” means all activities related to (i) 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), (ii) Phase IV Clinical
Trials and preclinical studies conducted after Marketing Approval (such as
carcinogenicity studies, preclinical studies to establish pediatric dosing and
similar activities) that are required or requested by a Regulatory Authority to
be conducted after Marketing Approval, as a condition of obtaining such
Marketing Approval; (iii) 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
(iv) 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 respect to the Compound and/or
Products in the Field for the Territory.
 

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1.40 “Development Costs” has the meaning ascribed to that term in Schedule
5.1.5.
1.41 “Development Plan” has the meaning ascribed to that term in
Section 5.1.1(b) and includes the Initial Development Plan and any amendments
thereto in accordance with Section 5.1.1(b).
1.42 “Discriminatory Conduct has the meaning ascribed to that term in Section
6.1.1(b).
1.43 “Dispute” has the meaning ascribed to that term in Section 16.2.1.
1.44 “Effective Date” has the meaning ascribed to that term in the first
paragraph of this Agreement.
1.45 “Election Notice” has the meaning ascribed to that term in Section 12.2.1.
1.46 “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.
1.47 “Equity Agreement” means the stock purchase agreement attached hereto as
Exhibit A.
1.48 “ERT” means enzyme replacement therapy.
1.49 “Escalation Notice” has the meaning ascribed to that term in
Section 4.1.5(a).
1.50 “Estimated Payment Report” has the meaning ascribed to that term in
Section 3.8.
1.51 “Excluded Item” has the meaning ascribed to that term in Section 11.1.2.
1.52 “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.
1.53 “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 the Product in
combination with ERT.
1.54 “First Opt-Out Quarter” has the meaning ascribed to that term in
Section 13.6.
1.55 “Force Majeure Event” has the meaning ascribed to that term in
Section 16.11.
1.56 “FTE” has the meaning ascribed to that term in Schedule 5.1.5.
1.57 “FTE Costs” has the meaning ascribed to that term in Schedule 5.1.5.
 

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1.58 “FTE Rate” has the meaning ascribed to that term in Schedule 5.1.5
1.59 “Generic Equivalent” means, as to any specific Product at issue which has
received Regulatory Approval in the country at issue, a non-innovator product
that: (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; (ii) is bioequivalent to the specific Product; and (iii) is
legally marketed in such country by an entity other than GSK, its Affiliates or
Sublicensees.
1.60 “Current Good Manufacturing Practices” or “cGMP” means the standards
relating to manufacturing practices for fine chemicals, intermediates, bulk
products or finished pharmaceutical products: (i) detailed in the U.S. Current
Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211 and The
Rules Governing Medicinal Products in the European Community, Volume IV Good
Manufacturing Practice for Medicinal Products, as each may be amended from time
to time; and/or (ii) outside the United States and European Union, promulgated
by any Regulatory Authority having jurisdiction over the manufacture of fine
chemicals, intermediates, bulk products or finished pharmaceutical products; and
subject to any arrangements, additions or clarifications agreed to from time to
time by the Parties in a quality agreement.
1.61 “GSK” has the meaning ascribed to that term in the first paragraph of this
Agreement.
1.62 “GSK Auditor” has the meaning ascribed to that term in Section 3.10.
1.63 “GSK Background IP” means all Patents and Know-How which (i) GSK or its
Affiliates Controls as of the Effective Date, or (ii) is developed by or on
behalf of GSK or its Affiliates or acquired by GSK or its Affiliates, in each
case, after the Effective Date outside the Program and without the use of
Program Improvements.
1.64 “GSK House Marks” has the meaning ascribed to that term in Section 6.3.
1.65 “GSK Indemnitees” has the meaning ascribed to that term in Section 15.2.
1.66 “GSK Supplied Material” has the meaning ascribed to that term in
Section 14.3.6.
1.67 “GSK Terminated Product Trademark” has the meaning ascribed to that term in
Section 14.3.9(a).
1.68 “GSK Trademark” has the meaning ascribed to that term in Section 2.4.
1.69 “Indemnitee” has the meaning ascribed to that term in Section 15.3.
 

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1.70 “Indemnitor” has the meaning ascribed to that term in Section 15.3.
1.71 “Initial Development Plan” has the meaning ascribed to that term in Section
5.1.1(a).
1.72 “Initial Press Release” has the meaning ascribed to that term in
Section 11.2.1.
1.73 “IND” means any Investigational New Drug Application (including any
amendments thereto) filed with the FDA pursuant to 21 C.F.R. §321 before the
commencement of clinical trials of a Product, or any comparable filings with any
Regulatory Authority in any other jurisdiction.
1.74 “Joint Program Patent” has the meaning ascribed to that term in
Section 7.3.3.
1.75 “Joint Steering Committee” or “JSC” has the meaning ascribed to that term
in Section 4.1.1.
1.76 “Know-How” means any proprietary technology, technical, scientific and
medical information, methods of use, processes, techniques, ideas, inventions
(excluding any inventions disclosed in any Patent or published Patent
application), improvements, modifications, know-how, practices, trade secrets,
chemistry, manufacturing and control data, quality control information and
procedures, and pharmacological, toxicological and preclinical and clinical test
data and results and regulatory information (including all documentation and
correspondence submitted or required to be submitted to a Regulatory Authority,
or received from a Regulatory Authority, in connection with a Marketing Approval
in any country), 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.
1.77 “Launch” means, on a country-by-country and Product-by-Product basis, the
date of the first ****** (or one of its Affiliates or permitted Sublicensees) in
such country; provided that the Launch of a Product in a country for a
particular indication shall be deemed to occur upon the first commercial sale of
a Product with labeling for such indication. Sales of a Product for registration
samples, compassionate use sales, named patient use and the like, and
inter-company transfers to Affiliates of GSK for resale will not constitute a
Launch.
1.78 “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.
1.79 “Liabilities” has the meaning ascribed to that term in Section 15.1.
1.80 “License” has the meaning ascribed to that term in Section 2.1.
1.81 “Licensed Technology” means all (i) Amicus Intellectual Property,
(ii) Program Improvements developed solely or jointly by Amicus or its
Affiliates (subject to Section 12.3) during the Term, and (iii) Program Patents
in the Territory owned solely or jointly by Amicus or its Affiliates (subject to
Section 12.3). For the avoidance of doubt, the “Licensed Technology” shall
include Amicus Proprietary Chaperone Technology, but solely to the extent such
Amicus Proprietary Chaperone Technology is necessary for the Development,
Manufacture or Commercialization of Product for the Territory.
 

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1.82 “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 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.
1.83 “Major EU Country” means ******, ******, ******, ****** or ******.
1.84 “Major Market” means ******, each ******and ******.
1.85 “Major Pharmaceutical Company” shall mean a company that is engaged in the
business of selling pharmaceutical products, whose worldwide revenues from such
sales (on a consolidated basis in the last full fiscal year prior to the closing
of any Change of Control) was in excess of ****** or a company engaged in
business in the life sciences field that is of an equivalent size. Any Affiliate
of such company shall be deemed to be a Major Pharmaceutical Company.
1.86 “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.
1.87 “Manufacturing Costs” has the meaning ascribed to that term in Schedule
5.1.5.
1.88 “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 ****** is obtained. For clarity,
however, it is understood that, as of the Effective Date, Marketing Approval in
the United States shall be deemed to occur upon ******. In the event that any
such ****** of any governmental agency in the United States is required at the
time that the Parties seek Marketing Approval for a Product in the United
States, then Marketing Approval in the United States shall not be deemed to
occur until ******. Notwithstanding the foregoing, Marketing Approval shall be
deemed to have occurred for a particular indication for a Product in such
jurisdiction upon the Launch of such Product in such jurisdiction with labeling
for such indication.
1.89 “Marketing Plan” means the strategic plan for the marketing, promotion and
other Commercialization of Product in the Territory, including without
limitation the Marketing Strategy, which will include the projected market
penetration for each Product in the Major Markets, in reasonable scope and
detail, as prepared by GSK in accordance with GSK’s normal and customary format
and process for such plans, and as amended from time to time by GSK during the
Term.
 

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1.90 “Marketing Strategy” means the marketing strategy for Product in the
Territory determined by GSK and reviewed by the Joint Steering Committee,
including product positioning, pricing, reimbursement, education programs,
medical affairs, publications, sales messages, marketing, distribution, and
Phase IV Clinical Studies, as such strategy may be amended by GSK from time to
time during the Term.
1.91 “NDA” means a New Drug Application as defined in Title 21 of the U.S. Code
of Federal Regulations, Section 314.50, et seq., which is filed with the FDA in
order to gain the FDA’s approval to commercialize a pharmaceutical product in
the United States for the indications set forth in the New Drug Application.
1.92 “Negotiation Period” has the meaning ascribed to that term in
Section 12.2.2.
1.93 “Net Sales” means the amount of gross sales of all Products sold by GSK,
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 the Selling Party in its financial statements prepared in
accordance with the International Financial Reporting Standards (“IFRS”),
applied on a consistent basis:
(a) quantity, trade and cash discounts actually allowed or given;
(b) discounts, replacements, credits or refunds actually allowed for the return
of rejected, outdated, damaged or returned Products;
(c) rebates, chargebacks and price adjustments actually allowed or given;
(d) sales or similar taxes (including duties or other similar governmental
charges or assessments) levied, or otherwise imposed on the sale of 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 GSK, any permitted
Sublicensee or any Affiliate of GSK for resale shall be excluded from Net Sales
calculations; provided, however, that the subsequent resale to a Third Party
shall be included in Net Sales hereunder;
 

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(ii) If a 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 GSK recognizes revenue with respect to any
such sales or transfers in which event such sales or transfers shall be included
in Net Sales hereunder; and
(v) for a Combination Therapy, the computation of Net Sales in a country shall
be based on ****** during the applicable Quarter although, if ******. For
purposes of this Section 1.93(f)(v), ******. If the Parties are unable to agree
on the allocation of Net Sales with respect to a Combination Therapy as provided
in this Section 1.93(f)(v), the matter shall be resolved in accordance with
Section 16.2.3 below. For the avoidance of doubt, if a Product is sold in
combination with a diagnostic device, the computation of Net Sales for such
Product shall be based solely on ******.
The Net Sales definition may be amended upon written notice from GSK only to
extent required to reflect changes to GSK’s accounting rules (e.g. a change from
IFRS to UK GAAP) that result from a merger, takeover, or change in applicable
law.
1.94 “Ongoing Trial” has the meaning ascribed to that term in Section 14.3.2.
1.95 “Out-of-Pocket Expenses” has the meaning ascribed to that term in
Schedule 5.1.5.
1.96 “Overage” has the meaning ascribed to that term in Section 5.1.6.
1.97 “Party” or “Parties” has the meaning ascribed to that term(s) in the first
paragraph of this Agreement.
1.98 “Patent” means any and all existing (as of the Effective Date) and future
patents and patent applications in any country or jurisdiction, including but
not limited to, any provisional applications, non-provisional applications, PCT
applications, re-issues, re-examinations, divisionals, continuations,
continuations-in-part, registrations, confirmations, validations,
re-validations, renewals, and extensions of term thereof (including
supplementary protection certificates and pediatric use extensions), including
utility, model, and design patents.
 

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1.99 “Patent Costs” means the reasonable fees and expenses paid to outside legal
counsel, and filing, maintenance and other out-of-pocket expenses paid to Third
Parties as incurred in connection with the prosecution and maintenance of
Patents.
1.100 “Person” means any individual, corporation (including any nonprofit
corporation), general or limited partnership, limited liability company, joint
venture, estate, trust, association, organization, labor union, or other entity.
1.101 “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.
1.102 “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.
1.103 “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
NDA, as more fully defined in 21 C.F.R. §312.21(c) or its successor regulation,
including any such clinical study in any country other than the United States.
1.104 “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 for a Product conducted after receipt of Marketing
Approval for such Product in the country in which such trial is being conducted
and that are required or requested by a Regulatory Authority to be conducted
after Marketing Approval, as a condition of or in connection with obtaining and
maintaining such Marketing Approval.
1.105 “Product” means, subject to Section 14.3.10(a), any pharmaceutical
preparation that incorporates Compound, whether or not as the sole active
ingredient, including any formulation thereof, such as intravenous, transdermal,
oral, or other dosage form.
1.106 “Product Acquisition Agreement” has the meaning ascribed to that term in
Section 12.2.2.
1.107 “Product Liability Claim” has the meaning ascribed to that term in Section
15.4.1.
1.108 “Program” means all activities directed to the Development, Manufacture
and/or Commercialization of Compound or Products for the Territory performed by
or on behalf of Amicus (or its Affiliates) and/or GSK (or its Affiliates or
Sublicensees) under this Agreement; provided, however, it is understood that all
activities related to the Development of Compound conducted either: (a) by
Amicus prior to the Effective Date; or (b), by Amicus with respect to a
Terminated Product(s) in the Affected Area after termination of this Agreement
in such country(ies) or with respect to such Product(s) (but not in its
entirety) by either GSK pursuant to Section 13.3 or by Amicus pursuant to
Section 13.2, will be deemed to have been conducted outside of the Program.
 

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1.109 “Program Improvements” means any and all confidential Know-How, and other
information that is developed by or on behalf of GSK (or its Affiliates or
Sublicensees) or Amicus (or its Affiliates, subject to Section 12.3) or jointly
by or on behalf of GSK and Amicus or any of their respective Affiliates (subject
to Section 12.3), in the performance of the Program, including inventions,
Know-How, and all other intellectual property relating to any of the foregoing;
provided, however, that Program Improvements will not include Amicus
Intellectual Property; and provided further that, Program Improvements shall not
include: (i) information which is or becomes part of the public domain through
no breach of this Agreement by GSK or Amicus or their respective Affiliates;
(ii) information which GSK can demonstrate by its written records was known by
GSK or its Affiliates prior to the Effective Date excluding any information
received by GSK under the terms of the Confidentiality Agreement; and
(iii) information which is independently developed by GSK or Amicus or their
respective Affiliates outside of the Program, and such independent development
can be demonstrated by written records. Any Program Improvement that is
developed solely by GSK or its Affiliate under this Agreement that was not
enabled by the use of any Amicus Intellectual Property or developed in the
performance of the Development Plan during the period in which Amicus and GSK
are sharing Development Costs pursuant to Section 5.1.5 shall be referred to
herein as a “GSK-Only Program Improvement.”
1.110 “Program Patent” means a Patent or Patent application disclosing and
claiming a Program Improvement.
1.111 “Protective Action” has the meaning ascribed to that term in Section 8.2.
1.112 “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.
1.113 “Regulatory Approval” means: (a) in the United States, written notice of
Marketing Approval by the FDA based on approval of an NDA, or sNDA, as
applicable, and (b) in any other country in 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 Approval from the European Medicines Agency shall
constitute written notice with respect to each and every such country.
1.114 “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.
 

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1.115 “Regulatory Exclusivity” means any exclusive marketing rights or data
exclusivity rights conferred by any applicable Regulatory Authority, other than
a Valid Claim, including any regulatory data protection exclusivity, including,
where applicable, pediatric exclusivity and/or orphan drug exclusivity and/or
any exclusivity afforded by restrictions on the granting by a Regulatory
Authority of regulatory approval to market a Generic Equivalent.
1.116 “Re-Offer Notice” has the meaning ascribed to that term in Section 12.2.3.
1.117 “Requesting Party” has the meaning ascribed to that term in
Section 11.2.2.
1.118 “Revised Terms” has the meaning ascribed to that term in Section 12.2.3.
1.119 “Royalty Term” has the meaning ascribed to that term in Section 3.4.2.
1.120 “Rules” has the meaning ascribed to that term in Section 16.2.2.
1.121 “Safety Issue” means any unexpected or untoward adverse event related to a
Product that is reported to a Party by a patient or physician, or about which a
Party becomes aware, which event raises a question about patient safety or the
efficacy of such Product and which event a Party considers to be serious enough
to contemplate taking a prompt affirmative action with respect to such Product.
1.122 “Senior Executives” has the meaning ascribed to that term in
Section 4.1.5(a).
1.123 “Subcommittee” has the meaning ascribed to that term in Section 4.2.
1.124 “Sublicensee” shall mean a Third Party to whom GSK has granted a right to
make, have made, sell, market, distribute and/or promote a Product in the
Territory pursuant to Section 2.2; and “Sublicense” shall mean an agreement or
arrangement between GSK and a Sublicensee granting such rights. As used in this
Agreement, “Sublicensee” shall not include a wholesaler or reseller of Product
who does not market such Product.
1.125 “Supply Transition Date” has the meaning ascribed to that term in
Section 6.5.1.
1.126 “Supply Transition Plan” has the meaning ascribed to that term in
Section 6.5.1.
1.127 “Term” has the meaning ascribed to that term in Section 13.1.
1.128 “Terminated Product(s)” has the meaning ascribed to that term in
Section 14.2.
 

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1.129 “Terminated Product Trademark” has the meaning ascribed to that term in
Section 14.3.9.
1.130 “Territory” means, subject to Section 14.3.10(a), all countries and
territories in the world.
1.131 “Third Party” means any Person other than Amicus or GSK or an Affiliate of
Amicus or GSK.
1.132 “Third Party Claim” has the meaning ascribed to that term in Section 15.1.
1.133 “Total Amicus Development Cost Cap” has the meaning ascribed to that term
in Schedule 5.1.5.
1.134 “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
(e) all rights in and to any of the foregoing.
1.135 “Trademark License Agreement” means an agreement in the form attached
hereto as Exhibit C or Exhibit D, as applicable.
1.136 “Treaty” has the meaning ascribed to that term in Section 3.11.
1.137 “Total Program Development Costs in the Initial Development Plan” means
the aggregate Development Costs for the Development of the Compound and Products
specified in the Initial Development Plan for each of the calendar years
beginning with calendar year 2011 up to and including calendar year 2015.
1.138 “United States” or “U.S.” means the fifty (50) states of the United States
of America, the District of Columbia and Puerto Rico.
1.139 “Valid Claim” means a claim of an issued, unexpired Amicus Patent or a
Program Patent (other than a Program Patent claiming a GSK-Only Program
Improvement, 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 1.138, a “Formulation Patent” means a Patent primarily
directed to an invention which is a formulation of Compound and one (1) or more
excipients, and a “Method of Manufacture Patent” means a Patent primarily
directed to an invention which is a method of manufacture of Compound or
Product.
 

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1.140 “Wind-Down Period” has the meaning ascribed to that term in
Section 14.3.3.
1.141 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) all references to a “business day” or “business days” in this Agreement
means any day other than a day which is a Saturday, a Sunday, any day banks are
authorized or required to be closed in the United States or any other day on
which GSK’s corporate headquarters in the United States are closed; 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. LICENSE
2.1 License Grant from Amicus. Subject to the terms and conditions of this
Agreement, Amicus hereby grants to GSK an exclusive license, with the right to
grant sublicenses in accordance with Section 2.2, under all Licensed Technology,
to Develop, make, use, sell, offer for sale and import Compound and Products, in
each case, solely in the Field and in the Territory (the “License”). The License
set forth in this Section 2.1 shall be exclusive even as to Amicus, except with
respect to Amicus’s right to: (i) co-Develop Compound and Products in the Field
and in the Territory in accordance with Article V; (ii) Manufacture Compound and
Products in accordance with Section 6.5; and (iii) Commercialize Compound and
Products in the Field and in the Territory in accordance with Article VI. For
the avoidance of doubt, the Licensed Technology licensed exclusively to GSK in
this Section 2.1 shall include any and all data resulting from any clinical
trials performed by Amicus, its Affiliates, and its licensees in the Territory
with respect to the Compound and Products, in each case subject to
Section 14.3.10(b) and to the extent that Amicus has the right to grant to GSK
access to such data from licensees. Subject to Section 14.3.10(b), to the extent
any clinical data with respect to the Compound and Product is owned or
controlled by a licensee of Amicus and is not included in the Amicus Know-How,
upon GSK’s written request, Amicus shall use all reasonable efforts to obtain
the right, at no cost to GSK, to sublicense to GSK, or otherwise obtain the
right for GSK, to access and make any other use of any such clinical trial data
within the scope of the License and otherwise in accordance with the terms and
conditions of this Agreement; provided that in no event shall Amicus be
obligated to undertake additional payment obligations to such licensees in order
to obtain such rights for GSK.
 

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2.2 Sublicensees. GSK shall have the right to grant sublicenses under the rights
granted to GSK in Section 2.1 without the prior written consent of Amicus: (a)
******; and (b) ******. In addition to the sublicense rights provided above in
clauses (a) and (b) of this Section 2.2 (a) and (b), GSK may engage Sublicensees
and grant Sublicenses in any country of the Territory, provided, however, that
GSK may not grant a sublicense to any Third Party listed on the attached
Schedule 2.2 without the prior written consent of Amicus, such consent not to be
unreasonably withheld. In any event, GSK shall ensure that each of its
Sublicensees is bound by a written agreement containing provisions at least as
protective of the Compound, the Products and Amicus as this Agreement; and GSK
shall remain responsible to Amicus for all activities of its Affiliates and
Sublicensees to the same extent as if such activities had been undertaken by GSK
itself. Promptly following the execution of each Sublicense, GSK shall provide
Amicus with a redacted copy of such Sublicense (redacted solely to the extent
necessary to prevent the disclosure of Third Party confidential information and
not redacting any terms or information that are necessary for Amicus to
determine GSK’s compliance with the provisions of this Agreement with respect to
the grant of such Sublicense).
2.3 License Grant from GSK. Subject to the terms and conditions of this
Agreement:
a) GSK hereby grants to Amicus a worldwide, non-exclusive, fully paid-up,
royalty-free right and license, with the right to grant sublicenses only upon
the prior written consent of GSK (which approval shall not be unreasonably
withheld), under all Program Improvements Controlled by GSK or its Affiliates
and Program Patents Controlled by GSK or its Affiliates to: (i) Develop Compound
and Product in the Field and in the Territory in accordance with Article V;
(ii) Manufacture Compound and Product as provided in Section 6.5; and
(iii) engage in Commercialization activities in accordance with the then-current
Marketing Plan with GSK in the Field and in the Territory solely in accordance
with Article VI.
b) GSK hereby grants to Amicus a worldwide, non-exclusive, fully paid-up,
royalty-free, irrevocable right and license, with the right to sublicense, under
any Program Patents Controlled by GSK or its Affiliates to make, have made, use,
sell, offer for sale, import, practice and otherwise exploit the Program
Improvements claimed in such Program Patents, subject to the exclusive rights
granted to GSK under this Agreement with respect to Compound and Products in the
Field in the Territory.
2.4 Trademarks. For all Trademarks Controlled by Amicus or any of its Affiliates
that the Joint Steering Committee determines should be used on a Product in a
country(ies) in the Territory (each, an “Amicus Trademark”), Amicus shall grant
to GSK a license, with the right to sublicense on the same terms as those set
forth in Section 2.2 above, in accordance with the terms of the Trademark
License Agreement (a form of which is attached hereto as Exhibit C), to use the
Amicus Trademark(s) in such country(ies) in the Territory in connection with the
making, having made, use, sale, offering for sale, importation, packaging,
distributing and promoting of Product in the Field and in such country(ies) in
the Territory. Such license under the Amicus Trademarks will include a right to
use the Amicus Trademark(s), other than Amicus House Marks, as part of a domain
name. For all Trademarks Controlled by GSK or any of its Affiliates that the
Joint Steering Committee determines should be used on a Product in a
country(ies) in the Territory (each, a “GSK Trademark”), GSK shall grant to
Amicus a license in accordance with the terms of the Trademark License
Agreement, a form of which is attached hereto as Exhibit D, to use the GSK
Trademark(s) solely in connection with Amicus’s right to (i) Develop Compound
and Product in the Field in the Territory as provided in Article V,
(ii) Manufacture Compound or Product in the Field and in the Territory in
accordance with Section 6.5, and (iii) engage in Commercialization activities in
accordance with the then-current Marketing Plan with GSK in the Field and in the
Territory solely in accordance with Article VI. Such license under the GSK
Trademarks will include also a right to use the GSK Trademark(s), other than GSK
House Marks, as part of a domain name.
 

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2.5 No Implied Licenses. Except as expressly set forth in this Agreement or in a
Trademark License Agreement, neither Party shall acquire any licenses or other
intellectual property right or interest, by implication or otherwise, in any
Know-How disclosed to it under this Agreement or under any Patents Controlled by
the other Party or its Affiliates. Without limiting the foregoing, nothing
herein shall be deemed to grant to GSK a right or license to any active
pharmaceutical ingredient other than the Compound.
III. CONSIDERATION
As partial consideration for the License granted to GSK in this Agreement, GSK
shall pay to Amicus in accordance with the payment provisions in Section 3.6 the
following amounts:
3.1 License Fee. Subject to Section 3.11 with respect to payment of taxes, in
addition to (and not in lieu of) royalty and milestone payments due under this
Agreement, GSK will make a one-time payment in an aggregate amount of thirty
million United States dollars (US $30,000,000) to Amicus representing a license
fee within ten (10) business days after receipt of an invoice therefor from
Amicus as provided in Section 3.6, which invoice shall not be sent by Amicus to
GSK prior to the Effective Date.
3.2 Equity Investment. In addition, GSK shall purchase from Amicus, a number of
shares of common stock of Amicus equal to nineteen and nine tenths percent
(19.9%) of the number of shares of common stock of Amicus issued and outstanding
immediately following the closing of the Equity Agreement, for an aggregate
consideration equal to the product of the number of such shares of common stock
of Amicus multiplied by the Per Share Price. For the purposes of this
Section 3.2, the “Per Share Price” shall be equal to ******. The Equity
Agreement shall be executed by the Parties on even date herewith, with GSK’s
payment to Amicus for such securities payable within ten (10) business days
after the Equity Agreement effective date.
3.3 Milestone Payments. Subject to Section 3.11 with respect to payment of
taxes, in addition to (and not in lieu of) the license fee set forth in
Section 3.1 and the royalty payments set forth in Section 3.4, GSK will pay to
Amicus the milestone payments set out below following the first achievement of
each of the corresponding milestone events no later than sixty (60) days
following the receipt of an invoice therefor from Amicus as provided in
Section 3.6. GSK shall notify Amicus in writing promptly, but in no event later
than ten (10) days, after the achievement of any of the following milestone
events, and no invoice for payment of a milestone shall be sent by Amicus to GSK
as provided herein prior to Amicus’s reasonable determination that the
corresponding milestone event has been achieved. Each of the following milestone
payments shall be payable only once, regardless of how many times the Product
achieves the milestone event and no milestones shall be paid by GSK for
milestone events that are not achieved.
 

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3.3.1 Filing and Approval Milestones. GSK shall pay to Amicus the amount set
forth below for the achievement of the corresponding filing and approval
milestones by GSK, its Affiliate or Sublicensee (or in the case of the Milestone
1 in the table below, by Amicus or its Affiliate):

          Filing and Approval Milestone Event   Milestone Payment  
1. ******
  $ ******  
2. ******
  $ ******  
3. ******
  $ ******  
4. ******
  $ ******  
5. ******
  $ ******  
6. ******
  $ ******  
7. ******
  $ ******  

3.3.2 Certain Terms Pertaining to Filing and Approval Milestones.
(a) Reduction to Certain Milestone Payments. With respect to Milestone ****** in
the table in Section 3.3.1 above, if ******, then the corresponding milestone
payment due upon the achievement of Milestone ****** shall be reduced to ******.
With respect to Milestone ****** in the table in Section 3.3.1 above, ******,
then the corresponding milestone payment due upon the achievement of Milestone
****** shall be reduced to ******.
(b) Certain Definitions. For the purposes of the milestone payments due under
Section 3.3.1:
(i) ******.
 

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3.3.3 Sales Performance Milestones. GSK shall pay to Amicus the amount set forth
below following the first achievement of the corresponding Sales Performance
milestones set out below:

          Sales Performance Milestones:   Milestone Payment  
******
  $ ******  
******
  $ ******  
******
  $ ******  
******
  $ ******  

3.4 Royalties.
3.4.1 Royalties on Products in the Territory. In addition to (and not in lieu
of) the license fee set forth in Section 3.1 and the milestone payments set
forth in Section 3.3, and subject to Sections 3.4.3-3.4.8, commencing on the
date of Launch of a Product in a country and until the expiration of the Royalty
Term in such country, GSK shall pay to Amicus royalties at the rate set forth
below on Net Sales of Product on a Product-by-Product and country-by-country
basis where such Product is covered by (i) a Valid Claim, or (ii) Regulatory
Exclusivity:

              Royalty (based   Total Annual Net Sales   on Net Sales)  
******
    ****** %
******
    ****** %
******
    ****** %
******
    ****** %

3.4.2 Royalty Term. Subject to Section 3.11 and Section 3.5.2(b), GSK shall pay
to Amicus royalties as set forth in Section 3.4.1 based on the total Net Sales
of Products during a calendar year in the Territory on a Product-by-Product and
country-by-country basis, for the longer of (i) the last to expire Valid Claim
covering such Product in such country, (ii) the date upon which any remaining
Regulatory Exclusivity with respect to such Product in such country expires, or
(iii) ten (10) years from the date of the first Launch of such Product in such
country (the “Royalty Term”).
 

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3.4.3 If, during the Royalty Term for a particular Product in a Major Market
country, a Product in such Major Market country is not covered by a Valid Claim
or Regulatory Exclusivity at the time of the first Launch of such Product in
such country but is or becomes covered by a claim of a pending Patent
application filed during the applicable Royalty Term that, if such claim issued
would be a Valid Claim covering the Product, then the royalty rates for such
Product in such Major Market country shall be reduced by ******percent (******)
of the royalty rates set forth in Section 3.4.1 otherwise due for the applicable
Royalty Term. The payments representing the remaining ****** of the royalties
that would otherwise have been payable to Amicus if the pending Patent
application had issued and had included a Valid Claim covering the Product in
such Major Market country shall be deposited by GSK into a mutually agreed Third
Party escrow account to be maintained by GSK. Upon the issuance of a Patent in
such Major Market country based upon any such pending Patent application
described above with a Valid Claim covering such Product in such Major Market
country, the remaining ****** of the royalties, plus interest accrued on such
amount, shall be promptly paid to Amicus and thereafter, GSK shall pay royalties
to Amicus on sales of such Product in such Major Market country at the full
rates set forth in Section 3.4.1 for the applicable Royalty Term; provided,
however, that if a Patent does not issue in such Major Market country from such
pending Patent application within ****** from the earliest priority filing date
of such Patent application in such Major Market country, then GSK shall retain
all such amounts paid into escrow, plus interest accrued to such escrow account;
******.
3.4.4 Subject to Section 3.5 below, during the applicable Royalty Term, GSK
shall pay royalties on a Product based upon the royalty rates as set forth in
Section 3.4.1 above for sales of such Product in all non-Major Market countries
during the applicable Royalty Term, even if such Product is not covered by a
Valid Claim or Regulatory Exclusivity in such non-Major Market country.
3.4.5 If, at any time during the Royalty Term, the only Valid Claim covering a
particular Product is a Valid Claim of a Joint Program Patent, then the
royalties rates for such Product during the applicable period shall be reduced
by ****** of the royalty rates set forth in Section 3.4.1; it being understood
that if during the Royalty Term in such country, such Product becomes covered by
any other Valid Claim, the applicable royalty rates shall be the full rates set
forth in Section 3.4.1.
3.4.6 Following the expiration of GSK’s obligation to pay royalties on a Product
as provided in Section 3.4.2 in a country, GSK shall have a perpetual (subject
to Section 14.3), exclusive, fully paid-up (subject to Section 3.5.2(b)) right
and license under the Licensed Technology in such country to make, use, sell,
offer for sale and import such Product in such country of the Territory.
3.4.7 If, the royalties due on Net Sales of Product in a particular Quarter in
any country of the Territory could be owed by GSK to Amicus pursuant to
Section 3.4.1, Section 3.4.3, Section 3.4.4 and/or Section 3.4.5, then the
actual royalties to be paid by GSK to Amicus, subject to Section 3.5, shall be
calculated in accordance with Section 3.4.1, Section 3.4.3, Section 3.4.4 or
Section 3.4.5 (but not more than one of the foregoing Sections) such that Amicus
shall be entitled to receive, and GSK shall pay to Amicus ****** in such country
of the Territory under any one (1) of the foregoing Sections; provided that in
no event shall GSK be obligated to pay to Amicus royalties on Net Sales of
Product in a particular Quarter in any country of the Territory pursuant to more
than one of the foregoing Sections.
 

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3.4.8 For purposes of this Section 3.4, a Valid Claim covers a Product if such
Valid Claim would be infringed, but for a license, by the Commercialization of
such Product in such country.
3.5 Certain Reductions to Royalties.
3.5.1 Generic Equivalent. During the Royalty Term, on a country-by-country and
Product-by-Product basis, if the cumulative unit volume of such Generic
Equivalent(s) sold by Third Parties in such country are equal to or greater than
****** of the combined unit volume of such Product and such Generic
Equivalent(s) for all indications in the aggregate in such country in any
calendar quarter determined by the number of prescriptions given for the Product
and such Generic Equivalent(s), in the aggregate during such calendar quarter
(as measured by a Scott Levin Associates audit or other mechanism mutually
agreed by the Parties), then the royalty rates applicable to Net Sales of such
Product by GSK, its Affiliate or Sublicensee in such country shall be ****** of
the royalty rates specified above in Section 3.4.1 with respect to Net Sales of
such Product in such country for so long as such competition exists, and such
reduced royalty shall be paid by GSK for the shorter of ****** from the date
upon which GSK’s royalty obligations were reduced pursuant to this Section 3.5.1
as a result of the sales of such Generic Equivalent(s), or ****** from the date
of the first Launch of the Product in such county, after which time GSK’s
license with respect to such Product would be converted into a perpetual,
exclusive, fully-paid, royalty-free (subject to Section 3.5.2(b)) license under
the Licensed Technology to make, have made, use, sale, offer for sale and import
such Product in such country in the Territory; provided, however, that GSK shall
no longer be entitled to reduce the royalty rates nor the period of GSK’s
royalty obligations as set forth above in this Section 3.5.1 if at any time
following a reduction in royalty rate pursuant to this Section 3.5.1 and prior
to the expiration of the Royalty Term set forth in this Section 3.5.1, such
Generic Equivalent(s) cease to equal ****** or more of the combined unit volume
of such Product and such Generic Equivalent(s) for all indications in the
aggregate in such country in any calendar quarter determined by the number of
prescriptions given for the Product and such Generic Equivalent(s), in the
aggregate during such calendar quarter (as measured by a Scott Levin Associates
audit or other mechanism mutually agreed by the Parties).
3.5.2 Third Party Obligations.
(a) During the Royalty Term, on a country-by-country basis, any milestones,
royalties and/or other license payments actually paid to a Third Party under a
written license agreement covering intellectual property which, following a
reasonable evaluation in accordance with normal business practice, GSK
determines is necessary to enable GSK to Develop, Manufacture, use, import or
sell Product in accordance with the Agreement such that, absent such Third Party
license the Development, Manufacture, or Commercialization of Product would
infringe such Third Party intellectual property, then such payments shall be
creditable by GSK against royalties payable to Amicus by GSK under the
Agreement; provided that the royalties due by GSK to Amicus in any Quarter shall
not be so reduced by more than ****** of the royalties that would otherwise be
payable by GSK to Amicus for such calendar quarter; provided further that GSK
can credit the remainder of such amounts paid to such Third Party against future
royalties payable to Amicus by GSK. If Amicus disputes the need of GSK to obtain
a Third Party license for the Product, then Amicus may provide written notice of
such dispute to the Joint Patent Subcommittee, and such dispute shall be
resolved in accordance with 4.2.1.
 

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(b) Amicus shall be solely responsible for payment of any and all royalties owed
by Amicus to a Third Party pursuant to any Background License Agreements that
are in effect as of the Effective Date of the Agreement, and a complete
description of the royalties payable under such Background License Agreements is
set forth on the attached Schedule 3.5.2; provided, however, that in no event
shall the reduction in the royalties to be paid by GSK to Amicus pursuant to
Section 3.5.1 or this Section 3.5.2 result in a payment of royalties by GSK to
Amicus that is less than the royalty amount(s) due by Amicus to such Third
Parties under such Background License Agreements; provided, further, that if
upon expiration of the Royalty Term for a particular Product in a particular
country, Amicus continues to owe to a Third Party royalties pursuant to a
Background License Agreement based upon sales of such Product by GSK, its
Affiliates or Sublicensees in such country, GSK shall continue to pay such Third
Party royalties to Amicus on sales of Products in such country at the same rate
as as Amicus pays to the Third Party as set forth on Schedule 3.5.2 for so long
as such royalties are payable to such Third Party under the applicable
Background License Agreement.
(c) In the event that Amicus intends to modify any of the terms of a Background
License Agreement pertaining to (x) the amount of royalties payable under such
Background License Agreement with respect to sales of Products in the Territory,
(y) the term for which such royalties are payable, or (z) the scope of any
rights or obligations granted to GSK under this Agreement, Amicus shall provide
notice of such intent to GSK within a reasonable period of time (but in no event
longer than five (5) business days) prior to making any such modifications. If
such modifications would increase the amount of any royalties payable with
respect to sales of Products in the Territory or the term for which such
royalties are payable or otherwise materially and adversely modify the scope of
any rights or obligations granted to GSK under this Agreement, Amicus shall not
proceed to so modify any such Background License Agreement without the prior
consent and approval of GSK (such approval not to be unreasonably withheld or
delayed).
3.5.3 Royalty Floor. Notwithstanding any other provision in this Agreement
(including any provisions for deductions or offsets from or against payments due
to Amicus), in no event shall the royalties payable by GSK with respect to Net
Sales of Products in any Quarter be reduced to less than ****** of the royalties
that would otherwise be payable by GSK to Amicus for such Quarter at the royalty
rates specified in Section 3.4.1 if none of the reductions, deductions and
offsets specified in Section 3.4 and this Section 3.5 were available.
3.6 Method of Payment. All payments made by a Party to another Party under this
Agreement shall be made by bank wire transfer in immediately available funds to
an account designated in an invoice from the Party to which such payments are
due, which invoice should include bank details, the contact name for any issue
resolution and be marked for the attention of the Alliance Manager of the Party
to whom such payment is due. All amounts owed by GSK to Amicus hereunder shall
be paid by an entity resident in the United Kingdom from a bank account located
in the United Kingdom. Unless otherwise expressly stated herein, all payments
made by GSK to Amicus pursuant to this Agreement shall be made within sixty
(60) days following receipt by GSK of an invoice from Amicus for such amounts.
 

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3.7 Foreign Exchange. With respect to sales of the Product invoiced in United
States dollars, the Net Sales and the amounts due hereunder will be expressed in
United States dollars. With respect to sales of the Product invoiced in a
currency other than United States dollars, the Net Sales and amounts due
hereunder will be reported in United States dollars, calculated using the
average exchange rates as calculated and utilized by GSK’s group reporting
system and published accounts. As of the Effective Date, the method utilized by
GSK’s group reporting system and published accounts uses spot exchange rates
sourced from Reuters/Bloomberg and, if the method used by GSK’s group reporting
system and published accounts is changed during the Term, GSK will notify Amicus
in writing of the revised method prior to GSK applying such method to exchange
rate calculations to be made with respect to Net Sales and amounts due under
this Agreement.
3.8 Reports and Royalty Payment. ******. Thereafter GSK shall, within ******
after the end of each Quarter, submit to Amicus, together with GSK’s payment for
the royalties due for each Quarter, on a Product-by-Product and
country-by-country basis, a written report (an “Actual Payment Report”) showing
the actual Net Sales and the royalties payable in accordance with Section 3.4 in
each case in U.S. dollars. In each country where Net Sales have occurred in a
currency other than United States dollars, such Net Sales will be converted to
United States Dollars in accordance with Section 3.7 above.
3.9 GSK Records. GSK will keep, and will require any Affiliates and Sublicensees
to keep, for three (3) years from the end of the Quarter to which they pertain,
or such longer period as may be required by applicable Law, complete and
accurate books of account and records for the purpose of determining the amounts
payable to or by Amicus pursuant to this Agreement, including Net Sales of
Product in the Territory in sufficient detail to allow the royalties to be
determined accurately. Amicus will have the right during such three (3) year
period to appoint an independent certified public accountant reasonably
acceptable to GSK (the “Amicus Auditor”) to inspect those books or records of
GSK for the purpose of determining the applicable amounts payable to or by
Amicus pursuant to this Agreement. Upon not less than sixty (60) days’ prior
written notice from Amicus, GSK will make such books and records and the books
and records of its Affiliates available (including any Net Sales reports
received from its Sublicensees selling Products) for inspection by such Amicus
Auditor during regular business hours at such place or places where such records
are customarily kept, to verify the accuracy of the reports and payments. The
Amicus Auditor will disclose to Amicus only the amount and accuracy of payments
reported and actually paid or otherwise payable under this Agreement. The Amicus
Auditor will send a copy of the report to GSK at the same time it is sent to
Amicus. ******. Notwithstanding the foregoing, in the event that Amicus
demonstrates sufficient cause, giving due consideration to each of the Parties’
resources, to support the conduct of an additional inspection pursuant to this
Section 3.9 within the same calendar year, the JSC shall discuss in good faith
whether to require such additional inspection to take place; provided that the
JSC may not unreasonably withhold its consent to such an inspection. The Amicus
Auditor shall be obligated to execute a reasonable confidentiality agreement
prior to commencing any such inspection. Amicus will bear all costs and expenses
associated with an audit conducted pursuant to this Section 3.9, provided,
however, that if the designated auditor discovers an underpayment of ****** or
more for any period covered by the inspection between the payments GSK has made
under this Agreement and the payments actually owed to Amicus under this
Agreement, then GSK will bear all costs and expenses associated with such audit
and, for the avoidance of doubt, such underpayment shall be considered a late
payment subject to interest pursuant to the terms of Section 16.12.
 

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3.10 Amicus Records. Amicus will keep, and will require any Affiliates 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 of Development Costs and amounts spent on research and
Development undertaken in accordance with this Agreement in sufficient detail to
allow the Development Costs 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 that pertain to Development Costs. Upon not less than
sixty (60) days’ prior written notice from GSK, Amicus shall permit such GSK
Auditor to inspect those books or records of Amicus that relate to its
Development Costs 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
to this Section 3.10 within the same calendar year, the JSC shall discuss in
good faith whether to require such additional inspection to take place; provided
that the JSC may not unreasonably withhold its consent to such an inspection.
The GSK Auditor shall be obligated to execute a reasonable confidentiality
agreement prior to commencing any such inspection. Inspections conducted under
this Section 3.10 shall be at the expense of GSK, provided, however, that if the
designated auditor establishes an overpayment by GSK in amounts payable
exceeding ****** of the amount of Development Costs paid for a period covered by
the inspection, then Amicus will bear all reasonable costs and expenses
associated with such audit and any amounts overpaid by GSK that are established
shall be paid by Amicus, together with interest on such overpaid amounts at the
rate set forth in Section 16.12. GSK agrees to treat all information learned in
the course of any audit or inspection as Confidential Information of Amicus.
3.11 Taxes.
3.11.1 Amicus warrants that Amicus is a resident for tax purposes of the United
States of America and that Amicus is entitled to relief from United Kingdom
income tax under the terms of the double tax agreement between the United
Kingdom and the United States of America (the “Treaty”). Amicus shall notify GSK
immediately in writing in the event that Amicus ceases to be entitled to such
relief.
 

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3.11.2 GSK shall cooperate with Amicus in obtaining formal certification of
Amicus’ entitlement to relief under the Treaty. Pending receipt of formal
certification from the United Kingdom Inland Revenue, GSK shall pay to Amicus
the full amount of the license fee required to be paid pursuant to Section 3.1
above, without deduction of any withholding tax in accordance with the Treaty.
Amicus agrees to indemnify and hold harmless GSK against any loss, damage,
expense or liability arising in any way from a breach of the above warranties or
any future claim by a United Kingdom tax authority alleging that GSK was not
entitled to deduct withholding tax on such payments at source at the Treaty rate
(other than due to Amicus having filed with the United States tax authority, but
not having obtained formal certification of Amicus’ entitlement to relief under
the Treaty from the United Kingdom Inland Revenue, prior to receiving GSK’s
payment pursuant to Section 3.1 above). The royalty and other payments under
this Agreement shall not be reduced by any taxes required to be withheld by any
taxing authority outside of the United Kingdom.
3.11.3 If GSK assigns this Agreement to an Affiliate and GSK or its Affiliate
becomes liable to withhold any taxes from royalties or other payments under this
Agreement, then GSK or its Affiliate shall pay to Amicus the full amount of any
royalty or other payment required to be paid, unreduced by any withholding tax
and shall pay any amount owed to the relevant tax authority; provided, however,
that to the extent Amicus is able to obtain credit for any taxes withheld
against Amicus’s tax liability and actually realizes a reduction in its tax
liability as a result of the utilization of such credit, Amicus shall refund to
GSK the amount of such net tax savings, as determined in the reasonable
discretion of Amicus.
3.11.4 All sums payable under this Agreement are exclusive of value added tax
and any other sales taxes. The Parties agree that, where appropriate, the
Parties shall provide each other with a valid tax invoice, and against such
invoice, the Parties shall pay the amount of any such tax to the other Party.
Should such amounts of tax be refunded subsequently by the fiscal authorities,
the Party receiving the refund shall immediately notify the other Party and
refund these monies within thirty (30) days of receipt of such funds.
IV. GOVERNANCE
4.1 Joint Steering Committee.
4.1.1 Formation. Within thirty (30) days following the Effective Date, Amicus
and GSK shall establish a joint steering committee (the “Joint Steering
Committee” or “JSC”) to oversee the Development and Commercialization of
Product, and to review and coordinate the Development of the Product in the
Field in the Territory, subject to the terms and conditions of Articles V and VI
herein.
 

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4.1.2 Membership. The Joint Steering Committee will be composed of six (6)
representatives: three (3) representatives nominated by Amicus and three
(3) representatives nominated by GSK. Each such representative on the Joint
Steering Committee shall be a senior executive or other member of senior
management (or their designees who shall have the necessary authority to make
decisions as such senior executives or other members of senior management, as
applicable) of the respective Party or an Affiliate of such Party, and in each
case such representatives shall have significant experience and responsibility
for oversight of the Product and shall be empowered by the Party whom they
represent to make decisions that are binding upon such Party with respect to the
Development, Manufacture and/or Commercialization, as applicable, of the
Compound and Product. Each Party may also have its Alliance Manager attend Joint
Steering Committee meetings as non-voting participants. GSK and Amicus will each
be entitled to replace its representatives on the Joint Steering Committee in
its sole discretion at any time during the Term with representatives of similar
experience and level of responsibility. The Joint Steering Committee shall be
chaired by a GSK representative. With the consent of the other Party (such
consent not to be unreasonably withheld), other employees or consultants of GSK
or Amicus or their respective Affiliates may attend Joint Steering Committee
meetings to present information or participate in discussions on an ad hoc basis
as non-voting participants or observers. The Parties shall cause their
respective members on the Joint Steering Committee to act in good faith in
carrying out their activities on the Joint Steering Committee.
4.1.3 Duties of the Joint Steering Committee. The Joint Steering Committee will:
(a) Review and approve the Development Plan (and the associated budget for
Development Costs included therein) on an annual basis, including any amendments
and updates thereto;
(b) Oversee the implementation of the Development Plan by the Parties and each
Party’s progress towards completion of the activities allocated to such Party
under the Development Plan;
(c) Review and approve changes to the Development Plan;
(d) To review and approve any necessary amendments to the Development Plan to
include Phase IV Clinical Study activities;
(e) Oversee the Commercialization of Products in the Field and in the Territory
during the Term;
(f) Provide a forum for the Parties to exchange information and coordinate their
respective activities as set forth in this Agreement with respect to matters
pertaining to the Development and Marketing Approvals for the Product in the
Territory;
(g) Designate a Trademark for use on each Product;
 

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(h) Review and approve all plans for publications of clinical trial results or
other scientific information; and
(i) Perform such other duties as are specifically assigned to the JSC in this
Agreement or otherwise agreed to in writing by the Parties.
4.1.4 Committee Meetings. The Joint Steering Committee shall meet at least once
per Quarter, or more or less often as otherwise agreed to by the Parties. Joint
Steering Committee meetings may be conducted by telephone, video-conference or
in person as agreed to by the Parties. Unless otherwise agreed by the Parties,
all in-person meetings for the Joint Steering Committee shall be held on an
alternating basis between Amicus’s facilities and GSK’s facilities. Each Party
shall bear its own personnel and travel costs and expenses relating to Joint
Steering Committee, Subcommittee, or Joint Patent Subcommittee meetings, and
such expenses shall not be included in Development Costs.
4.1.5 Decision-Making. Decisions of the Joint Steering Committee shall be made
by unanimous vote, with each Party having (1) vote and with at least one
(1) representative from each Party participating in any vote. Each Party will
use reasonable efforts to achieve consensus on the Joint Steering Committee. In
the event that the Joint Steering Committee fails to reach unanimous agreement
with respect to a particular matter within its authority within thirty (30) days
of the date such matter was first presented to the Joint Steering Committee,
then such matter shall be finally decided by GSK, as follows:
(a) Disputes Related to Product Development and Regulatory Issues. Either Party
may, by written notice to the other Party (an “Escalation Notice”), refer
disputes regarding Development of the Product in the Territory or regulatory
issues relating to the Product in the Territory to the chief executive officer
of Amicus (or his/her designee) and the GSK Head of Rare Diseases Unit (or
his/her designee) (the “Senior Executives”). The Parties’ respective Senior
Executives shall meet promptly, but in any event within thirty (30) days
following the referral of such matter to the Senior Executives, and shall
negotiate in good faith to resolve such matter. If the Senior Executives are
unable to resolve such dispute within ten (10) days following the initial
meeting of such Senior Executives, then the dispute shall be resolved by the GSK
Chairman of Research and Development, such decision by the GSK Chairman of
Research and Development shall become the decision of the JSC with respect to
the dispute specified in the applicable Escalation Notice.
(b) Disputes Related to Manufacturing and Commercialization of Product. GSK, via
the GSK representatives on the Joint Steering Committee, shall have the final
decision making authority for all disputes related to Manufacturing or
Commercialization of Product in the Territory, without the need to further
escalate such dispute. Any such decisions made by GSK shall become the decision
of the JSC.
 

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4.2 Subcommittees. From time to time, the Joint Steering Committee may establish
subcommittees to oversee particular projects or activities within the scope of
authority of the Joint Steering Committee, as it deems necessary or advisable
(each, a “Subcommittee”). Each Subcommittee shall consist of such number of
representatives of each Party as the Joint Steering Committee determines is
appropriate from time to time. Each Subcommittee shall meet with such frequency
as the Joint Steering Committee shall determine. Each Subcommittee shall operate
by unanimous vote in all decisions, with each Party having one (1) vote and with
at least one (1) representative from each Party participating in such vote. If,
with respect to a matter that is subject to a Subcommittee’s decision-making
authority, the Subcommittee cannot reach unanimity, except with respect to the
Joint Patent Subcommittee, the matter shall be immediately referred to the Joint
Steering Committee, which shall resolve such matter in accordance with
Section 4.1.5.
4.2.1 Joint Patent Subcommittee. Promptly after the first Joint Steering
Committee meeting the Parties will form a Joint Patent Subcommittee to oversee
the Patent issues pertaining to the Compound and Products. The Joint Patent
Subcommittee will be composed of one (1) representative (or such other number of
representatives as the Parties may agree) from each of the Parties. The Joint
Patent Subcommittee will serve as the forum to review and discuss and decide, in
the first instance, all matters relating to Patents and Know How included in
Amicus Intellectual Property, Program Improvements and Program Patents, shall
select Patent counsel to file and prosecute Patent applications included in
Amicus Intellectual Property, or constituting Program Patents, and will promptly
report all discussions and decisions to the Joint Steering Committee. The Joint
Patent Subcommittee shall operate by unanimous vote in all decisions, with each
Party having one (1) vote and with at least one (1) representative from each
Party participating in such vote. If the Joint Patent Subcommittee is unable to
agree on any matter considered by the Joint Patent Subcommittee within ten
(10) days after first considering such matter, it shall seek the opinion of
mutually acceptable outside counsel (such opinion to be provided within ten
(10) days of instruction) and, if the Joint Patent Subcommittee is still unable
to agree following receipt of such outside counsel’s opinion, such matter shall
be referred to the Senior Executives for resolution. If, after referral to the
Senior Executives, notwithstanding anything to the contrary in Section 4.1.5,
the matter has not been resolved, the Senior Executive of GSK shall make the
final decision within ten (10) days of being referred such matter (which
decision shall become the decision of the Joint Patent Subcommittee and the
JSC); ******, shall make the final decision with respect to any dispute
pertaining to ****** (which decision shall become the decision of the Joint
Patent Subcommittee and the JSC). At the discretion and upon unanimous consent
of the Joint Patent Subcommittee, any of the ten (10) day time limits in this
Section 4.2.1 may be shortened.
4.3 Alliance Managers. Within thirty (30) days following the Effective Date,
each Party shall appoint a representative (“Alliance Manager”) to facilitate
communications between the Parties and to act as a liaison between the Parties
with respect to such matters as the Parties may mutually agree in order to
maximize the efficiency of the collaboration. Each Alliance Manager shall be
permitted to attend meetings of the JSC as a nonvoting observer, subject to the
confidentiality provisions of Article XI. Each Party may replace its Alliance
Manager with an alternative representative at any time with prior written notice
to the other Party.
 

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4.4 General Communications. Each Party shall keep the other Party informed, by
way of updates to the Joint Steering Committee at its meetings and as otherwise
specified in this Agreement, or as reasonably requested by the other Party, as
to its progress and activities relating to the Development and Commercialization
of the Compound and Products in the Territory, including with respect to
regulatory matters and meetings with Regulatory Authorities,. In connection
therewith, Amicus and GSK shall provide each other through the Joint Steering
Committee with such information regarding such progress and activities under the
Development Plan and/or the Marketing Plan, or otherwise relating to the
Product, as the other Party may request from time to time.
4.5 Scope of Governance. Notwithstanding the creation of the Joint Steering
Committee, or any Subcommittee, each Party shall retain the rights, powers and
discretion granted to it hereunder, and the Joint Steering Committee shall not
be delegated or vested with rights, powers or discretion, unless such delegation
or vesting is expressly provided herein, or the Parties expressly so agree in
writing. Neither the Joint Steering Committee, nor any Subcommittee, will have
the power to amend or modify, or waive compliance with, this Agreement, and no
decision of the Joint Steering Committee, or any Party exercising a deciding
vote as provided in Section 4.1.5 or Section 4.2.1, as applicable, shall be in
contravention of any terms and conditions of this Agreement or shall result in
any obligations (including any obligation to incur or assume any financial or
other commitment, including without limitation allocation of additional FTEs to
the Program) being imposed on Amicus or its Affiliates, without the express
prior written consent of Amicus. It is understood and agreed that issues to be
formally decided by the Joint Steering Committee are only those specific issues
that are expressly provided in this Agreement to be decided by the Joint
Steering Committee.
V. PRODUCT DEVELOPMENT AND REGULATORY ACTIVITIES
5.1 Product Development. Subject to Section 4.1.5, the Joint Steering Committee
will oversee Development of the Compound and Products in the Territory in
accordance with the then-current Development Plan (including the associated
budget).
5.1.1 Development Plans.
(a) Initial Development Plan. An initial Development plan and budget for the
Product in the Field in the Territory is attached to this Agreement as
Schedule 5.1 and sets out separately the Development activities to be conducted
by each Party following the Effective Date and a budget for such activities (the
“Initial Development Plan”). The Initial Development Plan shall be deemed to be
the Development Plan for all purposes until such Initial Development Plan is
amended in accordance with Sections 5.1.1(b) below.
 

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(b) Amendments. Subject to Section 5.1.4(c), the Joint Steering Committee shall
review the Initial Development Plan (or as amended) (the Initial Development
Plan, as amended, the “Development Plan”) on an ongoing basis and no less
frequently than once each calendar year and shall amend the then-current
Development Plan as necessary to include a reasonably detailed written plan of
the JSC’s then-current estimate of the Development activities (and associated
budget) ****** of the period covered by such plan and an outline of Development
activities (and the associated budget for such Development activities) ******.
The JSC shall agree upon any amendments to be made to the Development Plan,
including any changes to the budget or timelines for such Development Plan,
******, provided, that the JSC shall, to the extent possible, ******.
Notwithstanding the foregoing, the JSC shall agree upon any extensions to the
timelines in the Development Plan that result directly from (i) material changes
to any activities pertaining to the goals specified in the Development Plan that
are required or reasonably requested by the FDA or other Regulatory Authority in
a Major Market, such that if not performed is likely, in the reasonable judgment
of the JSC, to jeopardize the receipt of Marketing Approval of the Product in
any such Major Market or (ii) other factors beyond a Party’s reasonable control.
In addition, (i) unless otherwise mutually agreed by the Parties in writing, the
then-current Development Plan will at all times provide for the allocation of
******Amicus FTEs in the performance of Development activities for Products in
the Field in the Territory for ******; and (ii) the number of Amicus FTEs
allocated under the then-current Development Plan to conduct Development
activities for Products in the Field in the Territory in any calendar year
covered by such Development Plan ****** shall not be decreased by the JSC by
more than ****** on less than ****** written notice to Amicus; provided that
upon the occurrence of a major adverse event in the Development activities
pursuant to the Development Plan (e.g. termination of a clinical study as a
result of an adverse event), the JSC may provide such a notice to Amicus within
a shorter period of time, but the JSC shall to provide Amicus as much notice as
is reasonably practical in the circumstances. If the JSC is unable to agree upon
any changes to be made to the Development Plan, including the budget included
therein, then, until such time as a revised Development Plan is approved by the
JSC, or established pursuant to Section 4.1.5(a) above: (x) the then-current
Development Plan shall continue to govern the Parties’ respective Development
activities under this Agreement; and (y) each Party shall be permitted to
conduct and/or commence Development activities allocated to such Party in such
preceding Development Plan and incur Development Costs consistent with such
preceding Development Plan, which Development Costs shall be shared by the
Parties in accordance with Sections 5.1.5 and 5.1.6 below and Schedule 5.1.5.
5.1.2 Conduct of Development Activities. Each Party shall conduct those
activities allocated to such Party under the Development Plan in compliance in
all material respects in accordance with good scientific and clinical practices,
and Laws applicable in the country in which such activities are conducted.
5.1.3 Development Activities of GSK. GSK shall use Commercially Reasonable
Efforts to carry out all clinical Development and other activities required to
obtain Regulatory Approval for at least ****** Product in the Field and in each
Major Market. Such efforts by GSK shall include, but shall not be limited to,
use of Commercially Reasonable Efforts (a) to achieve the specific overall
Development goals as set forth in the Initial Development Plan, (b) to achieve
such Development goals in accordance with the timelines specified in the
Development Plan, and (c) ******.
 

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5.1.4 Development Activities of Amicus. Amicus shall use Commercially Reasonable
Efforts to carry out all clinical Development and other activities allocated to
Amicus under the then-current Development Plan, in accordance with the
then-current Development Plan and as directed by the Joint Steering Committee.
Such efforts by Amicus shall include, but shall not be limited to, use of
Commercially Reasonable Efforts to achieve the goals of the then-current
Development Plan in accordance with the timelines specified therein.
(a) Except as otherwise mutually agreed in writing by the Parties and subject to
Section 5.1.4(b) below, following the Effective Date and with oversight by the
Joint Steering Committee, Amicus shall continue to conduct the existing 011
Phase III Clinical Study and the 012 Phase III Clinical Study, in each case as
set forth in the Development Plan.
(b) GSK may, in its sole discretion and at its sole option, elect to participate
in the conduct of the 011 Phase III Clinical Study and/or the 012 Phase III
Clinical Study, in each case under the direction of the Joint Steering
Committee. In the event that GSK elects to participate in the conduct of the 011
Phase III Clinical Study and/or the 012 Phase III Clinical Study, as applicable,
then GSK shall provide notice of its election to participate in such studies to
the Joint Steering Committee. Thereafter, subject to Section 5.1.1(b) above and
Section 5.1.4.(c) below, the JSC shall re-allocate responsibilities to each
Party in the Development Plan as necessary for the conduct of the 011 Phase III
Clinical Study and/or the 012 Phase III Clinical Study, as applicable.
(c) Without limiting Section 5.1.4(a) above, it is understood that the
Development Plan will at all times provide for Amicus to have an active role in
the Development activities for Products in the Field in the Territory.
5.1.5 Allocation of Funding of Development Plan. Subject to the terms and
conditions of this Agreement (including Sections 5.1.6, 12.1.2, 13.6, 14.2.2 and
14.3 below) and provided that Amicus’ share of the Development Costs incurred
under and in accordance with the Development Plan for each of the calendar years
of the Term of the Agreement shall be subject to the applicable Amicus Annual
Cost Cap and, ultimately, the Amicus Aggregate Development Cost Cap, Amicus and
GSK shall share in the Development Costs to jointly fund the Development of
Product for the Territory pursuant to the Development Plan, as follows and in
accordance with the provisions of Schedule 5.1.5:
(a) Amicus shall fund one hundred percent (100%) of the Development Costs as set
forth in the Initial Development Plan incurred in the conduct of Development
activities under and in accordance with then-current Development Plan from the
Effective Date through and until December 31, 2010 and the GSK 2010 FTE Costs
actually incurred by GSK, but Amicus shall not be obligated to fund more than an
amount equal to the Amicus Annual Cost Cap for calendar year 2010, and GSK shall
fund the remaining Development Costs incurred in the conduct of activities
during such period pursuant to the Development Plan for calendar year 2010. For
the avoidance of doubt, Amicus shall not defer until 2011 any costs incurred by
Amicus in conducting Development in 2010.
 

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(b) From January 1, 2011 through and including December 31, 2011, Amicus shall
fund fifty percent (50%) of the Development Costs incurred under and in
accordance with the then-current Development Plan during such period, but shall
not be obligated to fund more than an amount equal to the applicable Amicus
Annual Cost Cap, and GSK shall fund the remaining Development Costs incurred in
the conduct of activities during such period pursuant to the Development Plan.
(c) Except as provided in Section 5.1.6 below, from January 1, 2012 and for each
calendar year (or part thereof) thereafter until the Amicus Aggregate
Development Cost Cap is reached, Amicus shall fund on an annual basis
twenty-five percent (25%) of the Development Costs incurred under and in
accordance with the then-current Development Plan during such period, but shall
not be obligated to fund more than an amount equal to the Amicus Annual Cost Cap
for the relevant calendar year, and GSK shall fund the remaining Development
Costs incurred in the conduct of Development activities pursuant to the
Development Plan for each such calendar year.
(d) To the extent that, for any calendar year commencing with calendar year
2011, Amicus has been required, pursuant to Section 5.1.5(b) or (c) above, as
applicable, to fund an amount of Development Costs less than the Amicus Annual
Cost Cap for the applicable calendar year due to the actual amount of
Development Costs for such calendar year being less than the amount of
Development Costs budgeted in the then-current Development Plan for such
calendar year, then the difference between the Amicus Annual Cost Cap for such
calendar year and the share of the Development Costs for such calendar year
actually required to be paid by Amicus pursuant to Section 5.1.5(b) or (c)
above, as applicable, shall be carried forward into the next calendar year and
added to the Amicus Annual Cost Cap for that subsequent calendar year and each
subsequent year thereafter until such “carry-forward” amounts are exhausted;
provided, however that in no event shall the aggregate of the Amicus Annual Cost
Caps calculated in accordance with this Section 5.1.5(d) exceed the Amicus
Aggregate Development Cost Cap.
5.1.6 Funding for Excess Development Costs. If, prior to any termination of
Amicus’ co-Development rights and obligations pursuant to Sections 12.1.2, 13.6,
14.2.2 or 14.3, the total Development Costs incurred under and in accordance
with the Development Plan exceed the Total Program Development Costs in the
Initial Development Plan by more than ******, Amicus shall be responsible for
****** of such additional Development Costs that are between ****** and ******
of the Total Program Development Costs in the Initial Development Plan (such
additional Development Costs, the “Overage”) and GSK shall be responsible for
all additional Development Costs. Amicus shall pay its ****** share of the
Overage on a quarterly basis in accordance with the provisions of Schedule 5.1.5
until such amount is paid in full.
5.1.7 Use of Clinical Trial Data. Subject to Section 2.1 and pursuant to the
procedures set out in Section 5.2.3, Amicus shall make available to GSK, and GSK
shall have complete access to, at no charge to GSK, all clinical trial data and
all additional data, in each case, to the extent included in the Amicus
Know-How, resulting from any clinical trials performed by Amicus, its
Affiliates, or licensee with respect to the Compound and Product in the
Territory. GSK shall be free to use all such data and information, as necessary
or as required, to support the Development, Manufacture and Commercialization of
the Compound and Product in the Territory in accordance with the terms and
conditions of this Agreement.
 

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5.2 Regulatory Matters.
5.2.1 Assignment of, and Responsibility for, Regulatory Filings. Promptly
following the Effective Date, Amicus and GSK will establish a plan and timeline
to transfer and assign ownership of all existing Marketing Approvals and other
filings (if applicable) with Regulatory Authorities for the Compound and Product
in the Territory to GSK, except as solely necessary for Amicus to conduct the
011 Phase III Clinical Study and/or 012 Phase III Clinical Study, as applicable.
GSK thereafter shall own and shall have the sole responsibility, as overseen by
the Joint Steering Committee during the Development of Product, to hold and
maintain all Marketing Approvals and other filings with Regulatory Authorities
for the Products in the Territory and, during the Term, GSK shall use
Commercially Reasonable Efforts to hold and maintain all such Marketing
Approvals and filings with Regulatory Authorities. Further, GSK will be solely
responsible for filing and obtaining INDs, MAAs and/or Marketing Approvals
(including pricing or reimbursement approvals) from the applicable Regulatory
Authorities in connection with the Development, Manufacture, use, and
Commercialization of the Compound and Products in the Territory as overseen by
the Joint Steering Committee and GSK will use Commercially Reasonable Efforts to
obtain any such necessary approvals. GSK shall also be responsible for obtaining
any export approvals required by a relevant Regulatory Authority to import or
export the Product to any country within the Territory. All such activities
shall be done in consultation with the Joint Steering Committee, and GSK shall
reasonably consider in good faith the comments of Amicus with respect to such
activities. All such regulatory filings will be in the name of GSK or its
Affiliate, except where otherwise required by applicable Law in any country
within the Territory.
5.2.2 Regulatory Cooperation. GSK shall lead the liaison with, and will manage,
all interactions with Regulatory Authorities in the Territory in relation to the
Product during the Term of the Agreement. Subject to Section 4.1.5, GSK agrees
to consult with Amicus with respect to substantive interactions with Regulatory
Authorities in each of the Major Markets, provided, however, that such agreement
to consult with Amicus shall not be construed or interpreted to prevent or delay
GSK from making any decisions with respect to regulatory matters in a timely
manner (e.g. during a meeting with a Regulatory Authority). In any event, GSK
shall keep Amicus and the Joint Steering Committee informed with respect to all
interactions with Regulatory Authorities in the Territory and will reasonably
consider in good faith the comments of Amicus with respect to such activities.
Amicus will also provide reasonable cooperation and assistance to GSK, as
reasonably requested by GSK, in the event that GSK must respond to questions
from Regulatory Authorities in the Territory concerning Development activities
conducted by or on behalf of Amicus with the Compound and Product. If requested
by GSK, Amicus will attend all relevant meetings with Regulatory Agencies in an
observational and advisory role. Each Party will promptly provide the other
Party and the JSC with copies of, or electronic access to, all material
documents and correspondence received from, or submitted to, a Regulatory
Authority in each Major Market related to the Compound or a Product, including
any notices of, or requests for, any substantive meetings with a Regulatory
Authority in a Major Market relating to the Compound or a Product.
 

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5.2.3 Exchange of Data and Know-How.
(a) By Amicus. Promptly following the Effective Date, Amicus will make available
to GSK, at no cost or expense to GSK, all Amicus Know-How that is necessary or
materially useful for GSK to Develop, Manufacture, and Commercialize the
Compound and Products in the Territory, including all patent prosecution files
for all GSK Prosecuted Amicus Patents, data from any and all clinical trials and
preclinical studies and non-clinical development work for the Compound and
Products included in the Amicus Know-How that have been obtained by Amicus, its
Affiliates or licensees prior to the Effective Date. During the Term, Amicus
shall provide to GSK promptly upon the request of GSK and at no cost or expense
to GSK, all Amicus Know-How that has not previously been provided to GSK. Amicus
shall provide all Amicus Know-How in electronic form to the extent the same
exists in electronic form, and shall provide copies as reasonably requested and
an opportunity for GSK or its designee to inspect (and copy) all other materials
comprising such Know-How (including for example, original patient report forms
and other original source data). The Parties will cooperate and reasonably agree
upon formats and procedures to facilitate the orderly and efficient exchange of
the Amicus Know-How during the Term.
(b) Provision of Data to the JSC. Upon request by the JSC, each Party shall
promptly provide to the JSC summaries in reasonable detail of all data generated
or obtained in the course of such Party’s performance of activities under the
Development Plan.
5.2.4 Sharing of Regulatory Filings. Without limiting Section 5.2.3 above, each
Party shall, upon reasonable request of the other Party, permit the other Party
to access, and shall provide the other Party with sufficient rights to reference
and use in association with exercising its rights and performing its obligations
under this Agreement, all of such Party’s, and its Affiliates’ and, to the
extent it has the right to do so, its licensees’ and Sublicensees’ data,
regulatory filings and regulatory communications associated with any submissions
of MAAs or other approvals for Product in the Territory.
5.2.5 Clinical Trial Register. Notwithstanding anything in this Agreement to the
contrary, GSK shall have the right to publish in its clinical trial register the
results or summaries of the results of all clinical trials for the Compound and
Product conducted by either Party, their Affiliates, licensees’ and
Sublicensees’ (subject to Sections 5.2.4 and 11.5) in the Territory pursuant to
this Agreement.
5.2.6 Adverse Event Reporting.
(a) Pharmacovigilance Agreement. The Parties shall enter into a
pharmacovigilance agreement on terms no less stringent than those required by
ICH guidelines, including: (i) providing detailed procedures regarding the
maintenance of core safety information and the exchange of safety data relating
to the Compound and Products in the Territory within appropriate timeframes and
in an appropriate format to enable each Party to meet both expedited and
periodic regulatory reporting requirements; and (ii) ensuring compliance with
the reporting requirements of all applicable Regulatory Authorities on a
worldwide basis for the reporting of safety data in accordance with standards
stipulated in the ICH guidelines, and all applicable regulatory and legal
requirements regarding the management of safety data.
 

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(b) Adverse Event Reporting. As between the Parties: GSK shall be responsible
for the timely reporting of all Product quality complaints, adverse drug
reactions/experiences/events, Product complaints and safety data relating to the
Compound and Product to appropriate Regulatory Authorities in accordance with
the applicable Laws of the relevant countries and Regulatory Authorities in the
Territory. GSK shall respond in a timely manner to safety issues related to the
Product in the Territory, as required pursuant to applicable Law. GSK shall
ensure that its Affiliates and Sublicensees comply with such reporting
obligations in the Territory.
(c) Global Safety Database. As between the Parties: GSK shall maintain a unified
worldwide global safety database with respect to the Product in the Territory.
5.2.7 Termination of Ongoing Development and Committee Obligations. The Parties’
obligations under Sections 5.1 and 5.2 (and the Development Plans), and to share
Development Costs under Section 5.1.5 and 5.1.6 above, and Amicus’ supply and
Manufacturing obligations under Section 6.5 below, shall terminate ****** after
the Effective Date (to the extent such obligations have not already terminated
or expired). At such time, the Joint Steering Committee and all Subcommittees
will terminate. However, each Party will continue to have an approval right with
respect to matters specified to be decided by the Joint Steering Committee or
any Subcommittee under this Agreement. In such event, if the Parties are unable
to reach agreement on a matter specified in this Agreement to have been decided
by the Joint Steering Committee or such Subcommittee (other than the Joint
Patent Subcommittee), then the matter shall be determined in accordance with
Section 4.1.5(a). Further, in such event, if the Parties are unable to reach
agreement on a matter specified in this Agreement to have been decided by the
Joint Patent Subcommittee, then the Parties shall seek the opinion of mutually
acceptable outside counsel (such opinion to be provided within ten (10) days of
instruction) and, if the Parties are unable to agree following receipt of such
outside counsel’s opinion, then such matter shall be referred to the Senior
Executives for resolution. If, after referral to the Senior Executives,
notwithstanding anything to the contrary in Section 4.1.5, such matter has not
been resolved, the Senior Executive of GSK shall make the final decision within
ten (10) days of being referred such matter; except that the Senior Executive of
Amicus, not GSK, shall make the final decision with respect to any dispute
pertaining to an Amicus Prosecuted Patent.
 

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VI. COMMERCIALIZATION AND PROMOTION; TRANSFER OF
MANUFACTURING RESPONSIBILITIES AND INTERIM SUPPLY
6.1 Marketing Plan. Prior to the anticipated Launch of the first Product in the
United States or a Major EU Country, GSK shall prepare the Marketing Plan, which
shall include without limitation the Marketing Strategy, and shall provide such
Marketing Plan to the Joint Steering Committee. GSK, not less frequently than
******, will provide to the JSC summary updates to the Marketing Plan and
summary updates of Commercialization activities undertaken by GSK and its
Affiliates and Sublicensees pursuant to the Marketing Plan ******. In addition,
GSK will update the JSC on a rolling basis during the JSC’s quarterly meetings
with respect to activities conducted pursuant to the then-current Marketing Plan
******. Except for any Commercialization activities allocated to Amicus pursuant
to Section 6.1.2 below, GSK shall carry out all marketing, promotion and other
Commercialization activities of the Products in the Territory in accordance with
the then-current Marketing Plan
6.1.1 GSK’s Responsibility. GSK shall have, in GSK’s sole discretion and at its
sole expense, and using Commercially Reasonable Efforts, the exclusive right to
Manufacture (subject to Section 6.5 below), Commercialize, distribute, market,
provide sales force support for and to promote Product in the Field in the
Territory, including, without limitation, the exclusive right and responsibility
for the following in the Territory:
(a) negotiating with relevant governmental authorities and agencies and MCOs to
establish pricing and reimbursement for Products in the Territory;
(b) managed care contracting for Products in the Territory, provided that GSK
shall not engage in any Discriminatory Conduct with respect to managed care
(including, Medicare) contracting or otherwise relating to the Products. For the
purposes of this Section 6.1.1(b), “Discriminatory Conduct” shall be deemed to
occur if GSK or its Affiliate discounts the price of or positions Product in its
managed care contracting or otherwise to benefit or increase the sales of other
products of GSK or its Affiliate;
(c) receiving, accepting and filling orders for Products from customers in the
Territory;
(d) distributing Products to customers in the Territory;
(e) controlling invoicing, order processing and collecting accounts receivable
for sales of Products in the Territory;
(f) recording sales of Products in the Territory in its books of account for
sales;
(g) conducting disease awareness and education programs in the Territory; and
(h) any and all other Commercialization activities, in GSK’s discretion, related
to Compound or Product in the Territory.
 

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GSK shall use Commercially Reasonable Efforts to Commercialize the Product in
each of the Major Markets.
6.1.2 Amicus’ Responsibilities. Notwithstanding the foregoing, Amicus shall
have, and the Marketing Plan shall provide Amicus with the following, subject to
a determination by the JSC that Amicus shall have such a role, which
determination shall be made on reasonable (and in no event less than three
(3) months) written notice to Amicus:
(a) an active role in connection with:
(i) medical affairs activities with respect to Products in the United States;
(ii) medical liaison activities with respect to Products with key opinion
leaders in the United States;
(iii) disease awareness and education and patient advocacy programs with respect
to Products in the United States and such other countries within the Territory
as the Parties shall mutually agree; and
(b) an advisory role in connection with strategic marketing activities and
creation and maintenance of the Marketing Strategy for Products in the United
States and such other countries within the Territory as the Parties shall
mutually agree;
provided, however, that any activities conducted by Amicus in connection
therewith would be conducted by Amicus in accordance with the then-current
Marketing Plan using Commercially Reasonable Efforts and with GSK oversight and
in full compliance with and adherence to all applicable GSK policies (to the
extent the same and any updates thereto are disclosed to Amicus in writing) and
all applicable Laws.
6.2 Promotional Materials. The determination of the content, quantity, and
method of distribution of any promotional materials for the Compound or Product
for the Territory shall be the sole responsibility of GSK. Subject to
Section 6.3, GSK shall own all right, title and interest in and to all such
promotional materials created during the Term of the Agreement, including any
intellectual property rights therein or attendant thereto, excluding any Amicus
Trademark(s) and the Amicus House Marks.
 

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6.3 Use of Trademarks and House Marks. The Joint Steering Committee will
determine which Trademark or Trademarks will be used in marketing Product in the
Territory. Further, all packaging, and package inserts for Product in the
Territory shall, along with the GSK brand name and logo or other identifying
markings of GSK or its Affiliates (collectively, the “GSK House Marks”), include
the Amicus brand name and logo (such Amicus brand name and logo, collectively
“Amicus House Marks”) in reasonable size and prominence as allowed by applicable
Law; it being understood that the exact size, placement and prominence of such
Amicus House Marks shall be determined by GSK in its reasonable discretion.
Amicus hereby grants to GSK a non-exclusive, royalty-free license, with the
right to grant sublicenses as provided in Section 2.2, to use the Amicus House
Marks in connection with the developing, making, having made, use, sale,
offering for sale, importation, packaging, distributing and promotion of the
Products in the Field in the Territory. The ownership and all goodwill from the
use of the Amicus House Marks shall vest in and inure to the benefit of Amicus.
Solely to the extent necessary to preserve Amicus’s legal rights in the Amicus
House Marks, GSK shall submit to Amicus, not less than fifteen (15) days prior
to their proposed distribution, representative packaging for the Product
displaying the Amicus House Marks for Amicus’s review and written approval
solely with respect to GSK’s use of the Amicus House Marks, which approval will
not be unreasonably withheld or delayed. If Amicus has not responded within
thirty (30) days after the submission of such packaging for the Product,
Amicus’s approval to GSK’s use of the Amicus House Marks on such packaging will
be deemed to have been received. GSK may make any subsequent changes to
packaging bearing the Amicus House Marks, other than changes to the Amicus House
Marks, without the subsequent approval from Amicus.
6.4 Product Recalls. At the direction of the Joint Steering Committee and
subject to Article XV, GSK will have the responsibility for any total or partial
recall or market withdrawal of a Product in the Territory (whether voluntary or
not). Amicus will cooperate with and assist GSK in effecting such recall or
market withdrawal, including making available to GSK, upon request, all of
Amicus’s pertinent records. All costs associated with any total or partial
recall or market withdrawal of the Product in the Territory shall be borne by
GSK; provided that to the extent that such total or partial recall or market
withdrawal is as a result of Amicus’s (or Amicus’s Third Party manufacturer’s)
gross negligence or failure to comply with the terms of this Agreement, all such
costs shall be borne by Amicus.
6.5 Manufacturing Responsibilities. From the Effective Date, subject to Sections
6.5.1 and 6.5.2 below, GSK (itself or through an Affiliate) shall have the
exclusive right to Manufacture Compound and Product for distribution in the
Territory, including, without limitation, all batches of drug substance and drug
product (including any such batches of drug substance or drug product planned
for use to support registration and validation of Product), and will have the
right, in accordance with the terms of this Agreement, to appoint one or more
Third Parties to Manufacture Compound and Product for such purposes. For the
avoidance of doubt, GSK shall have the ultimate decision making authority over
the use of Third Parties in its manufacturing supply chain.
 

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6.5.1 Transition of Manufacturing and Supply Responsibilities. Promptly
following the Effective Date, Amicus and GSK shall develop and reasonably agree
upon a detailed plan (“Supply Transition Plan”) to transfer to GSK
responsibility for Manufacturing of the Compound and Products for use in the
Field in the Territory, such transfer of responsibility to occur no later than
****** (“Supply Transition Date”). Amicus shall cooperate in good faith with GSK
to effect the transfer of such Manufacturing responsibilities to GSK in an
orderly manner in accordance with the Supply Transition Plan. Without limiting
the foregoing, Amicus shall deliver to GSK in accordance with the Supply
Transition Plan, all information Controlled by Amicus (including such
information generated by Amicus’s Third Party manufacturer(s)) as is reasonably
necessary or useful for GSK or its Affiliates or its Third Party manufacturer,
to commence Manufacturing Compound or Product following the Supply Transition
Date. In connection therewith, any such Supply Transition Plan shall incorporate
the technology transfer requirements set forth in Schedule 6.5.1 attached
hereto, to the extent applicable.
6.5.2 Activities Prior to the Supply Transition Date. During the period on and
from the Effective Date until the Supply Transition Date, as between the
Parties, subject to Section 6.5.2(b):
(a) Amicus shall supply, or will direct its Third Party manufacturers to supply,
the requirements of Product and Compound necessary to conduct and complete the
clinical studies and other Development activities under the Development Plan,
and the costs of such quantities of Compound and Product shall be included in
the Development Costs to be shared by the Parties pursuant to Sections 5.1.5 and
5.1.6 and Schedule 5.1.5.
(b) Amicus shall maintain its arrangements with any Third Party manufacturers of
the Compound and/or Products in effect as of the Effective Date and shall, under
the direction of GSK, direct the management of its Third Party manufacturers in
existence as of the Effective Date. Notwithstanding the foregoing, in the event
that the JSC determines that the Parties should re-negotiate a current agreement
or arrangement for the supply of the Compound and Products, or negotiate an
agreement for the supply of the Compound and Products with a new Third Party
supplier, including but not limited to any agreement regarding the Manufacture
of validation batches of Compound or Product, then GSK shall have the right to
approve such Third Party supplier, to lead the negotiation of any such agreement
in such manner as the Parties may reasonably agree, and to enter into an
agreement with such Third Party regarding the supply of the Compound and
Products; and upon execution of any such agreement between GSK and a Third Party
supplier, Amicus shall be relieved of all of its obligations with respect to all
of the activities for the Compound and Product performed by such Third Party
supplier, and GSK shall have no further rights, under this Section 6.5.2. As
between the Parties, Amicus shall be responsible for making any payments due to
any of its Third Party manufacturers with respect to the Compound and/or
Products prior to the Supply Transition Date, it being understood that such
amounts shall be included in the Development Costs to be shared by the Parties
pursuant to Sections 5.1.5 and 5.1.6 and Schedule 5.1.5.
 

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(c) GSK shall have, and Amicus shall procure for GSK, the right for GSK to audit
and inspect each Amicus Third Party manufacturer’s records and those portions of
each facility used in the Manufacture of the active pharmaceutical ingredient,
drug substance and drug product related to the Compound or Product, in each case
on reasonable notice (and in any event not less than two (2) business days) and
during normal business hours for the purpose of ensuring compliance with this
Section 6.5.2. Amicus acknowledges that GSK Global Quality Policies and
Guidelines (a copy of which has been provided to Amicus prior to the Effective
Date) represent GSK’s interpretation of cGMPs and that GSK will use the GSK
Global Quality Policies and Guidelines to assess whether each Third Party
manufacturer has performed its obligations with respect to the active
pharmaceutical ingredient, drug substance and drug product related to the
Compound or Product in a manner that is consistent with cGMPs. Purposes for such
inspections may include cGMPs compliance, system audits, compiling information
for reporting obligations, compliance with specifications, compliance with
quality agreement, financial audits to verify amounts invoiced to GSK, and/or
investigations of complaints and/or compliance with any Laws, the Environmental,
Health and Safety Guidelines, or the terms of this Agreement (including all
representations and warranties of Amicus hereunder).
6.5.3 Activities After the Supply Transition Date. On and from the Supply
Transition Date, as between the Parties:
(a) GSK (itself or through an Affiliate or a Third Party manufacturer) shall
have the exclusive right to Manufacture Compound and Product for distribution in
the Territory; except that, if this Agreement is terminated by Amicus pursuant
to Section 13.2 or by GSK pursuant to Section 13.3 with respect to a particular
Product(s) and/or in a particular country(ies) of the Territory, Amicus shall
have the non-exclusive right to Manufacture Compound and/or Terminated Products
at locations within the Territory solely for use in the Development of any
Terminated Products and/or for sale and/or use in the Affected Area.
(b) At the written request of GSK, Amicus will assign or facilitate the transfer
to GSK of any agreements between Amicus and its Third Party manufacturers of the
Compound and/or Products existing as of the Effective Date, including any and
all such supply and quality agreements with such Third Party manufacturers, to
the fullest extent possible, provided that such assignment or transfer is
permitted under the supply agreement and/or is accepted by GSK and the Third
Party.
(c) GSK agrees to make available, and supply to Amicus, Amicus’s and its
Affiliates requirements of the Compound and the Products necessary or reasonably
useful for Amicus to conduct and complete the Development activities allocated
to Amicus and/or its Affiliates under and in accordance with the then-current
Development Plan; and the costs of such quantities of Compound and Product shall
be included in the Development Costs to be shared by the Parties pursuant to
Sections 5.1.5 and 5.1.6 and Schedule 5.1.5.
6.5.4 Supply of Compound and Product. Any quantities of Compound and Product to
be supplied by one Party to the other Party pursuant to this Section 6.5 will
meet applicable Compound or Product specifications. The specifications for the
Compound and Products as of the Effective Date attached hereto as Schedule 6.5.4
and shall be amended only upon agreement by the JSC. In addition, all quantities
of Compound and Product supplied by one Party to the other Party pursuant to
this Section 6.5 will not be misbranded or adulterated. All such Compound and/or
Product will be manufactured in accordance with cGMPs; provided, however, that a
Party may supply Compound not manufactured in accordance with cGMP if
specifically intended for non-human testing activities allocated to the other
Party under the Development Plan and as agreed to in writing in advance by such
other Party.
 

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VII. OWNERSHIP AND INTELLECTUAL PROPERTY
7.1 Ownership. Subject to GSK’s license rights under the License and any license
under the Amicus Trademarks and/or Amicus House Marks granted to GSK pursuant to
Sections 2.1, 2.4, or 6.3, as applicable, as between the Parties, Amicus will
own or Control the Amicus Intellectual Property, Amicus Confidential
Information, Amicus Know-How, Amicus Trademarks and Amicus House Mark owned or
Controlled by Amicus in the Territory as of the Effective Date. Subject to any
license or other rights granted to Amicus pursuant to the terms of Section 2.3,
2.4, or Section 14.3 below, GSK will own the GSK Confidential Information, GSK
Background IP, GSK Trademarks, and GSK House Marks owned or Controlled by GSK as
of the Effective Date. GSK shall own any Trademarks that are created or
designated by the JSC for use on the Product in the Territory after the
Effective Date, subject to Section 14.3.9.
7.2 Patent Applications on Licensed Technology.
7.2.1 GSK Control of Prosecution. Subject to any restrictions Amicus may have
under any Third Party agreement covering the Amicus Patents included in the
Licensed Technology (including the Background License Agreements) and except for
those Amicus Prosecuted Patents described below, GSK will assume control of,
******, prosecuting and maintaining such Patents included in the Amicus Patents
as of the Effective Date, or which may be filed in any country of the Territory
after the Effective Date, to the extent the same are directed to the Compound or
a Product, and/or Manufacturing and/or use thereof, in the Field in the
Territory (such Patents, excluding the Amicus Prosecuted Patents, are referred
to below as the “GSK Prosecuted Amicus Patents”). A list of the GSK Prosecuted
Amicus Patents, as of the Effective Date, is set forth on Schedule 7.2.1,
hereto. Amicus shall have the right, ******, to reasonably assist GSK in
connection with the filing, prosecution and maintenance of any GSK Prosecuted
Amicus Patents in the Territory. GSK shall use diligent efforts consistent with
those normally employed by GSK in the course of business to prosecute and
maintain the GSK Prosecuted Amicus Patents described in this Section 7.2.1 and
GSK will, in a timely manner, solicit Amicus’ comments regarding the prosecution
and maintenance of such GSK Prosecuted Amicus Patents and review of the nature
and text of any such Patent application and prosecution matters related thereto,
including any correspondence between GSK and any government intellectual
property or Patent authorities, agencies or other government bodies, in
reasonably sufficient time prior to filing thereof, and GSK shall give due
consideration to Amicus’ reasonable amendments to such correspondence. Without
prejudice to Section 7.2.4, in the event that GSK intends to disregard any of
Amicus’ amendments, GSK shall set up a meeting between Amicus’s and GSK’s
respective patent counsels to provide explanations therefor.
 

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7.2.2 Amicus Prosecuted Patents. Amicus will control, ******, prosecuting and
maintaining the Amicus Patents identified on Schedule 7.2.2 (together with
future Patents claiming priority thereto, the “Amicus Prosecuted Patents”). GSK
shall have the right, ******, to reasonably assist Amicus in connection with the
filing, prosecution and maintenance of any such Amicus Prosecuted Patents in the
Territory. Amicus shall use diligent efforts consistent with those normally
employed by Amicus in the course of business to prosecute and maintain the
Amicus Prosecuted Patents and Amicus will, in a timely manner, solicit GSK’s
comments regarding the prosecution and maintenance of such Amicus Prosecuted
Patents and review of the nature and text of any such Patent application and
prosecution matters related thereto, including any correspondence between Amicus
and any government intellectual property or Patent authorities, agencies or
other government bodies, in reasonably sufficient time prior to filing thereof,
and Amicus will give due consideration to GSK’s reasonable comments and
amendments. Without prejudice to Section 7.2.4, ******.
7.2.3 Segregation of Patent Applications. In the event that any Amicus Patent
contains claims to the Compound and/or Products (i.e. is a GSK Prosecuted Amicus
Patent) as well as the Amicus Proprietary Chaperone Technology more broadly or
any other compound or product owned or controlled by Amicus, the Parties shall
cooperate in good faith to segregate such Patents to allow Amicus to control the
prosecution and maintenance of Patent applications and Patents pertaining to
subject matter other than the Compound and/or Products. A list of such
Segregated Patents as of the Effective Date is set forth on Schedule 7.2.3
hereto.
7.2.4 Additional Matters. Any disagreements under this Section 7.2 shall be
referred to the Joint Patent Subcommittee for resolution as provided in
Section 4.2.1. For purposes of this Article 7, “prosecution and maintenance”
(including variations such as “prosecute and maintain”) means, with respect to a
Patent, the preparing, filing, maintenance and prosecution of such Patent, as
well as the conduct of interferences, oppositions, re-examination, re-issues and
other similar proceedings.
7.3 Program Improvements
7.3.1 To the extent that a Program Improvement is developed by or on behalf of
one Party, that Party will promptly disclose such Program Improvement to the
Joint Patent Subcommittee in writing with all relevant data supporting such
Program Improvement.
7.3.2 Each Party will, subject to the terms of Section 7.4, be sole owner of
Program Improvements invented solely by its employees and agents and the
employees and agents of its respective Affiliates and will do and procure all
necessary acts, and obtain all necessary assignments or other instruments as may
be required to confer such sole ownership on said Party. With respect to such
solely-invented Program Improvements, the Party owning such Program Improvement
will own any applications for Patent with respect thereto and any Patents issued
on such applications, unless such rights are assigned to the other Party
pursuant to Section 7.4.
7.3.3 The Parties will be the joint owners of Program Improvements invented
jointly by the employees and agents of the Parties or the employees and agents
of their respective Affiliates and any Program Patents covering such jointly
invented Program Improvements (each a “Joint Program Patent”). Each Party will
do and procure all necessary acts, and obtain all necessary assignments or other
instruments as may be required to confer such joint ownership on the Parties.
 

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7.3.4 Inventorship under this Agreement shall be determined in accordance with
the patent laws of the United States.
7.4 Abandonment of Patents and Applications. In the event that GSK decides not
to file, continue to prosecute or maintain a GSK Prosecuted Amicus Patent that
falls under Section 7.2, or either Party decides not to file, maintain a Patent
or to abandon a Patent application or issued Patent that falls under Section 7.3
(in either case, the “Abandoning Party”), such Abandoning Party will give
written notice to the other Party at least sixty (60) days prior to any public
disclosure, allowing such application to go abandoned, or prior to not taking a
necessary step to maintain such Patent, and the other Party will have the option
of taking over the prosecution or maintenance of such application or Patent at
its sole expense. If the other Party elects to take over the filing, prosecution
or maintenance of such application or Patent pursuant to this Section 7.4, the
Abandoning Party or Party giving permission will assign all its right, title and
interest in such application or Patent to the other Party, subject to the
Abandoning Party or Party giving permission retaining a non-exclusive,
perpetual, irrevocable, sublicensable, fully-paid-up license from the other
Party to such Patent or Patent application. The Party taking over prosecution,
or maintenance will, in a timely manner, solicit the Abandoning Party’s comments
in prosecution matters related to such applications, including any
correspondence between the Abandoning Party and any government intellectual
property or Patent authorities, agencies or other government bodies, in
reasonably sufficient time prior to filing thereof, and shall give due
consideration to the Abandoning Party’s comments. Any disagreements hereunder
shall be referred to the Joint Patent Subcommittee for resolution as provided in
Section 4.2.1.
7.5 Cooperation. Each Party will cooperate, and will require its employees,
Affiliates, consultants and subcontractors to cooperate, with all reasonable
requests of the other Party for assistance in preparation and prosecution and
maintenance of any applications for Patent and any Patent issuing therefrom and
any applications for Trademark and any registration issuing therefrom that is
owned by the requesting Party hereunder. GSK shall be solely responsible for any
and all costs associated with the GSK Trademarks and GSK House Marks, including
any Trademarks owned by GSK pursuant to Section 7.1 herein. Amicus shall be
solely responsible for any and all costs associated with the Amicus Trademarks
and Amicus House Marks.
 

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7.6 Patent Filing Procedures for Patents relating to Program Improvements.
7.6.1 Program Improvement relating to Compound or Product.
(a) If a Program Improvement relates to Compound or Product, then GSK will
determine whether or not to file a Patent application in the Territory on such
Program Improvement. If GSK elects to file such an application, ******
prosecuting and maintaining any Patents that issue thereon and will control the
prosecution of such application; however, Amicus shall have the right, ******,
to reasonably assist GSK in connection with the filing, prosecution and
maintenance of any Patent applications filed under this Section 7.6.1(a). GSK
shall use diligent efforts consistent with those normally employed by GSK in the
course of business to prosecute and maintain any such Patent application or
Patent described in this Section 7.6.1(a) and GSK will, in a timely manner,
solicit Amicus’ comments and review of the nature and text of any such
application and prosecution and maintenance matters related thereto, including
any correspondence between GSK and any government intellectual property or
Patent authorities, agencies, or other government bodies, in reasonably
sufficient time prior to filing thereof, and GSK shall give due consideration to
Amicus’ reasonable amendments to such correspondence. ******. Any remaining
disagreements hereunder, including filing, prosecution and maintenance decisions
or strategies and/or any disputes by Amicus regarding GSK’s determination to
disregard any of Amicus’ proposed amendments provided with respect to an
application for Patent or Patent described in this Section 7.6.1(a), shall be
referred to the Joint Patent Subcommittee for resolution as provided in Section
4.2.1; and
(b) If GSK elects not to file an application for Patent in any country in the
Territory covering any such Program Improvement, GSK shall give Amicus notice
thereof at least sixty (60) days prior to causing in any way such Program
Improvement to become unpatentable through disclosure, sale, or otherwise, and
Amicus shall thereafter have the right, at its sole expense, to prosecute and
maintain such Patent application in any such country. Any disagreements
hereunder shall be referred to the Joint Patent Subcommittee for resolution as
provided in Section 4.2.1.
7.6.2 Program Improvement not relating to Compound or Product.
(a) If a Program Improvement does not relate to Compound or Product, then Amicus
will determine whether or not to file a Patent application in the Territory on
such Program Improvement. If Amicus elects to file such an application, ******
prosecuting and maintaining any Patents that issue thereon and will control the
prosecution of such application; however, GSK shall have the right, ******, to
reasonably assist Amicus in connection with the filing, prosecution and
maintenance of any Patent applications filed under this Section 7.6.2(a). Amicus
shall use diligent efforts consistent with those normally employed by Amicus in
the course of business to prosecute and maintain any such Patent application or
Patent described in this Section 7.6.2(a) and Amicus will, in a timely manner,
solicit GSK’s comments and review of the nature and text of any such application
and prosecution and maintenance matters related thereto, including any
correspondence between Amicus and any government intellectual property or Patent
authorities, agencies, or other government bodies, in reasonably sufficient time
prior to filing thereof, and Amicus shall give due consideration to GSK’s
reasonable amendments to such correspondence. ******. Any remaining
disagreements hereunder, including filing, prosecution and maintenance decisions
or strategies, shall be referred to the Joint Patent Subcommittee for resolution
as provided in Section 4.2.1; and
 

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(b) If Amicus elects not to file an application for Patent in any country in the
Territory covering any such Program Improvement, Amicus shall give GSK notice
thereof at least sixty (60) days prior to causing in any way such Program
Improvement to become unpatentable through disclosure, sale, or otherwise, and
GSK shall thereafter have the right, at its sole expense, to prosecute and
maintain such Patent application in any such country. Any disagreements
hereunder shall be referred to the Joint Patent Subcommittee for resolution as
provided in Section 4.2.1.
7.7 Orange Book Listing; Patent Term Restoration and Supplemental Protection
Certificates.
7.7.1 GSK’s Obligations. GSK will be responsible for listing with the applicable
Regulatory Authorities in the Territory during the Term of the Agreement, all
applicable Patents included within the Licensed Technology in the U.S. FDA’s
Orange Book (or equivalent). Prior to such listings, the Parties will meet,
through the Joint Patent Subcommittee, to evaluate and identify all applicable
Patent rights, and subject to any restrictions Amicus may have under third party
agreements covering the Amicus Patents included in the Licensed Technology
(including the Background License Agreements), GSK will have the right to
review, where reasonable, original records relating to any invention for which
Patent rights are being considered for any such listing. Notwithstanding the
foregoing, GSK will determine, in its sole discretion, which Patents in the
Territory included within the Licensed Technology shall be listed in the Orange
Book (or equivalent) for a Product, regardless of which Party owns such Patent.
In addition, subject to any restrictions Amicus may have under third party
agreements covering the Amicus Patents included in the Licensed Technology
(including the Background License Agreements), GSK shall determine, in its sole
discretion, to which Patents included within the Licensed Technology (excluding
Patents relating solely to the Amicus Proprietary Chaperone Technology) GSK
would apply the U.S. Hatch-Waxman extension and Supplementary Protection
Certificate Extensions and other Patent Term Extensions for countries in the
Territory. The Parties will cooperate with each other in gaining Patent term
extension where applicable to Products. Upon GSK’s reasonable request, Amicus
shall timely provide any documentation or other assistance required in order to
obtain such Patent term extensions, subject to any restrictions Amicus may have
under third party agreements covering the applicable Amicus Patent (including
the Background License Agreements).
7.8 Trademark Filing Procedures. The Joint Steering Committee may also
designate, pursuant to Sections 2.4, 4.1.3 and 6.3, a Trademark for use on a
Product in the Territory after the Effective Date. In the event that the Joint
Steering Committee so designates a Trademark for use on a Product after the
Effective Date and determines that an application for Trademark registration
shall be made with respect to such designated Trademark (including determining
in which countries within the Territory such Trademark applications shall be
filed and maintained), GSK will undertake to thereafter file and maintain such
Trademark application for registration and Trademark registration, as
applicable. GSK shall be solely responsible for filing and maintaining, at its
sole expense, any GSK Trademarks, GSK House Marks and any GSK domain names owned
by GSK prior to the Effective Date and used on or in connection with Product.
Amicus shall be solely responsible for filing and maintaining, at its sole
expense, any Amicus Trademarks, Amicus House Marks and any Amicus domain names
owned by Amicus prior to the Effective Date and used on or in connection with
Product. In addition, each Party shall be responsible, at such Party’s expense,
for conducting Trademark searches, filing Trademark applications, and
maintaining any Trademark registrations for any Trademarks that are considered
by such Party to be a back-up Trademark for such Party’s Trademarks or House
Marks.
 

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VIII. ENFORCEMENT AND DEFENSE OF INTELLECTUAL PROPERTY
8.1 Notices. Each Party will advise the Joint Steering Committee and the Joint
Patent Subcommittee promptly upon its becoming aware of: (a) any unlicensed
activities which such Party believes may be an actual or impending infringement
of any Patent or other proprietary right owned or applied for by it or the other
Party included in the Amicus Patents or Program Patents by a Product, or the
Development, Manufacture, use, importation, or sale thereof; (b) any attack on
or appeal of the grant of any Patent owned or applied for by it or the other
Party to the extent containing claims to the Compound or a Product or the
Development, Manufacture, use, or sale thereof; (c) any application for Patent
by, or the grant of a Patent to, a Third Party in respect of rights which may be
related to the Compound or a Product so as to potentially materially affect the
Development, Manufacture, use, importation, or sale thereof; (d) any application
made for a compulsory license under any Patent owned or applied for by it or the
other Party and covering the Compound or Product or the Development,
Manufacture, use, importation, or sale thereof in the Territory; or (e) any
application for Patent by, or the grant of a Patent to, a Third Party in respect
of rights which may claim the same subject matter as, or conflict with, any
Patent owned or applied for by it or the other Party containing claims to the
Compound or a Product, or the Development, Manufacture, use, importation, or
sale thereof.
8.2 Control of Actions. Subject to any restrictions Amicus may have under a
Third Party agreement covering the Amicus Patents included in the Licensed
Technology (including the Background License Agreements), GSK will determine
whether or not to take whatever legal or other action is required in response to
activities in the Territory requiring notice under Section 8.1(a), (c) or (d) to
the extent such activities specifically relate to Compound or Product
(“Protective Action”). If GSK determines that such Protective Action is
warranted, in its sole discretion, then, subject to any restrictions Amicus may
have under a Third Party agreement covering the Amicus Patents included in the
Licensed Technology (including the Background License Agreements), GSK shall, at
GSK’s expense, commence, prosecute and control such Protective Action, including
the settlement thereof and the granting of any licenses or sublicense within the
scope of the License in the Territory under any Amicus Intellectual Property or
Program Improvement licensed to GSK hereunder. Amicus will cooperate with GSK in
such action, including being joined as a Party to such action if such joinder is
necessary for standing. Each Party may be represented by counsel of its own
selection at its own expense in such Protective Action. Any recovery obtained as
a result of such Protective Action and attributable to activities in the
Territory, whether by judgment, award, decree, or settlement, will, after
reimbursement of the Parties for their reasonable costs and expenses associated
with such Protective Action, be treated as Net Sales of Product. To the extent
such recovery is insufficient to reimburse the Parties’ associated reasonable
costs and expenses fully, then a Party’s share of such recovery will be the
product of the total amount recovered with that Party’s reasonable costs and
expenses divided by the sum of both Parties’ reasonable costs and expenses. The
Party responsible pursuant to Section 7.2, 7.3 or 7.6 above, as applicable for
prosecution and maintenance of the relevant Patent described in Section 8.1(b),
and Section 8.1(e) shall determine whether or not to take whatever legal or
other action is required with respect to the activities described in
Section 8.1(b) and Section 8.1(e). For the avoidance of doubt, Amicus will
determine and control any legal or other action in response to activities
equivalent to those described in Section 8.1(a), Section 8.1(c) and
Section 8.1(d) that do not specifically relate to Compound or Product.
 

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8.3 Trademark Infringement. Notice regarding potential infringement of and
control of any Protective Action relating to any Amicus Trademark or GSK
Trademark in any country of the Territory related to the Compound or a Product
or the Development, Manufacture, use, importation, or sale thereof in the
Territory will be addressed in accordance with the applicable Trademark License
Agreement.
8.4 Third Party Claims. GSK and Amicus will each promptly notify the Joint
Steering Committee and the Joint Patent Subcommittee of any Claim by a Third
Party against GSK or Amicus, or any Affiliate or sublicensee of Amicus or GSK,
alleging infringement of such Third Party’s intellectual property rights as a
result of the Development, Manufacture, marketing, sale, importation, or use of
the Compound or Product in the Territory. As directed by the Joint Steering
Committee, the Parties will cooperate and use Commercially Reasonable Efforts to
resolve such claimed infringement, and GSK shall be entitled to lead in the
defense and shall select its counsel, and Amicus shall have the right to
participate in such action, and to select its own counsel at its own expense. If
it appears reasonably likely that the claimed infringement will give rise to a
Claim for indemnification hereunder, then the Party against whom such Claim for
indemnification would be made will have the first right to defend against such
Claim in accordance with Article XV.
IX. REPRESENTATIONS AND WARRANTIES
9.1 Representations and Warranties of Both Parties. Amicus and GSK each hereby
represent and warrant to the other, as of the Effective Date, as follows:
9.1.1 It is a corporation, duly organized, validly existing and in good standing
under the laws of the jurisdiction of its incorporation and has all requisite
power and authority, corporate or otherwise, to conduct its business as now
being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement.
9.1.2 No consent, approval, order or authorization of, or registration,
declaration or filing with, any governmental agency is required to be obtained
or made by or with respect to such Party in connection with its execution,
delivery and performance of this Agreement.
9.1.3 The execution, delivery and performance by it of this Agreement and the
transactions contemplated thereby have been duly authorized by all necessary
corporate action and stockholder action and will not (i) violate any applicable
Laws or (ii) result in a breach of or constitute a default under any material
agreement, mortgage, lease, license, permit or other instrument or obligation to
which it is a party or by which it or its properties may be bound or affected.
 

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9.2 Representations and Warranties of Amicus. Amicus hereby represents and
warrants to GSK, as of the Effective Date, as follows:
9.2.1 It has the full right, power and authority to enter into this Agreement
and to grant the License to GSK.
9.2.2 Except as otherwise may have been disclosed by Amicus to GSK prior the
Effective Date, Amicus has received no notice that (a) the manufacture, sale,
importation or use of the Compound within the Field as contemplated hereby
infringes any Third Party rights, and (b) the Amicus Patents (to the extent
representing issued Patents) are invalid or unenforceable.
9.2.3 To Amicus’s knowledge, there are no errors in the inventorship set forth
in any of the Patent applications comprising Amicus Patents.
9.2.4 Except as provided or limited in Article II, the Amicus Intellectual
Property constitutes all intellectual property that is Controlled by Amicus and
used in the Development and/or Manufacture of the Compound, and Amicus does not
Control any additional Patents, Know-How or information that are necessary for
GSK to Develop, Manufacture and Commercialize the Compound.
9.2.5 To Amicus’s knowledge, no Third Party Controls any Patent that is
necessary for GSK to Develop, Manufacture and Commercialize the Compound as such
activities are currently conducted or currently proposed to be conducted.
9.2.6 It has not previously granted any right, license or interest in or to the
Amicus Patents, or any portion thereof, that is in conflict with the rights or
licenses granted to GSK under this Agreement.
9.2.7 There are no investigations, inquiries, actions or other proceedings
pending before any Regulatory Authority with respect to the Compound, and Amicus
has not received written notice threatening any such investigation, inquiry,
action or other proceeding.
9.2.8 The Development of the Compound by or on behalf of Amicus has been
conducted in compliance in all material respects with all applicable Laws; and
neither Amicus nor to Amicus’s knowledge, its Third Party contractors, have
received any written notice which has led Amicus to believe that any of the
Regulatory Approvals relating to the Compound or Product developed by Amicus are
not currently in good standing with the FDA or EMA and Amicus has no knowledge
that any of its Third Party contractors has developed Compound or Product in a
manner that does not comply in all material respects with all applicable Laws.
 

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9.2.9 Other than the Background License Agreements, as of the Effective Date,
there are no other agreements to which Amicus is a party or, to Amicus’s
knowledge, that would prevent Amicus from performing its obligations under this
Agreement or GSK from exercising the rights under the Amicus Intellectual
Property under and in accordance with the License.
9.2.10 To its knowledge, there is no pending or threatened product liability
action in relation to the Compound, and it is not aware of any grounds for any
such product liability action.
9.2.11 Amicus has all material permits, licenses, franchises, authorizations,
orders and approvals of, and has made all filings, applications and
registrations with, governmental entities that are required in order to permit
Amicus to own or lease properties and assets and to carry on its business as
presently conducted that are material to Amicus. Amicus has complied and is in
compliance in all material respects with all statutes, laws, regulations, rules,
judgments, orders and decrees of all governmental entities applicable to it that
pertain to its business, including but not limited to compliance with the U.S.
Foreign Corrupt Practices Act of 1977 (FCPA) (15 U.S.C. §§ 78dd-1, et seq.) and
any applicable similar laws in foreign jurisdictions in which Amicus is
currently, or has previously, conducted its business or is currently, or has
previously, conducted clinical trials. Amicus has not received any notice from a
governmental entity alleging noncompliance with any such applicable statutes,
laws, regulations, rules, judgments, orders and decrees, and, to the knowledge
of Amicus, Amicus is not under investigation with respect to, or threatened to
be charged, with any material violation of any applicable statutes, laws,
regulations, rules, judgments, orders or decrees of any governmental entities.
9.2.12 It has not, up through and including the Effective Date, knowingly
withheld any material information in its possession from GSK in response to
GSK’s reasonable inquiries in connection with GSK’s due diligence relating to
the Compound, this Agreement and the underlying transaction, and to its
knowledge, the information related to the Compound that Amicus has provided to
GSK prior to the Effective Date is up-to-date and accurate in all material
respects.
9.3 Mutual Limitations on Warranties. OTHER THAN THE REPRESENTATIONS AND
WARRANTIES MADE BY THE PARTIES PURSUANT TO SECTIONS 9.1 AND 9.2, THE PARTIES
DISCLAIM ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES WHETHER EXPRESS OR
IMPLIED, INCLUDING ANY REPRESENTATIONS OR 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.
 

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X. COVENANTS
10.1 Conduct of Activities.
10.1.1 Throughout the Term, Amicus and GSK will comply in all material respects
with all applicable Laws concerning the Development, Manufacture, and
Commercialization of the Compound or Products.
10.1.2 Neither Amicus nor GSK, nor any of their respective employees or
consultants who shall be undertaking any activities related to this Agreement or
the subject matter thereof, shall have been debarred or shall be the subject of
debarment or other disciplinary proceedings by the FDA or any Regulatory
Authority in the Territory.
10.2 Background License Agreements.
10.2.1 It is understood that certain Patents and Know-How included within the
Amicus Intellectual Property have been in-licensed pursuant to the Background
License Agreements and that the obligations of Amicus and the rights of GSK
under this Agreement shall be subject to, and limited by, the Background License
Agreements.
10.2.2 It is further understood that each Background License Agreement may
require that particular provisions be incorporated into a sublicense granted
thereunder. The text of any such provisions in the Background License Agreements
is set out on Schedule 10.2 attached hereto and shall be deemed incorporated by
reference into this Agreement. GSK agrees to be bound by the provisions set out
on Schedule 10.2 to the extent applicable to GSK in its capacity as a
sublicensee under each Background License Agreement and, to the extent required
by any Background License Agreement, the relevant Third Party licensor shall be
deemed to be a third party beneficiary of this Agreement for the purposes of
enforcing such Third Party licensor’s rights against GSK in its capacity as a
sublicensee under the applicable Background License Agreement. In addition, GSK,
in its capacity as a sublicensee under each Background License Agreement, agrees
to comply with the obligations applicable to sublicensees under such agreement,
as set forth on Schedule 10.2.
10.2.3 Except as the Parties may otherwise mutually agree or as provided in
Section 3.5.2(c), Amicus shall not amend, without the prior written consent of
GSK (such consent not to be unreasonably withheld or delayed), or voluntarily
terminate, its rights under any Background License Agreement in any manner that
would materially and adversely affect GSK’s rights and licenses under this
Agreement. Amicus shall promptly notify GSK of any notice of breach delivered by
it, or any termination or amendment of any of the Background License Agreements
that materially and adversely affects GSK’s rights and licenses under this
Agreement.
10.3 Non-Compete. ******.
10.4 Non-Solicitation. ******.
 

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XI. CONFIDENTIAL INFORMATION
11.1 Confidentiality.
11.1.1 During the Term and for five (5) years thereafter, each Party will keep,
and cause its Affiliates and Sublicensees, if any, to keep confidential all
Confidential Information of the other Party, and neither Party, nor any of its
Affiliates or Sublicensees, if any, will use or disclose the Confidential
Information of the other Party except as expressly permitted in this Agreement.
The Parties acknowledge that Confidential Information may have been disclosed by
either Party or its Affiliates to the other Party or its Affiliates pursuant to
the Confidentiality Agreement. All information disclosed pursuant to the
Confidentiality Agreement will be deemed Confidential Information of the
disclosing Party within the meaning of this Agreement and subject to the terms
hereof.
11.1.2 The fact that a particular item of information is not or has ceased to be
Confidential Information by virtue of one or more of the exclusions specified in
the definition of Confidential Information (the “Excluded Item”) shall not
relieve the Party who obtained or received 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 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.
 

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11.2 Disclosure of Terms; Public Announcements.
11.2.1 Initial Press Release. Notwithstanding Section 11.3 below, the Parties
have agreed on an initial press release of the transaction contemplated by this
Agreement which is attached hereto as Exhibit B (the “Initial Press Release”).
The Initial Press Release may be issued or used by each Party individually or by
the Parties jointly on or after the Effective Date. Thereafter, each Party may
disclose the information contained in such press release without need for
further approval by the other.
11.2.2 Further Publicity. The Parties acknowledge the importance of supporting
each other’s efforts to publicly disclose results and significant development
regarding the Compound and Products in the Territory and other activities in
connection with this Agreement in the Territory that reflect information that is
not otherwise permitted to be disclosed under this Article 11, beyond what is
required by Law, and each Party may make such public disclosures from time to
time with the approval of the other Party, which approval will not to be
unreasonably withheld or delayed. Such disclosures may include, without
limitation, achievement of milestones, significant events in the Development or
regulatory process and/or the Launch of a Product in a Major Market. When a
Party (the “Requesting Party”) elects to make any such public disclosure under
this Section 11.2.2, it will give the other Party (the “Cooperating Party”) at
least seven (7) business days notice to review and comment on such statement,
and in any event the Cooperating Party shall work diligently and reasonably to
agree on the text of any proposed disclosure in an expeditious manner. The
principles to be observed in such disclosures shall be accuracy, compliance with
applicable Law and regulatory guidance documents, reasonable sensitivity to
potential negative reactions of the FDA (and its foreign counterparts) and the
need to keep investors informed regarding the Requesting Party’s business.
11.3 Confidential Terms; Required Disclosure. Each Party agrees not to disclose
to any Third Party the terms of this Agreement without the prior written consent
of the other Party hereto, except each Party may disclose the terms of this
Agreement to its advisors (including financial advisors, attorneys and
accountants), actual or potential acquisition partners or private investors, and
others on a need to know basis, in each case under appropriate confidentiality
provisions substantially equivalent to those in this Agreement. A Party will be
entitled to disclose the terms of this Agreement and/or Confidential Information
of the disclosing Party where such disclosure is reasonably necessary to
prosecute or defend any litigation or otherwise enforce its rights pursuant to
this Agreement, or where demand for such disclosure is made on such Party or
otherwise required pursuant to: (i) a valid order of a court or other
governmental body or (ii) any other applicable Law; provided that if such Party,
as the receiving Party, intends to make such disclosure or receives such demand,
to the extent it may legally do so, the receiving Party shall give the
disclosing Party prompt notice thereof to enable the disclosing Party to seek a
protective order or other appropriate remedy concerning any such disclosure. The
receiving Party will co-operate with the disclosing Party at the disclosing
Party’s expense in connection with the disclosing Party’s efforts to obtain any
such order or other remedy. If any such order or other remedy does not fully
preclude disclosure, the receiving Party will make such disclosure only to the
extent that such disclosure is legally required and subject to confidentiality,
to the extent available. Notwithstanding the foregoing, the Parties agree to
work together to prepare a redacted version of this Agreement to be filed by
Amicus with the United States Securities Exchange Commission.
 

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11.4 Clinical Trial Register. Nothing herein shall limit GSK’s right to publish
in its clinical trial register the results or summaries of the results of all
clinical trials for the Compound or Products in the Territory as set forth in
Section 5.2.5 herein.
11.5 Publications. Except as otherwise expressly set forth herein and subject to
JSC review and approval of plans for publications as set forth in Section 4.1.3
(h) and excluding publications made pursuant to Section 11.4, GSK shall have the
right to publish manuscripts, abstracts, or other articles in scientific
journals pertaining specifically to any Product in the Territory without
obtaining the prior written consent of Amicus, and subject to the procedures
specified in this Section 11.5; provided, however, that Amicus shall have the
right to review and comment upon, such comments to be considered by GSK in good
faith, such manuscripts, abstracts, or other articles in which an Amicus
employee is also named as an author or which includes Know-How or other
information pertaining specifically to the Compound or a Product that has not
previously been published pursuant to this Section 11.5. Amicus may publish
manuscripts, abstracts, or other articles in scientific journals pertaining
specifically to Compound or Product in the Territory upon the prior written
consent of GSK, such consent not to be unreasonably withheld. In the event that
either Party desires to make a publication pursuant to this Section 11.5, such
Party shall provide a copy of the proposed manuscript (including abstracts, or
presentation to a journal, editor, meeting, seminar or other third party) to the
other Party for its review and comments at least forty-five (45) days (or
fourteen (14) days for any abstract submitted to a conference) prior to
submission of such proposed manuscript for publication; the object being to
prevent either the endangerment of applications for the protection of
intellectual property rights by premature publications detrimental to their
novelty or the disclosure of Confidential Information. If, during the forty-five
(45) days (or fourteen (14) days, as applicable) specified above the
non-publishing Party notifies the other Party that a proposed manuscript
contains patentable subject matter which requires protection, the non-publishing
Party may require the delay of the publication for a period of time not to
exceed forty-five (45) days (or fourteen (14) days, for any abstract submitted
to a conference) for the purpose of allowing the pursuit of such protection. The
publishing Party shall delete from the proposed manuscript prior to submission
all Confidential Information of the non-publishing Party that the non-publishing
Party identifies in good faith and requests to be deleted. If no response is
received from the non-publishing Party within forty-five (45) days (or fourteen
(14) days, as applicable) of the date the proposed manuscript was submitted to
the non-publishing Party, it may be conclusively presumed that the publication
may proceed without delay. Notwithstanding the foregoing, but without limiting
either Party’s rights under Section 11.3, in the event that a Party believes in
good faith that it is obligated or appropriate to disclose any information
pertaining to the safety of a Product, then such Party shall immediately notify
the other Party and the Senior Executives of each Party shall meet within ******
thereafter to discuss disclosure of such information. In the event that the
Senior Executives are unable to agree upon whether or not to disclose such
information within ****** after such meeting, then the matter shall be referred
to the Joint Steering Committee, which shall meet shall meet as expeditiously as
possible to fully and finally resolve the dispute.
 

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XII. CHANGE OF CONTROL
12.1 Change of Control of Amicus. Amicus shall notify GSK in writing within
fifteen (15) days of the closing of any Change of Control of Amicus. If, during
the Term, a Change of Control event occurs that involves a Major Pharmaceutical
Company, then:
12.1.1 Amicus’ rights and obligations to participate in any Commercialization
activities shall automatically terminate, effective as of the effective date of
the closing of the Change of Control event, without the need for further notice
of such termination;
12.1.2 GSK shall have the right, exercisable in GSK’s sole discretion upon
written notice to Amicus, to terminate any and all of Amicus’ rights to
co-Develop Product with GSK pursuant to this Agreement; and in such case, all of
Amicus’ rights and obligations to share in Development Costs incurred in the
Development of Products under Sections 5.1.5 and 5.1.6 and Schedule 5.1.5 shall
also terminate;
12.1.3 All of the rights and licenses granted to GSK pursuant to this Agreement
shall continue in full force and effect, unchanged and unaffected; and
12.1.4 GSK shall have the right to terminate and dissolve the JSC and to take
any actions, or make any decisions, in its sole discretion, previously reserved
for the JSC. Notwithstanding the foregoing, in such event, GSK shall not have
the right to terminate and dissolve the Joint Patent Subcommittee, and the Joint
Patent Subcommittee shall continue in effect with the responsibilities described
in, and decisions made in accordance with, Section 4.2.1 until the last Patent
application included within the Licensed Technology or Program Patents
Controlled by GSK has been granted or rejected in a final, unappealable decision
by the relevant governmental authority after which GSK may terminate and
dissolve the Joint Patent Subcommittee, and all obligations of the Joint Patent
Subcommittee shall vest exclusively in GSK, including the right to make a final
decision on matters originally within the scope of responsibilities of the Joint
Patent Subcommittee, except that Amicus, not GSK, shall have the right to make
the final decision with respect to any matter pertaining to an Amicus Prosecuted
Patent.
12.2 Divestment of Product.
12.2.1 If, as a result of a Change of Control of Amicus, Amicus becomes
obligated to divest rights to the Compound and/or Product in one (1) or more
countries in the Territory, Amicus shall promptly notify GSK in writing. Within
****** of the date of such notice from Amicus, GSK shall notify Amicus in
writing whether or not it is interested in acquiring all of Amicus’ rights to
the Compound and Product in such country or countries in the Territory
(“Election Notice”). If GSK does not provide an Election Notice to Amicus within
such ****** period, Amicus shall be free to grant one or more Third Parties
rights to acquire the Compound and Product in the applicable country or
countries of the Territory, without further obligation to GSK under this
Section 12.2.
 

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12.2.2 If GSK does provide an Election Notice to Amicus within the ****** period
specified in Section 12.2.1 above, the Parties shall discuss mutually acceptable
terms upon which GSK may acquire all of Amicus’ rights to the Compound and
Product in such country or countries in the Territory, including all of Amicus’
co-Development and Commercialization participation rights with respect to the
Product in such country or countries of the Territory. If the Parties agree on
such terms, the Parties shall prepare and execute a definitive agreement setting
forth the agreed terms (“Product Acquisition Agreement”). If the Parties have
not entered into a Product Acquisition Agreement within ****** after the date of
such Election Notice (“Negotiation Period”), then Amicus shall be free to
complete a sale of the Compound and Product in such country or countries in the
Territory to a Third Party without further obligation to GSK under this
Section 12.2; provided that Amicus shall not complete a sale of the Compound and
Product in such country or countries in the Territory to a Third Party on
financial terms more favorable than the last financial terms upon which Amicus
offered such rights to GSK during the Negotiation Period without first following
the procedures set forth in Section 12.2.3 below.
12.2.3 If Amicus wishes to offer to a Third Party the right to acquire the
Compound and Product in the applicable country or countries of the Territory on
financial terms that are more favorable than the last financial terms upon which
Amicus offered such rights to GSK, then to the extent that Amicus has a
continuing obligation to GSK under Section 12.2.2, Amicus shall provide notice
of the same to GSK (“Re-Offer Notice”) and provide a revised term sheet of
proposed terms (“Revised Terms”). In such event, the Parties shall repeat the
procedures of Section 12.2.2, except that the Negotiation Period shall be ******
from the date of the Re-Offer Notice and GSK’s Election Notice must be provided
within ****** of its receipt of the Re-Offer Notice. If GSK provides an Election
Notice pursuant to this Section 12.2.3 and desires to accept the Revised Terms,
it shall so agree in writing within the ****** Negotiation Period, in which case
the Parties shall enter into a Product Acquisition Agreement reflecting such
Revised Terms and such other terms as are reasonable.
12.2.4 The only obligations of GSK and Amicus under this Section 12.2 are as
expressly stated herein, and there are no further implied obligations relating
to the matters contemplated herein. Without limiting the foregoing, Amicus is
not obligated at any time to disclose the identity of any Third Party with whom
it is discussing a Third Party agreement. Notwithstanding the foregoing, in no
event shall GSK’s rights and licenses to the Product be altered by any such
divestiture by Amicus to a Third Party of Amicus’s rights to the Product in a
country or countries of the Territory.
 

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12.3 Amicus Intellectual Property. Notwithstanding any provision of this
Agreement, in the event of a Change of Control of Amicus, the scope of the
Licensed Technology (including the Amicus Patents, Amicus Know-How and other
Amicus Intellectual Property) and the Compound and Product and the rights and
licenses granted to GSK with respect to the Compound and Products under this
Agreement (including those in Sections 2.1, 2.2, 5.1.7 and 5.2.4 and Article
11), shall not include, and nothing herein shall be construed to include, any of
the Patents, Know-How or other intellectual property or subject matter that
(i) was owned or Controlled by the acquiring entity or its Affiliates prior to
the closing of such Change of Control of Amicus, or (ii) any intellectual
property rights that the acquiring entity or any of its Affiliates develops
following a Change of Control of Amicus independently without using any of the
Amicus Intellectual Property.
12.4 For the avoidance of doubt, except as set out in this Article 12, a Change
of Control of Amicus shall not otherwise affect the rights or obligations of the
Parties with respect to the Compound and Products in the Territory under this
Agreement, and shall not be deemed to modify or expand the scope of GSK’s rights
under Section 2.1 above.
XIII. TERM AND TERMINATION
13.1 Term. This Agreement shall commence on the Effective Date, and unless
terminated earlier as provided in this Article XIII, shall continue in full
force and effect on a country-by-country and Product-by-Product basis until the
expiration of the Royalty Term in each country in the Territory (the “Term”).
Upon the expiration of the Royalty Term in each country of the Territory,
subject to Section 3.5.2(b), GSK shall have a perpetual, exclusive, fully-paid
up, royalty-free license in such country under the Licensed Technology to make,
have made, use, sale, offer for sale and import Product in such country.
13.2 Termination for Material Breach. Either Party may terminate this Agreement
in its entirety, or at the non-breaching Party’s discretion, on a
country-by-country or Product-by-Product basis, by written notice to the other
Party in the event that the other Party is in material default or material
breach of any of its obligations hereunder, and fails to remedy such default or
breach within a period of ****** after written notice thereof was provided to
the breaching Party by the non-breaching Party. Any such termination shall
become effective at the end of such ****** period unless the breaching Party has
cured any such breach or default prior to the expiration of the ****** period.
13.3 Termination for Convenience. GSK may terminate this Agreement in its
entirety, or on a country-by-country or Product-by-Product basis, for any reason
whatsoever, upon ****** prior written notice to Amicus.
13.4 Bankruptcy. Either Party may terminate this Agreement in its entirety at
any time during the Term by giving written notice to the other Party if the
other Party files in any court or agency pursuant to any statute or regulation
of any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver or
trustee of the Party or of its assets, or if the other Party is served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition will not be dismissed within ****** after the filing thereof, or if the
other Party makes a general assignment for the benefit of creditors.
 

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13.5 By Mutual Consent. The Parties may terminate this Agreement in its entirety
or on a Product-by-Product or country-by-country basis at any time and for any
reason during the Term upon their mutual written agreement.
13.6 Termination of Amicus’ Co-Development Right for Product. After ******,
Amicus may, in its sole discretion, elect to terminate its right to co-Develop
Products with GSK pursuant to Section 5.1 and to share Development Costs
incurred in the Development of Products pursuant to Sections 5.1.5 and 5.1.6 and
Schedule 5.1.5 (such option, the “Co-Development Opt-Out”). To exercise the
Co-Development Opt-Out, Amicus shall provide written notice to GSK
(“Co-Development Opt-Out Notice”) at least ******prior to the beginning of the
first Quarter in which Amicus wishes such Co-Development Opt-Out to take effect,
which notice shall not be given prior to ****** (“First Opt-Out Quarter”). Upon
delivery of the Co-Development Opt-Out Notice, Amicus’s Co-Development rights
with respect to the Products pursuant to Section 5.1, and Amicus’ obligations to
pay Development Costs incurred in the Development of Products pursuant to
Sections 5.1.5 and 5.1.6 and Schedule 5.1.5, shall terminate as of the first day
of the First Opt-Out Quarter and the royalty rates applicable to Net Sales of
Products specified in Section 3.4.1 shall be reduced in accordance with the
specific methodology for such reduction set forth in Schedule 13.6.
XIV. EFFECTS OF TERMINATION
14.1 Accrued Obligations. The expiration or termination of this Agreement for
any reason shall not release either Party from any liability that, at the time
of such expiration or termination, has already accrued to the other Party or
that it is attributable to a period prior to such expiration or termination, nor
will any termination of this Agreement preclude either Party from pursuing any
and all rights and remedies it may have under this Agreement, or at law or in
equity, with respect to breach of this Agreement.
14.2 Rights upon Termination by GSK for Amicus Breach. If GSK terminates this
Agreement in its entirety, or terminates this Agreement with respect to a
Product or country, pursuant to Section 13.2, then the provisions of this
Section 14.2 shall apply. As used in this Section 14.2 and Section 14.3 below,
“Affected Area” shall mean the Territory in the case of termination of this
Agreement in its entirety, or the terminated country(ies) in the case of
termination of this Agreement with respect to such country(ies) and “Terminated
Product(s)” shall mean the Compound and all Products in the case of termination
of this Agreement in its entirety, or the terminated Product(s) in the case of
termination of this Agreement with respect to such Product(s).
 

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14.2.1 Licenses.
(a) The License granted to GSK pursuant to Section 2.1 above will survive any
such termination and will convert to an irrevocable exclusive license, with the
right to sublicense in accordance with Section 2.2, under the Licensed
Technology solely with respect to the Terminated Products in the Affected Area.
The licenses granted to GSK under any Amicus Trademark pursuant to a Trademark
License Agreement and/or the Amicus House Marks pursuant to Section 6.3 will
also survive any such termination and will convert to an irrevocable license
solely with respect to the Terminated Products in the Affected Area, with the
right to sublicense in accordance with the applicable Trademark License
Agreement or Section 6.3, as applicable; unless Amicus assigns any Amicus
terminated Product Trademark to GSK in accordance with Section 14.2.2 below, in
which event GSK’s license under the applicable Amicus Terminated Product
Trademark pursuant to the Trademark License Agreement shall terminate upon the
assignment of such Amicus Terminated Product Trademark to GSK.
(b) The licenses granted by GSK to Amicus pursuant to Section 2.3(a) to Develop
the Compound and Product in the Field in the Territory in accordance with
Article V shall survive any termination of this Agreement by GSK pursuant to
Section 13.2; unless GSK terminates this Agreement pursuant to Section 13.2 in
its entirety. If such termination by GSK occurs prior to the Supply Transition
Date, the Parties will work together in good faith to complete all activities
under the Supply Transition Plan as soon as possible after the date of such
termination.
14.2.2 Assignment of Amicus Trademarks. Within ****** after the effective date
of termination, upon request by GSK, Amicus shall either return to GSK or
destroy all tangible items pertaining to a Terminated Product in any country of
the Affected Area and comprising, bearing or containing any GSK Trademark and/or
GSK House Marks that is in Amicus’ possession. Effective upon the effective date
of termination, Amicus shall cease to use all Trademarks and trade names of GSK
(including the GSK House Marks and all GSK Trademarks) with respect to the
Terminated Products in the Affected Area, and all rights granted to Amicus
hereunder to use such Trademarks and trade names of GSK with respect to the
Compound and Terminated Products in the Affected Area shall terminate. In
addition, at GSK’s option, which shall be exercised by written notice to Amicus,
and upon payment by GSK of the out-of-pocket costs of assignments and of the
out-of-pocket costs incurred to identify, design and register (including but not
limited to clearance filing and maintaining) any Amicus Trademark selected by
the JSC for use with each Terminated Product in the Affected Area (each, an
“Amicus Terminated Product Trademark”), Amicus shall promptly assign to GSK, at
no additional cost to GSK (including no royalty obligations), all rights of
Amicus and its Affiliates in and to such Amicus Terminated Product Trademarks,
including all registrations and applications for registration for such Amicus
Terminated Product Trademarks in the Affected Area and all associated goodwill.
For the avoidance of doubt, the foregoing shall not include any Amicus House
Marks. Further, upon payment by GSK of the out-of-pocket costs of assignment and
registration, Amicus shall transfer to GSK all domain names established by
Amicus for use with a Terminated Product in any country of the Affected Area.
 

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14.2.3 Development. If GSK terminates this Agreement in its entirety, at GSK’s
election exercisable on written notice to Amicus no later than ****** following
the effective date of any such termination, GSK may assume the conduct of all
Development activities allocated to Amicus under the then-current Development
Plan and all Commercialization activities allocated to Amicus under the
then-current Marketing Plan (if any) in respect of the Products and thereafter,
GSK will perform any and all such Development and/or Commercialization
activities thereunder in accordance with the terms of this Agreement. Following
GSK’s termination and election to assume such Development and Commercialization
activities, Amicus shall have no further rights or obligations to Develop or
Commercialize the Products in the Territory, or to share in the Development
Costs incurred in the performance of the Development Plan after the date of such
notice of election from GSK. If GSK so elects, then GSK may off-set Amicus’
share (determined in accordance with Section 5.1.5) of any documented,
out-of-pocket expenses that GSK incurs directly as a result of the assumption,
and the conduct of any Development activities allocated to Amicus under the
Development Plan in effect as of the date of any such termination that are
assumed by GSK pursuant to this Section 14.2.3 against any milestone or royalty
payments owed to Amicus but not yet paid by GSK under Section 3.3 prior to the
date of GSK’s notice to Amicus of the applicable breach issued pursuant to
Section 13.2. If GSK terminates this Agreement pursuant to Section 13.2 only
with respect to a particular Product(s) and/or particular country(ies), the
rights and obligations of the Parties with respect to the Development of
Products and related maters set forth in Article V of this Agreement shall
survive with respect to the Terminated Products in the Affected Area.
14.2.4 Payment Obligations. Subject to Section 14.2.3, the obligations of GSK,
and the rights of Amicus, under Article III with respect to Terminated Products
in the Affected Area will survive any such termination.
14.2.5 Committees. For the avoidance of doubt, upon termination by GSK of this
Agreement in its entirety pursuant to the terms of Section 13.2 or 13.4, the
Joint Steering Committee shall cease to exist and, subject to this
Section 14.2.5 below, all obligations of the Joint Steering Committee shall vest
exclusively in GSK, including the right to make a final decision on matters
originally within the scope of responsibilities of the Joint Steering Committee,
subject to Section 4.4. Notwithstanding the foregoing, GSK shall not have the
right to terminate and dissolve the Joint Patent Subcommittee, and the Joint
Patent Subcommittee shall continue in effect with the responsibilities described
in, and decisions made in accordance with, Section 4.2.1 until the last Patent
application included within the Licensed Technology or Program Patents
Controlled by GSK has been granted or rejected in a final, unappealable decision
by the relevant governmental authority after which GSK may terminate and
dissolve the Joint Patent Subcommittee, and all obligations of the Joint Patent
Subcommittee shall vest exclusively in GSK, including the right to make a final
decision on matters originally within the scope of responsibilities of the Joint
Patent Subcommittee, except that Amicus, not GSK, shall have the right to make
the final decision with respect to any matter pertaining to an Amicus Prosecuted
Patent.
14.2.6 Additional Matters.
(a) Upon any termination of this Agreement by GSK pursuant to Section 13.2, all
of the Parties rights and obligations under Articles VII and VIII with respect
to the Licensed Intellectual Property, Program Patents and Program Improvements
shall survive.
 

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(b) Upon termination of this Agreement by GSK pursuant to Section 13.2: (i) with
respect to all Products in a particular country(ies), all of the Parties’ rights
and obligations under the Agreement with respect to all Products in all
countries outside of such Affected Area shall survive; or (ii) with respect to a
Product(s), but not all Products, all of the Parties’ rights and obligations
under the Agreement with respect all such Products (i.e., the non-Terminated
Products) in the Territory shall survive.
14.2.7 Non-Compete. ******.
14.2.8 Transition. Without limiting the foregoing, following termination as set
forth herein, Amicus shall use Commercially Reasonable Efforts to cooperate with
GSK and/or its designee to effect a smooth and orderly transition of any
Development, Manufacturing or Commercialization activities with respect to a
Terminated Product(s) in the Affected Area that were, prior to such termination,
allocated to Amicus under the Development Plan, the Supply Transition Plan
and/or the then-current Marketing Plan, respectively.
14.3 Rights upon Termination by Amicus for GSK Breach; or Termination by GSK for
Convenience. If Amicus terminates this Agreement in its entirety pursuant to
Section 13.2, or if GSK terminates this Agreement in its entirety or terminates
this Agreement with respect to a particular Product(s) or country(ies) in the
Territory, in each case pursuant to Section 13.3, then the provisions of this
Section 14.3 shall apply.
14.3.1 Licenses. Effective as of the date of termination, Amicus shall have and
is hereby granted by GSK a non-exclusive, irrevocable license, with the right to
grant sublicenses, under any Program Improvements and Program Patents that are
Controlled by GSK or its Affiliates, and any other Patents Controlled (to the
extent such Patents are in-licensed, solely to the extent that GSK has the right
to grant sublicenses under its licensed rights) by GSK or its Affiliates on the
effective date of termination that are necessary and actually practiced prior to
termination of this Agreement by GSK or its Affiliates in Developing,
Manufacturing, Commercializing and otherwise exploiting the Compound and
Terminated Products, for the purposes of Developing, Manufacturing,
Commercializing and otherwise exploiting the Compound and Terminated Products
for the Affected Area. Following the effective date of termination, the License
granted by Amicus to GSK under the Licensed Technology with respect to the
Terminated Product(s) in the Affected Area shall convert to a non-exclusive
license and shall be limited: (i) to the use of the Licensed Technology for the
purposes of permitting GSK to comply with its obligations under this
Section 14.3 for the applicable periods described in Sections 14.3.2, 14.3.3 and
14.3.6 below; except that (ii) GSK shall continue to have a non-exclusive
license under the Licensed Technology to make and/or have made the Terminated
Product(s) in the Affected Area solely for use and sale within the Territory,
unless or until this Agreement is terminated in its entirety. Except as provided
in the preceding sentence for the applicable periods described in such sentence,
the License, and all of GSK’s rights, under the Licensed Technology with respect
to the Terminated Products in the Affected Area shall terminate and shall
automatically revert to Amicus upon any such termination of this Agreement.
Further, any licenses granted by Amicus to GSK under the Amicus Trademarks
and/or Amicus House Marks granted pursuant to a Trademark License Agreement
and/or Section 6.3, respectively, for the Terminated Products in the Affected
Area shall immediately terminate, except to the extent necessary for the
purposes of permitting GSK to comply with its obligations under this
Section 14.3 for the applicable periods described in Sections 14.3.2, 14.3.3 and
14.3.6 below; and subject to the foregoing, all right, title and interest in and
to such Amicus Trademarks and Amicus House Marks with respect to the Terminated
Product(s) in the Affected Area shall automatically revert to Amicus.
 

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14.3.2 Development. In the event that, on the date of notice of such
termination, there are any ongoing clinical trials of any Terminated Product in
the Affected Area (or, if the Affected Area is less than the entire world, any
ongoing clinical trials of any Terminated Product that are specifically directed
to the requirements of a country within the Affected Area) (each, an “Ongoing
Trial”), to the extent and as requested by Amicus, following the effective date
of termination, GSK will promptly transition to Amicus or its designee, or
complete such Ongoing Trial(s). During the period in which GSK is performing
activities in accordance with this Section 14.3.2, GSK will remain responsible
for GSK’s share under Sections 5.1.5 and 5.1.6 of (i) any Development Costs
incurred in the continued conduct of such Ongoing Trials and (ii) any
Out-of-Pocket Expenses incurred by Amicus or GSK to transition any Ongoing
Trials (or portion thereof) to Amicus or its designee, as requested by Amicus.
14.3.3 Commercialization. To avoid disruption of supply of any Terminated
Products to patients if this Agreement is terminated after the Launch of a
Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees
shall continue to sell the Terminated Products in each country of the Affected
Area for which Marketing Approval of such Terminated Product has been obtained,
in accordance with the terms and conditions of this Agreement, until the date on
which Amicus notifies GSK that Amicus has secured an alternative distributor or
licensee for such Terminated Product in such country of the Affected Area, but
in no event more than ****** after the effective date of any such termination of
this Agreement (“Wind-Down Period”); provided that Amicus may terminate the
Wind-Down Period in any country(ies) of the Affected Area upon ****** written
notice to GSK; provided further that GSK shall not be obligated to promote the
sale of Terminated Products in the Affected Area during the Wind-Down Period.
Notwithstanding any other provision of this Agreement, during the Wind-down
Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the
Terminated Products in the Affected Area shall be non-exclusive and, without
limiting the foregoing, Amicus shall have the right to engage one or more other
distributor(s) and/or licensee(s) of any Terminated Product in all or part of
the Affected Area; provided, however, that in the event that Amicus does so
engage one or more other distributor(s) and/or licensee(s) of any Terminated
Product in all or part of the Affected Area, GSK shall have no further
obligation to continue to sell the Terminated Products in the Affected Area or
such part thereof, as applicable. Any Terminated Product sold or disposed by GSK
in the Affected Area during the Wind-down Period shall be subject to applicable
royalty payment obligations under Section 3.4 above, and for such purposes,
Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following
the expiration of the Wind-Down Period, GSK shall notify Amicus of any
quantities of Compound or Terminated Product(s) remaining in GSK’s or its
Affiliate’s inventory, as well as any components necessary for the Manufacture
of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory,
and Amicus shall have the option, upon notice to GSK, to repurchase any such
quantities of the Compound and/or Terminated Product(s) and/or components from
GSK at a price to be mutually agreed by the Parties. If Amicus so elects to
purchase any remaining quantities of Compound or Terminated Products or
components from GSK as set forth herein, GSK will transfer to Amicus such
quantities of inventory of Compound or Terminated Product(s) or components.
 

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14.3.4 Data and Know-How. GSK will, at the request of Amicus, provide Amicus
complete access to, and/or copies of, documentation pertaining to all
preclinical and clinical data and all regulatory data, and all other Program
Improvements, in each case as necessary for Amicus to Develop, Manufacture and
Commercialize the Compound and the Terminated Product(s) as of the date of
termination (including all Know-How pertaining to the Manufacture of the
Compound and Terminated Products, including Know-How corresponding to that
described in Schedule 6.5.1), that are Controlled by GSK or its Affiliates, and
Amicus shall have, and is hereby granted by GSK, an irrevocable, non-exclusive,
royalty-free right and license, with the right to sublicense, to use and
disclose all such data and other Program Improvements following any such
termination of this Agreement in accordance with the license granted to Amicus
pursuant to Section 14.3.1 above. In addition, all such data and other Program
Improvements generated by or under authority of GSK or its Affiliates hereunder
during the term of the Agreement shall, to the extent specifically pertaining to
a Terminated Product in the Affected Area (as well as, if any such termination
applies to this Agreement in its entirety, such items to the extent specifically
pertaining to the Compound), be deemed Confidential Information of Amicus to be
used solely in connection with the Compound and/or Products and not Confidential
Information of GSK (and will not be subject to the exclusions under
Section 1.35(a) and (d) above).
14.3.5 Regulatory Filings. At Amicus’ option, which shall be exercised by
written notice to GSK, GSK will assign and transfer (or cause to be assigned and
transferred) to Amicus or its designee (or to the extent not so assignable, GSK
shall take all reasonable action to make available to Amicus or its designee the
benefits of) all regulatory submissions and filings and marketing approvals
(including all INDs, MAAs and Marketing Approvals) related to the Compound or
the Terminated Product(s) in the Affected Area, including such regulatory
submissions and registrations made or owned by GSK’s Affiliates and
Sublicensees. In each case, unless otherwise required by any applicable Law, GSK
shall use all reasonable efforts to make such foregoing assignment (or
availability), within ****** after the effective date of any such termination
(or, with respect to any such regulatory filings pertaining to an Ongoing Trial
that GSK is continuing to conduct pursuant to Section 14.3.2 above, within
****** after the completion of such Ongoing Trial), provided, however, that in
the event that GSK is unable to make such assignment or to make such regulatory
filings available to Amicus within ****** after the effective date of any such
termination (or the completion of such Ongoing Trial, as applicable) due to
factors beyond GSK’s reasonable control, then GSK shall so notify Amicus and
(including the reason for any such delay) prior to the expiration of such ******
period and the Parties shall mutually agree (such agreement not to be
unreasonably withheld by either Party) an appropriate extension to such ******
period.
 

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14.3.6 Supply. If GSK is Manufacturing, itself or through a Third Party,
Compound or any Terminated Product (each a “GSK Supplied Material”), upon
request by Amicus, GSK will, or will cause such Third Party to, supply Amicus
with its (and its Affiliates’ and licensees’) reasonable requirements of each
GSK Supplied Material at GSK’s Manufacturing Costs therefor (provided that such
Manufacturing Costs of GSK shall not differ substantially from GSK’s
Manufacturing Costs for the applicable GSK Supplied Material in the year
immediately prior to the Wind Down Period) and on customary terms with respect
to quality, ordering and delivery, until Amicus, on a material-by-material
basis, using Commercially Reasonable Efforts, is able, itself or through a Third
Party, to Manufacture such GSK Supplied Material to meet such reasonable
requirements for the Terminated Products in the Affected Area, but in no event
shall GSK be obligated to supply Amicus with GSK Supplied Material for more than
****** as provided in this Section 14.3.6. If GSK is Manufacturing the
Terminated Products for the Affected Area through a Third Party, upon Amicus’
request, GSK shall use Commercially Reasonable Efforts to transition to Amicus
its arrangement with such Third Party contractor.
14.3.7 Transition. Without limiting the foregoing, GSK shall use Commercially
Reasonable Efforts to cooperate with Amicus and/or its designee to effect a
smooth and orderly transition in the Development, sale and ongoing marketing,
promotion and Commercialization of all Terminated Product(s) in the Affected
Area following termination as set forth herein.
14.3.8 Sublicensees. Any contracts with Sublicensees of any Terminated Product
in the Affected Area engaged by GSK, other than GSK’s Affiliates, shall be
assigned to Amicus to the extent GSK has the right to do so and Amicus so
requests. In the event such assignment is not requested by Amicus or GSK does
not have the right to do so, then the rights of such Sublicensees with respect
to the Terminated Product in the Affected Area shall terminate upon termination
of GSK’s rights with respect to the Terminated Products in the Affected Area.
GSK shall ensure that its Affiliates and such Sublicensees (if not assigned to
Amicus pursuant to this Section 14.3.8) shall transition all Terminated Products
in the Affected Area back to Amicus in the manner set forth in this Section 14.3
as if such Affiliate or Sublicensee were named herein.
14.3.9 Trademarks.
(a) Within ****** after the end of the Wind-Down Period upon request by Amicus,
GSK shall either return to Amicus or destroy all tangible items pertaining to a
Terminated Product in each country of the Affected Area and comprising, bearing
or containing any Amicus Trademark and/or the Amicus House Marks that is in
GSK’s possession. Effective upon the end of the Wind-Down Period, GSK shall
cease to use all Trademarks and trade names of Amicus (including the Amicus
House Marks and all Amicus Trademarks) with respect to the Terminated Products
in the Affected Area, and all rights granted to GSK hereunder to use such
Trademarks and trade names of Amicus with respect to the Compound and Terminated
Products in the Affected Area shall terminate. In addition, at Amicus’ option,
which shall be exercised by written notice to GSK, and upon payment by Amicus of
the out-of-pocket costs of assignments and of the out-of-pocket costs incurred
to identify, design and register (including but not limited to clearance filing
and maintaining) of any GSK Trademark selected by the JSC that had been used
with each Terminated Product in the Affected Area (each, a “GSK Terminated
Product Trademark”), GSK shall promptly assign to Amicus, ******, all rights of
GSK and its Affiliates in and to such GSK Terminated Product Trademarks,
including all registrations and applications for registration for such GSK
Terminated Product Trademarks in the Affected Area and all associated goodwill.
For the avoidance of doubt, the foregoing shall not include any GSK House Marks.
Further, upon payment by Amicus of the out-of-pocket costs of assignment and
registration, GSK shall transfer to Amicus all domain names established by GSK
for use with a Terminated Product in any country of the Affected Area.
 

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(b) Subject to, and without limiting Amicus’ rights under, Sections 14.3.1,
14.3.4 and 14.5, if GSK terminates this Agreement pursuant to Section 13.3, then
within ****** after the end of the Wind Down Period and upon the request of GSK,
Amicus shall either return to GSK or destroy all tangible items comprising,
bearing or containing any GSK Trademark (other than the GSK Terminated Product
Trademarks) and/or the GSK House Marks that are in Amicus’ possession. Effective
upon the end of the Wind Down Period, Amicus shall cease to use all Trademarks
and trade names of GSK (including the GSK House Marks and all GSK Trademarks,
other than the GSK Terminated Product Trademarks) with respect to the Terminated
Products in the Affected Area.
14.3.10 Termination solely with respect to a Product(s) or country(ies). Upon
termination of this Agreement by GSK pursuant to Section 13.3 or by Amicus
pursuant to Section 13.2 with respect to a Terminated Product(s) and/or the
Affected Area only, the Parties’ rights and obligations under the Agreement with
respect to all other Products in the Territory shall survive, subject to the
following provisions:
(a) Each country of the Affected Area shall cease to be a country within the
Territory and the definition of “Territory” in Section 1.130 shall be deemed to
be amended accordingly and all references to a Major Market shall be deemed to
be references to a “Major Market within the Territory”; similarly, each
Terminated Product shall cease to be a “Product” covered by this Agreement and
the definition of “Product” in Section 1.105 shall be deemed to be amended
accordingly;
(b) Notwithstanding any other provision of this Agreement, including the
definition of “Amicus Know-How” in Section 1.19 and Sections 2.1, 5.1.7 and
5.2.3, Amicus shall not have any obligation to make available to GSK any data or
other Know-How with respect to a Terminated Product generated by or on behalf of
Amicus, its Affiliates and/or licensees for the Affected Area following any such
termination and GSK shall have no rights to, and the License shall not include,
any such data or Know-How; in addition, all of GSK’s approval rights as set
forth in the second sentence of Section 11.5 shall immediately terminate,
provided, however, that nothing in this Section 14.3.10(b) shall otherwise
modify GSK’s rights or Amicus’ obligations set forth in Section 11.5, including
GSK’s right of pre-publication review and Amicus’ obligations to remove, at the
request of GSK, any GSK Confidential Information from any such publication;
 

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(c) Upon notice by one Party to the other Party, the Parties shall promptly meet
and negotiate in good faith appropriate downward adjustments to the levels of
Calendar Year Net Sales that trigger each milestone payment corresponding to a
sales milestone that includes Net Sales in the Affected Area as set forth in
Section 3.3.3 and to which each of the royalty rates applies as set forth in
Section 3.4.1; provided that if the Parties are unable to agree on such
adjustments within thirty (30) days following the date of any such notice from
Amicus, then either Party may, upon written notice to the other, refer such
dispute for resolution pursuant to the alternative dispute resolution as
contemplated by Section 16.2.3 (with the Parties expressly acknowledging that
any such modifications or revisions to the levels of Calendar Year Net Sales
will not, with reference to any other provision of this Agreement, be construed
as consequential or otherwise impermissible damages);
(d) As between the Parties, GSK shall continue to be responsible for
pharmacovigilance and adverse event reporting within the Territory with respect
to the Compound and Products as provided in Section 5.2.6 and Amicus shall be
responsible for pharmacovigilance with respect to the Terminated Products in the
Affected Area, and the Parties shall cooperate such that Amicus (or Amicus’
designee) is able to maintain a worldwide safety database for the Terminated
Products. The Parties shall promptly negotiate and implement any appropriate
amendments to the pharmacovigilance agreement described in Section 5.2.6(a) in
accordance with this Section 14.3.10(c); and
(e) The Parties rights and obligations under Section 7.1 shall survive; and
GSK’s rights and obligations under Article 7 regarding the prosecution and
maintenance of all GSK Prosecuted Amicus Patents and Program Patents in the
Affected Area to the extent pertaining to the Terminated Products shall
terminate from and after the date of any such termination and all such Patents
shall be deemed to be Amicus Prosecuted Patents; provided, however, that Amicus
will, in a timely manner, solicit GSK’s comments regarding the prosecution and
maintenance of such Amicus Patents and Program Patents and review of the nature
and text of any such Patent application and prosecution matters related thereto,
including any correspondence between Amicus and any government intellectual
property or Patent authorities, agencies or other government bodies, in
reasonably sufficient time prior to filing thereof, and Amicus will give due
consideration to GSK’s reasonable comments and amendments.
14.3.11 Non-Compete.
(a) Upon termination of this Agreement in its entirety by Amicus pursuant to
Section 13.2 or by GSK pursuant to Section 13.3: ******.
(b) Upon termination of this Agreement by Amicus pursuant to Section 13.2 or by
GSK pursuant to Section 13.3 with respect to particular Product(s) and/or
country(ies) of the Territory: ******.
 

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14.4 Rights upon Termination for Bankruptcy. Notwithstanding the bankruptcy of
Amicus, or the impairment of performance by Amicus of its obligations under this
Agreement as a result of bankruptcy or insolvency of Amicus as described in
Section 13.4, upon the termination of this Agreement by GSK pursuant to
Section 13.4, GSK will be entitled to retain all rights and licenses granted to
GSK by Amicus under this Agreement. All rights and licenses granted under or
pursuant to this Agreement by Amicus to GSK are, and will otherwise be deemed to
be, for purposes of Article 365(n) of the Bankruptcy Code, licenses of rights to
“intellectual property” as defined under Article 101(52) of the Bankruptcy Code.
The Parties agree that GSK, as a licensee of such rights under this Agreement,
will retain and may fully exercise all of its rights and elections under the
Bankruptcy Code. The Parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against Amicus under the
Bankruptcy Code, GSK will be entitled to a complete duplicate of (or complete
access to, as appropriate) any such intellectual property and all embodiments of
such intellectual property, and same, if not already in its possession, will be
promptly delivered to GSK (i) upon any such commencement of a bankruptcy
proceeding upon written request therefore by GSK, unless Amicus elects to
continue to perform all of its obligations under this Agreement, or (ii) if not
delivered under (i) above, upon the rejection of this Agreement by or on behalf
of Amicus upon written request therefore by GSK. The provisions of this
Section 14.4 shall apply mutatis mutandis to Amicus in the event of any
bankruptcy or insolvency of GSK as described in Section 13.4.
14.5 Return of Materials. No later than thirty (30) days after the expiration or
termination of this Agreement, each Party shall return or cause to be returned
to the other Party (or, at such other Party’s request, destroy and certify such
destruction) all Confidential Information received from the other Party and all
copies thereof that are in such Party’s possession, as well as all biological or
chemical materials delivered or provided by the other Party; provided, however,
that each Party may retain one (1) copy of such Confidential Information
received from the other Party for record purposes. Notwithstanding the
foregoing, to the extent that a Party has a continuing license pursuant to
Section 14.2 or Section 14.3 above, as applicable, after the termination of this
Agreement, such Party may retain the Confidential Information of the other Party
and use such Confidential Information solely to the extent necessary and for the
purpose of the continued practice of such license and in such event,
notwithstanding Section 11.1 above, such Party’s obligations under Article XI
above, shall continue for so long as such Party continues to practice such
license.
14.6 Survival. Upon the expiration or termination of this Agreement, all rights
and obligations of the Parties under this Agreement shall terminate except those
described in the following provisions (which such provisions shall survive for
the term specified therein and, if no such term is specified, then
indefinitely): Articles I, XIV, XV and XVI; Sections 3.9, 3.10, 11.1 and 11.3;
and GSK’s rights under Section 11.4 (solely to the extent GSK’s clinical trial
register includes the results of clinical trials for the Compound or Products
prior to any such termination).
 

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XV. INDEMNIFICATION AND LIMITATION OF LIABILITY
15.1 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 liabilities, damages,
penalties, fines, costs, expenses (including, reasonable attorneys’ fees and
other expenses of litigation) (“Liabilities”) from any claims, actions, suits or
proceedings brought by a Third Party (a “Third Party Claim”) incurred by any
Amicus Indemnitee, arising from, or occurring as a result of: (a) activities
relating to the Development, use, marketing, distribution, importation or sale
of any Compound and Product by GSK, its Affiliates, Sublicensees, or
subcontractors in the Territory; (b) any material breach of any representations,
warranties or covenants by GSK in Articles IX and X above; and/or (c) activities
relating to the Manufacture (after the Supply Transition Date) of any Compound
or Product by GSK, its Affiliates, Sublicensees, or subcontractors for
distribution in the Territory; except to the extent such Third Party Claims fall
within the scope of Amicus’s indemnification obligations set forth in
Section 15.2 below or result from the gross negligence or intentional misconduct
of a Amicus Indemnitee. For the avoidance of doubt, Product Liability Claims are
not subject to this Section 15.1 and are governed by the provisions of
Section 15.4 below.
15.2 Indemnification of GSK. Amicus shall indemnify and hold harmless each of
GSK, its Affiliates and Sublicensees and the directors, officers and employees
of GSK, its Affiliates and Sublicensees and the successors and assigns of any of
the foregoing (the “GSK Indemnitees”), from and against any and all Liabilities
from any Third Party Claims incurred by any GSK Indemnitee, arising from, or
occurring as a result of (a) activities related to the Development, or use of
any Compound and Product by Amicus, its Affiliates, Sublicensees or
subcontractors in the Territory; (b) any material breach of any representations,
warranties or covenants by Amicus in Article IX and X above; or (c) the
Manufacture of any Compound or Product by Amicus, its Affiliates, Sublicensees,
or subcontractors, prior to GSK’s assumption of responsibility for Manufacturing
the Compound and Product pursuant to Section 6.5 or Section 14.2.2(b); except to
the extent such Third Party Claims (i) fall within the scope of GSK’s
indemnification obligations set forth in Section 15.1 above or (ii) result from
the gross negligence or intentional misconduct of an GSK Indemnitee or
(iii) with respect to clause (c) above, result from Amicus’ compliance with any
direction of GSK pursuant to Section 6.5.2(a) above. For the avoidance of doubt,
Product Liability Claims are not subject to this Section 15.2 and are governed
by the provisions of Section 15.4 below.
15.3 Procedure. A Party that intends to claim indemnification under this
Article XV (the “Indemnitee”) shall promptly notify the other Party (the
“Indemnitor”) in writing of the assertion or the commencement of Third Party
Claim and will provide the Indemnitor such information with respect thereto that
the Indemnitor may reasonably request. The Indemnitor shall be entitled to
control and appoint lead counsel for such defense, in each case at its expense.
If the Indemnitor shall assume the control of the defense of any Third Party
Claim in accordance with the provisions of this Section 15.3, the Indemnitor
shall obtain the prior consent of the Indemnitee (which shall not be
unreasonably withheld) before entering into any settlement of such Third Party
Claim. The failure to deliver written notice to the Indemnitor within a
reasonable time after the commencement of any action with respect to a Third
Party Claim shall not relieve the Indemnitor of its obligations under this
Article XV unless the delay or failure is prejudicial to its ability to defend
such action. The Indemnitee under this Section 15.3 shall cooperate fully with
the Indemnitor and its legal representatives in the investigation of any action
with respect to a Third Party Claim covered by this indemnification.
 

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15.4 Product Liability.
15.4.1 Each Party shall notify the other Party as promptly as practicable if any
Third Party Claim is commenced or threatened against such Party in the Territory
alleging product liability, product defect, design, packaging or labeling
defect, failure to warn or any similar action relating to the use or safety of
Compound and Products in the Territory (a “Product Liability Claim”). For
clarity, a Product Liability Claim will not be deemed to include any Third Party
Claims relating to a Manufacturing defect of Compound and Products and
Sections 15.1 and 15.2 shall apply to any such Third Party Claims.
15.4.2 To the extent that either the GSK Indemnitees or the Amicus Indemnitees
incur, suffer, or are faced with any Product Liability Claims with respect to
the Product in the Territory, then ******.
15.4.3 GSK shall have the right to control and appoint lead counsel for the
defense of any such Product Liability Claims and to settle any such Product
Liability Claims, in its discretion, provided, that GSK shall reasonably consult
with and consider the input of Amicus with respect to such matters.
15.5 Insurance. In addition to its duty to indemnify, each Party will procure
product liability insurance in commercially reasonable amounts in view of its
activities. Alternatively, either Party may establish a program of self
insurance for the same risks. In either event, as reasonably requested in
writing by the other Party not more than once every twelve (12) months, each
Party will supply the other Party with evidence of such coverage during the time
any Product is being Developed, Manufactured or Commercialized by such Party or
any of its Affiliates, Sublicensees, designees or agents.
15.6 Disclaimer of Consequential Damages. IN NO EVENT WILL EITHER AMICUS OR GSK
BE LIABLE TO THE OTHER FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR
PUNITIVE DAMAGES ARISING UNDER OR AS A RESULT OF THIS AGREEMENT (OR THE
TERMINATION HEREOF) INCLUDING, BUT NOT LIMITED TO, THE LOSS OF PROSPECTIVE
PROFITS OR ANTICIPATED SALES.
 

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XVI. MISCELLANEOUS
16.1 Governing Law. For all matters other than the scope and validity of
Patents, this Agreement shall be deemed to have been made in the State of
Delaware and its form, execution, validity, construction and effect shall be
determined in accordance with the laws of the State of Delaware, without giving
effect to the principles of conflicts of law thereof and the Parties agree to
the personal jurisdiction of and venue in any federal or state court located in
Delaware. The application of the United Nations Convention for Contracts for the
International Sales of Goods is hereby expressly excluded.
16.2 Dispute Resolution.
16.2.1 The Parties agree that with respect to any disputes arising with respect
to the interpretation, breach, enforcement, termination or validity of this
Agreement (for the purposes of this Section 16.2, each a “Dispute”), the Dispute
shall first be presented to the Chief Executive Officer of Amicus and the GSK
Chairman of Research and Development, or their respective designees for
resolution. If the Amicus Chief Executive Officer and GSK Chairman or Research
and Development, or their respective designees, cannot resolve the Dispute
within ****** of the request to do so, either Party may initiate arbitration
proceedings with respect thereto as provided in Section 16.2.2 below. Prior to
the establishment of an arbitration tribunal, Amicus and GSK shall each have the
right to apply to any court of competent jurisdiction for appropriate interim or
provisional relief, as necessary to protect the rights or property of that
Party.
16.2.2 Any Dispute shall be finally resolved by arbitration in accordance with
the Commercial Arbitration Rules of the American Arbitration Association (“AAA”)
then in effect (the “Rules”), except as modified herein. The place of
arbitration shall be Wilmington, Delaware. If the amount in controversy ******,
there shall be one (1) neutral and impartial arbitrator who shall be agreed upon
by the Parties within twenty (20) days of receipt by respondent of a copy of the
demand for arbitration. If the amount in controversy ******, there shall be
three (3) arbitrators, of whom each Party shall appoint one (1) within thirty
(30) days of the receipt by the respondent of the 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.
 

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16.2.3 In the case of any Dispute arising under Section 1.93(f)(v) or
Section 14.3.10(c) or under Schedule 5.1.5, the procedures of this
Section 16.2.3 shall apply. Arbitration with respect to all such Disputes under
Section 1.93(f) (v) or Section 14.3.10(c) or under Schedule 5.1.5, as
applicable, 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 arising under Section 1.93(f)(v) or Section 14.3.10(c)
or under Schedule 5.1.5, as applicable, within ninety (90) days.
16.2.4 The arbitral tribunal is not empowered to award damages in excess of
compensatory damages, and each Party hereby irrevocably waives any right to
recover punitive, exemplary, multiple or similar damages with respect to any
Dispute. Any arbitration proceedings, decision, or award rendered hereunder and
the validity, effect, and interpretation of this arbitration provision shall be
governed by the Federal Arbitration Act, 9 U.S.C. §1 et seq. The decision of the
arbitral tribunal shall be in writing and, if applicable, shall state the
findings of fact and conclusions of law on which it is based. The decision of
the arbitral tribunal shall be final and binding upon the Parties regarding the
applicable Dispute presented to the arbitral tribunal. Judgment upon the
decision of the arbitral tribunal may be entered in any court having
jurisdiction. The arbitration proceedings and the decision of the arbitral
tribunal shall not be made public without the joint consent of the Parties and
each Party shall maintain the confidentiality of such proceedings and decision
unless each Party otherwise agrees in writing; provided that either Party may
make such disclosures as are permitted for Confidential Information of the other
Party under Article XI above. The Parties agree that they shall share equally
the cost of the arbitration filing and hearing fees, and the cost of the
arbitral tribunal and administrative fees of the AAA. Each Party shall bear its
own costs and attorneys’ and witnesses’ fees and associated costs and expenses.
The arbitral tribunal shall have full authority to grant provisional remedies
and to direct the Parties to request that any court modify or vacate any
temporary or preliminary relief issued by such court.
16.2.5 The Parties hereby submit to the exclusive jurisdiction of the federal
and state courts located in Delaware for the purpose of an order to compel
arbitration, for preliminary relief in aid of arbitration, or for a preliminary
injunction to maintain the status quo or prevent irreparable 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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16.3 Assignment and Binding Effect.
16.3.1 This Agreement may not be assigned, by operation of law or otherwise, by
either Party without the prior written consent of the other, except as otherwise
permitted under this Section 16.3:
(a) Amicus may assign this Agreement to an Affiliate or to a Third Party without
such prior written consent as part of a merger, consolidation, sale, or transfer
of all or substantially all its assets, but only if the assignee has or
simultaneously acquires all of the necessary rights and other assets to perform
Amicus’s obligations under this Agreement. A Change of Control or ownership of
Amicus by merger or otherwise will not constitute an impermissible assignment of
this Agreement by Amicus, provided, however, that such Change of Control event
shall be subject to the terms of Article XII herein.
(b) GSK may assign this Agreement to any Affiliate without the prior written
consent of Amicus. GSK may also assign this Agreement to a Third Party as part
of a merger, consolidation, sale, or transfer of all or substantially all its
assets, without the prior written consent of Amicus, but only if the assignee
has or simultaneously acquires all of the necessary rights and other assets to
perform GSK’s obligations under this Agreement.
16.3.2 No assignment under this Section 16.3 shall be effective unless the
intended assignee executes and delivers to the Party which is not the assignor a
writing whereby the assignee expressly undertakes to perform and comply with all
of its assignor’s obligations hereunder. Notwithstanding such undertaking, such
assignor shall continue to be primarily liable for such assignee’s performance
hereof and compliance herewith.
16.3.3 Any assignment in violation of this Section 16.3 shall be void and of no
effect.
16.3.4 This Agreement, and the rights and obligations of the Parties herein
contained, shall be binding upon, and shall inure to the benefit of, the Parties
and their respective legal representatives, successors and permitted assigns.
16.4 Independent Contractor Status. The relationship of the Parties is that of
independent contractors. Nothing in this Agreement will be construed to
constitute, create, give effect or otherwise imply a joint venture, agency,
partnership or other formal business organization or any employer/employee
relationship of any kind between the Parties.
 

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16.5 Notices. All notices, requests and other communications required or
permitted to be given hereunder or with respect hereto will be in writing and in
English, and may be given by (i) personal service, (ii) registered first-class
mail, postage prepaid, return receipt requested, (iii) express delivery service,
charges prepaid, or (iv) facsimile (complete transmission verified and a copy
promptly sent by another permissible method of providing notice described in
clauses (i), (ii) or (iii) above) and in each case addressed to the other Party
at the address for such Party as set forth below, and shall be effective upon
receipt in the case of clauses (i), (iii) or (iv) above, and five days after
mailing in the case of clause (ii) above.

         
 
  If to GSK:   Glaxo Group Limited
 
      Great West Road
 
      Brentford, Middlesex
 
      United Kingdom
 
      TW8 9GS
 
      Facsimile: +44 (020) 804 76904
 
      Attention: Company Secretary
 
       
 
  With a copy to:   GlaxoSmithKline
 
      980 Great West Road
 
      Brentford, Middlesex, TW8 9GS
 
      Facsimile: +44 (0) (208) 046-0641
 
      Attention: Marc Dunoyer
 
      President, GSK Rare Diseases
 
       
 
      And
 
       
 
      GlaxoSmithKline
 
      2301 Renaissance Boulevard
 
      Mail Code RN0220
 
      King of Prussia, PA 19406
 
      Facsimile: (610) 787-7084
 
      Attention: Vice President and Associate
 
      General Counsel, Legal Operations —
 
      Business Development Transactions
 
       
 
  If to Amicus:   Amicus Therapeutics, Inc.
 
      6 Cedar Brook
 
      Cranbury, New Jersey
 
      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

 

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The address of either Party set forth above may be changed from time to time by
written notice in the manner prescribed herein from the Party requesting the
change.
16.6 Further Assurances. The Parties will execute and deliver any further or
additional instruments or documents and perform any acts which may be reasonably
necessary in order to effectuate and carry out the purposes of this Agreement.
16.7 Waivers. The waiver by either Party of a default or a breach of any
provision of this Agreement by the other Party will not operate or be construed
to operate as a waiver of any subsequent default or breach. The continued
performance by either Party with knowledge of the existence of a default or
breach will not operate or be construed to operate as a waiver of any default or
breach. Any waiver by a Party of a particular provision or right will be in
writing, will be as to a particular matter and, if applicable, for a particular
period of time and will be signed by such Party.
16.8 Entire Agreement. This Agreement (including the Exhibits and Schedules
hereto), the Equity Agreement, any and all Trademark License Agreements and the
pharmacovigilance agreement described in Section 5.2.6(a) (in each case, if and
when executed by the Parties) constitute the entire agreement between the
Parties with respect to the subject matter hereof, and supersede all prior
agreements and negotiations with respect to such subject matter.
16.9 Severability. If any provision in this Agreement is deemed to be, or
becomes, invalid, illegal, void or unenforceable under applicable Laws, then:
(i) it will be deleted with respect to the applicable jurisdiction(s) to which
such Law pertains and the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired or affected in any way, and
(ii) the Parties will use Commercially Reasonable Efforts to substitute for the
invalid, illegal or unenforceable provision a valid, legal and enforceable
provision which conforms as nearly as possible with the original intent of the
Parties. ******. Any termination in accordance with the foregoing shall be
deemed a termination of this Agreement in its entirety pursuant to Section 13.3
if the Party who made the assertion was GSK, and shall be deemed a termination
of this Agreement in its entirety under Section 13.2 by reason of a breach by
Amicus, if Amicus is the Party who made such assertion.
16.10 Counterparts. This Agreement may be executed in more than one counterpart,
each of which shall be deemed to be an original but all of which taken together
shall be deemed a single instrument. A facsimile transmission of the signed
Agreement will be legal and binding on both Parties.
16.11 Force Majeure. Neither Party to this Agreement will be liable for failure
or delay in the performance of any of its obligations hereunder (other than the
failure to pay monies owed), if such failure or delay is due to acts of God,
earthquakes, fires, strikes, acts of war (whether declared or not), terrorism,
civil unrest, or intervention of any governmental authority or any other event
or occurrence beyond the reasonable control of such Party (a “Force Majeure
Event”), but any such delay or failure will be remedied by such Party as soon as
practicable after the removal of the cause of such failure or delay. Upon the
occurrence of Force Majeure Event, the Party failing or delaying performance
will promptly notify the other Party in writing, setting forth the nature of the
occurrence, its expected duration and how such Party’s performance is affected,
and the Party failing or delaying performance will use its Commercially
Reasonable Efforts to avoid or remove the causes of non-performance and shall
continue performance with the utmost dispatch whenever such causes are removed.
 

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Commission.

 

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16.12 Interest on Late Payments. If any Party fails to pay in full on or before
the date due any royalty, fee or other amount that is required to be paid to the
other Party under this Agreement, the paying Party will also pay to the other
Party (or its designee) interest at a rate equal to: (i) the prime rate as
reported by Citibank N.A., plus ******; or (ii) if lower, the maximum rate
permitted by law; calculated on the number of days such payment is delinquent,
compounded annually and computed on the basis of a three hundred sixty five
(365) day year.
16.13 Cumulative Remedies. Unless otherwise set forth in this Agreement, all
rights and remedies of the Parties, including all rights to payment, rights of
termination, rights to injunctive relief, and other rights provided under this
Agreement, shall be cumulative and in addition to all other remedies provided
for in this Agreement, in law, and in equity.
16.14 Amendment. This Agreement may not be amended, supplemented or otherwise
modified except by an instrument in writing signed by both Parties that
specifically refers to this Agreement.
16.15 Headings and References. All section headings contained in this Agreement
are for convenience of reference only and will not affect the meaning or
interpretation of this Agreement.
16.16 No Strict Construction. This Agreement has been prepared jointly and will
not be strictly construed against either Party.
[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 License and Collaboration Agreement to be executed by their
duly authorized representatives as of the date first written above.

                      AMICUS THERAPEUTICS, INC.       GLAXO GROUP LIMITED    
 
                   
By:
  /s/ John F. Crowley       By:   /s/ Paul Williamson    
 
 
 
Name: John F. Crowley          
 
Name: Paul Williamson    
 
  Title:   Chairman and CEO           Title:   Corporate Director    

 

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

 

 

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EXHIBIT A
EQUITY AGREEMENT
(See Exhibit 10.31 to Annual Report on Form 10-K filed on March 4, 2011)

 

 

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EXHIBIT B
INITIAL PRESS RELEASE
GSK and Amicus Therapeutics Enter Exclusive Worldwide Agreement to Develop and
Commercialize Amigal™ for Fabry Disease
-Amicus to receive $60M in upfront license payment and equity investment and
eligible for approximately $170M million in future potential milestone payments-
LONDON and CRANBURY, N.J., Oct 29, 2010 /PRNewswire via COMTEX News Network/ —
GlaxoSmithKline PLC (GSK) and Amicus Therapeutics (Nasdaq: FOLD) today announced
a definitive agreement to develop and commercialize Amigal™ (migalastat HCl),
currently in Phase 3 for the treatment of Fabry disease, a rare inherited
disorder. Under the terms of the agreement, GSK will receive an exclusive
worldwide license to develop, manufacture and commercialize migalastat HCl.
Additionally, as part of the agreement GSK and Amicus also intend to advance
clinical studies exploring the co-administration of migalastat HCl with enzyme
replacement therapy (ERT) for the treatment of Fabry disease.
Under the terms of the Agreement, Amicus will receive an upfront, license
payment of $30M from GSK and is eligible to receive further payments of
approximately $170M upon the successful achievement of development and
commercialization milestones, as well as tiered double-digit royalties on global
sales of migalastat HCl. GSK and Amicus will jointly fund development costs in
accordance with an agreed upon development plan. Additionally, as part of the
collaboration, GSK is purchasing 6.9 million shares of Amicus common stock at a
price of $4.56 per share. The total value of this equity investment to Amicus is
$31 million and represents a 19.9% ownership position for GSK in the Company.
The total cash up-front to Amicus from GSK for the upfront license payment and
equity investment is approximately $60 million.
“This strategic collaboration is another significant milestone in delivering our
vision for GSK Rare Diseases. Amicus’ scientific and clinical expertise in human
genetic diseases is among the best in the industry, and we are pleased to be
collaborators and investors in this exceptional company,” said Marc Dunoyer,
Global Head of GSK Rare Diseases and a member of the GSK Corporate Executive
Team. “Our focus now is to continue to advance Amigal for Fabry disease and it
is our hope to deliver a first-in-class, oral medicine to the thousands of
people worldwide living with this devastating rare disease.”
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics
said, “The completion of this agreement with GSK is a transformational event for
Amicus. It provides a strong validation of the potential for Amigal to become an
important new treatment option for people living with Fabry disease and for our
pharmacological chaperone technology broadly. GSK has extremely impressive
global clinical, regulatory and commercial expertise and a strong commitment to
the development of treatments for rare diseases. We look forward to working in
close partnership with them.” Crowley continued, “With this key strategic
alliance with GSK and the added financial strength it provides, Amicus is now
uniquely positioned to build shareholder value through our expertise in rare
disease drug development.”
About Amigal™ (migalastat HCl) for the Treatment of Fabry Disease
Migalastat HCl is an investigational treatment for Fabry disease and has the
potential to be the first in a new class of oral, small molecule medicines
called pharmacological chaperones. It is designed to selectively bind to and
stabilize the target enzyme alpha-galactosidase A (alpha-Gal A), which
facilitates proper trafficking of the enzyme to the lysosomes, where it is
needed to break down the target substrate globotriaosylceramide (GL-3).
Results from Phase 2 studies of migalastat HCl, which has orphan designation in
both the US and EU, demonstrated that in subjects identified as responders to
migalastat HCl treatment resulted in increased levels of alpha-Gal A, reduced
levels of GL-3 as measured in renal interstitial capillary cells from kidney
biopsies and in urine, and a potential positive impact on renal function.
Treatment with migalastat HCl has been generally well-tolerated, with no
drug-related serious adverse events. The most common adverse events were
headache, arthralgia and diarrhea.
A Phase 3 study (Study 011) commenced in the second quarter of 2009 and
treatment of the first patient began in the fourth quarter of 2009. This ongoing
study is a 6-month, randomized, double-blind trial comparing migalastat HCl to
placebo in 60 subjects in approximately 40 investigational sites worldwide. The
surrogate primary endpoint is the change in the amount of kidney interstitial
capillary GL-3. Subjects being enrolled are Fabry patients who have never
received enzyme replacement therapy (ERT), or who have not received ERT for at
least 6 months, and who have a mutation responsive to migalastat HCl.
GSK and Amicus today provided an update to the enrollment timeline for Study
011. Enrollment is now expected to be completed in the first quarter of 2011 and
preliminary results are expected to be announced in the second half of 2011.
Furthermore, a separate Phase 3 study (Study 012) is expected to commence before
year end. The study will be an 18-month, randomized, open-label study comparing
migalastat HCl to ERT in approximately 60 subjects. The primary outcome of
efficacy will be renal function as measured by glomerular filtration rate (GFR).
About Fabry Disease
Fabry disease is an inherited lysosomal storage disorder caused by deficiency of
an enzyme called alpha-galactosidase A (alpha-Gal A). The role of alpha-Gal A
within the body is to break down a complex lipid called globotriaosylceramide
(GL-3). Reduced or absent levels of alpha-Gal A activity leads to the
accumulation of GL-3 in the affected tissues, including the central nervous
system, heart, kidneys, and skin. This accumulation of GL-3 is believed to cause
the various symptoms of Fabry disease, including pain, kidney failure, and
increased risk of heart attack and stroke.

 

 

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It is currently estimated that Fabry disease affects approximately 5,000 to
10,000 people worldwide.
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 Therapeutics
Amicus Therapeutics is a biopharmaceutical company focused on developing
treatments for rare diseases. The Company is developing orally-administered,
small molecule drugs called pharmacological chaperones, a novel, first-in-class
approach to treating a broad range of diseases including lysosomal storage
disorders and CNS diseases. Amicus’ lead program is in Phase 3 for the treatment
of Fabry disease. For further information, please visit
www.amicustherapeutics.com.

     
Amicus Enquiries:
   
Analyst/Investor and Media enquiries:
  Jenene Thomas (609) 662-5084
 
   
GlaxoSmithKline Enquiries:
   
UK Media enquiries:
  David Mawdsley (020) 8047 5502
 
  Claire Brough (020) 8047 5502
 
  Stephen Rea (020) 8047 5502
 
  Alexandra Harrison (020) 8047 5502
 
  Jo Revill (020) 8047 5502
 
   
US Media enquiries:
  Nancy Pekarek (919) 483 2839
 
  Mary Anne Rhyne (919) 483 2839
 
  Kevin Colgan (919) 483 2839
 
  Sarah Alspach (919) 483 2839
 
   
European Analyst/Investor enquiries:
  Sally Ferguson (020) 8047 5543
 
  Gary Davies (020) 8047 5503
 
   
US Analyst/ Investor enquiries:
  Tom Curry (215) 751 5419
 
  Jen Hill Baxter (215) 751 7002

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 projected cash position for the Company, including achievement
of development and commercialization milestone payments and sales royalties
under our collaboration with GlaxoSmithKline. Words such as, but not limited to,
“look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,”
“plan,” “targets,” “likely,” “will,” “would,” “should” and “could,” and similar
expressions or words identify forward-looking statements. Such forward-looking
statements are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. The inclusion of forward-looking
statements should not be regarded as a representation by Amicus that any of its
plans will be achieved. Any or all of the forward-looking statements in this
press release may turn out to be wrong. They can be affected by inaccurate
assumptions Amicus might make or by known or unknown risks and uncertainties.
For example, with respect to statements regarding the goals, progress, timing
and outcomes of discussions with regulatory authorities and the potential goals,
progress, timing and results of preclinical studies and clinical trials, actual
results may differ materially from those set forth in this release due to the
risks and uncertainties inherent in the business of Amicus, including, without
limitation: the potential that results of clinical or pre-clinical studies
indicate that the product candidates are unsafe or ineffective; the potential
that it may be difficult to enroll patients in our clinical trials; the
potential that regulatory authorities may not grant or may delay approval for
our product candidates; the potential that preclinical and clinical studies
could be delayed because we identify serious side effects or other safety
issues; the potential that we will need additional funding to complete all of
our studies and, our dependence on third parties in the conduct of our clinical
studies. Further, the results of earlier preclinical studies and/or clinical
trials may not be predictive of future results. With respect to statements
regarding projections of the Company’s cash position, actual results may differ
based on market factors and the Company’s ability to execute its operational and
budget plans, including achievement of development and commercialization
milestone payments and sales royalties under our collaboration with
GlaxoSmithKline . 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, 2009. 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.
GSK’s 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 ‘Business Review’ in the company’ s Annual
Report on Form 20-F for 2009.

 

 

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EXHIBIT C
TRADEMARK LICENSE AGREEMENT
THIS TRADEMARK LICENSE AGREEMENT (“Agreement”) is made as of the
                     day of                     , 2010 (the “Effective Date”) by
and between Amicus Therapeutics, Inc., a Delaware corporation having a place of
business at 6 Cedar Brook Drive, Cranbury, New Jersey, 08512 (“Licensor”), as
licensor, and Glaxo Group Limited, a company organized under the laws of England
and Wales with its registered office at Glaxo Wellcome House, Berkeley Avenue,
Greenford, Middlesex, UB6 0NN, England (“Licensee”), as licensee. Licensee and
Licensor are sometimes collectively referred to herein as the “Parties” and
separately as a “Party.”
WHEREAS, pursuant to that certain License and Collaboration Agreement by and
between Licensee and Licensor, dated as of the                      day of
October, 2010 (the “License and Collaboration Agreement”), Licensor agreed to
license to Licensee certain trademarks in the Territory (as defined in the
License and Collaboration Agreement) as set forth on Exhibit A attached hereto,
including all common law rights to such trademarks in the Territory (the
“Licensed Marks”);
WHEREAS, Licensor is willing to grant, and Licensee is willing to receive, a
license to use the Licensed Marks in connection with Compound and Products (as
those terms are defined in the License and Collaboration Agreement) in the
Territory pursuant to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, agreements and
stipulations set forth herein and in the License and Collaboration Agreement,
the receipt and legal sufficiency of which are hereby mutually acknowledged,
Licensor and Licensee hereby agree as follows:
1. DEFINITIONS. Capitalized terms not otherwise defined in this Agreement shall
have the meanings set forth in the License and Collaboration Agreement.
2. GRANT OF LICENSE. During the Term of this Agreement, and pursuant to the
terms and conditions contained herein, Licensor hereby grants to Licensee and
its Affiliates, and Licensee and its Affiliates hereby accept, a non-exclusive,
royalty-free, sublicensable (subject to Section 8 hereof) license to use the
Licensed Marks in the Territory in connection with the making, having made, use,
sale, offering for sale, importation, packaging, distributing and promoting of
Product in the Field and in the country or countries of the Territory. In
addition, Licensee shall have the right to use the Licensed Marks (excluding
Amicus House Marks) as part of a domain name, subject to Licensor’s prior
written approval and provided that Licensee remains responsible for all costs
associated with development and operation of the associated website.

 

 

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3. USE OF THE LICENSED MARKS

  3.1.  
Upon reasonable advance written request, Licensee agrees to submit to Licensor
representative packaging for the Product displaying the Licensed Marks for
Licensor’s inspection. If Licensor reasonably determines that Licensee has
failed to maintain a level of quality consistent with those normally employed by
the Licensor in the use of the Licensor’s Trademarks, then Licensor may request
that Licensee take reasonable steps to remedy any such deficiencies and Licensee
agrees to take commercially reasonable actions to comply with such requests, and
in any event the Licensee shall not use or distribute any packaging for the
Product displaying the Licensed Marks until it has complied with such requests.

  3.2.  
Licensee and its Affiliates and Sub-licensees shall comply with all applicable
Laws pertaining to the Commercialization of Products bearing the Licensed Marks.

4. MAINTENANCE OF LICENSED MARKS.

  4.1.  
Licensor shall prosecute and maintain trademark applications and registrations
existing as of the Effective Date for the Licensed Marks used on or in
connection with Product in the Territory. All costs and expenses (including but
not limited to attorneys’ fees and expenses and official fees) of prosecuting
and maintaining applications and registrations existing as of the Effective Date
for the Licensed Marks shall be borne by Licensor. For the avoidance of doubt,
Licensee shall prepare, file, prosecute, maintain and own any Trademarks (other
than Amicus House Marks) that are created or designated by the JSC for use on
Product in the Territory after the Effective Date.

  4.2.  
Licensor shall not (i) abandon any rights in the Licensed Marks in the
Territory, (ii) abandon or allow to lapse any pending application for the
Licensed Marks in the Territory, or (iii) permit any active registration for the
Licensed Marks to lapse, expire or be cancelled in the Territory, without first
notifying Licensee.

5. TERM. This Agreement shall be effective commencing on the Effective Date and
shall continue perpetually unless terminated as set forth in Section 6 below.
6. TERMINATION.

  6.1.  
This Agreement shall terminate automatically, without notice or any further
action hereunder by either Party: (a) in its entirety upon the expiration or
termination of the License and Collaboration Agreement by a Party in its
entirety by Amicus pursuant to Section 13.2, by GSK pursuant to Section 13.3, or
by either Party pursuant to Section 13.4; or (b) with respect to a particular
Licensed Mark: (i) upon assignment of such Licensed Mark (other than an Amicus
House Mark) to Licensee if the License and Collaboration Agreement is terminated
by GSK pursuant to Section 13.2 with respect to the Product with which such
Licensed Mark is used in the country(ies) of the Territory in which such
Licensed Mark is registered or in use by a Party; or (ii) upon termination of
the License and Collaboration Agreement by GSK pursuant to Section 13.3, or by
Amicus pursuant to Section 13.2, of the License and Collaboration Agreement with
respect to the Product with which such Licensed Mark is used and/or in the
country(ies) of the Territory in which such Licensed Mark is registered or in
use by a Party.

 

 

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  6.2.  
The Parties may terminate this Agreement in its entirety or on a Licensed
Mark-by-Licensed Mark basis at any time and for any reason during the Term upon
their mutual written agreement; provided that the Parties shall agree to
terminate this Agreement, in its entirety, or on a Licensed Mark-by-Licensed
Mark or country-by-country basis, as applicable, if the JSC determines in
accordance with Section 2.4, 4.3.1 and 6.3 of the License and Collaboration
Agreement that such Licensed Mark(s) shall no longer be used with respect to a
Product(s) in a particular country(ies) of the Territory.

  6.3.  
Subject to and in accordance with Section 14.3 of the License and Collaboration
Agreement, upon termination or expiration of this Agreement, Licensee agrees (i)
immediately to discontinue, and to cause all of Licensee’s Affiliates and any
Sub-licensees of Licensee thereof immediately to discontinue, use of the
Licensed Marks; (ii) upon Licensor’s request, to return to Licensor or destroy
all tangible embodiments of any Licensed Marks; and (iii) if such items or
materials are destroyed by Licensee at Licensor’s request, to furnish Licensor
with certification and evidence of such destruction.

7. OWNERSHIP. Licensor represents and warrants, and Licensee acknowledges, that
the Licensed Marks are the sole and exclusive property of Licensor or its
Affiliates and all goodwill accrued through use of the Licensed Marks shall be
deemed to be the absolute property of Licensor or its Affiliates. Licensee
further acknowledges that nothing in this Agreement confers upon Licensee any
right of ownership in and to the Licensed Marks. Licensee agrees to reasonably
cooperate with Licensor to execute, deliver, and otherwise provide to Licensor
all information and documents reasonably requested for the purpose of
establishing, registering, evidencing or defending Licensor’s complete and
exclusive ownership of all rights, titles, and interests of every kind and
nature whatsoever in and to the Licensed Marks. Licensee agrees not to register,
use or authorize the use of any trademark or designation confusingly similar to
the Licensed Marks, and Licensee agrees not to challenge Licensor’s or its
Affiliates’ ownership of the Licensed Marks.
8. SUB-LICENCES. Licensee shall have the right to grant sublicenses under this
Agreement soley as and to the extent Licensee is permitted to grant Sublicenses
under and in accordance with Section 2.2 of the License and Collaboration
Agreement. In any event, Licensee shall ensure that each of its sublicensees is
bound by a written agreement containing provisions at least as protective of the
Licensed Marks and Licensor as this Agreement; and Licensee shall remain
responsible to Licensor for all activities of its Affiliates and sublicensees to
the same extent as if such activities had been undertaken by Licensee itself.
Promptly following the execution of each sublicense, Licensee shall provide
Licensor with a complete copy of such sublicense.

 

 

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

 

9. ASSIGNMENTS. Neither this Agreement, nor any of the rights or obligations of
a Party may be directly or indirectly assigned, sold, delegated or otherwise
disposed except by a Party in connection with an assignment of, and to the same
assignee as, the License and Collaboration Agreement in accordance with
Section 16.3 of the License and Collaboration Agreement.

  9.1.  
No assignment under this Section 9 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.

  9.2.  
Any assignment in violation of this Section 9 shall be void and of no effect.

  9.3.  
This Agreement, and the rights and obligations of the Parties herein contained,
shall be binding upon, and shall inure to the benefit of, the Parties and their
respective legal representatives, successors and permitted assigns.

10. AMENDMENTS. No waiver, amendment or modification of any provision hereof or
of any right or remedy hereunder shall be effective unless in writing and signed
by the Party against whom such waiver, amendment or modification is sought to be
enforced.
11. COUNTERPARTS. This Agreement may be executed in any number of counterparts,
each of which shall be deemed to be an original, but all of which together shall
constitute but one and the same instrument. Delivery of an executed counterpart
signature page of this Agreement by facsimile transmission shall be as effective
as delivery of a manually executed signature page.
12. APPLICABLE LAW AND DISPUTE RESOLUTION. This Agreement shall be governed by,
interpreted and construed, and all claims and disputes, whether in tort,
contract or otherwise be resolved in accordance with the substantive laws of the
State of Delaware without reference to any rules of conflict of laws. Any and
all disputes under this Agreement shall be resolved in accordance with
Section 16.2 of the License and Collaboration Agreement.
13. FURTHER ASSURANCES. Each of Party shall, at any time or from time to time
after the Effective Date, at the request and expense of the other Party, execute
and deliver to the other Party all such instruments and documents or further
assurances as the other Party may reasonably request in order to give effect to
the transactions contemplated by this Agreement, including but not limited to
Licensee’s request for Licensor’s cooperation to record or register this
Agreement with any applicable governmental entity.
14. REPRESENTATIONS AND WARRANTIES. Each Party represents and warrants that
(i) this Agreement has been duly and validly executed and delivered by such
Party and constitutes a legal and binding obligation of such Party, enforceable
against it in accordance with its terms, and (ii) it has all necessary right,
power and authority to execute and perform its obligations under this Agreement
and to grant the rights granted herein. Licensor further represents and warrants
that it is the owner of all right, title, and interest in and to the Licensed
Marks and that the execution, delivery, and performance of its obligations under
this Agreement will not conflict with or violate any agreement or other
obligation of Licensor or binding upon Licensor’s assets, including but not
limited to the Licensed Marks.

 

 

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

 

15. SEVERABILITY. If any provision of this Agreement is held to be illegal,
invalid or unenforceable under any present or future law, and if the rights or
obligations of either Party under this Agreement will not be materially and
adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement will remain in full force and effect and will not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable
provision, there will be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the
Parties.
16. WAIVER. No waiver by any Party in one or more instances of any of the
provisions of this Agreement or the breach thereof shall establish a precedent
for any other instance with respect to that or any other provision. Furthermore,
in case of waiver of a particular provision, all other provisions of this
Agreement will continue in full force and effect.
17. INTEGRATION. This Agreement (including Exhibits hereto), and the License and
Collaboration Agreement, embodies the entire agreement of the Parties hereto
with respect to the subject matter hereof and supersedes any and all prior
agreements with respect thereto.
[Remainder of page intentionally left blank]

 

 

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

          AMICUS THERAPEUTICS, INC.
      By:           Name:           Title:           GLAXO GROUP LIMITED
      By:           Name:           Title:        

 

 

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EXHIBIT A
TO TRADEMARK LICENSE AGREEMENT
LICENSED MARKS

              Registration/Application     Mark   No.   Territory/Country
 
       
AMIGAL
  3652668    US
 
       
AMIGAL
  128551900 (Application)   Canada
 
       
AMIGAL
  969558    Mexico
 
       
AMIGAL
  828170193 (Application)   Brazil
 
       
AMIGAL
  879558    EU (Austria, Benelux (Belgium, the Netherlands and Luxembourg),
Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Poland,
Portugal, Romania, the Slovak Republic, Slovenia, Spain, Sweden and the United
Kingdom)

Australia

Japan

Norway

Singapore

 

 

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EXHIBIT D
TRADEMARK LICENSE AGREEMENT
THIS TRADEMARK LICENSE AGREEMENT (“Agreement”) is made as of the
                     day of                     , 2010 (the “Effective Date”) by
and between Glaxo Group Limited, a company organized under the laws of England
and Wales with its registered office at Glaxo Wellcome House, Berkeley Avenue,
Greenford, Middlesex, UB6 0NN, England (“Licensor”), as licensor, and Amicus
Therapeutics, Inc., a Delaware corporation having a place of business at 6 Cedar
Brook Drive, Cranbury, New Jersey, 08512 (“Licensee”), as licensee. Licensee and
Licensor are sometimes collectively referred to herein as the “Parties” and
separately as a “Party.”
WHEREAS, pursuant to that certain License and Collaboration Agreement by and
between Licensee and Licensor, dated as of the                      day of
October, 2010 (the “License and Collaboration Agreement”), Licensor agreed to
license to Licensee certain trademarks in the Territory as set forth on
Exhibit A attached hereto, including all common law rights to such trademarks in
the Territory (the “Licensed Marks”);
WHEREAS, Licensor is willing to grant, and Licensee is willing to receive, a
license to use the Licensed Marks in connection with Compound and Products (as
those terms are defined in the License and Collaboration Agreement) in Territory
pursuant to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, agreements and
stipulations set forth herein and in the License and Collaboration Agreement,
the receipt and legal sufficiency of which are hereby mutually acknowledged,
Licensor and Licensee hereby agree as follows:

1.  
DEFINITIONS. Capitalized terms not otherwise defined in this Agreement shall
have the meanings set forth in the License and Collaboration Agreement.

2. GRANT OF LICENSE. During the Term of this Agreement, and pursuant to the
terms and conditions contained herein, Licensor hereby grants to Licensee and
its Affiliates, and Licensee and its Affiliates hereby accept, a non-exclusive,
royalty-free license to use the Licensed Marks in the country or countries of
the Territory solely in connection with Licensee’s right to:

  2.1.  
Develop Compound and Product in the Field as provided in Article V of the
License and Collaboration Agreement;

  2.2.  
Manufacture Compound or Product in the Field in accordance with Section 6.5 of
the License and Collaboration Agreement; and

  2.3.  
engage in Commercialization activities in accordance with the then-current
Marketing Plan in the Field in accordance with Article VI of the License and
Collaboration Agreement.

 

 

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

 

Licensee shall have the right to use the Licensed Marks (excluding GSK House
Marks) as part of a domain name, subject to Licensor’s prior written approval
and provided that Licensee remains responsible for all costs associated with
development and operation of the associated website.
3. USE OF THE LICENSED MARKS

  3.1.  
Upon reasonable advance written request, Licensee agrees to submit to Licensor
samples of the Product (to the extent Manufactured by Licensee or its designee)
and samples of packaging of the Product displaying the Licensed Marks for
Licensor’s inspection. If Licensor reasonably determines that Licensee has
failed to maintain a level of quality consistent with those normally employed by
the Licensor in the use of the Licensor’s Trademarks, then Licensor may request
that Licensee take reasonable steps to remedy any such deficiencies and Licensee
agrees to take commercially reasonable actions to comply with such requests, and
in any event, the Licensee shall not use or distribute Product or any packaging
for the Product displaying the Licensed Marks until it has complied with such
requests.

  3.2.  
Licensee and its Affiliates and sub-licensees shall comply with all applicable
laws and regulations pertaining to the Commercialization of Products bearing the
Licensed Marks, to the extent that Licensee shall perform any such
Commercialization activities under the License and Collaboration Agreement.

4. MAINTENANCE OF LICENSED MARKS.

  4.1.  
Licensor shall prepare, file, prosecute and maintain trademark applications and
registrations for the Licensed Marks used on or in connection with Product in
the Territory. All costs and expenses (including but not limited to attorneys’
fees and expenses and official fees) of preparing, filing, prosecuting and
maintaining the Licensed Marks shall be borne by Licensor.

  4.2.  
Licensor shall not (i) abandon any rights in the Licensed Marks in the
Territory, (ii) abandon or allow to lapse any pending application for the
Licensed Marks in the Territory, or (iii) permit any active registration for the
Licensed Marks to lapse, expire or be cancelled in the Territory, without first
notifying Licensee.

5. TERM. This Agreement shall be effective commencing on the Effective Date and
shall continue perpetually unless terminated as set forth in Section 6 below.
6. TERMINATION.

  6.1.  
This Agreement shall terminate automatically, without notice or any further
action hereunder by either Party: (a) in its entirety upon the expiration or
termination of the License and Collaboration Agreement in its entirety by GSK
pursuant to Section 13.2 of the License and Collaboration Agreement or by either
Party pursuant to Section 13.4 of the License and Collaboration Agreement; or
(b) with respect to a particular Licensed Mark, (i) upon assignment of such
Licensed Mark (other than a GSK House Mark) to Licensee, if the License and
Collaboration Agreement is terminated by GSK pursuant to Section 13.3, or by
Amicus pursuant to Section 13.2, of the License and Collaboration Agreement, or
(ii) upon termination of the License and Collaboration Agreement by GSK pursuant
to Section 13.2, with respect to the Product with which such Licensed Mark is
used and/or in the country(ies) of the Territory in which such Licensed Mark is
registered or in use by a Party.

 

 

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

 

  6.2.  
The Parties may terminate this Agreement in its entirety or on a Licensed
Mark-by-Licensed Mark basis at any time and for any reason during the Term upon
their mutual written agreement; provided that the Parties shall agree to
terminate this Agreement, in its entirety, or on a Licensed Mark-by-Licensed
Mark basis, as applicable, if the JSC determines in accordance with Section 2.4,
4.3.1 and 6.3 of the License and Collaboration Agreement that such Licensed
Mark(s) shall no longer be used with respect to a Product(s) in a particular
country(ies) of the Territory.

  6.3.  
Subject to and in accordance with Section 14.3 of the License and Collaboration
Agreement, upon termination or expiration of this Agreement, Licensee agrees,
with respect to any Licensed Marks that are not Terminated Product Trademarks
assigned (or to be assigned) to Amicus in accordance with Section 14.3.9 of the
License and Collaboration Agreement: (i) immediately to discontinue, and to
cause all of Licensee’s Affiliates and any sub-licensees of Licensee thereof
immediately to discontinue, use of such Licensed Marks; (ii) upon Licensor’s
request, to return to Licensor or destroy all tangible embodiments of any such
Licensed Marks; and (iii) if such items or materials are destroyed by Licensee
at Licensor’s request, to furnish Licensor with certification and evidence of
such destruction.

7. OWNERSHIP. Licensor represents and warrants, and Licensee acknowledges, that
the Licensed Marks are the sole and exclusive property of Licensor or its
Affiliates and all goodwill accrued through use of the Licensed Marks shall be
deemed to be the absolute property of Licensor or its Affiliates. Licensee
further acknowledges that nothing in this Agreement confers upon Licensee any
right of ownership in and to the Licensed Marks. Licensee agrees to reasonably
cooperate with Licensor to execute, deliver, and otherwise provide to Licensor
all information and documents reasonably requested for the purpose of
establishing, registering, evidencing or defending Licensor’s complete and
exclusive ownership of all rights, titles, and interests of every kind and
nature whatsoever in and to the Licensed Marks. Licensee agrees not to register,
use or authorize the use of any trademark or designation confusingly similar to
the Licensed Marks, and Licensee agrees not to challenge Licensor’s or its
Affiliates’ ownership of the Licensed Marks.

 

 

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

 

8. ASSIGNMENTS. Neither this Agreement, nor any of the rights or obligations of
a Party may be directly or indirectly assigned, sold, delegated or otherwise
disposed of by a Party except in connection with such Party’s assignment of, and
to the same assignee as, the License and Collaboration Agreement in accordance
with Section 16.3 of the License and Collaboration Agreement.

  8.1.  
No assignment under this Section 8 shall be effective unless the intended
assignee executes and delivers to the Party which is not the assignor a writing
whereby the assignee expressly undertakes to perform and comply with all of its
assignor’s obligations hereunder. Notwithstanding such undertaking, such
assignor shall continue to be primarily liable for such assignee’s performance
hereof and compliance herewith.

  8.2.  
Any assignment in violation of this Section 8 shall be void and of no effect.

  8.3.  
This Agreement, and the rights and obligations of the Parties herein contained,
shall be binding upon, and shall inure to the benefit of, the Parties and their
respective legal representatives, successors and permitted assigns.

9. AMENDMENTS. No waiver, amendment or modification of any provision hereof or
of any right or remedy hereunder shall be effective unless in writing and signed
by the Party against whom such waiver, amendment or modification is sought to be
enforced.
10. COUNTERPARTS. This Agreement may be executed in any number of counterparts,
each of which shall be deemed to be an original, but all of which together shall
constitute but one and the same instrument. Delivery of an executed counterpart
signature page of this Agreement by facsimile transmission shall be as effective
as delivery of a manually executed signature page.
11. APPLICABLE LAW AND DISPUTE RESOLUTION. This Agreement shall be governed by,
interpreted and construed, and all claims and disputes, whether in tort,
contract or otherwise be resolved in accordance with the substantive laws of the
State of Delaware without reference to any rules of conflict of laws. Any and
all disputes under this Agreement shall be resolved in accordance with
Section 16.2 of the License and Collaboration Agreement.
12. FURTHER ASSURANCES. Each of Party shall, at any time or from time to time
after the Effective Date, at the request and expense of the other Party, execute
and deliver to the other Party all such instruments and documents or further
assurances as the other Party may reasonably request in order to give effect to
the transactions contemplated by this Agreement, including but not limited to
Licensee’s request for Licensor’s cooperation to record or register this
Agreement with any applicable governmental entity.
13. REPRESENTATIONS AND WARRANTIES. Each Party represents and warrants that
(i) this Agreement has been duly and validly executed and delivered by such
Party and constitutes a legal and binding obligation of such Party, enforceable
against it in accordance with its terms, and (ii) it has all necessary right,
power and authority to execute and perform its obligations under this Agreement
and to grant the rights granted herein. Licensor further represents and warrants
that it is the owner of all right, title, and interest in and to the Licensed
Marks and that the execution, delivery, and performance of its obligations under
this Agreement will not conflict with or violate any agreement or other
obligation of Licensor or binding upon Licensor’s assets, including but not
limited to the Licensed Marks.

 

 

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

 

14. SEVERABILITY. If any provision of this Agreement is held to be illegal,
invalid or unenforceable under any present or future law, and if the rights or
obligations of either Party under this Agreement will not be materially and
adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement will remain in full force and effect and will not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable
provision, there will be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the
Parties.
15. WAIVER. No waiver by any Party in one or more instances of any of the
provisions of this Agreement or the breach thereof shall establish a precedent
for any other instance with respect to that or any other provision. Furthermore,
in case of waiver of a particular provision, all other provisions of this
Agreement will continue in full force and effect.
16. INTEGRATION. This Agreement (including Exhibits hereto), and the License and
Collaboration Agreement, embodies the entire agreement of the Parties hereto
with respect to the subject matter hereof and supersedes any and all prior
agreements with respect thereto.
[Remainder of page intentionally left blank]

 

 

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

 

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

          GLAXO GROUP LIMITED
      By:           Name:           Title:           AMICUS THERAPEUTICS, INC.
      By:           Name:           Title:        

 

 

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

 

EXHIBIT A
TO TRADEMARK LICENSE AGREEMENT
LICENSED MARKS

          Mark   Registration No.   Territory/Country          

 

 

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

 

Exhibit 10.30 (schedules)
Schedule 1.25
BACKGROUND LICENSE AGREEMENTS

1)   ******

2)   ******

3)   Amended and Restated Agreement between Mount Sinai School of Medicine of
New York University and Amicus Therapeutics, Inc., dated October 31, 2008.

 

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

 

 

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Exhibit 10.30 (schedules)
Schedule 1.34
DESCRIPTION OF COMPOUND
United States Adopted Name: migalastat
Other Chemical Names:

1)   1-deoxygalactonojirimycin   2)  
(2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol

Chemical Structure:
(FORMULA) [c13524c1352403.gif]
MOLECULAR FORMULA: C6H13NO4
MOLECULAR WEIGHT: 163.17
CAS REGISTRY NUMBER: 108147-54-2
 

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

 

 

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Exhibit 10.30 (schedules)
Schedule 2.2
RESTRICTED SUBLICENSEES
******
 

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

 

 

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Schedule 3.5.2
THIRD PARTY ROYALTIES OWED BY AMICUS
As of the Effective Date, pursuant to Amended and Restated Agreement between
Mount Sinai School of Medicine of New York University (“MSSM”) and Amicus
Therapeutics, Inc., dated October 31, 2008 (“MSSM License”) royalties are
payable by Amicus to MSSM at the rates specified below and otherwise in
accordance with the terms of the MSSM License:

  •   ******; and

  •   ******.

Capitalized terms used in this Schedule 3.5.2 and not defined in the License and
Collaboration Agreement to which this Schedule 3.5.2 is attached have the
meanings given to such terms in the MSSM License, a copy of which has been
provided by Amicus to GSK prior to the Effective Date.

 

 

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Exhibit 10.30 (schedules)
Schedule 5.1
INITIAL DEVELOPMENT PLAN
******
 

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

 

 

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Schedule 5.1.5
DEVELOPMENT COST SHARING
******

 

 

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Exhibit 10.30 (schedules)
Schedule 6.5.1
TECHNOLOGY TRANSFER REQUIREMENTS
Technology Transfer Requirements
Contacts

1.   Name, address, phone, FAX, and e-mail address key technical contacts at
Amicus and all third parties involved in process development, manufacture,
analysis, or release.

Materials

2.   Entire inventory of drug substance, and intermediates, along with their
batch histories, batch records and analytical results (to the extent such
histories, records and analytical results can be reproduced and transferred from
the site of the contract manufacturer).

3.   All drug substance primary reference standard and any reports describing
its characterization and assignment of purity.

4.   Working references standards for drug substance, intermediates and
impurities along with any report on their comparability, characterization, or
assignment of purity.

API (chemical synthesis)

5.   An updated schematic of the chemical synthesis, including typical yields
for each stage.

6.   Copies of detailed complete manufacturing instructions for all stages and
operations of the API chemical synthesis processes on the largest scale to date,
including all in-process analytical tests and methods.

7.   Available documented process knowledge established through development and
commercial supply.

8.   Cleaning method and validation reports for each stage of the chemical
processes.

9.   For all key raw materials, a table of suppliers, cost/kg, ordering lead
times, and buying specifications, including detailed specifications of any
components to the extent access to such information is provided to Amicus by the
contract manufacturer.

10.   A summary report describing the history of chemical synthesis process
development, changes and their reason, and optimization of the processes.

 

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

 

 

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Analytical

11.   A report summarizing available data describing the physical properties of
the drug substance, including MW, solubility, pI, etc as applicable.

12.   The Drug Substance Stability Report, including all data and methods.

13.   Current specifications for drug substance and starting materials,
including justification for the specifications.

14.   A complete drug substance batch history table, including lot number,
amount, Certificates of Analyses, and use or intended use (particularly for
safety assessment or clinical studies).

15.   A statement or certificate of available api inventory is free from
TSEs/BSEs.

16.   All analytical methods employed for analysis of the drug substance used in
safety assessment and clinical trial supplies. This should include
methods/limits of detection/limits of quantification for heavy metals and low
level potential genotoxic impurities if such analysis is performed.

17.   A table listing all impurities (by Retention Time of the major, Relative
Retention Time and {% (a/a) or (w/w)} of all impurities present in the drug
substance used in safety assessment studies and in the clinical trial supplies.

18.   A table or report describing drug substance impurities including critical
and typical levels, probable origins, and methods for control, particularly for
any known or potential highly-toxic or mutagenic impurities or degradants.

19.   A report summarizing effort to characterize drug substance impurities.

20.   A report summarizing the history of analytical methods development.

21.   A table of isolated intermediate acceptance criteria or buying
specifications, and their analytical methods (including purity profile),
including limits for any potentially mutagenic or highly toxic impurities.

22.   Recommended storage conditions for the drug substance and intermediates
suitable for international shipping.

23.   Any shipping studies data for drug substance and intermediates including
container specifications used for storage and shipping.

Drug Product: Formulation and Manufacturing

24.   Full analytical data on all batches of drug substance that have been
converted to drug product.

25.   Reports on and details of pre-formulation studies

26.   Reports on and details of development pharmaceutics, including all
formulation approaches considered and evaluated

27.   Any analytical methods developed or modified subsequent to formulation
development, method validation and drug product specifications.

28.   Results of any drug-excipient compatibility studies that have been
conducted if applicable.

 

 

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

 

29.   Any available drug product stability data

30.   Details of the manufacturing process

31.   Full manufacturing records to the extent access to such information is
provided to Amicus by the contract manufacturer (******)

32.   Statement or certificate that the drug product capsules do not contain
TSEs/BSEs.

33.   Inventory of all drug batches, with CoA, shelf life, input drug substance
and other details

34.   Formulation and process details of toxicology formulations and approaches
including crystal form of input drug substance

35.   Any shipping studies or data product including container specifications
used for storage and shipping.

Regulatory

36.   All CMC regulatory documentation including all regulatory filings,
including agency questions and responses, especially those related to any aspect
of primary drug substance manufacture, analysis, batch histories, impurity
profiles, or stability.

37.   Any regulatory data to support international shipment or shaking of drug
substance or process materials.

38.   Any drug substance process data or reports needed to support GSK
regulatory filings.

Environmental, Health and Safety

39.   Any worker safety information on the drug substance, formulation,
reagents/excipients, including toxicity (including exposure limits, where
known), thermal, gaseous or other hazards.

  •   MSDS (where applicable)     •   Occupational exposure limits or exposure
guidelines (where defined).     •   Occupational Hygiene monitoring and
analytical methods (where available)

 

 

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

 

40.   A report summarizing any environmental process safety assessment for the
API process, including

  •   Environmental fate and effects data (e.g., aquatic toxicity,
biodegradability, bioaccumulation potential) for API/materials/excipients.

  •   Chemical hazard data for the process used to manufacture drug substance
(e.g., material stability, hazardous incompatibilities, etc.)

Intellectual Property

  •   Reference to any Amicus intellectual property (e.g. patents, patent
applications) covering the drug substance, intermediates, or synthetic
processes.

 

 

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Exhibit 10.30 (schedules)
Schedule 6.5.4
AMICUS API AND DRUG PRODUCT SPECIFICATIONS
******
 

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

 

 

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

 

Exhibit 10.30 (schedules)
Schedule 7.2.1
GSK PROSECUTED AMICUS PATENTS
******
 

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

 

 

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Exhibit 10.30 (schedules)
Schedule 7.2.2
AMICUS PROSECUTED PATENTS
******
 

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

 

 

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

 

Exhibit 10.30 (schedules)
Schedule 7.2.3
PATENT APPLICATIONS TO BE SEGREGATED PER SECTION 7.2.3
******
 

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

 

 

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Exhibit 10.30 (schedules)
Schedule 10.2
BACKGROUND LICENSE AGREEMENT PROVISIONS
1. MSSM LICENSE
Pursuant to Section 2.d. of the MSSM License, GSK agrees: (i) to be bound by,
and comply with, Sections 6 (Confidential Information), 9 (Liability and
Indemnification) and 10 (Security for Indemnification) of the MSSM License
(substituting “GSK” for “AMICUS” in such provisions), the text of which is
included below and incorporated herein by reference, to the extent applicable to
GSK in its capacity as sublicensee; and (ii) that MSSM is an intended third
party beneficiary of the Agreement for purposes of enforcing such
indemnification and insurance provisions.
Pursuant to Section 2.c. of the MSSM License, GSK agrees: (a) the sublicense
granted by Amicus to GSK under the MSSM License shall be subject and subordinate
to the terms and conditions of the MSSM License; (b) such sublicense shall
expire automatically on the termination of the MSSM License; (c) such sublicense
shall not be assignable, in whole or in part; provided, however, that GSK may,
with written notice to MSSM, assign the sublicense in connection with a merger
or acquisition of GSK or the sale by the sublicensee of substantially all of its
assets; (d) GSK shall be entitled to grant further sublicenses, provided that
GSK complies with the obligations of Amicus under Section 2.c., Section 2.d. and
all other provisions of MSSM License relating to the grant of sublicenses by
Amicus under the MSSM License; and (e) both during the term of such sublicense
and thereafter GSK shall be bound by a secrecy obligation similar to that
imposed on Amicus in Section 6 of the MSSM License, and that GSK shall bind its
employees and agents, both during the terms of their employment and thereafter,
with a similar undertaking of secrecy. In addition, GSK, in its capacity as a
sublicensee under the MSSM License, specifically agrees to comply with the audit
rights applicable to sublicensees and the obligation to maintain books and
records to enable the determination of the amounts payable by Amicus, as a
result of the activities of GSK in its capacity as a sublicensee under the MSSM
License.
Provisions Extracted from MSSM License:
Capitalized terms in the following provisions of the MSSM License, but not
defined therein, shall have the meanings given to such terms in the MSSM
License.
 

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Commission.

 

 

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“6.   Confidential Information.

  a.   In the course of research to be performed under this Agreement, it will
be necessary for each party to disclose “Confidential Information” to the other.
For purposes of this Agreement, “Confidential Information” is defined as all
information, data and know-how disclosed by one party (the “Disclosing Party”)
to the other (the “Receiving Party”), either embodied in tangible materials
(including writings, drawings, graphs, charts, photographs, recordings,
structures, technical and other information) marked “Confidential” or, if
initially disclosed orally, which is reduced to writing marked “Confidential”
within 21 days after initial oral disclosure, other than that information which
is,

  i)   known by the Receiving Party at the time of its receipt, and not through
a prior disclosure by the Disclosing Party, as documented by the Receiving
Party’s business records; or

  ii)   at the time of disclosure, or thereafter becomes, published or otherwise
part of the public domain without breach of this Agreement by the Receiving
Party; or

  iii)   obtained from a third party who has the legal right to make such
disclosure and without any confidentiality obligation to the Disclosing Party;
or

  iv)   independently developed by the Receiving Party without the use of
Confidential Information received from the Disclosing Party and such independent
development can be documented by the Receiving Party; or

  v)   disclosed to governmental or other regulatory agencies in order to obtain
patents, provided that such disclosure may be made only to the extent reasonably
necessary to obtain such patents or authorizations, and further provided that
any such patent applications shall be filed in accordance with the terms of this
Agreement; or

  vi)   required by law, regulation, rule, act or order of any governmental
authority to be disclosed.

  b.   The Receiving Party agrees that at all times and notwithstanding any
termination, expiration, or cancellation hereunder, it will hold the
Confidential Information of the Disclosing Party in strict confidence, will use
all reasonable safeguards to prevent unauthorized disclosure by its employees
and agents. Notwithstanding the foregoing, the parties recognize that industry
standards with respect to the treatment of Confidential Information may not be
appropriate in an academic setting. However, MSSM agrees to retain Confidential
Information of AMICUS in the same manner and with the same level of
confidentiality as MSSM retains its own Confidential Information.

  c.   The Receiving Party will maintain reasonable procedures to prevent
accidental or other loss, including unauthorized publication of any Confidential
Information of the Disclosing Party. The Receiving Party will promptly notify
the Disclosing Party in the event of any loss or unauthorized disclosure of the
Confidential Information.

  d.   Upon termination or expiration of this Agreement, and upon written
request, the Receiving Party will promptly return to the Disclosing Party all
documents or other tangible materials representing Confidential Information and
all copies thereof.

  e.   The Receiving Party will immediately notify the Disclosing Party in
writing, if it is requested by a court order, a governmental agency, or any
other entity to disclose Confidential Information in the Receiving Party’s
possession. The Disclosing Party will have an opportunity to intervene by
seeking a protective order or other similar order, in order to limit or prevent
disclosure of the Confidential Information. The Receiving Party will disclose
only the minimum Confidential Information required to be disclosed in order to
comply, whether or not a protective order or other similar order is obtained by
the Disclosing Party.”

 

 

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“9.   Liability and Indemnification.

  a.   AMICUS shall indemnify, defend and hold harmless MSSM and its trustees,
officers, directors, medical and professional staff, employees, students and
agents and their respective successors, heirs and assigns (the “Indemnitees”),
against any liability, damage, loss or expense (including reasonable attorneys’
fees and expenses of litigation) incurred by or imposed upon the Indemnitees or
any one of them in connection with any claims, suits, actions, demands or
judgments: (i) arising out of the production, manufacture, sale, use in commerce
or in human clinical trials, lease, or promotion by AMICUS or by a licensee,
Affiliate or agent of AMICUS of any Licensed Product, process or service
relating to, or developed pursuant to, this Agreement, or (ii) arising out of
any other activities to be carried out pursuant to this Agreement.

  b.   AMICUS’s indemnification under subsection a(i), above, shall apply to any
liability, damage, loss or expense whether or not it is attributable to the
negligent activities of the Indemnitees. AMICUS’s indemnification under
subsection a(ii) above, shall not apply to any liability, damage, toss or
expense to the extent that it is attributable to the negligence, gross
negligence or intentional misconduct of the Indemnitees.

  c.   AMICUS shall, at its own expense, provide attorneys reasonably acceptable
to MSSM to defend against any actions brought or filed against any party
indemnified hereunder with respect to the subject of indemnity contained herein,
whether or not such actions are rightfully brought.

  d.   EXCEPT AS PROVIDED IN THIS SECTION 9, NEITHER PARTY SHALL BE LIABLE TO
THE OTHER FOR INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES.

 

 

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  10.   Security for Indemnification.

  a.   At such time as any Licensed Product is being commercially distributed or
sold (other than for the purpose of obtaining regulatory approvals) by AMICUS or
by a sub-licensee, Affiliate or agent of AMICUS and to the extent that it is
available on commercially reasonable terms, AMICUS shall at its sole cost and
expense, procure and maintain policies of comprehensive general liability
insurance in amounts not less than ****** per incident and ****** annual
aggregate and naming the indemnitees as additional insureds. Such comprehensive
general liability insurance shall provide (i) product liability coverage and
(ii) broad form contractual liability coverage for AMICUS’s indemnification
under Section 9 of this Agreement. The minimum amounts of insurance coverage
required under this Section 10 shall not be construed as a limit of AMICUS’s
liability with respect to its indemnification under Section 9 of this Agreement.

  b.   AMICUS shall provide MSSM with written evidence of such insurance upon
request of MSSM. AMICUS shall provide MSSM with written notice at least 60 days
prior to the cancellation, non-renewal or material change in such insurance; if
AMICUS does not obtain replacement insurance providing comparable coverage
within such 60 day period effective immediately upon notice to AMICUS, MSSM
shall have the right to terminate this Agreement effective at the end of such
60 day period without notice or any additional waiting periods.

  c.   AMICUS shall maintain such comprehensive general liability insurance
beyond the expiration or termination of this Agreement during: (i) the period
that any product, process or service, relating to, or developed pursuant to,
this Agreement is being commercially distributed or sold (other than for the
purpose of obtaining regulatory approvals) by AMICUS or by a licensee, Affiliate
or agent of AMICUS and (ii) a reasonable period after the period referred to in
(c)(i) above which in no event shall be less than seven years.”

 

 

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Exhibit 10.30 (schedules)
Schedule 13.6
CALCULATION OF ROYALTY RATE REDUCTION
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      ******   - Material has been omitted and filed separately with the
Commission.