EXHIBIT 10.20
LICENSE AND COLLABORATION AGREEMENT
dated as of November 7, 2007
by and between
Amicus Therapeutics, Inc.
and
Shire Pharmaceuticals Ireland Ltd.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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TABLE OF CONTENTS

              Page  
ARTICLE 1 DEFINITIONS
    1  
 
       
ARTICLE 2 GRANT OF RIGHTS
    11  
 
       
2.1 Amicus Grant
    11  
2.2 Sublicenses
    12  
2.3 Exchange of Data and Know-How
    13  
2.4 [***]
    13  
2.5 No Implied Licenses
    14  
 
       
ARTICLE 3 GOVERNANCE
    14  
 
       
3.1 Joint Steering Committee
    14  
3.2 Joint Development Committee
    15  
3.3 Joint Commercialization Committee
    16  
3.4 Special Committees and Sub-Committees; Financial Procedures
    16  
3.5 Committee Membership, Decision-Making and Operations
    17  
3.6 Alliance Managers
    19  
 
       
ARTICLE 4 DEVELOPMENT
    19  
 
       
4.1 Overall Efforts in Development
    19  
4.2 Development Plans
    19  
4.3 Post-Marketing Studies; Monitoring of Independent Trials
    21  
4.4 Subcontractors
    22  
4.5 Combination Products
    22  
4.6 Term of Ongoing Development and Committee Obligations
    23  
 
       
ARTICLE 5 COMMERCIALIZATION in the Shire Territory
    23  
 
       
5.1 General
    23  
5.2 Diligence
    23  
5.3 Territory Compliance
    23  
5.4 Bundling
    23  
 
       
ARTICLE 6 CERTAIN OTHER ACTIVITIES
    23  
 
       
6.1 Label Expansions and New Formulations within the Field
    23  
6.2 [***] for [***]’s
    28  
6.3 Related Products
    30  
6.4 Termination by JSC; Back-Up Compounds
    31  
6.5 Additional Terms Regarding Related Product/Back-Up Compound Opt-In Rights
    35  
6.6 Independent Development and Commercialization of Related Products
    36  
6.7 Reservation
    36  

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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              Page  
ARTICLE 7 PAYMENTS, ROYALTIES AND THE SHARING OF DEVELOPMENT COSTS
    37  
 
       
7.1 License Fee
    37  
7.2 Milestone Payments
    37  
7.3 Royalties
    39  
7.4 Development Cost Sharing
    43  
7.5 Payments under Existing In-Licenses
    44  
7.6 Other Payment Terms
    45  
7.7 Taxes
    45  
7.8 Records Retention; Audits
    46  
 
       
ARTICLE 8 MANUFACTURING AND SUPPLY
    47  
 
       
8.1 General
    47  
8.2 Supply Agreement
    48  
8.3 Limitation; Manufacturing by Shire
    48  
 
       
ARTICLE 9 REGULATORY MATTERS
    48  
 
       
9.1 Regulatory Responsibilities
    48  
9.2 Filings and Meetings with Regulatory Authorities.
    49  
9.3 Adverse Events and Post-Market Surveillance
    49  
9.4 Common Registration Dossier
    50  
9.5 Regulatory Inspections
    50  
9.6 Audit Rights
    50  
 
       
ARTICLE 10 INTELLECTUAL PROPERTY
    51  
 
       
10.1 Ownership
    51  
10.2 Patent Filing, Prosecution, and Maintenance
    52  
10.3 Enforcement Against Third Parties
    53  
10.4 Defense of Infringement Claims
    54  
10.5 Patent Marking
    55  
10.6 License of Third Party Rights.
    55  
 
       
ARTICLE 11 TRADEMARKS AND COPYRIGHTS
    56  
 
       
11.1 Product Marks
    56  
 
       
ARTICLE 12 REPRESENTATIONS, WARRANTIES AND COVENANTS
    57  
 
       
12.1 Mutual Representations, Warranties and Covenants
    57  
12.2 Amicus Additional Representations, Warranties and Covenants
    59  
12.3 Disclaimer
    63  
 
       
ARTICLE 13 INDEMNIFICATION; INSURANCE
    63  
 
       
13.1 Indemnification of Shire
    63  
13.2 Indemnification of Amicus
    63  

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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              Page  
13.3 Procedure
    64  
13.4 Insurance
    64  
 
       
ARTICLE 14 CONFIDENTIALITY
    64  
 
       
14.1 Confidentiality; Exceptions
    64  
14.2 Authorized Disclosure
    65  
14.3 Termination of Prior Agreement
    65  
14.4 Disclosure of Terms
    66  
14.5 Publications
    66  
14.6 Press Releases and Announcements
    66  
 
       
ARTICLE 15 TERM AND TERMINATION
    67  
 
       
15.1 Term
    67  
15.2 Termination for Breach
    67  
15.3 Termination by Shire
    67  
15.4 Termination for Bankruptcy
    68  
15.5 Effects of Expiration or Termination
    68  
15.6 Survival
    72  
 
       
ARTICLE 16 GENERAL PROVISIONS
    72  
 
       
16.1 Assignment
    72  
16.2 Independent Contractors
    73  
16.3 Third Party Beneficiaries
    73  
16.4 Waiver
    73  
16.5 Force Majeure
    73  
16.6 Severability
    73  
16.7 Governing Law; Dispute Resolution
    73  
16.8 Arbitration for Committee Disputes and Certain Other Disputes
    73  
16.9 Construction
    75  
16.10 Notices
    75  
16.11 Amendment
    76  
16.12 Entire Agreement
    76  
16.13 Execution in Counterparts; Facsimile Signatures
    76  
16.14 Provisions of Existing In-Licenses
    76  

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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EXECUTION COPY
LICENSE AND COLLABORATION AGREEMENT
     This License and Collaboration Agreement (this “Agreement”) is made as of
November 7, 2007 (the “Effective Date”), by and between Amicus Therapeutics,
Inc., a Delaware corporation (“Amicus”), and Shire Pharmaceuticals Ireland Ltd.,
a corporation organized under the laws of Ireland (“Shire” and each of Amicus
and Shire, a “Party”).
BACKGROUND
     A. Amicus has developed a platform for the treatment of human genetic
diseases comprising the use of small molecule drugs, referred to as
pharmacological chaperones, which selectively bind to an active site of a target
protein, thereby enhancing the protein’s stability and ability to fold into the
correct three-dimensional shape, to restore proper biological activity of the
target protein. Amicus currently is conducting human clinical trials on three
products containing such pharmacological chaperone compounds, which Amicus
refers to as Plicera™, Amigal™ and AT2220.
     B. Shire is an established pharmaceutical company which focuses its
experience and expertise in the development and commercialization of
pharmaceutical products in select areas, including among them, human genetic
disorders.
     C. Shire desires to acquire rights to the Licensed Products for
commercialization outside the United States, and to collaborate with Amicus in
the further Development of such Licensed Products, all on the terms and
conditions set forth below in this Agreement.
     Now, therefore, in consideration of the foregoing premises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:
ARTICLE 1
DEFINITIONS
     In addition to terms defined elsewhere in this Agreement, the following
terms shall have the respective meanings set out below, and grammatical
variations of such terms shall have corresponding meanings.
     1.1 “Affiliate” means, with respect to a Party, any person, corporation or
other entity which, directly or indirectly through one or more intermediaries,
controls, is controlled by or is under common control with such Party, as the
case may be. As used in this Section 1.1, “control” shall mean: (a) direct or
indirect beneficial ownership of at least 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 voting stock or other ownership interest in
such person, corporation or other entity; or (b) to possess, directly or
indirectly, the power to affirmatively direct the management and
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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policies of such person, corporation or other entity, whether through ownership
of voting stock or other ownership interest or by contract relating to voting
rights or corporate governance.
     1.2 “Amicus IP” shall mean the Amicus Know-How and Amicus Patent Rights,
defined as follows:
          1.2.1 “Amicus Know-How” means Know-How Controlled by Amicus as of the
Effective Date or during the Term, and that is necessary, useful or actually
used by Amicus to Develop, Manufacture or Commercialize Licensed Products in the
Field.
          1.2.2 “Amicus Patent Rights” means those Patent Rights listed on
Appendix 1 and any and all other Patent Rights Controlled by Amicus during the
Term that are necessary, useful or actually practiced by Amicus, to Develop,
Manufacture or Commercialize a Licensed Product in the Field. Appendix 1 shall
be updated from time to time as requested by either Party to reflect all
additional Patent Rights within the Amicus Patent Rights.
     1.3 “Commercialization” or “Commercialize” means activities directed to
marketing, advertising, promoting, detailing, distributing, importing or selling
a product, including Post-Marketing Studies, Manufacture of commercial supplies
and education, planning, product support and medical efforts related to a
product. For clarity, Manufacturing process development, scale-up and validation
of Manufacturing with respect to a Licensed Product prior to the first
Regulatory Approval in a Primary Market for such Licensed Product (or in
connection with establishing second source manufacturers or manufacturing sites)
shall not be deemed Commercialization and shall instead be considered
Development (unless and to the extent, in the case of validation batches, such
batches are used as commercial supplies), while further process development,
scale-up and/or validation of Manufacturing after the first Regulatory Approval
in a Primary Market for such Licensed Product shall be included within
Commercialization.
     1.4 “Commercially Reasonable Efforts” means, with respect to a Party, the
efforts and resources which would be used by that Party relating to a certain
activity or activities, consistent with its normal business practices for a
product at a similar stage in its development and of similar market potential in
a field of the biopharmaceutical industry of similar size as the Field that such
Party is seeking to Develop and Commercialize in a reasonably expeditious
manner.
     1.5 “Compound” means the following chemical entities:
          1.5.1 deoxygalactonojirimycin having the structure shown in
Exhibit 1.5.1, and any [***] thereof (“Deoxygalactonojirimycin” or “DGJ”);
          1.5.2 deoxynojirimycin having the structure shown in Exhibit 1.5.2,
and any [***] thereof (“Deoxynojirimycin” or “DNJ”);
          1.5.3 isofagomine having the structure shown in Exhibit 1.5.3, and any
enantiomers, [***] thereof (“Isofagomine” or “[***]”); and
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          1.5.4 any other chemical entity that the Parties agree to add as a
Compound under Section 6.3 or 6.4.4 below. If the Parties agree to add an
additional Compound as described in this Section 1.5.4, the Parties shall attach
to this Agreement an Exhibit 1.5.x, describing the chemical structure of such
compound, it being understood that only the chemical entity so described, plus
enantiomers, metabolites, salts and polymorphs thereof, shall be deemed so added
as a Compound.
     As used in this Agreement, any reference to a Compound shall be deemed to
include enantiomers, metabolites, salts and polymorphs thereof.
     1.6 “Controlled” means, with respect to any intellectual property right or
other intangible property, the possession by license or ownership by a Party (or
by an Affiliate (a) of such Party as of the Effective Date, (b) controlled, as
defined in Section 1.1 above, by such Party or such an Affiliate, or (c) that
first becomes an Affiliate after the Effective Date and is involved in the
Development of the Compounds) of the ability to grant to the other Party access
or a license or sublicense as provided herein without violating the terms of any
written contract with any Third Party.
     1.7 “Data” means any and all (a) research data, pharmacology data,
chemistry, manufacturing and control data, preclinical data, clinical data and
other similar technical and scientific data necessary, useful or actually used
in the Development or Manufacture of Licensed Products within the Field or
otherwise generated under the Development Plans and (b) all documentation and
correspondence submitted, or required to be submitted, to a Regulatory
Authority, or received from a Regulatory Authority, in connection with a
Regulatory Approval for a Licensed Product within the Field in any country,
including, without limitation, information in any drug master files or similar
documentation.
     1.8 “Development” means all activities related to (a) researching or
developing a Licensed Product, or obtaining Regulatory Approvals for such
products or indications (including Label Expansions and New Formulations within
the Field pursuant to Section 6.1) in the Territory, including preclinical
testing, toxicology, formulation, clinical trials, and regulatory affairs, as
well as (b) Phase IV Clinical Trials and preclinical studies conducted after
Regulatory Approval (such as carcinogenicity studies, preclinical studies to
establish pediatric dosing and the like) that are required or requested by a
Regulatory Authority to be conducted after Regulatory Approval, as a condition
of or in connection with obtaining such Regulatory Approval. Development shall
also include Manufacturing activities for the purposes of producing clinical
supplies (or materials used in preclinical testing or research), as well as
Manufacturing scale up, process development and validation for such a product
prior the first Regulatory Approval of such a product in the first Primary
Market (including manufacturing batches for validation and registration
purposes, to the extent such batches are not used as commercial supplies) and
the establishment of second source manufacturers or manufacturing sites.
Development shall not include Manufacture of commercial supplies or
Commercialization. As used herein “Develop” shall also include such activities
with respect to a Compound, Related Product or Back-Up Compound.
     1.9 “Development Costs” means, except as otherwise expressly provided in
this Agreement, the internal and external costs incurred by a Party or a
Subsidiary in performing
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Development activities in accordance with the applicable Development Plan,
including, (a) costs of clinical trials for Licensed Products in the Field and
related clinical trial materials, (b) costs of non-clinical studies and related
study materials, (c) costs associated with preparing and submitting Regulatory
Filings to obtain, maintain and/or expand Regulatory Approval of Licensed
Products in the Field, (d) costs associated with establishing and validating
Manufacturing facilities (including process development and optimization of
Manufacturing processes) to Manufacture Licensed Products in the Field and
(e) such other amounts as reflected in such Development Plan. For such purposes,
costs for a Party’s personnel performing the Development Plans shall, unless
otherwise determined by the JSC and reflected in the applicable Development
Plan, be calculated on the basis of the FTE Rate. Any dispute regarding
Development Costs shall be referred to the JDC for resolution in accordance with
the terms and conditions of this Agreement.
     1.10 “EMEA” means the European Medicines Agency or any successor agency
with responsibility for regulating the development, manufacture and sale of
human pharmaceutical products in the European Union.
     1.11 “[***]” means a meeting held with the responsible Party and the
Regulatory Authority of a Primary Market Country to review the data and results
of the Phase II Clinical Trials of a Licensed Product and to discuss with the
Regulatory Authority such Party’s plan to commence a Phase III Clinical Trial of
such Licensed Product and plans to complete additional work (e.g., preclinical
testing and manufacturing) in support of a future license application.
     1.12 “Ex-U.S. Platform Patent Rights” means those Amicus Patent Rights
listed on Appendix 2.
     1.13 “European Union” means Austria, Belgium, Bulgaria, the Czech Republic,
Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
     1.14 “FDA” means the United States Food and Drug Administration and any
successor thereto.
     1.15 “Field” means the diagnosis, treatment and/or prevention of
(a) Gaucher Disease, Fabry Disease or Pompe Disease, (b) to the extent the
Parties mutually agree, in accordance with Section 6.1.5 below, to include an
additional indication beyond those described in (a) above, such additional
indication and (c) if Shire duly exercises the [***]‘s Option, then with respect
to [***] for [***]’s (but only [***] for [***]’s), [***]’s.
     1.16 “First Commercial Sale” means the first bona fide commercial sale of a
Licensed Product for use in the Field within a country in the Territory
following issuance of all applicable Regulatory Approvals required prior to
commercial sale in such country.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     1.17 “FTE Rate” means initially $[***] per FTE (i.e., a full-time
equivalent person) per year, subject to adjustment as follows: Commencing as of
January 1, 2009, the FTE Rate shall increase on January 1 of each year by the
percentage increase in the Consumer Price Index, for All Urban Consumers, as
published by the U.S. Department of Labor, Bureau of Labor Statistics, since the
last such increase under this definition (or in the case of the first such
increase, the Effective Date) and such increase shall be effective for the
then-current and all subsequent Development Plans hereunder until further
modified under this definition. Any dispute regarding adjustment of the FTE Rate
shall be referred to the JDC for resolution in accordance with the terms and
conditions of this Agreement.
     1.18 “[***] for [***]’s” means a pharmaceutical product containing [***],
for the treatment or prevention of [***]’s. It is understood that references
herein to an [***] for [***]’s shall be deemed limited to the use of such
product only for the treatment and/or prevention of [***]’s, and shall not
include any other use of such product.
     1.19 “IND” means an Investigational New Drug Application filed with the FDA
or the equivalent application or filing necessary to commence clinical trials in
a foreign jurisdiction, as applicable.
     1.20 “Know-How” means all information, results and Data of any type, in any
tangible or intangible form pertaining to the Development, Manufacturing or
Commercialization of Licensed Products within the Field, including without
limitation databases, ideas, discoveries, inventions, trade secrets, practices,
methods, tests, assays, techniques, specifications, processes, formulations,
formulae, knowledge, know-how, skill, experience, materials, including
pharmaceutical, chemical and biological materials, products and compositions,
scientific, technical or test data (including pharmacological, biological,
chemical, biochemical, toxicological and clinical test data), analytical and
quality control data, stability data, studies, procedures, drawings, plans,
designs, diagrams, sketches, technology, documentation or descriptions.
Notwithstanding the foregoing, as used in this Agreement, “Know-How” (a) does
not include Patent Rights in the foregoing and (b) does not include methods,
assays, materials, techniques, or other items used or useful to perform drug
discovery or research in the Field, to the extent such items are not reasonably
necessary, useful or used to perform clinical trials or Manufacturing of
Licensed Products, preclinical testing in support of such clinical trials and/or
Manufacturing, or Commercialization of a Licensed Product within the Field.
     1.21 “Licensed Product” means (a) Amigal, (b) AT2220, (c) Plicera and
(d) any other pharmaceutical formulation of a Compound developed under a
Development Plan, or by Shire as an Independent Project in accordance with
Section 6.1 below or as part of a Combination Product in accordance with
Section 4.5, containing a Compound. For such purposes, and as otherwise used
herein:
          1.21.1 “Amigal” means that certain pharmaceutical product containing
the active chemical entity Deoxygalactonojirimycin, the formulation of which is
described in IND number 68,456;
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          1.21.2 “AT2220” means that certain pharmaceutical product containing
the active chemical entity Deoxynojirimycin, the formulation of which is
described in IND number 76,268; and
          1.21.3 “Plicera” means that certain pharmaceutical product containing
the active chemical entity Isofagomine the formulation of which is described in
IND number 73,475.
     1.22 “MAA” means any marketing authorization application for a country or
region, requesting approval from the applicable Regulatory Authority for
commercial sale of a Licensed Product in the Field in such country or region,
and all amendments and supplements filed to any such application.
     1.23 “Manufacture” means manufacturing and related activities, including
chemical synthesis, formulation, processing, testing, packaging, labeling,
storing, warehousing, quality control, quality assurance, releasing, disposing,
handling, shipping and all other activities undertaken or required to be
undertaken in order to manufacture and supply a Compound or Licensed Product.
     1.24 “NDA” means a New Drug Application for any product, as appropriate,
requesting permission to place a drug on the market in accordance with 21 C.F.R.
Part 314, and all supplements or amendments filed pursuant to the requirements
of the FDA, including all documents, data and other information concerning a
product which are reasonably necessary for FDA approval to market a product in
the United States.
     1.25 “Net Sales” means the gross amounts invoiced for sales of Licensed
Products in the Shire Territory by Shire, its Affiliates and/or its Sublicensees
to Third Parties, less deductions for the following costs actually allowed or
incurred:
          1.25.1 freight, postage and transportation charges on shipment of such
Licensed Product to the customer, including handling and insurance on such
shipment;
          1.25.2 sales (such as VAT or its equivalent) and excise taxes, other
consumption taxes, customs duties and other governmental charges imposed upon
the sale of such Licensed Product to the customer;
          1.25.3 charge-back payments, rebates, and similar product-specific
payments paid to a governmental entity specifically with respect to sales of
Licensed Products under a governmental rebate program;
          1.25.4 trade, quantity and cash discounts actually granted to the
customer with respect to the Licensed Product;
          1.25.5 credits, rebates and charge-backs, and allowances or credits to
the customer on account of damaged products, rejection or returns of Licensed
Products or on account of retroactive price reductions affecting such Licensed
Product;
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          1.25.6 actual bad debt expense not to exceed [***] of gross amounts
invoiced; and
          1.25.7 any item similar in character or substance to any of the
foregoing prevailing at the time and customary in the pharmaceutical industry at
the time as determined by the JSC.
     Notwithstanding the foregoing, the amounts described in [***]. Sales among
a Party and its Affiliates or permitted Sublicensees for resale shall be
excluded from the computation of Net Sales; provided, however, that the
subsequent resale shall be included in Net Sales hereunder. If a Licensed
Product is sold for consideration other than cash, the Net Sales from such sale
or transfer shall be deemed the then fair market value of such Licensed Product.
For clarity, Net Sales shall include sales of a Licensed Product made pursuant
to a pre-license sale through a named patient basis sales program or other
special access sales program. The supply of Licensed Products without charge
(x) as commercial samples, (y) as charitable donations or (z) for use in
Development and Post-Marketing Studies shall be excluded from the computation of
Net Sales.
     In the event that a Licensed Product is sold as part of a Combination
Product in accordance with Section 4.5, Net Sales from sales of such Combination
Product shall be determined pursuant to Section 4.5.
     1.26 “[***].
     1.27 “Patent Rights” means (a) all patents and patent applications
(including provisional applications), and all patents issuing thereon (including
utility, model and design patents and certificates of invention), (b) all
reissue patents, patents of addition, divisions, renewals, continuations,
continuations-in-part, substitutions, extensions (including supplemental
protection certificates), registrations, confirmations, re-examinations and
(c) foreign counterparts of any of the foregoing.
     1.28 “Phase II Clinical Trial” means a human clinical trial of a Licensed
Product conducted for purposes of preliminary determination of efficacy and/or
preliminary establishment of appropriate dosage ranges for efficacy and safety
in patients with the disease or condition being studied and that would satisfy
the requirements under 21 C.F.R. §312.21(b).
     1.29 “Phase III Clinical Trial” means a human clinical trial of a Licensed
Product intended to be a pivotal trial for obtaining Regulatory Approval or to
otherwise establish safety and efficacy in patients with the disease or
condition being studied for purposes of filing an NDA with the FDA or an MAA
with the EMEA and that would satisfy the requirements under 21 C.F.R.
§312.21(c).
     1.30 “Phase IV Clinical Trial” means a human clinical trial for a Licensed
Product conducted after receipt of Regulatory Approval in the country for which
such trial is being conducted and that is required or requested by a Regulatory
Authority to be conducted after Regulatory Approval, as a condition of or in
connection with obtaining and maintaining such Regulatory Approval.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     1.31 “Post-Marketing Studies” means marketing studies, epidemiological
studies, modeling and pharmacoeconomic studies, investigator sponsored clinical
trials and post-marketing surveillance studies of a Licensed Product, other than
Phase IV Clinical Trials, that are not intended for use as a basis for obtaining
Regulatory Approval (e.g., for a further indication, label expansion or
otherwise) with respect to such Licensed Product.
     1.32 “Primary Market” means any one or more of the following: United
States, France, Germany, Italy, Spain and the United Kingdom.
     1.33 “Product Marks” means the product-specific trademarks, logos, trade
dress, or other symbols which a Party uses to Commercialize a Licensed Product
in its Territory, but excluding the Amicus and Shire company names, tradenames,
logos, trade dress and the like.
     1.34 “Regulatory Authority” means any federal, national, multinational,
provincial, state or local regulatory agency, department, bureau or other
governmental entity, within a regulatory jurisdiction in the Territory, with the
authority to grant any approvals, licenses, registrations or authorizations
necessary for the Development, Manufacture, use, Commercialization or coverage
and reimbursement of a Licensed Product. For clarity, references in this
Agreement to “Regulatory Authority of a Primary Market Country” shall be deemed
to include the EMEA.
     1.35 “Regulatory Approval” means, with respect to a particular country, all
approvals (including, without limitation, where applicable, pricing and
reimbursement approval and schedule classifications), licenses, registrations or
authorizations by any Regulatory Authority necessary for the Development,
Manufacture, use, storage, import, transport, Commercialization or sale of a
Licensed Product in such country.
     1.36 “Regulatory Filings” means all documents filed with a Regulatory
Authority, including INDs, NDAs, MAAs, Drug Master Files and the like, as well
as their counterparts in jurisdictions other than the United States.
     1.37 “Related Agreement” means a Pharmacovigilance Agreement or other
agreements entered into by the Parties pursuant to or in connection with this
Agreement.
     1.38 “Sole Invention” means either a Shire Invention or an Amicus
Invention.
     1.39 “Sublicensee” shall mean a Third Party to whom Shire (or a
Sublicensee) has granted a right to make, use, sell, offer for sale, import or
Commercialize a Licensed Product in the Shire Territory pursuant to Section 2.2;
and “Sublicense” shall mean an agreement or arrangement granting such rights. As
used in this Agreement, “Sublicensee” shall not include a wholesaler or reseller
of a Licensed Product who does not market or promote such Licensed Product.
     1.40 “Territory” means both the Amicus Territory and the Shire Territory,
each as defined below:
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          1.40.1 “Amicus Territory” means the United States of America,
including the District of Columbia and including all possessions, territories
and protectorates thereof and shall include the European Union with respect to a
Licensed Product upon the reversion of the European Union with respect to such
Licensed Product in accordance with Section 7.2.5.
          1.40.2 “Shire Territory” means the entire world excluding the Amicus
Territory.
     As used herein, the phrase “a Party’s Territory” or “such Party’s
Territory” shall mean either the Amicus Territory or the Shire Territory, as the
context indicates.
     1.41 “Third Party” means any person or entity, including a governmental
entity, other than Amicus, Shire or their respective Affiliates.
     1.42 “Valid Claim” means a claim of a pending patent application or an
issued and unexpired patent, within the Amicus Patent Rights that has not been
held unpatentable, invalid or unenforceable by a court or other government
agency of competent jurisdiction in an unappealed or unappealable decision
(provided, however, that if the holding of such court or agency is later
reversed by a court or agency with appropriate authority, the claim shall be
reinstated as a Valid Claim) and has not been admitted to be invalid or
unenforceable through reissue, re-examination, disclaimer or otherwise nor lost
in an interference proceeding. Notwithstanding the foregoing, in the case of a
pending but unissued patent application, a pending claim of such application
shall not be deemed a Valid Claim if more than three (3) years have elapsed
since the first priority date to which such claim takes priority; such claim
shall thereafter not be deemed a Valid Claim until such claim issues in a patent
and otherwise meets this definition.
     1.43 The following terms have the meanings defined in the corresponding
sections of this Agreement referenced below:

              Defined Term   Section   Defined Term   Section
[***]
  7.2.4(e)   Manufacturing Cost   7.3.3(b)(ii)
Acting Party
  10.2.5   Materials   8.1
Alleged Infringement
  10.3.1   Milestone   7.2.3
Alliance Manager
  3.6   MSSM   16.14
Annual Net Sales
  7.3.1   MSSM Agreement   16.14
Amicus Indemnitees
  13.2   New Formulation   6.1.1
Amicus Invention
  10.1.2(a)   Non-Developing Party   6.1.2(b)
Auditing Party
  7.8.2   Notice Date   15.5.2(a)(ii)
Back-Up Compound
  6.4.4(a)   Notice Period   15.5.2(a)(ii)
Back-Up Compound Notice
  6.4.4(b)   Offer   6.2.2(a)
Back-Up Compound Opt In
Exercise Period
  6.4.4(c)   Opt-In Notice   6.1.3(a)
Back-Up Compound Opt In
  6.4.4(a)   Opt-In Period   6.1.3(a)

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Right
           
Breach Notice
  15.2   Opt-In Right   6.1.3
Business Day
  16.9   Shire Indemnitees   13.1
[***]
  7.2.4   Shire Invention   10.1.2(a)
Collaboration Results Publication
  14.5   Shire IP   6.1.1(d)(ii)
Combination Product
  4.5   [***]’s Option   6.2.1
Commercializing Party
  10.6.2   [***]’s Option Exercise Fee   6.2.1(b)
Committee
  3.4.1   [***]’s Option Notice   6.2.1(a)
Committee Co-Chair
  3.5.4   [***]’s Option Period   6.2.1(a)
Committee Dispute
  16.8.1   Permitted Overrun   7.4.2
[***]
  7.2.4(d)   Pharmacovigilance Agreement   9.3
Confidential Information
  14.1   Prosecuting Party   10.2.4
Confidentiality Agreement
  14.3   prosecution and maintenance   10.2.6
Cooperating Party
  14.6.2   Receiving Party   7.4.4(b)
Developing Party
  6.1.1   Reimbursable Share   6.1.3(c)
Development Period
  15.5.2(a)(ii)   Reimbursing Party   7.4.4(b)
Development Plan
  4.2.1   Related Product   6.3.1
Excess Costs
  7.4.2   Related Product Notice   6.3.1
Existing In-Licenses
  10.6.1   Related Product-Opt In Period   6.3.2
Force Majeure Event
  16.5   Related Product-Opt In Right   6.3.2
Forecast
  4.2.1   Requesting Party   6.4.1
Generic Competition
  7.3.2   Responding Party   7.8.2
Generic Version
  7.3.2   Reverted Products   15.5.2(a)(i)
Gross Margin
  7.3.3(b)(i)   RFR Acceptance   6.2.2(a)
[***]
  2.2.2(b)   RFR Acceptance Period   6.2.2(a)
Indemnitee
  13.3   Right of First Refusal   6.2.2
Indemnitor
  13.3   Right of First Refusal Notice   6.2.2(a)
Independent Development Costs
  6.1.2(c)(ii)   [***]   7.2.4(e)
Independent Project
  6.1.2(a)   [***]   2.4.1
Independent Trial
  4.3.2   Secondary Country   7.2.5
Initiating Party
  14.6.2   Special Committee   3.4.1
[***]
  7.2.4(c)   Spending Party   7.4.2
Inspected Party
  9.5   Statement of Costs   6.1.2(c)(i)
JAMS
  16.8.1(b)   Sublicensing Party   10.6.2
JCC
  3.3   [***]   7.2.4(a)

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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JDC
  3.2   [***]   7.2.4(b)
Joint Commercialization Committee
  3.3   Supply Agreement   8.2
Joint Development Committee
  3.2   Target   6.3.1
Joint Inventions
  10.1.2(a)   Term   15.1
Joint Patent Rights
  10.2.3   Terminated Product   6.4.4(a)
Joint Steering Committee
  3.1   Third Party Claim   13.1
JSC
  3.1   Third Party Technology   10.6.2
JSC Proposal Notice
  6.1.1   Trademark Licensee   11.1.3
Label Expansion
  6.1.1   Trademark Licensor   11.1.3
Laws
  16.9   [***]   2.4.3
Liabilities
  13.1   [***]   15.5.2(a)(ii)
Licensors
  10.6.1   Wind down Period   15.5.2(b)

ARTICLE 2
GRANT OF RIGHTS
     2.1 Amicus Grant. Subject to the terms and conditions of this Agreement,
Amicus hereby grants to Shire, under the Amicus IP:
          2.1.1 an exclusive license to use, import and sell or Commercialize
Licensed Products in the Field (excluding the treatment, prevention or diagnosis
of Fabry Disease with Amigal) in the Shire Territory, subject to Section 2.1.3;
          2.1.2 a sole license (with a right to sublicense) to use, import and
sell or Commercialize Amigal for the treatment, prevention or diagnosis of Fabry
Disease in the Shire Territory, subject to Section 2.1.3;
          2.1.3 a co-exclusive (with Amicus and its contractors or licensees)
license to Manufacture the Compounds and Licensed Products in the Territory for
use, import, sale or Commercialization within the Field in the Shire Territory
(specifically subject to Section 8.3 below) and to Develop the Licensed Products
within the Field (specifically subject to Section 6.1 below); provided, that if
a Party (or any other entity acting under authority of such Party) proposes to
perform clinical trials of a Licensed Product for an indication in the Field in
a country within the other Party’s Territory, the conduct of such trial in such
country shall be subject to such other Party’s approval, not to be unreasonably
withheld; and
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          2.1.4 the right to have the foregoing performed on its behalf by
subcontractors in accordance with Section 4.4.
     Shire agrees that neither it, nor any of its Affiliates, shall (a) practice
the Amicus IP other than as expressly authorized under this Article 2 if such
actions would constitute an infringement or misappropriation thereof nor
(b) Develop or Commercialize in the Amicus Territory a product containing a
Compound, except as a Licensed Product in accordance with this Agreement.
     2.2 Sublicenses.
          2.2.1 Affiliates. Shire may grant to one or more of its Affiliates a
Sublicense in connection with Shire’s Development, Manufacture and/or
Commercialization of the Compounds and Licensed Products under this Agreement;
provided that Shire shall remain responsible for the activities of such
Affiliate to the same extent as if such activities were conducted by Shire.
          2.2.2 Third Parties.
               (a) Shire may also grant to Third Parties a Sublicense under the
rights granted to Shire under Section 2.1 to one or more Licensed Products, to
the extent not in conflict with Section 2.1 or this Section 2.2.2.
               (b) Notwithstanding Paragraph (a) above, Shire may grant a
Sublicense under this Section 2.2.2 (i) only to a Third Party that is not a
“competitor of Amicus” and (ii) in a country where Shire or an Affiliate of
Shire has direct commercial operations in [***], only if Shire remains primarily
responsible for conducting Commercialization activities in such country. For
such purposes, a “competitor of Amicus” shall mean those companies listed on
Appendix 3 or as appended thereto upon the written agreement of the Parties.
          2.2.3 Conditions of Sublicenses. If Shire grants a Sublicense under
its rights in Section 2.1, such Sublicense shall be at least as protective of
the Compounds and Licensed Products as the terms and conditions of this
Agreement. Shire shall remain responsible for the performance of any of its
Sublicensees under such rights, and shall remain responsible for any payments
due hereunder with respect to activities of the Sublicensee. Shire shall use
Commercially Reasonable Efforts to ensure that its Sublicensees perform at the
same level as Shire is obligated to perform hereunder and do not engage in
activities that would be harmful to the Licensed Products or the business
related to the Licensed Products, and to take appropriate measures to remedy any
failure of a Sublicensee to comply with the foregoing. It is understood and
agreed that, except as may be otherwise agreed in writing by the Parties,
Sublicensees shall have no rights with respect to the Committees or with respect
to the Development Plans, nor to exercise any provision of this Agreement other
than the exercise of their rights pursuant to Section 2.1 above. Upon request,
Shire shall provide to Amicus a copy of the Sublicense, provided that the
agreement may be redacted to the extent not necessary for Amicus to understand
the scope and terms of such Sublicense. For purposes of clarity, Shire shall
have the right to redact all financial and other proprietary terms with
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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respect to any Sublicense agreement provided to Amicus as required hereunder to
the extent not required to determine that such Sublicense complies with this
Agreement.
     2.3 Exchange of Data and Know-How.
          2.3.1 By Amicus. Promptly following the Effective Date, Amicus will
make available to Shire, at no cost or expense to Shire, all Amicus Know-How
necessary, useful or used to Develop Licensed Products within the Field,
including all Data for such Licensed Products within the Field that Amicus has
of the Effective Date.
          2.3.2 By Either Party. During the Term, Amicus shall provide to Shire
additional Amicus Know-How developed pursuant to activities under the
Development Plans necessary, useful or used to Develop Licensed Products within
the Field, and Shire shall provide to Amicus any Know-How Controlled by Shire
and developed pursuant to activities under the Development Plans necessary,
useful or used to Develop the Licensed Products within the Field, in each case
that has not previously been provided hereunder, promptly upon request by the
other Party. The Party providing such Know-How shall provide the same in
electronic form to the extent the same exists in electronic form, and shall
provide copies as reasonably requested or an opportunity for the other Party to
inspect (and copy) all other materials comprising such Know-How (including, for
example, original patient report forms and other original source data, to the
extent allowable under Laws). Except as expressly provided, neither Party shall
be obligated under this Section 2.3.2 (or other provisions requiring disclosure
of Know-How hereunder) to provide to the other Party (a) any of the providing
Party’s Confidential Information that does not relate to a Licensed Product
within the Field, including competitive and marketing strategies generally
applicable to the providing Party’s products or (b) any information regarding
Commercialization except as necessary to Develop or Commercialize the Licensed
Products.
          2.3.3 Provision of Data to JDC. Upon request by the JDC, each Party
shall promptly provide the JDC with summaries in reasonable detail of all Data
generated or obtained in the course of such Party’s performance of activities
under the Development Plans.
          2.3.4 Level of Effort Required. Notwithstanding the foregoing, neither
Party shall be considered to be in breach of this Section 2.3 for failure to
disclose information, if, despite Commercially Reasonable Efforts, the
identification of such information is impractical.
          2.3.5 Right to Use. Each Party shall have the right to use Know-How to
be provided to such Party under this Section 2.3, in connection with the
Development and Commercialization of Compounds and Licensed Products hereunder.
     2.4 [***]. [***]
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     2.5 No Implied Licenses. No right or license under any either Party’s
Know-How, Patent Rights or other subject matter is granted or shall be deemed
granted by implication, estoppel or otherwise. All such rights or licenses are
granted only as expressly provided in this Agreement and the Related Agreements.
Without limiting the foregoing, nothing herein shall be deemed to grant to Shire
a right or license to any active pharmaceutical ingredient other than the
Compounds.
ARTICLE 3
GOVERNANCE
     3.1 Joint Steering Committee. Within thirty (30) days following the
Effective Date, the Parties shall establish a Joint Steering Committee (the
“Joint Steering Committee” or “JSC”). The JSC shall have the duties described in
Section 3.1.1 below.
          3.1.1 Duties. The Joint Steering Committee shall:
               (a) review and approve the Development Plans, and any material
changes thereto as shall be submitted by the JDC to the JSC for approval;
               (b) determine whether to terminate the joint Development of one
or more Licensed Products pursuant to Section 6.4 below;
               (c) determine actions necessary to prevent importation or sales
of Licensed Products sold by a Party into the other Party’s Territory by a Third
Party (e.g. determination that neither Party may sell to such Third Party);
               (d) resolve any matters submitted to the JSC by the JDC in
accordance with Section 16.8 below; and
               (e) perform such other duties as are specifically assigned to the
JSC in this Agreement.
          3.1.2 Additional Activities. In addition, at the meetings of the JSC,
the Parties will discuss the following matters as reasonably requested by either
Committee Co-chair of the JSC:
               (a) strategic direction for the Development, Manufacturing and
Commercialization of Licensed Products;
               (b) the progress of the Parties in executing the Development
Plans; and
               (c) any other matters pertaining to Development, Manufacturing
and Commercialization of Licensed Products in the Field in the Territory, and
the collaboration between the Parties. However, it is understood that the
decision-making authority of the JSC is limited to those matters described in
Section 3.1.1 above.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     3.2 Joint Development Committee. The Parties shall form a Joint Development
Committee (the “Joint Development Committee” or “JDC”), no later than thirty
(30) days following the Effective Date. The JDC shall have the duties described
in Section 3.2.1 below.
          3.2.1 Duties. The Joint Development Committee shall:
               (a) propose revisions to the Development Plans as needed, but no
less frequently than annually;
               (b) propose supplements or revisions to the applicable
Development Plans with respect to Label Expansions and New Formulations and
submit the same to the JSC for approval;
               (c) review and approve clinical protocols for Licensed Products
within the Field under the Development Plans;
               (d) review and finalize the common registration dossier for each
Licensed Product generated under a Development Plan;
               (e) monitor the progress of the activities undertaken by each of
the Parties pursuant to each Development Plan (including review of the conduct
of clinical trials conducted by each Party pursuant to a Development Plan);
               (f) monitor the rate of spending pursuant to activities under a
Development Plan against the budget for such activities in the Development Plan;
and
               (g) perform such other duties as are specifically assigned to the
JDC in this Agreement.
          3.2.2 Additional Activities. In addition, at the meetings of the JDC,
the Parties will discuss the following matters as reasonably requested by either
Committee Co-Chair of the JDC:
               (a) the progress of the activities undertaken by the Parties
pursuant to each Development Plan in relation to the corresponding budgets and
timelines;
               (b) the flow of information with respect to Development of the
Licensed Products within the Field;
               (c) the overall strategy for all material filings with applicable
Regulatory Authorities in the Primary Markets with respect to the Licensed
Products in the Field in the Shire Territory, in accordance with the Development
Plans, as well as regulatory strategy for Licensed Products in the Field in
Japan;
               (d) the Parties’ scientific presentation and publication strategy
relating to Licensed Products within the Field pursuant to Section 14.5 below,
until such time as the JCC is
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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formed pursuant to Section 3.3 below, at which time such matters shall be deemed
to be within the duties of the JCC under Section 3.3.1 below;
               (e) impact of operational activities related to Manufacturing,
(for example, forecast development, growth, changes, variances, manufacturing
process improvements, equipment/new facility introduction, capacity
improvements, cycle time and lead time reduction, improvement in shelf life,
inventory management, complaints, and in-market quality/performance reports);
and
               (f) any other matters pertaining to Development of Licensed
Products in the Field. However, it is understood that the decision-making
authority of the JDC is limited to those matters described in Section 3.2.1
above.
               3.3 Joint Commercialization Committee. The Parties shall form a
Joint Commercialization Committee (the “Joint Commercialization Committee” or
“JCC”), no later than thirty days following the Initiation of the First Phase
III Clinical Trial for a Licensed Product.
          3.3.1 Duties. The Joint Commercialization Committee shall serve as a
forum for communication regarding Commercialization activities and shall discuss
and review the following:
               (a) any Post-Marketing Studies proposed to be conducted by either
Party;
               (b) coordination of global branding to the extent practicable;
               (c) promotional and other Commercialization activities of the
Parties under this Agreement in the Amicus Territory and the Shire Territory,
including pre-launch and post-launch activities;
               (d) proposed Product Marks and branding strategy;
               (e) coordination of the participation of physicians who are key
opinion leaders during Development and Commercialization to achieve consistent
messaging and collaboration in connection with conferences and other marketing
activities, provided, however, that each Party shall have control over
Commercialization of Licensed Products in the Field in its respective Territory;
and
               (f) such other matters as appropriate to further the purposes of
this Agreement as determined by the Joint Steering Committee.
     For clarity, it is understood that the purpose of the JCC is to promote
communication and coordination regarding the foregoing matters and that the JCC
shall not have decision making authority.
     3.4 Special Committees and Sub-Committees; Financial Procedures.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          3.4.1 Special Committees and Sub-Committees. The JSC may from time to
time establish one or more special committees (each, a “Special Committee”),
each such Special Committee to consist of an equal number of representatives of
each Party as determined by the JSC, to perform certain duties and exercise
certain powers of the JSC as expressly delegated by the JSC to such Special
Committee. For example, it is understood that, from time to time, the JSC may
establish one or more Special Committees to coordinate intellectual property
matters in accordance with Article 10 below (it being understood such Special
Committee shall be for communication purposes and shall not have decision making
authority). Each of the JSC, JDC, JCC and any such Special Committee is referred
to herein as a “Committee.” Each Committee may from time to time establish
sub-committees to handle matters within the scope of its authority hereunder.
          3.4.2 Certain Financial Procedures. In addition, the JSC may establish
a Special Committee to approve procedures, formats and timelines consistent with
this Agreement for reporting financial data and monitoring financial performance
under this Agreement; and if the Parties, or such Special Committee, as
applicable, are unable to agree upon any such procedures, formats or timelines,
the matter shall be resolved as a Committee Dispute in accordance with the
provisions of Section 16.8 below.
3.5 Committee Membership, Decision-Making and Operations. 
          3.5.1 Membership of Committees. Each Committee shall be composed of an
equal number of representatives from each of Amicus and Shire. Unless the
Parties otherwise agree, the number of representatives for each of Amicus and
Shire shall be: (a) with respect to the JSC, three (3) representatives, (b) with
respect to the JDC, three (3) representatives and (c) with respect to the JCC,
three (3) representatives, and each of the above with ad hoc members as deemed
necessary by the relevant committee. At least one representative of each Party
on the JDC and JCC will be at the vice president level or above. All
representatives of each Party on the JSC will be at the vice president level or
above, subject to the next sentence, and at least one representative of each
Party on the JSC will be at the senior vice president (or its equivalent) level
or above. In addition, each Party’s Alliance Manager will serve on the JSC, JDC
and JCC in a nonvoting capacity. Each Party may replace any of its
representatives on a Committee at any time upon written notice to the other
Party, provided that such replacement is of comparable standing and authority
within that Party’s organization as the person he or she is replacing.
          3.5.2 Committee Meetings. Each Committee shall hold regularly
scheduled meetings at such times as it elects to do so, provided, however, that
(a) the JSC shall meet at least twice every calendar year, (b) the JDC shall
meet at least once every calendar quarter, unless the respective Committee
members otherwise agree and (c) the JCC shall meet at least twice every calendar
year. Each Party may also call for special meetings to resolve particular
matters requested by such Party. The applicable Committee Co-Chair shall provide
Committee members no less than fifteen (15) Business Days’ notice of each
regularly scheduled meeting, and no less than ten (10) Business Days’ notice, or
such shorter time period as a Committee Co-Chair deems appropriate under the
circumstances, but in no event less than two (2) Business Days’ notice, of any
special
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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meetings called by either Party. Meetings may be held by audio or video
teleconference with the consent of each Party, which shall not be unreasonably
withheld, provided that unless otherwise agreed at least two (2) of the meetings
of each of the JSC and JDC per calendar year shall be held in person. Locations
for meetings held in person shall alternate between Amicus’ facilities in
Cranbury, New Jersey, and Shire’s facilities in Cambridge, Massachusetts, or at
such other locations as the Parties may otherwise agree. A reasonable number of
other employees of each Party involved in the Development, Manufacture or
Commercialization of Licensed Products may attend Committee meetings as
nonvoting participants with the approval of the respective Committee, and, with
the consent of each Committee Co-Chair, which consent shall not be unreasonably
withheld, a reasonable number of consultants, representatives or advisors
involved in the Development, Manufacture or Commercialization of Licensed
Products may attend Committee meetings as nonvoting observers, provided that
such consultants, representatives and advisors are under obligations of
confidentiality and non-use applicable to the Confidential Information of each
Party that are at least as stringent as those set forth in Article 14. Each
Party shall be responsible for all of its own expenses of participating in the
JSC, JDC, JCC and any Special Committee.
          3.5.3 Decision-Making and Dispute Resolution. Decisions of each
Committee shall be made at a duly called meeting of the applicable Committee.
Shire’s members of each Committee shall collectively have one (1) vote and
Amicus’ members of each Committee shall collectively have one (1) vote, with
decisions made by unanimous vote (assuming a quorum of at least two (2)
representative members from each Party, and with each Party’s vote being cast by
such Party’s Committee Co-Chair of the relevant Committee). Each Committee may
act on a specific issue without a meeting if it is documented in a written
consent signed by each of the Co-Chairs of the applicable Committee from each
Party. Notwithstanding anything herein to the contrary, no Committee shall have
authority to amend, modify or waive compliance with this Agreement or the
Related Agreements. If a Committee fails to reach consensus on an issue
specifically designated in this Agreement for its decision, the matter shall be
resolved under the procedures set forth in Section 16.8.
          3.5.4 Committee Co-Chairs. Each calendar year, each Party shall
appoint one of its representatives on each Committee to co-chair meetings of
such Committee (the “Committee Co-Chair”). For each Committee, the Committee
Co-Chairs shall coordinate and prepare the agenda, ensure the orderly conduct of
meetings and prepare and issue minutes of each meeting within thirty (30) days
thereafter. Such minutes will not be finalized until the Committee Co-Chair from
each Party have reviewed and confirmed the accuracy of such minutes in writing.
The Committee Co-Chairs will solicit agenda items from the members of the
applicable Committee and provide an agenda along with appropriate information
for such agenda reasonably in advance of each meeting. It is understood that
such agenda will include all items requested by either Committee Co-chair for
inclusion therein.
          3.5.5 Reports. In addition, subject to the foregoing, each Party shall
keep the other Party (through the relevant Committees) informed of Development,
Manufacturing and Commercialization activities pertaining to Licensed Products
in the Field in the applicable Territory
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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by such Party, including by providing regular reports to the relevant Committees
summarizing such activities, and such other information as the other Party may
reasonably request from time to time.
     3.6 Alliance Managers.  Within thirty (30) days following the Effective
Date, each Party shall appoint a representative (an “Alliance Manager”), who
will be at the director (or its equivalent) level or above, 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 Party may replace its
Alliance Manager with an alternative representative satisfying the requirements
of this Section 3.6 at any time with prior written notice to the other Party.
ARTICLE 4
DEVELOPMENT
     4.1 Overall Efforts in Development.  Amicus and Shire shall establish and
implement the Development Plans in a prompt and expeditious manner with respect
to each Licensed Product within the Field, and in a manner that harmonizes the
Development of Licensed Products within the Field towards (a) a common
registration dossier as a basis for license applications in the Primary Markets
and, to the extent described in Section 4.2.5(e) below, Japan, and
(b) Regulatory Approval for such Licensed Product in each of the Primary
Markets. The Parties shall use Commercially Reasonable Efforts to ensure that
each Development Plan provides at all times for adequate resources to achieve
such result in an expeditious and efficient manner.

     4.2 Development Plans. 
          4.2.1 General. The JDC shall establish a rolling three (3) calendar
year plan and budget for the cooperative Development of each Licensed Product
within the Field under this Agreement (as such may be amended from time to time
in accordance with this Agreement, and as approved by the JSC, each a
“Development Plan”). Each Development Plan shall include (a) a reasonably
detailed written plan of Development activities and budget for the first
thirteen (13) months of such period, together with the JDC’s then-current
preliminary estimate of the Development activities and budget for the final
twenty-three (23) months of the rolling thirty-six (36) month period (such
twenty-three (23) month estimated plan and budget, together with the items in
clause (b) below for such 23-month period, being referred to below as the
“Forecast”), (b) an allocation of Development activities between the Parties for
the first thirteen (13) months of such period, including but not limited to the
number of allocated full time equivalent personnel and the applicable FTE Rate
and other out-of-pocket expenses to be incurred by each Party during such
period, together with an overall allocation of responsibilities for activities
to be conducted during the remaining twenty-three (23) months covered by such
Development Plan, and (c) the overall program of Development for such Licensed
Product within the Field, including clinical studies, regulatory strategies and
other elements for obtaining Regulatory Approval of such Licensed Product in
each country within the Primary Markets. It is understood that the JDC will
modify and update the Forecast annually in connection with the procedure for
amending and updating each Development Plan under Sections 4.2.3 and 4.2.4
below. In addition, the Parties shall cooperate to establish
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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additional non-binding forecasts of Development Costs for the rolling four
(4) year period beyond the three (3) year term of each Development Plan
(including as updated).
          4.2.2 Initial Development Plans. The initial Development Plans for
Plicera, Amigal and AT2220 are attached hereto as Appendix 4.
          4.2.3 Amendments. Each Development Plan shall be updated by the JDC
for approval by the JSC, not less than annually (as set forth in Section 4.2.4
below), or more frequently as needed to take into account completion,
commencement or cessation of Development activities not contemplated by the then
current Development Plan. The JDC will submit to the JSC for approval any
material amendment to each Development Plan in advance of implementation of such
amendment, including, without limitation, any amendment that effects a material
increase of the budget or timeline in effect for the current year of such
Development Plan, subject to Section 4.2.4 below.
          4.2.4 Timing and Process for Amendments. With respect to each
Development Plan, by September 15 of each calendar year after the Effective Date
commencing in 2008, the JDC shall present to the JSC for its review and approval
a proposed Development Plan for the next three (3) calendar years in the form
described in Section 4.2.1 above. If such revised Development Plan is not
approved by the JSC by January 1 of a calendar year, then, until such time as a
revised Development Plan is either approved by the JSC or established pursuant
to the dispute resolution procedure set forth in Section 16.8 below, (a) the
preceding Development Plan (including the Forecast for the applicable period)
shall continue to govern the Parties’ Development activities, (b) each Party
shall be permitted to conduct 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 Section 7.4.1 below, and (c) in any case each Party
may continue any on-going clinical trials initiated by such Party in accordance
with such preceding Development Plan, and the reasonable costs incurred by such
Party in connection with such clinical trials shall continue to be shared by the
Parties in accordance with Section 7.4.1 below.
          4.2.5 Development Activities. In addition to the information described
in Section 4.2.1 above, each Development Plan shall be as further described in
this Section 4.2.5.
               (a) Unless otherwise agreed by the Parties, each Development Plan
shall allocate to Shire responsibility for (i) strategic and operational control
of Regulatory Approval within the Shire Territory, including conducting meetings
on programs relating to Regulatory Filings and meetings on pivotal study
designs, and submissions leading up to and subsequent to the filings for
Regulatory Approval (such as scientific advice and pre-MAA meetings),
(ii) managing relationships with physicians and other key personnel at clinical
trial sites in the Shire Territory in connection with such Development Plan,
(iii) to the extent included in such Development Plan, any Development
activities to be undertaken in Japan, and (iv) such other activities as the
Parties mutually agree from time to time. In furtherance of the foregoing and as
contemplated by Section
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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9.22, Amicus shall have the opportunity to accompany Shire to meetings with
Regulatory Authorities in the Shire Territory.
               (b) Unless otherwise agreed by the Parties, each Development Plan
shall allocate to Amicus responsibility for (i) strategic and operational
control of Regulatory Approval (including conducting meetings and other related
activities as described in (a)(i) above) for the Amicus Territory, (ii) managing
relationships with physicians and other key personnel at clinical trial sites in
the Amicus Territory in connection with such Development Plan, (iii) control of
clinical operations for all phase I clinical trials and Phase II Clinical
Trials, and (iv) preclinical activities (including ongoing non-clinical
testing).
               (c) By January 15, 2008, the JSC shall establish the final
versions of the initial Development Plans referenced in Section 4.2.2, including
Development activities and budgets as contemplated by Section 4.2.1. Such final
Development Plans shall set forth the allocation between the Parties of
Development activities other than those described in (a) and (b) above. For
clarity, it is understood that, until such time such final versions of the
initial Development Plans are so established, the initial Development Plans
referenced in Section 4.2.2 shall continue to govern the Parties’ Development
activities. Notwithstanding anything herein, the 2008 budget for Development
shall not exceed [***]without the mutual consent of the Parties.
               (d) Notwithstanding anything herein, within the [***] of the
Effective Date no pivotal clinical trial or Phase III Clinical Trial under a
Development Plan shall be conducted without the prior written consent of each
Party.
               (e) Each Development Plan shall be directed to those activities
necessary to obtain Regulatory Approval of the applicable Licensed Product in
the Field in the Primary Markets and, to the extent the Parties agree, Japan. In
addition, the Parties may, from time to time, agree to include certain
Post-Marketing Studies under a Development Plan and to share the costs thereof
in accordance with Section 7.4 below; provided, however, that unless so
included, the conduct of Post-Marketing Studies shall be as addressed in
Section 4.3.
               (f) It is understood that, from time to time, it may be necessary
for Shire to conduct additional Development activities beyond that set forth in
a Development Plan, in order to obtain Regulatory Approval for a Licensed
Product in a country of the Shire Territory other than the Primary Markets.
Shire may conduct such additional Development activities outside of the
Development Plans at its own cost.
     4.3 Post-Marketing Studies; Monitoring of Independent Trials
          4.3.1 Post-Marketing Studies. For clarity, if a Party desires to
conduct a Post-Marketing Study that has not been approved by the Parties for
inclusion under the applicable Development Plan under Section 4.2.5(e) above,
such Party may perform such Post-Marketing Study, at its own expense. Further,
the Party conducting such Post-Marketing Study outside such Development Plan
shall not be required to share the Data (other than safety Data, in accordance
with

    [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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the Pharmacovigilance Agreement or as otherwise required by a governmental or a
regulatory authority or applicable Laws) resulting from such Post-Marketing
Study.
          4.3.2 Notice; Suspension of Independent Trials. The Party proposing to
conduct a Post-Marketing Study outside the applicable Development Plan in
accordance with Section 4.3.1 above or any other clinical trial of a Licensed
Product (other than [***] for [***]’s) but outside the Development Plan (each,
an “Independent Trial”) shall notify the other Party at least sixty (60) days
prior to submitting a protocol to the Institutional Review Board or Ethics
Committee, as applicable, for such Independent Trial (which notice shall include
a synopsis, in reasonable detail, of the proposed protocol). The Party proposing
to conduct such Independent Trial may proceed with such trial (as described in
its notice to the other Party) after such sixty (60) day notice period unless
such other Party reasonably and in good faith objects to such protocol on the
grounds that it would cause, or would have an unreasonable risk of causing, a
material adverse effect upon the Development or Commercialization of a Licensed
Product containing the same Compound. In the case of such an objection, the
objecting Party shall give written notice of its objection (including a
reasonably detailed explanation of the basis therefor) to the JSC within such
sixty (60) day period and the Party proposing such protocol shall not commence
such trial pending the resolution of such matter pursuant to this Section 4.3.2.
If the JSC is unable to reach consensus on such matter within thirty (30) days
after such matter is referred to the JSC, then, upon written notice of either
Party to the other Party, such matter shall be resolved as a Committee Dispute
in accordance with the provisions of Section 16.8 below.
     4.4 Subcontractors.  Except as otherwise set forth in this Agreement, each
Party may engage subcontractors to perform, under its direction, specific
functions that are assigned to it hereunder or that it carries out in the
exercise of its rights hereunder, in each case in accordance with this
Section 4.4. Each Party shall be fully responsible under this Agreement for the
performance hereof by its permitted subcontractors as if such Party so performed
this Agreement itself.
     4.5 Combination Products.  For purposes hereof, a “Combination Product”
means any Licensed Product containing a Compound combined with one or more other
active ingredients (e.g., a co-formulation) or a product in which both a
Licensed Product and one or more other products or components are packaged
together and sold for a combined price. In the event that Shire desires to
Develop or Commercialize a Combination Product:
          4.5.1 if such Combination Product, in Shire’s good faith
determination, is not intended for Commercialization outside the Shire Territory
and/or Shire does not Control the Patent Rights necessary to Develop and
Commercialize such Combination Product outside the Shire Territory, then
(a) Shire may Develop and Commercialize such Combination Product solely in the
Shire Territory and (b) the [***]; and
          4.5.2 if the Parties agree to Commercialize such Combination Product
in the Amicus Territory and Shire Controls the Patent Rights necessary to
Develop and Commercialize such Combination Product in the Amicus Territory, then
the Parties [***]. It is understood that neither Party is obligated to agree on
such terms and if the Parties cannot so agree the Combination
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Product shall not be included in a Development Plan and Shire may pursue such
Combination Product under Section 4.5.1.
     4.6 Term of Ongoing Development and Committee Obligations.  The Parties’
obligations under Sections 4.1 and 4.2 (and the Development Plans), and to share
Development Costs under Section 7.4.1 below, and Amicus’ supply and
Manufacturing obligations under Article 8 below, shall terminate eighteen
(18) years after the Effective Date. At such time, all Committees will
terminate. However, each Party will continue to have an approval right with
respect to matters specified to be decided by such Committees 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 such Committee, the
matter shall be determined by binding arbitration in accordance with the
procedures in Sections 16.8.1(b) through (d) below.
ARTICLE 5
COMMERCIALIZATION in the Shire Territory
     5.1 General.  Subject to the terms and conditions of this Agreement, Shire
shall have the sole right to control the Commercialization of the Licensed
Products in the Field in the Shire Territory.
     5.2 Diligence.  Shire shall use Commercially Reasonable Efforts to obtain
Regulatory Approval of, and to Commercialize, the Licensed Products in the Field
in the Shire Territory.
     5.3 Territory Compliance.  Each Party shall use diligent efforts to take
the actions necessary to prevent importation or sales of Licensed Products sold
by such Party into the other Party’s Territory by a Third Party, including any
such actions as are determined by the JSC under Section 3.1.1(c).
     5.4 Bundling. [***] in order to benefit sales or prices of other products
offered for sale by Shire to such customer or that discounts the price of the
Licensed Product disproportionately to the other products included in such
multiple product offering.
ARTICLE 6
CERTAIN OTHER ACTIVITIES
     6.1 Label Expansions and New Formulations within the Field. 
          6.1.1 Proposal to JSC. In the event that either Party (the “Developing
Party”) proposes to Develop (a) a Licensed Product for a label expansion within
the Field (a “Label Expansion”) or (b) a new pharmaceutical formulation
containing a Compound for an indication within the Field (a “New Formulation”),
such Party shall make a written proposal to the JSC for the Development thereof,
including a proposed work plan, budget, timeline, any Third Party Technology
under Section 10.6.2 and, in the case of Shire, any formulation technology under
Section 6.1.2(d)(iii) (the “JSC Proposal Notice”).
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (a) Inclusion within Development Plan. If the JSC determines to
include such Label Expansion or New Formulation in an applicable Development
Plan or where applicable a new Development Plan, then such Development Plan
shall include the work plan, budget and timeline proposed by the Developing
Party, or as the JSC may otherwise determine. For purposes of the JSC
determination of whether or not to include such Label Expansion or New
Formulation under the applicable Development Plan, the Developing Party shall be
deemed to have approved the proposal presented by it to the JSC as part of the
JSC Proposal Notice under Section 6.1.1 above.
          6.1.2 Independent Projects.
               (a) Election. If the JSC does not determine to include such Label
Expansion or New Formulation under the applicable Development Plan, then the
Developing Party shall have the right, subject to the Opt-In Right in
Section 6.1.3 below, to Develop and Commercialize such Label Expansion or New
Formulation for such Licensed Product outside the Development Plans solely in
the Developing Party’s respective Territory (subject to the proviso in
Section 2.1.3) at its own expense (it being understood that Development Costs
incurred in connection therewith shall not be shared under Section 7.4.1 below),
and such Label Expansion or New Formulation of such Licensed Product shall be
referred to herein as an “Independent Project.” Notwithstanding the above, the
Developing Party shall have the right to conduct non-clinical Development of an
Independent Project anywhere, including, but not limited to, outside its
Territory.
               (b) Provision of Development Update. Upon request by the
non-Developing Party (the “Non-Developing Party”), the Developing Party shall
provide to the Non-Developing Party a summary in reasonable detail of the
Development results to date pertaining to such Independent Project.
               (c) Statement of Independent Development Costs.
                    (i) Prior to sixty (60) days after the end of each calendar
year of an Independent Project, the Developing Party shall provide the
Non-Developing Party with a statement of the Independent Development Costs (as
defined below) for the prior year (each, a “Statement of Costs”) for such
Independent Project.
                    (ii) As used herein, “Independent Development Costs” shall
mean those internal and external costs actually incurred by the Developing Party
outside the Development Plans that are specifically allocable to the Development
of the applicable Independent Project. The allocation of such costs to an
Independent Project shall be determined in a manner consistent with the manner
in which costs are allocated to the Development Costs of Licensed Products under
the Development Plans. For such purposes, the internal Development costs of the
Developing Party shall be determined by applying the FTE Rate applied under the
Development Plans for the same period.
               (d) License; Disclosure of Know-How. If a Label Expansion or New
Formulation is included in the Development Plan in accordance with
Section 6.1.1(a) above, or if the
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Non-Developing Party exercises the Opt-In Right with respect to an Independent
Project in accordance with Section 6.1.3 below, the Developing Party shall
promptly provide to the Non-Developing Party Know-How Controlled by the
Developing Party that is necessary, useful or actually used to Develop such
Label Expansion, New Formulation or Independent Project and to Develop and
Commercialize such Licensed Product in accordance with this Agreement. In such
event:
                    (i) For clarity, it is understood that the licenses granted
to Shire under Section 2.1 above include the Licensed Product comprising such
Label Expansion, New Formulation or Independent Project, as the case may be; and
                    (ii) Subject to Sections 6.1.2(d)(iii) and 10.6.2, Amicus
shall have and is hereby granted a license, under Shire IP, to use, import, sell
and Commercialize such Licensed Product in the Amicus Territory, and to Develop
and Manufacture such Licensed Product, including the right to sublicense;
provided, however, that Amicus shall not conduct any clinical trial of such
Licensed Product in the Shire Territory without Shire’s consent (not to be
withheld unreasonably). As used herein, “Shire IP” shall mean (A) Know-How to be
disclosed to Amicus under this Section 6.1, and (b) Patent Rights Controlled by
Shire that are necessary or actually used to Develop, Manufacture or
Commercialize such Licensed Product.
                    (iii) If a New Formulation is to be licensed under
Section 6.1.2(d)(ii) above to Amicus and includes proprietary formulation
technology Controlled by Shire, then Amicus shall pay to Shire a royalty on net
sales of such New Formulation in the Amicus Territory pursuant to such license,
based on commercially reasonable terms; provided that in the case of a New
Formulation included in a Development Plan pursuant to Section 6.1.1(a) above,
such formulation technology was generated or acquired by Shire (A) outside of
this Agreement or (B) as part of a different Independent Project for which
Amicus did not exercise its Opt-In Right under Section 6.1.1(a) and Shire
thereafter conducted clinical Development. In addition such license shall be
subject to Section 10.6.2. If the Parties are unable to agree on the rate and
other terms of such royalty, the same shall be determined by the JSC. In such
event, if Shire Manufactures such New Formulation, then Shire will supply such
New Formulation to Amicus on reciprocal terms as provided in Article 8 below; in
each case, mutatis mutandis. If the Parties are unable to agree on the
application of any such terms, the matter shall be determined by the JSC. If
Amicus’ proposal for the royalty rate and other terms is not selected pursuant
to Section 16.8, Amicus may revoke its exercise of the Opt-In Right for such New
Formulation and such Opt-In Right for such New Formulation shall terminate as if
not exercised.
          6.1.3 Opt-In Right. In the case of an Independent Project, until the
end of the Opt-In Period (as defined below), the Non-Developing Party shall have
the right to opt-in for Development of the (a) the Label Expansion within the
Field with respect to the particular Licensed Product in question and/or (b) the
New Formulation of a Licensed Product, as applicable, comprising such
Independent Project, as follows (the “Opt-In Right”):
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (a) Notice. The Developing Party shall notify the Non-Developing
Party of a submission of a request to a Regulatory Authority of a Primary Market
country for the first [***] for an Independent Project, or the submission of the
protocol for the first Phase III Clinical Trial for an Independent Project to an
Institutional Review Board or Ethics Committee for approval, whichever occurs
first (the “Opt-In Notice”). As used herein, the “Opt-In Period” with respect to
an Independent Project shall mean the period beginning upon the date on which
the Non-Developing Party elected not to jointly Develop such Label Expansion or
New Formulation (as applicable) pursuant to Section 6.1.2(a) and ending on
 ninety (90) days after the later of (x) first [***] for such Independent
Project or (y) the submission of the protocol to such Institutional Review Board
or Ethics Committee for the first Phase III Clinical Trial of such Independent
Project, provided, that in the event (x) does not occur then upon  the dosing of
the first patient in the first Phase III Clinical Trial for such Independent
Project. Notwithstanding the foregoing, if so agreed by the Parties on a
case-by-case basis, the Opt-In Period may be extended and if extended, the
Non-Developing Party may exercise the Opt-In Right at such later time as is
mutually agreed upon by the Parties. The Opt-in Notice shall include a good
faith estimate of the date the Opt-In Period will expire, and notwithstanding
the foregoing, the Opt-In Period shall not expire prior to such estimated date.
               (b) Know-How. Promptly after a request by the Non-Developing
Party made during the applicable Opt-In Period, the Developing Party shall
provide to the Non-Developing Party reasonable access to the material Know-How
of the Developing Party pertaining to such Independent Project, and shall
cooperate to enable the Non-Developing Party to evaluate such Know-How, and
Independent Project, in a prompt and efficient manner. In addition the
Developing Party shall provide the Non-Developing Party safety data required in
accordance with the Pharmacovigilance Agreement or as otherwise required by a
governmental or a regulatory authority or applicable Laws. The Developing Party
shall similarly provide to the Non-Developing Party promptly a statement of the
total Independent Development Costs incurred by the Developing Party in
performing such Independent Project. If additional Know-How is generated, or
Independent Development Costs incurred, during the Opt-In Period after such
request, the Developing Party shall promptly make such information available to
the Non-Developing Party upon request to the extent necessary to enable the
Non-Developing Party to evaluate such Know-How and Independent Project.
Notwithstanding anything herein to the contrary, unless the Non-Developing Party
exercises its Opt-In Right under Section 6.1.3 below with respect to such
Independent Project, the Non-Developing Party shall not have the right to use,
and shall not use, such Know-How or Data pertaining to such Independent Project
provided to it pursuant to this Section 6.1.2(b) other than as safety data as
allowed pursuant to the Pharmacovigilance Agreement or as otherwise required by
a governmental or a regulatory authority or applicable Laws.
               (c) Exercise. To exercise the Opt-In Right with respect to an
Independent Project, the Non-Developing Party shall deliver, prior to the
expiration of the Opt-In Period for such Independent Project, written notice to
the Developing Party of such exercise and shall promptly reimburse the
Developing Party for the Non-Developing Party’s Reimbursable Share (as defined
below) of the Independent Development Costs incurred by the Developing Party in
performing such Independent Project (through the date of such exercise). For
such purpose, the Non-Developing
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Party’s “Reimbursable Share” shall mean [***] of the Independent Development
Costs for the Independent Project. In the event of a dispute as to the
calculation of Independent Development Costs to be reimbursed, the
Non-Developing Party shall promptly reimburse the Developing Party the amount
described above with respect to any undisputed Independent Development Costs,
and shall promptly reimburse any remainder (or if applicable the Developing
Party shall promptly refund any amounts that were so paid but subsequently found
not to be due) upon resolution of such dispute by the JSC and in the event that
the JSC is unable to resolve such dispute, the matter shall be resolved by an
audit in accordance with provisions of Sections 7.8.2 and 7.8.3. For purposes of
clarity, the Non-Developing Party shall be the Auditing Party in accordance with
Section 7.8.2.
          6.1.4 Further Development and Commercialization of Independent
Projects.
               (a) Generally. If the Non-Developing Party does not exercise its
Opt-In Right for an Independent Project during the Opt-In Period, then the
Developing Party shall have the right to continue the Development and
Commercialization of such Independent Project solely in its respective Territory
(subject to the proviso in Section 2.1.3), provided the Developing Party shall
have the right to conduct non-clinical Development anywhere, including, but not
limited to, outside its Territory. It is understood that Net Sales of Licensed
Products in the Shire Territory resulting from such Label Expansion or New
Formulation shall be included in Net Sales calculations for purposes of
Sections 7.2.2 and 7.3 below.
               (b) Clinical Trials. The conduct of clinical trials as part of an
Independent Project shall be subject to Section 4.3.2 above.
               (c) Manufacturing. If Shire elects to Develop and Commercialize a
New Formulation as an Independent Project, Amicus will supply to Shire in
accordance with Article 8 below additional quantities of the applicable Compound
for use in such New Formulation. Unless otherwise agreed, however, Amicus will
not be required to arrange for supplies of final formulated Licensed Products
incorporating such New Formulation, and Shire shall have the right to
Manufacture and have Manufactured such supplies of final formulated Licensed
Products incorporating such New Formulation.
          6.1.5 Activities Outside the Field. The application of
Sections 6.1.1–6.1.4 is limited to activities within the Field with respect to
the Licensed Products. In this regard nothing herein shall be deemed to grant to
Shire the right to Develop or Commercialize Licensed Products (including New
Formulations) outside the Field. The Parties may discuss from time to time
expanding the Field to include indications outside the Field for a given
Compound or Licensed Product, and if the Parties so agree, then the Field shall
be deemed to include such additional indication with respect to Licensed
Products containing such Compound. Unless so agreed, however, during the Term
(a) Amicus shall not, directly or indirectly, Develop (other than as a Licensed
Product in accordance with this Agreement) or Commercialize in the Shire
Territory a product containing a Compound other than an [***] for [***]’s and
(b) Shire shall not outside the Field, directly or indirectly, Develop or
Commercialize in the Shire Territory a product containing a Compound,. Subject
to (a) Sections 6.2.1 and 6.2.2, Amicus may, directly and/or indirectly,
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Develop or Commercialize an [***] for [***]’s in the Shire Territory and
(b) Section 4.3.2, Amicus may, directly and/or indirectly, Develop outside the
Field a product containing a Compound in the Shire Territory for
Commercialization in the Amicus Territory.
     6.2 [***] for [***]’s. 
          6.2.1 [***]’s Option. Subject to Section 6.2.1(e) below, Shire shall
have and Amicus hereby grants to Shire an option to expand the Field with
respect to products containing [***] as set forth below in this Section 6.2.1
(the “[***]’s Option”).
               (a) Notice. Upon the scheduling of the first [***] with respect
to an [***] for [***]’s, Amicus shall notify Shire in writing. Promptly
following such [***] with respect to an [***] for [***]’s, Amicus shall provide
to Shire written notice of such [***], together with the data package submitted
by Amicus to the FDA for purposes of such [***] (the “[***]’s Option Notice”).
Shire shall have the right to exercise the [***]’s Option within sixty (60) days
after its receipt of the [***]’s Option Notice (the “[***]’s Option Period”) by
providing written notice to Amicus of such intent to exercise the [***]’s
Option. Amicus shall promptly provide Shire any additional Data or information
(e.g. minutes of the [***] and response letter from the FDA with respect to the
[***]) that it has after providing the [***]’s Option Notice up to the exercise
or expiration of the [***]’s Option. For purposes of clarity, Amicus shall not
grant to a Third Party any license or other rights to Commercialize an [***] for
[***]’s in the Shire Territory prior to the expiration of the [***]’s Option
Period and further subject to Section 6.2.2 below.
               (b) Exercise. Upon exercise of the [***]’s Option within the
[***]’s Option Period and payment of the exercise fee (the “[***]’s Option
Exercise Fee”) within ten (10) Business Days [***], the Field with respect to
[***] (and any other [***] for [***]’s) shall be deemed to include the
diagnosis, treatment and/or prevention of [***]’s and the JDC shall promptly
propose, for approval by the JSC, modifications to the applicable Development
Plan to include Development of such [***] for [***]’s. Following exercise of the
[***]’s Option, Amicus shall continue performing further activities related to
the Development of such an [***] for [***]’s in accordance with its own
Development plans for a period of up to one (1) year after exercise of the
[***]’s Option, or until such earlier time as the JSC approves such a
Development Plan therefor, and thereafter the further Development of such [***]
for [***]’s shall be conducted in accordance with such Development Plan, as
modified by the JSC from time to time. All costs reasonably incurred by Amicus
in performing such activities (i.e., those after the exercise of the [***]’s
Option but prior to the JSC’s establishment of a modified Development Plan), and
those conducted pursuant to the modified Development Plan so established, shall
be shared in accordance with Section 7.4.1 below.
               (c) [***]’s Option Exercise Fee and Milestone Payments. In the
event Shire exercises the [***]’s Option in accordance with the foregoing, [***]
to be made by Shire with respect to the Development and Commercialization of
Licensed Products for [***]’s hereunder. It is understood that the amount of
such [***]’s Option Exercise Fee and milestone payments shall [***].
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (d) Cooperation. From the Effective Date until the end of the
[***]’s Option Period, Amicus shall keep Shire informed of Amicus’ progress in
Developing [***] for [***]’s and shall cooperate with Shire to facilitate
Shire’s understanding of the [***] for [***]’s, including, but not limited to,
providing access to all Data generated regarding [***] for [***]’s promptly upon
Shire’s written request.
               (e) Amicus’ Election Not to Proceed. If, prior to the [***]’s
Option Notice, Amicus notifies Shire in writing that it has made the election
not to further Develop for and/or seek Regulatory Approval for Commercialization
in the Shire Territory, or Commercialize, an [***] for [***]’s in the Shire
Territory, the [***]’s Option, and this Section 6.2.1, shall terminate and not
apply; provided, that if Amicus makes such election under this Section 6.2.1(e),
Amicus shall not (directly or indirectly) Commercialize an [***] for [***]’s in
the Shire Territory (for so long as [***] is a Compound hereunder).
          6.2.2 Right of First Refusal. Amicus hereby grants to Shire a right of
first refusal to Develop and exclusively Commercialize one or more [***] for
[***]’s in the Shire Territory as set forth below in this Section 6.2.2 (the
“Right of First Refusal”).
               (a) Procedure. Prior to granting to a Third Party a license or
other rights to Commercialize an [***] for [***]’s in the Shire Territory,
Amicus shall so advise Shire in writing setting forth the terms and conditions
under which Amicus would grant such rights (an “Offer”) and including a copy of
the proposed definitive agreement to grant such rights to Shire (a “Right of
First Refusal Notice”). [***] of the date of the Right of First Refusal Notice
(the “RFR Acceptance Period”), Shire shall notify Amicus in writing whether
Shire desires to enter into the transaction in the Right of First Refusal Notice
in accordance with the terms set forth therein, together with a fully executed
copy of the definitive agreement included in such Right of First Refusal Notice
(a “RFR Acceptance”). In the event that Shire shall have failed to deliver a RFR
Acceptance [***], then Shire shall be deemed to have waived its Right of First
Refusal under this Section 6.2.2, and Amicus shall be free to execute and close
on the Offer with a Third Party solely on the terms provided in the Right of
First Refusal Notice (which for purposes of clarity shall mean the execution by
a Third Party of the definitive agreement offered to Shire with such
non-substantive changes as are necessary to substitute such Third Party for
Shire); provided that if such definitive agreement is not consummated within
[***] after the end of the RFR Acceptance Period, or if, during such [***]
period Amicus proposes to grant to a Third Party rights to Commercialize an
[***] for [***]’s on terms that are different than those set forth in the Offer
(any terms different than those provided in the definitive agreement offered to
Shire), Amicus shall be obligated to follow the procedures set forth in this
Section 6.2.2 prior to granting to a Third Party any right or license to
Commercialize an [***] for [***]’s.
               (b) No Implied Obligations. The only obligations of Amicus under
this Section 6.2.2 and Section 6.2.1 above are as expressly stated therein, and
there are no further implied obligations relating to the matters contemplated
therein. Without limiting the foregoing, it is understood that (i) Amicus is not
obligated to identify the Third Party(ies) to whom Amicus would
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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grant rights to [***] for [***]’s, (ii) modifications or improvements may be
made to such [***] after the date of the Right of First Refusal Notice and
(iii) a transfer of rights in connection with an assignment of this Agreement in
accordance with Section 16.1 below shall not be subject to this Section 6.2.2,
provided, that this Section 6.2.2 shall apply to such assignee.
               (c) Termination. Section 6.2.2 shall terminate for all purposes
upon the first grant to a Third Party by Amicus of rights to Commercialize an
[***] for [***]’s in accordance with this Section 6.2.2; and in any case this
Section 6.2 (including both Sections 6.2.1 and 6.2.2 but not Section 6.2.1(e))
shall expire [***] after the First Commercial Sale of [***] (or, if earlier,
another Licensed Product containing [***]) within the Field in a Primary Market
country in the Shire Territory, after which time Amicus shall have no further
obligation and Shire shall have no further rights under this Section 6.2.
     6.3 Related Products. 
          6.3.1 Related Product Notice. At least thirty (30) days prior to
dosing the first patient in the first human clinical trial of a Related Product
within the Field, Amicus shall notify Shire in writing, which notice shall
include a copy of the IND submitted to the FDA or other applicable Regulatory
Authority for such trial (a “Related Product Notice”), subject to Section 6.3.6.
For purposes hereof, “Related Product” is defined as a small molecule that
selectively binds to the active site of (a) a-galactosidase A for the treatment
or prevention of Fabry Disease, (b) b-glucocerebrosidase for the treatment or
prevention of Gaucher Disease, (c) a-glucosidase for the treatment or prevention
of Pompe Disease or (d) to the extent the Parties agree pursuant to
Section 6.1.5 to expand the Field for a Compound and agree to add an additional
target for such Compound, such other target for such indication, and in each
such case whose primary therapeutic activity results from such selective
binding, provided, that the restrictions of this Section 6.3 shall not apply to
[***] for [***]’s or a Licensed Product being Commercialized pursuant to this
Agreement. Each of the enzymes referenced under clauses (a), (b), (c) and (d) of
this Section 6.3.1 is referred to herein as a “Target.”
          6.3.2 Related Product Opt-In Right. Shire shall have the right,
exercisable [***] after receiving the Related Product Notice (the “Related
Product Opt-In Period”), to designate that (a) the active pharmaceutical
ingredient of such Related Product shall be added as a Compound hereunder,
(b) the formulation described in the IND included in the Related Product Notice
shall be added as a Licensed Product hereunder and (c) the Field with respect to
such Licensed Product shall be limited to the specific disease for which such
Related Product is being developed (i.e., Gaucher Disease, Fabry Disease or
Pompe Disease or such other indication as is then included in the Field under
Section 6.1.5, as applicable) (the “Related Product Opt-In Right”).
          6.3.3 Exercise. To exercise the Related Product Opt-In Right with
respect to a Related Product, Shire shall deliver written notice to Amicus of
such exercise within the Related Product Opt-In Period for such Related Product,
and shall promptly reimburse Amicus for [***] of the costs incurred by Amicus
outside the Development Plans that are specifically attributable to the
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Development of such Related Product prior to such exercise, determined in
accordance with Section 6.5.4.
          6.3.4 Development Plan. Upon such timely exercise of the Related
Product Opt-In Right, the JDC and JSC shall promptly establish a new Development
Plan for such Related Product (i.e., as a Licensed Product).
          6.3.5 Milestone Payments and Royalties. Following exercise of the
Related Product Opt-In Right, Shire shall pay to Amicus royalty payments under
Section 7.3 with respect to such Related Product as a Licensed Product. In
addition, Shire shall pay to Amicus an additional set of Milestone payments for
such Related Product, in an amount equal to [***] of the amounts for the
achievement of the same events as provided for the first Licensed Product
Developed for the same Field under Section 7.2.1, provided, that such payments
shall not be due until the first Regulatory Approval of the first Licensed
Product for the same disease within the Field as that of such Related Product.
For clarity, upon Regulatory Approval of the first Licensed Product in a
particular Field, payments for Milestones (as provided in this Section) for a
Related Product previously achieved shall be due to Amicus.
          6.3.6 Related Products to be Commercialized Solely in the Amicus
Territory. Notwithstanding the foregoing, the Related Product Opt-In Right shall
not apply with respect to a particular Related Product that Amicus elects to
Commercialize solely in the Amicus Territory throughout the Term. Accordingly,
if Amicus notifies Shire in writing that it has made the election not to
Commercialize such Related Product in the Shire Territory, the Related Product
Opt-In Right, and this Section 6.3, shall not apply to such Related Product;
provided that if Amicus makes such election under this Section 6.3.6, Amicus
shall not Commercialize such Related Product (for so long as the same remains a
Related Product) in the Shire Territory prior to the end of the [***] period
following Regulatory Approval in the Shire Territory of the first Licensed
Product for such disease within the Field.
     6.4 Termination by JSC; Back-Up Compounds.  The JSC may, from time to time,
terminate the Development of a Licensed Product for the Shire Territory or the
Amicus Territory , in accordance with Section 6.4.1.
          6.4.1 Termination of Development in Shire Territory or Amicus
Territory. If, at the request of a Party (the “Requesting Party”), the JSC
determines that it is not commercially reasonable to continue to Develop and/or
to Commercialize a Licensed Product in the Requesting Party’s Territory
(regardless of whether it is commercially reasonable to do so in the other
Party’s Territory), then such Licensed Product shall be terminated in the
Requesting Party’s respective Territory (i.e., the Shire Territory if Shire is
the Requesting Party and the Amicus Territory if Amicus is the Requesting
Party). Upon such termination:
               (a) If such termination is with respect to the Amicus Territory
only, then: (i) the Licensed Product that was the subject of such termination
shall remain a Licensed Product for all purposes of this Agreement and shall not
revert to Amicus by reason of such termination, and the
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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provisions of Sections 6.4.2 and 6.4.3 shall not apply with respect to such
termination; (ii) Shire shall have the right to continue Developing and to
Commercialize such Licensed Product as an Independent Project outside the
Development Plans in the Shire Territory at its own expense (which costs shall
not be shared under Section 7.4.1); (iii) Amicus’ obligations under Sections 4.1
and 4.2, and under the Development Plan for such Licensed Product (to the extent
such Development Plan applies to such Licensed Product), shall terminate,
subject to Amicus using Commercially Reasonable Efforts to transition any such
Development activities that relate to Development and/or Commercialization of
such Licensed Product in the Shire Territory to Shire; and (iv) Amicus’
obligation to supply such Licensed Product under Article 8 shall terminate on
the second anniversary of such termination or such earlier date as Shire
establishes an alternative source of supply for such Licensed Product, during
which period Amicus shall cooperate reasonably to transition to Shire or its
designee the Manufacture of such Licensed Product. In the event of termination
for the Amicus Territory only under this Section 6.4.1(a), Amicus shall not
Develop or Commercialize such Licensed Product or the Compound contained therein
anywhere in the Territory during the remaining Term for so long as the same
remains a Licensed Product; or
               (b) If such termination is with respect to the Shire Territory,
then such Licensed Product shall cease to be a Licensed Product and the
provisions of Sections 6.4.2, 6.4.3 and 6.4.4 shall apply (in which case such
Licensed Product shall be deemed a Terminated Product), and Shire shall use
Commercially Reasonable Efforts to transition any Development activities that
relate to Commercialization of such Licensed Product in the Amicus Territory to
Amicus. For clarity, Shire shall have no further obligations under this
Agreement with respect to such Licensed Product under Sections 4.1 and 4.2, the
Development Plan for such Licensed Product, and Article 5.
          6.4.2 Intentionally Omitted.
          6.4.3 Reversion.
               (a) In the event a Licensed Product ceases to be a Licensed
Product pursuant to Section  6.4.1(b) or 7.2.5, or Section 15.3.2, (i) such
Licensed Product shall be deemed a “Reverted Product” under Section 15.5.2,
(ii) the Compound contained therein shall cease to be a Compound for all
purposes of this Agreement to the extent no other Licensed Product containing
such Compound is actively being Developed (including clinical Development) or
Commercialized by Shire hereunder, (iii) Shire shall have no further rights
under Section 4.3.2 with respect to clinical trials involving such Licensed
Product, (iv) Amicus shall have no further obligations under Article 8 with
respect to such Licensed Product, (v) Shire shall have no further prosecution,
maintenance and enforcement rights under Sections 10.2 and 10.3 with respect to
Patent Rights specifically directed to such Licensed Product, (vi) Shire shall
have no further rights under Section 14.5 with respect to such Licensed Product,
and (vii)  the provisions of Sections 15.5.2(a), (c), (d), (e), (f), (g) and
(h) shall then apply with respect to such Licensed Product as if this Agreement
had terminated under Section 15.3.1. For clarity, Shire shall have no further
obligations under this Agreement with respect to such Licensed Product under
Sections 4.1 and 4.2, the Development Plan for such Licensed Product, and
Article 5.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (b) In addition, subject to subsection (iv) below, in the event
of such reversion:
                    (i) with respect to Amigal, then Fabry Disease (plus any
additional indication for DGJ included within the Field pursuant to
Section 6.1.5) shall thereafter be excluded from the definition of Field; and
the compounds and products described in Section 6.3.1(a) shall cease to be
Related Products;
                    (ii) with respect to Plicera, then Gaucher Disease (plus any
additional indication for [***] included within the Field pursuant to
Section 6.1.5 or Section 6.2) shall thereafter be excluded from the definition
of Field; the obligations under Sections 6.2.1 and 6.2.2 shall terminate; and
the compounds and products described in Section 6.3.1(b) shall cease to be
Related Products; and
                    (iii) with respect to AT2220, then Pompe Disease (plus any
additional indication for DNJ included within the Field pursuant to
Section 6.1.5) shall thereafter be excluded from the definition of Field; and
the compounds and products described in Section 6.3.1(c) shall cease to be
Related Products; in each of subsections (i) and (ii) above and this
subsection (iii), for all purposes of this Agreement.
                    (iv) Notwithstanding the foregoing, if (x) a salt,
enantiomer, metabolite or polymorph of such Compound is then actively being
Developed (including clinical Development) or being Commercialized, or (y) an
additional Compound has been added to this Agreement under Sections 6.3 or 6.4.4
(or 1.5.4) for a disease described in subsection (b)(i), (ii) or (iii) above and
such Development is continuing under a Development Plan or as an Independent
Project (or a Licensed Product is being Commercialized hereunder for such
disease), then in either such case such disease shall not be deemed excluded
from the Field under this Section 6.4.3 unless such Compound becomes a Reverted
Product; and in the case of subsection (ii) if another Licensed Product
containing [***] is actively being Developed (including clinical Development) or
Commercialized hereunder, then Sections 6.2.1 and 6.2.2 shall not terminate
pursuant to subsection (ii) above.
          6.4.4 Back-Up Compounds.
               (a) Back-Up Compound Opt-In Right. If a Licensed Product is
terminated pursuant to Section 6.4.1(b) or 6.4.2 (a “Terminated Product”) and at
such time there is no other Licensed Product containing the same Compound as the
Terminated Product being Developed hereunder for the disease within the Field to
which such Terminated Product was directed, then upon request by Shire, the JSC
shall take the actions set forth in this Section 6.4.4 to select a Back-Up
Compound (as defined below) to be added as a Compound hereunder (the “Back-Up
Compound Opt-In Right”). For purposes hereof, a “Back-Up Compound” shall mean an
active pharmaceutical ingredient Controlled by Amicus:
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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                    (i) that is a Related Product for the same Target and
disease within the Field as the applicable Terminated Product (e.g., a Related
Product described in Section 6.3.1(a), if the Terminated Product was being
Developed for Fabry Disease); and
                    (ii) that is either (x) referenced on Exhibit 6.4.4 hereto,
(y) (A) for which Amicus has performed or is performing human clinical trials
for such disease within the Field, or (B) for which Amicus first initiates such
a human clinical trial within three (3) years after the date of such
termination, or (z) a pre-clinical compound for which Amicus has performed at
least one (1) study in an animal model in the Field that Amicus has not
designated as a candidate for Development outside the Field.
               (b) Notice. Promptly following termination of a Licensed Product
as described in this Section 6.4.4(a)Amicus shall provide the JSC and Shire with
a description of the Back-Up Compound(s) in existence at the time of such
notice. If Shire exercised the Back-Up Compound Opt-In Right but the JSC does
not select any of the Back-Up Compounds in existence at such time, and Amicus
within three (3) years after the date of such termination initiates a human
clinical trial of a Back-Up Compound within the Field, then Amicus shall notify
the JSC at least thirty (30) days before initiating the first such trial or
conducting the first such pre-clinical animal study of the first such Back-Up
Compound (each of the notices in (i) and (ii), a “Back-Up Compound Notice”).
               (c) Exercise. To exercise the Back-Up Compound Opt-In Right,
Shire shall notify Amicus and the JSC in writing of such exercise within [***]
after its receipt of the Back-Up Compound Opt-In Notice (the “Back-Up Opt-In
Exercise Period”). Upon Shire’s timely exercise of the Back-Up Compound Opt-In
Right, the JSC may select one such Back-Up Compound to be included in the
Development Plan pursuant to such Back-Up Compound Opt-In Right provided, that
the JSC may select multiple Back-Up Compounds from those referenced in Exhibit
6.4.4. It is understood that the JSC (rather than Shire) shall select the
Back-Up Compound to be added as a Compound pursuant to such Back-Up Compound
Opt-In Right. Upon the JSC’s selection, and Shire’s acceptance, of the Back-Up
Compound:
                    (i) such Back-Up Compound shall become a Compound hereunder,
and the Field with respect to Licensed Products containing such Compound shall
be the same disease within the Field for the applicable Terminated Product;
                    (ii) Shire shall promptly reimburse Amicus for [***] of the
costs incurred by Amicus outside the Development Plans that are specifically
attributable to the Development of such Back-Up Compound during the period prior
to such exercise, determined in accordance with Section 6.5.4;
                    (iii) any unpaid milestone payments under Section 7.2.1 with
respect to the applicable Terminated Product shall be payable upon achievement
of such Milestone by a Licensed Product containing such Back-Up Compound; and
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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                    (iv) Amicus may elect, within [***] following such Back-Up
Compound becoming a Compound, to terminate Development and Commercialization of
such Compound and any Licensed Product containing such Compound in the Amicus
Territory provided, Amicus shall not have the right to terminate a Back-Up
Compound selected by the JSC, if Amicus had proposed that the JSC select such
Back-Up Compound.
               (d) Failure to Exercise. If (i) Shire does not exercise the
Back-Up Compound Opt-In Right with respect to a particular Terminated Product
within the applicable Back-Up Opt-In Exercise Period, (ii) no Back-Up Compound
is designated as a Compound under this Section 6.4.4 with respect to the
Terminated Product within three (3) years following the date such Terminated
Product is terminated under Section 6.4.1(b) or 6.4.2, or (iii) Shire does not
accept the Back-Up Compound selected by the JSC within [***] of the selection of
the JSC, then in any such case the Back-Up Compound Opt-In Right, and the
provisions of this Section 6.4.4, shall terminate with respect to that
Terminated Product and all Back-Up Compounds directed to the disease within the
Field with respect to which such Terminated Product was directed, provided,
Shire shall be deemed to have accepted the Back-Up Compound selected by the JSC,
if Shire had proposed that the JSC select such Back-Up Compound.
     6.5 Additional Terms Regarding Related Product/Back-Up Compound Opt-In
Rights. 
          6.5.1 Confirmation of Termination. In the case of a JSC vote to
terminate a Licensed Product under Section 6.4.1 or 6.4.2, each Party’s vote on
the JSC must be reflected in a written notice signed by both the Committee
Co-Chair and the Chief Executive Officer of such Party.
          6.5.2 Additional Know-How. During the Related Product Opt-In Period
and the sixty (60) day period after each Back-Up Compound Notice, Amicus shall
provide Shire with reasonable access to other Data and Know-How Controlled by
Amicus with respect to the Related Product or Back-Up Compound(s) contained in
the applicable Related Product Opt-In Notice or Back-Up Compound Notice.
However, notwithstanding anything herein to the contrary, unless such Related
Product or Back-Up Compound becomes a Licensed Product or Compound in accordance
with Section 6.3 or 6.4, Shire shall not have the right to use, and shall not
use, such Know-How pertaining to such Related Product or Back-Up Compound
provided to it pursuant to this Section 6.5.2 or otherwise to obtain Regulatory
Approval of, or to Commercialize, any product.
          6.5.3 Transition of Development Following Exercise of Opt-In Right.
Following exercise of the Related Product Opt-In Right or the selection of a
Back-Up Compound upon exercise of the Back-Up Compound Opt-In Right, Amicus
shall continue performing further activities related to the Development of such
Related Product or Back-Up Compound, as applicable, in accordance with Amicus’
own Development plans for a period of up to one (1) year after the exercise of
such Related Product Opt-In Right or selection, respectively, or until such
earlier time as the JSC establishes such new Development Plan. Thereafter, the
further Development of such Licensed Product shall be conducted in accordance
with such Development Plan, as modified by the JSC from time to time. All costs
reasonably incurred by Amicus in performing such activities (i.e., those after
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Shire’s exercise of the applicable Opt-In Right, but prior to the JSC’s
establishment of a new Development Plan), and those conducted pursuant to the
new Development Plan so established, shall be shared in accordance with
Section 7.4.1. Following exercise of the Related Product Opt-In Right or Back-Up
Compound Opt-In Right, and adoption of the new Development Plan, the Parties
shall use Commercially Reasonable Efforts to ensure an orderly transition and
uninterrupted Development of the Related Product or Back-Up Compound that was
the subject of such Opt-In Right, respectively.
          6.5.4 Regarding Amount of Reimbursement. With respect to the
calculation of costs to be reimbursed under Sections 6.3.3, 6.4.4(c)(ii) or
6.5.3, internal Development costs shall be determined by applying the FTE Rate
used under the Development Plans for the same period. In the event of a dispute
as to the costs to be reimbursed under such Sections, the matter shall be
resolved by the JSC; and in such case, prompt reimbursement shall be made in the
amount described above with respect to any undisputed amounts and any disputed
amounts shall be promptly reimbursed upon resolution of such dispute by the JSC
or pursuant to Section 16.8.
          6.5.5 Term of Related Product and Back-Up Compound Opt-In Rights.
Within thirty (30) days after the first Regulatory Approval of a Licensed
Product in the first Primary Market of the Shire Territory, Section 6.3 and
Section 6.4.4 shall each terminate with respect to all Related Products, and all
Back-Up Compounds, directed to the same disease within the Field as such
Licensed Product. For example, upon the first Regulatory Approval for Amigal,
(a) Shire would have no further Related Product Opt-In Right with respect to any
small molecule that selectively binds to the active site of a-galactosidase A
for the diagnosis, treatment or prevention of Fabry Disease and (b) Shire would
have no further Back-Up Compound Opt-In Right if Amigal (or any other Licensed
Product being developed for Fabry Disease) thereafter becomes a Terminated
Product.
     6.6 Independent Development and Commercialization of Related Products. 
          6.6.1 Neither Party shall, directly or indirectly, Commercialize a
Related Product within the Field in the Shire Territory until [***] after the
First Commercial Sale in the first Primary Market country in the Shire Territory
of the Licensed Product directed toward the same Target as such Related Product.
In addition, unless the Parties agree otherwise, Shire shall not and, solely
with respect to a Related Product for which Amicus has elected solely to
Commercialize in the Amicus Territory under Section 6.3.6, Amicus shall not,
directly or indirectly, Develop such a Related Product prior to such First
Commercial Sale; provided that such restriction shall apply neither to
non-clinical Development activities, nor to clinical trials in healthy
volunteers, with respect to a Related Product.
          6.6.2 For clarity, it is understood that Section 6.3 through 6.5 above
shall not apply with respect to [***] for [***]’s or other products outside the
Field.
     6.7 Reservation.  For clarity, is understood that, except as expressly
provided in Section 4.3.2, this Agreement shall not be deemed to limit Amicus’
right to Manufacture, Develop,
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Commercialize and otherwise use, import or exploit (a) Compounds or Licensed
Products for use within or outside the Field within the Amicus Territory, or
(b) subject to Sections 6.2.1 and 6.2.2 above, an [***] for [***]’s for use in
the Shire Territory.
ARTICLE 7
PAYMENTS, ROYALTIES AND THE SHARING OF DEVELOPMENT COSTS
     7.1 License Fee.  Shire shall pay to Amicus a license fee in the amount of
Fifty Million Dollars ($50,000,000), within three (3) Business Days after the
Effective Date, in accordance with Section 7.6. The license fee set forth in
this Section 7.1 shall not be refundable or creditable against any future
milestone payments, royalties or other payments by Shire to Amicus under this
Agreement.
     7.2 Milestone Payments
          7.2.1 Development Milestone Payments. Shire shall pay to Amicus the
Milestone payments set forth below following the first achievement by Amicus or
Shire, or any of their Affiliates or Sublicensees, of the corresponding
Milestone event set forth below with respect to a Licensed Product:

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

For purposes of clarity, the above payments for achievement of a Milestone shall
only be paid once under this Section 7.2.1 irrespective of how many Licensed
Products achieve such Milestones. For clarity, additional milestones may be due
pursuant to Sections 6.2.1(c) and 6.3.5.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          7.2.2 Net Sales Milestone Payments. In addition, Shire shall pay to
Amicus the Milestone payments set forth below at such time as the aggregate
annual Net Sales of all Licensed Products during a particular calendar year
first reaches the following amounts in the Shire Territory:

      Aggregate Annual Net Sales of All Licensed     Products in the Shire
Territory   Milestone Payment Amount   $[***]   $[***] $[***]   $[***] $[***]  
$[***] $[***]   $[***]

Notwithstanding anything herein, in no event shall any two Milestone payments
under this Section 7.2.2 be due in the same calendar year; [***]. For purposes
of clarity, the above payments for achievement of a Milestone under this
Section 7.2.2 shall only be paid once under this Agreement.
          7.2.3 Reports and Payments. Each Party shall notify the other Party of
its achievement of any of the foregoing milestone events under Sections 7.2.1
and 7.2.2 (each, a “Milestone”) and Amicus shall provide Shire an invoice of
such Milestone achievement, and payment of the amount corresponding to such
Milestone, except as expressly provided otherwise in Section 7.2.2, shall be due
within fourteen (14) Business Days of receipt by Shire of an invoice of such
achievement. For the avoidance of doubt, the Milestone payments set forth in
this Section 7.2 shall not be creditable against any future Milestone payments,
royalties or other payments by Shire to Amicus under this Agreement.
          7.2.4 Certain Terms. For purposes of the milestone payments due under
Section 7.2.1:

  (a)   [***].     (b)   [***].     (c)   [***].     (d)   [***].     (e)  
[***].

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (f) For purposes of this Article 7, a [***] shall be deemed to
constitute a [***] if the JDC determines to proceed with filing an [***] based
upon the use of Data from such [***] as a pivotal trial.
               (g) A Milestone shall be deemed achieved for Fabry Disease,
Gaucher Disease or Pompe Disease if the Milestone is met for an indication
involving such disease.
               (h) If, upon first achievement of a particular Milestone under
Section 7.2.1 above with respect to a particular Licensed Product, the amounts
corresponding to any Milestone with respect to such Licensed Product that
precede such Milestone in the table under Section 7.2.1 above have not been
previously paid, then such previous amounts that have not been paid shall also
become due and payable subject to Section 7.2.2.
          7.2.5 Reversion. Notwithstanding the foregoing, if at the time the
first Regulatory Approval is obtained for a Licensed Product in the first
Primary Market country in the Shire Territory where (a) neither the sale nor use
of such Licensed Product is covered by a Valid Claim and (b) such Licensed
Product has no regulatory or orphan drug exclusivity in such Primary Market
country, Shire may within thirty (30) days of such Regulatory Approval elect to
(i) terminate this Agreement in its entirety with respect to such Licensed
Product, under Section 15.3.2, in which case the Milestone payment for
Regulatory Approval under Section 7.2.1 shall not be due for such Licensed
Product irrespective of Section 7.2, (ii) terminate this Agreement with respect
to such Licensed Product for the European Union only by providing notice as such
and further no Milestone payment for such Regulatory Approval shall be due at
such time for such Licensed Product irrespective of Section 7.2 or (iii) pay the
Milestone payment for Regulatory Approval and continues as otherwise provided in
the Agreement. In the event Shire elects subsection (ii) above, upon Regulatory
Approval in the (x) first Secondary Country, Shire shall pay [***], (y) second
Secondary Country, Shire shall pay [***] and (z) remaining Secondary Country,
Shire shall pay [***], in each case of the Milestone payment that would have
been paid upon the Regulatory Approval of such Licensed Product had Shire not
made its election to terminate this Agreement with respect to such Licensed
Product for the European Union. “Secondary Country” shall mean any one of the
following: Japan, Brazil or Israel. In the event Shire elects (ii), then the
European Union shall thereafter be included in the Amicus Territory with respect
to such Licensed Product; and Section 6.4.3 above shall apply to such Licensed
Product with respect to the European Union (and in the event of any dispute as
to how Section 6.4.3 would apply in such case, the matter shall be determined by
the JSC).
          7.3 Royalties.  Subject to this Section 7.3, Shire shall pay to Amicus
royalties at the following rates on the Annual Net Sales (as defined below) by
Shire, its Affiliates and its Sublicensees of each Licensed Product:
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          Royalty Tier   Annual Net Sales of Each Licensed Product   Royalty
Rate  
1
  Portion up to and including $[***]   [***]%
2
  Portion above $[***] and up to and including $[***]   [***]%
3
  Portion above $[***] and up to and including $[***]   [***]%
4
                 Portion above $[***]   [***]%

          7.3.1 Calculation. For such purposes, “Annual Net Sales” means total
Net Sales of a particular Licensed Product in a particular calendar year for
which royalties are due pursuant to this Agreement. For purposes of this
Agreement, units of Licensed Products shall be considered sold, and the
corresponding Net Sales shall be deemed to have accrued, when revenue is
recognized in accordance with U.S. GAAP.
          7.3.2 Generic Competition Reduction. Notwithstanding the foregoing, if
there is Generic Competition in a Calendar Quarter in a country within the Shire
Territory with respect to a Licensed Product, the royalties due on sales of
Licensed Product for such Calendar Quarter in such country shall be reduced as
follows:

      Percentage of Generic Competition in   Royalty Reduction on Net Sales from
a Country   such Country   >[***]% <[***]%   [***]% = [***]% <[***]%   [***]% =
[***]%   [***]%

     “Generic Competition,” with respect to a Licensed Product in a country in
the Shire Territory, shall exist after one or more Generic Versions of such
Licensed Product are being marketed in such country. The percentage of Generic
Competition in a country shall be calculated by dividing the aggregate unit
volume of Generic Version(s) of such Licensed Product by the total prescription
unit volume of such Licensed Product and such Generic Version(s) combined, in
the aggregate, in such country in a calendar quarter (as measured by a
Scott-Levin Associates audit or other mechanism determined by the JSC); and
“Generic Version” shall mean a product that: (x) (1) with respect to the
European Union or Japan [***] and (2) with respect to all other countries in the
Shire Territory has the same active ingredient as the Compound in the Licensed
Product and is legally substituted by pharmacies in such country for the
Licensed Product [***].
     The adjustment under this Section 7.3.2 shall be reconciled at the end of
each calendar year to take into account the total volume for the year of the
particular Generic Version and such Licensed Product and the royalty rate
applicable for such calendar year under this Section 7.3.2 as
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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determined by the JSC (such that total adjustment for the year shall be
calculated on annual basis for such calendar year).
          7.3.3 Gross Margin Adjustment.
               (a) In the event that Shire’s average Gross Margin (as defined
below) for a particular Licensed Product during any calendar quarter is less
than [***]%, the difference between such average Gross Margin and [***]% shall
be offset against the royalties otherwise payable with respect to such Licensed
Product during such calendar quarter pursuant to Section 7.3 above, provided,
however, that in no event shall: (a) the total royalty rate under Section 7.3 be
reduced by more than [***]%, or (b) the royalty rate under Royalty Tier 1 be
reduced to less than [***]%; and in any event there shall be no such reduction,
under this Section 7.3.3, of the royalty rates under Royalty Tiers 3 and 4.
               (b) For purposes hereof:
                    (i) “Gross Margin” is defined as the Net Sales of such
Licensed Product less the Manufacturing Cost (as defined below) of such Licensed
Product for the units of Licensed Product whose sale generated the Net Sales for
the period in question, provided, however, that for purposes of calculating
Shire’s Gross Margin under this Section 7.3.3, Shire’s Manufacturing Cost shall
be deemed not to exceed Amicus’ Manufacturing Cost for the same Licensed Product
during the same period; and
                    (ii) “Manufacturing Cost” is defined as, with respect to a
Licensed Product sold by a Party: (A)(1) the amount paid by such Party for such
Licensed Product manufactured by a Third Party or (2) the cost of direct
materials and direct labor for such Licensed Product manufactured by such Party
or its Affiliate, plus a reasonable allocation of direct manufacturing overhead,
not to exceed [***] of such materials and labor costs; (B) the net cost or
credit to such Party of any value-added taxes or duties actually paid or
utilized on account of such materials; (C) out-of-pocket transportation costs,
including clearance and storage of such materials (if necessary), and transit
insurance on account of such materials; (D) the costs of reasonable quantities
of material destroyed in quality control testing on account of such Licensed
Product (as such costs are calculated under clauses (A) through (C) above); and
(E) in the case of a Licensed Product manufactured by a Third Party, the
internal costs of such Party pertaining to the procurement of such materials
(e.g., for quality assurance and quality control activities), not to exceed
[***] of the Manufacturing Cost of such Licensed Product.
     7.3.4 Third Party Royalties. If Shire is required (a) to enter into an
agreement to license or acquire rights under Third Party Patent Rights that are
necessary to use, import, Manufacture or Commercialize (i) a Compound contained
in a Licensed Product or (ii) the Licensed Products as existing as of the
Effective Date and (b) pursuant to such agreement, to pay to a Third Party
royalties or other payments in order to use, import, Manufacture or
Commercialize a Licensed Product within the Field in a country of the Shire
Territory, then Shire may deduct up to [***] of the commercially reasonable
royalty or other payments payable to such Third Party from the royalty
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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thereafter payable to Amicus under Section 7.3 above with respect to such
Licensed Product in such country, provided that the royalty paid to Amicus shall
not be [***] of what Amicus would have received otherwise pursuant to the terms
of this Agreement; provided, further, that this Section 7.3.4 shall not apply to
Patent Rights listed on Schedule 7.3.4. In the event of a dispute between the
Parties whether such Third Party license is required, such dispute shall be
resolved by the JSC based upon the well reasoned opinion of qualified
independent patent counsel retained by the JSC.
          7.3.5 Reports and Royalty Payment. Within ten (10) Business Days after
the end of each calendar quarter, Shire shall deliver to Amicus a report setting
out all details necessary to calculate the royalty payments due under this
Section 7.3 with respect to Net Sales made in that calendar quarter, including:
               (a) units of Licensed Products sold in the Shire Territory during
the relevant calendar quarter [***];
               (b) gross sales of Licensed Products in the Shire Territory in
the relevant calendar quarter [***], including the gross sales price of each
Licensed Product;
               (c) Net Sales of Licensed Products in the relevant calendar
quarter on a country-by-country basis;
               (d) all relevant deductions in accordance with Section 1.25 and
this Section 7.3;
               (e) all relevant exchange rate conversions; and
               (f) such other information as requested by Amicus regarding the
Commercialization of Licensed Products in the Shire Territory as necessary to
satisfy Amicus’ reporting obligations to its licensors under the Existing
In-Licenses.
     Any amounts due under this Section 7.3 for such calendar quarter shall be
paid within thirty (30) days after the end of such calendar quarter.
          7.3.6 Royalty Term. The obligation of Shire to pay royalties pursuant
to this Section 7.3 shall continue for each Licensed Product, on a Licensed
Product-by-Licensed Product and country-by-country basis, until the latest of:
               (a) Expiration of the last to expire Valid Claim covering the
use, importation, or sale of such Licensed Product in the country of sale;
               (b) The loss of all regulatory exclusivity (including orphan drug
exclusivity) to market such Licensed Product in such country; or
               (c) Fifteen (15) years after the First Commercial Sale of such
Licensed Product in such country.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     7.4 Development Cost Sharing7.4.1 Development Costs. Subject to the terms
and conditions of this Agreement, each Party shall be responsible for fifty
percent (50%) of all Development Costs incurred in accordance with the
Development Plans.
          7.4.2 Cost Overruns. With respect to Development Costs to be shared by
the Parties under Section 7.4.1 above, if the total Development Costs incurred
by a Party (such party, the “Spending Party”) in a calendar year exceed the
costs budgeted for such Party in the applicable then current Development Plan,
then the other Party shall continue to bear its share of such costs under
Section 7.4.1 above, notwithstanding such overrun, up to its share of [***] of
the budgeted amounts (the “Permitted Overrun”), but such other Party shall not
be responsible for its share of such aggregate costs in excess of the Permitted
Overrun (the “Excess Costs”), without the approval of the JSC, which shall not
be unreasonably withheld.
          7.4.3 Commercialization Costs. For clarity, it is understood that each
Party shall be responsible for all Commercialization costs incurred by such
Party.
          7.4.4 Procedure for Sharing Development Costs.
               (a) Each Party shall calculate and maintain records of all
Development Costs incurred by it in accordance with Section 7.8.
               (b) So that the Parties will share equally the Development Costs
incurred in accordance with the Development Plans pursuant to Section 7.4.1
above, balancing payments shall be made as follows: On or before the fifteenth
day of each month, the Party who is budgeted to incur the lesser amount of
Development Costs during such month (as reflected in the then current
Development Plans) (the “Reimbursing Party”) shall pay to the other Party (the
“Receiving Party”) an amount equal to (i) fifty percent (50%) of the Development
Costs budgeted to be incurred by the Receiving Party during such month, less
(ii) fifty percent (50%) of the Development Costs to be incurred by the
Reimbursing Party during such month, all in accordance with the Development
Plans then in effect. Unless otherwise specified in the applicable Development
Plan, amounts budgeted thereunder for a period exceeding the length of a month
will be deemed budgeted in equal amounts for each month within such period.
Within ten (10) days following the last day of each month during any period in
which activities are being performed under a Development Plan hereunder, each
Party shall provide to the other a good faith estimate of the Development Costs
actually incurred by such Party during the month then ended, in a form
determined by the JDC.
               (c) The Parties shall use good faith efforts to keep each other
apprised of variances in Development budgets and to notify each other with
respect thereto.
               (d) Within thirty (30) days following the last day of each
calendar quarter (March 31, June 30, September 30, and December 31) during the
Term, the Parties shall reconcile the advanced payments made in accordance with
paragraph (b) above with the Development Costs actually incurred to date by each
Party, and within such thirty (30) day period the Parties shall make such
balancing payment(s) as are necessary to achieve the result that each Party has
funded fifty
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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percent (50%) of the total Development Costs through such March 31, June 30,
September 30 or December 31 date, as applicable.
               (e) Any dispute regarding Development Costs under this
Section 7.4 shall be resolved by the JDC. The existence of any dispute regarding
Development Costs or any other matter under this Section 7.4 shall not relieve a
Party of its obligation to continue to pay prospectively each month its
allocated portion of Development Costs in accordance with this Section 7.4 and
the Development Plans. In the event of any such dispute, any undisputed amount
shall be paid within the time periods specified in this Section 7.4, and the
Party disputing any amount shall pay to the other Party within such time periods
[***] of the disputed amount.
          7.4.5 Funding Under Initial Development Plans. It is understood that,
beginning upon the Effective Date, the Parties will fund in accordance with this
Section 7.4 the Development Costs incurred by Amicus under the initial
Development Plans attached as Appendix 4. The Parties acknowledge, however, that
the number of FTEs reflected in such initial Development Plans has not been
agreed as of the Effective Date. Accordingly, if the final Development Plans
established in accordance with Section 4.2.5(b) provide for fewer FTEs than
those reflected in such initial Development Plans (or if the Parties sooner
agree on a lower number of FTEs), then Shire shall receive a credit for its
portion of the costs of such excess FTEs reimbursed by Shire under this
Section 7.4, in the amount of one half of the FTE Rate multiplied by the number
of such excess FTEs, prorated for the period of time from the Effective Date
until the date such final Development Plans are so approved. Such credit shall
be applied in equal monthly amounts over the first six months following the
approval of such final Development Plans.
     7.5 Payments under Existing In-Licenses. 
          7.5.1 Generally. Other than as specifically provided in
Sections 7.5.2, 7.5.3. 10.2.1 and 10.2.2 below, Shire shall have no
responsibility for Third Party payments due with respect to the Development,
Manufacture or Commercialization of the Licensed Products under the Existing
In-Licenses, and such payments shall be borne solely by Amicus.
          7.5.2 Royalty Reductions. Amicus shall be responsible for paying any
royalties owed to Third Parties under Amicus’ Existing In-Licenses. However,
during the royalty term (as determined under Section 7.3.6) where a reduction of
royalties due to Amicus under Section 7.3 with respect to a Licensed Product in
a country of the Shire Territory occurs under Sections 7.3.2, 7.3.3, 7.3.4,
7.3.6 or 15.5.4 of this Agreement [***] with respect to sales of such Licensed
Product in such country, Shire shall promptly reimburse Amicus [***]. If, with
respect to a Licensed Product, upon the [***] Amicus continues to be obligated
to make royalty payments to a Third Party under an Existing In-License with
respect to sales of such Licensed Product in such country, then (x) Amicus shall
promptly notify Shire of the amount of such royalty rate for sales of such
Licensed Product and the period for which it is obligated to make such payments
in such country and (y) within thirty (30) days after receipt of such notice
Shire shall notify Amicus of its election to (1) terminate its sublicense under
such Existing In-License in which case such sublicense will terminate whereby no
further royalties shall be due from Shire for sales of such Licensed Product in
such country or (2)
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
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make royalty payments to Amicus for the amounts owed by Amicus under such
Existing In-License for the period so specified in the notice provided under
subsection (y) above and at the lower of the royalty rate so specified in such
notice and the applicable rate specified in subsection (b) above.
          7.5.3 Sublicenses. In the event that the granting of a Sublicense
under the rights granted to Shire under Section 2.1 triggers any payment
obligation by Amicus under any Existing In-License (other than the payment of
running royalties), Shire shall be responsible for, and shall promptly pay to
Amicus upon request, any such amounts when they become due.
     7.6 Other Payment Terms. 
          7.6.1 Payment Method. All payments between the Parties under this
Agreement (including, without limitation, the payments due under this Article 7)
shall be made by bank wire transfer in immediately available funds to an account
designated by the Party to which such payments are due. All payments due under
this Agreement which are not timely paid shall bear interest to the extent
permitted by Law at a rate equal to the U.S Prime Lending Rate, as quoted in The
Wall Street Journal (U.S. Eastern Edition), effective for the date on which the
payment was due. This Section 7.6.1 shall in no way limit any other remedies
available to the Parties.
          7.6.2 Currency. All dollar amounts in this Agreement are stated in,
and all payments under this Agreement shall be made in, United States Dollars.
With respect to amounts invoiced or incurred in a currency other than United
States Dollars, (i) for calculation of Net Sales, the amount in foreign
currencies shall be converted into United States Dollars using the average rate
of exchange for such currencies for the relevant month as sourced from
www.oanda.com, and (ii) for calculation of all other sums due under this
Agreement, the amount in foreign currencies shall be converted into United
States Dollars using the exchange rate for such currencies for the date of the
respective invoice and where such exchange rate shall be the mid-price exchange
rate taken from Bloomberg as published on the date of the relevant invoice or
such other publication as may be mutually agreed between the Parties.
     7.7 Taxes
          7.7.1 Notice. Each Party will provide the other Party with reasonable
advance notice of tax withholding obligations to which it reasonably believes
that it is subject. Any withholding or other taxes that either Party is required
by law to withhold or pay on behalf of the other Party, with respect to any
payments to such other Party hereunder or any of the Related Agreements, shall
be deducted from such payments and paid to the appropriate tax authority
contemporaneously with the remittance to the other Party, provided, however,
that the withholding Party shall furnish the other Party with proper evidence of
the taxes so paid. Each Party shall cooperate with the other and furnish the
other Party with appropriate documents to secure application of the most
favorable rate of withholding tax under Law (or exemption from such withholding
tax payments, as applicable), and, at the request of the payee Party, payment of
any amount subject to withholding shall be deferred until the appropriate
documents have been furnished.
          7.7.2 Certain Taxes.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
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               (a) Notwithstanding Section 7.7.1 above, subject to compliance
with Section 7.7.2(b) and (c) below any payments to Amicus hereunder shall be
made free and clear of, and Shire shall indemnify and hold Amicus harmless
against, any Irish tax (whether withheld at the source or otherwise) imposed on
or in relation to any payment made under this Agreement that would not have
arisen had the paying entity been a corporation formed under the laws of the
United States; provided, however, that Shire shall not be required to indemnify
Amicus for Irish taxes imposed on the net income of Amicus by reason of Amicus
(or its successors under Section 16.1 below) having (or having attributable to
it) a permanent establishment, branch, agency or Irish tax resident corporation
in Ireland, other than a permanent establishment, branch, agency or Irish tax
resident corporation created as a result of Amicus entering into this Agreement
or undertaking any action required under this Agreement.
               (b) Amicus agrees to use diligent efforts to obtain, as promptly
as practicable after the Effective Date, a completed US tax Form 6166 from the
IRS and shall forward it with a completed Irish tax Form IC3/6166 to Shire
requesting that the Irish Revenue Commissioners issue a direction to Shire to
make all payments under this Agreement without withholding or deduction for or
on account of Irish tax. In addition, Amicus agrees to use diligent efforts,
upon request and at the expense of Shire, to recover from the Irish Revenue
Commission any refundable tax, and/or to challenge an assessment of any other
Irish tax, indemnified by Shire under Section 7.7.2(a) above.
               (c) Amicus warrants that as of the Effective Date it is, and the
indemnity and agreement not to withhold under Section 7.7.1 above is conditioned
upon Amicus (and its successors under Section 16.1) being on the date of any
payment under this Agreement, a resident in the United States for the purposes
of the Convention between the Government of Ireland and Government of the United
States of America for the avoidance of double taxation and the prevention of
fiscal evasion with respect to taxes on income and capital gains signed 28th day
of July, 1997.
     7.8 Records Retention; Audits. 
          7.8.1 Record Retention. Each Party will maintain complete and accurate
books, records and accounts used for the determination of expenses incurred in
connection with the performance of Development of Licensed Products within the
Field (and of [***] for [***]’s) or otherwise relevant for the calculation of
Net Sales, in sufficient detail to confirm the accuracy of any payments required
under this Agreement, which books, records and accounts will be retained by such
Party for five (5) years after the end of the period to which such books,
records and accounts pertain, or longer as is required by Law.
          7.8.2 Request. Upon the written request of a Party (the “Auditing
Party”) and not more than once each calendar year, the other Party (the
“Responding Party”) shall permit the Auditing Party, accompanied by an
independent certified public accounting firm of internationally recognized
standing, selected by the Auditing Party and reasonably acceptable to the
Responding Party, to have access during normal business hours to the records of
the Responding Party as may be
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
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reasonably necessary to verify the accuracy of the financial reports and
calculations made under this Article 7 for any quarter ending not more than five
(5) years prior to the date of such request.
          7.8.3 Discrepancies. If, as a result of such audit, it is established
that additional amounts were owed by the Responding Party for the audited
period, such Party shall pay such additional amounts within thirty (30) days
after the date such discrepancy is established. The determination by such public
accounting firm shall be definitive and final. The fees charged by such
accounting firm shall be paid by the Auditing Party; provided, however, that if
the audit establishes that the aggregate amounts payable by the Responding Party
for the period covered by the audit are more than one hundred five percent
(105%) of the aggregate amounts actually paid for such period, then the
Responding Party shall pay the reasonable fees and expenses charged by such
accounting firm. The Auditing Party shall treat all financial information
subject to review under this Section 7.8 as confidential, and shall cause its
accounting firm to retain all such financial information in confidence.
ARTICLE 8
MANUFACTURING AND SUPPLY
     8.1 General.  It is understood that Amicus procures supplies of Licensed
Products from Third Party contractors. Accordingly, subject to the terms and
conditions of this Agreement, Amicus shall cooperate with Shire to obtain from
such Third Party contractors quantities of Licensed Products and Compounds
(collectively, the “Materials”) to supply Shire’s reasonable requirements for
Materials for the Shire Territory. In furtherance of the preceding sentence:
          8.1.1 Procedures for Clinical Supply. The JDC shall establish as soon
as practicable following the Effective Date procedures for the supply of
Licensed Products to Shire for use in performing Shire’s Development activities
under the Development Plan or Independent Projects.
          8.1.2 Interim Procedures. Pursuant to such procedures:
               (a) Amicus shall procure Materials on behalf of and as reasonably
requested in writing by Shire, consistent with Amicus’ arrangements with its
suppliers; and
               (b) Materials ordered by Amicus from such supplier on behalf of
Shire shall be charged to the Development Costs, or Shire (in the case of an
Independent Project) in an amount equal to the amount paid by Amicus for such
Materials, plus (i) any other documented out-of-pocket costs incurred by Amicus
directly in connection with procuring such Materials, and (ii) any internal
costs of Amicus pertaining to the procurement of such Materials (e.g., for
quality assurance and quality control activities), provided that such internal
costs do not exceed [***] of the overall cost of such Materials.
     8.1.3 Form. The Materials supplied to Shire pursuant to Section 8.1 above
shall be supplied in the same form as like Materials are supplied to Amicus, or
as otherwise established by
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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the JDC or by agreement of the Parties, it being understood that any differences
in such form requested by Shire shall be at Shire’s expense.
          8.1.4 Shortage of Supply. The procedures and arrangements to be
established by the JDC under Section 8.1.1 above shall include reasonable
mechanisms to avoid shortage of supply, including procedures for buffer stock
inventories to be maintained by the Parties on a proportionate basis, and/or
establishing second source manufacturers or manufacturing sites. If, prior to
the establishment and implementation of such procedures, Shire’s requirements of
Materials cannot be fulfilled in accordance with this Article 8, the total
available quantities of Licensed Products shall be allocated among the Parties
on a reasonable worldwide basis (based upon the needs of the Development Plans
and any Independent Projects, and if such Licensed Product is then being
Commercialized, sales history and reasonably forecasted demand for such Licensed
Product), as determined by the JSC.
     8.2 Supply Agreement.  Upon Shire’s written request, the Parties shall use
good faith efforts to enter into a commercial supply agreement (a “Supply
Agreement”) within six (6) months of such request consistent with this Article 8
on commercially reasonable terms documenting the arrangement by which Amicus
shall supply Shire’s reasonable requirements for Materials at cost for the Shire
Territory, which Supply Agreement shall contain forecasting and ordering
procedures (including lead times), product specifications, delivery terms and
other appropriate provisions and be consistent with Amicus’ contractual
arrangements with its Third Party suppliers.
     8.3 Limitation; Manufacturing by Shire.  Amicus shall (a) cooperate fully
with Shire to make available for the benefit of Shire the benefits of Amicus’
supply agreements and/or arrangements with its Third Party suppliers of
Materials and (b) administer such agreements or arrangements diligently and
pursue its rights and remedies thereunder. It is understood, Amicus shall not be
liable for a default or a failure of supply due to default of the Third Party
suppliers. Notwithstanding anything in this Agreement, after the first Phase II
Clinical Trial for a Licensed Product, Shire shall have the right to
Manufacture, or engage a Third Party to Manufacture, Shire’s requirements of
Materials for the Shire Territory. Promptly following Shire’s request, Amicus
shall transfer, or cause to be transferred, to Shire or such Third Party
manufacturer all Amicus Know-How that is necessary, useful or actually used for
such Manufacture of Materials (and the cost of such transfer of Amicus Know-How
shall be shared equally by the Parties), and shall make personnel of Amicus
reasonably available to assist Shire and/or its contractor in implementing the
Amicus Know-How necessary to Manufacture such Materials. In any event the
Parties shall cooperate to use the same process in Manufacturing Materials for
use in Development.
ARTICLE 9
REGULATORY MATTERS
     9.1 Regulatory Responsibilities.  Unless otherwise agreed between the
Parties:
          9.1.1 Amicus Territory Regulatory Responsibility. As between the
Parties, Amicus shall be responsible for filing, obtaining and maintaining, in
its own name, Regulatory Filings and
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
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Regulatory Approvals for Development and Commercialization of Licensed Products
in the Amicus Territory except as otherwise provided in the Development Plan.
          9.1.2 Shire Territory Regulatory Responsibility. As between the
Parties, Shire shall be responsible for filing, obtaining and maintaining, in
its own name, Regulatory Filings and Regulatory Approvals for Development and
Commercialization of Licensed Products in the Field in the Shire Territory
except as otherwise provided in the Development Plan.
     9.2 Filings and Meetings with Regulatory Authorities.
          9.2.1 Regulatory Filings and Correspondence. The Party with
responsibility for regulatory matters in a Primary Market country shall provide
the other Party’s representatives on the JDC with copies of all Regulatory
Filings and all minutes of any meetings, telephone conferences and/or
discussions with the Regulatory Authority of such Primary Market country, and
shall promptly notify the other Party’s representatives on the JDC with respect
to any material changes or material matters that may arise in connection with
Regulatory Approvals of Licensed Products within such Primary Market country, in
each case to the extent it has the right to do so. Each Party will provide the
other Party with translations of such documents into English to the extent
prepared or obtained for its own use and requested by the other Party.
Notwithstanding the foregoing, during the Term, Amicus shall not have the right
to use for purposes of obtaining Regulatory Approval of Amigal for Fabry Disease
in the Shire Territory any Regulatory Filing generated under the applicable
Development Plan by Shire, for so long as Amigal remains a Licensed Product
hereunder.
          9.2.2 Meetings. The Party with primary responsibility for regulatory
matters in a Primary Market within the Shire Territory shall, to the extent
reasonably practicable: (a) promptly provide the JDC with reasonable advance
written notice of any material Regulatory Filings, meetings, telephone
conferences and/or other discussions with the Regulatory Authority of such
country (including in all cases the EMEA), scheduled or unscheduled, that
pertain to Licensed Products in the Field, (b) afford representatives of such
other Party an opportunity to comment on such Regulatory Filings, and accept
such comments or notify such other Party of the reason for not accepting any
such comments, and (c) afford representatives of such other Party an opportunity
to attend all such meetings, telephone conferences and/or discussions with the
Regulatory Authority of such country solely in an observatory capacity. For
clarity, Shire shall be the Party with primary responsibility for regulatory
matters in the Shire Territory unless otherwise provided in the Development
Plan.
     9.3 Adverse Events and Post-Market Surveillance.  With respect to adverse
drug experiences, as defined by 21 C.F.R. Section 314.80 and/or 600.80 (as
applicable), and IND safety reports, as referenced in 21 C.F.R. Section 312.32,
and like regulations of other Regulatory Authorities, the Party with regulatory
responsibility for a country shall be responsible for and shall establish
operating procedures to report to the appropriate Regulatory Authority in that
country all adverse drug experiences in accordance with the Laws of the relevant
countries and agencies. The Parties agree to implement, as soon as reasonably
practicable, a separate agreement setting forth the
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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pharmacovigilance responsibilities and procedures for safety information
exchange (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement
shall contain such terms as are reasonable and customary for arrangements of
this type, and shall in all events include such terms as are necessary to ensure
that both Parties are able to comply with applicable Laws pertaining to adverse
events and safety reporting and provide that there shall be one global safety
database maintained by Amicus or its designee and accessible to both Parties.
The JDC shall determine standard operating procedures by which the Parties shall
have access to such global safety database.
     9.4 Common Registration Dossier.  A primary objective of each Development
Plan is to Develop and produce a common registration dossier to serve as a basis
for license applications to be filed in each of the Primary Market countries.
Unless otherwise determined by the JDC, Amicus shall be responsible for
preparing such common registration dossier, and the costs incurred in connection
therewith shall be deemed to be Development Costs for purposes of this
Agreement.
     9.5 Regulatory Inspections.  If either Party or its Affiliates or
contractors (an “Inspected Party”) are to be inspected by a Regulatory Authority
regarding the Development or Manufacture of a Licensed Product, in each case
within the Field, the Inspected Party shall promptly notify the JDC of the
inspection in advance. The Inspected Party shall, where practicable, permit
representatives of each of Shire and Amicus to participate as observers with
respect to such inspection, and shall provide the JDC with a written report of
any such inspection, noting with specificity any records or documents reviewed
by the regulatory inspector, and including copies of any FDA 483s (or their
foreign equivalent) or written communications provided by any Regulatory
Authority relating to such inspection. The Inspected Party shall also provide an
opportunity for the JDC to assist in responding to any issues or concerns
relating to such inspections, and shall provide copies of all communications to
and from any Regulatory Authority relating thereto to the JDC. The Parties shall
cooperate in good faith and otherwise mutually support any such inspections by
the FDA or other Regulatory Authority of facilities, clinical investigators or
contract manufacturers. In furtherance of the preceding sentence, if the
Inspected Party receives a request by a Regulatory Authority to inspect any
facilities of the other Party, such other Party shall cooperate with and makes
its facilities available for such inspection.
     9.6 Audit Rights.  Each Party shall have the right, during normal business
hours, and no more than once per year, with more frequent audits upon agreement
of the Parties, to inspect and audit: (a) those portions of the facilities of
each Party, Affiliate, Sublicensee, subcontractor and investigator site used in
the performance of the applicable Development Plan or the Manufacturing of
Materials to be supplied hereunder, to ascertain compliance with Laws and
Regulatory Approvals, including cGLP, cGCP and cGMP, and conformance with the
applicable specifications and quality assurance standards, provided that the
inspecting Party shall on such occasions be accompanied by a representative of
the other Party; and (b) any of the other Party’s documentation or its
Affiliates’, Sublicensees’, subcontractors’ or investigators’ documentation
relating to such Development Plan or Manufacturing of the Materials to be
supplied hereunder, including, to the extent permitted by Law and any privacy
policies, the medical records of any patient participating in any clinical study
under the Development Plan. A Party’s audit rights shall be limited by
pre-existing bona fide Third Party
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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agreements or confidentiality obligations, provided, however, that each Party
shall use its reasonable efforts to (1) obtain audit rights for the other Party
under such pre-existing agreements and (2) ensure such other Party is granted
audit rights to the same extent which a Party has audit rights in any future
agreements.
ARTICLE 10
INTELLECTUAL PROPERTY
     10.1 Ownership. 
          10.1.1 Clinical Data. To the extent a Party has the right to do so,
each Party shall assign to the other Party a joint ownership interest in all
Data with respect to Licensed Products generated in the course of performing
clinical trials conducted under the Development Plans, excluding any inventions
and Patent Rights therein (which are addressed in Section 10.1.2 below). For
clarity, it is understood that the foregoing applies only to clinical data, and
does not apply, for example, to related Regulatory Filings.
          10.1.2 Inventions; Patent Rights.
               (a) Subject to Section 10.1.2(b) below, title to all inventions,
and all Patent Rights therein, made solely by Shire personnel in connection with
this Agreement shall be owned by Shire (“Shire Invention”); title to all
inventions, and all Patent Rights therein, made solely by Amicus personnel in
connection with this Agreement shall be owned by Amicus (“Amicus Invention”);
and title to all inventions, and all Patent Rights therein, made jointly by
personnel of Amicus and Shire in connection with this Agreement shall be jointly
owned by Amicus and Shire (“Joint Inventions”). For such purposes, a Party’s
personnel shall include personnel of such Party’s Affiliates who are engaged in
the Development or Commercialization of Licensed Products (to the extent such
personnel are carrying out activities in connection with this Agreement).
               (b) Notwithstanding paragraph (a) above, Shire hereby each grants
and agrees to grant, to Amicus an exclusive license, with the right to
sublicense, under Shire Inventions, and Shire’s interest in Joint Inventions,
that are made in connection with the Development or use of Compounds or Licensed
Products, in each case that are improvements to the chaperone composition
technology covered by the Amicus Patent Rights, or the manufacture, testing or
use thereof, or that constitute a modification of a Compound, to make, use,
sell, offer for sale and import and otherwise exploit such inventions subject to
the inclusion of such inventions in the licenses granted in Article 2.
               (c) In addition, Shire hereby grants to Amicus a non-exclusive
license, with right to sublicense, to practice and otherwise exploit Patent
Rights in Shire Inventions made by Shire in connection with the Development or
use of a Compound or Licensed Product.
          10.1.3 Joint Ownership.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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               (a) Except as expressly provided in this Agreement (including
Section 10.1.3(b) below), it is understood that neither Party shall have an
obligation to obtain approval of, nor pay a share of the proceeds to, the other
Party to practice, enforce, license, assign or otherwise exploit Joint
Inventions and Data jointly owned pursuant to Section 10.1 above, and each Party
hereby waives any right it may have under the applicable Laws of any
jurisdiction to require such approval or accounting. The Parties shall
reasonably cooperate with each other and take any actions reasonably necessary
to effect the purposes of this Section 10.1.3.
               (b) Notwithstanding the foregoing, neither Party shall, without
the consent of the other Party (which consent shall not be unreasonably
withheld), grant to a Third Party a license under Patent Rights in a Joint
Invention, other than (i) in connection with a collaboration with such Third
Party, (ii) for use with products developed in whole or in part by such Party,
or (iii) together with other technology or intellectual property Controlled by
such Party.
     10.2 Patent Filing, Prosecution, and Maintenance10.2.1  By Shire. Shire
shall have the right to control the filing for, prosecution and maintenance of
the Amicus Patent Rights in the name of Amicus (or Amicus’ Licensor), excluding
the Ex-U.S. Platform Patent Rights, solely with respect to the Licensed Products
in the Field in all jurisdictions outside the United States using counsel of its
choice, and Amicus shall reimburse Shire for [***] of the out-of-pocket expenses
reasonably incurred by Shire in performing such activities.
          10.2.2 By Amicus. Amicus shall have the right to control the filing
for, prosecution and maintenance of: (a) the Amicus Patent Rights in the United
States and (b) the Ex-U.S. Platform Patent Rights in all jurisdictions outside
the United States, using counsel of its choice, and Shire shall have the option
to either reimburse Amicus for fifty percent (50%) of the out-of-pocket expenses
reasonably incurred by Amicus in performing the activities under (b) above or,
within sixty days of a request for such reimbursement, opt to have such Patent
Rights excluded from the licenses granted herein (in which case such Patent
Rights shall be excluded from Amicus Patent Rights hereunder and Section 7.5.2
shall not apply for amounts due by Amicus to a Third Party under such Existing
In-License where all Amicus Patent Rights under such Existing In-License have
been excluded from the licenses granted herein and no such Patent Rights cover
Manufacturing of Materials by Amicus for Shire).
          10.2.3 Jointly Owned Patent Rights. The filing for, prosecution and
maintenance of Patent Rights covering Joint Inventions (the “Joint Patent
Rights”) shall be as determined by the Parties, and the out-of-pocket costs
thereof shall be shared equally by the Parties.
          10.2.4 Right to Consult and Advise. During the Term, each Party filing
for, prosecuting and/or maintaining Patent Rights pursuant to this Section 10.2
(the “Prosecuting Party”) shall copy the other Party, or have the other Party
copied, on all material or substantive documents regarding such Patent Rights,
in each case that are directly related to Licensed Products in the Field or
cover Joint Patent Rights, which are received from or to be filed in any patent
office in the Territory, promptly following receipt from the patent office and
within a reasonable time prior to filing with the patent office (but not less
than thirty (30) days), as applicable, including copies of
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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each patent application, office action, response to office action, declaration,
information disclosure statement, request for terminal disclaimer, request for
patent term extension and request for reexamination. Consistent with the
foregoing, such other Party shall have the right to comment on the prosecution
of such Patent Rights, in each case that are directly related to Licensed
Products in the Field or are Joint Patent Rights, by the Prosecuting Party and
provide such comments to the Prosecuting Party’s patent counsel, and the
Prosecuting Party shall consider all such comments in good faith. If such other
Party fails to provide its comments with respect to the prosecution by the
Prosecuting Party of such patent application or patent reasonably in advance of
the deadline for filing or otherwise responding to the relevant matter in the
relevant patent office (but not less than five (5) Business Days), the
Prosecuting Party shall be free to act without consideration of such other
Party’s comments, provided that the Prosecuting Party has provided the other
Party with the relevant information not less than ten (10) Business Days prior
to such deadline or response.
          10.2.5 Abandonment of Prosecution. The Prosecuting Party will notify
the other Party in the event it desires to abandon its efforts with respect to
the prosecution and maintenance of any Patent Rights being prosecuted by the
Prosecuting Party under this Section 10.2, to the extent such Patent Rights
pertain to the Licensed Products in the Field in the Shire Territory or the
Joint Patent Rights. Notification will be given within a reasonable period
(i.e., with sufficient time for such other Party to take whatever action may be
necessary) prior to the date on which such Patent Rights will lapse, go
abandoned (other than to file continuation application for the same subject
matter) or otherwise diminish (but not less than sixty (60) days). Such other
Party (the “Acting Party”) will then have the right, exercisable upon written
notification to the Prosecuting Party, to assume full responsibility, at its
discretion and its sole cost and expense, to file, prosecute, maintain or
conduct any interferences, re-examinations, reissues and oppositions in the
Shire Territory, or in the case of Joint Patent Rights, any country or
countries; provided that, in the case of Shire being the Acting Party with
respect to Patent Rights (other than Joint Patent Rights) Controlled by Amicus,
such right shall be limited to the extent such Patent Rights pertain to a
Licensed Product in the Field in the Shire Territory.
          10.2.6 Scope of Activities. For the purposes of this Section 10.2,
“prosecution and maintenance” shall mean, with respect to a patent, the
preparing, filing, prosecuting and maintenance of such patent, as well as
re-examinations, reissues and requests for patent term extensions and the like
with respect to such patent, together with the conduct of interferences, the
defense of oppositions and other similar proceedings and appeals thereof with
respect to a patent, but shall not include enforcement litigation or the defense
of declaratory judgment actions. Also, as used in this Section 10.2, to
“abandon” particular Patent Rights shall include deciding not to defend against
an opposition, not to defend an interference or similar proceeding, not to
pursue an appeal of an adverse decision or not to pursue particular claims, in
each case with respect to such Patent Rights in the United States Patent &
Trademark Office or a corresponding patent examining authority in another
country.
     10.3 Enforcement Against Third Parties. 
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          10.3.1 Notice. If either Party reasonably believes that a Third Party
is conducting any activities in the Shire Territory that may constitute actual
or potential infringement of the Amicus Patent Rights, in each case with respect
to a Generic Version of a Licensed Product or a Related Product in the Field in
the Shire Territory (each, an “Alleged Infringement”), such Party shall promptly
notify the other Party of such activities.
          10.3.2 Shire’s First Right to Enforce. Except as otherwise
agreed, Shire shall have the first right to bring and control any action or
proceeding under such Patent Rights in respect to an Alleged Infringement
occurring in the Shire Territory. If Shire fails to bring an action or
proceeding with respect to an Alleged Infringement occurring in the Shire
Territory within one hundred twenty (120) days following a request by Amicus to
do so, Amicus shall have the right to bring and control any such action or
proceeding with respect to Amicus Patent Rights.
          10.3.3 Cooperation. The Parties shall reasonably cooperate with each
other in all actions or proceedings described in this Section 10.3, to the
extent pertaining to an Alleged Infringement. The non-controlling Party agrees
to be joined as a party plaintiff if necessary to prosecute the action or
proceeding and shall provide all reasonable cooperation (including any necessary
use of its name) required to prosecute such litigation; provided that the
controlling Party shall reimburse the non-controlling Party for out-of-pocket
expenses reasonably incurred in providing such cooperation at the controlling
Party’s request. The non-controlling Party will be entitled to be represented by
counsel of its own choice at its own expense.
          10.3.4 Recoveries. Any recovery obtained by any Party as a result of
any proceeding described in this Section 10.3, by settlement or otherwise, shall
be applied in the following order of priority: (a) first, to reimburse each
Party for all litigation costs in connection with such proceeding paid by that
Party and not otherwise recovered (on a pro rata basis based on each Party’s
respective litigation costs, to the extent the recovery was less than all such
litigation costs); and (b) second, the remainder shall be shared in the ratio of
two-thirds (2/3) to Shire and one-third (1/3) to Amicus.
     10.4 Defense of Infringement Claims.  If a Licensed Product becomes the
subject of a Third Party’s claim or assertion of infringement of a patent
relating to the making, using, sale, offer for sale or importation of such
Licensed Product within the Field in the Shire Territory, the Party first having
notice of the claim or assertion shall promptly notify the other Party, and the
Parties shall promptly confer to consider the claim or assertion and the
appropriate course of action. If the claim or assertion names Shire as
Defendant, then Shire shall have the right to control the defense of any
proceeding, and Amicus shall have right to join in such defense at its own
expense. Unless the Parties otherwise agree in writing, each Party shall have
the right to defend itself against a suit that names such Party as a defendant,
and the other Party shall have the right to join in such defense at its own
expense. Neither Party shall enter into any settlement of any action described
in this Section 10.4, or otherwise consent to an adverse judgment in any such
action, that imposes a financial obligation on the other Party, or that admits
the infringement or validity of any Third Party Patent without the other Party’s
written consent, which consent shall not be unreasonably withheld. In any event,
each Party shall reasonably assist the other Party and cooperate in connection
with any
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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litigation in which such Party is not named as a defendant, at the defending
Party’s request and expense.
     10.5 Patent Marking.  Shire agrees to mark, and require their contractors
and permitted Sublicensees to mark, all Licensed Products sold or distributed
for the Shire Territory pursuant to this Agreement in accordance with the
applicable patent statutes or regulations in the country or countries of
Manufacture or sale thereof, to the extent required by Law.
     10.6 License of Third Party Rights. . 
          10.6.1 Existing Third Party Technology. It is understood that certain
Patents Rights for the Shire Territory within the Amicus Patent Rights have been
in-licensed pursuant to certain existing in-license agreements listed in
Exhibit 10.6.1 hereto (the “Existing In-Licenses”). As required for the
furtherance of the objectives of this Agreement, Amicus shall maintain the
Existing In-Licenses and timely pay all fees due thereunder. In addition, it is
understood by the Parties that their respective rights under Sections 10.2 and
10.3 above with respect to the Amicus Patent Rights licensed to Amicus under the
Existing In-Licenses are subject to and limited by the applicable terms and
conditions of the Existing In-Licenses. Amicus agrees to use Commercially
Reasonable Efforts to persuade its licensors pursuant to such licenses
(“Licensors”) to fully cooperate with Shire in the defense or prosecution of any
proceedings hereunder, and shall use reasonable efforts to cause the Licensors
not to enter into any settlement, agreement, consent judgment or other voluntary
final disposition of any proceeding or threatened proceeding which would
adversely affect Shire or its rights and licenses hereunder.
          10.6.2 Third Party Technology Acquired after Effective Date. In
addition, if after the Effective Date, Amicus or Shire (the “Sublicensing
Party”) acquire rights from a Third Party that are to be licensed to the other
Party under this Agreement, including with respect to a Related Product or
Back-Up Compound under Section 6.3 or 6.4.4, respectively (“Third Party
Technology”), but that is subject to royalty or other payment obligations to the
Third Party, then the following shall apply: The licenses granted to the other
Party (the “Commercializing Party”) hereunder with respect to such Third Party
Technology shall be subject to the Commercializing Party’s promptly reimbursing
the Sublicensing Party for any milestone payments, royalties or other amounts
that become owing to such Third Party by reason of the Commercializing Party’s
exercise of such license or sublicense to the Third Party Technology. To the
extent that any such payments made by a Party under an agreement to acquire
Third Party Technology are not attributable to either Territory, but are
attributable to the acquisition of rights to a Third Party Technology used for a
Licensed Product, a reasonable portion of such amounts as determined by the JSC
shall be deemed Development Costs to be shared under Section 7.4.1 (unless
excluded from the licenses hereunder as provided in this Section 10.6.2). At the
inception of the inclusion of any Third Party Technology in such license under
this Agreement and thereafter upon request by the Commercializing Party, the
Sublicensing Party shall disclose to the Commercializing Party a true, complete
and correct written description of such payment obligations, and the
Commercializing Party’s obligation to reimburse such amounts following such
request shall be limited to those payment obligations as so disclosed by
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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the Commercializing Party. In the event that the Commercializing Party does not
promptly reimburse the Sublicensing Party for such amounts upon request (such
amounts as determined by the JSC in accordance with this Agreement, to the
extent so provided above), then such Third Party Technology shall thereafter be
deemed excluded from the licenses or other subject matter licensed hereunder.
Notwithstanding the above, this Section 10.6.2 shall not apply to Patent Rights
licensed by Shire from a Third Party and covered by Section 7.3.4 above.
ARTICLE 11
TRADEMARKS AND COPYRIGHTS
     11.1 Product Marks
          11.1.1 Display. All packaging materials, labels and promotional
materials for the Licensed Products in the Shire Territory shall be at the sole
discretion of Shire, provided, that such packaging materials and labels shall
display the Amicus trade name in reasonable size and prominence, as determined
by the JCC in accordance with applicable Laws and applicable local regulations.
          11.1.2 Selection; Title. Within the framework of the JCC, the Parties
shall work together and seek to agree on the selection of Product Marks for each
Licensed Product in the Territory. Notwithstanding the foregoing, each Party
shall have final decision on the selection of Products Marks for each Licensed
Product in its Territory. Each Party shall own rights to any Product Mark which
is created by it or on its behalf and used in the Commercialization of a
Licensed Product in the Territory, including all goodwill arising out of the use
of such Product Mark. Each Party agrees that it will not use marks in the other
Party’s Territory for any other products other than the Licensed Product that
are confusingly similar to such Product Mark.
          11.1.3 Grant of License. Subject to the terms and conditions of this
Agreement, each Party (the “Trademark Licensor”) hereby grants to the other
Party (the “Trademark Licensee”) an exclusive license to use the Trademark
Licensor’s Product Marks in Trademark Licensee’s Territory for the packaging,
marketing, sale and promotion of the applicable Licensed Product in accordance
with the Trademark Licensor’s reasonable trademark usage guidelines, provided,
however, that in the event a Party, after the Effective Date, generates a new
Trademark for Licensed Products, the other Party shall not have a license to
such new Trademark unless it reimburses the other Party for fifty (50%) of the
costs incurred to identify, design and register (including clearance and
registerability searches) such Trademark.
          11.1.4 Registration of Trademarks; Recordation. Each Trademark
Licensee shall file, register and maintain for the Term appropriate
registrations for the Trademark Licensor’s Product Marks in the name of the
Trademark Licensor, as mutually agreed by the Parties, in each country of the
Territory in which the Licensed Products are or will be sold, at its own
expense. In those countries where a trademark license must be recorded, the
Trademark Licensor will provide to the Trademark Licensee, on the Trademark
Licensee’s written request, a separate trademark license for the Trademark
Licensor’s Product Marks and will arrange for the recordation of such trademark
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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license with the appropriate governmental agency, at the Trademark Licensee’s
expense, promptly following receipt of such license from the Trademark Licensor.
Each Party shall cooperate in the preparation and execution of such documents
          11.1.5 Approval of Materials. To the extent necessary to preserve the
Trademark Licensor’s legal rights in its Product Marks, the Trademark Licensee
shall submit representative promotional materials, packaging and samples of a
Licensed Product displaying the Product Marks for the Trademark Licensor’s
review and approval prior to the first use of such promotional materials,
packaging or Licensed Product and prior to any subsequent change or addition to
such promotional materials, packaging or Licensed Product; provided that if the
Trademark Licensor has not responded within twenty (20) days after the Trademark
Licensee’s receipt of such promotional materials, packaging or Licensed Product,
the Trademark Licensor’s approval will be deemed to have been received. In any
case, neither Party will permit the quality of the Licensed Products with which
the other Party’s Product Marks are used to deteriorate so as to affect
adversely the goodwill associated with such Product Marks.
          11.1.6 Enforcement. Amicus and Shire shall reasonably cooperate with
each other to protect each other’s Product Marks. The JSC shall determine
whether and to what extent to institute and prosecute or defend any actions or
proceedings involving or affecting the Trademark Licensor’s Product Marks in the
Trademark Licensee’s Territory. The Parties shall reasonably cooperate in any
action taken to enforce or defend the other Party’s Product Marks in the
Territory, including taking appropriate appeals.
ARTICLE 12
REPRESENTATIONS, WARRANTIES AND COVENANTS
     12.1 Mutual Representations, Warranties and Covenants. Each Party hereby
represents, warrants and covenants to the other Party as follows:
          12.1.1 Due Organization. Such Party is a corporation duly organized,
validly existing and in good standing under the laws of the jurisdiction of its
incorporation, and is qualified to do business and is in good standing as a
foreign corporation in each jurisdiction in which the conduct of its business or
the ownership of its properties requires such qualification and failure to have
such qualification would prevent it from performing its obligations under this
Agreement.
          12.1.2 Due Execution. The execution, delivery and performance by such
Party of this Agreement have been duly authorized by all necessary corporate
action and do not and will not (i) require any consent or approval of its
stockholders, (ii) violate any provision of any Law, order, writ, judgment,
injunction, decree, determination or award presently in effect having
applicability to it or any provision of its charter or bylaws or (iii) conflict
with or constitute a default under any other agreement to which such Party is a
party.
          12.1.3 Binding Agreement. This Agreement is a legal, valid and binding
obligation of such Party, enforceable against it in accordance with the terms
and conditions hereof (except as
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the enforcement of
creditors’ rights generally.
          12.1.4 Authorizations. Such Party has obtained all authorizations,
consents and approvals, governmental or otherwise, necessary for such Party to
grant the rights and licenses granted by such Party under this Agreement, and to
otherwise perform such Party’s obligations under this Agreement.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          12.1.5 Third Party Agreements. Such Party has not previously granted
and, during the Term will not grant, any rights in conflict with the rights and
licenses granted herein. As of the Effective Date, there are no existing
agreements, options, commitments or rights with, of or to any person or entity
to acquire or obtain any rights with respect to such Party’s intellectual
property, which are in conflict with the rights and licenses granted herein.
          12.1.6 Debarment. Such Party has not been debarred or is subject to
debarment and neither it not any of its Affiliates have used or will use in any
capacity, in connection with the Development or Commercialization of Licensed
Products, any person or entity who has been debarred pursuant to Section 306 of
the United States Federal Food, Drug and Cosmetic Act, or who is subject of a
conviction described in such Section 306. Further, such Party agrees to inform
the other Party in writing immediately if it or any person or entity who is
performing services hereunder is debarred or is the subject of a conviction
described in such Section 306, or if any action, suit, claim, investigation or
legal administrative proceeding is pending or, to the best of such Party’s
knowledge, is threatened, relating to the debarment of such Party, its
Affiliates or any person or entity used in any capacity by such Party or its
Affiliates in connection with the Development, Manufacturing or
Commercialization of Licensed Products.
          12.1.7 Development Activities. To the best of such Party’s knowledge,
such Party, its contractors and its consultants have conducted and shall
continue to conduct, as applicable, all research and Development, including
non-clinical studies and clinical studies of Licensed Products and all
Manufacturing of Materials in accordance with all material provisions of
applicable Laws or standards of the United States and other countries in which
such activities are conducted. Such Party has conducted or is planning to
conduct, as applicable, appropriate audits of its contract-manufacturer
organizations and contract research organizations relating to compliance with
Laws and has found no circumstances that such Party believes would be likely to
have a material adverse effect on the Development, Manufacturing, use or
Commercialization of Materials as contemplated by this Agreement. Neither such
Party nor, to its knowledge, any officer, employee or agent of such Party has
made or shall make, as applicable, an untrue statement of a material fact to any
Regulatory Authority with respect to Licensed Products (whether in any
submission to such Regulatory Authority or otherwise), or knowingly failed to
disclose or shall knowingly fail to disclose, as applicable, a material fact
required to be disclosed to any Regulatory Authority with respect to Licensed
Products.
     12.2 Amicus Additional Representations, Warranties and Covenants. Except as
disclosed on Schedule 12.2 attached hereto, Amicus hereby represents, warrants
and covenants to Shire as of the Effective Date as follows:
          12.2.1 Existing In-License.
               (a) The Existing In-Licenses are in full force and effect, and to
the best of Amicus’ knowledge as of the Effective Date, no Party to such
agreements (including Amicus) is in breach or default thereunder. Amicus has not
waived or allowed to lapse or terminate any of its rights relating to the
Compounds or Licensed Products under the Existing-In-Licenses.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (b) Amicus has provided a true and complete copy of each Existing
In-License to Shire.
               (c) Amicus will not during the Term amend such Existing-In
Licenses in a manner that would adversely affect the rights, obligations or
economic interests of Shire under this Agreement without Shire’s prior written
consent.
               (d) Amicus shall, or shall cause Licensors to, furnish Shire with
copies of all notices received by Amicus relating to any alleged breach or
default by Amicus under the Existing-In-Licenses within five (5) Business Days
after Amicus’ receipt thereof. In the event Amicus does not resolve any such
alleged breach, it shall notify Shire within a sufficient period of time before
the expiration of the cure period for such breach under such Existing-In-License
such that Shire is able to cure or otherwise resolve such alleged breach. If
Shire makes any payments to a Licensor in connection with the cure or other
resolution of such alleged breach of Amicus, then Shire may credit the amount of
such payments (to the extent such amount was actually due under the applicable
Existing In-License) against any royalties or other payments payable to Amicus
pursuant to this Agreement.
               (e) Amicus shall promptly furnish Shire with copies of (a) all
amendments of the Existing In-Licenses and (b) correspondence (or in the case of
oral discussions, summary of such discussions) with or from and reports received
from or provided to Licensors to the extent material to Shire or its rights
granted under this Agreement.
               (f) Amicus shall use Commercially Reasonable Efforts to obtain
standby licenses in favor of Shire under each of the Existing-In Licenses as
promptly as practicable following the Effective Date.
          12.2.2 Intellectual Property. As of the Effective Date:
               (a) The Amicus Patent Rights, Amicus Know-How and Product Marks
licensed to Shire pursuant to this Agreement constitute all of the intellectual
property that is Controlled by Amicus and used in the Development, Manufacture
or Commercialization of Plicera, Amigal and AT2220 and, to the best of Amicus’
knowledge, the Development, Manufacture or Commercialization of Plicera, Amigal
and AT2220 in the Shire Territory do not infringe the intellectual property
rights of any Third Party.
               (b) To the best of Amicus’ knowledge, Amicus Patent Rights and
Amicus Know-How are the only intellectual property rights required in order to
Manufacture, Develop, use, import and/or sell or Commercialize Plicera, Amigal
and AT2220 in the Shire Territory.
               (c) Amicus holds good title to and is the legal and beneficial
owner or licensee of the Amicus Patent Rights and Amicus Know-How free and clear
of any lien, mortgage, security interest, pledge, restriction on
transferability, defect of title or other claim, charge or encumbrance (other
than the terms of the Existing In-Licenses), and Amicus has not granted any
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Third Party any right, title or interest in the Amicus Patent Rights or Amicus
Know-How directly relating to the Development, Manufacture or Commercialization
of Licensed Products in the Shire Territory.
               (d) Appendix 1 sets forth all of the Amicus Patent Rights,
including the legal and beneficial owner or applicant for registration of each
Amicus Patent Right.
               (e) All actions required to maintain the good standing of the
Amicus Patent Rights (including payment of all applicable fees due and payable
to a governmental authority before the Effective Date and timely compliance with
filing, prosecution and maintenance requirements) have been taken.
               (f) There are no claims, judgments or settlements against or owed
by Amicus, nor any pending reissue, reexamination, interference, opposition or
similar proceedings, with respect to the Amicus Patent Rights or Amicus
Know-How, and Amicus has not received written notice as of the Effective Date of
any threatened claims or litigation or any reissue, reexamination, interference,
opposition or similar proceedings seeking to invalidate or otherwise challenge
the Amicus Patent Rights or Amicus Know-How.
               (g) To the best of Amicus’ knowledge, there are no pending Third
Party patent applications which, if issued, would materially adversely affect
the right of Shire to practice under the Amicus Patent Rights in accordance with
this Agreement.
               (h) To the best of Amicus’ knowledge, there have been no and
there is no reason to believe that there will be any, inventorship challenges
with respect to any of the Amicus Patent Rights.
               (i) The Amicus IP is not and, to the best of Amicus knowledge
during the Term, will not become subject to any rights granted in favor of a
Third Party that are in conflict with or otherwise restrict the rights granted
to Shire hereunder (subject to the Existing In-Licenses).
               (j) All current and former employees and consultants of Amicus
and its Affiliates who are or have been substantively involved in the design,
review, evaluation or development of the Compounds and Licensed Products have
executed written contracts or are otherwise obligated to protect the
confidential status and value thereof and to vest in Amicus or its Affiliates
exclusive ownership of the Compounds and Licensed Products (to the extent
invented by such persons).
          12.2.3 Regulatory, Clinical, Preclinical and Clinical Studies. As of
the Effective Date:
               (a) Regulatory Filings. Neither Amicus nor its Affiliates, nor,
to the best of Amicus’ knowledge, its subcontractors, has received any notice in
writing or otherwise has knowledge of any facts which have led Amicus to believe
that any of the Regulatory Filings relating
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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to Plicera, Amigal or AT2220 are not currently in good standing with the FDA or
any other applicable Regulatory Authority.
               (b) No Inquiries. Neither Amicus, nor to the best of Amicus’
knowledge, its subcontractors has received written notice of any proceedings
pending before or threatened by any Regulatory Authority with respect to
Plicera, Amigal or AT2220 or any facility where any such product is
Manufactured.
               (c) Disclosure. Amicus has disclosed to Shire and/or made
available to Shire for review all relevant data and documentation (including,
without limitation, all relevant correspondence with Regulatory Authorities,
both in the United States and outside the United States, related to the
foregoing) in its possession or control, that would be material in order to
assess the safety and efficacy of Licensed Products, including all such
pre-clinical and clinical data and all such efficacy data regarding Licensed
Products.
               (d) Safety Issues. Amicus is not aware of any safety, efficacy,
or regulatory issues, other than the information that has previously been made
available to Shire, that would preclude Shire or Amicus, or their licensees and
contract service organizations, from researching, Developing, Manufacturing or
Commercializing Licensed Products in compliance with Laws, including but not
limited to issues relating to the system for maintaining relevant documents, the
internal audit systems, and any other regulatory-related matter.
          12.2.4 Manufacture and Supply.
     The JSC shall approve the terms and conditions of all manufacture and
supply agreements and other arrangements under which Amicus procures Materials
for use under the Development Plans or for supply to Shire under this Agreement.
The Parties intend that (i) Shire and its Affiliates shall be third party
beneficiary of such warranty and covenants in any manufacture and supply
agreements and other arrangements under which Amicus procures Materials for use
under the Development Plans or for supply to Shire under this Agreement and
(ii) Amicus shall make available to Shire any benefits under indemnification
provisions under any manufacture and supply agreements.
          12.2.5 [***] for [***]’s.
               (a) Amicus has disclosed and made available to Shire for review
all material Data or summaries thereof (including, without limitation, all
relevant correspondence with Regulatory Authorities, both in the United States
and outside the United States, related to the foregoing) in Amicus’ possession
or Control with respect to [***] (including [***]) for the treatment, prevention
and diagnosis of [***]’s, including, without limitation, all such pre-clinical
and clinical data and all such efficacy data regarding [***] for [***]’s.
               (b) Amicus shall allocate at least [***] full time equivalent
personnel to identify, Develop and/or acquire a molecule as a substitute for
[***] for the treatment and/or
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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prevention of [***]’s, provided, however, that Amicus may terminate such
activities, and its obligation under this Section 12.2.5(b): (i) upon the first
[***] with respect to an [***] for [***]’s, or if earlier, upon termination of
the [***]’s Option under Section 6.2.1(e), or (ii) at such earlier time as the
JDC, upon the request of Amicus, determines that Commercially Reasonable Efforts
to find such substitute would not require the continuation of such activities.
Amicus shall provide periodic updates regarding activities conducted by it
pursuant to its obligations under this Section (including the results of such
activities) at the request of Shire and further shall provide an annual report
on such activities and results.
     12.3 Disclaimer. EXCEPT AS SET FORTH IN THIS ARTICLE 12, AMICUS AND SHIRE
EXPRESSLY DISCLAIM ANY OTHER WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE, WITH RESPECT TO THE PATENT RIGHTS OR KNOW-HOW OR THE
SUBJECT MATTER OF THIS AGREEMENT (INCLUDING WITH RESPECT TO LICENSED PRODUCTS
AND ANY RESEARCH AND DEVELOPMENT ACTIVITIES RELATING THERETO), INCLUDING ANY
IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A
PARTICULAR PURPOSE.
ARTICLE 13
INDEMNIFICATION; INSURANCE
     13.1 Indemnification of Shire. Amicus shall indemnify and hold harmless
each of Shire, its Affiliates and the directors, officers and employees of such
entities and the successors and assigns of any of the foregoing (the “Shire
Indemnitees”) from and against any and all liabilities, damages, penalties,
fines, costs and expenses (including reasonable attorneys’ fees and other
expenses of litigation) (collectively, “Liabilities”) resulting from claims,
actions, suits or proceedings brought by a Third Party (a “Third Party Claim”)
that are incurred by any Shire Indemnitee, arising from or occurring as a result
of: (a) the Development or Commercialization of any Licensed Product, or other
product containing the Compound, in the Amicus Territory, in each case by or
under authority of Amicus or its Affiliates, (b) any gross negligence or willful
misconduct of Amicus, its Affiliates, or their officers, directors, employees,
contractors, consultants, agents, representatives, or licensees in the exercise
of any obligations under this Agreement or (c) any material breach by Amicus of
any representations, warranties or covenants set forth in this Agreement, except
to the extent such Third Party Claims fall within the scope of Shire’s
indemnification obligations set forth in Section 13.2.
     13.2 Indemnification of Amicus. Shire shall indemnify and hold harmless
each of Amicus, its Affiliates and the directors, officers 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 from any Third Party
Claims incurred by any Amicus Indemnitee, arising from or occurring as a result
of (a) the Development or Commercialization of any Licensed Product in the Shire
Territory, in each case by or under authority of Shire or its Affiliates or
Sublicensees, (b) any gross negligence or willful misconduct of Shire, its
Affiliates or Sublicensees, or their officers, directors, employees,
contractors, consultants, agents, representatives, or licensees in the exercise
of any obligations under
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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this Agreement or (c) any material breach by Shire of any representations,
warranties or covenants set forth in this Agreement, except to the extent such
Third Party Claims fall within the scope of Amicus’ indemnification obligations
set forth in Section 13.1.
     13.3 Procedure. A Party that intends to claim indemnification under this
Article 13 (the “Indemnitee”) shall promptly notify the other Party (the
“Indemnitor”) in writing of any Third Party Claim in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall have
the right to control the defense and/or settlement thereof with counsel of its
choice as long as such counsel is reasonably acceptable to the Indemnitee. The
Indemnitee shall have the right to participate in such defense and/or settlement
at its own expense with counsel of its choice. The indemnity arrangement in this
Section 13.3 shall not apply to amounts paid in settlement of any action with
respect to a Third Party Claim if such settlement is effected without the
consent of the Indemnitor, which consent shall not be unreasonably withheld or
delayed. 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 relieve such Indemnitor of any Liabilities that result from
any delay in providing such notice which materially prejudices the defense of
such Third Party Claim under this Section 13.3, but the omission to so deliver
written notice to the Indemnitor shall not relieve the Indemnitor of any
liability that it may have to any Indemnitee otherwise than under this
Section 13.3. The Indemnitee under this Section 13.3 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 Article 13.
     13.4 Insurance. Each Party shall procure and maintain insurance, including
product liability insurance, which is consistent with normal business practices
of prudent companies similarly situated at all times during which any Licensed
Product is being clinically tested in human subjects or commercially distributed
or sold by such Party and the insurance coverage shall in no event be less than:
(a) prior to the First Commercial Sale of a Licensed Product anywhere in the
world, $[***] per loss occurrence and $[***] in the aggregate, and (b) after
such First Commercial Sale, $[***] per loss occurrence and $[***] in the
aggregate. It is understood that such insurance shall not be construed to create
a limit of either Party’s liability with respect to its indemnification
obligations under this Article 13. Each Party shall provide the other Party with
written evidence of such insurance upon request. Each Party shall provide the
other Party with written notice at least thirty (30) days prior to the
cancellation, non-renewal or material change in such insurance or self insurance
which materially adversely affects the rights of the other Party hereunder.
ARTICLE 14
CONFIDENTIALITY
     14.1 Confidentiality; Exceptions. Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing, the Parties agree that the
receiving Party shall keep confidential and shall not publish or otherwise
disclose or use for any purpose other than as provided for in this Agreement any
information and other confidential and proprietary materials furnished to it by
the other Party pursuant to this Agreement collectively and except to the extent
any of Sections
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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14.1.1. to 14.1.4 are applicable (“Confidential Information”), except to the
extent that it can be established by the receiving Party that such Confidential
Information:
          14.1.1 was in the lawful knowledge and possession of the receiving
Party prior to the time it was disclosed to, or learned by, the receiving Party,
or was otherwise developed independently by the receiving Party, as evidenced by
written records kept in the ordinary course of business, or other documentary
proof of actual use by the receiving Party;
          14.1.2 was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
          14.1.3 became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement; or
          14.1.4 was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others.
     14.2 Authorized Disclosure. Except as otherwise expressly provided in this
Agreement, each Party may use and disclose Confidential Information of the other
Party as follows: (a) under appropriate confidentiality provisions substantially
equivalent to those in this Agreement, in connection with the performance of its
obligations or exercise of rights granted or reserved in this Agreement
(including to grant licenses and sublicenses permitted hereunder, and in the
case of Amicus, to Develop, Manufacture and Commercialize Licensed Products and
Compounds for use in the Amicus Territory and, in the case of [***] for [***]’s,
outside the Field), (b) to the extent such disclosure is reasonably necessary in
filing or prosecuting patent, copyright and trademark applications, complying
with the terms of licenses from Third Parties, prosecuting or defending
litigation, complying with applicable governmental regulations, obtaining
Regulatory Approval, conducting preclinical or clinical trials, or marketing
Licensed Products, or otherwise required by Law (including securities Laws),
provided, however, that if a Party is required by Law to make any such
disclosure of the other Party’s Confidential Information it will, except where
impracticable for necessary disclosures (for example, in the event of medical
emergency), give reasonable advance notice to the other Party of such disclosure
requirement and, except to the extent inappropriate in the case of patent
applications, use its reasonable efforts to secure confidential treatment of
such Confidential Information required to be disclosed, (c) in communication
with investors, consultants, advisors or others on a need to know basis, in each
case under appropriate confidentiality provisions substantially equivalent to
those of this Agreement, (d) in the case of Amicus, to the extent necessary to
comply with its obligations to provide progress reports to its licensors under
the Existing In-Licenses, under appropriate confidentiality provisions, or
(e) to the extent mutually agreed to by the Parties.
     14.3 Termination of Prior Agreement. This Agreement supersedes the
Confidentiality Agreement between the Parties dated June 6, 2007
(“Confidentiality Agreement”), including all
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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modifications thereto. All Confidential Information (as defined in the
Confidentiality Agreement) exchanged between the Parties under such agreement
shall be deemed Confidential Information and shall be subject to the terms of
this Article 14.
     14.4 Disclosure of Terms. Each Party agrees not to disclose to any Third
Party the terms of this Agreement without the prior written consent of the other
Party, except as permitted for disclosures of Confidential Information pursuant
to Section 14.2.
     14.5 Publications. Except as required by applicable Law, each Party agrees
that it shall not publish or present the results of Development work or
Post-Marketing Studies conducted by such Party that are directed to any Licensed
Product for an indication in the Field, including but not limited to studies or
clinical trials carried out by such Party as part of a Development Plan under
this Agreement (each, a “Collaboration Results Publication”), without providing
the other Party the opportunity for prior review, it being understood, however,
that publication of such Collaboration Results Publication shall not require
approval of the other Party. Each Party shall provide to the other Party the
opportunity to review any of the submitting Party’s proposed abstracts,
manuscripts or presentations (including information to be presented verbally)
comprising such a Collaboration Results Publication (including any proposed
Third Party publication submitted to the submitting Party for review and
approval, to the extent the applicable terms of any agreement with such Third
Party permit) at least fifteen (15) days prior to their intended presentation or
submission for publication. Once such abstracts, manuscripts or presentations
have been reviewed by each Party, the same information contained in such
abstracts, manuscripts or presentations does not have to be provided again to
the other Party for review for a later submission for publication. Each Party
shall also have the right to require that its Confidential Information be
removed from any such approved Collaboration Results Publication.
Notwithstanding the foregoing, any Collaboration Results Publication shall be
delayed upon the request of Party for a period not less than sixty (60) days, if
such Party requests such delay in order to allow for filing a patent application
or taking such measures as such Party deems appropriate to establish and
preserve its proprietary rights.
     14.6 Press Releases and Announcements
          14.6.1 Initial Release. On the Effective Date or, if mutually agreed,
promptly after the Effective Date, each Party shall have the right to release a
press release announcing this Agreement and the relationship of the Parties,
provided each Party’s such press release will be in the form provided to the
other Party prior to the Effective Date. Thereafter, Shire and Amicus may each
disclose to Third Parties the information contained in each such press release
without the need for further approval by the other.
          14.6.2 Further Publicity. The Parties acknowledge the importance of
supporting each other’s efforts to publicly disclose results and significant
developments regarding Licensed Products in the Shire Territory and other
activities in connection with this Agreement in the Shire Territory that may
involve Confidential Information of the other Party generated or obtained in
connection with this Agreement pertaining to the Licensed Products, beyond what
is required by Law, and each Party may make such public disclosures from time to
time with the approval of the
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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other Party. Such disclosures may include, without limitation, achievement of
Development milestones, significant events in the Development and regulatory
process with respect to Licensed Products, Commercialization activities and the
like. When a Party (the “Initiating Party”) elects to make any such public
disclosure under this Section 14.6.2, it will give the other Party (the
“Cooperating Party”) at least five (5) Business Days notice to review and
comment on such statement, it being understood that if the Cooperating Party
does not notify the Initiating Party in writing within such five (5) Business
Day period of any objections, such disclosure shall be deemed approved, and in
any event the Cooperating Party shall work diligently and reasonably to agree on
the text of any approved disclosure in an expeditious manner. The principles to
be observed in such disclosures shall include 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 Initiating Party’s business.
ARTICLE 15
TERM AND TERMINATION
     15.1 Term. The term of this Agreement (the “Term”) shall begin on the
Effective Date and shall continue on a Licensed Product by Licensed Product
basis until the expiration of the royalty term as per Section 7.3.6 above for
such Licensed Product, unless and until earlier terminated as permitted under
this Agreement. Upon expiration (but not earlier termination) of this Agreement
with respect to a Licensed Product, Shire shall have a fully paid up, license to
Develop, use and Commercialize such Licensed Product within the Field in the
Shire Territory, provided, that Shire’s license to Develop and Manufacture shall
be a worldwide license.
     15.2 Termination for Breach. In the event of a material breach of this
Agreement, the non-breaching Party shall have the right to give written notice
(the “Breach Notice”) to the breaching Party, specifying the breach in
reasonable detail. The breaching Party shall have [***] after the Breach Notice
to cure any such breach. If, at the end of such [***] period, the breach remains
uncured, then the non-breaching Party shall have the right to terminate this
Agreement upon written notice, in its entirety or on a Licensed
Product-by-Licensed Product basis.
     15.3 Termination by Shire.
          15.3.1 Generally. Subject to Section 15.3.4 below, Shire may terminate
this Agreement for any reason upon [***] prior written notice to Amicus
          15.3.2 Licensed Product by Licensed Product. In addition, subject to
Section 15.3.4 below, Shire may terminate this Agreement as to any Licensed
Product, upon [***] prior written notice to Amicus.
          15.3.3 Safety. In addition, if Shire exercises its right of
termination under this Section 15.3 because it reasonably believes that a
Licensed Product is unsafe for human use, then Shire shall promptly provide
Amicus with reasonable evidence of such safety concern and notwithstanding
Section 6.4.2 and Section 15.5 below, Shire may cease to conduct any further
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Development or Commercialization of such Licensed Product. If Shire invokes this
Section 15.3.3 without a reasonable basis, it is understood that doing so shall
be deemed a breach of this Agreement, and Amicus shall have the right to pursue
any remedies available for such breach under applicable Law or this Agreement.
          15.3.4 Initial Period. Notwithstanding the foregoing, Shire shall not
issue any notice of termination under (a) Section 15.3.1 within [***] after the
Effective Date or (b) Section 15.3.2 within [***] after the Effective Date,
provided, that it shall not issue any notice of termination under Section 15.3.2
within [***] after the Effective Date with respect to more than two (2) Licensed
Products.
     15.4 Termination for 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 for the other Party or its assets, or if the other Party
is served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed with ninety (90) days after
the filing thereof, or if the other Party makes a general assignment for the
benefit of creditors.
     15.5 Effects of Expiration or Termination
          15.5.1 Accrued Obligations. Expiration or termination of this
Agreement for any reason shall not release either Party any obligation or
liability which, at the time of such expiration or termination, has already
accrued to the other Party or which is attributable to a period prior to such
expiration or termination.
          15.5.2 Termination by Amicus under Section 15.2 or Action of Shire
under Section 15.3.1. If this Agreement is terminated by Amicus under
Section 15.2 or by Shire pursuant to Section 15.3.1, then:
               (a) Development.
                    (i) If, on the date of notice of such termination, Shire was
conducting any ongoing clinical trials of one or more Licensed Products
(collectively with all Licensed Products for which the Agreement is terminated,
“Reverted Products”), then, to the extent and as requested by Amicus, Shire
shall promptly transition such clinical trials to Amicus or (except for
Independent Projects) continue to conduct such clinical trials for a period
requested by Amicus up to [***] after the effective date of such termination.
During this period, the out-of-pocket costs that Shire reasonably incurs in
performing such clinical trials at Amicus’ request shall be deemed Wind-Down
Development Expenses for purposes of (and shall be shared by the Parties in
accordance with) Section 15.5.2(a)(ii) below.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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                    (ii) [***] (the “Notice Period”) following the date of the
notice of termination under Section 15.2 or 15.3.1, as applicable (the “Notice
Date”), and (B) any [***], or by [***] in performing activities at Amicus’
request under Section 15.5.2(a)(i) above, during the [***] period following the
Notice Period (the “Development Period”) for clinical trials initiated prior to
the Notice Date in accordance with the applicable Development Plan (collectively
(A) and (B), the [***]) (for clarity such [***] shall not include any expenses
for activities related to Independent Projects); provided that, with respect to
the [***] described in (B) above, [***] shall be reduced from [***]. Promptly
following the end of each calendar quarter until the end of the Development
Period, each Party shall provide written documentation of the actual [***] that
have then been incurred by it and that reflect the Development conducted
according to this Section 15.5.2(a)(ii) since the last such report, and the
Parties shall [***] in accordance with Section 7.4.4(c) above, until all such
Wind-Down Development Expenses have been so reported and paid. In the event the
budget in the applicable Development Plan does not extend for the full duration
of the Development Period, such budget shall be deemed extended until the end of
the Development Period to include the costs of such continuing Development
activities. As used herein, [***] shall mean (x) [***] to Third Party
contractors performing work under the applicable Development Plan (such as CRO’s
or clinical trial sites), as well as (y) the [***] of Licensed Products consumed
in performing such clinical trials.
               (b) Commercialization. With respect to Licensed Products being
Commercialized at the time of such termination, Shire, its Affiliates and
permitted Sublicensees shall continue to sell the Reverted Products in each
country in the Shire Territory for which Regulatory Approval has been obtained,
in accordance with the terms and conditions of this Agreement, for a period
requested by Amicus not to exceed the lower of [***] from the effective date of
termination or upon the completion of the transfer of Regulatory Approvals
allowing Amicus or its designee to sell such License Product (the “Wind-down
Period”), provided that Amicus may terminate the Wind-down Period upon [***]
written notice to Shire and provided, further, that Shire shall not be obligated
to promote the sale of Reverted Products in the Shire Territory during the
Wind-down Period. Notwithstanding any other provision of this Agreement, during
the period from and after the notice of termination, Shire’s and its Affiliates’
and permitted Sublicensees’ rights with respect to the Reverted Products in the
Shire Territory shall be non-exclusive. All Net Sales from sales of Reverted
Products sold or disposed by Shire in the Shire Territory during the Wind-down
Period shall be paid to Amicus, less (x) a fixed distribution fee equal to [***]
of such Net Sales and (y) the Manufacturing Cost of quantities of the Licensed
Product included in such Net Sales. Except as provided in this
Section 15.5.2(b), after termination, Shire and its Affiliates and Sublicensees
shall not sell any quantities of Reverted Products produced or obtained pursuant
to this Agreement.
               (c) Transition Assistance. Shire shall cooperate with reasonable
requests by Amicus to achieve, as promptly as reasonably practicable during the
period from notice of termination until the end of the Wind-down Period, a
smooth and orderly transition to Amicus of the Development and Commercialization
of the Reverted Products in the Territories, including making its personnel and
other resources reasonably available to Amicus. If Shire has entered into
contracts with contractors (including contract manufacturers) or vendors that
are necessary or useful for
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Amicus to take over responsibility with respect to the Reverted Products in the
Territories, then Shire shall, to the extent possible and requested in writing
by Amicus, assign all of the relevant Third Party agreements to Amicus, or
otherwise cooperate to make such arrangements available to Amicus or its
designee for purposes of the Licensed Products.
               (d) Assignment of Regulatory Filings and Regulatory Approvals.
Shire shall assign and transfer, or cause to be assigned and transferred, to
Amicus all Regulatory Filings and Regulatory Approvals solely for the Reverted
Products made or owned by Shire and its Affiliates, and shall take such actions
and execute such other instruments, assignments and documents as may be
necessary to effect the transfer of rights under such Regulatory Filings and
Regulatory Approvals to Amicus (or, if not so assignable or not solely related
to Related Products, Shire shall take all reasonable actions to make available
to Amicus the benefits of such Regulatory Filings and Regulatory Approvals).
Shire shall require each of its Sublicensees and any other Third Party that
holds Regulatory Filing or Regulatory Approvals under authority from Shire
hereunder solely related to Reverted Products to transfer any such Regulatory
Filings and Regulatory Approvals to Amicus if this Agreement terminates (or, if
not so assignable or not solely related to Related Products, Shire shall take
all reasonable actions to make available to Amicus the benefits of such
Regulatory Filings and Regulatory Approvals). In each case, unless otherwise
prohibited by any applicable Laws, the foregoing assignment (or availability)
shall be made within [***] after termination of this Agreement.
               (e) Data and Know-How Disclosure. Within [***] after the Notice
Date, Shire shall disclose to Amicus (to the extent Shire has not already
disclosed to Amicus) all Know-How in Shire’s or its Affiliates’ possession or
Control with respect to the Reverted Products Developed under this Agreement.
Such disclosure shall be in electronic form to the extent available and, if
reasonably necessary in connection with Amicus’ further Development, Manufacture
or Commercialization of the Reverted Products, shall include original hardcopies
or duplicate copies thereof to the extent available, as required. Amicus shall
be free to use this Know-How in accordance with the license under
Section 15.5.2(f) below.
               (f) Licenses. Shire shall grant, and hereby grants, to Amicus,
effective upon the Notice Date, a perpetual, fully paid-up non-exclusive
license, with the right to grant and authorize sublicenses, to use Shire
Inventions (including under all Patent Rights inherent thereto), the Know-How
provided or to be provided to Amicus under this Agreement and all copyrighted
materials Controlled by Shire, in each case pertaining to the Reverted Products,
to Develop, Commercialize, Manufacture and otherwise exploit the Reverted
Products, or other products containing a Compound (other than, in the case of
termination under Sections 6.4.3 or 15.3.2, Compounds included in Licensed
Products for which Shire retains its license under Section 2.1).
               (g) Trademarks and Copyrights. Upon payment of the costs incurred
to identify, design and register (including clearance and registerability
searches) of Product Marks (to the extent not previously paid by Amicus pursuant
to Section 11.1.3), Shire shall promptly assign to Amicus, at Amicus’ sole
reasonable expense (with no royalty obligations) all rights of Shire in and
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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to the Product Marks and other product-specific trademarks for Reverted
Products, including applicable registrations and associated goodwill.
               (h) Sublicenses. Each Sublicense granted by Shire or its
Affiliates hereunder shall, at the request of Amicus and in its discretion, be
assigned to Amicus to the furthest extent possible. In the event that such
assignment is not requested by Amicus or is not approved by such Sublicensee,
then the rights of such Sublicensee with respect to Reverted Products in the
Shire Territory shall terminate upon termination of Shire’s license with respect
to the Shire Territory. Shire shall ensure that its Affiliates and Sublicensees
(if the applicable Sublicense is not assigned to Amicus pursuant to this
Section 15.5.2(h)) transition the Reverted Products back to Amicus in the manner
set forth in this Section 15.5.2 as if such Affiliate or Sublicensee were named
herein.
          15.5.3 Partial Termination. If this Agreement is terminated under
Section 15.2 or 15.3.2 with respect to one or more Licensed Products but not
this Agreement in its entirety, it is understood that Section 6.4.3 shall apply
with respect to such terminated Licensed Product.
          15.5.4 Termination by Shire under Section 15.2. If this Agreement is
terminated by Shire under Section 15.2, then:
               (a) Licenses and Payments. Shire shall continue to retain the
licenses and other rights granted to Shire under Article 2 and 11 above,
provided that Shire continues to fulfill its payment obligations under Article 7
above, subject to any right of offset Shire may have under applicable Law for
damages resulting from Amicus’ breach of this Agreement; provided that any
royalties due under Section 7.3 and milestone payments due under Section 7.2.1
that are achieved after the date of such termination shall be reduced by [***]%,
provided, that in the event any Licensed Product is then being Commercialized,
any royalty due under Section 7.3 for such Licensed Product shall be reduced by
[***]%.
               (b) Development. Notwithstanding anything herein to the contrary,
commencing upon the effective date of termination, Shire shall be permitted to
engage in Development activities outside of the applicable Development Plan(s)
with respect to Licensed Products in the Field in the Shire Territory, and Shire
shall not be required to provide to Amicus under Section 2.3 or Article 9 above
the Data and other results of such activities nor permit Amicus to have access
to or participate in regulatory matters in the Shire Territory related to such
activities in accordance with Article 9.
               (c) Data and Know-How Disclosure. Within [***] after the
termination of this Agreement, Amicus shall, at Shire’s sole reasonable expense,
disclose to Shire (to the extent Amicus has not already disclosed to Shire) all
Know-How in Amicus’ or its Affiliates’ possession or Control required to be
disclosed under Section 2.3.2 above.
               (d) Reservation of Rights. The exercise by Shire of its rights
under this Section 15.5.4 shall in no way limit any other remedies available to
Shire in connection with such termination.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          15.5.5 Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by one Party to the other are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and
other similar foreign Laws, licenses of rights to “intellectual property” as
defined under Section 101 of the U.S. Bankruptcy Code or such foreign Laws. Each
Party, as a Sublicensee of rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the U.S. Bankruptcy Code
and other similar foreign Laws.
          15.5.6 Public Disclosure. The Parties shall use good faith efforts to
coordinate any public disclosure regarding any termination under this Agreement,
subject to compliance with applicable Laws, including securities Laws.
     15.6 Survival.
          15.6.1 Surviving Articles and Sections. Articles 1, and 16, and
Sections 2.3.5 (with respect to Amicus’ rights thereunder) 4.5.2 (with respect
to licenses granted thereunder), 6.1.2(d) (with respect to licenses granted
thereunder), 10.1, 13.1-13.3 and 14.1-14.4, 15.1, 15.5 and 15.6 shall survive
expiration or termination of this Agreement for any reason. Except as otherwise
provided in this Article 15, all rights and obligations of the Parties under
this Agreement shall terminate upon expiration or termination of this Agreement
for any reason.
          15.6.2 Committee Decisions. To the extent that any provision of this
Agreement that provides for a decision to be made by a Committee survives
termination of this Agreement pursuant to this Article 15, such matter shall be
decided by the Parties jointly, and any dispute between the Parties with respect
to any such matter shall be resolved as if it were a Committee Dispute under
Section 16.8 below.
ARTICLE 16
GENERAL PROVISIONS
     16.1 Assignment. This Agreement shall not be assignable by either Party to
any Third Party hereto without the written consent of the other Party hereto,
except that (a) either Party may assign this Agreement without the other Party’s
consent to an entity that acquires substantially all of the business or assets
of the assigning Party (or, in the case of Shire, Shire’s [***] business),
whether by merger, asset sale or otherwise, provided that the acquirer assumes
this Agreement in writing or by operation of law; and (b) either Party may
assign this Agreement to an Affiliate upon written notice to the non-assigning
Party; provided that in the case of (b), (i) the assigning Party guarantees the
performance of this Agreement by such Affiliate and (ii) if the non-assigning
Party reasonably believes that assignment to such Affiliate would result in
adverse tax consequences to the non-assigning Party, such assignment shall not
be made without the non-assigning Party’s consent, such consent not to be
unreasonably withheld. Subject to the foregoing, this Agreement shall inure to
the benefit of each Party, its successors and permitted assigns. Any assignment
of this Agreement in contravention of this Section 16.1 shall be null and void.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     16.2 Independent Contractors. The Parties are and shall at all time be
independent contractors. In performing under this Agreement, neither Party is an
agent, employee, employer, joint venturer or partner of the other. Neither Party
shall incur or hold itself out to Third Parties as having the authority to incur
any expenses, liabilities or obligations on behalf of the other Party. This
Agreement is not a partnership agreement and nothing in this Agreement shall be
construed to establish a relationship of co-partners or joint venturers between
the Parties.
     16.3 Third Party Beneficiaries. This Agreement shall not confer any third
party beneficiary rights or remedies upon any Affiliate of a Party or any Third
Party, except as otherwise provided in Section 16.4.
     16.4 Waiver. No waiver by a Party in any one or more instances shall be
deemed to be a continuing waiver, a further waiver, a waiver of any other
provision of this Agreement or a waiver of this Agreement as a whole. No waiver
of any right under this Agreement shall be effective unless it is documented in
a writing signed by the Party providing the waiver.
     16.5 Force Majeure. A failure by a Party to perform any obligation under
this Agreement that is prevented by an occurrence beyond the reasonable control
of the non-performing Party (and which did not occur as a result of its
financial condition, negligence or fault), including acts of God, embargoes,
fires, floods, explosions, riots, wars, civil disorders, terrorist acts,
rebellion or acts of sabotage (a “Force Majeure Event”), shall not constitute a
breach of this Agreement so long as that Party notifies the other Party as soon
as practicable and uses Commercially Reasonable Efforts to resume performance as
soon as possible. Neither Party shall be entitled to rely on a Force Majeure
Event to relieve it from an obligation to pay money (including any interest for
delayed payment) which would otherwise be due and payable under this Agreement.
     16.6 Severability. If any term of this Agreement is held invalid, illegal
or unenforceable in any jurisdiction, then, to the fullest extent permitted by
Law (a) all other terms shall remain in full force and effect in such
jurisdiction, (b) such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction and (c) the Parties shall negotiate in good faith such terms as may
be necessary in order to correct any imbalance of rights and obligations that
results from such invalidity, illegality or unenforceability in the relevant
jurisdiction.
     16.7 Governing Law; Dispute Resolution. This Agreement shall be governed by
and interpreted under, and any court action shall apply, the Laws of the State
of New York, excluding its conflicts of Laws principles. Subject to
Section 16.8, any dispute as to the performance, enforcement, termination,
validity or interpretation of this Agreement shall be brought only in a federal
court of competent jurisdiction (or a state court if no federal court has
jurisdiction) located in New York, New York and the Parties hereby submit to the
exclusive jurisdiction and venue of such courts.
     16.8 Arbitration for Committee Disputes and Certain Other Disputes.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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          16.8.1 Committee Disputes. The Parties agree that the inability of the
JSC, JDC, JCC or any Special Committee to reach consensus on a decision that is
expressly designated in this Agreement to be made by such Committee (a
“Committee Dispute”) shall be resolved through the procedures set forth in this
Section 16.8.
               (a) In the event that the JDC, JCC or a Special Committee is
unable to reach consensus on a decision within the authority of such Committee,
such Committee Dispute shall be first referred to the JSC by a Co-Chair of the
JDC, JCC or such Special Committee, as applicable, who has concluded in good
faith that there has been sufficient discussion of the matter and that
resolution is unlikely, and the JSC shall consider such matter within fourteen
(14) days. If the JSC is unable to reach a unanimous decision as to such
Committee Dispute, or to a Committee Dispute within the direct authority of the
JSC, within such fourteen (14) day period, such Committee Dispute shall
similarly be referred for joint and mutual resolution by the Chief Executive
Officer (or his/her designee) of each Party. If such Committee Dispute is not
resolved by the Chief Executive Officers (or their respective designees) within
thirty (30) days after being referred for their joint and mutual resolution,
then such Committee Dispute shall, upon written notice of either Party to the
other Party, be resolved by final, binding arbitration in accordance with the
provisions of Sections 16.8.1(b) through (d).
               (b) The arbitration shall be conducted by the Judicial
Arbitration and Mediation Services (or its successor entity) (“JAMS”) under its
rules of arbitration then in effect, except as modified in this Agreement. The
arbitration shall be conducted in the English language, by a single arbitrator.
If the Parties are unable to agree on an arbitrator, the arbitrator shall be
selected in accordance with the JAMS rules, or if the JAMS rules do not provide
for such selection, by the chief executive of JAMS. At his or her election, the
arbitrator may engage an independent expert with experience in the subject
matter of the dispute to advise the arbitrator, but final decision making
authority shall remain in the arbitrator. The arbitrator shall determine what
discovery will be permitted, consistent with the goal of reasonably controlling
the cost and time that the Parties must expend for discovery, provided that the
arbitrator shall permit such discovery as he or she deems necessary to permit an
equitable resolution of the dispute.
               (c) The Parties and the arbitrator shall use all reasonable
efforts to complete any such arbitration within ninety (90) days, and such
arbitration 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 a written report setting forth its
final position with respect to the substance of the dispute and the arbitrator
shall then select one of the Party’s positions as his or her final decision. The
arbitrator shall not have authority to render any substantive decision other
than to so select the position of either Amicus or Shire. Further, to the extent
applicable, the arbitrator shall make such decision based on the underlying
agreement of the Parties that the Parties are equally sharing all costs for
Development of Licensed Products (other than under an Independent Project) in
order to achieve Regulatory Approval in each of the Primary Market countries.
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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               (d) The Parties agree that the decision of the arbitrator shall
be the binding remedy between them regarding the dispute presented to the
arbitrator, and in the case of a Committee Dispute shall become the decision of
the JSC on the matter. The arbitration proceedings and the decision of the
arbitrator shall be deemed Confidential Information of both Parties under
Article 14 above. Unless otherwise mutually agreed upon by the Parties, the
arbitration proceedings shall be conducted in New York, New York. The Parties
agree that they shall share equally the cost of the arbitration filing and
hearing fees, the cost of the independent expert retained by the arbitrator and
the cost of the arbitrator and administrative fees of JAMS. Each Party shall
bear its own costs and attorneys’ and witnesses’ fees and associated costs and
expenses.
          16.8.2 Disputes Regarding the Right of First Refusal. The Parties
agree that it is important to be able to resolve any disputes regarding
Sections 2.4, 6.1.3, 6.2.1 6.2.2, 6.3.2, 6.3.3, 6.4.4 or 6.5.5 above quickly. In
the event of a dispute under such provison, such dispute shall be resolved under
binding arbitration in accordance with Section 16.8.1(b)-(d).
     16.9 Construction. Unless the context of this Agreement clearly requires
otherwise, (a) references to any gender include all genders, (b) “including” has
the inclusive meaning frequently identified with the phrase “including but not
limited to” or “including without limitation” and (c) references to “hereunder”
or “herein” relate to this Agreement. The section and other headings contained
in this Agreement are for reference purposes only and shall not control or
affect the construction of this Agreement or the interpretation thereof in any
respect. Section, subsection, Appendix and Schedule references are to this
Agreement unless otherwise specified. Each accounting term used herein that is
not specifically defined herein shall have the meaning given to it under U.S.
GAAP, but only to the extent consistent with its usage and the other definitions
in this Agreement. In addition: (a) “Business Day” means a day other than a
Saturday, Sunday or a day that is a statutory holiday in the United Kingdom or a
federal holiday in the United States; and (b) “Laws” means all laws, ordinances,
rules, directives and regulations of any kind of any governmental or regulatory
authority of a country in the Territory (including Regulatory Authorities), in
each case to the extent applicable to the respective activities of a Party that
are being performed.
     16.10 Notices. All notices that are required or permitted hereunder shall
be in writing and shall be sufficient if personally delivered or sent by
registered or certified mail, Federal Express or other international business
delivery service. Any notices shall be deemed given upon the earlier of the date
when received at, or the third day after the date when sent by registered or
certified mail or the day after the date when sent by Federal Express or other
international business delivery service to, the address set forth below, unless
such address is changed by notice to the other Party:
If to Shire:
Shire Pharmaceuticals Ireland Ltd.
5 Riverwalk
Citywest Business Campus
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Dublin 24
Ireland
Fax: 00 353 1 429 7701
Attention: Legal Department
with a copy to:
Morgan, Lewis & Bockius LLP
502 Carnegie Center
Princeton, NJ 08540
Fax: (609) 919-6701
Attention: Randall B. Sunberg, Esq.
If to Amicus:
Amicus Therapeutics, Inc.
6 Cedar Brook Drive
Cranbury, NJ 08512
Fax: (609) 662-2001
Attention: President
with a copy to:
Wilson Sonsini Goodrich & Rosati
650 Page Mill Road
Palo Alto, CA 94304
Fax: (650) 493-6811
Attention: Kenneth A. Clark, Esq.
     16.11 Amendment. This Agreement may be amended or modified only by a
writing signed by each of the Parties.
     16.12 Entire Agreement. This Agreement and the Related Agreements between
the Parties constitute the entire understanding between the Parties as of the
Effective Date with respect to the subject matter hereof and thereof and
supersede all related prior or contemporaneous oral communications, agreements
or discussions with respect to the subject matter hereof or thereof.
     16.13 Execution in Counterparts; Facsimile Signatures. This Agreement may
be executed in two counterparts, each of which counterparts, when so executed
and delivered, shall be deemed to be an original, and both of which
counterparts, taken together, shall constitute one and the same instrument even
if both Parties have not executed the same counterpart. Signatures provided by
facsimile transmission shall be deemed to be original signatures.
     16.14 Provisions of Existing In-Licenses. Pursuant to Section 2(d) of the
Licensed Agreement between Amicus and Mount Sinai School of Medicine of New York
University
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(“MSSM”) dated April 15, 2002, as amended (the “MSSM Agreement”), (a) Shire
agrees to be bound by Sections 6, 9 and 10 of the MSSM Agreement, the text of
which is attached hereto as Exhibit 16.14 and incorporated herein by reference,
to the extent applicable to Shire in its capacity as a sublicensee thereunder
and (b) MSSM shall be deemed to be a third party beneficiary of this Agreement
for purposes of enforcing Sections 9 and 10 of the MSSM Agreement against Shire
in its capacity as a sublicensee thereunder. In addition, Shire, in its capacity
as a sublicensee under the Existing In-Licenses, agrees to comply with the audit
rights applicable to sublicensees thereunder.
(The remainder of this page is intentionally left blank; the signature page
follows.)
     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     IN WITNESS WHEREOF, each of the Parties, by their duly authorized officers,
have executed this Agreement as of the Effective Date.

                  AMICUS THERAPEUTICS, INC.   SHIRE PHARMACEUTICALS IRELAND LTD.
   
By:
  /s/ John F. Crowley   By:   /s/ Susan Connell    
 
 
 
     
 
   
Name:
  John F. Crowley   Name:   Susan Connell    
Title:
  President and Chief Executive Officer   Title:   Director    

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

-2-

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APPENDIX 1
Amicus Patent Rights

                              Patent                 Application No.   No.  
Country   Title   Legal Owner   Beneficial Owner
09/087804
    6274597     US   Method Of Enhancing Lyosomal Alpha-Galactosidase A   Mount
Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
[***]
                       
 
                       
09/604053
    6583158     US   Method For Enhancing Mutant Enzyme Activities In Lysosomal
Storage Disorders   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
09/927285
    6774135     US   Method Of Enhancing Lysosomal Alpha-Galactosidase A   Mount
Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
09/948348
    6599919     US   Method For Enhancing Mutant Enzyme Activities In Lysosomal
Storage Disorders   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
10/172604
    6589964     US   Method for Enhancing Mutant Enzyme Activities In Lysosomal
Storage Disorders   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
10/304395
    6916829     US   Method For Enhancing Mutant Enzyme Activity In Gaucher
Disease   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
[***]
                       
 
                       
10/989258
    7141582     US   Method Of Enhancing Mutant Enzyme Activity In Gaucher
Disease   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

                              Patent                 Application No.   No.  
Country   Title   Legal Owner   Beneficial Owner
[***]
                       
 
                       
[***]
                       
 
                       
 [***]
                       
 
                       
95911229.3
    0749423     CH   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
69531098.4
    0749423     DE   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     EP   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     FR   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     GB   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     SE   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
7-523172
          JP   Use Of Hydroxy Alkyl Piperidine And Pyrrolidine Compounds To
Treat Diabetes   Novo Nordisk A/S   Amicus Therapeutics, Inc.
 
                       
 [***]
                       

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 2 -

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

 

APPENDIX 2
Ex-U.S. Platform Patent Rights

                          Application   Patent                 No.   No.  
Country   Title   Legal Owner   Beneficial Owner
09/087804
    6274597     US   Method Of Enhancing Lyosomal Alpha-Galactosidase A   Mount
Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
[***]
                       
 
                       
09/604053
    6583158     US   Method For Enhancing Mutant Enzyme Activities In Lysosomal
Storage Disorders   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
09/927285
    6774135     US   Method Of Enhancing Lysosomal Alpha-Galactosidase A   Mount
Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
09/948348
    6599919     US   Method For Enhancing Mutant Enzyme Activities In Lysosomal
Storage Disorders   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
10/172604
    6589964     US   Method for Enhancing Mutant Enzyme Activities In Lysosomal
Storage Disorders   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
10/304395
    6916829     US   Method For Enhancing Mutant Enzyme Activity In Gaucher
Disease   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
[***]
                       

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

                          Application   Patent                 No.   No.  
Country   Title   Legal Owner   Beneficial Owner
10/989258
    7141582     US   Method Of Enhancing Mutant Enzyme Activity In Gaucher
Disease   Mount Sinai School of Medicine   Amicus Therapeutics, Inc.
 
                       
[***]
                       
 
                       
08/404077
    5863903     US   Use Of Hydroxy Alkyl Piperidine And Pyrrolidine Compounds
To Treat Diabetes   Novo Nordisk A/S   Amicus Therapeutics, Inc.
 
                       
95911229.3
    0749423     CH   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
69531098.4
    0749423     DE   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     EP   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     FR   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     GB   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
95911229.3
    0749423     SE   Piperidines And Pyrrolidines   Novo Nordisk A/S   Amicus
Therapeutics, Inc.
 
                       
[***]
                       

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 2 -

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

 

APPENDIX 3
Amicus Competitors
     The companies to be listed on this Appendix 3 pursuant to Sections 2.2.2(b)
and 2.4.4 are as set forth in that certain letter from Douglas A. Branch to Gary
Clements dated as of the Effective Date.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

APPENDIX 4
Initial Development Plan
     [***]
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

EXHIBIT 1.5.1
Deoxygalactonojirimycin
     [***]
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

EXHIBIT 1.5.2
Deoxynojirimycin
     [***]
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

EXHIBIT 1.5.3
Isofagomine
[***]
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

EXHIBIT 6.4.4
The Back-up Compounds referenced in §6.6.4(c)(ii) are as set forth in Appendix A
of that certain letter from Douglas A. Branch to Gary Clements dated as of the
Effective Date.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

EXHIBIT 10.6.1
Existing In-Licenses

1)   Agreement, dated as of April 15, 2002, as amended, by and between Amicus
and Mount Sinai School of Medicine of New York University

2)   Exclusive License Agreement, dated as of June 8, 2005, by and between
Amicus and Novo Nordisk, A/S

     [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 2 -

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EXHIBIT 16.14
Sections 6, 9 and 10 of the MSSM Agreement
     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.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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

 

          c. The Receiving Party will maintain reasonable procedures to prevent
accidental or other loss, including unauthorized publication of any Confidential
Information of the Disclosing Party. The Receiving Party will promptly notify
the Disclosing Party in the event of any loss or unauthorized disclosure of the
Confidential Information.
          d. Upon termination or expiration of this Agreement, and upon written
request, the Receiving Party will promptly return to the Disclosing Party all
documents or other tangible materials representing Confidential Information and
all copies thereof.
          e. The Receiving Party will immediately notify the Disclosing Party in
writing, if it is requested by a court order, a governmental agency, or any
other entity to disclose Confidential Information in the Receiving Party’s
possession. The Disclosing Party will have an opportunity to intervene by
seeking a protective order or other similar order, in order to limit or prevent
disclosure of the Confidential Information. The Receiving Party will disclose
only the minimum Confidential Information required to be disclosed in order to
comply, whether or not a protective order or other similar order is obtained by
the Disclosing Party.
     9. Liability and Indemnification.
          a. AMICUS shall indemnify, defend and hold harmless MSSM and its
trustees, officers, directors, medical and professional staff, employees,
students and agents and their respective 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, loss 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.
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 2 -

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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.
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 3 -

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

 

SCHEDULE 7.3.4
     U.S. Patent No. 6,344,475
     U.S. Patent No. 6,270,954
     U.S. Patent No. 6,541,195
     U.S. Patent No. 5,900,360
     Australian Patent No. AU 775 575 B2
     Australian Patent No. AU 734 905 B2
     [***]
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 4 -

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

 

SCHEDULE 12.2
     This Schedule 12.2 is made and given pursuant to Section 12.2 of the
Agreement. The section numbers below correspond to the section numbers of the
Agreement. Nothing in this Schedule 12.2 is intended to broaden the scope of any
representation or warranty contained in the Agreement or to create any covenant.
The information contained in this Schedule 12.2 is provided solely for purposes
of making disclosures to Shire under the Agreement. In disclosing such
information, Amicus does not waive any attorney-client privilege associated with
such information or any protection afforded by the work-product doctrine with
respect to any of the matters disclosed or discussed in this Schedule 12.2.
          [***]
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 5 -

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

 

Letter from Douglas A. Branch to Gary Clements dated as of the Effective Date
November 7, 2007
Mr. Gary Clements
Senior Business Development Director
Shire Human Genetic Therapies
700 Main Street
Cambridge, MA 02139

          Re:   License and Collaboration Agreement (the “Agreement”) by and
between Amicus Therapeutics, Inc. (“Amicus”) and Shire Pharmaceuticals Ireland
Ltd. (“Shire”)

          Dear Mr. Clements:
               In connection with Sections 2.2.2(b) and 2.4.4 of the
above-referenced Agreement, Appendix A to this letter sets forth the companies
to be listed on Appendix 3 of the Agreement.
Very truly yours,
/s/ Douglas Branch
Douglas A. Branch
Vice President and General Counsel
     Acknowledged by:
     /s/ Gary Clements
                                                                 
     Mr. Gary Clements
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 6 -

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

 

APPENDIX A
     [***]
        .
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 7 -

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

 

November 7, 2007
Mr. Gary Clements
Senior Business Development Director
Shire Human Genetic Therapies
700 Main Street
Cambridge, MA 02139

           Re:   License and Collaboration Agreement (the “Agreement”) by and
between Amicus Therapeutics, Inc. (“Amicus”) and Shire Pharmaceuticals Ireland
Ltd. (“Shire”)

          Dear Mr. Clements:
               As required by Section 6.4.4(a)(ii) of the above-referenced
Agreement, Appendix A to this letter contains the list of Back-Up Compounds
referenced therein.
Very truly yours,
/s/ Douglas Branch
Douglas A. Branch
Vice President and General Counsel
     Acknowledged by:
     /s/ Gary Clements
                                                                 
     Mr. Gary Clements
          [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

- 8 -

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

 

APPENDIX A
     [***]
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.