LICENSE AND COLLABORATION AGREEMENT

EXHIBIT 10.20

LICENSE AND COLLABORATION AGREEMENT

dated as of November 7, 2007

Amicus Therapeutics, Inc.

and

Shire Pharmaceuticals Ireland Ltd.

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.

		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.

		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.

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

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.

          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.

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.

     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.

          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.

          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.

     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.

          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.

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.

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.

          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.

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.

     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.

     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.

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.

          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.

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.

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.

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.

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.

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.

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.

               (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.

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.

               (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.

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.

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.

               (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.

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.

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.

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.

               (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.