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Exhibit 10.41 COLLABORATIVE RESEARCH AND LICENSE
AGREEMENT between ARCHEMIX CORP. and
ELAN PHARMA INTERNATIONAL, LIMITED June 30, 2006
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
TABLE OF CONTENTS
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Page
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1.
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DEFINITIONS
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1
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2.
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ADMINISTRATION OF THE COLLABORATION
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31
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2.1
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Joint Management Committee
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31
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2.2
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Joint Project Team
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35
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3.
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RESEARCH PROGRAM
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40
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3.1
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Implementation of the Research Program
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40
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3.2
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Research Plan; Annual Research Plans
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40
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3.3
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Conduct of Research Program
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42
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3.4
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Records
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43
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3.5
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Selection of Program Targets
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45
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3.6
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Identification of Collaboration Compounds, IL-23
Aptamers and Lead Compounds
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47
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3.7
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Clinical Candidates
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47
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3.8
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Identification of Back-up Collaboration
Compounds
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48
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3.9
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Failed Targets
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48
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3.10
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Supply of Proprietary Materials
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49
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3.11
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Research Program Term
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49
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4.
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DEVELOPMENT PROGRAM; COMMERCIALIZATION OF
PRODUCTS
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49
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4.1
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Objectives of the Development Program
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49
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4.2
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Responsibility for Development of Clinical
Candidates and Commercialization of Products
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49
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4.3
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Annual Development Plans
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50
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4.4
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Product Commercialization Plans
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51
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4.5
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Supply of Products for Development and
Commercialization
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52
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4.6
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Development and Commercialization Diligence
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54
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4.7
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Compliance
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55
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4.8
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Cooperation
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55
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4.9
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Exchange of Reports; Information; Updates
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55
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4.10
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Development and Commercialization Rights and
Restrictions
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58
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4.11
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Co-Development Option
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59
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4.12
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Reconciliation and Auditing of Operating Income
(Loss)
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66
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5.
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PAYMENTS
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68
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5.1
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Upfront Fee
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68
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5.2
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R&D Funding
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68
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CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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5.3
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Milestone Payments
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70
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5.4
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Payment of Royalties; Royalty Rates; Accounting and
Records
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74
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6.
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TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY;
NON-SOLICITATION
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81
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6.1
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Confidentiality
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81
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6.2
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Publicity
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83
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6.3
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Publications and Presentations
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84
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6.4
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Prohibition on Solicitation
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84
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7.
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LICENSE GRANTS; EXCLUSIVITY
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85
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7.1
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Research and Development Licenses
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85
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7.2
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Commercialization License
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88
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7.3
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Right to Sublicense
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88
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7.4
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No Other Rights
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89
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7.5
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Exclusivity
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89
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8.
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INTELLECTUAL PROPERTY RIGHTS
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90
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8.1
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ARCHEMIX Intellectual Property Rights
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90
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8.2
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ELAN Intellectual Property Rights
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90
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8.3
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Joint Technology Rights
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90
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8.4
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Patent Coordinators
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91
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8.5
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Inventorship
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91
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8.6
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Cooperation
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91
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9.
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INTELLECTUAL PROPERTY
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91
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9.1
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Patent Filing, Prosecution and Maintenance
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91
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9.2
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Legal Actions
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95
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9.3
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Trademark and Copyright Ownership Prosecution,
Defense and Enforcement
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100
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9.4
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Third Party Licenses
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101
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10.
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TERM AND TERMINATION
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101
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10.1
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Term
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101
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10.2
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Termination
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102
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10.3
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Consequences of Termination of Agreement
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103
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11.
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REPRESENTATIONS AND WARRANTIES
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110
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11.1
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Mutual Representations and Warranties
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110
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11.2
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Additional Representations of ARCHEMIX
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110
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11.3
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Acknowledgments of ELAN
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111
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CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ii
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11.4
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Acknowledgement of ARCHEMIX
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112
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12.
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INDEMNIFICATION
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112
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12.1
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Indemnification of ELAN by ARCHEMIX
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112
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12.2
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Indemnification of ARCHEMIX by ELAN
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113
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12.3
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Indemnification of Gilead and UTC by ELAN
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114
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12.4
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Co-Developed Products
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114
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12.5
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Conditions to Indemnification
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115
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12.6
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Warranty Disclaimer
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115
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12.7
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Limited Liability
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116
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13.
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MISCELLANEOUS
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116
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13.1
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Mediation
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116
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13.2
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Change of Control
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116
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13.3
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Notices
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120
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13.4
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Governing Law
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121
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13.5
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Binding Effect
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121
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13.6
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Headings
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121
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13.7
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Counterparts
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121
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13.8
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Amendment; Waiver
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121
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13.9
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No Third Party Beneficiaries
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122
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13.10
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Purposes and Scope
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122
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13.11
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Assignment and Successors
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122
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13.12
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Divestment Offer
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122
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13.13
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Force Majeure
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123
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13.14
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Interpretation
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123
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13.15
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Integration; Severability
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124
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13.16
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Equitable Relief
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124
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13.17
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HSR Filing
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124
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CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
iii
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List of Exhibits and Schedules
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Exhibit A
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Annual Research Plan
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Exhibit B
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Annual Development Plan
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Schedule 1
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Program Targets
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Schedule 2
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Excluded Targets
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Schedule 3
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Licensed Patent Rights
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Schedule 4
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Calculation of Operating Income (Loss)
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Schedule 5
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Excluded Aptamers
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Schedule 6
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Clinical Candidate Selection Criteria
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Schedule 7
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Form of Press Release
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Schedule 8
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Regional Offices or Countries in which Patent
Applications are to be Nationalized or Otherwise Prosecuted, Filed
and Maintained
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Schedule 9
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Structure of ARC2350
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CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
iv
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
This COLLABORATIVE RESEARCH AND
LICENSE AGREEMENT (this "Agreement") is entered into as of
June 30, 2006, by and between Archemix Corp., a Delaware
corporation with offices at 300 Third Street, Cambridge, MA 02142
("ARCHEMIX"), and Elan Pharma International Limited, a private
company limited by shares organized under the laws of Ireland with
offices at Monksland, Athlone, County Westmeath, Ireland ("ELAN").
Each of ELAN and ARCHEMIX is sometimes referred to individually
herein as a "Party" and are sometimes referred to collectively as
the "Parties." WHEREAS, ARCHEMIX has
developed and controls certain technology, patent rights and
proprietary materials related to (a) its proprietary IL-23
aptamers, (b) the identification and optimization of other
aptamers using its proprietary SELEX™ process and
SELEX™ technology, and (c) the use of such aptamers for
treating, preventing or delaying onset or progression of human
diseases or conditions; and WHEREAS,
ELAN is engaged in the research, development and commercialization
of human therapeutics; and WHEREAS,
the Parties desire to enter into a collaboration for the purposes
of (a) further developing and commercializing ARCHEMIX’
IL-23 aptamers and (b) identifying aptamers against targets
that fulfill certain criteria, and developing and commercializing
products derived from such aptamers for the prevention, treatment
and delay of onset or progression of disease.
NOW, THEREFORE, in consideration of
the mutual covenants contained herein, and for other good and
valuable consideration, the Parties hereto, intending to be legally
bound, hereby agree as follows: 1. DEFINITIONS
Whenever used in this Agreement with
an initial capital letter, the terms defined in this
Section 1, Schedule 4 and elsewhere throughout the
Agreement shall have the meanings specified. CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
1.1 " AAA " means
the American Arbitration Association.
1.2 " Adverse Event "
means any untoward, undesired or unplanned medical occurrence in a
human clinical trial subject or a patient, which occurrence has a
temporal relationship to administration of a Clinical Candidate or
Product, whether or not considered related to the Clinical
Candidate or Product, including, without limitation, any
undesirable sign (including abnormal laboratory findings of
clinical concern), symptom or disease that may be associated with
the use of such Clinical Candidate or Product.
1.3 " Affiliate "
means, with respect to any Person, any other Person that, directly
or indirectly, controls, or is controlled by, or is under common
control with, such Person. For purposes of this definition,
"control" means (a) ownership of fifty percent (50%) or more
of the shares of stock entitled to vote for the election of
directors in the case of a corporation, fifty percent (50%) or more
of the equity interests in the case of any other type of legal
entity, (b) status as a general partner in any partnership, or
(c) any other arrangement whereby a Person controls or has the
right to control the board of directors of a corporation or
equivalent governing body of an entity.
1.4 " [***] Agreement "
means any transaction (including any partnership or strategic
alliance) between ARCHEMIX and a Third Party for the purpose of
licensing that Third Party or collaborating with that Third Party
to identify, develop and commercialize therapeutic Aptamers against
[***] for the treatment of [***] diseases, but excluding
(a) any transaction with a Third Party involving any
fee-for-service or sponsored research agreement or arrangement
relating to performance of services (including manufacturing) or
research by a Third Party solely for ARCHEMIX, or (b) any
agreement or arrangement involving the payment to ARCHEMIX or any
of its Affiliates of governmental research or grant funding or
research or grant funding from a non-profit organization in the
absence of a license, collaboration or similar agreement.
1.5 " [***] " or "
[***] " means the cleavage product of the [***]
occurring predominantly as the [***], as described in [***].
1.6 " Annual Development
Plan " means, with respect to each Clinical Candidate and
Contract Year, the written plan for the Development of such
Clinical Candidate for such Contract CONFIDENTIAL Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
2
Year, as such written plan may be amended, modified or updated,
as further described in section 4.3.
1.7 " Annual Net Sales
" means, with respect to any Calendar Year, the aggregate amount of
the Net Sales during such Calendar Year.
1.8 " Annual Research Plan
" means the written plan describing the activities to be
carried out by each Party during each Contract Year of the Research
Program Term in conducting the Research Program pursuant to this
Agreement, as prepared by the JPT and approved by the JMC, and as
such written plan may be amended, modified or updated, as further
described in Section 3.2. 1.9 "
Applicable Laws " means federal, state, local,
national and supra-national laws, statutes, rules and regulations,
including any rules, regulations or requirements of Regulatory
Authorities, national securities exchanges or securities listing
organizations, that are in effect from time to time during the Term
and apply to a particular activity hereunder.
1.10 " Aptamer " means
(i) any naturally or non-naturally occurring oligonucleotide
identified by ARCHEMIX through the SELEXÔ Process that binds
with high specificity and affinity to a Target; and (ii) any
oligonucleotide Derived from the oligonucleotide of (i) that
has such high specifity and affinity.
1.11 " Aptamer-Generic Patent
Rights " means Patent Rights that cover only
Aptamer-Generic Technology. 1.12 "
Aptamer-Generic Technology " means any
Technology relating generally to aptamers, or their methods of use,
that is not Program Aptamer Specific Technology.
1.13 " ARCHEMIX Annual FTE
Commitment " means the annual FTE commitment of ARCHEMIX to
the Research Program, which shall equal [***] FTEs per Contract
Year, unless otherwise agreed by the Parties.
1.14 " ARCHEMIX Background
Technology " means any Technology that is used by ARCHEMIX,
or provided by ARCHEMIX for use, or that is otherwise necessary or
useful in the performance of the Research Program, the Development
or Co-Development of Lead Compounds, Clinical Candidates and/or the
Commercialization of Products that is (a) Controlled by
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
3
ARCHEMIX as of the Effective Date or (b) Made by employees
of, or consultants to, ARCHEMIX after the Effective Date other than
in the conduct of ARCHEMIX Research Activities or ARCHEMIX
Development Activities and without the use in a material respect of
any ELAN Technology, ELAN Materials, ELAN Patent Rights, ELAN
Product Patent Rights, ELAN Product Technology or Program
Technology. For purposes of clarity, ARCHEMIX Background Technology
(a) shall include the SELEX™ Process and SELEX™
Technology and (b) shall not include, and shall not be
included in, ARCHEMIX Program Technology or ARCHEMIX’
interest in Joint Technology. 1.15 "
ARCHEMIX Co-Development Percentage " means a whole
number percentage less than or equal to [***] percent ([***]%) and
greater than or equal to [***] percent ([***]%) specified by
ARCHEMIX pursuant to Sections 4.11.1 and 4.11.2.
1.16 " ARCHEMIX
Decision " means a decision with respect to the following
issues: (a) how to perform the [***] against [***] identified for
inclusion in the Research Program in accordance with
Section 3.5.1; (b) the expansion, [***], of the number of
FTEs to be provided by ARCHEMIX under the Research Program in any
Contract Year beyond the ARCHEMIX Annual FTE Commitment (including
without limitation, the application of additional ARCHEMIX FTEs
beyond the ARCHEMIX Annual FTE Commitment to the [***]);
(c) any activity requiring ARCHEMIX to apply significantly
(i.e., at least [***]%) more resources (other than FTEs) to the
Research Program than are specified by the Annual Research Plan;
(d) to incur any [***] except as provided in
Section 3.3.5; (e) whether ELAN has nominated as a Program
Target a Target that ARCHEMIX determines in good faith, after
consultation with, and, if requested by ELAN, obtaining a letter
from, ARCHEMIX’ outside counsel (which counsel shall be of
nationally recognized reputation in the life sciences field)
confirming such determination, that an executed written agreement
between ARCHEMIX and a Third Party prohibits ARCHEMIX from allowing
ELAN to designate such Target as a Program Target; provided, that,
to the extent permitted by any such agreement, ARCHEMIX shall
provide ELAN with a redacted copy of such agreement which shall
include those provisions that are reasonably relevant to such
determination, subject to the confidentiality obligations
hereunder; and (f) whether ARCHEMIX should [***] obtain a
license to a Blocking Third Party Patent or any other Third Party
Patent Rights. Notwithstanding CONFIDENTIAL Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
4
the foregoing, the characterization of the matters described in
Section 1.16(b) above as an ARCHEMIX Decision shall not affect
the agreement of ARCHEMIX to reasonably consider in good faith
using its commercially reasonable discretion any requests of ELAN
to increase the number of ARCHEMIX FTEs to be provided in the
Research Program beyond the ARCHEMIX Annual FTE Commitment or to
increase other resources to be utilized by ARCHEMIX in the Research
Program. 1.17 " ARCHEMIX
Development Activities " means all Development or
Co-Development activities specified to be conducted by ARCHEMIX in
any Annual Development Plan (or amendment thereto) and approved by
ARCHEMIX’ representatives on the JMC.
1.18 " ARCHEMIX Field "
means the use of Aptamers for all therapeutic purposes and
applications. 1.19 "
ARCHEMIX-Gilead License Agreement " means the License
Agreement between Gilead Sciences, Inc. and ARCHEMIX dated
October 21, 2001, and any amendments thereto.
1.20 " ARCHEMIX
Materials " means any Proprietary Materials that are
Controlled by ARCHEMIX and used by ARCHEMIX, or provided by
ARCHEMIX for use, in the Research Program, the Development Program
and/or any other activities conducted hereunder, and that are not
Joint Technology or Program Technology. For purposes of clarity,
ARCHEMIX Materials shall include all Aptamers Controlled by
ARCHEMIX and provided by ARCHEMIX for use in the Research Program
and/or for the Development of Clinical Candidates that are not
Joint Technology or Program Technology.
1.21 " ARCHEMIX Patent
Rights " means any Patent Rights Controlled by ARCHEMIX
that contain one or more claims that cover ARCHEMIX Technology.
1.22 " ARCHEMIX Program
Technology " means any Program Technology that (a) is
not ELAN Product Technology or Joint Technology, (b) is Made
by or through employees of, or consultants to, ARCHEMIX, alone or
with a Third Party, and (c) does not use in a material respect
or benefit in a material respect from any ELAN Technology, ELAN
Product Technology, ELAN Product Patent Rights, ELAN Materials,
ELAN Patent Rights or Joint Technology. CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
5
1.23 " ARCHEMIX Research
Activities " means all activities specified to be conducted
by ARCHEMIX in any Annual Research Plan (or amendment thereto) that
are (a) approved by the JMC and (b) to the extent
involving matters that are ARCHEMIX Decisions, approved by ARCHEMIX
in accordance with Section 2.1.5.
1.24 " ARCHEMIX-SomaLogic
Agreement " means the License Agreement by and between
ARCHEMIX and SomaLogic, Inc. dated as of September 4, 2003,
and any amendments thereto. 1.25 "
ARCHEMIX Technology " means, collectively, ARCHEMIX
Background Technology and ARCHEMIX Program Technology.
1.26 " Calendar Year "
means each successive period of twelve (12) months commencing
on January 1 and ending on December 31.
1.27 " Change of
Control " means, with respect to a Party, (a) a
merger, consolidation, share exchange or other similar transaction
involving such Party and any Third Party which results in the
holders of the outstanding voting securities of such Party
immediately prior to such merger, consolidation, share exchange or
other similar transaction ceasing to hold more than fifty percent
(50%) of the combined voting power of the surviving, purchasing or
continuing entity immediately after such merger, consolidation,
share exchange or other similar transaction, (b) any
transaction or series of related transactions (other than an
investment transaction by an entity not engaged in the
pharmaceutical or biotechnology business, the purpose of which is
to raise capital for a Party) in which a Third Party, together with
its Affiliates, becomes the beneficial owner of fifty percent (50%)
or more of the combined voting power of the outstanding securities
of such Party, or (c) the sale or other transfer to a Third
Party of all or substantially all of such Party’s assets
which relate to this Agreement. 1.28
" Clinical Candidate Selection Criteria " or "
CCSC " means the guideline criteria for selecting Lead
Compounds that are sufficiently promising to warrant further
Development as Clinical Candidates (a) as set forth in
Schedule 7 attached hereto for IL-23, and (b) as
such Schedule 7 shall be amended from time to time by
the JMC with respect to the other Program Targets listed on
Schedule 1 as of the Effective Date and/or to any other
Program Target CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
6
to be included in the Research Program, which amendment shall
occur before any activities with respect to such Program Target are
initiated, in any material respect, in the Research Program.
1.29 " Co-Developed
Product " means a Psoriatic Diseases Co-Developed Product
and/or a Non-Parenteral Co-Developed Product.
1.30 " Co-Development "
means Development of a Co-Developed Product after ARCHEMIX’
exercise of a Co-Development Option as described in
Section 4.11.1. 1.31 "
Co-Development Territory " means any or all of:
(a) the United States of America and its territories and
possessions; (b) all countries that comprise the European
Union; and/or (c) all countries other than those described in
(a) or (b). 1.32 "
Collaboration " means the alliance of ARCHEMIX and
ELAN established pursuant to this Agreement for the purposes of
identifying, researching and Developing Collaboration Aptamers and
Commercializing Products in the Territory.
1.33 " Collaboration
Aptamer " means any or all of IL-23 Aptamers, Development
Leads, Collaboration Compounds, Program Aptamers, Patented
Aptamers, Lead Compounds, Clinical Candidates and/or Products.
1.34 " Collaboration
Compound " means any Program Aptamer that binds a Program
Target other than IL-23 that is identified by performing the
SELEX™ Process against a Program Target other than IL-23 in
the conduct of the Research Program or any Aptamer Derived
therefrom that binds a Program Target other than IL-23.
1.35 " Collaboration
Product " means any pharmaceutical or medicinal item,
substance or formulation that contains, incorporates or comprises a
Collaboration Compound or any Aptamer Derived therefrom that binds
a Program Target other than IL-23.
1.36 " Combination
Product " means a combination or bundled product that is
sold together in a single package or as a unit at a single price by
a Party, its Affiliate or Sublicensee and that includes: (a) a
Product; and (b) a Supplemental Product that is not within the
Licensed Patent Rights, where both the Product and the Supplemental
Product are required to treat the intended Indication and/or to
achieve the intended use or effect. CONFIDENTIAL Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
7
1.37 "
Commercialization " means any and all activities
related to the offering for sale and/or sale of a Product after
Commercialization Regulatory Approval has been obtained, including
but not limited to activities related to marketing, manufacturing
for commercial distribution, educating providers and consumers,
contracting, pharmacoeconomics studies, payer reimbursement,
promoting, detailing, distributing, importing, conducting
post-marketing human clinical studies and interacting with
Regulatory Authorities regarding the foregoing. When used as a
verb, to "Commercialize" or "Commercializing" means to engage in
Commercialization and "Commercialized" has a corresponding meaning.
1.38 " Commercially Reasonable
Efforts " means (a) with respect to activities of
ARCHEMIX in the Research Program, or, with respect to the conduct
of ARCHEMIX Development Activities, or the Commercialization of
Co-Developed Products, if any, the efforts and resources comparable
to those undertaken by ARCHEMIX in pursuing the research,
discovery, development and intellectual property protection of
proprietary materials and the development of product candidates and
commercialization of products, as applicable, that are not subject
to the Collaboration and that are at an equivalent stage of
development or commercialization and have similar market potential
and are at a similar stage in their lifecycle, and (b) with
respect to activities of ELAN in the Research Program, the
Development of a particular Clinical Candidate or the
Commercialization of a particular Product, the efforts and
resources comparable to those undertaken by ELAN in pursuing
intellectual property protection and development of product
candidates and commercialization of products, as applicable, that
are not subject to the Collaboration and that are at an equivalent
stage of development or commercialization and have similar market
potential and are at a similar stage in their lifecycle. For
purposes of both (a) and (b) above, all relevant factors
as measured by the facts and circumstances at the time such efforts
are due shall be taken into account, including, as applicable D and
without limitation, mechanism of action; efficacy and safety;
product profile; actual or anticipated Regulatory Authority
approved labeling; the nature and extent of market exclusivity
(including patent coverage, proprietary position and regulatory
exclusivity; cost, time required for and likelihood of obtaining
Commercialization Regulatory Approval; competitiveness of
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
8
alternative products and market conditions; actual or projected
profitability and availability of capacity to manufacture and
supply for commercial sale). 1.39 "
Commercialization Regulatory Approval " means, with
respect to any Product, the Regulatory Approval required by
Applicable Laws to sell such Product in a country or region.
"Commercialization Regulatory Approval" shall include, without
limitation, the approval of any Drug Approval Application. For
purposes of clarity, "Commercialization Regulatory Approval" in the
United States shall mean final approval of an NDA for a first
Indication or sNDA for a second or later Indication permitting
marketing of the applicable Product in interstate commerce in the
United States. "Commercialization Regulatory Approval" in the
European Union shall mean marketing authorization for the
applicable Product pursuant to Council Directive 2001/83/EC, as
amended, or Council Regulation 2309/93/EEC, as amended; and
"Commercialization Regulatory Approval" in Japan shall mean final
approval of an application submitted to the Ministry of Health,
Labor and Welfare and the publication of a New Drug Approval
Information Package permitting marketing of the applicable Product
in Japan, as any of the foregoing may be amended from time to time.
1.40 " Competitive Entity
" means any Third Party in the top [***] ([***]) companies
ranked by [***] in the most recently completed Calendar Year for
which such ranking is readily available from an unaffiliated Third
Party. 1.41 " Competitive
Program " means any research, development or
commercialization activity that involves an aptamer that targets a
Program Target. 1.42 "
Confidential Information " means (a) with
respect to ARCHEMIX, all embodiments of ARCHEMIX Technology and
ARCHEMIX shall be deemed the "disclosing party" and ELAN the
"receiving party" with respect thereto; (b) with respect to
ELAN, all embodiments of ELAN Technology and/or ELAN Product
Technology and ELAN shall be deemed the "disclosing party" and
ARCHEMIX the "receiving party" with respect thereto; and (c) with
respect to each Party, each of which shall be deemed both the
"disclosing party" and "receiving party" with respect thereto,
(i) all embodiments of Joint Technology, (ii) all
information, Technology and Proprietary Materials, to the extent
not described in (a) or (b), disclosed or provided by or on
behalf of such Party (the "disclosing Party") to the other Party
(the CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
9
"receiving Party") or to any of the receiving party’s
employees, consultants, Affiliates or Sublicensees, (iii) the
terms of this Agreement and (iv) all Technology generated
hereunder in connection with the Research Program, the Development
(including the Co-Development) of Clinical Candidates, and the
Commercialization of Products; provided that none of the foregoing
shall be Confidential Information if: (A) as of the date of
disclosure, it is known to the receiving Party or its Affiliates,
as demonstrated by credible written documentation, other than by
virtue of a prior confidential disclosure by or on behalf of the
other Party; (B) as of the date of disclosure it is in the
public domain, or it subsequently enters the public domain through
no unauthorized disclosure and no fault of the receiving Party;
(C) it is obtained by the receiving Party from a Third Party
having a lawful right to make such disclosure free from any
obligation of confidentiality to the other Party; or (D) it is
independently developed by or for the receiving Party without
benefit from, reference to or use of any Confidential Information
of the other Party as demonstrated by credible written
documentation. For purposes of clarity, unless excluded from
Confidential Information pursuant to the proviso at the end of the
preceding sentence or otherwise allocated to one or both of the
Parties pursuant to (a), (b) or (c) above, (1) any
scientific, technical or financial information Controlled, as
between the Parties, solely by one Party and disclosed at any
meeting of the JMC or JPT, or disclosed through an audit or other
report under this Agreement, shall constitute Confidential
Information of the Controlling Party, and (2) any data,
documentation or other information regarding an Amyloid Beta
Agreement disclosed by or on behalf of ARCHEMIX pursuant to
Section 4.10.2 shall constitute Confidential Information of
ARCHEMIX. 1.43 " Contract
Year " means (a) the period beginning on the Effective
Date and ending on the first anniversary of the last day of the
calendar month in which the Effective Date falls and (b) each
succeeding twelve (12) month period thereafter.
1.44 " Control " or "
Controlled " means (a) with respect to
Technology or Patent Rights, the possession by a Party of the right
to grant a license or sublicense to such Technology or Patent
Rights as provided herein without the payment of additional
consideration to, and without violating the terms of any agreement
or arrangement with, any Third Party and without violating any
Applicable Laws and (b) with respect to Proprietary Materials,
the possession by a CONFIDENTIAL Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
10
Party of the right to supply such Proprietary Materials to the
other Party as provided herein without the payment of additional
consideration to, and without violating the terms of any agreement
or arrangement with, any Third Party and without violating any
Applicable Laws. 1.45 "
Derived " means identified, obtained, developed,
created, synthesized, generated, designed or resulting from; based
upon; containing or incorporating; conjugated to or complexed with
(whether directly or indirectly, or in whole or in part).
1.46 " Development " or
" Develop " means all pre-clinical and clinical
activities performed to obtain Regulatory Approval of a product up
to and including the obtaining of Commercialization Regulatory
Approval of such product. For purposes of clarity, these activities
include, without limitation, test method development and stability
testing, regulatory toxicology studies, formulation, process
development, manufacturing, manufacturing scale-up,
development-stage manufacturing, quality assurance/quality control
development, statistical analysis and report writing, clinical
trial design and operations, preparing and filing Drug Approval
Applications, and all regulatory affairs related to the foregoing.
When used as a verb, "Developing" means to engage in Development
and "Developed" has a corresponding meaning.
1.47 " Development
Costs " means the reasonable out-of-pocket costs and
internal costs incurred by a Party (or for its account by an
Affiliate or a Third Party) consistent with the respective
Development activities of such Party as set forth in the Annual
Development Plan or as mutually agreed by the Parties, and
specifically attributable to Development or Co-Development of a
Development Lead, Clinical Candidate or Product. For purposes of
this definition (a) out-of-pocket costs means the actual
amounts paid to a Third Party for specific external Development or
Co-Development activities applicable to a Development Lead,
Clinical Candidate or Product, including, without limitation,
Manufacturing Costs and all filing fees required for and other
costs associated with, any Regulatory Filings; (b) internal
costs means the applicable FTE Rate multiplied by the number of FTE
hours utilized in the relevant period on activities directly
relating to the Development or Co-Development of a Development
Lead, Clinical Candidate or Product in accordance with the Annual
Development Plan or as mutually agreed by the Parties; and
(c) the reasonable out-of-pocket and internal costs of
obtaining Development Leads, Clinical Candidates or Products for
use in the activities in clause (a), including without limitation
internal CONFIDENTIAL Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11
Manufacturing Costs. For the avoidance of doubt, Development
Costs shall include the costs incurred by either Party in
conducting clinical trials with respect to a Development Lead,
Clinical Candidate or Product. 1.48 "
Development Lead " means [***] (a) [***] the [***]and
(b) [***] in [***] by [***] for the [***] of [***].
1.49 " Development
Program " means, with respect to each Clinical Candidate,
the Development activities to be conducted during the Term with
respect to such Development Lead or Clinical Candidate pursuant to
the Annual Development Plan, with the objective of developing such
Development Lead or Clinical Candidate into a Product.
1.50 " Diagnosis "
means (a) the determination or monitoring of (i) the
presence or absence of a disease, (ii) the stage, progression
or severity of a disease or (iii) the effect on a disease of a
particular treatment; and/or (b) the selection of patients for
a particular treatment with respect to a disease. For purposes of
clarity, the term Diagnosis shall not include the delay of onset or
progression of, or treatment or prevention of, an Indication.
1.51 " Diagnostic
Product " means In Vitro Diagnostics, In Vivo
Diagnostic Agents and any product used for Diagnosis.
1.52 " Diligence
Indication " means (i) for IL-23 Aptamers, each of
Crohn’s Disease, multiple sclerosis, psoriasis and rheumatoid
arthritis, and (ii) for Collaboration Compounds other than
IL-23 Aptamers, any single Indication.
1.53 " Drug Approval
Application " means, with respect to a Product in a
particular country or region, an application for Commercialization
Regulatory Approval for such Product in such country or region,
including without limitation: (a) an NDA or sNDA; (b) a
counterpart of an NDA or sNDA in any country or region in the
Territory; and (c) all supplements and amendments to any of
the foregoing. 1.54 " Early
Stage Development Costs " means, with respect to a
Co-Developed Product, all Development Costs incurred by ELAN with
respect to such Co-Developed Product during the period commencing
on the date of designation by ELAN of the Development Lead or
Clinical Candidate from which such Co-Developed Product was
Derived, or constituting such Co- CONFIDENTIAL Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
12
Developed Product, and continuing up to the date that the
Parties begin Co-Developing that Co-Developed Product.
1.55 " ELAN Background
Technology " means any Technology that is used by ELAN, or
provided by ELAN for use, or that is otherwise necessary or useful
in the performance of the Research Program, the Development or
Co-Development of Lead Compounds or Clinical Candidates and/or the
Commercialization of Products that is (a) Controlled by ELAN
as of the Effective Date or (b) Made by employees of, or
consultants to, ELAN after the Effective Date other than in the
conduct of ELAN Research Activities or ELAN Development Activities
and without the use in a material respect of any ARCHEMIX
Technology, ARCHEMIX Patent Rights, ARCHEMIX Materials or Program
Technology. For purposes of clarity, ELAN Background Technology
(a) shall not include, and shall not be included in, ELAN
Program Technology, ELAN Product Technology or ELAN’s
interest in Joint Technology. 1.56 "
ELAN Decision " means any decision with respect to
the following issues: (a) subject to Section 3.5.1(b), the
replacement of any Program Target with another Target; (b) the
nomination of an IL-23 Aptamer or a Collaboration Compound as a
Lead Compound; (c) the nomination of a Lead Compound as a
Clinical Candidate; (d) the [***] of [***] to be [***] in
[***] to the [***]; (e) the use or application by ELAN of
[***] and/or [***] and [***] in the conduct of the Research Program
and/or the Development of Clinical Candidates; and (f) whether
ELAN should [***] obtain a license to a Blocking Third Party Patent
or any other Third Party Patent Rights.
1.57 " ELAN Development
Activities " means all Development activities specified to
be conducted by ELAN in any Annual Development Plan (or amendment
thereto). 1.58 " ELAN
Materials " means any Proprietary Materials that are
Controlled by ELAN and used by ELAN, or provided by ELAN for use,
in the Research Program, the Development Program and/or any other
activities conducted hereunder, and that are not Joint Technology
or Program Technology. 1.59 "
ELAN Patent Rights " means any Patent Rights
Controlled by ELAN that contain one or more claims that cover ELAN
Technology. CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
13
1.60 " ELAN Product Patent
Rights " means any Patent Rights that contain one or more
claims that cover ELAN Product Technology.
1.61 " ELAN Product
Technology " means any Technology that is Made by employees
of, or consultants to, ELAN, alone or jointly with any other entity
(including ARCHEMIX) in the course of Development (but not
Co-Development) of Development Leads and Clinical Candidates and/or
Commercialization of Products other than Co-Developed Products;
provided however, that any Technology that relates to the conduct
of the SELEX™ Process or the use of the SELEX™
Technology shall not be considered to be ELAN Product Technology.
For purposes of clarity, ELAN Product Technology shall not be
included in Joint Technology. 1.62 "
ELAN Program Technology " means any Program
Technology that (a) is not ELAN Product Technology or Joint
Technology; (b) is Made by or through employees of, or
consultants to, ELAN, alone or with any Third Party; and
(c) does not use in a material respect or benefit in a
material respect from any ARCHEMIX Technology, ARCHEMIX Materials,
ARCHEMIX Patent Rights or Joint Technology.
1.63 " ELAN Research
Activities " means (a) all activities specified to be
conducted by ELAN in any Annual Research Plan (or amendment
thereto) that are (i) approved by the JMC and (ii) to the
extent involving matters that are ELAN Decisions, approved by ELAN
in accordance with Section 2.1.5, and (b) all research
activities conducted by ELAN with respect to any Development Leads,
Lead Compounds and Clinical Candidates undergoing Development and
Products undergoing Commercialization.
1.64 " ELAN Technology
" means, collectively, ELAN Background Technology and ELAN Program
Technology. 1.65 " Enriched
Pool " means a pool of oligonucleotides used to perform the
SELEX™ Process against a Program Target in the performance of
the Research Program that (a) has undergone [***] or more
[***] of [***] and (b) wherein, using an [***] with [***] of
[***] (i.e., [***] and [***] of the applicable Program Target, at
least [***]% of the input pool of [***] is [***] in the assay by
the Program Target and the [***] fraction of the [***] pool is at
least [***] to the [***] fraction for [***] (i.e., [***]) pool of
[***]. CONFIDENTIAL Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
14
1.66 " Effective
Date " means the date first set forth above.
1.67 " Excepted
Decision " means any of the following decisions requiring
the unanimous approval of all members of the JMC: (a) any
decision as to whether a milestone has been achieved under this
Agreement for which a milestone payment is payable; (b) any
Significant Co-Development Decision made [***] Phase III Clinical
Trials with respect to the Co-Development of a [***] in a [***];
and (c) any disagreement between the Parties on the
appropriate method of determining royalties for a Combination
Product in accordance with Section 5.4.1(f).
1.68 " Excluded Aptamer
" means any Aptamer listed on Schedule 5 .
1.69 " Excluded Target
" means any Target listed on Schedule 2 .
1.70 " Failed Target "
means any Program Target or proposed Program Target as to which the
JPT concludes and the JMC agrees that, after using Commercially
Reasonable Efforts to identify Aptamers, or based on prior
activities of ARCHEMIX, [***] is unable or unlikely to identify
[***] against such Program Target.
1.71 " FDA " means the
United States Food and Drug Administration or any successor agency
or authority thereto. 1.72 "
FDCA " means the United States Federal Food, Drug,
and Cosmetic Act, as amended. 1.73 "
First Commercial Sale " means, with respect to a
Product in a country in the Territory, the first sale, transfer or
disposition for value to an end-user of such Product in such
country. 1.74 " Force
Majeure " means any occurrence beyond the reasonable
control of a Party that (a) prevents or substantially
interferes with the performance by such Party of any of its
obligations hereunder and (b) occurs by reason of any act of
God, flood, fire, explosion, earthquake, strike, lockout, labor
dispute, casualty or accident, or war, revolution, civil commotion,
act of terrorism, blockage or embargo, or any injunction, law,
order, proclamation, CONFIDENTIAL Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
15
regulation, ordinance, demand or requirement of any government
or of any subdivision, authority or representative of any such
government, to the extent and for the duration of such occurrence.
1.75 " FTE " shall mean
[***] hours of work devoted to or in support of the ARCHEMIX
Research Activities or the ARCHEMIX Development Activities that is
carried out by one or more employees, contract personnel or
consultants of ARCHEMIX, measured in accordance with
ARCHEMIX’ time allocation practices from time to time.
1.76 " FTE Cost "
means, for any period, the FTE Rate multiplied by the applicable
number of FTEs in such period. 1.77 "
FTE Rate " means [***] Dollars (US $[***]); provided
that on January 1 of each Calendar Year in the Term, commencing
with January 1, 2007, the FTE Rate will be [***] by
multiplying the FTE Rate applicable on December 31 of the
immediately preceding Calendar Year by [***], where [***] is the
Consumer Price Index for All Urban Consumers in the Boston
Metropolitan Area published by the Bureau of Labor Statistics of
the United States Department of Labor for [***] in the immediately
preceding [***] and [***] is the Consumer Price Index for All Urban
Consumers in the Boston Metropolitan Area published by the Bureau
of Labor Statistics of the United States Department of Labor
(i) for the [***] the Effective Date for the period commencing
on the Effective Date and continuing until the [***] of the [***]
ended [***] and (ii) for each [***] thereafter, for the [***]
in the immediately preceding [***] (e.g. in [***] is [***] as at
[***] and [***] is [***] as at [***]). Any such [***] shall be
rounded to the nearest [***] US Dollars ($[***]).
1.78 " Fully-Exercised
Co-Developed Product " means any Co-Developed Product with
respect to which the ARCHEMIX Co-Development Percentage is [***]
percent ([***]%). 1.79 "
GAAP " means United States generally accepted
accounting principles, consistently applied.
1.80 " Hatch-Waxman Act
" means the Drug Price Competition and Patent Term Restoration Act
of 1984, as amended. 1.81 " HSR
Act " means the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended. CONFIDENTIAL Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
16
1.82 " IL-23 " means
the Program Target designated and defined as IL-23 on Schedule
1 attached hereto. 1.83 "
IL-23 Aptamer " means (a) any Program Aptamer
that binds IL-23 that is identified by performing the SELEX™
Process against IL-23 in the conduct of the Research Program or any
Aptamer Derived therefrom that binds IL-23, and/or (b) any
Aptamer that binds IL-23 that is covered by one or more of the
claims of the IL-23 Patent Applications or any Aptamer that binds
IL-23 Derived therefrom. For purposes of clarity, IL-23 Aptamers
include, without limitation, ARC2350 and all IL-23 Back-Up
Compounds. 1.84 " IL-23 Back_Up
Compounds " means all IL-23 Aptamers other than ARC2350.
1.85 " IL-23 Patent
Applications " means (a) the following patent
applications: (i) United States Patent Application Serial
No. 11/075649; (ii) PCT Patent Application Serial No.
US2005/007666; and (iii) United States Patent Application
Serial No. 11/234676 and (b) all applications,
substitutions, continuations, continuations-in-part, divisions,
renewals, all letters patent granted thereon, and all reissues,
re-examinations and extensions thereof, and all foreign
counterparts of any of the foregoing.
1.86 " IL-23 Product "
means any pharmaceutical or medicinal item, substance or
formulation that contains, incorporates or comprises an IL-23
Aptamer or an Aptamer Derived therefrom that binds specifically to
IL-23. 1.87 " IND "
means: (a) an Investigational New Drug Application as defined
in the FDCA and regulations promulgated thereunder or any successor
application or procedure required to initiate clinical testing of a
Clinical Candidate in humans in the United States; (b) a
counterpart of an Investigational New Drug Application that is
required in any other country or region in the Territory before
beginning clinical testing of a Clinical Candidate in humans in
such country or region; and (c) all supplements and amendments
to any of the foregoing. 1.88
"IND Acceptance " means, with respect to an IND, the
earlier of the receipt of notification of acceptance of such IND
from the FDA or the expiration of thirty (30) days from the
date of filing of such IND with the FDA. CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
17
1.89 " Indication "
means any human disease or condition which can be treated,
prevented, cured or the onset or progression of which can be
delayed and which would require the filing of a separate NDA or
sNDA to obtain Commercialization Regulatory Approval for such
disease or condition. 1.90 "
Initiation " means, with respect to a human clinical
trial, the first date that a subject or patient is dosed in such
clinical trial. 1.91 " In
Vitro Diagnostics " means the use of the SELEX™
Process or Aptamers or PhotoAptamers identified through the use of
the SELEX™ Process in the assay, testing or determination,
outside of a living organism, of a substance in a test material.
In Vitro Diagnostics shall include, among other things, the
use of the SELEX™ Process or Aptamers or PhotoAptamers
identified through the use of the SELEX™ Process in the
assay, testing or determination: (a) outside of a living
organism, (i) of a human substance in a test material, often
to identify or follow the progression of a disease or disorder, or
to select a patient for treatment; (ii) of a plant substance,
animal substance or other substance in a test material, often to
identify or follow the progression of a disease, process, or
disorder in a human or non-human organism; and (iii) of
environmental substances (as in water quality testing); and
(b) of a substance on a test material such as cells (as in
FACS analysis or other measurements of pathogens within biological
samples). 1.92 " In Vivo
Diagnostic Agent " means any product containing one or more
Aptamers that is used for any human in vivo diagnostic
purpose related to ( inter alia ) the identification,
quantification or monitoring of the propensity toward, or actual
existence of, any disease state. 1.93
" Joint Management Committee " or " JMC
" means the committee composed of ARCHEMIX and ELAN representatives
established pursuant to Section 2.1.
1.94 " Joint Patent
Rights " means Patent Rights that contain one or more
claims that cover Joint Technology.
1.95 " Joint Project
Team " or " JPT " means the committee
composed of ARCHEMIX and ELAN representatives established pursuant
to Section 2.2. CONFIDENTIAL Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
18
1.96 " Joint
Technology " means (a) any Program Technology that is
(i) jointly Made by employees of, or consultants to, ELAN and
employees of, or consultants to, ARCHEMIX in the performance of the
Research Program, or (ii) Made solely by employees of, or
consultants to, either Party with the use in a material respect of
any Technology, Patent Rights or Proprietary Materials Controlled
by the other Party or any other Joint Technology; (b) any
Program Aptamer; (c) any Patented Aptamer; and (d) any
Program Technology that relates to Pegylation. For purposes of
clarity, (i) any Program Technology that relates to the
conduct of the SELEX™ Process or the use of the SELEX™
Technology shall not be considered to be Joint Technology, and
(ii) Joint Technology shall not include any IL-23 Aptamers
Made by ARCHEMIX as of the Effective Date, and any Product Derived
from any such IL-23 Aptamers without the use in a material respect
of any Technology, Patent Rights or Proprietary Materials
Controlled by ELAN. 1.97 "
Knowledge " means, with respect to a Party, the
actual knowledge of the chief executive officer or any vice
president of such Party. 1.98 "
Lead Selection Criteria " or " LSC "
means the guideline criteria for selecting Collaboration Compounds
or IL-23 Aptamers that are sufficiently promising to warrant
further research as a Lead Compound, such criteria to be set forth
in the Annual Research Plan with respect to the Program Targets
listed on Schedule 1 as of the Effective Date and/or to
any other Program Target to be included in the Research Program
before any activities with respect to such Program Target are
initiated in the Research Program. For purposes of clarity, the LSC
for a Program Target shall include, at a minimum, binding affinity,
specificity, activity and size criteria but shall not include
animal efficacy, animal toxicology, process development or cost of
goods criteria. 1.99 " Licensed
Patent Rights " means any ARCHEMIX Patent Rights and
ARCHEMIX’ interest in Joint Patent Rights that
(a) contain one or more claims that cover any Collaboration
Aptamer, including its manufacture or its formulation or a method
of its delivery or of its use, or (b) claim inventions that are
necessary for ELAN to exercise the licenses granted to it pursuant
to Sections 7.1.1 and 7.2.1 under the Licensed Patent Rights
described in subsection (a). For purposes of clarity, (a) the
Licensed Patent Rights shall exclude any Patent Rights that relate
to the conduct of the SELEX™ Process and/or the use of the
SELEX™ Technology; (b) the CONFIDENTIAL Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
19
Licensed Patent Rights as of the Effective Date include without
limitation the Patent Rights listed on Schedule 3
attached hereto; and (c) ARCHEMIX shall update
Schedule 3 not less than annually during the Term to
add any additional Patent Rights that become Licensed Patent
Rights. 1.100 " Licensed
Technology " means any ARCHEMIX Technology and
ARCHEMIX’ interest in Joint Technology that (a) relates
to any Collaboration Aptamer, including its manufacture or its
formulation or a method of its delivery or of its use or
(b) is necessary for ELAN to exercise the licenses granted to
it pursuant to Section 7.1.1 and 7.2.1 under the Licensed
Technology described in subsection (a).
1.101 " Made " means
(a) with respect to patentable Technology, discovered,
conceived or first reduced to practice, whether actively or
constructively, and (b) with respect to all other Technology,
first generated, identified, synthesized or developed.
1.102 " Major Market
Country " means [***] of the [***] and [***]For [***] of
[***] the[***] and [***] 1.103 "
NDA " means a New Drug Application, as defined in the
FDCA and regulations promulgated thereunder or any successor
application or procedure required to sell a Product in the United
States. 1.104 " Net
Sales " means the gross amount billed or invoiced by ELAN
or any of its Affiliates or Sublicensees to Third Parties
throughout the Territory for sales or other dispositions or
transfers for value of Products less (i) allowances for normal
and customary trade (including those granted in core distribution
agreements and inventory management agreements), quantity and cash
discounts actually allowed and taken, (ii) transportation,
insurance and postage charges, if paid by ELAN or any Affiliate or
Sublicensee of ELAN and included on any such entity’s bill or
invoice as a separate item, (iii) credits, chargebacks,
rebates, returns pursuant to agreements (including, without
limitation, managed care agreements) or government regulations, to
the extent actually allowed, and (iv) any tax, tariff, customs
duty, excise or other duty or other governmental charge (other than
a tax on income) levied on the sale, transportation or delivery of
Product and actually paid by ELAN, or any of its Affiliates or
Sublicensees. In addition, Net Sales are subject to the following:
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
20
(a) If
ELAN or any of its Affiliates or Sublicensees effects a sale,
disposition or transfer of a Product to a customer in a particular
country other than on customary commercial terms or as part of a
package of products and services (but not in a Combination
Product), the Net Sales of such Product to such customer shall be
deemed to be "the fair market value" of such Product. For purposes
of this subsection (a), "fair market value" shall mean the value
that would have been derived had such Product been sold as a
separate product to another customer in the country concerned on
customary commercial terms.
(b) In
the case of pharmacy incentive programs, hospital performance
incentive program chargebacks, disease management programs, similar
programs or discounts on "bundles" of products, all discounts and
the like shall be allocated among products on the basis on which
such discounts and the like were actually granted or, if such basis
cannot be determined, in proportion to the respective list prices
of such products.
(c) For
purposes of clarity, use of any Product in clinical trials,
pre-clinical studies or other research or development activities,
or disposal or transfer of Products for a bona fide charitable
purpose or purposes of a commercially reasonable sampling program
shall not give rise to any Net Sales.
1.105 " Non-Parenteral
" means all methods of administering a therapeutic substance or
medication to a patient that do not involve puncture of the skin or
any active delivery through the skin through the use of a device.
1.106 " Non-Parenteral
Co-Development Option " means any Co-Development Option for
an IL-23 Product intended to treat any Indication in a
Non-Parenteral formulation. 1.107 "
Non-Parenteral Co-Developed Product " means any
(a) IL-23 Product or (b) IL-23 Aptamer in Development as
a Development Lead or a Clinical Candidate, in either case that is
intended to treat any Indication in a Non-Parenteral formulation
and as to which ARCHEMIX has exercised the Non-Parenteral
Co-Development Option. 1.108 "
Non-Parenteral Option Termination Date " means, with
respect to each potential IL-23 Product Developed to treat any
Indication in a Non-Parenteral formulation, the CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
21
date estimated in good faith by ELAN to be [***] days before the
date of Initiation of the initial Phase II Clinical Trial with
respect to such potential IL-23 Product.
1.109 " Operating Income
(Loss) " has the meaning set forth on
Schedule 4 attached hereto.
1.110 " Option Termination
Date " means a Psoriatic Diseases Option Termination Date
or a Non-Parenteral Option Termination Date.
1.111 " Patent Rights "
means issued patents and pending patent applications (which, for
purposes of this Agreement, include certificates of invention,
applications for certificates of invention and priority rights) in
any country or region, including all provisional applications,
substitutions, continuations, continuations-in-part, divisions,
renewals, all letters patent granted thereon, and all reissues,
re-examinations and extensions thereof, and all foreign
counterparts of any of the foregoing.
1.112 " Patented Aptamer
" means any Aptamer claimed in or covered by Program
Aptamer-Specific Patent Rights. 1.113
" Pegylation " means Technology relating to the
covalent or non-covalent linking of any polyalkylene oxide and/or
polyalkylene ether moiety (including but not limited to
polyethylene glycol and polypropylene glycol) to another compound,
such as an Aptamer. 1.114 "
Permitted Screening Activities " means, [***] to any
[***]any [***] ARCHEMIX [***] to such [***] for [***] for [***] for
the [***] of [***] Aptamers [***] to a [***] a [***]; provided,
however, [***] of a [***] as a [***] be a [***] if and only if (a)
[***] with [***] (i.e., [***] into a [***] ARCHEMIX [***] of any
[***] or [***] as [***] under this [***] or if ARCHEMIX [***]
ARCHEMIX [***] under this [***] or (b) [***] is no [***], ARCHEMIX
[***] ELAN, [***] or [***] in the [***] ELAN, [***] as a[***] for
such [***] 1.115 "
Person " means an individual, sole proprietorship,
partnership, limited partnership, limited liability partnership,
corporation, limited liability company, business trust, joint stock
company, trust, incorporated association, joint venture or similar
entity or organization, including a government or political
subdivision, department or agency of a government.
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
22
1.116 " Phase I Clinical
Trial " means a clinical trial conducted in accordance with
a protocol approved by the JMC, in healthy humans or patients,
which clinical trial is designed to establish the safety, drug-drug
interactions and/or pharmacokinetics of an investigational drug
given its intended use, and to support continued testing of such
drug in Phase II Clinical Trials.
1.117 " Phase II Clinical
Trial " means a clinical trial conducted in patients with a
particular disease or condition in accordance with a protocol
approved by the JMC, which clinical trial is designed to establish
the safety, appropriate dosage and pharmacological activity of an
investigational drug given its intended use, and to initially
explore its efficacy for such disease or condition.
1.118 " Phase III Clinical
Trial " means a pivotal clinical trial conducted in
patients with a particular disease or condition in accordance with
a protocol approved by the JMC, which clinical trial is designed to
ascertain efficacy and safety of an investigational drug for its
intended use and to define warnings, precautions and Adverse Events
that are associated with the Clinical Candidate in the dosage range
intended to be prescribed, with the purpose of preparing and
submitting applications for Regulatory Approval or label expansion
to the pertinent Regulatory Authority in any country.
1.119 " Product " means
any IL-23 Product and/or any Collaboration Product.
1.120 " Product
Commercialization Plan " means, with respect to each
Product, the written plan for the Commercialization of such Product
in the Territory (including, without limitation, expected
manufacturing scale-up, manufacture, formulation and filling
requirements for such Product and a detailed strategy, budget and
proposed timelines), as such plan may be amended or updated.
1.121 " Product
Trademarks " means any trademark or trade name, whether or
not registered, or any trademark application or renewal, extension
or modification thereof, in the Territory, or any trade dress and
packaging, in each case (a) that are applied to or used with
any Product by ELAN and (b) together with all goodwill
associated therewith and promotional materials relating thereto.
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
23
1.122 " Program Aptamer
" means any Program Oligonucleotide that is an Aptamer that
binds a Program Target and that is identified in the performance of
the Research Program or during Development and/or any Aptamer that
binds a Program Target that is Derived from such Program
Oligonucleotide, regardless of its stage of research or
Development, including, without limitation, Lead Compounds and
Clinical Candidates. 1.123 "
Program Aptamer-Specific Patent Rights " means all
Patent Rights that cover only Program Aptamer-Specific Technology.
1.124 " Program
Aptamer-Specific Technology " means any Program Technology
that relates specifically and solely to (i) any Program
Aptamer, IL-23 Aptamer or Product or (ii) the manufacture,
formulation, delivery or use of a Program Aptamer, IL-23 Aptamer or
Product. 1.125 " Program
Oligonucleotide " means the [***] and [***] obtained from
an [***] and [***] and [***] in the performance of [***] against a
[***] that is not a [***]. 1.126 "
Program Technology " means any Technology (including,
without limitation, any new and useful process, method of
manufacture or composition of matter) or Proprietary Materials that
are Made by either Party in the conduct of the Research Program or
the Co-Development of Clinical Candidates and/or Co-Developed
Products. For the avoidance of doubt, Program Technology does not
include, and is not included in, ELAN Background Technology,
ARCHEMIX Background Technology or ELAN Product Technology.
1.127 " Program Target
" means the Targets listed on Schedule 1 , as amended
from time to time in accordance with Section 3.5; provided,
however, that there shall be no more than four (4) Targets
listed on Schedule 1 at any point in time, and each of
these shall be a Target that ELAN reasonably believes based on
publicly available literature or proprietary data has activity in
the Target Selection Field. For purposes of clarity, the term
Program Target shall include as the Target against which the
SELEX™ Process may be performed (a) in the case of a
ligand, (i) the designated ligand and the designated
components or subunits [***] and (ii) [***] to which [***] and the
[***] or [***] of such [***]but [***] any other [***] or other
[***] that [***] with such [***] or [***] or such [***] or [***];
(b) [***] of a [***], (i) the [***] and the [***] or [***] of
such [***], and (ii) a [***] to which [***] and the [***] or
[***] of such [***] but [***] any CONFIDENTIAL Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
24
other [***] or other [***] that [***] a [***] with such [***] or
[***] or such [***] or[***]; (c) [***] of a [***] or [***] of a
[***], (i) the [***], and (ii) a [***] to which [***] and
the [***]or [***] of such [***] but [***] any other [***] or other
[***]that [***] a [***] with such [***] or [***] or such [***] or
[***]; and (d) [***] of a [***] or [***] of a [***], (i) the
[***] or [***], and (ii) a [***] to which [***] and the [***]
or [***] of such [***]but [***] any other [***] or other[***] that
[***] a [***] with such [***] or [***] or such [***] or [***]. By
way of example, the [***] (i) the [***] and [***] and
(ii) the [***] and [***]. 1.128
" Proprietary Materials " means tangible chemical,
biological or physical materials (a) that are furnished by or
on behalf of one Party to the other Party in connection with this
Agreement, whether or not specifically designated as proprietary by
the transferring Party or (b) that are otherwise first Made by
a Party in the conduct of the Research Program or the Development
Program. 1.129 " Psoriatic
Diseases " means psoriatic diseases, including without
limitation psoriasis and psoriatic arthritis.
1.130 " Psoriatic Diseases
Co-Development Option " means any Co-Development Option for
a parenteral formulation of an IL-23 Product intended to treat
Psoriatic Diseases. 1.131 "
Psoriatic Diseases Co-Developed Product " means any
(a) parenteral IL-23 Product or (b) IL-23 Aptamer in
Development as a Development Lead or Clinical Candidate in a
parenteral formulation, in either case that is intended to treat
Psoriatic Diseases and as to which ARCHEMIX has exercised the
Psoriatic Diseases Co-Development Option.
1.132 " Psoriatic Diseases
Option Termination Date " means, with respect to each
parenteral formulation of a potential IL-23 Product Developed for
the treatment of Psoriatic Diseases, the date estimated in good
faith by ELAN to be [***] ([***]) days before the date of
Initiation of the initial Phase II Clinical Trial with respect to
that potential IL-23 Product. 1.133
" Quarter " means the stub period beginning on the
Effective Date and ending on the last day of the calendar quarter
in which the Effective Date falls, and thereafter each successive
period of three (3) consecutive calendar months ending on
March 31, June 30, September 30 or December 31.
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
25
1.134 " Radio
Therapeutic " means any product for human therapeutic use
that contains one or more Aptamers that targets specifically any
diseased tissue, cells or disease-specific molecules or any tissue
or cells which are affected by a disease or located in the close
neighborhood of a disease process and is linked to or incorporates
(a) radionucleotides or (b) any structure or elements
which develop therapeutic effects similar to the effect of linking
or incorporating radionucleotides after submission of any kind of
radiation. 1.135 " Regulatory
Approval " means, with respect to any country or region in
the Territory, any approval or license of any Regulatory Authority
required for the manufacture, use, storage, importation,
exportation, transport, sale or other distribution of a Product for
use in such country or region. 1.136
" Regulatory Authority " means the FDA, or any
counterpart of the FDA outside the United States, or any other
national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other
governmental entity with authority over the distribution,
importation, exportation, manufacture, production, use, storage,
transport, clinical testing or sale of a Product.
1.137 " Regulatory
Filings " means, collectively: (a) all INDs, license
applications, drug master files, applications for designation as an
"Orphan Product(s)" under the Orphan Drug Act, for "Fast Track"
status under Section 506 of the FDCA (21 U.S.C. § 356) or
for a Special Protocol Assessment under Section 505(b)(4)(B)
and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)), NDAs,
BLAs and all other similar filings (including, without limitation,
counterparts of any of the foregoing in any country or region in
the Territory); (b) all supplements and amendments to any of
the foregoing; and (c) all data and other information
contained in, and correspondence relating to, any of the foregoing.
1.138 " Rejected Program
Target " means any Program Target that is rejected by
written notice from ELAN pursuant to Section 3.5.1(a).
1.139 " Research
Program " means the research program to be conducted by the
Parties during the Research Program Term pursuant to the Annual
Research Plan, including but not limited to the identification and
initial testing of Collaboration Compounds and IL-23 Aptamers,
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
26
the selection of Lead Compounds from Collaboration Compounds and
IL-23 Aptamers and the selection of Clinical Candidates from such
Lead Compounds for further Development. For purposes of clarity,
the Research Program does not include any Development activities
performed in the course of the Development Program.
1.140 " Research Program
Term " means, subject to Section 13.2.1(b), the period
beginning on the Effective Date and ending on the last day of the
third Contract Year or such later date as the Parties may mutually
agree in writing; provided, that, if this Agreement is terminated
prior to the end of the Research Program Term, the effective date
of such early termination specified in the termination notice shall
become the last day of the Research Program Term.
1.141 " Royalty-Bearing
Product " means (a) any Product that is not a
Co-Developed Product, (b) any Product contained in a
Combination Product that is not a Co-Developed Product and
(c) any Co-Developed Product to the extent sold outside of a
Co-Development Territory or for an Indication or in a formulation
other than one for which Co-Development occurs.
1.142 " Royalty Term "
means, with respect to each Royalty-Bearing Product in each country
in the Territory, the period beginning on the date of First
Commercial Sale of such Royalty-Bearing Product in such country and
ending on the later to occur of (a) expiration of the last to
expire Valid Claim of the Licensed Patent Rights or ELAN Joint
Product Patent Rights in such country that covers such
Royalty-Bearing Product or its identification, manufacture, use,
import, offer for sale or sale or (b) [***] years from the date of
the First Commercial Sale of such Royalty-Bearing Product in such
country. 1.143 " ROW "
means all countries and territories of the world other than the
United States and its territories and possessions and the Major
Market Countries. 1.144 "
SELEXTM Portfolio " means those
Patent Rights licensed by Gilead to ARCHEMIX pursuant to the
ARCHEMIX-Gilead License Agreement.
1.145 " SELEXTM
Process " means any process for the identification or
generation of a nucleic acid that binds to a Target by means other
than Watson-Crick base-pairing, including without limitation any
such process that (a) is covered by, or is described in, the
SELEX™ Portfolio, including without limitation U.S. Patent
Nos. [***] or [***], (b) is covered by, or is
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
27
described in, any other Patent Rights Controlled by ARCHEMIX,
and (c) any continuations, divisionals and continuations-in
part substitutions, renewals, reissues, re-examinations and
extensions of and improvements to the inventions covered by, or
described in, the foregoing Patent Rights.
1.146 " SELEXTM
Technology " means any process for modifying,
optimizing and/or stabilizing an aptamer wherein such modification,
optimization or stabilization includes, without limitation
minimization, truncation, conjugation other than Pegylation,
complexation, substitution, deletion and/or incorporation of
modified nucleotides. 1.147 "
Serious Adverse Event " means an Adverse Event
occurring at any dose of a drug that: results in death; poses an
immediate risk of death; requires inpatient hospitalization;
results in a persistent and/or significant disability, illness or
incapacity; or results in a congenital anomaly or birth defect. An
Adverse Event that does not fulfill the above criteria nonetheless
may be considered a Serious Adverse Event when, based upon
reasonable medical judgment, it may jeopardize the patient or
subject and may require medical or surgical intervention to prevent
one of the above outcomes. 1.148 "
Significant Co-Development Decision " means (i) [***]
that would [***] be [***] to [***] the [***] of [***] and/or [***]
to be [***]ARCHEMIX[***] a [***] with [***] and (ii) [***] with
[***] to the [***] and [***] of [***] to, the [***] of [***] for,
and [***] and [***] with the [***], such [***] for the [***] and
[***]. 1.149 " sNDA "
means a Supplemental New Drug Application, as defined in the FDCA
and applicable regulations promulgated thereunder.
1.150 " Sublicense
Agreement " means any agreement entered into by ELAN with a
Sublicensee. 1.151 "
Sublicensee " means any Third Party to which a Party
grants a sublicense under the licenses granted to it under
Section 7.1 or 7.2. 1.152 "
Supplemental Product " means a product having
independent, supplementary or enabling therapeutic effect (e.g., as
a catalyst or adjuvant) or diagnostic utility or that has
independent function as a medical device or means of
administration. CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
28
1.153 " Target "
means a protein, cytokine, enzyme, receptor, transducer,
transcription factor, antigen or any other non-nucleic acid
molecule. 1.154 " Target
Selection Field " means the treatment or prevention in
humans of any autoimmune or inflammatory Indication.
1.155 " Technology "
means, collectively, inventions, discoveries, improvements, trade
secrets and proprietary methods, whether or not patentable,
including without limitation: (a) methods of production or use of,
and structural and functional information pertaining to, chemical
compounds and (b) compositions of matter, data, formulations,
processes, techniques, know-how and results (including without
limitation any negative results).
1.156 " Terminated Program
Aptamer " means (a) all Program Aptamers that bind
specifically to any Rejected Program Target, (b) upon any
termination of this Agreement by ARCHEMIX pursuant to
Section 10.2.3 or the first sentence of Section 10.2.2 or
by ELAN pursuant to Section 10.2.1, all Collaboration Aptamers, and
(c) upon any termination of ELAN’s license by ARCHEMIX
pursuant to the last sentence of Section 10.2.2, the relevant
Collaboration Aptamers binding specifically to the Program Target
for which such license is terminated due to failure to meet its
diligence obligations, as provided in Section 10.3.4.
1.157 " Territory "
means all countries and territories of the world.
1.158 " Third Party "
means a Person other than ELAN and ARCHEMIX and their respective
Affiliates. 1.159 " URC License
Agreement " means the Restated Assignment and License
Agreement, dated July 17, 1991, by and between University
Research Corporation and Gilead as successor in interest to
NeXstar. 1.160 " UTC "
means University Technology Corporation, the successor to the
University Research Corporation.
1.161 " Valid Claim "
means any claim of a pending patent application which has been
pending for a period of ten (10) years or less from its
earliest priority filing date or an issued unexpired patent that
(a) has not been finally cancelled, withdrawn, abandoned or
rejected by any CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
29
administrative agency or other body of competent jurisdiction,
(b) has not been permanently revoked, held invalid, or
declared unpatentable or unenforceable in a decision of a court or
other body of competent jurisdiction that is unappealable or
unappealed within the time allowed for appeal, (c) has not
been rendered unenforceable through disclaimer or otherwise, and
(d) is not lost through an interference proceeding.
Additional Definitions
. In addition, each of the following definitions shall have the
respective meanings set forth in the section of this Agreement
indicated below:
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Definition
|
|
Section
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[***] Notice Period
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|
|
4.10.2
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[***] Opportunity Notice
|
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|
4.10.2
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[***]ROFN Notice
|
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4.10.2
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ARCHEMIX Change of Control Notice
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13.2.1
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(a)
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ARCHEMIX Indemnitees
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12.2
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Back-up Collaboration Compound
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3.8.1
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Blocking Third Party Patent
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9.4
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Claims
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12.1
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Clinical Candidate
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3.7
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Co-Development Net Sales
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4.12
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(b)
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Co-Development Option
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4.11.1
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(b)
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Co-Development Option Notice
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4.11.1
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(b)
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Collaboration Manager
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2.2.6
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Dedicated Equipment
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3.3.5
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Designated Senior Officers
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2.1.5
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Disputed Matter
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2.1.5
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Divestment Opportunity Notice
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13.12
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Divestment Opportunity Notice Period
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13.12
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Divestment Opportunity ROFN Notice
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13.12
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ELAN Change of Control Notice
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13.2.2
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(a)
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ELAN Indemnitees
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12.1
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Filing Party
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9.1.4
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50/50 Offset
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5.4.1
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(c)
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Final Offer
|
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13.11
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Gilead Indemnitee
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12.5
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Indemnified Party
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12.5
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Indemnifying Party
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12.3
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Infringement
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9.2.1
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(a)
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Infringement Notice
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9.2.1
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(a)
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Lead Compound
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3.6.2
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Losses
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12.1
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Non-Filing Party
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9.1.4
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CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
30
|
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Definition
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Section
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Non-Parenteral Option Exercise Period
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4.11.1
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(b)
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Patent Coordinator
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8.4
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Proprietary Chemistry
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5.4.1
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(c)
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Psoriatic Diseases Option Exercise Period
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4.11.1
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(b)
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Quarterly Report
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4.12
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R&D Costs
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10.3.6
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Recipient Party
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3.10
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Refunded Products
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4.13
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Roll-Over Payment
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4.11.7
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Supply Agreement
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4.5.2
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Term
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10.1
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Third Party License
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5.4.1
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(c)
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Third Party Payments
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5.4.1
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(c)
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Transferring Party
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3.10
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2. ADMINISTRATION OF THE COLLABORATION
2.1 Joint Management
Committee .
2.1.1
Establishment . ARCHEMIX and ELAN hereby
establish the Joint Management Committee. The JMC shall have and
perform the responsibilities set forth in Section 2.1.4.
2.1.2
Membership . Each Party shall designate, in
its sole discretion, [***] members to the JMC, which shall be
members of its, or its Affiliates’, management. Unless
otherwise agreed by the Parties, one of ELAN’s designees
shall be designated by ELAN as the Chair. Each Party shall have the
right at any time to substitute individuals, on a permanent or
temporary basis, for any of its previously designated
representatives to the JMC, by giving written notice to the other
Party. Initial designees of the Parties to the JMC shall be as
follows:
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For ARCHEMIX:
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Duncan Higgons
Page Bouchard
Chuck Wilson
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For ELAN:
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Ivan Lieberburg
Ted Yednock
Elizabeth Messersmith
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CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
31
2.1.3
Meetings.
(a)
Schedule of Meetings; Agenda . The JMC shall establish a
schedule of times for regular meetings, taking into account the
planning needs of the Collaboration and its responsibilities.
Special meetings of the JMC may be convened by any member upon
[***] days (or, if such meeting is proposed to be conducted by
teleconference, upon [***] days) written notice to the other
members; provided that (i) notice of any such special meeting
may be waived at any time, either before or after such meeting, and
such waiver shall be the equivalent to the giving of a valid notice
hereunder, and (ii) attendance of any member at a special
meeting shall constitute a valid waiver of notice from such member.
In no event shall the JMC meet less frequently than once in each
Calendar Year. Regular and special meetings of the JMC may be held
in person or by teleconference or videoconference; provided that
meetings held in person shall alternate between the respective
offices of the Parties. The Chair shall prepare and circulate to
each JMC member an agenda for each JMC meeting not later than [***]
prior to such meeting.
(b)
Quorum; Voting; Decisions . At each JMC meeting (i) the
presence in person of at least [***] members designated by each
Party shall constitute a quorum. The JMC shall use reasonable
efforts in good faith to resolve by unanimous consent any issue
within its jurisdiction. Alternatively, the JMC may act by written
consent signed by [***] member designated by each Party, subject to
Section 2.1.5. Whenever any action by the JMC is called for
hereunder during a time period in which the JMC is not scheduled to
meet, the chair of the JMC shall cause the JMC to take the action
in the requested time period by calling a special meeting or by
circulating a draft written consent. If the JMC is unable to
unanimously agree with respect to any issue, notwithstanding the
exercise of reasonable efforts, [***] shall have the tie-breaking
vote as stated in Section 2.1.5. Representatives of each Party
or of its Affiliates who are not members of the JMC, and
consultants who are subject to confidentiality obligations no less
stringent than those contained herein, may attend JMC meetings as
non-voting observers with the consent of the other Party, which
shall not be unreasonably withheld, conditioned or delayed.
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
32
(c)
Minutes . The JMC shall keep minutes of its meetings that
record all decisions and all actions recommended or taken in
reasonable detail. Drafts of the minutes shall be prepared and
circulated to the members of the JMC within a reasonable time after
the meeting, not to exceed [***] business days. The chair of the
JMC shall have responsibility for the preparation and circulation
of draft minutes. Each member of the JMC shall have the opportunity
to provide comments on the draft minutes. The minutes shall be
approved, disapproved and revised as necessary at the next JMC
meeting or within [***] days of the meeting, whichever occurs
first. Upon approval, final minutes of each meeting shall be
circulated to the members of the JMC by the chair of the JMC.
(d)
Expenses . ARCHEMIX and ELAN shall each bear all expenses of
their respective JMC members related to their participation on the
JMC and attendance at JMC meetings.
2.1.4
Responsibilities . The JMC shall be responsible for
(a) overseeing the conduct and progress of the Research
Program, and (b) providing a forum for the exchange of
information between the Parties with respect to the Development of
Program Aptamers, Lead Compounds and Clinical Candidates that are,
or are eligible for designation as, Co-Developed Products and the
Co-Development and Commercialization of Co-Developed Products in
the applicable Co-Development Territory(ies), Indication and
formulation; provided however, that the JMC shall not be
responsible for overseeing the Development or Commercialization of
any Products. Without limiting the generality of the foregoing, the
JMC shall have the following responsibilities:
(a) overseeing
the JPT’s performance of its responsibilities;
(b) reviewing
each Annual Research Plan, each Annual Development Plan for
Clinical Candidates eligible for designation as Co-Developed
Products and for Co-Developed Products in the applicable
Co-Development Territory(ies), Indication and formulation, and,
only if ELAN alone (rather than with or through a Sublicensee) is
Commercializing a Co-Developed Product, each Product
Commercialization Plan for a Co-Developed Product in the applicable
Co-Development Territory(ies), Indication and formulation
(including all budgets applicable thereto); provided, that, ELAN
agrees to use Commercially CONFIDENTIAL Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
33
Reasonable Efforts to include the JMC rights set forth in this
Section 2.1.4(b) in each Sublicense Agreement;
(c) approving
any Annual Research Plan;
(d) directing
the preparation of, and reviewing each amendment to, any Annual
Research Plan and/or budget applicable thereto;
(e) approving
any amendment or update to an Annual Research Plan;
(f) reviewing
data, reports or other information submitted to it by the JPT from
time to time;
(g) discussing
the progress of the Commercialization of each Co-Developed Product
in the applicable Co-Development Territory(ies), Indication and
formulation in accordance with the applicable Product
Commercialization Plan, if ELAN alone (rather than with or through
a Sublicensee) is marketing a Co-Developed Product; provided, that,
ELAN agrees to use Commercially Reasonable Efforts to include the
JMC rights set forth in this Section 2.1.4(g) in each
Sublicense Agreement;
(h) resolving
all JPT matters that are in dispute;
(i) reviewing
any proposal of the JPT to nominate any Collaboration Compound or
IL-23 Aptamer as a Lead Compound or any proposal of the JPT to
nominate any Lead Compound as a Clinical Candidate; and
(j) making
such other decisions as may be delegated to the JMC pursuant to
this Agreement or by mutual written agreement of the Parties after
the Effective Date.
2.1.5
Dispute Resolution . The JMC members shall use
reasonable efforts to reach agreement on any and all matters. In
the event that, despite such reasonable efforts, agreement on a
particular matter cannot be reached by the JMC within [***] days
after the JMC first meets to consider such matter (each such
matter, a "Disputed Matter"), then, if the Disputed Matter involves
an ELAN Decision or any matter other than an Excepted Decision or
an ARCHEMIX Decision, and except as set forth in the last sentence
of this section, ELAN shall CONFIDENTIAL Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
34
have the right to make the final decision on such Disputed
Matter, but shall only exercise such right in good faith using its
commercially reasonable discretion after consideration of the
positions of both Parties. Notwithstanding the foregoing,
(i) if the Disputed Matter involves an ARCHEMIX Decision, then
ARCHEMIX shall have the right to make the final decision on such
Disputed Matter but shall only exercise such right in good faith
using its commercially reasonable discretion after consideration of
the positions of both Parties, and (ii) if the Disputed Matter
involves an Excepted Decision, the Chair of the JMC shall refer
such Disputed Matter to the President of ARCHEMIX and the President
(US) of ELAN (the "Designated Senior Officers"), who shall
promptly initiate discussions in good faith to resolve such
Disputed Matter. If the Disputed Matter is not resolved by the
Designated Senior Officers within thirty (30) days after the
date the Designated Senior Officers first met to consider such
Disputed Matter or sixty (60) days after the date the JMC
first met to consider such Disputed Matter, then subject to
Section 13.1, either Party may seek any remedy, at law or in
equity, that may be available. For purposes of clarity, under no
circumstances shall the determination of whether ELAN or ARCHEMIX
has used or is using Commercially Reasonable Efforts be submitted
for resolution under this Section 2.1.5.
2.2 Joint Project Team
.
2.2.1
Establishment . ARCHEMIX and ELAN hereby establish
the Joint Project Team. The JPT shall have and perform the
responsibilities set forth in Section 2.2.4.
2.2.2
Membership . Each Party shall designate, in its sole
discretion, [***] members to the JPT (which members shall be
employees or consultants of such Party or an Affiliate of such
Party). Unless otherwise agreed by the Parties, one of
ARCHEMIX’ designees shall be designated by ARCHEMIX as the
chair of the JPT. Each Party shall have the right at any time to
substitute individuals, on a permanent or temporary basis, for any
of its previously designated representatives to the JPT, by giving
written notice to the other Party. Initial designees of the Parties
to the JPT shall be as follows:
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For ARCHEMIX:
|
|
Shannon Pendergrast
Sharon Cload
Page Bouchard (Chair)
|
CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
35
|
|
|
|
|
|
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For ELAN:
|
|
Nicki Vasquez
Brian Wipke
Jane Gunther
|
2.2.3
Meetings.
(a)
Schedule of Meetings; Agenda . The JPT shall establish a
schedule of times for regular meetings, in no event less frequently
than once per [***] taking into account, without limitation, the
planning needs of the Research Program and its responsibilities. In
addition, special meetings may be convened by any member upon [***]
days (or, if such meeting is proposed to be conducted by
teleconference, upon [***] days) written notice to the other
members; provided that (i) notice of any such special meeting
may be waived at any time, either before or after such meeting, and
such waiver shall be the equivalent to the giving of a valid notice
hereunder, and (ii) attendance of any member at a special
meeting shall constitute a valid waiver of notice from such member.
Regular and special meetings of the JPT may be held in person or by
teleconference or videoconference; provided that meetings held in
person shall alternate between the respective offices of the
Parties. The Chair shall prepare and circulate to each JPT member
an agenda for each JPT meeting no later than [***] prior to such
meeting.
(b)
Quorum; Voting; Decisions . At each JPT meeting,
(i) the presence in person of at least [***] members
designated by each Party shall constitute a quorum and
(ii) all members designated by each Party who are present
shall have [***] on all matters before the JPT at such meeting. All
decisions of the JPT shall be made by unanimous vote.
Alternatively, the JPT may act by written consent signed by at
least [***] members designated by each Party. Whenever any action
by the JPT is called for hereunder during a time period in which
the JPT is not scheduled to meet, the Chair shall cause the JPT to
take the action in the requested time period by calling a special
meeting or by circulating a written consent. Representatives of
each Party or of its Affiliates who are not members of the JPT
(including, without limitation, the Patent Coordinators) may attend
JPT meetings as non-voting observers without the consent of the
other Party. In the event that the JPT is unable to resolve any
matter before it, such matter shall be referred to the JMC to be
resolved in accordance with Section 2.1.5.
(c)
Minutes . The JPT shall keep minutes of its meetings that
record all decisions and all actions recommended or taken in
reasonable detail. Drafts of the minutes CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
36
shall be prepared and circulated to the members of the JPT
within a reasonable time after the meeting, not to exceed [***]
business days. The chair shall have responsibility for the
preparation and circulation of draft minutes. Each member of the
JPT shall have the opportunity to provide comments on the draft
minutes. The minutes shall be approved, disapproved and revised as
necessary at the next JPT meeting. Upon approval, the chair of the
JPT shall circulate final minutes of each meeting to the members of
the JPT.
(d)
Expenses . ARCHEMIX and ELAN shall each bear all expenses of
their respective JPT members related to their participation on the
JPT and attendance at JPT meetings.
2.2.4
Responsibilities . The JPT shall be responsible for
(i) overseeing the conduct and progress of the Research
Program and (ii) recommending Program Aptamers to the JMC for
nomination as Lead Compounds and Clinical Candidates. Without
limiting the generality of the foregoing, the JPT shall have the
following responsibilities:
(a) preparing
or directing the preparation of, and recommending to the JMC for
its approval, all Annual Research Plans and budgets therefor;
(b) preparing
or directing the preparation of all amendments to JMC-approved
Annual Research Plans as it deems appropriate in furtherance of the
objectives of the Research Program as set forth in the Annual
Research Plan and submitting such amendments to the JMC for its
consideration;
(c) monitoring
the progress of each Annual Research Plan and of each Party’s
activities thereunder;
(d) providing
a forum for consensual decision making with respect to the Research
Program;
(e) reviewing
data, reports or other information submitted by either Party with
respect to work conducted in the Research Program;
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
37
(f) preparing
for the JMC on at least a semi-annual basis a progress report for
the Research Program in reasonable detail and providing to the JMC
such additional information as it may request;
(g) recommending
amendments to the Lead Selection Criteria and Clinical Candidate
Selection Criteria as it deems appropriate, in furtherance of the
objectives of the Research Program as set forth in the Research
Plan;
(h) considering
the need for, and recommending as appropriate, the identification
and research of Back-Up Collaboration Compounds;
(i) nominating
Collaboration Compounds or IL-23 Aptamers as Lead Compounds for
acceptance by the JMC;
(j) nominating
Lead Compounds as Clinical Candidates for acceptance by the JMC;
(k) discussing
all Annual Development Plans for Co-Developed Products in the
applicable Co-Development Territory(ies), Indication and
formulation;
(l) discussing
all amendments to the Annual Development Plans described in
Section 2.2.4(k), above and submitting such amendments to the
JMC for its consideration;
(m) reviewing
data, reports or other information submitted by either Party with
respect to work conducted in the Development of Clinical Candidates
that are, or are eligible for designation as, Co-Developed
Products;
(n) preparing
for the JMC on at least an annual basis a reasonably detailed
progress report regarding the Development of Development Leads and
Clinical Candidates that are, or are eligible for designation as,
Co-Developed Products in the applicable Co-Development
Territory(ies), Indication and formulation and providing to the JMC
such additional information as it may reasonably request on this
subject; CONFIDENTIAL Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
38
(o) implementing
a mutually acceptable mechanism for reporting Adverse Events
between the Parties for each Development Lead, Clinical Candidate
and Product;
(p) discussing
strategies for the promotion and marketing of all Co-Developed
Products in the applicable Co-Development Territory(ies),
Indication and formulation if ELAN alone (rather than with or
through a Sublicensee) is or will be promoting and marketing a
Co-Developed Product; provided, that, ELAN agrees to use
Commercially Reasonable Efforts to include the JPT rights set forth
in this Section 2.2.4(p) in each Sublicense Agreement;
(q) discussing
the Product Commercialization Plan for each Co-Developed Product in
the applicable Co-Development Territory(ies), Indication and
formulation, if ELAN alone (rather than with or through a
Sublicensee) is or will be Commercializing a Co-Developed Product;
provided, that, ELAN agrees to use Commercially Reasonable Efforts
to include the JPT rights set forth in this Section 2.2.4(q)
in each Sublicense Agreement;
(r) discussing
the short-term and long-term sales forecasts for Co-Developed
Products in the applicable Co-Development Territory(ies),
Indication and formulation if ELAN alone (rather than with or
through a Sublicensee) is or will be Commercializing a Co-Developed
Product; provided, that, ELAN agrees to use Commercially Reasonable
Efforts to include the JPT rights set forth in this
Section 2.2.4(r) in each Sublicense Agreement;
(s) discussing
all recalls, market withdrawals and any other corrective actions
related to Co-Developed Products in the applicable Co-Development
Territory(ies), Indication and formulation; and
(t) making
any other decisions and performing such activities as may
reasonably be delegated to the JPT pursuant to this Agreement or by
mutual written agreement of the Parties after the Effective Date.
2.2.5
Interests of the Parties . Notwithstanding any other
provisions of this Agreement, all decisions made and all actions
taken by the JPT shall be made or taken in the best interest of the
Collaboration. CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
39
2.2.6
Alliance Management . Each Party shall appoint a
person who shall oversee contact between the Parties for all
matters related to the Collaboration between meetings of the JMC
and JPT and shall have such other responsibilities as the Parties
may mutually agree in writing after the Effective Date (each, a
"Collaboration Manager"). Each Party may replace its Collaboration
Manager at any time by notice in writing to the other Party. The
initial Collaboration Managers shall be:
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For ARCHEMIX:
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Page Bouchard
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For ELAN:
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Brian Wipke
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3. RESEARCH PROGRAM
3.1 Implementation of the
Research Program . The objectives of the Research Program
shall be the identification of (i) Collaboration Compounds or
IL-23 Aptamers for nomination by the JPT to the JMC for approval as
Lead Compounds and (ii) Lead Compounds for recommendation by
the JPT to the JMC as Clinical Candidates for Development with a
view to the subsequent Commercialization of Products Derived
therefrom. Except for the ELAN Research Activities, if any, which
shall be conducted by ELAN at its sole expense, ARCHEMIX shall
conduct the Research Program. 3.2
Research Plan; Annual Research Plans . The initial
Annual Research Plan and budget, which describes the research
activities to be carried out by each Party during the first
Contract Year of the Research Program Term, shall be prepared by
the JPT, submitted to the JMC for its approval and attached hereto
as Exhibit A within [***] days of the Effective Date.
For each Contract Year during the Research Program Term commencing
with the second Contract Year, an Annual Research Plan and budget
shall be prepared by or at the direction of the JPT and submitted
to the JMC for its approval. The JPT shall manage the preparation
of each Annual Research Plan in a manner designed to obtain JMC
approval no later than [***] days prior to the end of the
then-current Contract Year. Each Annual Research Plan shall:
(a) set forth (i) the research objectives and activities
to be performed for the Contract Year covered by the Annual
Research Plan with reasonable specificity, (ii) the research
plans and protocols to be employed to complete each stage of the
Research Program, (iii) changes to the LSC, CCSC and
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
40
other criteria or changes thereto that the JPT will utilize to
evaluate the results of the Research Program to nominate Lead
Compounds and Clinical Candidates, (iv) the Party that shall
be responsible for performing such activities, (v) a timeline
and budget for such activities, and (vi) with respect to ARCHEMIX
Research Activities and ELAN Research Activities, the number of
FTEs estimated to be required to perform such activities and the
corresponding FTE Cost for such activities; and (b) shall be
consistent with the other terms of this Agreement. Without limiting
the generality of the foregoing, the objectives of each Annual
Research Plan shall include, as appropriate from time to time
during the Research Program Term, conducting the necessary research
activities to identify Collaboration Compounds or IL-23 Aptamers or
to determine whether Collaboration Compounds, IL-23 Aptamers or
Lead Compounds should be nominated to the JMC as Lead Compounds or
Clinical Candidates, as applicable.
Except as provided in
Section 5.2.1, ELAN shall fund a minimum of [***] ARCHEMIX
FTEs in the aggregate during the three (3) year Research
Program Term. Unless otherwise agreed by the Parties, the annual
distribution of ARCHEMIX FTEs funded by ELAN shall equal the
ARCHEMIX Annual FTE Commitment. The JPT shall have the right to
increase the number of FTEs to be provided by ARCHEMIX for any
Contract Year; provided, that, any increase, at ELAN’s
request, in excess of the ARCHEMIX Annual FTE Commitment for any
Contract Year shall be an ARCHEMIX Decision. Any Annual Research
Plan may be amended from time to time by the JPT and submitted for
approval by the JMC pursuant to 2.1.4. Each amendment, modification
and update to the Annual Research Plan shall include the resulting
changes to the budget and shall be set forth in a written document
prepared by, or at the direction of, the JPT and approved by the
JMC, shall specifically state that it is an amendment, modification
or update to the Annual Research Plan and shall be attached to the
minutes of the meeting of the JMC at which such amendment,
modification or update was approved by the JMC. Without limiting
the nature or frequency of any other amendments, modifications or
updates to the Research Plan that may be approved by the JMC, the
Annual Research Plan shall be updated at least once prior to the
end of each Contract Year to describe the research activities to be
carried out by each Party during the following Contract Year during
the Research Program Term in conducting the Research Program
pursuant to this Agreement. CONFIDENTIAL Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
41
3.3 Conduct of Research
Program .
3.3.1
ARCHEMIX Responsibilities . During the Research
Program Term, ARCHEMIX shall, subject to the provisions of
Section 1.16, (a) use Commercially Reasonable Efforts to
conduct the ARCHEMIX Research Activities assigned to it, using the
number of FTEs set forth in the Annual Research Plan and
(b) commit such resources other than personnel as are
reasonably necessary to conduct such ARCHEMIX Research Activities.
In the event that ARCHEMIX reasonably concludes in good faith that
a Program Target may be a Failed Target, ARCHEMIX shall provide
written notice to the JPT within [***] days of reaching such
conclusion, providing bona fide scientific evidence in support of
such conclusion. The JPT shall discuss the data and information
generated with respect to such Program Target, and shall determine
whether such Program Target shall be proposed to the JMC for
designation as a Failed Target, as described in Section 3.9.
3.3.2
ELAN Responsibilities . During the Research Program
Term, ELAN shall (a) pay ARCHEMIX the FTE Rate per FTE per
Contract Year in accordance with Section 5.2, (b) commit
such resources as are reasonably necessary to conduct the ELAN
Research Activities set forth in the Annual Research Plan, and
(c) use Commercially Reasonable Efforts to conduct the ELAN
Research Activities set forth in the Annual Research Plan.
3.3.3
Compliance and Funding . Each Party shall perform its
obligations under each Annual Research Plan and this Agreement
using Commercially Reasonable Efforts in good faith and in
compliance in all material respects with all Applicable Laws. For
purposes of clarity, with respect to each activity performed under
an Annual Research Plan or Annual Development Plan that will or
would reasonably be expected to generate data to be submitted to a
Regulatory Authority in support of a Regulatory Filing or Drug
Approval Application, the Party performing such activity shall
comply in all material respects with the regulations and guidance
of the FDA that constitute Good Laboratory Practice or Good
Manufacturing Practice (or, if and as appropriate under the
circumstances, International Conference on Harmonization
(ICH) guidance or other comparable regulation and guidance of
any Regulatory Authority in any country or region in the
Territory). Each Party shall be solely responsible for paying the
salaries CONFIDENTIAL Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
42
and benefits of its employees and amounts due to consultants
conducting its activities under Annual Research Plans.
3.3.4
Cooperation . Scientists at ARCHEMIX and ELAN shall
cooperate in the performance of the Research Program and, subject
to the terms of this Agreement and any confidentiality obligations
to Third Parties, shall exchange such data, information and
materials as are reasonably necessary or useful for the other Party
to perform its obligations under any Annual Research Plan.
3.3.5
Purchase of Dedicated Equipment . If, during the Term
of this Agreement, ELAN determines in its sole discretion that it
is necessary or advisable to purchase Dedicated Equipment in order
for ARCHEMIX to perform any ARCHEMIX Research Activities under the
Research Program, then ELAN shall provide ARCHEMIX with written
notice of such determination, and ARCHEMIX shall provide ELAN with
the estimated price for such purchase and quality parameters for
such Dedicated Equipment, for ELAN’s approval of such price
and features. Promptly after the consummation of such purchase, if
approved, ARCHEMIX shall provide ELAN with a copy of the invoice or
invoices reflecting such purchase, and ELAN shall reimburse
ARCHEMIX for the purchase of all such Dedicated Equipment within
thirty (30) days of its receipt of such invoice; provided,
however, that no costs reimbursed by ELAN hereunder (or
depreciation of such purchased equipment or instruments) shall be
included within the calculation of any Development Costs under this
Agreement. ELAN shall retain title and ownership of all such
Dedicated Equipment and, at its expense upon reasonable notice to
ARCHEMIX, shall have the right to remove such Dedicated Equipment
from ARCHEMIX’ facilities, at such time as such Dedicated
Equipment is no longer required for use by ARCHEMIX in the conduct
of the Research Program. As used in this section, "Dedicated
Equipment" means any equipment, instrument or machinery used by
ARCHEMIX exclusively in the conduct of the Research Program.
3.4 Records.
3.4.1
Record Keeping. CONFIDENTIAL Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
43
(a)
Research Program Records . Each Party shall maintain
complete and accurate records of its activities in the Research
Program in sufficient detail, in good scientific manner and
otherwise in a manner that reflects all work done and results
achieved. Subject to Article 6, each Party shall provide the
other Party with access during normal business hours and upon
reasonable advance notice to inspect and copy such records,
including without limitation laboratory notebooks, to the extent
reasonably required for the performance of the requesting
Party’s obligations and/or exercise of the requesting
Party’s rights under this Agreement, provided that the
audited Party may redact information not relevant to the Research
Program prior to such audit. Notwithstanding the foregoing, except
for purposes of the information-sharing and cooperation provisions
of Articles 8 and 9, ELAN shall not have the right to audit or copy
any records that relate to work done on any Terminated Program
Aptamer after the date that an Aptamer or Collaboration Compound
has become a Terminated Program Aptamer.
(b)
Record-Keeping Policies . Without limiting the generality of
Section 3.4.1(a), each Party agrees to maintain a policy that
requires its employees and consultants to record and maintain all
data and information developed during the Research Program.
3.4.2
Reports . ARCHEMIX shall keep the JPT regularly
informed of the progress of the Research Program. Without limiting
the generality of the foregoing, ARCHEMIX shall, at least once each
[***] during the Research Program Term, (a) provide reports to
the JPT in reasonable detail regarding the status of its activities
under the Research Program, (b) advise the JPT of its
identification of Collaboration Compounds and IL-23 Aptamers and
provide the JPT with any supporting data applicable to such
Collaboration Compounds and IL-23 Aptamers, (c) provide the
JPT with the results of activities conducted in the Research
Program with respect to each Collaboration Compound and IL-23
Aptamer so as to enable the JPT to determine whether such
Collaboration Compound or IL-23 Aptamer meets the LSC and should be
proposed to the JMC as a Lead Compound, (d) provide the JPT
with the results of activities conducted in the Research Program
with respect to each Lead Compound so as to enable the JPT to
determine whether such Lead Compound meets the CCSC and should be
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
44
proposed to the JMC as a Clinical Candidate and (e) provide
to the JPT such additional information that it has in its
possession as may be reasonably requested from time to time by the
JPT. ELAN shall provide the JPT, on at least a [***], with reports
in reasonable detail regarding the status of all ELAN Research
Activities and such additional information that it has in its
possession as may be reasonably requested from time to time by the
JPT. 3.5 Selection of Program
Targets.
3.5.1
Selection of Program Targets.
(a)
Selection and Rejection of Program Targets . The Parties
hereby acknowledge that (i) three (3) initial Program
Targets in addition to IL-23 have been designated by the Parties as
of the Effective Date, and (ii) the Research Program will
initially include work on IL-23 and [***] as Program Targets, as
set forth in the Annual Research Plan. If, at any time during the
Research Program Term, ELAN decides that it wishes to replace a
Program Target with another Target, then (a) it shall provide
written notice of such decision to ARCHEMIX, which notice shall
state the reason for ELAN’s decision, (b) all activities
with respect to such Program Target under the Research Program
shall immediately cease, and (c) such Program Target shall be
deemed to be a Rejected Program Target as of the date of such
written notice.
(b)
Replacement of Program Targets .
(i)
Replacement Right . ELAN shall have the right at any time
during the Research Program Term to propose that any additional
Target that ELAN reasonably believes based on published literature
or proprietary data is useful within the Target Selection Field and
that is not an Excluded Target replace a Program Target, by
providing written notice to ARCHEMIX. ARCHEMIX shall accept or
refuse the additional Target within [***] days after receipt of
such notice from ELAN. A Target proposed by ELAN for inclusion in
the Research Program shall only be refused by ARCHEMIX in good
faith, and only if: (1) it is an [***], (2) ARCHEMIX is
prohibited by an executed contract from licensing Aptamers against
such Target to ELAN, subject to the procedure set forth in the
definition of ARCHEMIX Decision (Section 1.16(e)),
(3) ARCHEMIX is in active negotiations, as[***] by [***] with
a Third Party with respect to a license, collaboration or similar
agreement relating to Aptamers against such Target,
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
45
(4) ARCHEMIX is developing, and has not ceased developing,
for its own benefit, Aptamers against such Target as [***] by the
[***] of the [***] such [***] ARCHEMIX’ [***] (or [***]) of
the [***] of such [***], or (5) it is a [***]. As promptly as
practicable after designation of a new Program Target or the
decision to initiate research on a Program Target listed on
Schedule 4 as of the Effective Date, the JPT shall
(A) develop and submit to the JMC for its approval the LSC and
CCSC for such Target and (B) prepare an update to the Annual
Research Plan to include the ARCHEMIX Research Activities to be
conducted to identify Collaboration Compounds against such Program
Target for potential nomination as a Lead Compound and to identify
one or more Lead Compounds against such Program Target for
potential nomination as a Clinical Candidate.
(ii)
Designation by ELAN . At the time of nomination of a new or
replacement Program Target, ELAN shall (a) designate the
Program Target (describing the applicable ligand, receptor and any
subunits [***]) to be [***] in [***]the [***], such [***] to be
[***] on [***] in the[***] or [***] ELAN, and (b) [***]
ARCHEMIX’ [***] ARCHEMIX [***] ELAN [***] in [***] such [***]
such [***] and any [***] and [***]). In [***], if [***] the [***]
of a [***] and its [***] or [***], ELAN [***] on [***] or [***]
that the [***] other [***] or [***], ELAN [***] ARCHEMIX [***]
which [***] such [***] or [***] and (b) [***] ARCHEMIX’ [***]
the [***] upon [***] ELAN [***] in [***] such [***] or [***]
ARCHEMIX’ [***] of such [***], such [***] or [***] shall be
[***] to be [***] of the [***]such [***] or [***] may be [***]
ARCHEMIX [***]Section 3.5.1(b). [***] to the [***],
ARCHEMIX’ [***] of the [***] such [***] or [***] to the
[***]ELAN’s [***] shall not be [***] to be a [***] of this
[***].
(iii)
Release of Restrictions . ARCHEMIX shall give ELAN prompt
written notice during the Research Program Term if the restrictions
on any Excluded Target described in Sections 3.5.1(b)(i)(1)(2)(3)
or (4) lapse, or are otherwise terminated, such that the
previously refused Target becomes eligible for inclusion as a
Program Target.
(iv)
Termination of Replacement Right . Notwithstanding anything
to the contrary in this Agreement, ELAN’s right to replace
Program Targets pursuant to Section 3.5.1(b)(i) shall
terminate on the [***] of [***] of the [***] by [***] of the [***].
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
46
3.5.2
Limitation on Number of Program Targets . ARCHEMIX
shall not be required to work on more than [***] Program Targets
(including IL-23) at any given time during the Research Program
Term; provided, that (a) any Program Target that becomes a
[***] or [***] shall not be counted as a Program Target for
purposes of this limitation, and (b) this Section 3.5.2
shall not limit or otherwise affect ARCHEMIX’ obligation to
consider in good faith using its commercially reasonably discretion
any request of ELAN to work on additional Program Targets and/or
apply additional resources to the Research Program beyond those
contemplated by the Annual Research Plan.
3.6 Identification of
Collaboration Compounds, IL-23 Aptamers and Lead Compounds
.
3.6.1
Identification of Program Oligonucleotides . ARCHEMIX
shall use Commercially Reasonable Efforts in good faith to perform
the SELEX™ Process to identify Program Oligonucleotides in
accordance with each Annual Research Plan, as amended.
3.6.2
Lead Compounds . Within [***] days after its receipt
of each report from ARCHEMIX identifying a Collaboration Compound
or IL-23 Aptamer which ARCHEMIX reasonably believes meets the
applicable LSC (or which ARCHEMIX otherwise reasonably believes
should be a Lead Compound), the JPT shall review the data and
information and determine whether to nominate the Collaboration
Compound or IL-23 Aptamer for designation by ELAN as a Lead
Compound. Once the JPT has reached a decision regarding nomination
of any such Collaboration Compound or IL-23 Aptamer as a Lead
Compound, the JPT shall promptly furnish all available information
to ELAN. ELAN shall consider such nomination within [***] days, and
if ELAN determines that the Collaboration Compound or IL-23 Aptamer
meets the LSC or is otherwise acceptable and so advises ARCHEMIX in
writing, such Collaboration Compound or IL-23 Aptamer shall be
designated a "Lead Compound" for purposes of this Agreement. As of
the Effective Date, the ARC2350 Aptamer shall be deemed to be a
Lead Compound. 3.7 Clinical
Candidates . Within [***] days after its receipt of each
report from ARCHEMIX identifying a Lead Compound which ARCHEMIX
reasonably believes meets the applicable CCSC (or which ARCHEMIX
otherwise reasonably believes should be a candidate
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
47
for Development), the JPT shall review the data and information
and determine whether to nominate the Lead Compound for designation
as a Clinical Candidate. Once the JPT has reached a decision
regarding nomination of any such Lead Compound, the JPT shall
promptly furnish all available information to ELAN. ELAN shall
consider such nomination within [***] days, and if ELAN determines
that the Lead Compound meets the CCSC or is otherwise acceptable to
ELAN and so advises ARCHEMIX in writing, such Lead Compound shall
be designated a "Clinical Candidate" for purposes of this
Agreement. 3.8 Identification of Back-up Collaboration
Compounds .
3.8.1
Back-Up Collaboration Compounds . Subject to the
terms set forth in the definition of ARCHEMIX Decision, for each
Lead Compound or Clinical Candidate approved by ELAN or the JMC, as
applicable, upon the written request of ELAN, ARCHEMIX will use
Commercially Reasonable Efforts to conduct ARCHEMIX Research
Activities in order to deliver to ELAN [***] Aptamers, in [***] to
the [***] or [***], which may be [***] as a [***] Aptamer [***] the
[***] Aptamers [***] in [***] from such [***] or [***] Aptamer, a
[***] All activities conducted by ARCHEMIX to identify each Back-Up
Collaboration Compound shall be performed as ARCHEMIX Research
Activities as part of the Research Program and the Annual Research
Plan shall be amended accordingly. The rights and obligations of
the Parties relating to each Back-Up Collaboration Compound shall
be identical to those applicable to the accompanying Lead Compound
or Clinical Candidate, except as may be otherwise expressly
provided herein.
3.8.2
Back-Up Notices . ELAN shall notify ARCHEMIX in
writing in the event ELAN determines to replace a Lead Compound or
Clinical Candidate with the applicable Back-Up Collaboration
Compound or to Develop the Back-Up Collaboration Compound in
addition to the Lead Compound or Clinical Candidate. Subsequent to
such notice, any reference to the Lead Compound or Clinical
Candidate shall be deemed (as applicable) either to include, or to
be made to, the Back-Up Collaboration Compound for the purposes of
this Agreement. 3.9 Failed
Targets . If at any time during the Research Program the
JPT determines, and the JMC agrees, that a Program Target shall be
designated as a Failed Target, all research activities directed to
such Failed Target shall cease, and ELAN shall, to the extent and
as CONFIDENTIAL Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
48
provided for in Section 3.5, select a new Program Target,
and such Failed Target shall no longer be considered a part of the
Research Program. 3.10 Supply
of Proprietary Materials . From time to time during the
Research Program Term, either Party (the "Transferring Party") may
supply the other Party (the "Recipient Party") with Proprietary
Materials Controlled by the transferring Party for use in the
Research Program. Each Recipient Party hereby agrees that
(a) it shall not use the other party’s Proprietary
Materials for any purpose other than exercising its rights or
performing its obligations hereunder; (b) it shall use such
Proprietary Materials only in compliance with all Applicable Laws;
(c) it shall not transfer any such Proprietary Materials to
any Third Party without the prior written consent of the
Transferring Party, except as expressly permitted in this
Agreement; (d) the Recipient Party shall not acquire any
right, title or interest in or to such Proprietary Materials solely
as a result of such supply by the Transferring Party; and
(e) upon the expiration or termination of the Research Program
Term, the Recipient Party shall, if and as instructed by the
Transferring Party, either destroy or return any such Proprietary
Materials that are not the subject of the grant of a continuing
license hereunder. 3.11
Research Program Term . The Research Program shall
commence on the Effective Date and shall continue until the last
day of the Research Program Term. In the event ELAN decides to seek
an extension of the Research Program beyond the third Contract
Year, it will promptly notify ARCHEMIX. ELAN will use commercially
reasonable efforts to make any such decision and notify ARCHEMIX at
least [***] months prior to the end of the then-current Research
Program Term. 4. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF
PRODUCTS [***] 4.1
Objectives of the Development Program . The
objectives of the Development Program shall be the Development of
Clinical Candidates to enable the Commercialization of Products in
the Territory. 4.2
Responsibility for Development of Clinical Candidates and
Commercialization of Products . Except for the ARCHEMIX
Development Activities, if any, to be conducted by ARCHEMIX and
subject to Section 4.11.1(c), ELAN shall have the sole right
CONFIDENTIAL Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
49
and responsibility (subject to Sections 4.6 and 7.3), at
its sole expense, to conduct all aspects of the Development of Lead
Compounds and Clinical Candidates in accordance with the applicable
Annual Development Plan, and all aspects of the Commercialization
of Products in accordance with the applicable Product
Commercialization Plan, in the Territory, including, without
limitation, the conduct of: (i) all IND-enabling non-clinical
studies that are outside of the Research Program; (ii) all
activities related to human clinical trials (including, without
limitation, Phase I Clinical Trials, Phase II Clinical Trials and
Phase III Clinical Trials); (iii) subject to ARCHEMIX’ rights
under Section 4.5, all activities relating to the manufacture
and supply of Clinical Candidates and Products (including all
required process development and scale up work with respect
thereto) for Development and Commercialization purposes; and
(iv) all pre-marketing, marketing, promotion, sales,
distribution, import and export activities (including securing
reimbursement, conducting sales and marketing activities, recalls,
withdrawals, any post-marketing trials or post-marketing safety
surveillance, and maintaining databases) for Products, subject to
the oversight of the JPT. Without limiting the generality of the
foregoing, ELAN shall have the sole right and responsibility
(subject to Section 4.6), at its sole expense, (i) to
make all Regulatory Filings for Clinical Candidates and Products
and file all Drug Approval Applications and otherwise seek
Regulatory Approvals for Products, as well as to conduct all
correspondence and communications with Regulatory Authorities
regarding such matters and (ii) to report Adverse Events to
Regulatory Authorities if and to the extent required by Applicable
Laws. All Regulatory Approvals for Products shall be owned by ELAN,
subject to Section 10.3 and 10.4.
4.3 Annual Development
Plans . Subject to Section 4.11.1(c), within [***]
days after the designation pursuant to Section 3.7 of a
Clinical Candidate eligible for designation as a Co-Developed
Product, ELAN shall prepare an Annual Development Plan and budget
for Development of such Clinical Candidate for the balance of the
Contract Year during which the recommendation of such Clinical
Candidate is approved. Thereafter, for each Contract Year during
the Term in which such Clinical Candidate is so eligible, and for
each Co-Developed Product in the applicable Co-Development
Territory, Indication and formulation, ELAN shall prepare and
submit to the JMC for its review, an Annual Development Plan and
Development CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
50
budget for each Clinical Candidate and/or Co-Developed Product.
Each Annual Development Plan shall: (a) set forth (i) the
Development objectives, activities, priorities, timelines, budget
and resources for the Contract Year covered by the Annual
Development Plan with reasonable specificity, (ii) which
activities are ARCHEMIX Development Activities, (iii) with
respect to such ARCHEMIX Development Activities, the number of FTEs
estimated to be required to perform such activities and the
corresponding FTE Cost, and (iv) the expected Regulatory
Filings and Drug Approval Applications to be prepared and filed and
the expected timetable of completing such Development activities;
and (b) be consistent with the other terms of this Agreement.
The initial Annual Development Plan shall be prepared by ELAN and
submitted to the JMC for its review within [***] days of the day on
which the JMC approves the selection of a Clinical Candidate based
on a Lead Compound and in any event, on or prior to the initiation
of Development activities with respect to the initial Clinical
Candidate. Each amendment, modification and update to any such
Annual Development Plan shall include the resulting changes to the
budget and shall be set forth in a written document prepared by
ELAN and submitted to the JMC, shall specifically state that it is
an amendment, modification or update to that Annual Development
Plan and shall be attached to the minutes of the meeting of the JMC
at which such amendment, modification or update was reviewed by the
JMC. Without limiting the nature or frequency of any other
amendments, modifications or updates to the Annual Development
Plan, such Annual Development Plan shall be updated at least once
prior to the end of each Contract Year in which an Annual
Development Plan has been approved to describe the Development
activities to be carried out by each Party during the following
Contract Year in conducting the applicable Development Program
pursuant to this Agreement. 4.4
Product Commercialization Plans . Subject to
Section 4.11.1(c), if ELAN alone (rather than with or through
a Sublicensee) is marketing a Co-Developed Product, within [***]
days after the Initiation of the first Phase III Clinical Trial for
a Co-Developed Product, ELAN shall prepare and provide to the JPT
for its review and discussion a Product Commercialization Plan for
each Co-Developed Product in the applicable Co-Development
Territory(ies), Indication and formulation, and shall update and
submit such Product Commercialization Plan to the JPT for review
and discussion not less than annually; provided, that, ELAN shall
use Commercially CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
51
Reasonable Efforts to include the obligations set forth in this
Section 4.4 in each Sublicense Agreement.
4.5 Supply of Products for
Development and Commercialization .
4.5.1
Negotiation by the Parties . The Parties shall
discuss in good faith the manufacturing responsibilities for each
Product that is Developed and Commercialized under this Agreement
as set forth in this Section 4.5.
4.5.2
ARCHEMIX Right to Supply Products . ARCHEMIX shall
have the right, but not the obligation, to exercise a time-limited
option to enter into negotiations with ELAN for a separate supply
and quality agreement detailing the terms under which ARCHEMIX
would manufacture by itself (not by or through a Third Party
manufacturer), and supply the active pharmaceutical ingredient for
any Product to ELAN (the "Supply Agreement"). ARCHEMIX may exercise
its Supply Agreement option as to any Product by providing ELAN
with written notice at any time prior to the Initiation of the
first Phase III Clinical Trial for such Product. If ARCHEMIX
provides such written notice and reasonably appears able to supply
the Product without impeding the Product Commercialization Plan,
delaying the timeframe planned for Regulatory Approval and Product
launch or limiting the Product shelf life, ARCHEMIX and ELAN shall
negotiate in good faith for up to [***] days following ELAN’s
receipt of such notice to enter into the Supply Agreement, which
would include, without limitation, the provisions described in
Section 4.5.3. For clarity, nothing contained in this
Section 4.5.2 shall constitute an offer by ARCHEMIX to sell
any Product, and neither Party shall be obligated to enter into any
Supply Agreement. If the Parties do not enter into a Supply
Agreement for such Product within such time period, then ELAN shall
have no further obligation to ARCHEMIX with respect to such
Product.
4.5.3
Essential Terms of Supply . Any Supply Agreement
entered into between the Parties shall contain the following terms
and conditions, as well as other terms and conditions typically
contained in supply agreements for products of similar nature and
market potential: CONFIDENTIAL Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
52
(a) ELAN
shall order amounts of Products, and ARCHEMIX shall deliver all
such ordered amounts, in accordance with specified forecasting
parameters, advance ordering timeframes and delivery timeframes to
be agreed upon by the Parties;
(b) ARCHEMIX
shall deliver such amounts of Products meeting applicable
specifications and legal requirements ordered in accordance with
the foregoing (including such agreed upon timeframes) in a timely
manner;
(c) ELAN
shall have appropriate remedies for the failure of ARCHEMIX to
perform its obligations specified in (b), including without
limitation that ELAN shall have the right to manufacture the
Product itself or select a Third Party manufacturer if ARCHEMIX
fails to perform such obligations;
(d) the
transfer price for supply of Product to ELAN shall be agreed upon
by the Parties and set forth in such agreement,
(e) all
Products supplied by ARCHEMIX shall be supplied FCA place of
manufacture, Incoterms 2000;
(f) ARCHEMIX
shall maintain a commercially reasonable backup supply of Product
at one remote location to ensure ARCHEMIX’ ability to supply
continuously Products to ELAN in accordance with such agreement;
(g) ELAN
shall have the right to establish a second source, within or
outside of ELAN, if ELAN’s requirements of Products cannot be
met despite ARCHEMIX’ meeting its obligations under (b);
(h) ARCHEMIX
shall provide reasonable assistance to ELAN and/or any Third Party
manufacturer, as applicable, that assumes responsibility for
manufacturing Product to enable ELAN or such Third Party to make
Products in the manner then made by ARCHEMIX, and shall grant all
licenses necessary for such purpose;
(i) ELAN
shall have the right to inspect the packaging and labeling prior to
use, and upon reasonable notice to inspect the plant and premises
used, and processes CONFIDENTIAL Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
53
and records of the packaging and storage employed, by ARCHEMIX
in connection with manufacture and supply of Product; and
(j) If
the Supply Agreement is terminated other than because of a material
breach by ELAN, a provision similar in effect to
Section 10.3.1(g) of this Agreement shall govern
ARCHEMIX’ obligation to continue to supply Products to ELAN.
4.6 Development and
Commercialization Diligence .
4.6.1
General Diligence Obligations . ELAN and its
Affiliates shall exercise Commercially Reasonable Efforts during
the Term to conduct the ELAN Development Activities and to
Commercialize Products in the Territory. ARCHEMIX and its
Affiliates shall exercise Commercially Reasonable Efforts during
the Term to conduct ARCHEMIX Development Activities, as applicable.
4.6.2
Specific Diligence Obligations .
(a)
Specific Diligence Obligations . During the Term, ELAN shall
use Commercially Reasonable Efforts (i) to Develop at [***]
Clinical Candidate targeted at IL-23 and to Commercialize
[***]IL-23 Product for each Diligence Indication in the United
States and a Major Market Country, and (ii) to Develop
[***]Clinical Candidate targeted at each Program Target other than
IL-23 and to Commercialize [***]Collaboration Product for each
active Program Target other than IL-23 in the United States and a
Major Market Country.
(b)
Effect of Breach of Diligence Obligations . If ARCHEMIX at
any time believes that ELAN is not meeting a diligence obligation
pursuant to Section 4.6.2(a), ARCHEMIX may give written notice
to ELAN requesting written justification, in the form of detailed
reasons that would support the proposition that ELAN is meeting
such diligence obligations. In such event, ELAN shall provide such
written justification to ARCHEMIX within [***] days after such
notice is given. In the event that ARCHEMIX does not agree with
such justification, then the Parties shall meet within [***] days
after such justification is given to discuss the basis for
ARCHEMIX’ belief that ELAN has failed to meet such diligence
obligation. If ARCHEMIX does not receive ELAN’s justification
within [***] days after ARCHEMIX first provides such a notice to
ELAN, or if ARCHEMIX, following any such CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
54
meeting occurring within such [***] day time period, still
believes that ELAN has not met its diligence obligation pursuant to
Section 4.6.2(a), then ARCHEMIX shall have the right, in its
sole discretion, to exercise any or all rights or remedies that it
may have under this Agreement, at law or in equity.
4.7 Compliance . Each
Party shall perform its obligations under each Annual Development
Plan and this Agreement using Commercially Reasonable Efforts in
good faith and in compliance in all material respects with all
Applicable Laws. For purposes of clarity, with respect to each
activity performed under an Annual Development Plan that will or
would reasonably be expected to generate data to be submitted to a
Regulatory Authority in support of a Regulatory Filing or Drug
Approval Application, the Party performing such activity shall
comply in all material respects with, if and as applicable, the
regulations and guidance of the FDA that constitute Good Laboratory
Practice, Good Manufacturing Practice or Good Clinical Practices,
(or, if and as appropriate under the circumstances, International
Conference on Harmonization (ICH) guidance or other comparable
regulation and guidance of any Regulatory Authority in any country
or region in the Territory). Each Party shall be solely responsible
for paying the salaries and benefits of its employees and amounts
due to consultants conducting its activities under Annual
Development Plans. 4.8
Cooperation . Scientists at ARCHEMIX and ELAN shall
cooperate in the performance of each Development Program and,
subject to the terms of this Agreement and any confidentiality
obligations to Third Parties, shall exchange such data, information
and materials as are reasonably necessary for the other Party to
perform its obligations under any Annual Development Plan. 4.9
Exchange of Reports; Information; Updates .
4.9.1
Development Program Reports . Each Party shall keep
the JPT generally informed of the progress of its efforts to
Develop Clinical Candidates in the Territory. Without limiting the
generality of the foregoing, each Party shall, on at least a [***],
provide the JPT with reports in reasonable detail regarding the
status of all preclinical IND-enabling studies and activities
(including toxicology and pharmacokinetic studies), clinical trials
and other activities conducted by or on behalf of each Party under
the Development Program with respect to any CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
55
Development Lead or Clinical Candidate that is being
Co-Developed or is eligible for Co-Development, or any Co-Developed
Product, together with such additional information in its
possession as may be reasonably requested from time to time by the
JPT.
4.9.2
Commercialization Reports . ELAN shall keep the JPT
generally informed of the progress of ELAN’s efforts to
Commercialize Products in the Territory through periodic updates.
Without limiting the generality of the foregoing, if ELAN alone
(rather than with or through a Sublicensee) is Commercializing a
Co-Developed Product, ELAN shall provide the JPT with [***] written
updates to each Product Commercialization Plan for each
Co-Developed Product in the applicable Co-Development
Territory(ies), Indication and formulation, which shall
(a) summarize ELAN’s efforts to Commercialize such
Co-Developed Product in the applicable Co-Development
Territory(ies), Indications and formulations, (b) identify the
Regulatory Filings and Drug Approval Applications with respect to
such Co-Developed Product that ELAN or any of its Affiliates or
Sublicensees have filed, sought or obtained in the prior [***]
month period or reasonably expect to make, seek or attempt to
obtain in the following [***] month period and (c) to the
extent not prohibited by Applicable Laws, summarize all
post-marketing clinical and other data generated by ELAN with
respect to such Co-Developed Product in the applicable
Co-Development Territory(ies), Indication and formulation;
provided, that, ELAN agrees to use Commercially Reasonable Efforts
to include the obligations set forth in this Section 4.9.2 in
each Sublicense Agreement. In addition, each Party (but not a
Sublicensee) shall be required to provide such additional
information that it has in its possession as may be reasonably
requested from time to time by the JPT and/or the JMC regarding the
Commercialization of any Product; provided, that, ELAN agrees to
use Commercially Reasonable Efforts to include the foregoing
obligation in each Sublicense Agreement.
4.9.3
Adverse Event Reports; Review of Regulatory Filings and
Correspondence .
(a)
Adverse Events . In addition to the updates described in
Section 4.9.1 and 4.9.2, ELAN shall provide ARCHEMIX with all
Adverse Event information and product complaint information
relating to Clinical Candidates or Products as such information is
compiled or prepared by ELAN in the normal course of business
within time frames consistent CONFIDENTIAL Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
56
with reporting obligations under Applicable Laws. All such
Adverse Event and product complaint information shall be sent to
ARCHEMIX in accordance with Section 13.1 and shall constitute
Confidential Information of ELAN; provided, that, ARCHEMIX shall
have the right to disclose any Serious Adverse Event to Third
Parties solely to the extent required by Applicable Laws
(including, without limitation, any applicable regulations of the
FDA) or as required in writing by the FDA.
(b)
Preparation of Drug Approval Applications . Except as
provided in Section 4.9.3(d) and (e), ELAN shall
(i) consult with ARCHEMIX in good faith in the preparation of
all Drug Approval Applications for Co-Developed Products for the
applicable Indication and formulation and (ii) consider all
comments of ARCHEMIX in good faith, taking into account the best
interests of the Collaboration and of the Co-Development of the
applicable Clinical Candidate and Commercialization of the
applicable Co-Developed Product for the applicable Indication and
formulation on a global basis.
(c)
Regulatory Meetings; Review of Other Regulatory Filings and
Correspondence . Except as provided in Section 4.9.3(d),
ELAN shall (i) use reasonable efforts to provide ARCHEMIX with
at least [***] days advance notice of any meeting with the FDA or
other Regulatory Authority regarding a Drug Approval Application
relating to, or Regulatory Approval for, any Clinical Candidate
that is being Co-Developed or is eligible for Co-Development, or
any Co-Developed Product, and ARCHEMIX may elect to send one person
reasonably acceptable to ELAN to participate (at ARCHEMIX’
sole cost and expense) solely as an observer in such meeting;
(ii) subject to any Third Party confidentiality obligations,
provide ARCHEMIX with drafts of each Regulatory Filing or other
material regulatory document or correspondence with a Regulatory
Authority pertaining to any Clinical Candidate that is being
Co-Developed or is eligible for Co-Development or any Co-Developed
Product and is prepared for submission to the FDA or other
Regulatory Authority, sufficiently in advance of submission so that
ARCHEMIX may review and comment on the substance of such Regulatory
Filing or other document or correspondence; and (iii) promptly
provide ARCHEMIX with copies of any document or other
correspondence received from the FDA pertaining to any Clinical
Candidate that is being Co-Developed or is eligible for
Co-Development, or any Co-Developed Product. If CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
57
ARCHEMIX has not commented on such Regulatory Filing or other
document or correspondence within [***] days (or, in the case of an
IND, [***] days) after it is provided to ARCHEMIX, then ARCHEMIX
shall be deemed to have no comments on such Regulatory Filing or
other documents or correspondence. ELAN shall consider all comments
of ARCHEMIX in good faith.
(d)
Co-Developed Products . ELAN shall (i) use reasonable
efforts to provide ARCHEMIX with copies of each Regulatory Filing
or other material regulatory document or correspondence with a
Regulatory Authority pertaining to any Clinical Candidate that is
being Co-Developed or is eligible for Co-Development and any
Co-Developed Product so that ARCHEMIX may review and provide
comment on the substance of such Regulatory Filing or other
document or correspondence and (ii) promptly provide ARCHEMIX with
copies of any document or correspondence received from the FDA
pertaining to such Clinical Candidate or Co-Developed Product.
4.10 Development and
Commercialization Rights and Restrictions .
4.10.1
Development and Commercialization Rights . Except as
provided in this Section 4.10 or Section 4.11.1(c), ELAN shall
have the exclusive right during the Term to Develop Clinical
Candidates and Commercialize Products in the Territory.
4.10.2
Right of First Negotiation for [***] . If at any time
during the Term, ARCHEMIX determines to formally pursue an [***]
Agreement, ARCHEMIX shall give written notice to ELAN (the "[***]
Opportunity Notice") describing and specifying the status of
Development of the Technology, Patent Rights and particular
products that ARCHEMIX reasonably expects to be involved in the
[***] Agreement. ELAN shall have [***] days following the date that
the [***] Opportunity Notice is given by ARCHEMIX (the "[***]
Notice Period") to give written notice to ARCHEMIX that it wishes
to enter into negotiations with ARCHEMIX with respect to such [***]
Agreement (an "[***]ROFN Notice"); provided that, if ELAN
determines not to give an [***]ROFN Notice prior to expiration of
the [***] Notice Period, it shall in good faith provide written
notice to ARCHEMIX promptly upon such determination that it
declines to enter into negotiations. If ELAN gives written notice
within the [***] Notice Period that it wishes to enter into
negotiations with ARCHEMIX, the Parties shall CONFIDENTIAL
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
58
negotiate in good faith with respect to an [***] Agreement for a
period of up to [***] days from the end of the [***] Notice Period.
If the Parties do not agree upon financial terms with respect to
the [***] Agreement within the [***] day negotiation period,
ARCHEMIX shall thereafter have no obligation to ELAN with respect
thereto and shall have the unencumbered right to negotiate and
execute an
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