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Exhibit 10.40 EXECUTION COPY COLLABORATIVE
RESEARCH AND LICENSE AGREEMENT between ARCHEMIX
CORP. and TAKEDA PHARMACEUTICAL COMPANY LIMITED
June 11, 2007 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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19
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2.1 Joint Steering Committee
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19
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2.2 Joint Project Team
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21
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3.
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RESEARCH PROGRAM
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24
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3.1 Objectives of the Research Program
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24
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3.2 Annual Research Plans
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24
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3.3 Conduct of Research Program
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25
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3.4 Records
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26
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3.5 Selection of Program Targets
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27
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3.6 Identification of Optimized Lead Compounds
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28
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3.7 Supply of Proprietary Materials
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29
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3.8 Research Program Term
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29
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3.9 Evaluation of Program Aptamers for Satisfaction
of OLSC Prior to Expiration of Research Program Term
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29
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3.10 Evaluation of Program Aptamers for
Satisfaction of OLSC After Expiration of Research Program Term
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29
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4.
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DEVELOPMENT PROGRAM; COMMERCIALIZATION OF
PRODUCTS
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29
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4.1 Objectives of the Development Program
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30
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4.2 Responsibility for Development and
Commercialization of Products
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30
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4.3 Technical Assistance
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30
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4.4 Development and Commercialization
Obligations
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30
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4.5 Cooperation
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31
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4.6 Exchange of Reports; Information; Updates
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31
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4.7 Product Recalls
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32
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5.
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PAYMENTS
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33
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5.1 Upfront Technology Access and License Fee
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33
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5.2 R&D Funding
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33
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5.3 Milestone Payments
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34
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5.4 Payment of Royalties; Royalty Rates; Accounting
and Records
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36
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6.
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TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY;
NON-SOLICITATION.
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40
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6.1 Confidentiality
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40
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6.2 Publicity
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41
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6.3 Publications and Presentations
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41
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6.4 Prohibition on Solicitation
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42
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7.
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LICENSE GRANTS; ASSIGNMENT; EXCLUSIVITY
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42
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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.
i
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Page
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7.1 Research and Development Licenses
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42
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7.2 Commercialization License
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47
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7.3 Right to Sublicense
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48
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7.4 Right to Subcontract
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48
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7.5 No Other Rights
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48
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7.6 Exclusivity
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48
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8.
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INTELLECTUAL PROPERTY RIGHTS
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49
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8.1 ARCHEMIX Intellectual Property Rights
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50
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8.2 Program Generic Patent Rights
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50
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8.3 TAKEDA Intellectual Property Rights
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50
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8.4 Program Aptamer-Specific Patent Rights
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50
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8.5 Joint Technology Rights
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50
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8.6 Patent Coordinators
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50
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8.7 Inventorship
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51
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8.8 Technology Disputes
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51
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8.9 Cooperation
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51
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9.
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FILING, PROSECUTION AND MAINTENANCE OF PATENT
RIGHTS
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51
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9.1 Patent Filing, Prosecution and Maintenance
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51
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9.2 Legal Actions
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54
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10.
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TERM AND TERMINATION
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59
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10.1 Term
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59
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10.2 Termination
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59
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10.3 Consequences of Termination of Agreement
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60
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10.4 Surviving Provisions
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63
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11.
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REPRESENTATIONS AND WARRANTIES
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63
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11.1 Mutual Representations and Warranties
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63
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11.2 Acknowledgment and Covenants of TAKEDA
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63
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11.3 Representations and Warranties of ARCHEMIX
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64
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12.
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INDEMNIFICATION
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65
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12.1 Indemnification of TAKEDA by ARCHEMIX
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65
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12.2 Indemnification of ARCHEMIX by TAKEDA
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65
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12.3 Indemnification of [***] and [***] by
TAKEDA
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66
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12.4 Conditions to Indemnification
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66
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12.5 Warranty Disclaimer
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66
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12.6 No Warranty of Success
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67
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12.7 Limited Liability
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67
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13.
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MISCELLANEOUS
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67
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13.1 Dispute Resolution
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67
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13.2 Litigation; Jurisdiction
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67
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13.3 Notices
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67
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13.4 Governing Law
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68
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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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ii
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Page
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13.5 Binding Effect
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68
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13.6 Headings
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68
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13.7 Counterparts
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68
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13.8 Amendment; Waiver
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68
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13.9 No Third Party Beneficiaries
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69
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13.10 Purposes and Scope
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69
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13.11 Assignment and Successors
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69
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13.12 Force Majeure
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69
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13.13 Interpretation
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69
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13.14 Integration; Severability
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69
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13.15 Further Assurances
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70
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List of Schedules
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Schedule 1
Optimized Lead Compound Selection Criteria
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Schedule 2A Program
Targets
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Schedule 2B Target
Replacement List
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Schedule 3
Licensed Patent Rights
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Schedule 4
Excluded Aptamers
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Schedule 5 Form
of Press Release
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Schedule 6
Program Chemistry
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Schedule 7
Ligands to Program Targets/Pre-approved Replacement Targets
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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
COLLABORATIVE RESEARCH AND LICENSE AGREEMENT
This COLLABORATIVE RESEARCH AND
LICENSE AGREEMENT (this "Agreement") is entered into as of
June 11, 2007, by and between Archemix Corp., a Delaware
corporation with offices at 300 Third Street, Cambridge, MA 02142
("ARCHEMIX"), and Takeda Pharmaceutical Company Limited, a Japanese
corporation with a principal place of business at 1-1, Doshomachi
4-chome, Chuo-ku, Osaka 540-8645, Japan ("TAKEDA"). Each of TAKEDA
and ARCHEMIX is sometimes referred to individually herein as a
"Party" and collectively as the "Parties."
WHEREAS, ARCHEMIX has developed and
controls certain technology, patent rights and proprietary
materials related to (a) the identification and optimization
of aptamers using its proprietary SELEX Process and SELEX
Technology (each as defined herein), and (b) the use of such
aptamers for treating, preventing or delaying the onset or
progression of human diseases or conditions; and
WHEREAS, TAKEDA 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 identifying aptamers
against certain identified targets, and developing and
commercializing human therapeutic products Derived (as defined
herein) from such aptamers. 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 shall have the meanings specified.
1.1 " Adverse Event "
means any event temporally related to the administration of a
Product that results in any of the following outcomes: death, a
life-threatening adverse drug experience, inpatient
hospitalization, prolongation of existing hospitalization, a
persistent or significant disability/incapacity, or a congenital
anomaly/birth defect. Important medical events that may not result
in death, be life-threatening, or require hospitalization may be
considered an Adverse Event when, based upon appropriate medical
judgment, they may jeopardize the patient or subject and may
require medical or surgical intervention to prevent one of the
outcomes listed in this definition.
1.2 " Affiliate "
means, with respect to any Person, any other Person that, directly
or indirectly through one or more affiliates, 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, or
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
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.
whereby a Person controls or has the right to control the board
of directors of a corporation or equivalent governing body of an
entity other than a corporation. 1.3
" Annual Net Sales " means, with respect to any
Fiscal Year, the aggregate amount of the Net Sales for such Fiscal
Year. 1.4 Annual Research
Plan " means, with respect to the Program Targets, the
written plan describing the research activities to be carried out
by each Party during each Fiscal Year of the Research Program Term
in conducting the Research Program pursuant to this Agreement with
respect to such Program Targets, as such written plan may be
amended, modified or updated, as further described in
Section 3.2. 1.5 "
Applicable Laws " means Federal, state, local,
national and supra-national laws, statutes, rules and regulations,
including any rules, regulations, guidance, guidelines 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. 1.6 "
Aptamer " means (a) any naturally or
non-naturally occurring oligonucleotide identified by ARCHEMIX that
binds to a Target with high specificity and affinity and
(b) any oligonucleotide Derived from any such oligonucleotide
that has such high specificity and affinity.
1.7 " Aptamer-Antidote
Combination Product " means [***] of the [***] of (a) [***]
aptamer [***], or [***] and (b) a [***] the [***] of
such[***]. 1.8 " ARCHEMIX
Additional Activities " means any activities, other than
ARCHEMIX Research Activities, that (a) TAKEDA reasonably
requests in writing that ARCHEMIX perform and (b) ARCHEMIX is
reasonably capable of providing. For purposes of clarity, such
ARCHEMIX Additional Activities shall include, and unless otherwise
agreed by the Parties in writing, be limited to: (i) the use by
TAKEDA of certain ARCHEMIX employees and/or long-term consultants
of ARCHEMIX to provide advice with respect to issues with respect
to which ARCHEMIX has expertise or experience [***], without [***]
with[***]and/or [***] and (ii) the transfer by ARCHEMIX to
TAKEDA of methods and protocols Controlled by ARCHEMIX that may
reasonably assist TAKEDA in the Development and/or
Commercialization of Products. 1.9 "
ARCHEMIX Background Technology " means any Technology
that is used by ARCHEMIX, or provided by ARCHEMIX for use, in the
Research Program and/or the Development Program that is
(a) Controlled by ARCHEMIX as of the Effective Date or (b)
conceived or first reduced to practice by employees of, or
consultants to, ARCHEMIX after the Effective Date other than in the
conduct of ARCHEMIX Research Activities and/or ARCHEMIX Additional
Activities. For purposes of clarity, (i) ARCHEMIX Background
Technology shall include any Technology described in (a) and
(b) of this Section 1.9 that is an improvement upon the
SELEX Process and/or SELEX Technology and (ii) ARCHEMIX
Program Technology or ARCHEMIX’s interest in Joint Technology
shall not include ARCHEMIX Background Technology. 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
1.10 " ARCHEMIX
Decision " means a decision with respect to the following
issues: (a) the manner by which ARCHEMIX conducts the [***]
against [***]; (b) whether ARCHEMIX is to incur any [***]
under the Research Program except for [***] that are included in
any Annual Research Plan by mutual agreement of the Parties and
without TAKEDA exercising the deciding vote under Section 2.1.6 to
cause its inclusion; (c) whether ARCHEMIX is [***] any
ARCHEMIX Additional Activities; (d) whether ARCHEMIX is to incur
any [***] in the performance of [***] and/or ARCHEMIX Additional
Activities except for [***] that are included in the Annual
Research Plan by mutual agreement of the Parties and without TAKEDA
exercising the deciding vote under Section 2.1.6 to cause its
inclusion; and (e) the number of FTEs to be provided by
ARCHEMIX in each Annual Research Plan to the extent such number of
FTEs exceeds [***] FTEs per Fiscal Year.
1.11 " ARCHEMIX-Gilead License
Agreement " means the License Agreement between Gilead
Sciences, Inc. and ARCHEMIX dated October 21, 2001, as
amended. 1.12 " ARCHEMIX Patent
Rights " means any Patent Rights Controlled by ARCHEMIX
that contain one or more claims that cover ARCHEMIX Technology.
1.13 " ARCHEMIX Program
Technology " means (a) any oligonucleotide of an
Enriched Pool that is not a Program Aptamer; (b) any Program
Technology, other than Program Aptamer-Specific Technology, that is
conceived or first reduced to practice by employees of, or
consultants to, ARCHEMIX, alone or jointly with any Third Party;
and (c) any Program Technology, regardless of whether
conceived or first reduced to practice by employees of, or
consultants to, ARCHEMIX, TAKEDA, or both Parties, alone or jointly
with any Third Party, that is an improvement to the SELEX Process
or SELEX Technology. 1.14 "
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 JPT and
the JSC and (b) to the extent involving matters that are
ARCHEMIX Decisions, approved by ARCHEMIX in accordance with
Section 2.1.6. 1.15 "
ARCHEMIX Technology " means, collectively, ARCHEMIX
Background Technology and ARCHEMIX Program Technology.
1.16 " Challenge "
means any formal written filing with a government patent agency or
court of law in any country made independent of and not in response
to a material breach of this Agreement where such filing calls into
question the validity or enforceability of any Royalty Triggering
Patent Rights scheduled according to Section 9.2.4, including
without limitation by (a) filing a declaratory judgment action
in which any Royalty Triggering Patent Rights are alleged to be
invalid or unenforceable; (b) citing prior art pursuant to 35
U.S.C. §301, filing a request for re-examination of any
Royalty Triggering Patent Rights pursuant to 35 U.S.C. §302
and/or §311, or provoking or becoming party to an interference
with an application for Licensed Patent Rights pursuant to 35
U.S.C. §135; or (c) filing or commencing any
re-examination, opposition, cancellation, nullity or similar
proceedings against any Royalty Triggering Patent Right in any
country. Notwithstanding the foregoing, any action with respect to
the Prosecution of Patent Rights taken by a Party in accordance
with Section 9.1 shall not be deemed to be a Challenge for purposes
of this Agreement. 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
1.17 " 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. 1.18
" Collaboration " means the alliance of ARCHEMIX and
TAKEDA established pursuant to this Agreement for the purposes of
identifying, researching, Developing and Commercializing Products
in the Field in the Territory. 1.19 "
Collaboration Aptamer " means, collectively, all
Program Aptamers and Optimized Lead Compounds.
1.20 " 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
TAKEDA, its Affiliates or Sublicensees and that includes:
(a) a Product; and (b) a Supplemental Product.
1.21 "
Commercialization " or " Commercialize
" means any and all activities directed to the
commercialization of a Product after Commercialization Regulatory
Approval has been obtained, including marketing, manufacturing for
commercial sale, promoting, detailing, distributing, offering to
sell and selling a Product, importing a Product for sale,
conducting post-marketing human clinical studies and interacting
with Regulatory Authorities regarding the foregoing. When used as a
verb, "to Commercialize" and "Commercializing" means to engage in
Commercialization and "Commercialized" has a corresponding meaning.
1.22 " Commercialization
Regulatory Approval " means, with respect to any Product,
the Regulatory Approval required by Applicable Laws to sell such
Product for use in the Field in a country or region in the
Territory. "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 the first
Indication or sNDA for an additional 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 supplemented or amended
from time to time. 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
1.23 " Commercially
Reasonable Efforts " or " Commercially Reasonable
" means (a) with respect to the manner by which ARCHEMIX
performs (i) the activities assigned to ARCHEMIX in the
Research Program and (ii) ARCHEMIX Additional Activities, if
any, efforts and resources that are 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, as applicable, that are not
subject to the Collaboration and that are at an equivalent stage of
research, development or commercialization and have similar market
potential and are at a similar stage in their lifecycle, and
(b) with respect to activities of TAKEDA in the Research
Program, and the Development and/or Commercialization of a
particular Product, the efforts and resources comparable to those
undertaken by TAKEDA in pursuing intellectual property protection,
development and commercialization of similar products that are not
subject to the Collaboration, taking into account the
product’s stage of development and/or commercialization,
risks and probabilities of success, market potential, and stage in
their lifecycle. For purposes of (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 and without limitation, mechanism of action; efficacy
and safety; product profile; actual or anticipated Regulatory
Authority approved labelling; and 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
alternative products and market conditions; actual or projected
profitability and availability of capacity to manufacture and
supply for commercial sale). 1.24 "
Competitive Program " means any research, development
or commercialization activity that involves an aptamer that targets
a Program Target for use in the Field.
1.25 " Confidential
Information " means all information, Technology and
Proprietary Materials disclosed or provided by or on behalf of one
Party (the "disclosing Party") to the other Party (the "receiving
Party") or to any of the receiving Party’s employees,
consultants, Affiliates or sublicensees (or Sublicensees, as the
case may be); 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 contemporaneous credible written documentation,
other than by virtue of a prior confidential disclosure to such
receiving Party; (B) as of the date of disclosure it is in the
public domain, or it subsequently enters the public domain through
no fault of the receiving Party or its Affiliates; (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 disclosing Party or its Affiliates; or
(D) it is independently developed by or for the receiving
Party or its Affiliates without reference to or use of any
Confidential Information of the disclosing Party as demonstrated by
contemporaneous credible written documentation. The foregoing
notwithstanding (i) all tangible embodiments of ARCHEMIX
Technology shall be ARCHEMIX Confidential Information,
(ii) all tangible embodiments of TAKEDA Technology shall be
TAKEDA Confidential Information, and (iii) all tangible
embodiments of Joint Technology shall be ARCHEMIX Confidential
Information and TAKEDA Confidential Information. Notwithstanding
anything herein to the contrary, the terms of this Agreement shall
constitute Confidential Information of each Party.
1.26 " 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
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
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 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. 1.27 "
CTN " means the notification submitted to the
Japanese Ministry of Health, Labor and Welfare prior to the
Initiation of a clinical trial in Japan.
1.28 " 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).
1.29 " Development " or
" Develop " means, with respect to each Product on or
after the selection of the Optimized Lead Compound from which such
Product is Derived, all non-clinical and clinical activities
performed in order to obtain Regulatory Approval of such Product,
in accordance with this Agreement up to and including the obtaining
of Commercialization Regulatory Approval of such Product. For
purposes of clarity, these activities include, without limitation,
in vivo animal efficacy testing, preclinical safety testing,
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. 1.30 "
Development Program " means the Development
activities to be conducted during the Term with respect to each
Product on or after the selection of the Optimized Lead Compound
from which such Product is Derived with the objective of developing
such Product. 1.31 "
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.
1.32 " Diagnostic
Product " means In Vitro Diagnostics, In Vivo
Diagnostic Agents and any other aptamer product used for Diagnosis.
For purposes of clarity, the term Diagnostic Product shall not
include a product used for the delay of onset or progression of, or
treatment or prevention of, an Indication.
1.33 " Discontinued Competitive
Target " means any Program Target so designated by TAKEDA
pursuant to Section 7.6.1(b) following a Change of Control of
ARCHEMIX. 1.34 " 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 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
an NDA or sNDA in any country or region in the Territory
(including, without limitation, a CTN); and (c) all
supplements and amendments to any of the foregoing.
1.35 " E5 Country "
means each of the [***] and [***].
1.36 " Effective Date "
means the date first set forth above.
1.37 " 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 [***] and (b) wherein, [***] with
[***] of [***] (e.g., [***] and [***] of the applicable Program
Target, [***]% of the input pool of [***] is [***] in the [***] by
the Program Target and the [***]fraction of the [***] pool is at
least [***] [***]relative to the [***] fraction for the [***]
(i.e., [***]) pool of [***]. 1.38 "
Excepted Decision " means any of the following
decisions requiring the unanimous approval of all members of the
JSC: (a) any decision as to whether a milestone has been
achieved under this Agreement for which a milestone payment is
payable; and (b) any decision as to the appropriate method of
determining royalties for a Combination Product pursuant to the
last sentence of Section 5.4.1(h).
1.39 " Excluded Aptamer
" means any Aptamer listed on Schedule 4 attached
hereto. 1.40 " Exclusivity
Term " means, (a) with respect to each Program Target,
the period commencing on the Effective Date and continuing until
the later of (i) the third anniversary of the Effective Date,
and (ii) such date as TAKEDA is no longer either
(A) evaluating Collaboration Aptamers directed to such Program
Target pursuant to Section 3.10; (B) Developing and/or
Commercializing a Product directed to such Program Target in any
country in the Territory, or (C) providing the R&D Funding
contemplated by Section 5.2 applicable to such Program Target,
and (b) with respect to each Pre-approved Replacement Target, the
period commencing on the Effective Date and continuing until the
second anniversary of the Effective Date.
1.41 " Failed Compound
" means any Collaboration Aptamer directed against a Failed Target.
1.42 " Failed Target "
means any Program Target as to which the JSC determines that [***]
is unable or unlikely to identify an [***] against such Program
Target. For purposes of clarity, a Failed Target shall no longer be
considered a Program Target for purposes of this Agreement once
such Program Target becomes a Failed Target.
1.43 " FDA " means the
United States Food and Drug Administration or any successor agency
or authority thereto. 1.44 "
FDCA " means the United States Federal Food, Drug,
and Cosmetic Act, as amended. 1.45 "
Field " means the treatment, prevention, cure or
delay of onset or progression of all human therapeutic
Indications.
|
|
|
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
1.46 " 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. For purposes of clarity,
the use of any Product in clinical trials, pre-clinical studies or
other research or development activities, or the disposal or
transfer of Products for a bona fide charitable purpose or a
commercially reasonable sampling program, shall not be considered
to be a sale, transfer or disposal for value to an end user.
1.47 " Fiscal Quarter "
means each successive period of three (3) consecutive calendar
months commencing on January 1, April 1, July 1 or
October 1, as the case may be, and ending on March 31,
June 30, September 30 or December 31, respectively;
provided, that, the initial Fiscal Quarter shall commence on the
Effective Date and end on June 30, 2007.
1.48 " Fiscal Year "
means each successive period of twelve (12) months commencing
on April 1 and ending on March 31; provided, that, the first
Fiscal Year shall commence on the Effective Date and end on
March 31, 2008. 1.49 "
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, regulation, ordinance, demand
or requirement of any government or of any subdivision, authority
or representative of any such government.
1.50 " FTE " shall mean
[***] hours of work devoted to or in support of the ARCHEMIX
Research Activities and/or the ARCHEMIX Additional Activities that
is carried out by one or more employees of ARCHEMIX, measured in
accordance with ARCHEMIX’s time allocation practices as
applicable at the relevant time. 1.51
" FTE Cost " means, for any period, the FTE Rate
multiplied by the applicable number of FTEs in such period.
1.52 " FTE Rate " means
[***] Dollars (US $[***]). For purposes of clarity, the FTE Rate
does not include any [***] set forth in Section 5.2.4.
1.53 " GAAP " means
United States generally accepted accounting principles,
consistently applied. 1.54 "
Generic Product " means a pharmaceutical product that
(i) contains the same active ingredient as the Product, and
(ii) is bioequivalent to such Product.
1.55 " [***] Study "
means a study performed in accordance with the [***].
1.56 " Hatch-Waxman Act
" means the Drug Price Competition and Patent Term Restoration Act
of 1984, as amended. 1.57 "
ICC " means the International Chamber of Commerce.
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
1.58 " 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
Collaboration Aptamer 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 Collaboration Aptamer in humans in
such country or region; and (c) all supplements and amendments
to any of the foregoing. 1.59 "
Indication " means any human indication, disease or
condition, which can be treated, prevented, cured or the
progression of which can be delayed.
1.60 " Initiation "
means, with respect to a human clinical trial, the first date that
a subject or patient is dosed in such clinical trial.
1.61 " In Vitro
Diagnostics " means the use of the SELEX Process or
aptamers 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 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) and
(c) any other in vitro diagnostic use of the SELEX
Process or aptamers identified through the use of the SELEX Process
in drug development processes, including target identification,
pre-clinical and clinical testing, and the following more specific
examples of uses of aptamer technology: (i) to observe,
through protein profiling, protein levels moving up or down in
diseases or models of diseases, and to evaluate whether such
proteins are sensible targets for the development of therapeutic
agents; (ii) to observe coordinated expression of protein
pathways in a variety of biological states in various systems;
(iii) to study protein or metabolite levels during
pre-clinical drug candidate evaluation in response to putative
therapeutic agents during clinical trials ( e.g. , as
markers of efficacy or response); and (iv) to study human
protein or metabolite levels in response to putative therapeutic
agents during clinical trials ( e.g. , as markers of
efficacy or response). Notwithstanding the above, In Vitro
Diagnostics does not include any of the above-identified
activities directed at the discovery or Development of Aptamers by
TAKEDA under and pursuant to the terms of this Agreement.
1.62 " 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. For purposes of clarity, the use or development of
an aptamer for the treatment of human disease does not constitute
In Vivo Diagnostics . 1.63 "
Joint Patent Rights " means Patent Rights that
contain one or more claims that cover Joint Technology. 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
1.64 " Joint Project
Team " or " JPT " means the committee
composed of ARCHEMIX and TAKEDA representatives established
pursuant to Section 2.2. 1.65 "
Joint Steering Committee " or " JSC "
means the committee composed of ARCHEMIX and TAKEDA representatives
established pursuant to Section 2.1.
1.66 " Joint Technology
" means any Program Technology, other than Program Aptamer-Specific
Technology, that is jointly conceived or reduced to practice by
employees of, or consultants to, TAKEDA and employees of, or
consultants to, ARCHEMIX. For purposes of clarity, any Program
Technology that relates to the SELEX Process or to the SELEX
Technology shall not be considered Joint Technology irrespective of
which Party conceived or reduced to practice such Program
Technology. 1.67 "
Knowledge " means, with respect to a Party, the
actual knowledge of the chief executive officer or any vice
president of such Party. 1.68 "
Licensed Patent Rights " means any ARCHEMIX Patent
Rights and ARCHEMIX’s interest in Joint Patent Rights that
(a) contain one or more claims that cover any Collaboration
Aptamer, including its manufacture or formulation or a method of
its delivery or use, or (b) are necessary for TAKEDA to
exercise the licenses and rights granted to it pursuant to
Article 7. Licensed Patent Rights existing as of the Effective
Date, include, without limitation, those Patent Rights listed on
Schedule 3 attached hereto . For purposes of
clarity, Licensed Patent Rights shall exclude any Patent Rights, on
a claim by claim basis, that relate solely to the SELEX Process and
the SELEX Technology. 1.69 "
Licensed Technology " means any ARCHEMIX Technology
and ARCHEMIX’s 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 TAKEDA to exercise the
licenses and rights granted to it pursuant to Article 7.
1.70 " Minimum FTE Funding
Commitment " means, on a Fiscal Quarter by Fiscal Quarter
basis, with respect to each Target designated as a Program Target
pursuant to Section 3.5.1 during the Research Program Term and
for which an Optimized Lead Compound has not been identified, the
funding of [***] FTE. For purposes of clarity, the Minimum FTE
Funding Commitment per Program Target per Fiscal Quarter set
forth in the preceding sentence corresponds to [***] FTEs per
Program Target on an annual basis. To the extent that the first
Fiscal Quarter following the Effective Date of this Agreement is
not a full three months, the Minimum FTE Funding Commitment for
such first Fiscal Quarter shall be prorated to account for the
ratio between the total days remaining in such Fiscal Quarter
following the Effective Date and the total days in such Fiscal
Quarter. 1.71 " Minimum
Program Target Commitment " means one (1) Program
Target upon the initiation of research by ARCHEMIX on a first
Program Target pursuant to Section 3.3.1; two (2) Program
Targets upon the initiation of research by ARCHEMIX on a second
Program Target; and, upon the initiation of research by ARCHEMIX on
a third Program Target, a number of Program Targets [***] to the
[***] between (a) [***] the number of Program Targets for which an
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
[***] has been [***], and (b) the [***] of the number of
Program Targets for which an [***] has [***] been [***] and the
number of [***] Targets listed on [***] .
1.72 " 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.
1.73 " Net Sales "
means the gross amount billed or invoiced by TAKEDA 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, as determined in accordance with GAAP, (a)
allowances for normal and customary trade, quantity and cash
discounts actually allowed and taken, (b) transportation,
insurance and postage charges, if prepaid by TAKEDA or any
Affiliate or Sublicensee of TAKEDA and included on any such
party’s bill or invoice as a separate item, (c) credits,
rebates, returns (including product recalls) pursuant to agreements
(including, without limitation, managed care agreements) or
government regulations, to the extent actually allowed or
implemented, including without limitation, with respect to any Net
Sales in Japan, any sales-based contribution for "Drug Induced
Suffering" and any sales-based contribution for "Contribution for
Measure for Drug Safety," in each case as required by Applicable
Laws or any Regulatory Authority, in the amount determined by and
payable to the Pharmaceuticals and Medical Devices Agency
(so-called "KIKO"), (d) sales, use and other consumption taxes
similarly incurred to the extent included on the bill or invoice as
a separate item. In addition, Net Sales are subject to the
following:
(a) If
TAKEDA 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, 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 or such other reasonable allocation method as the
Parties shall agree.
(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 a commercially reasonable sampling program, shall not
give rise to any Net Sales. 1.74 "
Optimized Lead Compound " or " Optimized
Lead " means any Program Aptamer that the JSC accepts as
meeting the OLSC for such Program Target and any Aptamer Derived
therefrom. The Parties agree that any Program Aptamer for which
[***] shall be deemed to have been accepted as an Optimized Lead
Compound by the JSC. 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
1.75 " Optimized Lead
Compound Selection Criteria " or " OLSC "
means the guideline criteria for selecting Program Aptamers that
are sufficiently promising to warrant further research as an
Optimized Lead Compound. The OLSC for the initial three
(3) Program Targets listed in Schedule 2A attached hereto
as agreed upon between the Parties is incorporated into
Schedule 1. The OLSC shall be defined by the JSC for
Pre-Approved Replacement Target as soon as practicable after the
selection of any Pre-approved Replacement Targets pursuant to
Section 3.5.1, but in any event, prior to the commencement of
research activities with respect to any such Pre-approved
Replacement Target. 1.76 "
Patent Rights " means the rights and interests in and
to 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.
1.77 " Permitted
Activities " means (a) [***] to [***] and [***], any [***]
ARCHEMIX [***] or [***] for ARCHEMIX and/or for [***] for the [***]
of [***] to a [***] than such [***] or [***], as [***], and (b)
[***] ARCHEMIX [***] and/or [***] Aptamers [***] and [***];
provided, that, ARCHEMIX [***] or [***] in the [***] and/or [***]
of any [***] Aptamers [***] of the [***]
1.78 " 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.
1.79 " Phase I Clinical
Trial " means a clinical trial conducted 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.
1.80 " Phase II Clinical
Trial " means a clinical trial conducted in patients with a
particular disease or condition, 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.
1.81 " Phase III Clinical
Trial " means a pivotal clinical trial conducted in
patients with a particular disease or condition, 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 an
investigational drug 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. 1.82 "
Product " means any pharmaceutical or medicinal item,
substance or formulation that contains, incorporates or comprises a
Collaboration Aptamer. 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
1.83 " Product
Trademark " 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 specifically applied to
or used with and obtained for any Product by TAKEDA and
(b) together with all goodwill associated therewith and
promotional materials relating thereto.
1.84 " Program Aptamer
" means (a) any [***] oligonucleotide that (i) is an
Aptamer that [***] and (ii) was first identified in the
performance of the Research or Development Program, (b) [***]
Aptamers Controlled by ARCHEMIX as of the Effective Date that [***]
to the applicable Program Target, and (c) any [***] any [***]
this Section 1.84(a) or (b) where such Aptamer was first
identified in the performance of the Research Program or
Development Program and binds to a Program Target.
1.85 " Program Aptamer-Specific
Patent Rights " means all Patent Rights, on a claim by
claim basis, that contain, as a specific element, Program
Aptamer-Specific Technology. Program Aptamer-Specific Patent Rights
where ARCHEMIX is the sole inventor or a joint inventor with TAKEDA
shall be "ARCHEMIX Program Aptamer-Specific Patent Rights" and
Program Aptamer-Specific Patent Rights where TAKEDA is the sole
inventor shall be "TAKEDA Program Aptamer-Specific Patent Rights."
1.86 " Program Aptamer-Specific
Technology " means any Program Technology Controlled by
either Party at any time during the Exclusivity Term for a given
Program Target that (a) has as an element thereof a
Collaboration Aptamer, including any Program Technology relating to
the composition, production, manufacture, formulation, delivery or
use of a Collaboration Aptamer and is specific for that Program
Target; and/or (b) is specific for that Program Target. For
purposes of illustration with respect to Sections 1.85, 1.86,
1.88 and 1.89, (i) the nucleotide sequence of an Aptamer that
binds a Program Target would be considered Program Aptamer-Specific
Technology and any Patent Rights that specify that nucleotide
sequence would be considered Program Aptamer-Specific Patent Rights
and (ii) the composition of the oligonucleotide pool (e.g.,
deoxy purines and 2’ O-methyl substituted pyrimidines) from
which the specific nucleotide sequence was obtained would be
considered Program Generic Technology and any Patent Rights that
encompass the pool composition but do not specify the particular
nucleotide sequence(s) of an Aptamer that bind to a Program Target
would be considered Program Generic Patent Rights.
1.87 " Program
Chemistry " means the proprietary molecules, methods and/or
processes listed on Schedule 6 attached hereto to be
used by ARCHEMIX in the conduct of the Research Program and any
proprietary molecules, methods and/or processes generically
identified on Schedule 6 .
1.88 " Program Generic Patent
Rights " means all Patent Rights, on a claim by claim
basis, that cover Program Generic Technology but do not contain as
a specific element Program Aptamer-Specific Technology.
1.89 " Program Generic
Technology " means any Program Technology that is not
Program Aptamer-Specific Technology and that relates generally to
the composition, discovery, generation, optimization, manufacture,
formulation, delivery or use of aptamers. 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
1.90 Program Target
" means the Targets listed on Schedule 2A attached
hereto, as amended from time to time in accordance with
Section 3.5. 1.91 "
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 conceived or first reduced to practice (actively or
constructively) by either Party in the conduct of the Research
Program and/or the Development Program and by ARCHEMIX in the
conduct of ARCHEMIX Additional Activities.
1.92 " 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 conceived and reduced to practice
in the conduct of the Research Program or the Development Program.
1.93 " Prosecution " or
" Prosecute " means the preparation, filing,
prosecution and/or maintenance of Patent Rights including any
reissue and re-examination proceedings relating to the foregoing;
provided, however, that any interference, opposition or similar
proceedings relating to any Aptamer-Specific Patent Rights shall be
classified as an Infringement subject to Section 9.2.1(b)(ii).
1.94 " Quarterly FTE
Payment " means the amount of R&D Funding payable by
TAKEDA to ARCHEMIX for FTEs for each Fiscal Quarter of the Research
Program Term pursuant to Section 5.2, which shall equal the
product of the number of FTEs required by the Minimum FTE Funding
Commitment times the number of Program Targets required by the
Minimum Program Target Commitment times the FTE Rate.
1.95 " 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. 1.96 " R&D
Funding " means the aggregate funding provided by TAKEDA to
ARCHEMIX in connection with the conduct by ARCHEMIX of the ARCHEMIX
Research Activities and/or ARCHEMIX Additional Activities, as the
case may be, which shall be equal to the aggregate FTE Cost for all
FTEs expended by ARCHEMIX in connection therewith, based on the FTE
Rate. 1.97 " Regulatory
Approval " means, with respect to any country or region in
the Territory, any approval, product and establishment license,
registration or authorization of any Regulatory Authority required
for the manufacture, use, storage, importation, exportation,
distribution, transport or sale of a Product in the Field in such
country or region. 1.98 "
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 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
distribution, importation, exportation, manufacture, production,
use, storage, transport, clinical testing or sale of a Product.
1.99 " Regulatory
Filings " means, collectively: (a) all INDs,
establishment 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 and 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.
1.100 " Research
Program " means the research program to be conducted by the
Parties during the Research Program Term pursuant to the Annual
Research Plan up to and including the selection of Optimized Lead
Compounds. For purposes of clarity, the Research Program does not
include any Development activities performed in the course of the
Development Program. 1.101 "
Research Program Term " means the period beginning on
the Effective Date and ending on June 11, 2010, or such later
date as the Parties may mutually agree in writing; provided, that,
(a) the Research Program Term ending June 11, 2010, may
be extended for up to two (2) additional periods of one
(1) year each upon the mutual agreement of the Parties,
subject to ARCHEMIX’s commitment to continue to provide FTEs,
and TAKEDA’s commitment to continue to provide ARCHEMIX with
the R&D Funding applicable thereto pursuant to
Section 5.2.1, in order to discover Optimized Lead Compounds
for one or more Program Targets; and (b) if this Agreement is
terminated prior to the end of the Research Program Term, the
effective date of such early termination shall become the last day
of the Research Program Term. For purposes of clarity, under no
circumstances shall the Research Program Term be extended beyond
the fifth anniversary of the Effective Date.
1.102 " ROW Territory "
means all counties and territories of the world other than the
[***]. 1.103 " Royalty
Term " means, on a Product-by-Product and
country-by-country basis, the period beginning on the date of First
Commercial Sale of a given Product in a country and ending on the
later to occur of (a) expiration of the last to expire Valid
Claim of a Royalty Triggering Patent Right as to such Product in
such country and (b) [***] years from the date of the First
Commercial Sale of such Product in such country. For purposes of
clarity, [***] years after the First Commercial Sale of a Product,
the Royalty Term will expire as to a given Product in a given
country if the Product is being manufactured, used, offered for
sale or sold without the infringement of any Valid Claim of any
Royalty Triggering Patent Rights as a result of such activities.
1.104 " Royalty Triggering
Patent Rights " means, on a Product-by-Product and
country-by-country basis, those Valid Claims within the Licensed
Patent Rights, ARCHEMIX Program Aptamer-Specific Patent Rights and
Joint Patent Rights, that are scheduled according to
Section 9.2.4, subject to the dispute resolution procedures
set forth in Section 9.2.4, that would be infringed by the
manufacture, use, offer for sale or sale of a Product in a given
country absent the 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
license granted under this Agreement. For purposes of clarity,
the making, using, offering for sale and selling activities of a
particular Product may be covered by Royalty Triggering Patent
Rights in one country and not be covered by any Royalty Triggering
Patent Rights in another country. Also for purposes of clarity,
TAKEDA Program Aptamer-Specific Patent Rights are excluded from
Royalty Triggering Patent Rights.
1.105 " SELEX Portfolio
" means those Patent Rights licensed by Gilead to ARCHEMIX pursuant
to the ARCHEMIX-Gilead License Agreement.
1.106 " SELEX Process "
means any process for the identification or generation of an
oligonucleotide that binds to a Target by means other than
Watson-Crick base-pairing including any process that is covered by,
(a) the SELEX Portfolio, including, without limitation, U.S.
Patent Nos. [***] or [***] and any continuations, divisionals, and
continuations-in-part, substitutions, renewals, reissues,
re-examinations and extensions thereof, or (b) any other
Patent Rights directed to the SELEX Process Controlled by ARCHEMIX.
1.107 " SELEX
Technology " means (a) oligonucleotides that bind to a
Target by means other than Watson-Crick base-pairing that consist
of or incorporate structural elements that are generally applicable
to such oligonucleotides independent of Targets (e.g., a novel
nucleoside, bond or linkage or combination(s) thereof, for example,
deoxypurine and 2’O-methyl substituted prymidine
compositions) as used in such oligonucleotides, and (b) any
process for modifying, optimizing and/or stabilizing
oligonucleotides that bind to a Target by means other than
Watson-Crick base-pairing that is generally applicable to such
oligonucleotides independent of Targets wherein such modification,
optimization or stabilization includes, without limitation,
minimization, truncation, conjugation, pegylation, complexation,
substitution, deletion and/or incorporation of modified
nucleotides; provided, however, that SELEX Technology does not
include Program Aptamers. 1.108 "
sNDA " means a Supplemental New Drug Application, as
defined in the FDCA and applicable regulations promulgated
thereunder. 1.109 " Sublicense
Agreement " means any agreement entered into by TAKEDA with
a Sublicensee. 1.110 "
Sublicensee " means any Third Party to which TAKEDA
grants a sublicense under the licenses granted to it under
Section 7.1 or 7.2. 1.111 "
Supplemental Product " means a therapeutically active
ingredient incorporated into a Combination Product where such
therapeutically active ingredient is not a Product.
1.112 " TAKEDA Background
Technology " means any Technology that is used by TAKEDA,
or provided by TAKEDA for use, in the Research Program and/or
Development Program that is (a) Controlled by TAKEDA as of the
Effective Date or (b) conceived or first reduced to practice
by employees of, or consultants to, TAKEDA after the Effective Date
other than in the conduct of TAKEDA Research Activities or TAKEDA
Development Activities. For purposes of clarity, TAKEDA Program
Technology or TAKEDA’s interest in Joint Technology shall not
include TAKEDA Background Technology. 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
1.113 " TAKEDA Patent
Rights " means any Patent Rights Controlled by TAKEDA that
contain one or more claims that cover TAKEDA Technology.
1.114 " TAKEDA Program
Technology " means (a) any Program Technology that is
not ARCHEMIX Program Technology or Joint Technology; and
(b) any Program Aptamer-Specific Technology.
1.115 " TAKEDA Research
Activities " means all activities specified to be conducted
by TAKEDA in any Annual Research Plan (or amendment thereto) that
are approved by the JPT and JSC. For purposes of clarity, TAKEDA
Research Activities may include the contribution by TAKEDA to the
Research Program of certain disease biology and cellular assay
expertise and Technology. 1.116 "
TAKEDA Technology " means, collectively, TAKEDA
Background Technology and TAKEDA Program Technology.
1.117 " Target " means
a protein, cytokine, enzyme, receptor, transducer, transcription
factor, antigen or any other non-nucleic acid molecule.
1.118 " Target Replacement
List " means the list of Targets on Schedule 2B
attached hereto, as amended pursuant to Section 3.5.1.
1.119 " 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).
1.120 " Terminated Product
" means any Product which TAKEDA was Developing or
Commercializing as to which TAKEDA determined to discontinue
Development and provided a Product Termination Notice to ARCHEMIX
pursuant to Section 7.1.2(d)(i)
1.121 " Territory "
means all countries and territories of the world.
1.122 " Third Party "
means a Person other than TAKEDA and ARCHEMIX and their respective
Affiliates. 1.123 " ULEHI
" means University License Equity Holdings, Inc., formerly
known as UTC. 1.124 " URC
License Agreement " means the Restated Assignment and
License Agreement, dated July 17, 1991, by and between
University Research Corporation and Gilead Sciences, Inc. as
successor in interest to NeXstar Pharmaceuticals.
1.125 " UTC " means
University Technology Corporation, the successor to the University
Research Corporation. 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
1.126 " Valid Claim
" means any claim of an issued, unexpired patent that (a) has
not been finally cancelled, withdrawn, abandoned or rejected by any
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.
1.127 " Waived Compound
" means any Collaboration Aptamer directed against a Waived
Target. 1.128 " Waived
Target " means any Program Target for which TAKEDA has
discontinued the Research Program prior to the designation of an
Optimized Lead Compound for such Program Target and provided a
Waived Target Designation Notice to ARCHEMIX pursuant to
Section 7.1.2.(c)(i).
Additional Definitions . In addition, each of the
following definitions shall have the respective meanings set forth
in the section of this Agreement indicated below:
|
|
|
|
|
Definition
|
|
Section
|
|
Applicable Milestone Payment
|
|
7.1.2(d)(ii)(F)
|
|
Applicable Percentage
|
|
7.1.2(d)(ii)(F)
|
|
ARCHEMIX Commitment
|
|
7.1.2(d)(ii)
|
|
ARCHEMIX Indemnitees
|
|
12.2
|
|
Claims
|
|
12.1
|
|
Clinical Data
|
|
7.1.2(e)(ii)(F)
|
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Designated Senior Officers
|
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13.1
|
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Disputed Patent Matter
|
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9.1.1(b)
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Disputed Royalty Matter
|
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5.4.1(i)
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Dispute
|
|
13.1(a)
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Disputed Matter
|
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2.1.3(c)
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Exclusive License Notice
|
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7.1.2(f)(ii)
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Failed Target Opportunity Notice
|
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7.1.2(c)(iv)
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[***]% Royalty Reduction
|
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5.4.1(e)
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Filing Party
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9.1.4
|
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[***] Indemnitee
|
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12.3
|
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Indemnified Party
|
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12.4
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Indemnifying Party
|
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12.4
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Infringement
|
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9.2.1(a)
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Infringement Notice
|
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9.2.1(a)
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Losses
|
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12.1
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Material Use
|
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7.1.2(d)(ii)(F)
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Milestone Payment Due Date
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7.1.2(d)(ii)(F)
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Non-Filing Party
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9.1.4
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Notice Period
|
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7.1.2(c)(iv)
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Patent Coordinator
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8.6
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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
|
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Definition
|
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Section
|
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Pre-approved Replacement Target
|
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3.5.1(b)
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Proceeding
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13.2
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Product Termination Notice
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7.1.2(d)(i)
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Quarterly Reconciliation Statement
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5.2.1
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Recipient Party
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3.7
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Requested Chemistry
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5.4.1(d)
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ROFN Notice
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7.1.2(c)(iv)
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TAKEDA Indemnitees
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12.1
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Term
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10.1
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Third Party Chemistry Payments
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5.4.1(d)
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Third Party Costs
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5.2.4
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Third Party Payments
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5.4.1(d)
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Transferring Party
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3.7
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Waived Target Designation Notice
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7.1.2(c)(i)
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2. ADMINISTRATION OF THE COLLABORATION
2.1 Joint Steering
Committee .
2.1.1
Establishment . Within [***] days from the Effective
Date, ARCHEMIX and TAKEDA shall identify the members of the Joint
Steering Committee. Unless otherwise agreed by the Parties, the
term for the JSC shall commence as of the Effective Date and
continue until the last day of the Research Program Term. The JSC
shall have and perform the responsibilities set forth in
Section 2.1.4.
2.1.2
Membership . Each Party shall designate in writing,
in its sole discretion, [***] members to the JSC, which shall be
employees of such Party or an Affiliate of such Party. Unless
otherwise agreed by the Parties, one of TAKEDA’s designees
shall be designated by TAKEDA 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 JSC, by giving written notice to the other
Party.
2.1.3
Meetings .
(a)
Schedule of Meetings; Agenda . The JSC shall establish a
schedule of times for regular meetings, taking into account the
planning needs of the Collaboration and its responsibilities. In
urgent cases, special meetings of the JSC 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 JSC meet less frequently than once in
each Fiscal Quarter. Regular and special meetings of the JSC 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
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
circulate to each JSC member an agenda for each JSC meeting not
later than one (1) week prior to such meeting.
(b)
Quorum; Voting. At each JSC meeting (i) the presence in
person of [***] member 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 JSC at such
meeting. Alternatively, the JSC may act by written consent signed
by [***] member designated by each Party. Whenever any action by
the JSC is called for hereunder during a time period in which the
JSC is not scheduled to meet, the Chair shall cause the JSC 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 JSC may
attend JSC meetings as non-voting observers with the consent of the
other Party, which shall not be unreasonably withheld, conditioned
or delayed.
(c)
Decisions. The JSC members shall use reasonable efforts to
reach unanimous agreement on any and all matters. Such reasonable
efforts shall, if reasonably requested by any member of the JSC,
include the engagement of a mutually acceptable Person who is not
affiliated with either Party and has particular experience or
expertise with respect to a particular matter to advise the JSC,
the expense of which engagement shall be borne equally by the
Parties. In the event that, despite such reasonable efforts,
agreement on a particular matter cannot be reached by the JSC
within [***] days after the JSC first meets to consider such matter
(each such matter, a "Disputed Matter"), then such Disputed Matter
will be decided pursuant to Section 2.1.6 and/or
Section 13.1.
(d)
Minutes . The JSC 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 JSC 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 JSC shall have the opportunity to
provide comments on the draft minutes. The minutes shall be
approved, disapproved and revised as necessary at the next JSC
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 JSC by the Chair.
2.1.4
Responsibilities . The JSC shall be responsible for
overseeing the conduct and progress of and making all significant
decisions regarding the scope, content, cost, and timing of the
Research Program. Without limiting the generality of the foregoing,
the JSC shall have the following responsibilities:
(a) overseeing
the JPT’s performance of its responsibilities;
(b) reviewing
and approving each Annual Research Plan;
(c) reviewing
and approving any amendment to an Annual Research Plan approved by
the JPT and submitted to it for its approval;
(d) reviewing
data, reports or other information submitted to it by the JPT from
time to time; 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
(e) resolving
all JPT matters that are in dispute;
(f) defining
the characteristics of the OLSC for each Program Target;
(g) reviewing
and either approving or rejecting any decision of the JPT to
nominate any Program Aptamer as an Optimized Lead Compound;
(h) determining
whether a Program Target should be designated as a Failed Target;
(i) determining
whether a milestone has been achieved under this Agreement for
which a milestone payment is payable;
(j) determining
the appropriate method of determining royalties for a Combination
Product pursuant to the last sentence of Section 5.4.1(i); and
(k) making
such other decisions as may be delegated to the JSC pursuant to
this Agreement or by mutual written agreement of the Parties after
the Effective Date.
2.1.5
Interests of the Parties . Notwithstanding any other
provisions of this Agreement, all decisions made and all actions
taken by the JSC shall be made or taken in the best interest of the
Collaboration.
2.1.6
Research Related Dispute Resolution . If a Disputed
Matter arises within the JSC through the course of seeking to make
decisions pursuant to Section 2.1.3(c), such Disputed Matter
shall be resolved pursuant to this Section 2.1.6. If the
Disputed Matter does not involve an Excepted Decision or an
ARCHEMIX Decision, and except as set forth in the last sentence of
this section, TAKEDA shall have the sole right to make the final
decision on such Disputed Matter, but shall only exercise such
right in good faith after full consideration of the positions of
both Parties. Notwithstanding the foregoing, (a) if the
Disputed Matter involves an ARCHEMIX Decision, then ARCHEMIX shall
have the sole right to make the final decision on such Disputed
Matter but shall only exercise such right in good faith after full
consideration of the positions of both Parties and (b) if the
Disputed Matter involves an Excepted Decision, the Disputed Matter
shall be resolved in accordance with Section 13.1. For
purposes of clarity, except with respect to ARCHEMIX Decisions and
Excepted Decisions, TAKEDA shall have the sole and final
decision-making authority regarding all issues with respect to the
Development of Optimized Lead Compounds and the Commercialization
of Products and under no circumstances shall the determination of
whether TAKEDA or ARCHEMIX has used or is using Commercially
Reasonable Efforts be submitted for resolution under this
Section 2.1.6 2.2 Joint
Project Team .
2.2.1
Establishment . Within [***] days from the Effective
Date, ARCHEMIX and TAKEDA shall identify the members of the Joint
Project Team. Unless otherwise agreed by the Parties, the term for
the JPT shall commence as of the Effective Date and continue until
the last day of the Research Program Term. The JPT shall have and
perform the responsibilities set forth in Section 2.2.4. 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
2.2.2
Membership . Each Party shall designate in writing,
in its sole discretion, [***] members to the JPT which shall be
employees of such Party or an Affiliate of such Party. Unless
otherwise agreed by the Parties, one of [***] designees shall be
designated by [***] 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.
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
urgent cases, 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 of the JPT shall prepare and
circulate to each JPT member an agenda for each JPT meeting no
later than [***] prior to such meeting.
(b)
Quorum; Voting . 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. 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 of
the JPT 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.
(c)
Decisions . The JPT shall resolve all matters before it by
unanimous vote of the JPT. In the event that the JPT is unable to
resolve any matter before it, such matter shall be referred to the
JSC for decision, and, in case the JSC is unable to resolve the
matter, it shall be resolved in accordance with Section 2.1.6.
(d)
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 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 of the
JPT 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 or revised as necessary at the next JPT
meeting; and then sent to the JSC members of each Party who may
nullify any decision by the JPT affecting the scope, content, cost,
and timing of the Research 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
Program. The decisions specified in the JPT minutes shall be
deemed ratified if no written objection is raised within [***] days
of the JPT minutes being sent to the JSC members. Upon approval,
final minutes of each meeting shall be circulated to the members of
the JPT by the chair of the JPT.
2.2.4
Responsibilities . The JPT shall be responsible for
overseeing the day-to-day conduct and progress of the Research
Program and the recommendation of Optimized Lead Compounds. Without
limiting the generality of the foregoing, the JPT shall have the
following responsibilities:
(a) preparing
or directing the preparation of all Annual Research Plans to be
submitted to the JSC for approval by the JSC;
(b) preparing
or directing the preparation of any amendments to an Annual
Research Plan that the JPT unanimously deems appropriate in
furtherance of the objectives of the Research Program as set forth
in the Annual Research Plan, provided, however, that only the JSC
may approve an amendment to an Annual Research Plan submitted to
the JSC for approval by the JSC;
(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;
(f) preparing
for the JSC on at least a semi-annual basis a progress report for
the Research Program in reasonable detail and providing to the JSC
such additional information as it may request;
(g) recommending
to the JSC amendments to the OLSC as it deems appropriate in
furtherance of the objectives of the Research Program, as set forth
in the Annual Research Plan;
(h) recommending
to the JSC that a Program Target be designated as a Failed Target;
(i) nominating
Program Aptamers as Optimized Lead Compounds for acceptance by the
JSC; and
(j) making
any other decisions as may be delegated to the JPT by JSC as
reflected in the approved minutes of the JSC.
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. 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
3. RESEARCH PROGRAM
3.1 Objectives of the Research
Program . The objectives of the Research Program shall be
the identification of Program Aptamers for nomination by the JPT to
the JSC for approval as Optimized Lead Compounds pursuant to this
Agreement. Except for the TAKEDA Research Activities, if any, which
shall be conducted by TAKEDA at its sole expense, ARCHEMIX shall
have the primary right and responsibility to conduct the Research
Program. 3.2 Annual Research
Plans
3.2.1
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 Fiscal Year of the
Research Program Term for the initial Program Targets shall be
prepared by the JPT and submitted to, and approved by, the JSC
within [***] days of the Effective Date. For each subsequent Fiscal
Year during the Research Program Term commencing with the second
Fiscal Year, an Annual Research Plan and budget shall be prepared
by or at the direction of the JPT and submitted to the JSC for its
approval. The JPT shall manage the preparation of each Annual
Research Plan in a manner designed to obtain JSC approval no later
than [***] days prior to the end of the then-current Fiscal Year.
Each Annual Research Plan shall: (a) set forth (i) the
research objectives and activities to be performed for the Fiscal
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 OLSC for each Program Target and any
other criteria that the JPT utilizes to evaluate the results of the
Research Program in order to nominate Optimized Lead Compounds for
Program Targets, (iv) the Party that shall be responsible for
performing such activities, (v) a timeline and budget for such
activities (including any Third Party Costs), and (vi) with
respect to ARCHEMIX Research Activities, the number of FTEs
estimated to be required to perform 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 Program
Aptamers or to determine whether Program Aptamers should be
nominated to the JSC as Optimized Lead Compounds. Any Annual
Research Plan may be amended from time to time by the JSC pursuant
to Section 2.1.4. Each amendment, modification and update to
the Annual Research Plan shall include the resulting changes to the
budget, including the number of FTEs to be utilized by ARCHEMIX,
and shall be set forth in a written document prepared by, or at the
direction of, the JPT and approved by the JSC, 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 JSC at which such amendment, modification or update was
approved by the JSC. Without limiting the nature or frequency of
any other amendments, modifications or updates to the Annual
Research Plan that may be approved by the JSC, the Annual Research
Plan shall be updated at least once prior to the end of each Fiscal
Year to describe the research activities to be carried out by each
Party during the upcoming Fiscal Year during the Research Program
Term in conducting the Research Program pursuant to this Agreement.
3.2.2
Minimum Research Commitment . TAKEDA shall at all
times during the Research Program Term provide research support for
a number of Program Targets equal to the 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
Minimum Program Target Commitment and ARCHEMIX shall provide
sufficient resources to perform its obligations pursuant to the
Annual Research Plan for such Program Targets.
3.2.3
Minimum FTE Funding Commitment . During the Research
Program Term, TAKEDA shall provide funding equal to at least the
Minimum FTE Funding Commitment for as many Program Targets as are
required under the Minimum Program Target Commitment.
3.3 Conduct of Research
Program .
3.3.1
ARCHEMIX Responsibilities . Except as set forth in
Section 3.3.2, ARCHEMIX shall have the primary right and
responsibility for all activities with respect to the Research
Program, including all activities with respect to the
identification of Program Aptamers, up through the identification
of an Optimized Lead Compound pursuant to Section 3.6. Without
limiting the foregoing, during the Research Program Term, ARCHEMIX
shall (a) conduct the ARCHEMIX Research Activities using the
number of FTEs set forth in the Annual Research Plan, and
(b) conduct the ARCHEMIX Additional Activities as requested by
TAKEDA pursuant to Section 4.3 using a standard of care not
less than Commercially Reasonable Efforts. For the first three
(3) Program Targets, ARCHEMIX shall insure that ARCHEMIX
Research Activities are initiated at a rate of [***] Program Target
per Fiscal Quarter with [***] Program Target being initiated, to
the extent possible, within [***] days of the Effective Date.
Notwithstanding the foregoing, in no event shall ARCHEMIX be
required to initiate ARCHEMIX Research Activities and/or ARCHEMIX
Additional Activities for more than [***] Program Target per [***].
3.3.2
TAKEDA Responsibilities . During the Research Program
Term, TAKEDA shall: (a) provide ARCHEMIX with such TAKEDA
Background Technology, and conduct such TAKEDA Research Activities,
if any, as may be necessary or useful to further the objectives of
the Research Program or as otherwise may be set forth in any Annual
Research Plan; (b) pay ARCHEMIX each Quarterly FTE Payment in
accordance with Section 5.2.1 and the R&D Funding to the
extent the R&D Funding exceeds the Quarterly FTE Payments;
(c) give ARCHEMIX not less than [***] days’ written
notice in the event that TAKEDA requires a number of FTEs above
[***] FTEs in any Fiscal Year; (d) commit such resources as
are reasonably necessary to conduct the TAKEDA Research Activities,
if any, set forth in any Annual Research Plan; and (e) use
Commercially Reasonable Efforts to conduct the TAKEDA Research
Activities, if any, set forth in any Annual Research Plan.
3.3.3
Compliance and Funding . Each Party shall perform its
obligations under each Annual Research Plan 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 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, benefits and taxes of its employees conducting
its activities under Article 3 of this Agreement. 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
3.3.4
Cooperation . Scientists at ARCHEMIX and TAKEDA 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 for the other Party to
perform its obligations under any Annual Research Plan.
3.4 Records .
3.4.1
Record Keeping .
(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 review such records to the extent
reasonably required for the performance of such other Party’s
obligations and/or exercise of such other Party’s rights
under this Agreement; provided, that, the non-reviewing Party may
redact information not relevant to the Research Program prior to
such review. Notwithstanding the foregoing, except in conjunction
with a Proceeding pursuant to Section 13.2, TAKEDA shall not
have the right to review any records relating to any Failed
Compounds, Waived Compounds or Terminated Products, except for
records relating to activities conducted in the Research Program,
in which case TAKEDA shall have the right to review such records
for up to [***] years after the designation of any such Failed
Compounds, Waived Compounds or Terminated Products for purposes of,
and in connection with, an audit conducted in accordance with
Section 5.2.3.
(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 and TAKEDA shall keep the JPT
regularly informed of the progress of the Research Program. Without
limiting the generality of the foregoing, (a) ARCHEMIX shall,
at each meeting of the JPT, (i) provide reports to the JPT in
reasonable detail regarding the status of its activities under the
Research Program, (ii) advise the JPT of its identification of
Program Aptamers and provide the JPT with any supporting data
applicable to such Program Aptamers, (iii) provide the JPT
with the results of activities conducted in the Research Program
with respect to each Program Aptamer so as to enable the JPT to
determine whether such Program Aptamer meets the OLSC and should be
proposed to the JSC as an Optimized Lead Compound, (iv) provide the
JPT with such additional information that it has in its possession
as may be reasonably requested from time to time by the JPT, and
(v) provide TAKEDA, on or before [***] days from the
termination or expiration of the Research Program Term, with a
final report regarding all ARCHEMIX Research Activities conducted
by ARCHEMIX during the Research Program Term to the extent not
previously included in the reports described above, and
(b) TAKEDA shall, at each meeting of the JPT, (i) provide
the JPT with reports in reasonable detail regarding the status of
all TAKEDA Research Activities, if any, and such additional
information that it has in its possession as may be reasonably
requested from time to time by the JPT and (ii) provide
ARCHEMIX, on or before [***] days from the termination or
expiration of the Research Program Term, with a final report
regarding all 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
TAKEDA Research Activities, if any, conducted by TAKEDA during
the Research Program Term to the extent not previously included in
the reports described above. 3.5
Selection of Program Targets .
3.5.1
Selection of Program Targets.
(a)
Initial Program Targets . The Parties hereby acknowledge and
agree that three (3) Program Targets, as set forth on
Schedule 2A , have been designated by the Parties as of
the Effective Date. The Parties further acknowledge and agree that
there is a [***]that [***] will [***] for the [***] and that the
Parties shall promptly, but in no event later than [***] months
from the initiation of ARCHEMIX Research Activities against any
such Program Target, evaluate the need to replace each such Program
Target with a Pre-approved Replacement Target. For purposes of
clarity, if after [***] months from the initiation of ARCHEMIX
Research Activities against a Program Target no Collaboration
Aptamers binding to such Program Target have been identified,
either Party shall have the right to designate such Program Target
a Failed Target; provided, that, if the other Party disagrees with
the designation, the Research Activities shall be carried out with
respect to such Program Target for an additional [***] months and
if no Aptamers have been identified upon the expiration of this
[***] month period, such Program Target shall be deemed to have
been designated a [***] by the JSC for purposes of this Agreement
without any further action of either Party.
(b)
Target Replacement List . The Parties hereby acknowledge and
agree that three (3)Targets, as set forth on the Target Replacement
List on Schedule 2B , have been designated by the
Parties as replacement Targets as of the Effective Date (each such
Target, a "Pre-approved Replacement Target"). TAKEDA shall have the
right at any time during the first two (2) Fiscal Years of the
Research Program Term to request that a Pre-approved Replacement
Target on the Target Replacement List be replaced with another new
Pre-approved Replacement Target for any reason in accordance with
Section 3.5.1(c). Upon designation of a Pre-approved
Replacement Target as a Program Target, the Pre-approved
Replacement Target will be removed from the Target Replacement List
and no additional Target will be added in its place on the Target
Replacement List.
(c)
Replacement of Pre-approved Replacement Targets on Target
Replacement List . To the extent TAKEDA has the right to
propose that a Target be added to the Target Replacement List as a
replacement for one of the then named Pre-approved Replacement
Targets as described in Section 3.5.1(b), TAKEDA shall provide
written notice to ARCHEMIX. ARCHEMIX shall accept or reject the
proposed Target within [***] days after receipt of such notice from
TAKEDA. A Target proposed by TAKEDA for inclusion as a Pre-approved
Replacement Target on the Target Replacement List shall only be
rejected by ARCHEMIX if: (i) ARCHEMIX is prohibited by an
executed contract from licensing Aptamers against such proposed
Target or its [***](s), (ii) ARCHEMIX is in active
negotiations with a Third Party with respect to a license,
collaboration or similar agreement relating to Aptamers against
such Target or its [***](s), (iii) ARCHEMIX is actively
researching or developing, and has not ceased to research or
develop, for its own benefit, Aptamers against such Target or its
[***](s) under an internal research or development program against
such Target; or (iv) ARCHEMIX reasonably believes in good
faith that the conduct of research and/or Development activities
with respect to 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
such Target as contemplated by this Agreement would infringe the
Patent Rights or misappropriate the Technology of a Third Party.
Should ARCHEMIX reject a proposed replacement Target for one of the
Pre-approved Replacement Targets on the Target Replacement List
under Section 3.5.1(c)(iii), if (i) ARCHEMIX discontinues its
internal research for such Target during the Research Program Term,
and (ii) TAKEDA is still able to replace a Pre-approved
Replacement Target at such time, then ARCHEMIX shall notify TAKEDA
of the ability to replace one of the Pre-approved Replacement
Targets on Target Replacement List with such previously nominated
Target.
(d)
Replacement of Program Targets . If at any time during the
first two (2) full years of the Research Program Term
following the Effective Date, (i) the JSC designates a Program
Target as a Failed Target or (ii) a Program Target becomes a
Waived Target, then (A) all activities under the Research
Program with respect to such Failed Target or Waived Target shall
cease; and (B) TAKEDA shall name one of the Pre-approved
Replacement Targets from the Target Replacement List as a Program
Target in place of such Failed Target or Waived Target within [***]
days of such date and ARCHEMIX shall begin work to the extent
possible on such new Program Target immediately thereafter.
(e)
Obligations of JPT . As promptly as practicable after
designation of a new Program Target in accordance with
Section 3.5.1(d), the JPT shall (i) develop and submit to
the JSC for its approval the OLSC for such new Program Target and
(ii) prepare an update to the Annual Research Plan to
(A) include the ARCHEMIX Research Activities to be conducted
to identify Program Aptamers against such new Program Target for
potential nomination as an Optimized Lead Compound and (B) identify
any Proprietary Materials, TAKEDA Background Technology and/or
TAKEDA Research Activities that will be provided or conducted by
TAKEDA pursuant to Section 3.3.2(a).
3.5.2
Termination of Replacement Right . Notwithstanding
anything to the contrary in this Agreement, TAKEDA’s right to
add Pre-approved Replacement Targets to the Target Replacement List
pursuant to Section 3.5.1(b) and/or replace Program Targets
pursuant to Section 3.5.1(d) shall terminate on the second
full year anniversary of the Effective Date of the Agreement.
3.6 Identification of Optimized
Lead Compounds . Within [***] days after its receipt of
each report from ARCHEMIX pursuant to Section 3.4.2
identifying a Program Aptamer as meeting the applicable OLSC (or
which either Party reasonably believes should be an Optimized Lead
Compound), the JPT shall review the data and information and
determine whether to nominate the Program Aptamer to the JSC for
designation as an Optimized Lead Compound. If the JPT elects to
nominate any such Program Aptamer as an Optimized Lead Compound,
the JPT shall promptly furnish all available information to the
JSC. The JSC shall consider such nomination within [***] days, and
if the JSC agrees that the Program Aptamer meets the OLSC, it shall
be designated as such by the JSC and such Program Aptamer shall be
deemed to be an Optimized Lead Compound for purposes of this
Agreement. Notwithstanding the above, TAKEDA shall have the
exclusive right to affirmatively designate a given Program Aptamer
as an Optimized Lead Compound at any time for any reason. For
purposes of clarity, any decision that a Program Aptamer does not
meet the applicable OLSC and thus should not be 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
designated an Optimized Lead Compound shall at all times be an
Excepted Decision pursuant to Section 1.38.
3.7 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 of the
Transferring Party for use in the Research Program. In connection
therewith, each Recipient Party hereby agrees that (a) it
shall not use such Proprietary Materials for any purpose other than
exercising its rights or performing its obligations under this
Agreement; (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 by this Agreement; (d) the Recipient Party shall not
acquire any right, title or interest in or to such Proprietary
Materials 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. 3.8 Research
Program Term . The Research Program shall commence on the
Effective Date and shall continue until the last day of the
Research Program Term. Notwithstanding the foregoing, if, upon the
expiration of the Research Program Term, ARCHEMIIX has not
completed any ARCHEMIX Research Activities contemplated by the
applicable Annual Research Plan, then, subject to TAKEDA continuing
to make the R&D Funding contemplated by Section 5.2.1 with
respect to such ARCHEMIX Research Activities, ARCHEMIX shall
continue to conduct such ARCHEMIX Research Activities until the
earlier of (a) the completion of such ARCHEMIX Research
Activities and (b) the fifth anniversary of the Effective
Date. 3.9 Evaluation of Program
Aptamers for Satisfaction of OLSC Prior to Expiration of Research
Program Term . Upon the [***] ARCHEMIX [***] in [***] to
[***] whether a [***] the [***], ARCHEMIX [***] TAKEDA [***] a
[***] of such [***] to [***] TAKEDA to [***], and, to the [***] in
[***] of such [***] to [***] TAKEDA to [***] whether such [***] the
[***]. TAKEDA [***]to [***] of such [***] of [***] to [***] whether
such [***] the [***] to [***] whether such [***] the [***].
3.10 Evaluation of Program
Aptamers for Satisfaction of OLSC After Expiration of Research
Program Term . To the extent that the Parties are
researching a particular Program Target as of the expiration of the
Research Program Term and TAKEDA is evaluating Collaboration
Aptamer(s) for such Program Target pursuant to Section 3.9,
then, regardless of the expiration of the Research Program Term,
TAKEDA shall have the time allotted under Section 3.9 to
evaluate whether such Collaboration Aptamer(s) satisfy the OLSC
before being required to vote whether such Collaboration Aptamer(s)
satisfy the OLSC. During such time extending beyond the expiration
of the Research Program Term, the Program Target(s) associated with
the Collaboration Aptamer(s) under evaluation shall remain Program
Target(s) and the Exclusivity Term shall be extended pursuant to
Section 1.40. 4. DEVELOPMENT PROGRAM; COMMERCIALIZATION
OF PRODUCTS 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
4.1 Objectives of the
Development Program . The objectives of the Development
Program shall be the selection and Development of Optimized Lead
Compounds and Products Derived therefrom to enable the
Commercialization of such Products in the Field in the Territory.
4.2 Responsibility for
Development and Commercialization of Products . TAKEDA
shall have [***] and [***], consistent with Commercially Reasonable
Efforts, for all aspects of the Development and Commercialization
of Products in the Field in the Territory, including, without
limitation, the conduct of: (a) all in vivo efficacy
studies and primate PK studies if desired, and all IND-enabling
non-clinical studies that are outside of the Research Program;
(b) all activities related to human clinical trials
(including, without limitation, Phase I Clinical Trials, Phase II
Clinical Trials and Phase III Clinical Trials); (c) all
activities relating to the manufacture and supply of Products
(including all required process development and scale up work with
respect thereto); and (d) all pre-marketing, marketing,
promotion, sales, distribution, import and export activities
(including securing reimbursement, conducting sales and marketing
activities and any post-marketing trials or post-marketing safety
surveillance and maintaining databases). Without limiting the
generality of the foregoing, TAKEDA shall have [***] in the
exercise of Commercially Reasonable Efforts, (i) to make all
Regulatory Filings for Products and file all Drug Approval
Applications and otherwise seek all Regulatory Approvals for
Products, as well as to conduct all correspondence and
communications with Regulatory Authorities regarding such matters,
and (ii) to report all Adverse Events to Regulatory
Authorities if and to the extent required by Applicable Laws. All
Regulatory Filings and Regulatory Approvals for Products shall be
owned by TAKEDA, subject to Sections 7.1.2(c) and 10.3.
4.3 Technical
Assistance . During the Term, ARCHEMIX may, upon
TAKEDA’s reasonable request, conduct ARCHEMIX Additional
Activities, that may be necessary or useful to assist TAKEDA or its
Affiliates and Sublicensees in the research, Development or
Commercialization of Products; provided, that, ARCHEMIX Additional
Activities shall be subject to the payment by TAKEDA of the R&D
Funding applicable thereto pursuant to Section 5.2.1. Unless
otherwise agreed to by the Parties, all ARCHEMIX Additional
Activities shall be conducted by ARCHEMIX at its facility. For
purpose of clarity, and notwithstanding Section 1.10(c),
ARCHEMIX will endeavour, to the extent that ARCHEMIX is reasonably
capable, to perform ARCHEMIX Additional Activities if such efforts
can reasonably be expected to benefit the Collaboration.
4.4 Development and
Commercialization Obligations .
4.4.1
Diligence Obligations . With respect to each Aptamer
that is designated as an Optimized Lead Compound, TAKEDA shall
exercise Commercially Reasonable Efforts during the Term to Develop
and Commercialize Products Derived from such Optimized Lead
Compound in the Field in the Territory.
4.4.2
Justification . If ARCHEMIX at any time believes that
TAKEDA is not meeting its diligence obligations pursuant to
Section 4.4.1, ARCHEMIX may give written notice to TAKEDA
describing, in as much detail as is reasonably possible, the bases
upon which it believes that TAKEDA is not meeting such diligence
obligations. TAKEDA shall provide ARCHEMIX with a written response
within [***] days after such written notice by ARCHEMIX is given,
responding to the allegations raised by ARCHEMIX as to whether
TAKEDA is meeting 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
its diligence obligations. In the event that TAKEDA does not
provide a good faith written response to ARCHEMIX within such [***]
day period, then ARCHEMIX shall have the option, in its sole
discretion, to deem TAKEDA to have materially breached this
Agreement pursuant to Section 10.2.2, but only as to the
Product(s) and country(ies) in relation to which ARCHEMIX raised
the assertion that TAKEDA has not met its diligence obligations. If
TAKEDA provides a good faith written response to ARCHEMIX within
such [***] day period, and if ARCHEMIX nonetheless maintains its
assertion that TAKEDA is not meeting such diligence obligations,
such dispute will be resolved according to Section 13.1. In
addition, if the Parties disagree as to whether the written
response provided by TAKEDA constitutes a good faith written
response, such dispute will be resolved according to
Section 13.1.
4.4.3
Uncontrollable Delays . The Parties understand and
agree that delays outside the control of TAKEDA may occur with
regard to the Development and/or Commercialization of Products and
that the occurrence of such delays, in and of themselves, shall not
be grounds for ARCHEMIX to claim that TAKEDA has not been using
Commercially Reasonable Efforts to avoid the occurrence of such
delays or to reduce the impact of such delays following their
occurrence.
4.4.4
Compliance . TAKEDA shall perform its Development and
Commercialization activities in good scientific manner and in
compliance in all material respects with all Applicable Laws. For
purposes of clarity, with respect to each activity 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, TAKEDA 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, benefits and taxes of its employees conducting its
activities under Article 4 of this Agreement.
4.5 Cooperation .
Scientists at ARCHEMIX and TAKEDA 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 the Development Program. 4.6
Exchange of Reports; Information; Updates .
4.6.1
Preclinical Development of Products . Subject to
Section 7.6.1(b), TAKEDA shall keep ARCHEMIX informed of the
progress of its preclinical efforts to Develop Products in the
Field in the Territory by providing ARCHEMIX at least once each
Fiscal Quarter with a report in reasonable detail regarding the
status of all preclinical IND-enabling studies and other
preclinical activities (including toxicology and pharmacokinetic
studies) for Products.
4.6.2
Clinical Development of Products . Subject to
Section 7.6.1(b), TAKEDA shall keep ARCHEMIX informed of the
progress of its clinical efforts to Develop Products in the Field
in the Territory by providing ARCHEMIX at least [***] with a report
in reasonable detail 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
regarding the status of all Products undergoing clinical
Development by TAKEDA in sufficient detail so as to allow ARCHEMIX
to monitor TAKEDA’s satisfaction of its diligence obligations
as set forth in Section 4.4.1. Such reports shall identify the
Regulatory Filings and Drug Approval Applications with respect to
such Product that TAKEDA or any of its Affiliates or Sublicensees
have filed, sought or obtained and summarize all clinical and other
data, whether positive or negative, generated by TAKEDA with
respect to Products.
4.6.3
Commercialization Reports . Subject to
Section 7.6.1(b), TAKEDA shall keep ARCHEMIX informed of the
progress of its efforts to Commercialize Products in the Field in
the Territory by providing ARCHEMIX at least [***] with a report in
reasonable detail regarding the status of all Products being
Commercialized by TAKEDA in sufficient detail so as to allow
ARCHEMIX to monitor TAKEDA’s satisfaction of its diligence
obligations as set forth in Section 4.4.
4.6.4
Adverse Event Reports . In addition to the updates
described in Sections 4.6.1 through 4.6.3, TAKEDA shall
provide ARCHEMIX with all Adverse Event information relating to
Products as required by the Applicable Law(s) under which such
Products are being Developed, such information to be compiled or
prepared by TAKEDA and provided to ARCHEMIX in the normal course of
TAKEDA’s business in connection with the Development of such
Products and, in any event, within time frames consistent with
reporting obligations under Applicable Laws. If TAKEDA determines
that any reported Adverse Event is aptamer-specific, TAKEDA shall
so notify ARCHEMIX within the earlier of [***] days or the time
frames that are consistent with reporting obligations under
Applicable Laws. In such event, ARCHEMIX may provide such Adverse
Event information to the extent reasonably necessary to licensees
of ARCHEMIX who are currently researching, Developing or
Commercializing Aptamers for therapeutic purposes; provided, that,
such licensees who are informed by ARCHEMIX (i) have already agreed
to maintain the confidentia
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