exv10w15



 





Exhibit 10.15




COLLABORATIVE RESEARCH AND LICENSE AGREEMENT




between




ARCHEMIX CORP.




and




ELAN PHARMA INTERNATIONAL, LIMITED




June 30, 2006




CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




 









 





TABLE OF CONTENTS




	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	Page
	1.	 	DEFINITIONS	 	 	1	 
	 
	 	 	 	 	 	 	 	 	 	 
	2.	 	ADMINISTRATION OF THE COLLABORATION	 	 	31	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	2.1	 	 	Joint Management Committee
	 	 	31	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	2.2	 	 	Joint Project Team
	 	 	35	 
	 
	 	 	 	 	 	 	 	 	 	 
	3.	 	RESEARCH PROGRAM	 	 	40	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.1	 	 	Implementation of the Research Program
	 	 	40	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.2	 	 	Research Plan; Annual Research Plans
	 	 	40	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.3	 	 	Conduct of Research Program
	 	 	42	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.4	 	 	Records
	 	 	43	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.5	 	 	Selection of Program Targets
	 	 	45	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.6	 	 	Identification of Collaboration Compounds, IL-23 Aptamers
and Lead Compounds
	 	 	47	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.7	 	 	Clinical Candidates
	 	 	47	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.8	 	 	Identification of Back-up Collaboration Compounds
	 	 	48	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.9	 	 	Failed Targets
	 	 	48	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.10	 	 	Supply of Proprietary Materials
	 	 	49	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	3.11	 	 	Research Program Term
	 	 	49	 
	 
	 	 	 	 	 	 	 	 	 	 
	4.	 	DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS	 	 	49	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.1	 	 	Objectives of the Development Program
	 	 	49	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.2	 	 	Responsibility for Development of Clinical Candidates and
Commercialization of Products
	 	 	49	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.3	 	 	Annual Development Plans
	 	 	50	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.4	 	 	Product Commercialization Plans
	 	 	51	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.5	 	 	Supply of Products for Development and Commercialization
	 	 	52	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.6	 	 	Development and Commercialization Diligence
	 	 	54	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.7	 	 	Compliance
	 	 	55	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.8	 	 	Cooperation
	 	 	55	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.9	 	 	Exchange of Reports; Information; Updates
	 	 	55	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.10	 	 	Development and Commercialization Rights and Restrictions
	 	 	58	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.11	 	 	Co-Development Option
	 	 	59	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	4.12	 	 	Reconciliation and Auditing of Operating Income (Loss)
	 	 	66	 
	 
	 	 	 	 	 	 	 	 	 	 
	5.	 	PAYMENTS	 	 	68	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	5.1	 	 	Upfront Fee
	 	 	68	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	5.2	 	 	R&D Funding
	 	 	68	 






CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




i 









 





	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	5.3	 	 	Milestone Payments
	 	 	70	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	5.4	 	 	Payment of Royalties; Royalty Rates;
Accounting and Records
	 	 	74	 
	 
	 	 	 	 	 	 	 	 	 	 
	6.	 	TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION	 	 	81	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	6.1	 	 	Confidentiality
	 	 	81	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	6.2	 	 	Publicity
	 	 	83	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	6.3	 	 	Publications and Presentations
	 	 	84	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	6.4	 	 	Prohibition on Solicitation
	 	 	84	 
	 
	 	 	 	 	 	 	 	 	 	 
	7.	 	LICENSE GRANTS; EXCLUSIVITY	 	 	85	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	7.1	 	 	Research and Development Licenses
	 	 	85	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	7.2	 	 	Commercialization License
	 	 	88	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	7.3	 	 	Right to Sublicense
	 	 	88	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	7.4	 	 	No Other Rights
	 	 	89	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	7.5	 	 	Exclusivity
	 	 	89	 
	 
	 	 	 	 	 	 	 	 	 	 
	8.	 	INTELLECTUAL PROPERTY RIGHTS	 	 	90	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8.1	 	 	ARCHEMIX Intellectual Property Rights
	 	 	90	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8.2	 	 	ELAN Intellectual Property Rights
	 	 	90	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8.3	 	 	Joint Technology Rights
	 	 	90	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8.4	 	 	Patent Coordinators
	 	 	91	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8.5	 	 	Inventorship
	 	 	91	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	8.6	 	 	Cooperation
	 	 	91	 
	 
	 	 	 	 	 	 	 	 	 	 
	9.	 	INTELLECTUAL PROPERTY	 	 	91	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	9.1	 	 	Patent Filing, Prosecution and Maintenance
	 	 	91	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	9.2	 	 	Legal Actions
	 	 	95	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	9.3	 	 	Trademark and Copyright Ownership Prosecution,
Defense and Enforcement
	 	 	100	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	9.4	 	 	Third Party Licenses
	 	 	101	 
	 
	 	 	 	 	 	 	 	 	 	 
	10.	 	TERM AND TERMINATION	 	 	101	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	10.1	 	 	Term
	 	 	101	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	10.2	 	 	Termination
	 	 	102	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	10.3	 	 	Consequences of Termination of Agreement
	 	 	103	 
	 
	 	 	 	 	 	 	 	 	 	 
	11.	 	REPRESENTATIONS AND WARRANTIES	 	 	110	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	11.1	 	 	Mutual Representations and Warranties
	 	 	110	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	11.2	 	 	Additional Representations of ARCHEMIX
	 	 	110	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	11.3	 	 	Acknowledgments of ELAN
	 	 	111	 






CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




ii 









 





	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	11.4	 	 	Acknowledgement of ARCHEMIX
	 	 	112	 
	 
	 	 	 	 	 	 	 	 	 	 
	12.

	 	INDEMNIFICATION
	 	 	112	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.1	 	 	Indemnification of ELAN by ARCHEMIX
	 	 	112	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.2	 	 	Indemnification of ARCHEMIX by ELAN
	 	 	113	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.3	 	 	Indemnification of Gilead and UTC by ELAN
	 	 	114	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.4	 	 	Co-Developed Products
	 	 	114	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.5	 	 	Conditions to Indemnification
	 	 	115	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.6	 	 	Warranty Disclaimer
	 	 	115	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	12.7	 	 	Limited Liability
	 	 	116	 
	 
	 	 	 	 	 	 	 	 	 	 
	13.	 	MISCELLANEOUS	 	 	116	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.1	 	 	Mediation
	 	 	116	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.2	 	 	Change of Control
	 	 	116	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.3	 	 	Notices
	 	 	120	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.4	 	 	Governing Law
	 	 	121	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.5	 	 	Binding Effect
	 	 	121	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.6	 	 	Headings
	 	 	121	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.7	 	 	Counterparts
	 	 	121	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.8	 	 	Amendment; Waiver
	 	 	121	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.9	 	 	No Third Party Beneficiaries
	 	 	122	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.10	 	 	Purposes and Scope
	 	 	122	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.11	 	 	Assignment and Successors
	 	 	122	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.12	 	 	Divestment Offer
	 	 	122	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.13	 	 	Force Majeure
	 	 	123	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.14	 	 	Interpretation
	 	 	123	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.15	 	 	Integration; Severability
	 	 	124	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.16	 	 	Equitable Relief
	 	 	124	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	13.17	 	 	HSR Filing
	 	 	124	 






CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




iii 









 





	 	 	 
	List of Exhibits and Schedules
	Exhibit A

	 	Annual Research Plan
	 
	 	 
	Exhibit B

	 	Annual Development Plan
	 
	 	 
	Schedule 1

	 	Program Targets
	 
	 	 
	Schedule 2

	 	Excluded Targets
	 
	 	 
	Schedule 3

	 	Licensed Patent Rights
	 
	 	 
	Schedule 4

	 	Calculation of Operating Income (Loss)
	 
	 	 
	Schedule 5

	 	Excluded Aptamers
	 
	 	 
	Schedule 6

	 	Clinical Candidate Selection Criteria
	 
	 	 
	Schedule 7

	 	Form of Press Release
	 
	 	 
	Schedule 8

	 	Regional Offices or Countries in which Patent
Applications are to be Nationalized or Otherwise
Prosecuted, Filed and Maintained
	 
	 	 
	Schedule 9

	 	Structure of ARC2350






CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




iv 









 





COLLABORATIVE RESEARCH AND LICENSE AGREEMENT




     This COLLABORATIVE RESEARCH AND LICENSE AGREEMENT (this “Agreement”) is entered into as of
June 30, 2006, by and between Archemix Corp., a Delaware corporation with offices at 300 Third
Street, Cambridge, MA 02142 (“ARCHEMIX”), and Elan Pharma International Limited, a private company
limited by shares organized under the laws of Ireland with offices at Monksland, Athlone, County
Westmeath, Ireland (“ELAN”). Each of ELAN and ARCHEMIX is sometimes referred to individually
herein as a “Party” and are sometimes referred to collectively as the “Parties.”



     WHEREAS, ARCHEMIX has developed and controls certain technology, patent rights and proprietary
materials related to (a) its proprietary IL-23 aptamers, (b) the identification and optimization of
other aptamers using its proprietary SELEXTM process and SELEXTM technology, and (c) the use of such
aptamers for treating, preventing or delaying onset or progression of human diseases or conditions;
and



     WHEREAS, ELAN is engaged in the research, development and commercialization of human
therapeutics; and



     WHEREAS, the Parties desire to enter into a collaboration for the purposes of (a) further
developing and commercializing ARCHEMIX’ IL-23 aptamers and (b) identifying aptamers against
targets that fulfill certain criteria, and developing and commercializing products derived from
such aptamers for the prevention, treatment and delay of onset or progression of disease.



     NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good
and valuable consideration, the Parties hereto, intending to be legally bound, hereby agree as
follows:



1. DEFINITIONS




     Whenever used in this Agreement with an initial capital letter, the terms defined in this
Section 1, Schedule 4 and elsewhere throughout the Agreement shall have the meanings
specified.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




 









 





     1.1 “AAA” means the American Arbitration Association.



     1.2 “Adverse Event” means any untoward, undesired or unplanned medical occurrence in a
human clinical trial subject or a patient, which occurrence has a temporal relationship to
administration of a Clinical Candidate or Product, whether or not considered related to the
Clinical Candidate or Product, including, without limitation, any undesirable sign (including
abnormal laboratory findings of clinical concern), symptom or disease that may be associated with
the use of such Clinical Candidate or Product.



     1.3 “Affiliate” means, with respect to any Person, any other Person that, directly or
indirectly, controls, or is controlled by, or is under common control with, such Person. For
purposes of this definition, “control” means (a) ownership of fifty percent (50%) or more of the
shares of stock entitled to vote for the election of directors in the case of a corporation, fifty
percent (50%) or more of the equity interests in the case of any other type of legal entity, (b)
status as a general partner in any partnership, or (c) any other arrangement whereby a Person
controls or has the right to control the board of directors of a corporation or equivalent
governing body of an entity.



     1.4 “[***] Agreement” means any transaction (including any partnership or strategic
alliance) between ARCHEMIX and a Third Party for the purpose of licensing that Third Party or
collaborating with that Third Party to identify, develop and commercialize therapeutic Aptamers
against [***] for the treatment of [***] diseases, but excluding (a) any transaction with a Third
Party involving any fee-for-service or sponsored research agreement or arrangement relating to
performance of services (including manufacturing) or research by a Third Party solely for ARCHEMIX,
or (b) any agreement or arrangement involving the payment to ARCHEMIX or any of its Affiliates of
governmental research or grant funding or research or grant funding from a non-profit organization
in the absence of a license, collaboration or similar agreement.



     1.5 “[***]” or “[***]” means the cleavage product of the [***] occurring
predominantly as the [***], as described in [***].



     1.6 “Annual Development Plan” means, with respect to each Clinical Candidate and
Contract Year, the written plan for the Development of such Clinical Candidate for such Contract



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




2









 




Year, as such written plan may be amended, modified or updated, as further described in section
4.3.




     1.7 “Annual Net Sales” means, with respect to any Calendar Year, the aggregate amount
of the Net Sales during such Calendar Year.



     1.8 “Annual Research Plan” means the written plan describing the activities to be
carried out by each Party during each Contract Year of the Research Program Term in conducting the
Research Program pursuant to this Agreement, as prepared by the JPT and approved by the JMC, and as
such written plan may be amended, modified or updated, as further described in Section 3.2.



     1.9 “Applicable Laws” means federal, state, local, national and supra-national laws,
statutes, rules and regulations, including any rules, regulations or requirements of Regulatory
Authorities, national securities exchanges or securities listing organizations, that are in effect
from time to time during the Term and apply to a particular activity hereunder.



     1.10 “Aptamer” means (i) any naturally or non-naturally occurring oligonucleotide
identified by ARCHEMIX through the SELEXÔ Process that binds with high specificity and
affinity to a Target; and (ii) any oligonucleotide Derived from the oligonucleotide of (i) that has
such high specifity and affinity.



     1.11 “Aptamer-Generic Patent Rights” means Patent Rights that cover only
Aptamer-Generic Technology.



     1.12 “Aptamer-Generic Technology” means any Technology relating generally to
aptamers, or their methods of use, that is not Program Aptamer Specific Technology.



     1.13 “ARCHEMIX Annual FTE Commitment” means the annual FTE commitment of ARCHEMIX to
the Research Program, which shall equal [***] FTEs per Contract Year, unless otherwise agreed by
the Parties.



     1.14 “ARCHEMIX Background Technology” means any Technology that is used by ARCHEMIX,
or provided by ARCHEMIX for use, or that is otherwise necessary or useful in the performance of the
Research Program, the Development or Co-Development of Lead Compounds, Clinical Candidates and/or
the Commercialization of Products that is (a) Controlled by



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




3









 




ARCHEMIX as of the Effective Date or (b) Made by employees of, or consultants to, ARCHEMIX after the Effective Date other than in the
conduct of ARCHEMIX Research Activities or ARCHEMIX Development Activities and without the use in a
material respect of any ELAN Technology, ELAN Materials, ELAN Patent Rights, ELAN Product Patent
Rights, ELAN Product Technology or Program Technology. For purposes of clarity, ARCHEMIX
Background Technology (a) shall include the SELEXTM Process and SELEXTM Technology and (b) shall not
include, and shall not be included in, ARCHEMIX Program Technology or ARCHEMIX’ interest in Joint
Technology.




     1.15 “ARCHEMIX Co-Development Percentage” means a whole number percentage less than or
equal to [***] percent ([***]%) and greater than or equal to [***] percent ([***]%) specified by
ARCHEMIX pursuant to Sections 4.11.1 and 4.11.2.



     1.16 “ARCHEMIX Decision” means a decision with respect to the following issues: (a)
how to perform the [***] against [***] identified for inclusion in the Research Program in
accordance with Section 3.5.1; (b) the expansion, [***], of the number of FTEs to be provided by
ARCHEMIX under the Research Program in any Contract Year beyond the ARCHEMIX Annual FTE Commitment
(including without limitation, the application of additional ARCHEMIX FTEs beyond the ARCHEMIX
Annual FTE Commitment to the [***]); (c) any activity requiring ARCHEMIX to apply significantly
(i.e., at least [***]%) more resources (other than FTEs) to the Research Program than are specified
by the Annual Research Plan; (d) to incur any [***] except as provided in Section 3.3.5; (e)
whether ELAN has nominated as a Program Target a Target that ARCHEMIX determines in good faith,
after consultation with, and, if requested by ELAN, obtaining a letter from, ARCHEMIX’ outside
counsel (which counsel shall be of nationally recognized reputation in the life sciences field)
confirming such determination, that an executed written agreement between ARCHEMIX and a Third
Party prohibits ARCHEMIX from allowing ELAN to designate such Target as a Program Target; provided,
that, to the extent permitted by
any such agreement, ARCHEMIX shall provide ELAN with a redacted copy of such agreement which
shall include those provisions that are reasonably relevant to such determination, subject to the
confidentiality obligations hereunder; and (f) whether ARCHEMIX should [***] obtain a license to a
Blocking Third Party Patent or any other Third Party Patent Rights. Notwithstanding



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




4









 




the foregoing, the characterization of the matters described in Section 1.16(b) above as an ARCHEMIX Decision
shall not affect the agreement of ARCHEMIX to reasonably consider in good faith using its
commercially reasonable discretion any requests of ELAN to increase the number of ARCHEMIX FTEs to
be provided in the Research Program beyond the ARCHEMIX Annual FTE Commitment or to increase other
resources to be utilized by ARCHEMIX in the Research Program.




     1.17 “ARCHEMIX Development Activities” means all Development or Co-Development
activities specified to be conducted by ARCHEMIX in any Annual Development Plan (or amendment
thereto) and approved by ARCHEMIX’ representatives on the JMC.



     1.18 “ARCHEMIX Field” means the use of Aptamers for all therapeutic purposes and
applications.



     1.19 “ARCHEMIX-Gilead License Agreement” means the License Agreement between Gilead
Sciences, Inc. and ARCHEMIX dated October 21, 2001, and any amendments thereto.



     1.20 “ARCHEMIX Materials” means any Proprietary Materials that are Controlled by
ARCHEMIX and used by ARCHEMIX, or provided by ARCHEMIX for use, in the Research Program, the
Development Program and/or any other activities conducted hereunder, and that are not Joint
Technology or Program Technology. For purposes of clarity, ARCHEMIX Materials shall include all
Aptamers Controlled by ARCHEMIX and provided by ARCHEMIX for use in the Research Program and/or for
the Development of Clinical Candidates that are not Joint Technology or Program Technology.



     1.21 “ARCHEMIX Patent Rights” means any Patent Rights Controlled by ARCHEMIX that
contain one or more claims that cover ARCHEMIX Technology.



     1.22 “ARCHEMIX Program Technology” means any Program Technology that (a) is not ELAN
Product Technology or Joint Technology, (b) is Made by or through employees of, or consultants to,
ARCHEMIX, alone or with a Third Party, and (c) does not use in a material respect or benefit in a
material respect from any ELAN Technology, ELAN Product Technology, ELAN Product Patent Rights,
ELAN Materials, ELAN Patent Rights or Joint Technology.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




5









 





     1.23 “ARCHEMIX Research Activities” means all activities specified to be conducted by
ARCHEMIX in any Annual Research Plan (or amendment thereto) that are (a) approved by the JMC and
(b) to the extent involving matters that are ARCHEMIX Decisions, approved by ARCHEMIX in accordance
with Section 2.1.5.



     1.24 “ARCHEMIX-SomaLogic Agreement” means the License Agreement by and between
ARCHEMIX and SomaLogic, Inc. dated as of September 4, 2003, and any amendments thereto.



     1.25 “ARCHEMIX Technology” means, collectively, ARCHEMIX Background Technology and
ARCHEMIX Program Technology.



     1.26 “Calendar Year” means each successive period of twelve (12) months commencing on
January 1 and ending on December 31.



     1.27 “Change of Control” means, with respect to a Party, (a) a merger, consolidation,
share exchange or other similar transaction involving such Party and any Third Party which results
in the holders of the outstanding voting securities of such Party immediately prior to such merger,
consolidation, share exchange or other similar transaction ceasing to hold more than fifty percent
(50%) of the combined voting power of the surviving, purchasing or continuing entity immediately
after such merger, consolidation, share exchange or other similar transaction, (b) any transaction
or series of related transactions (other than an investment transaction by an entity not engaged in
the pharmaceutical or biotechnology business, the purpose of which is to raise capital for a Party)
in which a Third Party, together with its Affiliates, becomes the beneficial owner of fifty percent
(50%) or more of the combined voting power of the outstanding securities of such Party, or (c) the
sale or other transfer to a Third Party of all or substantially all of such Party’s assets which
relate to this Agreement.



     1.28 “Clinical Candidate Selection Criteria” or “CCSC” means the guideline
criteria for selecting Lead Compounds that are sufficiently promising to warrant further
Development as Clinical Candidates (a) as set forth in Schedule 7 attached hereto for
IL-23, and (b) as such Schedule 7 shall be amended from time to time by the JMC with
respect to the other Program Targets listed on Schedule 1 as of the Effective Date and/or
to any other Program Target



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




6









 




to be included in the Research Program, which amendment shall occur
before any activities with respect to such Program Target are initiated, in any material respect, in the Research Program.




     1.29 “Co-Developed Product” means a Psoriatic Diseases Co-Developed Product and/or a
Non-Parenteral Co-Developed Product.



     1.30 “Co-Development” means Development of a Co-Developed Product after ARCHEMIX’
exercise of a Co-Development Option as described in Section 4.11.1.



     1.31 “Co-Development Territory” means any or all of: (a) the United States of America
and its territories and possessions; (b) all countries that comprise the European Union; and/or (c)
all countries other than those described in (a) or (b).



     1.32 “Collaboration” means the alliance of ARCHEMIX and ELAN established pursuant to
this Agreement for the purposes of identifying, researching and Developing Collaboration Aptamers
and Commercializing Products in the Territory.



     1.33 “Collaboration Aptamer” means any or all of IL-23 Aptamers, Development Leads,
Collaboration Compounds, Program Aptamers, Patented Aptamers, Lead Compounds, Clinical Candidates
and/or Products.



     1.34 “Collaboration Compound” means any Program Aptamer that binds a Program Target
other than IL-23 that is identified by performing the SELEXTM Process against a Program Target other
than IL-23 in the conduct of the Research Program or any Aptamer Derived therefrom that binds a
Program Target other than IL-23.



     1.35 “Collaboration Product” means any pharmaceutical or medicinal item, substance or
formulation that contains, incorporates or comprises a Collaboration Compound or any Aptamer
Derived therefrom that binds a Program Target other than IL-23.



     1.36 “Combination Product” means a combination or bundled product that is sold
together in a single package or as a unit at a single price by a Party, its Affiliate or
Sublicensee and that includes: (a) a Product; and (b) a Supplemental Product that is not within the
Licensed Patent Rights, where both the Product and the Supplemental Product are required to treat
the intended Indication and/or to achieve the intended use or effect.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




7









 





     1.37 “Commercialization” means any and all activities related to the offering for sale
and/or sale of a Product after Commercialization Regulatory Approval has been obtained, including
but not limited to activities related to marketing, manufacturing for commercial distribution,
educating providers and consumers, contracting, pharmacoeconomics studies, payer reimbursement,
promoting, detailing, distributing, importing, conducting post-marketing human clinical studies and
interacting with Regulatory Authorities regarding the foregoing. When used as a verb, to
“Commercialize” or “Commercializing” means to engage in Commercialization and “Commercialized” has
a corresponding meaning.



     1.38 “Commercially Reasonable Efforts” means (a) with respect to activities of
ARCHEMIX in the Research Program, or, with respect to the conduct of ARCHEMIX Development
Activities, or the Commercialization of Co-Developed Products, if any, the efforts and resources
comparable to those undertaken by ARCHEMIX in pursuing the research, discovery, development and
intellectual property protection of proprietary materials and the development of product candidates
and commercialization of products, as applicable, that are not subject to the Collaboration and
that are at an equivalent stage of development or commercialization and have similar market
potential and are at a similar stage in their lifecycle, and (b) with respect to activities of ELAN
in the Research Program, the Development of a particular Clinical Candidate or the
Commercialization of a particular Product, the efforts and resources comparable to those undertaken
by ELAN in pursuing intellectual property protection and development of product candidates and
commercialization of products, as applicable, that are not subject to the Collaboration and that
are at an equivalent stage of development or commercialization and have similar market potential
and are at a similar stage in their lifecycle. For purposes of both (a) and (b) above, all
relevant factors as measured by the facts and circumstances at the time such efforts are due shall
be taken into account, including, as applicable
D
and without limitation, mechanism of action; efficacy and safety; product profile; actual or
anticipated Regulatory Authority approved labeling; the nature and extent of market exclusivity
(including patent coverage, proprietary position and regulatory exclusivity; cost, time required
for and likelihood of obtaining Commercialization Regulatory Approval; competitiveness of



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




8









 




alternative products and market conditions; actual or projected profitability and availability of
capacity to manufacture and supply for commercial sale).




     1.39 “Commercialization Regulatory Approval” means, with respect to any Product, the
Regulatory Approval required by Applicable Laws to sell such Product in a country or region.
“Commercialization Regulatory Approval” shall include, without limitation, the approval of any Drug
Approval Application. For purposes of clarity, “Commercialization Regulatory Approval” in the
United States shall mean final approval of an NDA for a first Indication or sNDA for a second or
later Indication permitting marketing of the applicable Product in interstate commerce in the
United States. “Commercialization Regulatory Approval” in the European Union shall mean marketing
authorization for the applicable Product pursuant to Council Directive 2001/83/EC, as amended, or
Council Regulation 2309/93/EEC, as amended; and “Commercialization Regulatory Approval” in Japan
shall mean final approval of an application submitted to the Ministry of Health, Labor and Welfare
and the publication of a New Drug Approval Information Package permitting marketing of the
applicable Product in Japan, as any of the foregoing may be amended from time to time.



     1.40 “Competitive Entity” means any Third Party in the top [***] ([***]) companies
ranked by [***] in the most recently completed Calendar Year for which such ranking is readily
available from an unaffiliated Third Party.



     1.41 “Competitive Program” means any research, development or commercialization
activity that involves an aptamer that targets a Program Target.



     1.42 “Confidential Information” means (a) with respect to ARCHEMIX, all embodiments of
ARCHEMIX Technology and ARCHEMIX shall be deemed the “disclosing party” and ELAN the “receiving
party” with respect thereto; (b) with respect to ELAN, all embodiments of ELAN Technology and/or
ELAN Product Technology and ELAN shall be deemed the “disclosing party” and ARCHEMIX the “receiving
party” with respect thereto; and (c)
with respect to each Party, each of which shall be deemed both the “disclosing party” and
“receiving party” with respect thereto, (i) all embodiments of Joint Technology, (ii) all
information, Technology and Proprietary Materials, to the extent not described in (a) or (b),
disclosed or provided by or on behalf of such Party (the “disclosing Party”) to the other Party (the



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




9









 




“receiving Party”) or to any of the receiving party’s employees, consultants, Affiliates or
Sublicensees, (iii) the terms of this Agreement and (iv) all Technology generated hereunder in
connection with the Research Program, the Development (including the Co-Development) of Clinical
Candidates, and the Commercialization of Products; provided that none of the foregoing shall be
Confidential Information if: (A) as of the date of disclosure, it is known to the receiving Party
or its Affiliates, as demonstrated by credible written documentation, other than by virtue of a
prior confidential disclosure by or on behalf of the other Party; (B) as of the date of disclosure
it is in the public domain, or it subsequently enters the public domain through no unauthorized
disclosure and no fault of the receiving Party; (C) it is obtained by the receiving Party from a
Third Party having a lawful right to make such disclosure free from any obligation of
confidentiality to the other Party; or (D) it is independently developed by or for the receiving
Party without benefit from, reference to or use of any Confidential Information of the other Party
as demonstrated by credible written documentation. For purposes of clarity, unless excluded from
Confidential Information pursuant to the proviso at the end of the preceding sentence or otherwise
allocated to one or both of the Parties pursuant to (a), (b) or (c) above, (1) any scientific,
technical or financial information Controlled, as between the Parties, solely by one Party and
disclosed at any meeting of the JMC or JPT, or disclosed through an audit or other report under
this Agreement, shall constitute Confidential Information of the Controlling Party, and (2) any
data, documentation or other information regarding an Amyloid Beta Agreement disclosed by or on
behalf of ARCHEMIX pursuant to Section 4.10.2 shall constitute Confidential Information of
ARCHEMIX.




     1.43 “Contract Year” means (a) the period beginning on the Effective Date and ending
on the first anniversary of the last day of the calendar month in which the Effective Date falls
and (b) each succeeding twelve (12) month period thereafter.



     1.44 “Control” or “Controlled” means (a) with respect to Technology or Patent
Rights, the possession by a Party of the right to grant a license or sublicense to such Technology
or Patent Rights as provided herein without the payment of additional consideration to, and without
violating the terms of any agreement or arrangement with, any Third Party and without violating any
Applicable Laws and (b) with respect to Proprietary Materials, the possession by a



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




10









 





Party of the right to supply such Proprietary Materials to the other Party as provided herein without the
payment of additional consideration to, and without violating the terms of any agreement or
arrangement with, any Third Party and without violating any Applicable Laws.




     1.45 “Derived” means identified, obtained, developed, created, synthesized, generated,
designed or resulting from; based upon; containing or incorporating; conjugated to or complexed
with (whether directly or indirectly, or in whole or in part).



     1.46 “Development” or “Develop” means all pre-clinical and clinical activities
performed to obtain Regulatory Approval of a product up to and including the obtaining of
Commercialization Regulatory Approval of such product. For purposes of clarity, these activities
include, without limitation, test method development and stability testing, regulatory toxicology
studies, formulation, process development, manufacturing, manufacturing scale-up, development-stage
manufacturing, quality assurance/quality control development, statistical analysis and report
writing, clinical trial design and operations, preparing and filing Drug Approval Applications, and
all regulatory affairs related to the foregoing. When used as a verb, “Developing” means to engage
in Development and “Developed” has a corresponding meaning.



     1.47 “Development Costs” means the reasonable out-of-pocket costs and internal costs
incurred by a Party (or for its account by an Affiliate or a Third Party) consistent with the
respective Development activities of such Party as set forth in the Annual Development Plan or as
mutually agreed by the Parties, and specifically attributable to Development or Co-Development of a
Development Lead, Clinical Candidate or Product. For purposes of this definition (a) out-of-pocket
costs means the actual amounts paid to a Third Party for specific external Development or
Co-Development activities applicable to a Development Lead, Clinical Candidate or Product,
including, without limitation, Manufacturing Costs and all filing fees required for and other costs
associated with, any Regulatory Filings; (b) internal costs means the applicable FTE Rate
multiplied by the number of FTE hours utilized in the relevant period on activities directly
relating to the Development or Co-Development of a Development Lead, Clinical Candidate or Product
in accordance with the Annual Development Plan or as mutually agreed by the Parties; and (c) the
reasonable out-of-pocket and internal costs of obtaining Development Leads, Clinical Candidates or
Products for use in the activities in clause (a), including without limitation internal



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




11









 




Manufacturing Costs. For the avoidance of doubt, Development Costs shall include the costs
incurred by either Party in conducting clinical trials with respect to a Development Lead, Clinical
Candidate or Product.




     1.48 “Development Lead” means [***] (a) [***] the [***]and (b) [***] in [***] by [***]
for the [***] of [***].



     1.49 “Development Program” means, with respect to each Clinical Candidate, the
Development activities to be conducted during the Term with respect to such Development Lead or
Clinical Candidate pursuant to the Annual Development Plan, with the objective of developing such
Development Lead or Clinical Candidate into a Product.



     1.50 “Diagnosis” means (a) the determination or monitoring of (i) the presence or
absence of a disease, (ii) the stage, progression or severity of a disease or (iii) the effect on a
disease of a particular treatment; and/or (b) the selection of patients for a particular treatment
with respect to a disease. For purposes of clarity, the term Diagnosis shall not include the delay
of onset or progression of, or treatment or prevention of, an Indication.



     1.51 “Diagnostic Product” means In Vitro Diagnostics, In Vivo Diagnostic Agents and
any product used for Diagnosis.



     1.52 “Diligence Indication” means (i) for IL-23 Aptamers, each of Crohn’s Disease,
multiple sclerosis, psoriasis and rheumatoid arthritis, and (ii) for Collaboration Compounds other
than IL-23 Aptamers, any single Indication.



     1.53 “Drug Approval Application” means, with respect to a Product in a particular
country or region, an application for Commercialization Regulatory Approval for such Product in
such country or region, including without limitation: (a) an NDA or sNDA; (b) a counterpart of an
NDA or sNDA in any country or region in the Territory; and (c) all supplements and amendments
to any of the foregoing.



     1.54 “Early Stage Development Costs” means, with respect to a Co-Developed Product,
all Development Costs incurred by ELAN with respect to such Co-Developed Product during the period
commencing on the date of designation by ELAN of the Development Lead or Clinical Candidate from
which such Co-Developed Product was Derived, or constituting such Co-



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




12









 




Developed Product, and continuing up to the date that the Parties begin Co-Developing that Co-Developed Product.




     1.55 “ELAN Background Technology” means any Technology that is used by ELAN, or
provided by ELAN for use, or that is otherwise necessary or useful in the performance of the
Research Program, the Development or Co-Development of Lead Compounds or Clinical Candidates and/or
the Commercialization of Products that is (a) Controlled by ELAN as of the Effective Date or (b)
Made by employees of, or consultants to, ELAN after the Effective Date other than in the conduct of
ELAN Research Activities or ELAN Development Activities and without the use in a material respect
of any ARCHEMIX Technology, ARCHEMIX Patent Rights, ARCHEMIX Materials or Program Technology. For
purposes of clarity, ELAN Background Technology (a) shall not include, and shall not be included
in, ELAN Program Technology, ELAN Product Technology or ELAN’s interest in Joint Technology.



     1.56 “ELAN Decision” means any decision with respect to the following issues: (a)
subject to Section 3.5.1(b), the replacement of any Program Target with another Target; (b) the
nomination of an IL-23 Aptamer or a Collaboration Compound as a Lead Compound; (c) the nomination
of a Lead Compound as a Clinical Candidate; (d) the [***] of [***] to be [***] in [***] to the
[***]; (e) the use or application by ELAN of [***] and/or [***] and [***] in the conduct of the
Research Program and/or the Development of Clinical Candidates; and (f) whether ELAN should [***]
obtain a license to a Blocking Third Party Patent or any other Third Party Patent Rights.



     1.57 “ELAN Development Activities” means all Development activities specified to be
conducted by ELAN in any Annual Development Plan (or amendment thereto).



     1.58 “ELAN Materials” means any Proprietary Materials that are Controlled by ELAN and
used by ELAN, or provided by ELAN for use, in the Research Program, the Development Program and/or
any other activities conducted hereunder, and that are not Joint Technology or Program Technology.



     1.59 “ELAN Patent Rights” means any Patent Rights Controlled by ELAN that contain one
or more claims that cover ELAN Technology.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




13









 





     1.60 “ELAN Product Patent Rights” means any Patent Rights that contain one or more
claims that cover ELAN Product Technology.



     1.61 “ELAN Product Technology” means any Technology that is Made by employees of, or
consultants to, ELAN, alone or jointly with any other entity (including ARCHEMIX) in the course of
Development (but not Co-Development) of Development Leads and Clinical Candidates and/or
Commercialization of Products other than Co-Developed Products; provided however, that any
Technology that relates to the conduct of the SELEXTM Process or the use of the SELEXTM Technology
shall not be considered to be ELAN Product Technology. For purposes of clarity, ELAN Product
Technology shall not be included in Joint Technology.



     1.62 “ELAN Program Technology” means any Program Technology that (a) is not ELAN
Product Technology or Joint Technology; (b) is Made by or through employees of, or consultants to,
ELAN, alone or with any Third Party; and (c) does not use in a material respect or benefit in a
material respect from any ARCHEMIX Technology, ARCHEMIX Materials, ARCHEMIX Patent Rights or Joint
Technology.



     1.63 “ELAN Research Activities” means (a) all activities specified to be conducted by
ELAN in any Annual Research Plan (or amendment thereto) that are (i) approved by the JMC and (ii)
to the extent involving matters that are ELAN Decisions, approved by ELAN in accordance with
Section 2.1.5, and (b) all research activities conducted by ELAN with respect to any Development
Leads, Lead Compounds and Clinical Candidates undergoing Development and Products undergoing
Commercialization.



     1.64 “ELAN Technology” means, collectively, ELAN Background Technology and ELAN
Program Technology.



     1.65 “Enriched Pool” means a pool of oligonucleotides used to perform the SELEXTM
Process against a Program Target in the performance of the Research Program that (a) has undergone
[***] or more [***] of [***] and (b) wherein, using an [***] with [***] of [***] (i.e., [***] and
[***] of the applicable Program Target, at least [***]% of the input pool of [***] is [***] in the
assay by the Program Target and the [***] fraction of the [***] pool is at least [***] to the [***]
fraction for [***] (i.e., [***]) pool of [***].



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




14









 





     1.66 “Effective Date” means the date first set forth above.



     1.67 “Excepted Decision” means any of the following decisions requiring the unanimous
approval of all members of the JMC: (a) any decision as to whether a milestone has been achieved
under this Agreement for which a milestone payment is payable; (b) any Significant Co-Development
Decision made [***] Phase III Clinical Trials with respect to the Co-Development of a [***] in a
[***]; and (c) any disagreement between the Parties on the appropriate method of determining
royalties for a Combination Product in accordance with Section 5.4.1(f).



     1.68 “Excluded Aptamer” means any Aptamer listed on Schedule 5.



     1.69 “Excluded Target” means any Target listed on Schedule 2.



     1.70 “Failed Target” means any Program Target or proposed Program Target as to which
the JPT concludes and the JMC agrees that, after using Commercially Reasonable Efforts to identify
Aptamers, or based on prior activities of ARCHEMIX, [***] is unable or unlikely to identify [***]
against such Program Target.



     1.71 “FDA” means the United States Food and Drug Administration or any successor
agency or authority thereto.



     1.72 “FDCA” means the United States Federal Food, Drug, and Cosmetic Act, as amended.



     1.73 “First Commercial Sale” means, with respect to a Product in a country in the
Territory, the first sale, transfer or disposition for value to an end-user of such Product in such
country.



     1.74 “Force Majeure” means any occurrence beyond the reasonable control of a Party
that (a) prevents or substantially interferes with the performance by such Party of any of its
obligations hereunder and (b) occurs by reason of any act of God, flood, fire, explosion,
earthquake, strike, lockout, labor dispute, casualty or accident, or war, revolution, civil
commotion, act of terrorism, blockage or embargo, or any injunction, law, order, proclamation,



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




15









 




regulation, ordinance, demand or requirement of any government or of any subdivision, authority or
representative of any such government, to the extent and for the duration of such occurrence.




     1.75 “FTE” shall mean [***] hours of work devoted to or in support of the ARCHEMIX
Research Activities or the ARCHEMIX Development Activities that is carried out by one or more
employees, contract personnel or consultants of ARCHEMIX, measured in accordance with ARCHEMIX’
time allocation practices from time to time.



     1.76 “FTE Cost” means, for any period, the FTE Rate multiplied by the applicable
number of FTEs in such period.



     1.77 “FTE Rate” means [***] Dollars (US $[***]); provided that on January 1 of each
Calendar Year in the Term, commencing with January 1, 2007, the FTE Rate will be [***] by
multiplying the FTE Rate applicable on December 31 of the immediately preceding Calendar Year by
[***], where [***] is the Consumer Price Index for All Urban Consumers in the Boston Metropolitan
Area published by the Bureau of Labor Statistics of the United States Department of Labor for [***]
in the immediately preceding [***] and [***] is the Consumer Price Index for All Urban Consumers in
the Boston Metropolitan Area published by the Bureau of Labor Statistics of the United States
Department of Labor (i) for the [***] the Effective Date for the period commencing on the Effective
Date and continuing until the [***] of the [***] ended [***] and (ii) for each [***] thereafter,
for the [***] in the immediately preceding [***] (e.g. in [***] is [***] as at [***] and [***] is
[***] as at [***]). Any such [***] shall be rounded to the nearest [***] US Dollars ($[***]).



     1.78 “Fully-Exercised Co-Developed Product” means any Co-Developed Product with
respect to which the ARCHEMIX Co-Development Percentage is [***] percent ([***]%).



     1.79 “GAAP” means United States generally accepted accounting principles, consistently
applied.



     1.80 “Hatch-Waxman Act” means the Drug Price Competition and Patent Term Restoration
Act of 1984, as amended.



     1.81 “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




16









 





     1.82 “IL-23” means the Program Target designated and defined as IL-23 on Schedule
1 attached hereto.



     1.83 “IL-23 Aptamer” means (a) any Program Aptamer that binds IL-23 that is identified
by performing the SELEXTM Process against IL-23 in the conduct of the Research Program or any
Aptamer Derived therefrom that binds IL-23, and/or (b) any Aptamer that binds IL-23 that is covered
by one or more of the claims of the IL-23 Patent Applications or any Aptamer that binds IL-23
Derived therefrom. For purposes of clarity, IL-23 Aptamers include, without limitation, ARC2350
and all IL-23 Back-Up Compounds.



     1.84 “IL-23 Back_Up Compounds” means all IL-23 Aptamers other than ARC2350.



     1.85 “IL-23 Patent Applications” means (a) the following patent applications: (i)
United States Patent Application Serial No. 11/075649; (ii) PCT Patent Application Serial No.
US2005/007666; and (iii) United States Patent Application Serial No. 11/234676 and (b) all
applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters
patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign
counterparts of any of the foregoing.



     1.86 “IL-23 Product” means any pharmaceutical or medicinal item, substance or
formulation that contains, incorporates or comprises an IL-23 Aptamer or an Aptamer Derived
therefrom that binds specifically to IL-23.



     1.87 “IND” means: (a) an Investigational New Drug Application as defined in the FDCA
and regulations promulgated thereunder or any successor application or procedure required to
initiate clinical testing of a Clinical Candidate in humans in the United States; (b) a counterpart
of an Investigational New Drug Application that is required in any other country or region in
the Territory before beginning clinical testing of a Clinical Candidate in humans in such country
or region; and (c) all supplements and amendments to any of the foregoing.



     1.88 “IND Acceptance” means, with respect to an IND, the earlier of the receipt of
notification of acceptance of such IND from the FDA or the expiration of thirty (30) days from the
date of filing of such IND with the FDA.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




17









 





     1.89 “Indication” means any human disease or condition which can be treated,
prevented, cured or the onset or progression of which can be delayed and which would require the
filing of a separate NDA or sNDA to obtain Commercialization Regulatory Approval for such disease
or condition.



     1.90 “Initiation” means, with respect to a human clinical trial, the first date that a
subject or patient is dosed in such clinical trial.



     1.91 “In Vitro Diagnostics” means the use of the SELEXTM Process or Aptamers or
PhotoAptamers identified through the use of the SELEXTM 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 SELEXTM Process or Aptamers or
PhotoAptamers identified through the use of the SELEXTM Process in the assay, testing or
determination: (a) outside of a living organism, (i) of a human substance in a test material, often
to identify or follow the progression of a disease or disorder, or to select a patient for
treatment; (ii) of a plant substance, animal substance or other substance in a test material, often
to identify or follow the progression of a disease, process, or disorder in a human or non-human
organism; and (iii) of environmental substances (as in water quality testing); and (b) of a
substance on a test material such as cells (as in FACS analysis or other measurements of pathogens
within biological samples).



     1.92 “In Vivo Diagnostic Agent” means any product containing one or more Aptamers that
is used for any human in vivo diagnostic purpose related to (inter alia) the identification,
quantification or monitoring of the propensity toward, or actual existence of, any disease state.



     1.93 “Joint Management Committee” or “JMC” means the committee composed of
ARCHEMIX and ELAN representatives established pursuant to Section 2.1.



     1.94 “Joint Patent Rights” means Patent Rights that contain one or more claims that
cover Joint Technology.



     1.95 “Joint Project Team” or “JPT” means the committee composed of ARCHEMIX
and ELAN representatives established pursuant to Section 2.2.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




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     1.96 “Joint Technology” means (a) any Program Technology that is (i) jointly Made by
employees of, or consultants to, ELAN and employees of, or consultants to, ARCHEMIX in the
performance of the Research Program, or (ii) Made solely by employees of, or consultants to, either
Party with the use in a material respect of any Technology, Patent Rights or Proprietary Materials
Controlled by the other Party or any other Joint Technology; (b) any Program Aptamer; (c) any
Patented Aptamer; and (d) any Program Technology that relates to Pegylation. For purposes of
clarity, (i) any Program Technology that relates to the conduct of the SELEXTM Process or the use of
the SELEXTM Technology shall not be considered to be Joint Technology, and (ii) Joint Technology
shall not include any IL-23 Aptamers Made by ARCHEMIX as of the Effective Date, and any Product
Derived from any such IL-23 Aptamers without the use in a material respect of any Technology,
Patent Rights or Proprietary Materials Controlled by ELAN.



     1.97 “Knowledge” means, with respect to a Party, the actual knowledge of the chief
executive officer or any vice president of such Party.



     1.98 “Lead Selection Criteria” or “LSC” means the guideline criteria for
selecting Collaboration Compounds or IL-23 Aptamers that are sufficiently promising to warrant
further research as a Lead Compound, such criteria to be set forth in the Annual Research Plan with
respect to the Program Targets listed on Schedule 1 as of the Effective Date and/or to any
other Program Target to be included in the Research Program before any activities with respect to
such Program Target are initiated in the Research Program. For purposes of clarity, the LSC for a
Program Target shall include, at a minimum, binding affinity, specificity, activity and size
criteria but shall not include animal efficacy, animal toxicology, process development or cost of
goods criteria.



     1.99 “Licensed Patent Rights” means any ARCHEMIX Patent Rights and ARCHEMIX’ interest
in Joint Patent Rights that (a) contain one or more claims that cover any Collaboration Aptamer,
including its manufacture or its formulation or a method of its delivery or of its use, or (b)
claim inventions that are necessary for ELAN to exercise the licenses granted to it pursuant to
Sections 7.1.1 and 7.2.1 under the Licensed Patent Rights described in subsection (a). For
purposes of clarity, (a) the Licensed Patent Rights shall exclude any Patent Rights that relate to
the conduct of the SELEXTM Process and/or the use of the SELEXTM Technology; (b) the



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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Licensed Patent Rights as of the Effective Date include without limitation the Patent Rights
listed on Schedule 3 attached hereto; and (c) ARCHEMIX shall update Schedule 3 not
less than annually during the Term to add any additional Patent Rights that become Licensed Patent
Rights.



     1.100 “Licensed Technology” means any ARCHEMIX Technology and ARCHEMIX’ interest in
Joint Technology that (a) relates to any Collaboration Aptamer, including its manufacture or its
formulation or a method of its delivery or of its use or (b) is necessary for ELAN to exercise the
licenses granted to it pursuant to Section 7.1.1 and 7.2.1 under the Licensed Technology described
in subsection (a).



     1.101 “Made” means (a) with respect to patentable Technology, discovered, conceived or
first reduced to practice, whether actively or constructively, and (b) with respect to all other
Technology, first generated, identified, synthesized or developed.



     1.102 “Major Market Country” means [***] of the [***] and [***]For [***] of [***]
the[***] and [***]



     1.103 “NDA” means a New Drug Application, as defined in the FDCA and regulations
promulgated thereunder or any successor application or procedure required to sell a Product in the
United States.



     1.104 “Net Sales” means the gross amount billed or invoiced by ELAN or any of its
Affiliates or Sublicensees to Third Parties throughout the Territory for sales or other
dispositions or transfers for value of Products less (i) allowances for normal and customary trade
(including those granted in core distribution agreements and inventory management agreements),
quantity and cash discounts actually allowed and taken, (ii) transportation, insurance and postage
charges, if paid by ELAN or any Affiliate or Sublicensee of ELAN and included on any such entity’s
bill or invoice as a separate item, (iii) credits, chargebacks, rebates, returns pursuant to
agreements (including, without limitation, managed care agreements) or government regulations, to
the extent actually allowed, and (iv) any tax, tariff, customs duty, excise or other duty or other
governmental charge (other than a tax on income) levied on the sale, transportation or delivery of
Product and actually paid by ELAN, or any of its Affiliates or Sublicensees. In addition, Net
Sales are subject to the following:




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



20









 





          (a) If ELAN or any of its Affiliates or Sublicensees effects a sale, disposition or transfer
of a Product to a customer in a particular country other than on customary commercial terms or as
part of a package of products and services (but not in a Combination Product), the Net Sales of
such Product to such customer shall be deemed to be “the fair market value” of such Product. For
purposes of this subsection (a), “fair market value” shall mean the value that would have been
derived had such Product been sold as a separate product to another customer in the country
concerned on customary commercial terms.




          (b) In the case of pharmacy incentive programs, hospital performance incentive program
chargebacks, disease management programs, similar programs or discounts on “bundles” of products,
all discounts and the like shall be allocated among products on the basis on which such discounts
and the like were actually granted or, if such basis cannot be determined, in proportion to the
respective list prices of such products.




          (c) For purposes of clarity, use of any Product in clinical trials, pre-clinical studies or
other research or development activities, or disposal or transfer of Products for a bona fide
charitable purpose or purposes of a commercially reasonable sampling program shall not give rise to
any Net Sales.




     1.105 “Non-Parenteral” means all methods of administering a therapeutic substance or
medication to a patient that do not involve puncture of the skin or any active delivery through the
skin through the use of a device.



     1.106 “Non-Parenteral Co-Development Option” means any Co-Development Option for an
IL-23 Product intended to treat any Indication in a Non-Parenteral formulation.



     1.107 “Non-Parenteral Co-Developed Product” means any (a) IL-23 Product or (b) IL-23
Aptamer in Development as a Development Lead or a Clinical Candidate, in either case that is
intended to treat any Indication in a Non-Parenteral formulation and as to which ARCHEMIX has
exercised the Non-Parenteral Co-Development Option.



     1.108 “Non-Parenteral Option Termination Date” means, with respect to each potential
IL-23 Product Developed to treat any Indication in a Non-Parenteral formulation, the



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.






21









 








date estimated in good faith by ELAN to be [***] days before the date of Initiation of the
initial Phase II Clinical Trial with respect to such potential IL-23 Product.



     1.109 “Operating Income (Loss)” has the meaning set forth on Schedule 4
attached hereto.



     1.110 “Option Termination Date” means a Psoriatic Diseases Option Termination Date or
a Non-Parenteral Option Termination Date.



     1.111 “Patent Rights” means issued patents and pending patent applications (which, for
purposes of this Agreement, include certificates of invention, applications for certificates of
invention and priority rights) in any country or region, including all provisional applications,
substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent
granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign
counterparts of any of the foregoing.



     1.112 “Patented Aptamer” means any Aptamer claimed in or covered by Program
Aptamer-Specific Patent Rights.



     1.113 “Pegylation” means Technology relating to the covalent or non-covalent linking
of any polyalkylene oxide and/or polyalkylene ether moiety (including but not limited to
polyethylene glycol and polypropylene glycol) to another compound, such as an Aptamer.



     1.114 “Permitted Screening Activities” means, [***] to any [***]any [***] ARCHEMIX
[***] to such [***] for [***] for [***] for the [***] of [***] Aptamers [***] to a [***] a [***];
provided, however, [***] of a [***] as a [***] be a [***] if and only if (a) [***] with [***]
(i.e., [***] into a [***] ARCHEMIX [***] of any [***] or [***] as [***] under this [***] or if
ARCHEMIX [***] ARCHEMIX [***] under this [***] or (b) [***] is no [***], ARCHEMIX [***] ELAN, [***]
or [***] in the [***] ELAN, [***] as a[***] for such [***]



     1.115 “Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability company, business trust,
joint stock company, trust, incorporated association, joint venture or similar entity or
organization, including a government or political subdivision, department or agency of a
government.


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



22









 





     1.116 “Phase I Clinical Trial” means a clinical trial conducted in accordance with a
protocol approved by the JMC, in healthy humans or patients, which clinical trial is designed to
establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug
given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.



     1.117 “Phase II Clinical Trial” means a clinical trial conducted in patients with a
particular disease or condition in accordance with a protocol approved by the JMC, which clinical
trial is designed to establish the safety, appropriate dosage and pharmacological activity of an
investigational drug given its intended use, and to initially explore its efficacy for such disease
or condition.



     1.118 “Phase III Clinical Trial” means a pivotal clinical trial conducted in patients
with a particular disease or condition in accordance with a protocol approved by the JMC, which
clinical trial is designed to ascertain efficacy and safety of an investigational drug for its
intended use and to define warnings, precautions and Adverse Events that are associated with the
Clinical Candidate in the dosage range intended to be prescribed, with the purpose of preparing and
submitting applications for Regulatory Approval or label expansion to the pertinent Regulatory
Authority in any country.



     1.119 “Product” means any IL-23 Product and/or any Collaboration Product.



     1.120 “Product Commercialization Plan” means, with respect to each Product, the
written plan for the Commercialization of such Product in the Territory (including, without
limitation, expected manufacturing scale-up, manufacture, formulation and filling requirements for
such Product and a detailed strategy, budget and proposed timelines), as such plan may be amended
or updated.



     1.121 “Product Trademarks” means any trademark or trade name, whether or not
registered, or any trademark application or renewal, extension or modification thereof, in the
Territory, or any trade dress and packaging, in each case (a) that are applied to or used with any
Product by ELAN and (b) together with all goodwill associated therewith and promotional materials
relating thereto.


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



23









 





     1.122 “Program Aptamer” means any Program Oligonucleotide that is an Aptamer that
binds a Program Target and that is identified in the performance of the Research Program or during
Development and/or any Aptamer that binds a Program Target that is Derived from such Program
Oligonucleotide, regardless of its stage of research or Development, including, without limitation,
Lead Compounds and Clinical Candidates.



     1.123 “Program Aptamer-Specific Patent Rights” means all Patent Rights that cover only
Program Aptamer-Specific Technology.



     1.124 “Program Aptamer-Specific Technology” means any Program Technology that relates
specifically and solely to (i) any Program Aptamer, IL-23 Aptamer or Product or (ii) the
manufacture, formulation, delivery or use of a Program Aptamer, IL-23 Aptamer or Product.



     1.125 “Program Oligonucleotide” means the [***] and [***] obtained from an [***] and
[***] and [***] in the performance of [***] against a [***] that is not a [***].



     1.126 “Program Technology” means any Technology (including, without limitation, any
new and useful process, method of manufacture or composition of matter) or Proprietary Materials
that are Made by either Party in the conduct of the Research Program or the Co-Development of
Clinical Candidates and/or Co-Developed Products. For the avoidance of doubt, Program Technology
does not include, and is not included in, ELAN Background Technology, ARCHEMIX Background
Technology or ELAN Product Technology.



     1.127 “Program Target” means the Targets listed on Schedule 1, as amended from
time to time in accordance with Section 3.5; provided, however, that there shall be no more than
four (4) Targets listed on Schedule 1 at any point in time, and each of these shall be a
Target that ELAN reasonably believes based on publicly available literature or proprietary data has
activity in the Target Selection Field. For purposes of clarity, the term Program Target shall
include as the Target against which the SELEXTM Process may be performed (a) in the case of a
ligand, (i) the designated ligand and the designated components or subunits [***] and (ii) [***] to
which [***] and the [***] or [***] of such [***]but [***] any other [***] or other [***] that [***]
with such [***] or [***] or such [***] or [***]; (b) [***] of a [***], (i) the [***] and the [***]
or [***] of such [***], and (ii) a [***] to which [***] and the [***] or [***] of such [***] but
[***] any


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



24









 





other [***] or other [***] that [***] a [***] with such [***] or [***] or such [***] or[***];
(c) [***] of a [***] or [***] of a [***], (i) the [***], and (ii) a [***] to which [***] and the
[***]or [***] of such [***] but [***] any other [***] or other [***]that [***] a [***] with such
[***] or [***] or such [***] or [***]; and (d) [***] of a [***] or [***] of a [***], (i) the [***]
or [***], and (ii) a [***] to which [***] and the [***] or [***] of such [***]but [***] any other
[***] or other[***] that [***] a [***] with such [***] or [***] or such [***] or [***]. By way of
example, the [***] (i) the [***] and [***] and (ii) the [***] and [***].



     1.128 “Proprietary Materials” means tangible chemical, biological or physical
materials (a) that are furnished by or on behalf of one Party to the other Party in connection with
this Agreement, whether or not specifically designated as proprietary by the transferring Party or
(b) that are otherwise first Made by a Party in the conduct of the Research Program or the
Development Program.



     1.129 “Psoriatic Diseases” means psoriatic diseases, including without limitation
psoriasis and psoriatic arthritis.



     1.130 “Psoriatic Diseases Co-Development Option” means any Co-Development Option for a
parenteral formulation of an IL-23 Product intended to treat Psoriatic Diseases.



     1.131 “Psoriatic Diseases Co-Developed Product” means any (a) parenteral IL-23 Product
or (b) IL-23 Aptamer in Development as a Development Lead or Clinical Candidate in a parenteral
formulation, in either case that is intended to treat Psoriatic Diseases and as to which ARCHEMIX
has exercised the Psoriatic Diseases Co-Development Option.



     1.132 “Psoriatic Diseases Option Termination Date” means, with respect to each
parenteral formulation of a potential IL-23 Product Developed for the treatment of Psoriatic
Diseases, the date estimated in good faith by ELAN to be [***] ([***]) days before the date of
Initiation of the initial Phase II Clinical Trial with respect to that potential IL-23 Product.



     1.133 “Quarter” means the stub period beginning on the Effective Date and ending on
the last day of the calendar quarter in which the Effective Date falls, and thereafter each
successive period of three (3) consecutive calendar months ending on March 31, June 30, September
30 or December 31.


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



25









 





     1.134 “Radio Therapeutic” means any product for human therapeutic use that contains
one or more Aptamers that targets specifically any diseased tissue, cells or disease-specific
molecules or any tissue or cells which are affected by a disease or located in the close
neighborhood of a disease process and is linked to or incorporates (a) radionucleotides or (b) any
structure or elements which develop therapeutic effects similar to the effect of linking or
incorporating radionucleotides after submission of any kind of radiation.



     1.135 “Regulatory Approval” means, with respect to any country or region in the
Territory, any approval or license of any Regulatory Authority required for the manufacture, use,
storage, importation, exportation, transport, sale or other distribution of a Product for use in
such country or region.



     1.136 “Regulatory Authority” means the FDA, or any counterpart of the FDA outside the
United States, or any other national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity with authority over the
distribution, importation, exportation, manufacture, production, use, storage, transport, clinical
testing or sale of a Product.



     1.137 “Regulatory Filings” means, collectively: (a) all INDs, license applications,
drug master files, applications for designation as an “Orphan Product(s)” under the Orphan Drug
Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special
Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)),
NDAs, BLAs and all other similar filings (including, without limitation, counterparts of any of the
foregoing in any country or region in the Territory); (b) all supplements and amendments to any of
the foregoing; and (c) all data and other information contained in, and correspondence relating to,
any of the foregoing.



     1.138 “Rejected Program Target” means any Program Target that is rejected by written
notice from ELAN pursuant to Section 3.5.1(a).



     1.139 “Research Program” means the research program to be conducted by the Parties
during the Research Program Term pursuant to the Annual Research Plan, including but not limited to
the identification and initial testing of Collaboration Compounds and IL-23 Aptamers,


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



26









 





the selection of Lead Compounds from Collaboration Compounds and IL-23 Aptamers and the
selection of Clinical Candidates from such Lead Compounds for further Development. For purposes of
clarity, the Research Program does not include any Development activities performed in the course
of the Development Program.



     1.140 “Research Program Term” means, subject to Section 13.2.1(b), the period
beginning on the Effective Date and ending on the last day of the third Contract Year or such later
date as the Parties may mutually agree in writing; provided, that, if this Agreement is terminated
prior to the end of the Research Program Term, the effective date of such early termination
specified in the termination notice shall become the last day of the Research Program Term.



     1.141 “Royalty-Bearing Product” means (a) any Product that is not a Co-Developed
Product, (b) any Product contained in a Combination Product that is not a Co-Developed Product and
(c) any Co-Developed Product to the extent sold outside of a Co-Development Territory or for an
Indication or in a formulation other than one for which Co-Development occurs.



     1.142 “Royalty Term” means, with respect to each Royalty-Bearing Product in each
country in the Territory, the period beginning on the date of First Commercial Sale of such
Royalty-Bearing Product in such country and ending on the later to occur of (a) expiration of the
last to expire Valid Claim of the Licensed Patent Rights or ELAN Joint Product Patent Rights in
such country that covers such Royalty-Bearing Product or its identification, manufacture, use,
import, offer for sale or sale or (b) [***] years from the date of the First Commercial Sale of
such Royalty-Bearing Product in such country.



     1.143 “ROW” means all countries and territories of the world other than the United
States and its territories and possessions and the Major Market Countries.



     1.144 “SELEXTM  Portfolio” means those Patent Rights licensed by Gilead to
ARCHEMIX pursuant to the ARCHEMIX-Gilead License Agreement.



     1.145 “SELEXTM  Process” means any process for the identification or
generation of a nucleic acid that binds to a Target by means other than Watson-Crick base-pairing,
including without limitation any such process that (a) is covered by, or is described in, the
SELEXTM Portfolio, including without limitation U.S. Patent Nos. [***] or [***], (b) is covered by,
or is


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



27









 





described in, any other Patent Rights Controlled by ARCHEMIX, and (c) any continuations,
divisionals and continuations-in part substitutions, renewals, reissues, re-examinations and
extensions of and improvements to the inventions covered by, or described in, the foregoing Patent
Rights.



     1.146 “SELEXTM  Technology” means any process for modifying, optimizing
and/or stabilizing an aptamer wherein such modification, optimization or stabilization includes,
without limitation minimization, truncation, conjugation other than Pegylation, complexation,
substitution, deletion and/or incorporation of modified nucleotides.



     1.147 “Serious Adverse Event” means an Adverse Event occurring at any dose of a drug
that: results in death; poses an immediate risk of death; requires inpatient hospitalization;
results in a persistent and/or significant disability, illness or incapacity; or results in a
congenital anomaly or birth defect. An Adverse Event that does not fulfill the above criteria
nonetheless may be considered a Serious Adverse Event when, based upon reasonable medical judgment,
it may jeopardize the patient or subject and may require medical or surgical intervention to
prevent one of the above outcomes.



     1.148 “Significant Co-Development Decision” means (i) [***] that would [***] be [***]
to [***] the [***] of [***] and/or [***] to be [***]ARCHEMIX[***] a [***] with [***] and (ii) [***]
with [***] to the [***] and [***] of [***] to, the [***] of [***] for, and [***] and [***] with the
[***], such [***] for the [***] and [***].



     1.149 “sNDA” means a Supplemental New Drug Application, as defined in the FDCA and
applicable regulations promulgated thereunder.



     1.150 “Sublicense Agreement” means any agreement entered into by ELAN with a
Sublicensee.



     1.151 “Sublicensee” means any Third Party to which a Party grants a sublicense under
the licenses granted to it under Section 7.1 or 7.2.



     1.152 “Supplemental Product” means a product having independent, supplementary or
enabling therapeutic effect (e.g., as a catalyst or adjuvant) or diagnostic utility or that has
independent function as a medical device or means of administration.


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



28









 





     1.153 “Target” means a protein, cytokine, enzyme, receptor, transducer, transcription
factor, antigen or any other non-nucleic acid molecule.



     1.154 “Target Selection Field” means the treatment or prevention in humans of any
autoimmune or inflammatory Indication.



     1.155 “Technology” means, collectively, inventions, discoveries, improvements, trade
secrets and proprietary methods, whether or not patentable, including without limitation: (a)
methods of production or use of, and structural and functional information pertaining to, chemical
compounds and (b) compositions of matter, data, formulations, processes, techniques, know-how and
results (including without limitation any negative results).



     1.156 “Terminated Program Aptamer” means (a) all Program Aptamers that bind
specifically to any Rejected Program Target, (b) upon any termination of this Agreement by ARCHEMIX
pursuant to Section 10.2.3 or the first sentence of Section 10.2.2 or by ELAN pursuant to Section
10.2.1, all Collaboration Aptamers, and (c) upon any termination of ELAN’s license by ARCHEMIX
pursuant to the last sentence of Section 10.2.2, the relevant Collaboration Aptamers binding
specifically to the Program Target for which such license is terminated due to failure to meet its
diligence obligations, as provided in Section 10.3.4.



     1.157 “Territory” means all countries and territories of the world.



     1.158 “Third Party” means a Person other than ELAN and ARCHEMIX and their respective
Affiliates.



     1.159 “URC License Agreement” means the Restated Assignment and License Agreement,
dated July 17, 1991, by and between University Research Corporation and Gilead as successor in
interest to NeXstar.



     1.160 “UTC” means University Technology Corporation, the successor to the University
Research Corporation.



     1.161 “Valid Claim” means any claim of a pending patent application which has been
pending for a period of ten (10) years or less from its earliest priority filing date or an issued
unexpired patent that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



29









 





administrative agency or other body of competent jurisdiction, (b) has not been permanently
revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other
body of competent jurisdiction that is unappealable or unappealed within the time allowed for
appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not
lost through an interference proceeding.



     Additional Definitions. In addition, each of the following definitions shall have the
respective meanings set forth in the section of this Agreement indicated below:



	 	 	 	 	 
	Definition	 	Section
	[***] Notice Period

	 	 	4.10.2	 
	[***] Opportunity Notice

	 	 	4.10.2	 
	[***]ROFN Notice

	 	 	4.10.2	 
	ARCHEMIX Change of Control Notice

	 	 	13.2.1	(a)
	ARCHEMIX Indemnitees

	 	 	12.2	 
	Back-up Collaboration Compound

	 	 	3.8.1	 
	Blocking Third Party Patent

	 	 	9.4	 
	Claims

	 	 	12.1	 
	Clinical Candidate

	 	 	3.7	 
	Co-Development Net Sales

	 	 	4.12	(b)
	Co-Development Option

	 	 	4.11.1	(b)
	Co-Development Option Notice

	 	 	4.11.1	(b)
	Collaboration Manager

	 	 	2.2.6	 
	Dedicated Equipment

	 	 	3.3.5	 
	Designated Senior Officers

	 	 	2.1.5	 
	Disputed Matter

	 	 	2.1.5	 
	Divestment Opportunity Notice

	 	 	13.12	 
	Divestment Opportunity Notice Period

	 	 	13.12	 
	Divestment Opportunity ROFN Notice

	 	 	13.12	 
	ELAN Change of Control Notice

	 	 	13.2.2	(a)
	ELAN Indemnitees

	 	 	12.1	 
	Filing Party

	 	 	9.1.4	 
	50/50 Offset

	 	 	5.4.1	(c)
	Final Offer

	 	 	13.11	 
	Gilead Indemnitee

	 	 	12.5	 
	Indemnified Party

	 	 	12.5	 
	Indemnifying Party

	 	 	12.3	 
	Infringement

	 	 	9.2.1	(a)
	Infringement Notice

	 	 	9.2.1	(a)
	Lead Compound

	 	 	3.6.2	 
	Losses

	 	 	12.1	 
	Non-Filing Party

	 	 	9.1.4	 






CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



30









 






	 	 	 	 	 
	Definition	 	Section
	Non-Parenteral Option Exercise Period

	 	 	4.11.1	(b)
	Patent Coordinator

	 	 	8.4	 
	Proprietary Chemistry

	 	 	5.4.1	(c)
	Psoriatic Diseases Option Exercise Period

	 	 	4.11.1	(b)
	Quarterly Report

	 	 	4.12	 
	R&D Costs

	 	 	10.3.6	 
	Recipient Party

	 	 	3.10	 
	Refunded Products

	 	 	4.13	 
	Roll-Over Payment

	 	 	4.11.7	 
	Supply Agreement

	 	 	4.5.2	 
	Term

	 	 	10.1	 
	Third Party License

	 	 	5.4.1	(c)
	Third Party Payments

	 	 	5.4.1	(c)
	Transferring Party

	 	 	3.10	 






2. ADMINISTRATION OF THE COLLABORATION




     2.1 Joint Management Committee.



          2.1.1  Establishment. ARCHEMIX and ELAN hereby establish the Joint Management
Committee. The JMC shall have and perform the responsibilities set forth in Section 2.1.4.




          2.1.2  Membership. Each Party shall designate, in its sole discretion, [***] members
to the JMC, which shall be members of its, or its Affiliates’, management. Unless otherwise agreed
by the Parties, one of ELAN’s designees shall be designated by ELAN as the Chair. Each Party shall
have the right at any time to substitute individuals, on a permanent or temporary basis, for any of
its previously designated representatives to the JMC, by giving written notice to the other Party.
Initial designees of the Parties to the JMC shall be as follows:




	 	 	 	 	 
	 

	 	For ARCHEMIX:
	 	Duncan Higgons

Page Bouchard

Chuck Wilson
	 
	 	 	 	 
	 

	 	For ELAN:
	 	Ivan Lieberburg

Ted Yednock

Elizabeth Messersmith






CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



31









 






          2.1.3 Meetings.




               (a) Schedule of Meetings; Agenda. The JMC shall establish a schedule of times for
regular meetings, taking into account the planning needs of the Collaboration and its
responsibilities. Special meetings of the JMC may be convened by any member upon [***] days (or,
if such meeting is proposed to be conducted by teleconference, upon [***] days) written notice to
the other members; provided that (i) notice of any such special meeting may be waived at any time,
either before or after such meeting, and such waiver shall be the equivalent to the giving of a
valid notice hereunder, and (ii) attendance of any member at a special meeting shall constitute a
valid waiver of notice from such member. In no event shall the JMC meet less frequently than once
in each Calendar Year. Regular and special meetings of the JMC may be held in person or by
teleconference or videoconference; provided that meetings held in person shall alternate between
the respective offices of the Parties. The Chair shall prepare and circulate to each JMC member an
agenda for each JMC meeting not later than [***] prior to such meeting.



               (b) Quorum; Voting; Decisions. At each JMC meeting (i) the presence in person of at
least [***] members designated by each Party shall constitute a quorum. The JMC shall use
reasonable efforts in good faith to resolve by unanimous consent any issue within its jurisdiction.
Alternatively, the JMC may act by written consent signed by [***] member designated by each Party,
subject to Section 2.1.5. Whenever any action by the JMC is called for hereunder during a time
period in which the JMC is not scheduled to meet, the chair of the JMC shall cause the JMC to take
the action in the requested time period by calling a special meeting or by circulating a draft
written consent. If the JMC is unable to unanimously agree with respect to any issue,
notwithstanding the exercise of reasonable efforts, [***] shall have the tie-breaking vote as
stated in Section 2.1.5. Representatives of each Party or of its Affiliates who are not members of
the JMC, and consultants who are subject to confidentiality obligations no less stringent than
those contained herein, may attend JMC meetings as non-voting observers with the consent of the
other Party, which shall not be unreasonably withheld, conditioned or delayed.


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



32









 





               (c) Minutes. The JMC shall keep minutes of its meetings that record all decisions and
all actions recommended or taken in reasonable detail. Drafts of the minutes shall be prepared and
circulated to the members of the JMC within a reasonable time after the meeting, not to exceed
[***] business days. The chair of the JMC shall have responsibility for the preparation and
circulation of draft minutes. Each member of the JMC shall have the opportunity to provide
comments on the draft minutes. The minutes shall be approved, disapproved and revised as necessary
at the next JMC meeting or within [***] days of the meeting, whichever occurs first. Upon
approval, final minutes of each meeting shall be circulated to the members of the JMC by the chair
of the JMC.



               (d) Expenses. ARCHEMIX and ELAN shall each bear all expenses of their respective JMC
members related to their participation on the JMC and attendance at JMC meetings.



          2.1.4 Responsibilities. The JMC shall be responsible for (a) overseeing the conduct
and progress of the Research Program, and (b) providing a forum for the exchange of information
between the Parties with respect to the Development of Program Aptamers, Lead Compounds and
Clinical Candidates that are, or are eligible for designation as, Co-Developed Products and the
Co-Development and Commercialization of Co-Developed Products in the applicable Co-Development
Territory(ies), Indication and formulation; provided however, that the JMC shall not be responsible
for overseeing the Development or Commercialization of any Products. Without limiting the
generality of the foregoing, the JMC shall have the following responsibilities:




               (a) overseeing the JPT’s performance of its responsibilities;



               (b) reviewing each Annual Research Plan, each Annual Development Plan for Clinical Candidates
eligible for designation as Co-Developed Products and for Co-Developed Products in the applicable
Co-Development Territory(ies), Indication and formulation, and, only if ELAN alone (rather than
with or through a Sublicensee) is Commercializing a Co-Developed Product, each Product
Commercialization Plan for a Co-Developed Product in the applicable Co-Development Territory(ies),
Indication and formulation (including all budgets applicable thereto); provided, that, ELAN agrees
to use Commercially



CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



33









 







Reasonable Efforts to include the JMC rights set forth in this Section 2.1.4(b) in each
Sublicense Agreement;



               (c) approving any Annual Research Plan;



               (d) directing the preparation of, and reviewing each amendment to, any Annual Research Plan
and/or budget applicable thereto;



               (e) approving any amendment or update to an Annual Research Plan;



               (f) reviewing data, reports or other information submitted to it by the JPT from time to time;



               (g) discussing the progress of the Commercialization of each Co-Developed Product in the
applicable Co-Development Territory(ies), Indication and formulation in accordance with the
applicable Product Commercialization Plan, if ELAN alone (rather than with or through a
Sublicensee) is marketing a Co-Developed Product; provided, that, ELAN agrees to use Commercially
Reasonable Efforts to include the JMC rights set forth in this Section 2.1.4(g) in each Sublicense
Agreement;



               (h) resolving all JPT matters that are in dispute;



               (i) reviewing any proposal of the JPT to nominate any Collaboration Compound or IL-23 Aptamer
as a Lead Compound or any proposal of the JPT to nominate any Lead Compound as a Clinical
Candidate; and



               (j) making such other decisions as may be delegated to the JMC pursuant to this Agreement or
by mutual written agreement of the Parties after the Effective Date.



          2.1.5 Dispute Resolution. The JMC members shall use reasonable efforts to reach
agreement on any and all matters. In the event that, despite such reasonable efforts, agreement on
a particular matter cannot be reached by the JMC within [***] days after the JMC first meets to
consider such matter (each such matter, a “Disputed Matter”), then, if the Disputed Matter involves
an ELAN Decision or any matter other than an Excepted Decision or an ARCHEMIX Decision, and except
as set forth in the last sentence of this section, ELAN shall




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



34









 








have the right to make the final decision on such Disputed Matter, but shall only exercise
such right in good faith using its commercially reasonable discretion after consideration of the
positions of both Parties. Notwithstanding the foregoing, (i) if the Disputed Matter involves an
ARCHEMIX Decision, then ARCHEMIX shall have the right to make the final decision on such Disputed
Matter but shall only exercise such right in good faith using its commercially reasonable
discretion after consideration of the positions of both Parties, and (ii) if the Disputed Matter
involves an Excepted Decision, the Chair of the JMC shall refer such Disputed Matter to the
President of ARCHEMIX and the President (US) of ELAN (the “Designated Senior Officers”), who shall
promptly initiate discussions in good faith to resolve such Disputed Matter. If the Disputed
Matter is not resolved by the Designated Senior Officers within thirty (30) days after the date the
Designated Senior Officers first met to consider such Disputed Matter or sixty (60) days after the
date the JMC first met to consider such Disputed Matter, then subject to Section 13.1, either Party
may seek any remedy, at law or in equity, that may be available. For purposes of clarity, under no
circumstances shall the determination of whether ELAN or ARCHEMIX has used or is using Commercially
Reasonable Efforts be submitted for resolution under this Section 2.1.5.



     2.2 Joint Project Team.



          2.2.1 Establishment. ARCHEMIX and ELAN hereby establish the Joint Project Team. The
JPT shall have and perform the responsibilities set forth in Section 2.2.4.




          2.2.2 Membership. Each Party shall designate, in its sole discretion, [***] members
to the JPT (which members shall be employees or consultants of such Party or an Affiliate of such
Party). Unless otherwise agreed by the Parties, one of ARCHEMIX’ designees shall be designated by
ARCHEMIX as the chair of the JPT. Each Party shall have the right at any time to substitute
individuals, on a permanent or temporary basis, for any of its previously designated
representatives to the JPT, by giving written notice to the other Party. Initial designees of the
Parties to the JPT shall be as follows:




	 	 	 	 	 
	 

	 	For ARCHEMIX:
	 	Shannon Pendergrast

Sharon Cload

Page Bouchard (Chair)






CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



35









 






	 	 	 	 	 
	 

	 	For ELAN:
	 	Nicki Vasquez

Brian Wipke

Jane Gunther






          2.2.3 Meetings.




               (a) Schedule of Meetings; Agenda. The JPT shall establish a schedule of times for
regular meetings, in no event less frequently than once per [***] taking into account, without
limitation, the planning needs of the Research Program and its responsibilities. In addition,
special meetings may be convened by any member upon [***] days (or, if such meeting is proposed to
be conducted by teleconference, upon [***] days) written notice to the other members; provided that
(i) notice of any such special meeting may be waived at any time, either before or after such
meeting, and such waiver shall be the equivalent to the giving of a valid notice hereunder, and
(ii) attendance of any member at a special meeting shall constitute a valid waiver of notice from
such member. Regular and special meetings of the JPT may be held in person or by teleconference or
videoconference; provided that meetings held in person shall alternate between the respective
offices of the Parties. The Chair shall prepare and circulate to each JPT member an agenda for
each JPT meeting no later than [***] prior to such meeting.



               (b) Quorum; Voting; Decisions. At each JPT meeting, (i) the presence in person of at
least [***] members designated by each Party shall constitute a quorum and (ii) all members
designated by each Party who are present shall have [***] on all matters before the JPT at such
meeting. All decisions of the JPT shall be made by unanimous vote. Alternatively, the JPT may act
by written consent signed by at least [***] members designated by each Party. Whenever any action
by the JPT is called for hereunder during a time period in which the JPT is not scheduled to meet,
the Chair shall cause the JPT to take the action in the requested time period by calling a special
meeting or by circulating a written consent. Representatives of each Party or of its Affiliates
who are not members of the JPT (including, without limitation, the Patent Coordinators) may attend
JPT meetings as non-voting observers without the consent of the other Party. In the event that the
JPT is unable to resolve any matter before it, such matter shall be referred to the JMC to be
resolved in accordance with Section 2.1.5.



               (c) Minutes. The JPT shall keep minutes of its meetings that record all decisions and
all actions recommended or taken in reasonable detail. Drafts of the minutes


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



36









 





shall be prepared and circulated to the members of the JPT within a reasonable time after the
meeting, not to exceed [***] business days. The chair shall have responsibility for the
preparation and circulation of draft minutes. Each member of the JPT shall have the opportunity to
provide comments on the draft minutes. The minutes shall be approved, disapproved and revised as
necessary at the next JPT meeting. Upon approval, the chair of the JPT shall circulate final
minutes of each meeting to the members of the JPT.



               (d) Expenses. ARCHEMIX and ELAN shall each bear all expenses of their respective JPT
members related to their participation on the JPT and attendance at JPT meetings.



          2.2.4 Responsibilities. The JPT shall be responsible for (i) overseeing the conduct
and progress of the Research Program and (ii) recommending Program Aptamers to the JMC for
nomination as Lead Compounds and Clinical Candidates. Without limiting the generality of the
foregoing, the JPT shall have the following responsibilities:




               (a) preparing or directing the preparation of, and recommending to the JMC for its approval,
all Annual Research Plans and budgets therefor;



               (b) preparing or directing the preparation of all amendments to JMC-approved Annual Research
Plans as it deems appropriate in furtherance of the objectives of the Research Program as set forth
in the Annual Research Plan and submitting such amendments to the JMC for its consideration;



               (c) monitoring the progress of each Annual Research Plan and of each Party’s activities
thereunder;



               (d) providing a forum for consensual decision making with respect to the Research Program;



               (e) reviewing data, reports or other information submitted by either Party with respect to
work conducted in the Research Program;


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



37









 





               (f) preparing for the JMC on at least a semi-annual basis a progress report for the Research
Program in reasonable detail and providing to the JMC such additional information as it may
request;



               (g) recommending amendments to the Lead Selection Criteria and Clinical Candidate Selection
Criteria as it deems appropriate, in furtherance of the objectives of the Research Program as set
forth in the Research Plan;



               (h) considering the need for, and recommending as appropriate, the identification and research
of Back-Up Collaboration Compounds;



               (i) nominating Collaboration Compounds or IL-23 Aptamers as Lead Compounds for acceptance by
the JMC;



               (j) nominating Lead Compounds as Clinical Candidates for acceptance by the JMC;



               (k) discussing all Annual Development Plans for Co-Developed Products in the applicable
Co-Development Territory(ies), Indication and formulation;



               (l) discussing all amendments to the Annual Development Plans described in Section 2.2.4(k),
above and submitting such amendments to the JMC for its consideration;



               (m) reviewing data, reports or other information submitted by either Party with respect to
work conducted in the Development of Clinical Candidates that are, or are eligible for designation
as, Co-Developed Products;



               (n) preparing for the JMC on at least an annual basis a reasonably detailed progress report
regarding the Development of Development Leads and Clinical Candidates that are, or are eligible
for designation as, Co-Developed Products in the applicable Co-Development Territory(ies),
Indication and formulation and providing to the JMC such additional information as it may
reasonably request on this subject;


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



38









 





               (o) implementing a mutually acceptable mechanism for reporting Adverse Events between the
Parties for each Development Lead, Clinical Candidate and Product;



               (p) discussing strategies for the promotion and marketing of all Co-Developed Products in the
applicable Co-Development Territory(ies), Indication and formulation if ELAN alone (rather than
with or through a Sublicensee) is or will be promoting and marketing a Co-Developed Product;
provided, that, ELAN agrees to use Commercially Reasonable Efforts to include the JPT rights set
forth in this Section 2.2.4(p) in each Sublicense Agreement;



               (q) discussing the Product Commercialization Plan for each Co-Developed Product in the
applicable Co-Development Territory(ies), Indication and formulation, if ELAN alone (rather than
with or through a Sublicensee) is or will be Commercializing a Co-Developed Product; provided,
that, ELAN agrees to use Commercially Reasonable Efforts to include the JPT rights set forth in
this Section 2.2.4(q) in each Sublicense Agreement;



               (r) discussing the short-term and long-term sales forecasts for Co-Developed Products in the
applicable Co-Development Territory(ies), Indication and formulation if ELAN alone (rather than
with or through a Sublicensee) is or will be Commercializing a Co-Developed Product; provided,
that, ELAN agrees to use Commercially Reasonable Efforts to include the JPT rights set forth in
this Section 2.2.4(r) in each Sublicense Agreement;



               (s) discussing all recalls, market withdrawals and any other corrective actions related to
Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation;
and



               (t) making any other decisions and performing such activities as may reasonably be delegated
to the JPT pursuant to this Agreement or by mutual written agreement of the Parties after the
Effective Date.



          2.2.5 Interests of the Parties. Notwithstanding any other provisions of this
Agreement, all decisions made and all actions taken by the JPT shall be made or taken in the best
interest of the Collaboration.




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



39









 








          2.2.6 Alliance Management. Each Party shall appoint a person who shall oversee
contact between the Parties for all matters related to the Collaboration between meetings of the
JMC and JPT and shall have such other responsibilities as the Parties may mutually agree in writing
after the Effective Date (each, a “Collaboration Manager”). Each Party may replace its
Collaboration Manager at any time by notice in writing to the other Party. The initial
Collaboration Managers shall be:




	 	 	 	 	 
	 

	 	For ARCHEMIX:
	 	Page Bouchard
	 
	 	 	 	 
	 

	 	For ELAN:
	 	Brian Wipke






3. RESEARCH PROGRAM




     3.1 Implementation of the Research Program. The objectives of the Research Program
shall be the identification of (i) Collaboration Compounds or IL-23 Aptamers for nomination by the
JPT to the JMC for approval as Lead Compounds and (ii) Lead Compounds for recommendation by the JPT
to the JMC as Clinical Candidates for Development with a view to the subsequent Commercialization
of Products Derived therefrom. Except for the ELAN Research Activities, if any, which shall be
conducted by ELAN at its sole expense, ARCHEMIX shall conduct the Research Program.



     3.2 Research Plan; Annual Research Plans. The initial Annual Research Plan and
budget, which describes the research activities to be carried out by each Party during the first
Contract Year of the Research Program Term, shall be prepared by the JPT, submitted to the JMC for
its approval and attached hereto as Exhibit A within [***] days of the Effective Date. For
each Contract Year during the Research Program Term commencing with the second Contract Year, an
Annual Research Plan and budget shall be prepared by or at the direction of the JPT and submitted
to the JMC for its approval. The JPT shall manage the preparation of each Annual Research Plan in
a manner designed to obtain JMC approval no later than [***] days prior to the end of the
then-current Contract Year. Each Annual Research Plan shall: (a) set forth (i) the research
objectives and activities to be performed for the Contract Year covered by the Annual Research Plan
with reasonable specificity, (ii) the research plans and protocols to be employed to complete each
stage of the Research Program, (iii) changes to the LSC, CCSC and


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



40









 





other criteria or changes thereto that the JPT will utilize to evaluate the results of the
Research Program to nominate Lead Compounds and Clinical Candidates, (iv) the Party that shall be
responsible for performing such activities, (v) a timeline and budget for such activities, and (vi)
with respect to ARCHEMIX Research Activities and ELAN Research Activities, the number of FTEs
estimated to be required to perform such activities and the corresponding FTE Cost for such
activities; and (b) shall be consistent with the other terms of this Agreement. Without limiting
the generality of the foregoing, the objectives of each Annual Research Plan shall include, as
appropriate from time to time during the Research Program Term, conducting the necessary research
activities to identify Collaboration Compounds or IL-23 Aptamers or to determine whether
Collaboration Compounds, IL-23 Aptamers or Lead Compounds should be nominated to the JMC as Lead
Compounds or Clinical Candidates, as applicable.



     Except as provided in Section 5.2.1, ELAN shall fund a minimum of [***] ARCHEMIX FTEs in the
aggregate during the three (3) year Research Program Term. Unless otherwise agreed by the Parties,
the annual distribution of ARCHEMIX FTEs funded by ELAN shall equal the ARCHEMIX Annual FTE
Commitment. The JPT shall have the right to increase the number of FTEs to be provided by ARCHEMIX
for any Contract Year; provided, that, any increase, at ELAN’s request, in excess of the ARCHEMIX
Annual FTE Commitment for any Contract Year shall be an ARCHEMIX Decision. Any Annual Research
Plan may be amended from time to time by the JPT and submitted for approval by the JMC pursuant to
2.1.4. Each amendment, modification and update to the Annual Research Plan shall include the
resulting changes to the budget and shall be set forth in a written document prepared by, or at the
direction of, the JPT and approved by the JMC, shall specifically state that it is an amendment,
modification or update to the Annual Research Plan and shall be attached to the minutes of the
meeting of the JMC at which such amendment, modification or update was approved by the JMC.
Without limiting the nature or frequency of any other amendments, modifications or updates to the
Research Plan that may be approved by the JMC, the Annual Research Plan shall be updated at least
once prior to the end of each Contract Year to describe the research activities to be carried out
by each Party during the following Contract Year during the Research Program Term in conducting the
Research Program pursuant to this Agreement.


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



41









 





     3.3 Conduct of Research Program.



          3.3.1 ARCHEMIX Responsibilities. During the Research Program Term, ARCHEMIX shall,
subject to the provisions of Section 1.16, (a) use Commercially Reasonable Efforts to conduct the
ARCHEMIX Research Activities assigned to it, using the number of FTEs set forth in the Annual
Research Plan and (b) commit such resources other than personnel as are reasonably necessary to
conduct such ARCHEMIX Research Activities. In the event that ARCHEMIX reasonably concludes in good
faith that a Program Target may be a Failed Target, ARCHEMIX shall provide written notice to the
JPT within [***] days of reaching such conclusion, providing bona fide scientific evidence in
support of such conclusion. The JPT shall discuss the data and information generated with respect
to such Program Target, and shall determine whether such Program Target shall be proposed to the
JMC for designation as a Failed Target, as described in Section 3.9.




          3.3.2 ELAN Responsibilities. During the Research Program Term, ELAN shall (a) pay
ARCHEMIX the FTE Rate per FTE per Contract Year in accordance with Section 5.2, (b) commit such
resources as are reasonably necessary to conduct the ELAN Research Activities set forth in the
Annual Research Plan, and (c) use Commercially Reasonable Efforts to conduct the ELAN Research
Activities set forth in the Annual Research Plan.




          3.3.3 Compliance and Funding. Each Party shall perform its obligations under each
Annual Research Plan and this Agreement using Commercially Reasonable Efforts in good faith and in
compliance in all material respects with all Applicable Laws. For purposes of clarity, with
respect to each activity performed under an Annual Research Plan or Annual Development Plan that
will or would reasonably be expected to generate data to be submitted to a Regulatory Authority in
support of a Regulatory Filing or Drug Approval Application, the Party performing such activity
shall comply in all material respects with the regulations and guidance of the FDA that constitute
Good Laboratory Practice or Good Manufacturing Practice (or, if and as appropriate under the
circumstances, International Conference on Harmonization (ICH) guidance or other comparable
regulation and guidance of any Regulatory Authority in any country or region in the Territory).
Each Party shall be solely responsible for paying the salaries




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



42









 








and benefits of its employees and amounts due to consultants conducting its activities under
Annual Research Plans.



          3.3.4 Cooperation. Scientists at ARCHEMIX and ELAN shall cooperate in the performance
of the Research Program and, subject to the terms of this Agreement and any confidentiality
obligations to Third Parties, shall exchange such data, information and materials as are reasonably
necessary or useful for the other Party to perform its obligations under any Annual Research Plan.




          3.3.5 Purchase of Dedicated Equipment. If, during the Term of this Agreement, ELAN
determines in its sole discretion that it is necessary or advisable to purchase Dedicated Equipment
in order for ARCHEMIX to perform any ARCHEMIX Research Activities under the Research Program, then
ELAN shall provide ARCHEMIX with written notice of such determination, and ARCHEMIX shall provide
ELAN with the estimated price for such purchase and quality parameters for such Dedicated
Equipment, for ELAN’s approval of such price and features. Promptly after the consummation of such
purchase, if approved, ARCHEMIX shall provide ELAN with a copy of the invoice or invoices
reflecting such purchase, and ELAN shall reimburse ARCHEMIX for the purchase of all such Dedicated
Equipment within thirty (30) days of its receipt of such invoice; provided, however, that no costs
reimbursed by ELAN hereunder (or depreciation of such purchased equipment or instruments) shall be
included within the calculation of any Development Costs under this Agreement. ELAN shall retain
title and ownership of all such Dedicated Equipment and, at its expense upon reasonable notice to
ARCHEMIX, shall have the right to remove such Dedicated Equipment from ARCHEMIX’ facilities, at
such time as such Dedicated Equipment is no longer required for use by ARCHEMIX in the conduct of
the Research Program. As used in this section, “Dedicated Equipment” means any equipment,
instrument or machinery used by ARCHEMIX exclusively in the conduct of the Research Program.




     3.4 Records.



          3.4.1 Record Keeping.






CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



43









 








               (a) Research Program Records. Each Party shall maintain complete and accurate records
of its activities in the Research Program in sufficient detail, in good scientific manner and
otherwise in a manner that reflects all work done and results achieved. Subject to Article 6, each
Party shall provide the other Party with access during normal business hours and upon reasonable
advance notice to inspect and copy such records, including without limitation laboratory notebooks,
to the extent reasonably required for the performance of the requesting Party’s obligations and/or
exercise of the requesting Party’s rights under this Agreement, provided that the audited Party may
redact information not relevant to the Research Program prior to such audit. Notwithstanding the
foregoing, except for purposes of the information-sharing and cooperation provisions of Articles 8
and 9, ELAN shall not have the right to audit or copy any records that relate to work done on any
Terminated Program Aptamer after the date that an Aptamer or Collaboration Compound has become a
Terminated Program Aptamer.



               (b) Record-Keeping Policies. Without limiting the generality of Section 3.4.1(a),
each Party agrees to maintain a policy that requires its employees and consultants to record and
maintain all data and information developed during the Research Program.



          3.4.2 Reports. ARCHEMIX shall keep the JPT regularly informed of the progress of the
Research Program. Without limiting the generality of the foregoing, ARCHEMIX shall, at least once
each [***] during the Research Program Term, (a) provide reports to the JPT in reasonable detail
regarding the status of its activities under the Research Program, (b) advise the JPT of its
identification of Collaboration Compounds and IL-23 Aptamers and provide the JPT with any
supporting data applicable to such Collaboration Compounds and IL-23 Aptamers, (c) provide the JPT
with the results of activities conducted in the Research Program with respect to each Collaboration
Compound and IL-23 Aptamer so as to enable the JPT to determine whether such Collaboration Compound
or IL-23 Aptamer meets the LSC and should be proposed to the JMC as a Lead Compound, (d) provide
the JPT with the results of activities conducted in the Research Program with respect to each Lead
Compound so as to enable the JPT to determine whether such Lead Compound meets the CCSC and should
be




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



44









 








proposed to the JMC as a Clinical Candidate and (e) provide to the JPT such additional
information that it has in its possession as may be reasonably requested from time to time by the
JPT. ELAN shall provide the JPT, on at least a [***], with reports in reasonable detail regarding
the status of all ELAN Research Activities and such additional information that it has in its
possession as may be reasonably requested from time to time by the JPT.



     3.5 Selection of Program Targets.



          3.5.1 Selection of Program Targets.




               (a) Selection and Rejection of Program Targets. The Parties hereby acknowledge that
(i) three (3) initial Program Targets in addition to IL-23 have been designated by the Parties as
of the Effective Date, and (ii) the Research Program will initially include work on IL-23 and [***]
as Program Targets, as set forth in the Annual Research Plan. If, at any time during the Research
Program Term, ELAN decides that it wishes to replace a Program Target with another Target, then (a)
it shall provide written notice of such decision to ARCHEMIX, which notice shall state the reason
for ELAN’s decision, (b) all activities with respect to such Program Target under the Research
Program shall immediately cease, and (c) such Program Target shall be deemed to be a Rejected
Program Target as of the date of such written notice.



               (b) Replacement of Program Targets.



                    (i) Replacement Right. ELAN shall have the right at any time during the Research
Program Term to propose that any additional Target that ELAN reasonably believes based on published
literature or proprietary data is useful within the Target Selection Field and that is not an
Excluded Target replace a Program Target, by providing written notice to ARCHEMIX. ARCHEMIX shall
accept or refuse the additional Target within [***] days after receipt of such notice from ELAN. A
Target proposed by ELAN for inclusion in the Research Program shall only be refused by ARCHEMIX in
good faith, and only if: (1) it is an [***], (2) ARCHEMIX is prohibited by an executed contract
from licensing Aptamers against such Target to ELAN, subject to the procedure set forth in the
definition of ARCHEMIX Decision (Section 1.16(e)), (3) ARCHEMIX is in active negotiations, as[***]
by [***] with a Third Party with respect to a license, collaboration or similar agreement relating
to Aptamers against such Target,


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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(4) ARCHEMIX is developing, and has not ceased developing, for its own benefit, Aptamers
against such Target as [***] by the [***] of the [***] such [***] ARCHEMIX’ [***] (or [***]) of the
[***] of such [***], or (5) it is a [***]. As promptly as practicable after designation of a new
Program Target or the decision to initiate research on a Program Target listed on Schedule
4 as of the Effective Date, the JPT shall (A) develop and submit to the JMC for its approval
the LSC and CCSC for such Target and (B) prepare an update to the Annual Research Plan to include
the ARCHEMIX Research Activities to be conducted to identify Collaboration Compounds against such
Program Target for potential nomination as a Lead Compound and to identify one or more Lead
Compounds against such Program Target for potential nomination as a Clinical Candidate.



                    (ii) Designation by ELAN. At the time of nomination of a new or replacement Program
Target, ELAN shall (a) designate the Program Target (describing the applicable ligand, receptor and
any subunits [***]) to be [***] in [***]the [***], such [***] to be [***] on [***] in the[***] or
[***] ELAN, and (b) [***] ARCHEMIX’ [***] ARCHEMIX [***] ELAN [***] in [***] such [***] such [***]
and any [***] and [***]). In [***], if [***] the [***] of a [***] and its [***] or [***], ELAN
[***] on [***] or [***] that the [***] other [***] or [***], ELAN [***] ARCHEMIX [***] which [***]
such [***] or [***] and (b) [***] ARCHEMIX’ [***] the [***] upon [***] ELAN [***] in [***] such
[***] or [***] ARCHEMIX’ [***] of such [***], such [***] or [***] shall be [***] to be [***] of the
[***]such [***] or [***] may be [***] ARCHEMIX [***]Section 3.5.1(b). [***] to the [***],
ARCHEMIX’ [***] of the [***] such [***] or [***] to the [***]ELAN’s [***] shall not be [***] to be
a [***] of this [***].



                    (iii) Release of Restrictions. ARCHEMIX shall give ELAN prompt written notice during
the Research Program Term if the restrictions on any Excluded Target described in Sections
3.5.1(b)(i)(1)(2)(3) or (4) lapse, or are otherwise terminated, such that the previously refused
Target becomes eligible for inclusion as a Program Target.



                    (iv) Termination of Replacement Right. Notwithstanding anything to the contrary in
this Agreement, ELAN’s right to replace Program Targets pursuant to Section 3.5.1(b)(i) shall
terminate on the [***] of [***] of the [***] by [***] of the [***].


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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          3.5.2 Limitation on Number of Program Targets. ARCHEMIX shall not be required to work
on more than [***] Program Targets (including IL-23) at any given time during the Research Program
Term; provided, that (a) any Program Target that becomes a [***] or [***] shall not be counted as a
Program Target for purposes of this limitation, and (b) this Section 3.5.2 shall not limit or
otherwise affect ARCHEMIX’ obligation to consider in good faith using its commercially reasonably
discretion any request of ELAN to work on additional Program Targets and/or apply additional
resources to the Research Program beyond those contemplated by the Annual Research Plan.




     3.6 Identification of Collaboration Compounds, IL-23 Aptamers and Lead Compounds.



          3.6.1 Identification of Program Oligonucleotides. ARCHEMIX shall use Commercially
Reasonable Efforts in good faith to perform the SELEXTM Process to identify Program Oligonucleotides
in accordance with each Annual Research Plan, as amended.




          3.6.2 Lead Compounds. Within [***] days after its receipt of each report from
ARCHEMIX identifying a Collaboration Compound or IL-23 Aptamer which ARCHEMIX reasonably believes
meets the applicable LSC (or which ARCHEMIX otherwise reasonably believes should be a Lead
Compound), the JPT shall review the data and information and determine whether to nominate the
Collaboration Compound or IL-23 Aptamer for designation by ELAN as a Lead Compound. Once the JPT
has reached a decision regarding nomination of any such Collaboration Compound or IL-23 Aptamer as
a Lead Compound, the JPT shall promptly furnish all available information to ELAN. ELAN shall
consider such nomination within [***] days, and if ELAN determines that the Collaboration Compound
or IL-23 Aptamer meets the LSC or is otherwise acceptable and so advises ARCHEMIX in writing, such
Collaboration Compound or IL-23 Aptamer shall be designated a “Lead Compound” for purposes of this
Agreement. As of the Effective Date, the ARC2350 Aptamer shall be deemed to be a Lead Compound.




     3.7 Clinical Candidates. Within [***] days after its receipt of each report from
ARCHEMIX identifying a Lead Compound which ARCHEMIX reasonably believes meets the applicable CCSC
(or which ARCHEMIX otherwise reasonably believes should be a candidate


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



47









 





for Development), the JPT shall review the data and information and determine whether to
nominate the Lead Compound for designation as a Clinical Candidate. Once the JPT has reached a
decision regarding nomination of any such Lead Compound, the JPT shall promptly furnish all
available information to ELAN. ELAN shall consider such nomination within [***] days, and if ELAN
determines that the Lead Compound meets the CCSC or is otherwise acceptable to ELAN and so advises
ARCHEMIX in writing, such Lead Compound shall be designated a “Clinical Candidate” for purposes of
this Agreement.



3.8 Identification of Back-up Collaboration Compounds.




          3.8.1 Back-Up Collaboration Compounds. Subject to the terms set forth in the
definition of ARCHEMIX Decision, for each Lead Compound or Clinical Candidate approved by ELAN or
the JMC, as applicable, upon the written request of ELAN, ARCHEMIX will use Commercially Reasonable
Efforts to conduct ARCHEMIX Research Activities in order to deliver to ELAN [***] Aptamers, in
[***] to the [***] or [***], which may be [***] as a [***] Aptamer [***] the [***] Aptamers [***]
in [***] from such [***] or [***] Aptamer, a [***] All activities conducted by ARCHEMIX to
identify each Back-Up Collaboration Compound shall be performed as ARCHEMIX Research Activities as
part of the Research Program and the Annual Research Plan shall be amended accordingly. The rights
and obligations of the Parties relating to each Back-Up Collaboration Compound shall be identical
to those applicable to the accompanying Lead Compound or Clinical Candidate, except as may be
otherwise expressly provided herein.




          3.8.2 Back-Up Notices. ELAN shall notify ARCHEMIX in writing in the event ELAN
determines to replace a Lead Compound or Clinical Candidate with the applicable Back-Up
Collaboration Compound or to Develop the Back-Up Collaboration Compound in addition to the Lead
Compound or Clinical Candidate. Subsequent to such notice, any reference to the Lead Compound or
Clinical Candidate shall be deemed (as applicable) either to include, or to be made to, the Back-Up
Collaboration Compound for the purposes of this Agreement.




     3.9 Failed Targets. If at any time during the Research Program the JPT determines,
and the JMC agrees, that a Program Target shall be designated as a Failed Target, all research
activities directed to such Failed Target shall cease, and ELAN shall, to the extent and as


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



48









 





provided for in Section 3.5, select a new Program Target, and such Failed Target shall no
longer be considered a part of the Research Program.



     3.10 Supply of Proprietary Materials. From time to time during the Research Program
Term, either Party (the “Transferring Party”) may supply the other Party (the “Recipient Party”)
with Proprietary Materials Controlled by the transferring Party for use in the Research Program.
Each Recipient Party hereby agrees that (a) it shall not use the other party’s Proprietary
Materials for any purpose other than exercising its rights or performing its obligations hereunder;
(b) it shall use such Proprietary Materials only in compliance with all Applicable Laws; (c) it
shall not transfer any such Proprietary Materials to any Third Party without the prior written
consent of the Transferring Party, except as expressly permitted in this Agreement; (d) the
Recipient Party shall not acquire any right, title or interest in or to such Proprietary Materials
solely as a result of such supply by the Transferring Party; and (e) upon the expiration or
termination of the Research Program Term, the Recipient Party shall, if and as instructed by the
Transferring Party, either destroy or return any such Proprietary Materials that are not the
subject of the grant of a continuing license hereunder.



     3.11 Research Program Term. The Research Program shall commence on the Effective Date
and shall continue until the last day of the Research Program Term. In the event ELAN decides to
seek an extension of the Research Program beyond the third Contract Year, it will promptly notify
ARCHEMIX. ELAN will use commercially reasonable efforts to make any such decision and notify
ARCHEMIX at least [***] months prior to the end of the then-current Research Program Term.



4. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS [***]




     4.1 Objectives of the Development Program. The objectives of the Development Program
shall be the Development of Clinical Candidates to enable the Commercialization of Products in the
Territory.



     4.2 Responsibility for Development of Clinical Candidates and Commercialization of
Products. Except for the ARCHEMIX Development Activities, if any, to be conducted by ARCHEMIX
and subject to Section 4.11.1(c), ELAN shall have the sole right


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



49









 





and responsibility (subject to Sections 4.6 and 7.3), at its sole expense, to conduct all
aspects of the Development of Lead Compounds and Clinical Candidates in accordance with the
applicable Annual Development Plan, and all aspects of the Commercialization of Products in
accordance with the applicable Product Commercialization Plan, in the Territory, including, without
limitation, the conduct of: (i) all IND-enabling non-clinical studies that are outside of the
Research Program; (ii) all activities related to human clinical trials (including, without
limitation, Phase I Clinical Trials, Phase II Clinical Trials and Phase III Clinical Trials); (iii)
subject to ARCHEMIX’ rights under Section 4.5, all activities relating to the manufacture and
supply of Clinical Candidates and Products (including all required process development and scale up
work with respect thereto) for Development and Commercialization purposes; and (iv) all
pre-marketing, marketing, promotion, sales, distribution, import and export activities (including
securing reimbursement, conducting sales and marketing activities, recalls, withdrawals, any
post-marketing trials or post-marketing safety surveillance, and maintaining databases) for
Products, subject to the oversight of the JPT. Without limiting the generality of the foregoing,
ELAN shall have the sole right and responsibility (subject to Section 4.6), at its sole expense,
(i) to make all Regulatory Filings for Clinical Candidates and Products and file all Drug Approval
Applications and otherwise seek Regulatory Approvals for Products, as well as to conduct all
correspondence and communications with Regulatory Authorities regarding such matters and (ii) to
report Adverse Events to Regulatory Authorities if and to the extent required by Applicable Laws.
All Regulatory Approvals for Products shall be owned by ELAN, subject to Section 10.3 and 10.4.



     4.3 Annual Development Plans. Subject to Section 4.11.1(c), within [***] days after
the designation pursuant to Section 3.7 of a Clinical Candidate eligible for designation as a
Co-Developed Product, ELAN shall prepare an Annual Development Plan and budget for Development of
such Clinical Candidate for the balance of the Contract Year during which the recommendation of
such Clinical Candidate is approved. Thereafter, for each Contract Year during the Term in which
such Clinical Candidate is so eligible, and for each Co-Developed Product in the applicable
Co-Development Territory, Indication and formulation, ELAN shall prepare and submit to the JMC for
its review, an Annual Development Plan and Development


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



50









 





budget for each Clinical Candidate and/or Co-Developed Product. Each Annual Development Plan
shall: (a) set forth (i) the Development objectives, activities, priorities, timelines, budget and
resources for the Contract Year covered by the Annual Development Plan with reasonable specificity,
(ii) which activities are ARCHEMIX Development Activities, (iii) with respect to such ARCHEMIX
Development Activities, the number of FTEs estimated to be required to perform such activities and
the corresponding FTE Cost, and (iv) the expected Regulatory Filings and Drug Approval Applications
to be prepared and filed and the expected timetable of completing such Development activities; and
(b) be consistent with the other terms of this Agreement. The initial Annual Development Plan
shall be prepared by ELAN and submitted to the JMC for its review within [***] days of the day on
which the JMC approves the selection of a Clinical Candidate based on a Lead Compound and in any
event, on or prior to the initiation of Development activities with respect to the initial Clinical
Candidate. Each amendment, modification and update to any such Annual Development Plan shall
include the resulting changes to the budget and shall be set forth in a written document prepared
by ELAN and submitted to the JMC, shall specifically state that it is an amendment, modification or
update to that Annual Development Plan and shall be attached to the minutes of the meeting of the
JMC at which such amendment, modification or update was reviewed by the JMC. Without limiting the
nature or frequency of any other amendments, modifications or updates to the Annual Development
Plan, such Annual Development Plan shall be updated at least once prior to the end of each Contract
Year in which an Annual Development Plan has been approved to describe the Development activities
to be carried out by each Party during the following Contract Year in conducting the applicable
Development Program pursuant to this Agreement.



     4.4 Product Commercialization Plans. Subject to Section 4.11.1(c), if ELAN alone
(rather than with or through a Sublicensee) is marketing a Co-Developed Product, within [***] days
after the Initiation of the first Phase III Clinical Trial for a Co-Developed Product, ELAN shall
prepare and provide to the JPT for its review and discussion a Product Commercialization Plan for
each Co-Developed Product in the applicable Co-Development Territory(ies), Indication and
formulation, and shall update and submit such Product Commercialization Plan to the JPT for review
and discussion not less than annually; provided, that, ELAN shall use Commercially


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



51









 





Reasonable Efforts to include the obligations set forth in this Section 4.4 in each Sublicense
Agreement.



     4.5 Supply of Products for Development and Commercialization.



          4.5.1 Negotiation by the Parties. The Parties shall discuss in good faith the
manufacturing responsibilities for each Product that is Developed and Commercialized under this
Agreement as set forth in this Section 4.5.




          4.5.2 ARCHEMIX Right to Supply Products. ARCHEMIX shall have the right, but not the
obligation, to exercise a time-limited option to enter into negotiations with ELAN for a separate
supply and quality agreement detailing the terms under which ARCHEMIX would manufacture by itself
(not by or through a Third Party manufacturer), and supply the active pharmaceutical ingredient for
any Product to ELAN (the “Supply Agreement”). ARCHEMIX may exercise its Supply Agreement option as
to any Product by providing ELAN with written notice at any time prior to the Initiation of the
first Phase III Clinical Trial for such Product. If ARCHEMIX provides such written notice and
reasonably appears able to supply the Product without impeding the Product Commercialization Plan,
delaying the timeframe planned for Regulatory Approval and Product launch or limiting the Product
shelf life, ARCHEMIX and ELAN shall negotiate in good faith for up to [***] days following ELAN’s
receipt of such notice to enter into the Supply Agreement, which would include, without limitation,
the provisions described in Section 4.5.3. For clarity, nothing contained in this Section 4.5.2
shall constitute an offer by ARCHEMIX to sell any Product, and neither Party shall be obligated to
enter into any Supply Agreement. If the Parties do not enter into a Supply Agreement for such
Product within such time period, then ELAN shall have no further obligation to ARCHEMIX with
respect to such Product.




          4.5.3 Essential Terms of Supply. Any Supply Agreement entered into between the
Parties shall contain the following terms and conditions, as well as other terms and conditions
typically contained in supply agreements for products of similar nature and market potential:




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



52









 








               (a) ELAN shall order amounts of Products, and ARCHEMIX shall deliver all such ordered amounts,
in accordance with specified forecasting parameters, advance ordering timeframes and delivery
timeframes to be agreed upon by the Parties;



               (b) ARCHEMIX shall deliver such amounts of Products meeting applicable specifications and
legal requirements ordered in accordance with the foregoing (including such agreed upon timeframes)
in a timely manner;



               (c) ELAN shall have appropriate remedies for the failure of ARCHEMIX to perform its
obligations specified in (b), including without limitation that ELAN shall have the right to
manufacture the Product itself or select a Third Party manufacturer if ARCHEMIX fails to perform
such obligations;



               (d) the transfer price for supply of Product to ELAN shall be agreed upon by the Parties and
set forth in such agreement,



               (e) all Products supplied by ARCHEMIX shall be supplied FCA place of manufacture, Incoterms
2000;



               (f) ARCHEMIX shall maintain a commercially reasonable backup supply of Product at one remote
location to ensure ARCHEMIX’ ability to supply continuously Products to ELAN in accordance with
such agreement;



               (g) ELAN shall have the right to establish a second source, within or outside of ELAN, if
ELAN’s requirements of Products cannot be met despite ARCHEMIX’ meeting its obligations under (b);



               (h) ARCHEMIX shall provide reasonable assistance to ELAN and/or any Third Party manufacturer,
as applicable, that assumes responsibility for manufacturing Product to enable ELAN or such Third
Party to make Products in the manner then made by ARCHEMIX, and shall grant all licenses necessary
for such purpose;



               (i) ELAN shall have the right to inspect the packaging and labeling prior to use, and upon
reasonable notice to inspect the plant and premises used, and processes


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



53









 





and records of the packaging and storage employed, by ARCHEMIX in connection with manufacture
and supply of Product; and



               (j) If the Supply Agreement is terminated other than because of a material breach by ELAN, a
provision similar in effect to Section 10.3.1(g) of this Agreement shall govern ARCHEMIX’
obligation to continue to supply Products to ELAN.



     4.6 Development and Commercialization Diligence.



          4.6.1 General Diligence Obligations. ELAN and its Affiliates shall exercise
Commercially Reasonable Efforts during the Term to conduct the ELAN Development Activities and to
Commercialize Products in the Territory. ARCHEMIX and its Affiliates shall exercise Commercially
Reasonable Efforts during the Term to conduct ARCHEMIX Development Activities, as applicable.




          4.6.2 Specific Diligence Obligations.




               (a) Specific Diligence Obligations. During the Term, ELAN shall use Commercially
Reasonable Efforts (i) to Develop at [***] Clinical Candidate targeted at IL-23 and to
Commercialize [***]IL-23 Product for each Diligence Indication in the United States and a Major
Market Country, and (ii) to Develop [***]Clinical Candidate targeted at each Program Target other
than IL-23 and to Commercialize [***]Collaboration Product for each active Program Target other
than IL-23 in the United States and a Major Market Country.



               (b) Effect of Breach of Diligence Obligations. If ARCHEMIX at any time believes that
ELAN is not meeting a diligence obligation pursuant to Section 4.6.2(a), ARCHEMIX may give written
notice to ELAN requesting written justification, in the form of detailed reasons that would support
the proposition that ELAN is meeting such diligence obligations. In such event, ELAN shall provide
such written justification to ARCHEMIX within [***] days after such notice is given. In the event
that ARCHEMIX does not agree with such justification, then the Parties shall meet within [***] days
after such justification is given to discuss the basis for ARCHEMIX’ belief that ELAN has failed to
meet such diligence obligation. If ARCHEMIX does not receive ELAN’s justification within [***]
days after ARCHEMIX first provides such a notice to ELAN, or if ARCHEMIX, following any such


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



54









 





meeting occurring within such [***] day time period, still believes that ELAN has not met its
diligence obligation pursuant to Section 4.6.2(a), then ARCHEMIX shall have the right, in its sole
discretion, to exercise any or all rights or remedies that it may have under this Agreement, at law
or in equity.



     4.7 Compliance. Each Party shall perform its obligations under each Annual
Development Plan and this Agreement using Commercially Reasonable Efforts in good faith and in
compliance in all material respects with all Applicable Laws. For purposes of clarity, with
respect to each activity performed under an Annual Development Plan that will or would reasonably
be expected to generate data to be submitted to a Regulatory Authority in support of a Regulatory
Filing or Drug Approval Application, the Party performing such activity shall comply in all
material respects with, if and as applicable, the regulations and guidance of the FDA that
constitute Good Laboratory Practice, Good Manufacturing Practice or Good Clinical Practices, (or,
if and as appropriate under the circumstances, International Conference on Harmonization (ICH)
guidance or other comparable regulation and guidance of any Regulatory Authority in any country or
region in the Territory). Each Party shall be solely responsible for paying the salaries and
benefits of its employees and amounts due to consultants conducting its activities under Annual
Development Plans.



     4.8 Cooperation. Scientists at ARCHEMIX and ELAN shall cooperate in the performance
of each Development Program and, subject to the terms of this Agreement and any confidentiality
obligations to Third Parties, shall exchange such data, information and materials as are reasonably
necessary for the other Party to perform its obligations under any Annual Development Plan.



4.9 Exchange of Reports; Information; Updates.




          4.9.1 Development Program Reports. Each Party shall keep the JPT generally informed
of the progress of its efforts to Develop Clinical Candidates in the Territory. Without limiting
the generality of the foregoing, each Party shall, on at least a [***], provide the JPT with
reports in reasonable detail regarding the status of all preclinical IND-enabling studies and
activities (including toxicology and pharmacokinetic studies), clinical trials and other activities
conducted by or on behalf of each Party under the Development Program with respect to any




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



55









 








Development Lead or Clinical Candidate that is being Co-Developed or is eligible for
Co-Development, or any Co-Developed Product, together with such additional information in its
possession as may be reasonably requested from time to time by the JPT.



          4.9.2 Commercialization Reports. ELAN shall keep the JPT generally informed of the
progress of ELAN’s efforts to Commercialize Products in the Territory through periodic updates.
Without limiting the generality of the foregoing, if ELAN alone (rather than with or through a
Sublicensee) is Commercializing a Co-Developed Product, ELAN shall provide the JPT with [***]
written updates to each Product Commercialization Plan for each Co-Developed Product in the
applicable Co-Development Territory(ies), Indication and formulation, which shall (a) summarize
ELAN’s efforts to Commercialize such Co-Developed Product in the applicable Co-Development
Territory(ies), Indications and formulations, (b) identify the Regulatory Filings and Drug Approval
Applications with respect to such Co-Developed Product that ELAN or any of its Affiliates or
Sublicensees have filed, sought or obtained in the prior [***] month period or reasonably expect to
make, seek or attempt to obtain in the following [***] month period and (c) to the extent not
prohibited by Applicable Laws, summarize all post-marketing clinical and other data generated by
ELAN with respect to such Co-Developed Product in the applicable Co-Development Territory(ies),
Indication and formulation; provided, that, ELAN agrees to use Commercially Reasonable Efforts to
include the obligations set forth in this Section 4.9.2 in each Sublicense Agreement. In addition,
each Party (but not a Sublicensee) shall be required to provide such additional information that it
has in its possession as may be reasonably requested from time to time by the JPT and/or the JMC
regarding the Commercialization of any Product; provided, that, ELAN agrees to use Commercially
Reasonable Efforts to include the foregoing obligation in each Sublicense Agreement.




          4.9.3 Adverse Event Reports; Review of Regulatory Filings and Correspondence.




               (a) Adverse Events. In addition to the updates described in Section 4.9.1 and 4.9.2,
ELAN shall provide ARCHEMIX with all Adverse Event information and product complaint information
relating to Clinical Candidates or Products as such information is compiled or prepared by ELAN in
the normal course of business within time frames consistent


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



56









 





with reporting obligations under Applicable Laws. All such Adverse Event and product
complaint information shall be sent to ARCHEMIX in accordance with Section 13.1 and shall
constitute Confidential Information of ELAN; provided, that, ARCHEMIX shall have the right to
disclose any Serious Adverse Event to Third Parties solely to the extent required by Applicable
Laws (including, without limitation, any applicable regulations of the FDA) or as required in
writing by the FDA.



               (b) Preparation of Drug Approval Applications. Except as provided in Section 4.9.3(d)
and (e), ELAN shall (i) consult with ARCHEMIX in good faith in the preparation of all Drug Approval
Applications for Co-Developed Products for the applicable Indication and formulation and (ii)
consider all comments of ARCHEMIX in good faith, taking into account the best interests of the
Collaboration and of the Co-Development of the applicable Clinical Candidate and Commercialization
of the applicable Co-Developed Product for the applicable Indication and formulation on a global
basis.



               (c) Regulatory Meetings; Review of Other Regulatory Filings and Correspondence.
Except as provided in Section 4.9.3(d), ELAN shall (i) use reasonable efforts to provide ARCHEMIX
with at least [***] days advance notice of any meeting with the FDA or other Regulatory Authority
regarding a Drug Approval Application relating to, or Regulatory Approval for, any Clinical
Candidate that is being Co-Developed or is eligible for Co-Development, or any Co-Developed
Product, and ARCHEMIX may elect to send one person reasonably acceptable to ELAN to participate (at
ARCHEMIX’ sole cost and expense) solely as an observer in such meeting; (ii) subject to any Third
Party confidentiality obligations, provide ARCHEMIX with drafts of each Regulatory Filing or other
material regulatory document or correspondence with a Regulatory Authority pertaining to any
Clinical Candidate that is being Co-Developed or is eligible for Co-Development or any Co-Developed
Product and is prepared for submission to the FDA or other Regulatory Authority, sufficiently in
advance of submission so that ARCHEMIX may review and comment on the substance of such Regulatory
Filing or other document or correspondence; and (iii) promptly provide ARCHEMIX with copies of any
document or other correspondence received from the FDA pertaining to any Clinical Candidate that is
being Co-Developed or is eligible for Co-Development, or any Co-Developed Product. If


CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



57









 





ARCHEMIX has not commented on such Regulatory Filing or other document or correspondence
within [***] days (or, in the case of an IND, [***] days) after it is provided to ARCHEMIX, then
ARCHEMIX shall be deemed to have no comments on such Regulatory Filing or other documents or
correspondence. ELAN shall consider all comments of ARCHEMIX in good faith.



               (d) Co-Developed Products. ELAN shall (i) use reasonable efforts to provide ARCHEMIX
with copies of each Regulatory Filing or other material regulatory document or correspondence with
a Regulatory Authority pertaining to any Clinical Candidate that is being Co-Developed or is
eligible for Co-Development and any Co-Developed Product so that ARCHEMIX may review and provide
comment on the substance of such Regulatory Filing or other document or correspondence and (ii)
promptly provide ARCHEMIX with copies of any document or correspondence received from the FDA
pertaining to such Clinical Candidate or Co-Developed Product.



     4.10 Development and Commercialization Rights and Restrictions.



          4.10.1 Development and Commercialization Rights. Except as provided in this Section
4.10 or Section 4.11.1(c), ELAN shall have the exclusive right during the Term to Develop Clinical
Candidates and Commercialize Products in the Territory.




          4.10.2 Right of First Negotiation for [***]. If at any time during the Term, ARCHEMIX
determines to formally pursue an [***] Agreement, ARCHEMIX shall give written notice to ELAN (the
“[***] Opportunity Notice”) describing and specifying the status of Development of the Technology,
Patent Rights and particular products that ARCHEMIX reasonably expects to be involved in the [***]
Agreement. ELAN shall have [***] days following the date that the [***] Opportunity Notice is
given by ARCHEMIX (the “[***] Notice Period”) to give written notice to ARCHEMIX that it wishes to
enter into negotiations with ARCHEMIX with respect to such [***] Agreement (an “[***]ROFN Notice”);
provided that, if ELAN determines not to give an [***]ROFN Notice prior to expiration of the [***]
Notice Period, it shall in good faith provide written notice to ARCHEMIX promptly upon such
determination that it declines to enter into negotiations. If ELAN gives written notice within the
[***] Notice Period that it wishes to enter into negotiations with ARCHEMIX, the Parties shall




CONFIDENTIAL


Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.


58









 




negotiate in good faith with respect to an [***] Agreement for a period of up to [***] days
from the end of the [***] Notice Period. If the Parties do not agree upon financial terms with
respect to the [***] Agreement within the [***] day negotiation period, ARCHEMIX shall thereafter
have no obligation to ELAN with respect thereto and shall have the unencumbered right to negotiate
and execute an [***] Agreement with any Third Party.




     4.11 Co-Development Option.



          4.11.1 Exercise of Co-Development Options.




               (a) ELAN Notice. For each IL-23 Aptamer undergoing Development as a potential IL-23
Product, ELAN shall give written notice to ARCHEMIX of the Non-Parenteral Option Termination Date
or Psoriatic Diseases Option Termination Date, if applicable, at least [***] days before such
Option Termination Date. In the event ELAN revises its estimate of the date of Initiation of the
relevant Phase II Clinical Trial to a later date, ELAN shall so notify ARCHEMIX and the relevant
Option Termination Date shall be extended to the date [***] days before the revised estimated date
of Initiation of the relevant Phase II Clinical Trial. In no event will any Psoriatic Diseases
Option Termination Date or Non-Parenteral Option Termination Date occur any sooner than the date
specified in ELAN’s initial written notice thereof. If ELAN fails to give any such written notice
at least [***] days before an Option Termination Date, such Option Termination Date shall be [***]
days after ELAN actually gives such notice, and if ELAN never gives such notice, such Option
Termination Date shall be [***] days after ARCHEMIX has Knowledge of the actual Initiation of the
relevant Phase II Clinical Trial.



               (b) Co-Development Option. ARCHEMIX shall have the option, exercisable on a one-time
basis for each IL-23 Aptamer undergoing Development as a potential IL-23 Product (the
“Co-Development Option”), but not the obligation, to Co-Develop any IL-23 Aptamer (within the
applicable Indication and formulation and, as to the Psoriatic Diseases Co-Development Option,
within the applicable Co-Development Territory(ies)), and to share a certain percentage of the
Operating Income (Loss) applicable to that IL-23 Aptamer within the applicable Co-Development
Territory(ies), Indication and formulation by providing written notice to ELAN, which notice shall
specify the applicable potential IL-23 Aptamer, the



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.




59









 







applicable Co-Development Territory(ies) (as to the Psoriatic Diseases Co-Development Option)
and the applicable ARCHEMIX Co-Development Percentage (the “Co-Development Option Notice”). The
Co-Development Option shall only be exercised upon ARCHEMIX’ payment of the applicable
Co-Development Option Exercise Fee (as defined in Section 4.11.1(b) below) either (i) with respect
to each Psoriatic Diseases Co-Development Option, at any time during the period commencing on the
Effective Date and ending on the Psoriatic Diseases Option Termination Date (the “Psoriatic
Diseases Option Exercise Period”) or (ii) with respect to each Non-Parenteral Co-Development
Option, at any time during the period commencing on the Effective Date and ending on the
Non-Parenteral Option Termination Date (the “Non-Parenteral Option Exercise Period”). If such
payment is timely made as provided in the previous sentence, (i) the IL-23 Aptamer that is the
subject of the Co-Development Option shall thereafter be deemed to be a Co-Developed Product
(within the applicable Indication and formulation and, as to the Psoriatic Diseases Co-Development
Option, for the applicable Co-Development Territory(ies)) for purposes of this Agreement, (ii)
ARCHEMIX shall thereafter pay to ELAN the ARCHEMIX Co-Development Percentage of all Development
Costs and Commercialization Costs applicable to that Co-Developed Product, either for the Territory
and relevant formulations as to the Non-Parenteral Co-Development Option or for the applicable
Co-Development Territory(ies), Indications and formulations as to the Psoriatic Diseases
Co-Development Option, and (iii) ARCHEMIX shall share in the fraction of Operating Income (Loss)
derived from such Co-Developed Product in the Territory for the relevant formulation (as to the
Non-Parenteral Co-Development Option) or the applicable Co-Development Territory(ies), Indications
and formulations (as to the Psoriatic Diseases Co-Development Option) in accordance with Section
4.11.3, equal to the applicable ARCHEMIX Co-Development Percentage multiplied by the applicable
Operating Income (Loss) for that Co-Development Product within the applicable Co-Development
Territory(ies), Indications and formulations. The Net Sales used to calculate Operating Income
(Loss) for purposes of the Psoriatic Diseases Co-Development Option shall consist only of Net Sales
derived from prescriptions written by Board-certified dermatologists and any other medical
professionals whose prescriptions for Psoriatic Diseases (versus other Indications) are capable of
being segregated, as reasonably determined in good faith by the JMC. The appropriate method of
allocating Development Costs and Commercialization Costs on a Co-



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



60









 







Development Territory by Co-Development Territory basis shall be discussed in good faith between
the Parties at the time the Psoriatic Diseases Co-Development Option Notice is given to ARCHEMIX,
and shall be subject to the dispute resolution procedure set forth in Section 13.1 if the Parties
cannot mutually agree upon such matter within [***] days after such discussions commence. ARCHEMIX
shall not be entitled to receive milestone payments or royalties for milestone events or Net Sales
occurring with respect to such Co-Developed Product for the applicable Co-Development Territory (or
the Territory for Non-Parenteral Co-Developed Products) and for the relevant Indications and
formulations being Co-Developed, after ARCHEMIX has given the applicable Co-Development Option
Notice. If ARCHEMIX does not timely exercise its Co-Development Option within the applicable
Option Exercise Period and timely pay the applicable Co-Development Option Exercise Fee, ELAN shall
be free thereafter to Develop the applicable IL-23 Aptamer and/or IL-23 Product on its own or have
it Developed under sublicense to a Third Party for any and all Indications and formulations
throughout the Territory with no further option exercisable by ARCHEMIX. Notwithstanding any of
the foregoing, in no event shall ARCHEMIX be entitled to co-promote any Product (whether or not it
has Co-Developed such Product) with ELAN.




               (c) Fully-Exercised Co-Developed Product. If an ARCHEMIX Co-Development Option Notice
covers a Fully-Exercised Co-Developed Product in a Non-Parenteral formulation, all Significant
Co-Development Decisions made on and after the Initiation of Phase III Clinical Trials with respect
to Development of that Fully-Exercised Co-Developed Product in the Territory and the applicable
Indications and formulations shall be [***] by the Parties and shall be [***]. [***] other
decisions with respect to Development of any Co-Developed Products shall be made by [***].



               (d) Clarification. For purposes of clarity, (i) if ARCHEMIX exercises a
Non-Parenteral Co-Development Option, it shall not have any right to Co-Develop any parenteral
formulation of that Product that may later be Developed by ELAN unless such parenteral formulation
is for any Psoriatic Diseases for which ARCHEMIX has exercised its Psoriatic Diseases
Co-Development Option, and (ii) if ARCHEMIX exercises a Psoriatic



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



61









 




Diseases Co-Development Option, it shall not have any right to Co-Develop that Clinical
Candidate or Product for any non-Psoriatic Diseases.




          4.11.2 Specification of ARCHEMIX Co-Development Percentage. Subsequent to the
exercise of a Co-Development Option as provided in Section 4.11.1, ARCHEMIX agrees to pay an amount
equal to the aggregate Development Costs and Commercialization Costs that both Parties incur with
respect to that Co-Developed Product for the relevant Co-Development Territory(ies), Indications
and formulations, multiplied by the applicable ARCHEMIX Co-Development Percentage. The Parties
hereby agree that (a) once a Co-Development Option has been exercised, the applicable ARCHEMIX
Co-Development Percentage for that Co-Developed Clinical Candidate and Co-Developed Product shall
be fixed and not subject to change and (b) if ELAN amends or adjusts its estimate, or either Party
exceeds the budget, for Development Costs and Commercialization Costs with respect to the
Co-Developed Product, ARCHEMIX shall remain obligated to pay the ARCHEMIX Co-Development Percentage
of such revised estimate or increased expense.




          4.11.3 Co-Development Option Exercise Fee.




               (a) With respect to each Psoriatic Diseases Co-Developed Product, the term “Co-Development
Option Exercise Fee” shall mean: (i) if the Co-Development Territory set forth in the
Co-Development Option Notice includes the United States, a one-time payment equal to [***]% times
the applicable ARCHEMIX Co-Development Percentage times the Early Stage Development Costs
applicable to such Psoriatic Diseases Co-Developed Product; (ii) if the Co-Development Territory
set forth in the Co-Development Option Notice includes only the European Union, a one-time payment
equal to [***]% times the applicable ARCHEMIX Co-Development Percentage times the Early Stage
Development Costs applicable to such Psoriatic Diseases Co-Developed Product; and (iii) if the
Co-Development Territory set forth in the Co-Development Option Notice includes everywhere in the
world other than the U.S. and the European Union, a one-time payment equal to [***]% times the
applicable ARCHEMIX Co-Development Percentage times the Early Stage Development Costs applicable to
such Psoriatic Diseases Co-Developed Product. For convenience, the option exercise percentage is
calculated based upon three assumed elements: (1) that the market split by countries is assumed as
United



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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States — [***]%, European Union — [***]% and everywhere in the world other than the U.S. and
the European Union — [***]%; (2) that the market potential for Psoriasis is assumed as [***]% of
the total IL-23 product market potential; and (3) that the premium for opting in to Co-Development
at Phase II is [***]%. Therefore, the Co-Development Percentage for the United States is calculated
as [***]%. For example, if ARCHEMIX were to exercise its Co-Development Option with respect to a
Psoriatic Diseases Co-Developed Product, and in doing so (x) elected a [***] percent ([***]%)
Co-Development Percentage, (y) elected the United States and the European Union as Co-Development
Territories and (z) did not elect everywhere else in the world as a Co-Development Territory, then
the Co-Development Option Exercise Fee would be a one-time payment equal to [***]% of the
Development Costs and Commercialization Costs applicable to such Psoriatic Diseases Co-Developed
Product (i.e., [***]).




               (b) With respect to the Non-Parenteral Development Option, the term “Co-Development Option
Exercise Fee” shall mean: a one-time payment equal to [***] times the applicable ARCHEMIX
Co-Development Percentage times the applicable Early Stage Development Costs applicable to such
Non-Parenteral IL-23 Product.



          4.11.4 Additional Information; Estimated Development Costs. As soon as practicable
following ARCHEMIX’ request after receipt of notice under Section 4.11.1, the Parties shall meet to
discuss whether or not ARCHEMIX intends to exercise the applicable Co-Development Option. In
addition, not less than once during the Psoriatic Diseases Option Exercise Period and/or
Non-Parenteral Option Exercise Period, ELAN shall provide ARCHEMIX with (i) a schedule summarizing
all Development Costs and Commercialization Costs incurred with respect to the relevant
Non-Parenteral IL-23 Product(s) or Psoriatic Diseases IL-23 Product(s), as the case may be; (ii)
ELAN’s non-binding good faith estimate of all Development Costs and Commercialization Costs it
expects to incur with respect to such Non-Parenteral IL-23 Product(s) or Psoriatic Diseases IL-23
Product(s), as the case may be, over the next four (4) Quarters; and (iii) any additional
information Controlled by ELAN that ELAN reasonably determines is necessary for ARCHEMIX to decide
whether to exercise such Co-Development Option. In addition, ELAN shall provide prompt written
updates of any material changes to any material and/or information provided to ARCHEMIX under this
Section 4.11.4.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



63









 








          4.11.5 Estimated Development Costs. If ARCHEMIX exercises its Co-Development Option
for an IL-23 Product as set forth in Sections 4.11.1 and 4.11.2, ELAN shall provide ARCHEMIX with
ELAN’s revised non-binding, good faith estimate of all Development Costs and Commercialization
Costs it expects to incur with respect to that Co-Developed Product (for the applicable Indications
and formulations and, as to the Psoriatic Diseases Co-Development Option, Co-Development
Territory(ies)) during the next four (4) Quarters on or before the first day of each full Quarter
after the date of exercise.




          4.11.6 Reconciliation and Auditing of Development Costs and Commercialization Costs.




               (a) Reconciliation. Within [***] days following the end of each [***] following the
exercise of the Co-Development Option applicable to a given Co-Developed Product, each of ARCHEMIX
and ELAN shall submit to the other Party a written report setting forth in reasonable detail all
Development Costs and Commercialization Costs incurred by each such Party over such Quarter for the
Co-Developed Product for the applicable Indication formulation and Co-Development Territory(ies).
Within [***] days following the receipt by ELAN of ARCHEMIX’ written report, ELAN shall prepare and
submit to ARCHEMIX a written report setting forth in reasonable detail (a) the calculation of all
such Development Costs and Commercialization Costs incurred by both Parties over such [***] and (b)
the calculation of the net amount owed by ARCHEMIX to ELAN or by ELAN to ARCHEMIX in order to
ensure the appropriate sharing of such Development Costs and Commercialization Costs in accordance
with the ARCHEMIX Co-Development Percentage. The net amount payable shall be paid by ARCHEMIX or
ELAN to the other, as applicable, within [***] days after the distribution by the JPT of such
written report.



               (b) Records; Audit Rights. Each Party shall keep and maintain for [***] years
complete and accurate records of Development Costs and Commercialization Costs incurred with
respect to Co-Developed Products for the applicable Indications, formulations and Co-Development
Territory(ies) in sufficient detail to allow confirmation of same by the JPT, the JMC and the other
Party. Each Party shall have the right for a period of [***] Calendar Years after such Development
Costs and Commercialization Costs are reconciled in accordance with



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



64









 




Section 4.11.6(a) to appoint at its expense an independent certified public accountant
reasonably acceptable to the other Party to audit the relevant records of the other Party and its
Affiliates to verify that the amounts of such Development Costs and Commercialization Costs were
correctly determined. The audited Party and its Affiliates shall each make its records available
for audit by such independent certified public accountant during regular business hours at such
place or places where such records are customarily kept, upon [***] days written notice from the
auditing Party, solely to verify that such Development Costs and Commercialization Costs were
correctly determined. Such audit right shall not be exercised by the auditing Party more than once
in any Calendar Year and no period may be audited more than once. All records made available for
audit shall be deemed to be Confidential Information of the audited Party. The results of each
audit, if any, shall be reported in writing to both Parties promptly (but in no event later than
[***] days) after the audit and shall be binding on both Parties. In the event there was an error
in the amount of Development Costs and/or Commercialization Costs reported by the audited Party
hereunder, (a) if the amount of such costs was over reported, the audited Party shall promptly (but
in any event no later than [***] days after the audited Party’s receipt of the report so
concluding) make payment to the auditing Party of the amount required to achieve the appropriate
sharing of such costs, and (b) if the amount of such costs was under reported, the auditing Party
shall promptly (but in any event no later than [***] days after the auditing Party’s receipt of the
report so concluding) make payment to the audited Party of the amount required to achieve the
appropriate sharing of such costs. The auditing Party shall bear the full cost of such audit
unless such audit discloses an under-payment by the audited Party of more than [***] percent
([***]%) of its portion of the relevant amount of Development Costs and Commercialization Costs in
any Calendar Year, in which case the audited Party shall reimburse the auditing Party for all costs
incurred by the auditing Party in connection with such audit.




          4.11.7 Roll-Over Payments. If, in any [***], the actual Development Costs and
Commercialization Costs to be borne by ARCHEMIX with respect to a Co-Developed Product for that
[***] exceeds by greater than [***] percent ([***]%) ARCHEMIX’ share of ELAN’s last good faith
estimate given before the start of the previous [***] as provided in Section 4.11.5,



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



65









 







ARCHEMIX may, upon written notice to ELAN, delay payment of its share of any such excess until
the subsequent [***] (the “Roll-Over Payment”).




     4.12 Reconciliation and Auditing of Operating Income (Loss).



               (a) Quarterly Report. Unless otherwise delegated by the JPT or as otherwise agreed to
by the Parties, ELAN shall be responsible for issuing a written report (each, a “Quarterly Report”)
to the JPT and ARCHEMIX within [***] days after the end of the last month of each Quarter, which
Quarterly Report shall include the following calculations for such preceding Quarter (for the
applicable Indications, formulations and, as to Psoriatic Diseases Co-Developed Products,
Co-Development Territory(ies)): (i) the quantity of Co-Developed Products sold by ELAN, its
Affiliates or Sublicensees; (ii) the calculation of Net Sales with respect to such Co-Developed
Products; (iii) the amount of Operating Income (Loss) calculated in accordance with Schedule
4; and (iv) the amount of Operating Income (Loss) that each Party is entitled to, based on the
ARCHEMIX Co-Development Percentage.



               (b) Audit Rights. ELAN shall keep and maintain for [***] years complete and accurate
records of Operating Income (Loss) and Net Sales of Co-Developed Products for the relevant
Co-Development Territory(ies), Indications and formulations (“Co-Development Net Sales”) in
sufficient detail to allow confirmation of same by the JPT, the JMC and ARCHEMIX. ARCHEMIX shall
have the right for a period of [***] Calendar Years after such Operating Income (Loss) and
Co-Development Net Sales are reconciled in accordance with Section 4.11.6(a) to appoint at its
expense an independent certified public accountant reasonably acceptable to ELAN to audit the
relevant records of ELAN and its Affiliates to verify that the amount of such Operating Income
(Loss) and Co-Development Net Sales are correctly determined. ELAN and its Affiliates shall each
make its relevant records available for audit by such independent certified public accountant
during regular business hours at such place or places where such records are customarily kept, upon
[***] days written notice from ARCHEMIX, solely to verify that such Operating Income (Loss) and
Co-Development Net Sales hereunder were correctly determined. Such audit right shall not be
exercised by ARCHEMIX more than once in any Calendar Year and no period may be audited more than
once. All records made available for audit shall be deemed to be Confidential Information of ELAN.
The results


CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



66









 




of each audit, if any, shall be reported in writing to both Parties promptly (but in no event
later than [***] days) after the audit and shall be binding on both Parties. In the event there
was an error in the amount of such Operating Income (Loss) and Co-Development Net Sales reported by
ELAN hereunder, (a) if the effect of the error resulted in an underpayment to ARCHEMIX, ELAN shall
promptly (but in any event no later than [***] days after ELAN’s receipt of the report so
concluding) make payment to ARCHEMIX of the underpayment amount, and (b) if the effect of the error
resulted in an overpayment to ARCHEMIX, ARCHEMIX shall promptly (but in any event no later than
[***] days after ARCHEMIX’ receipt of the report so concluding) make payment to ELAN of the
overpayment amount. ARCHEMIX shall bear the full cost of such audit unless such audit discloses an
underpayment by ELAN of more than [***] percent ([***]%) of the aggregate amount of ARCHEMIX’ share
of Operating Income (Loss) in any Calendar Year, in which case ELAN shall reimburse ARCHEMIX for
all reasonable costs incurred by ARCHEMIX in connection with such audit.




     4.13 Product Recalls; True-Up. In the event that any Regulatory Authority issues or
requests a recall or takes similar action in connection with a Product, or in the event a Party
reasonably believes that an event, incident or circumstance has occurred that may result in the
need for a recall, market withdrawal or other corrective action regarding a Product, such Party
shall promptly advise the other Party thereof by telephone or facsimile. Following such
notification, ELAN shall decide and have control of (a) whether to conduct a recall or market
withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory
Authority, in which case it shall be required in the applicable country or countries) or to take
other corrective action in any country and (b) the manner in which any such recall, market
withdrawal or corrective action shall be conducted; provided that ELAN shall keep ARCHEMIX
regularly informed regarding any such recall, market withdrawal or corrective action. Except with
respect to events related to the manufacture of Product by ARCHEMIX as set forth in any Supply
Agreement that may be executed by the Parties, ELAN shall bear all expenses of any such recall,
market withdrawal or corrective action that does not involve a Co-Developed Product (including,
without limitation, expenses for notification, destruction and return of the affected Product). If
the recall involves a Co-Developed Product, then ARCHEMIX shall bear



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



67









 







that share of the recall, market withdrawal or corrective action expenses that is equal to the
applicable ARCHEMIX Co-Development Percentage. Further, if any royalties have been paid to
ARCHEMIX on Net Sales of affected Products which have subsequently become subject to a refund
(“Refunded Products”) then, to the extent such refunds are actually paid by ELAN, ELAN shall have
the right to offset the amount of royalties previously paid to ARCHEMIX that are applicable to such
Refunded Products against future royalties paid by ELAN pursuant to Section 5.4.



5. PAYMENTS




     5.1 Upfront Fee. ELAN shall pay ARCHEMIX a non-refundable one-time upfront fee in the
amount of Seven Million Dollars (US $7,000,000) by wire transfer within thirty (30) days of the
Effective Date, according to instructions that ARCHEMIX shall provide.



5.2 R&D Funding.




          5.2.1 Payment of FTE Costs. ELAN shall pay ARCHEMIX the aggregate FTE Cost for all
FTEs expended by ARCHEMIX in performing its activities under the Annual Research Plan(s) as
described in Section 3.2, subject to this Section 5.2, based on the FTE Rate; provided however,
that in the event of termination of this Agreement pursuant to Section 10.2.1 prior to expiration
of the Research Program Term, no further payments for future FTE Costs shall be due after the date
of the termination notice and any payment made by ELAN for FTE Costs that would have been incurred
after the date of termination shall be promptly refunded to ELAN. On the Effective Date and on the
first day of each subsequent Quarter during the Research Program Term, ELAN shall make a payment
equal to the estimated FTE Cost for such Quarter, as reflected in the then-current Annual Research
Plan and all then-current Annual Development Plans, but in no event shall such payment be less than
[***] Dollars ($[***]). To enable ELAN to reconcile amounts paid hereunder, ARCHEMIX shall provide
ELAN with quarterly reconciliation statements that specify the actual number of ARCHEMIX FTEs
performing activities under the Research Program and Development Program to no fewer than [***]
decimal places for the last Quarter in the aggregate, within [***] days of the completion of each
Quarter during the Research Program Term. If, with respect to a particular Quarter (a) the FTE
Cost attributable to the number of FTEs specified in the quarterly reconciliation statement



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



68









 







for such Quarter is more than the minimum amount set forth above but less than the estimated
FTE Costs set forth in the Annual Research Plan and all Annual Development Plans for such Quarter
in the aggregate and paid for by ELAN, ELAN shall have the right to immediately apply the excess
paid by it towards the FTE Cost due to ARCHEMIX in subsequent Quarters until such balance is zero;
or (b) the FTE Cost attributable to the number of FTEs specified in the quarterly reconciliation
statement for such Contract Quarter is, due to the written request of ELAN for additional FTEs,
more than the estimated FTE Costs set forth in the Annual Research Plan and all Annual Development
Plans for such Quarter in the aggregate, ELAN shall pay the deficiency with its payment under this
Section 5.2 for the next Quarter. If, upon the expiration or termination of the Research Program
Term, ARCHEMIX was unable to make available [***] FTEs for the conduct of the Research Program,
then, to the extent requested by ELAN (a) ARCHEMIX shall be obligated to provide ELAN, at no
further cost to ELAN, with a number of FTEs equal to the difference between [***] FTEs and the
number of FTEs actually made available by ARCHEMIX and (b) the Research Program Term shall be
extended for an [***] until such FTEs have been [***] utilized.




          5.2.2 Application of R&D Funding Obligation. Notwithstanding anything to the contrary
in this Section 5.2, if at any time during the third Contract Year of the Research Program Term,
(a) ELAN is performing research, Development or Commercialization activities against each of three
(3) separate Program Targets, and (b) ARCHEMIX has no obligation to conduct any ARCHEMIX Research
Activities or Development activities in any Annual Research Plan or Annual Development Plan, then
ELAN shall have the right to apply the unused portion of the FTE funding contemplated by Section
5.2.1 for such third Contract Year towards any future activities with respect to the research or
development of aptamers that bind Program Targets that ELAN requests ARCHEMIX to perform at any
time during the next five (5) years.




          5.2.3 R&D Funding Audit Rights. ARCHEMIX shall keep complete and accurate books and
financial records pertaining to the number of FTEs utilized in conducting the Research Program and
the ARCHEMIX Development Activities and details of the activities performed by such FTEs, which
books and financial records shall contain sufficient detail to allow confirmation of same by the
JPT, the JMC and ELAN and shall be retained by



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



69









 







ARCHEMIX until [***] Calendar Years after the end of the Contract Year to which they pertain.
ELAN shall have the right to appoint at its expense an independent certified public accountant
reasonably acceptable to ARCHEMIX to audit, upon [***] days written notice, the books and financial
records of ARCHEMIX relating to the number of FTEs utilized in conducting the Research Program
and/or the ARCHEMIX Development Activities, and their activities, during any Quarter(s); provided,
that, ELAN shall not have the right to audit any Quarter with respect to each of the Research
Program and the ARCHEMIX Development Activities more than once. All books and financial records
made available for such audit shall be deemed to be Confidential Information of ARCHEMIX. The
results of each audit, if any, shall be reported in writing to both Parties promptly (but in no
event later than [***] days) after the audit and shall be binding on both Parties. In the event
there was an error relating to the reported FTEs utilized in conducting the Research Program and/or
the ARCHEMIX Development Activities, (a) if the effect of the error resulted in an overpayment by
ELAN, ARCHEMIX shall promptly (but in any event no later than [***] days) after ARCHEMIX’ receipt
of the report so concluding, make payment to ELAN of the overpayment and (b) if the effect of the
error resulted in an underpayment by ELAN, then ELAN shall promptly (but in no event later than
[***] days after ELAN’s receipt of the report so concluding) make payment to ARCHEMIX of the
underpayment amount. ELAN shall bear the full cost of such audit unless such audit discloses an
over reporting by ARCHEMIX of more than [***] percent ([***]%) of the aggregate amount of FTE Costs
reportable in any Quarter, in which case ARCHEMIX shall reimburse ELAN for all reasonable costs
incurred by ELAN in connection with such audit.




     5.3 Milestone Payments.



          5.3.1 Milestones.




               (a) Regulatory Milestones.




               (i) Collaboration Products. ELAN shall make each of the following
non-refundable, non-creditable (except as provided in Section 5.3.2) payments to ARCHEMIX
within [***] days after the occurrence of the following milestone events for each of the first
two (2) Collaboration Products for each Program Target other than IL-23 to



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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achieve the following milestones, regardless of the number of Collaboration Products that
are Developed and Commercialized under this Agreement.



	 	 	 
	Milestone Event	 	Payments
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]






     If payment is made for any of milestones 2, 3, 4, 5, 6, or either of 7 or 8, with respect to
any Collaboration Product and any of the preceding milestone payments (except milestone 7 in the
case of payment of milestone 8) have not been made with respect to such Collaboration Product, then
such earlier milestone payments shall be made concurrently therewith (for example, if milestone 6
[***] is paid, but milestone 5 [***] has not been paid, then milestone payments 6 and 5 shall both
be made on the basis of the achievement of milestone 6).




               (ii) IL-23 Products. ELAN shall make each of the following non-refundable,
non-creditable (except as provided in Section 5.3.2) payments to ARCHEMIX within [***] days
after the occurrence of the following milestone events for each of the first



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



71









 







three (3) IL-23 Products to achieve the following milestones, regardless of the number of
IL-23 Products that are Developed and Commercialized under this Agreement:



	 	 	 
	Milestone Event	 	Payments
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	9. [***]
	 	$[***]






     If payment is made for any of milestones 2, 3, 4, 5, 6, 7, 8 or 9 with respect to any
Indication for any IL-23 Product and any of the preceding milestone payments [***] have not been
made with respect to such Indication for such IL-23 Product, then such earlier milestone payments
shall be made concurrently therewith (for example, if milestone 7 [***] is paid, but milestone 6
[***] has not paid, then milestone payments 7 and 6 shall both be made on the basis of the
achievement of Milestone 7.




               (iii) Effect of Development of Multiple Products for Same Indication on Obligation to
Pay Milestones. If ELAN Develops more than one Clinical Candidate or Lead Compound for a
given Program Target and a given Indication, (a) ELAN shall make all milestone payments for
the first Clinical Candidate or Lead Compound that achieves any milestone events for that
Indication as set forth in Section 5.3.1(a); and (b) subject to subsection (v) below, ELAN
shall make the milestone payments for the



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



72









 







subsequent Clinical Candidates or Lead Compounds that achieve a milestone event occurring
at or after the Initiation of [***] (e.g., milestone events [***] under Sections 5.3.1(a)(i)
and/or 5.3.1(a)(ii)) for that Program Target and that Indication; provided, that, if such
subsequent Clinical Candidates or Lead Compounds are later designated by ELAN for the
treatment of an Indication other than Indications for which the first Clinical Candidate or
Lead Compound that is the subject of a [***] is Developed, ELAN shall then pay all applicable
milestones for such subsequent Clinical Candidates or Lead Compounds except any that have
already been paid, but including all milestone payments that are in arrears.




               (iv) For purposes of this Section 5.3.1, only a Clinical Candidate, Lead Compound, IL-23
Product or Collaboration Product comprising, consisting of or incorporating a separate new
chemical entity shall be considered to be a separate Clinical Candidate, Lead Compound, IL-23
Product or Collaboration Product, as the case may be, for which separate milestones may be due
and payable.



               (b) Sales Milestones. ELAN shall, with respect to each IL-23 Product, make each of
the following non-refundable payments within [***] days after the first occurrence of the
corresponding milestone event for such IL-23 Product:



	 	 	 
	Milestone Event	 	IL-23 Products
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]
	[***]
	 	$[***]






          5.3.2 Effect of Discontinued Development on Obligation to Pay Milestones for Both IL-23
Products and Collaboration Products. For purposes of clarity, notwithstanding Section 5.3.1,
if (a) ELAN makes any milestone payments for a Lead Compound, Clinical Candidate or Product and (b)
ELAN subsequently terminates Development



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



73









 







of such Lead Compound, Clinical Candidate or Product, ELAN shall only be obligated to make
payments corresponding to those milestone events that occur for a subsequently Developed Lead
Compound, Clinical Candidate or Product binding to the same Program Target for which it had not
previously made payments under Section 5.3.1 with respect to the terminated Lead Compound, Clinical
Candidate or Product.




          5.3.3 Determination that Milestone Events have Occurred. ELAN shall provide ARCHEMIX
with prompt written notice upon each occurrence of a milestone event set forth in Section 5.3.1.
In the event that, notwithstanding the fact that ELAN has not given such a notice, ARCHEMIX
believes any such milestone event has occurred, it shall so notify ELAN in writing and shall
provide to ELAN data, documentation or other information that supports its belief. Any dispute
under this Section 5.3.3 that relates to whether or not a milestone event has occurred shall be
referred to the JMC to be resolved as an Excepted Decision.




     5.4 Payment of Royalties; Royalty Rates; Accounting and Records.



          5.4.1 Payment of Royalties.




               (a) Royalty Rates. ELAN shall pay ARCHEMIX a royalty based on Annual Net Sales of
each Royalty-Bearing Product in each Calendar Year (or partial Calendar Year) commencing with the
First Commercial Sale of such Royalty-Bearing Product in any country in the Territory and ending
upon the last day of the last Royalty Term for such Royalty-Bearing Product, at the following
rates:




               (i) Collaboration Products:



	 	 	 
	Annual Net Sales Worldwide	 	Royalty Rate (%)
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%







               (ii) IL-23 Products:



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



74









 





	 	 	 
	Annual Net Sales in the U.S.	 	Royalty Rate (%)
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%






	 	 	 
	Annual Net Sales	 	 
	in the Major Market Countries	 	Royalty Rate (%)
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%






	 	 	 
	Annual Net Sales In ROW	 	Royalty Rate (%)
	[***]
	 	[***]%
	[***]
	 	[***]%
	[***]
	 	[***]%






               The following hypothetical example illustrates the calculation of royalties under Section
5.4.1(a): If, in any Calendar Year during the Term, Annual Net Sales of a Collaboration Product
are $[***], the applicable royalty would be $[***], [***]% of Net Sales for Net Sales up to $[***],
[***]% of Net Sales for Net Sales over $[***] and up to $[***] and [***]% of Net Sales for Net
Sales over $[***].



               (b) No Patent Coverage. Notwithstanding anything to the contrary in Section 5.4.1(a),
in the event that ELAN sells, in any country, a Royalty-Bearing Product that is not covered by a
Valid Claim in such country of (i) the Licensed Patent Rights and/or (ii) any



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



75









 




ELAN Joint Product Patent Rights (as defined below), all applicable royalties in effect with
respect to such Royalty-Bearing Product in such country as specified in Section 5.4.1 shall be
reduced to [***] percent ([***]%) until the last day of the Royalty Term with respect to such
Royalty-Bearing Product in such country. For purposes of this Section 5.4.1(b) and Section
7.1.2(c) only, the term “ELAN Joint Product Patent Rights” means Patent Rights that cover ELAN
Product Technology that is jointly discovered, conceived or reduced to practice (whether actively
or constructively) by employees of, or consultants to, ELAN and employees of, or consultants to,
ARCHEMIX other than as a result of the participation by ARCHEMIX employees or consultants on the
JMC or the JPT as described in Article 2.




               (c) Royalty Offsets. In the event that ELAN, in order to successfully research,
Develop and Commercialize a Product, or practice the licenses granted to it hereunder in any
country, reasonably determines that it is legally or commercially necessary to make and actually
makes any payments to any Third Party (“Third Party Payments”) in order to obtain a license or
other right, title or interest in and to an issued patent and/or, solely to the extent described in
the last sentence of this Section 5.4.1(c), a pending patent application (a “Third Party License”),
then the royalties payable to ARCHEMIX for such Product under Section 5.4.1(a) with respect to such
country may be reduced by [***] percent ([***]%) of the amount of such Third Party Payments;
provided that such reductions shall not reduce the royalty that would otherwise be payable for such
Product under Section 5.4.1 by more than [***] percent ([***]%) of the amount otherwise payable
with respect to Net Sales of such Product in such country (the “[***] Offset”). Unused [***]
Offset credits may be carried over from one royalty period to the next, subject to the latter [***]
([***]%) limitation set forth above; provided, that (i) unused [***] Offset credits may only be
applied in a subsequent royalty period after the reductions to be applied in such period pursuant
to the first sentence of this Section 5.4.1(c) have been fully applied and (ii) any unused [***]
Offset credits that have not been offset against royalty payments under this Section 5.4.1(c)
within [***] years following accrual may not be carried over to any future royalty periods;
provided, that, unused [***] Offset credits accrued prior to the First Commercial Sale of a Product
may be applied as provided above for a period of [***] years commencing on the date of First
Commercial Sale. Notwithstanding the foregoing, ELAN shall



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



76









 




be solely responsible for, and the royalties payable to ARCHEMIX pursuant to Section 5.4.1
shall not be reduced by, any Third Party Payments solely to obtain a Third Party License to either
(a) a proprietary method of administering or packaging a pharmaceutical (for clarity, excluding
proprietary molecules, methods and/or processes of formulation and drug delivery technologies such
as controlled release, transdermal delivery, nanotechnology and lyophilizing, all of which may be
technologies for which such [***] Offset is available), or (b) a patent that had issued, or a
patent application that was published and pending in the United States or a Major Market Country or
with the European Patent Office or as a PCT application, at the time a Target was designated a
Program Target by ELAN, and which then contained a valid or patentable claim that covered the
Program Target (as agreed by the Patent Coordinators or, in the event they cannot reach agreement
in good faith, a mutually-selected neutral Third Party patent attorney). For purposes of clarity,
the [***] Offset shall apply to (i) all Third Party Payments for Third Party Licenses related to
IL-23, which was chosen as a Target by ARCHEMIX prior to the Effective Date, and (ii) all Third
Party Payments for Third Party Licenses relating to a Program Target, where such Third Party
License is (1) for issued patents or pending patent applications that issued, were published or
otherwise became publicly available after the date that ELAN designated that Program Target, or (2)
pending patent applications that were published and pending in a country other than the United
States or a Major Market Country or with the European Patent Office or as a PCT application on or
before the date that ELAN designated that Program Target or (3) in settlement of litigation with
respect to such Program Target.




               (d) Know-How Payments. The Parties hereby acknowledge and agree that any royalties
that are payable for a Product described in Section 5.4.1(b) shall be in consideration of (i)
ARCHEMIX’ expertise and know-how concerning the identification of Aptamers, including its
development of the SELEXTM Process and its other Aptamer-related development activities conducted
prior to the Effective Date; (ii) the performance by ARCHEMIX of the Research Program, (iii) the
disclosure by ARCHEMIX to ELAN of results obtained in the Research Program; (iv) the licenses
granted to ELAN hereunder with respect to Licensed Technology and Joint Technology that are not
within the claims of any Patent Rights Controlled by ARCHEMIX; (v) the restrictions on ARCHEMIX in
Section 7.5; and (vi) the “head start” afforded to ELAN by each of the foregoing.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



77









 





               (e) Payment Dates and Reports. Royalty payments shall be made by ELAN within [***]
days after the end of each [***] commencing with the [***] in which the First Commercial Sale of a
Product occurs. ELAN shall also provide, at the same time each such payment is made, a report
showing: (a) the Net Sales of each Product by type of Product and country in the Territory; (b) the
basis for any deductions from gross amounts billed or invoiced to determine Net Sales; (c) the
applicable royalty rates for such Product; (d) the exchange rates used in calculating any of the
foregoing; and (e) a calculation of the amount of royalty due to ARCHEMIX.



               (f) Combination Products. The earned royalty due on a Combination Product shall be
determined pro rata on a Combination Product-by-Combination Product and country-by-country basis,
by multiplying Net Sales of the Combination Product by the fraction A/(A+B), where A is the invoice
price of the Royalty-Bearing Product when sold separately and B is the invoice price of the
Supplemental Product when sold separately by a Party, its Affiliate or its Sublicensee or, if not
sold by them, then the average invoice price when sold separately by Third Parties. If the
Supplemental Product in the Combination Product is not sold separately by any Person, Net Sales
shall be calculated by multiplying actual net revenues derived from sales of the Combination
Product by the fraction A/C, where A is as previously defined and C is the invoice price of the
Combination Product sold by a Party, its Affiliate or its Sublicensee. For purposes of clarity,
the average invoice price and the actual net revenues for any Supplemental Product shall be for a
quantity comparable to that contained in the Combination Product and shall be of the same class,
purity and potency as that contained in the Combination Product. If neither the Royalty-Bearing
Product nor the Supplemental Product included in the Combination Product, or the Combination
Product itself, or both, are sold separately, Net Sales shall be calculated based on the mutual
written agreement of the Parties as to a reasonable allocation between the Royalty-Bearing Product
and the Supplemental Product, taking into account total manufacturing costs, proprietary protection
and relative contribution thereof. If the Parties are unable to reach agreement on an appropriate
method of determining royalties for a Combination Product, the matter shall be submitted to the JMC
for resolution under Section 2.1.5.



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



78









 





          5.4.2 Records; Audit Rights. ELAN and its Affiliates and Sublicensees shall keep and
maintain for [***] years from the date of each payment of royalties hereunder complete and accurate
records of gross sales and Net Sales by ELAN and its Affiliates and Sublicensees of each Product,
in sufficient detail to allow royalties to be determined accurately. ARCHEMIX shall have the right
for a period of [***] years after receiving any such royalty payment to appoint at its expense an
independent certified public accountant reasonably acceptable to ELAN to audit the relevant records
of ELAN and its Affiliates and Sublicensees to verify that the amount of such payment was correctly
determined. ELAN and its Affiliates and Sublicensees shall each make its records available for
audit by such independent certified public accountant during regular business hours at such place
or places where such records are customarily kept, upon [***] days written notice from ARCHEMIX,
solely to verify that royalty payments hereunder were correctly determined. Such audit right shall
not be exercised by ARCHEMIX more than [***] in any [***] or more than [***] with respect to sales
of a particular Product in a particular period. All records made available for audit shall be
deemed to be Confidential Information of ELAN. The results of each audit, if any, shall be
promptly (but in any event no later than [***] days) after the audit reported to both Parties in
writing and shall be binding on both Parties. In the event there was an underpayment by ELAN
hereunder, ELAN shall promptly (but in any event no later than [***] days after ELAN’s receipt of
the report so concluding) make payment to ARCHEMIX of any shortfall. ARCHEMIX shall bear the full
cost of such audit unless such audit discloses an underreporting by ELAN of more than [***] percent
([***]%) of the aggregate amount of royalties payable in any Calendar Year, in which case ELAN
shall reimburse ARCHEMIX for all costs incurred by ARCHEMIX in connection with such audit.




          5.4.3 Overdue Royalties and Milestones. All royalty payments not made within the time
period set forth in Section 5.4.1(e), including underpayments discovered during an audit, and all
milestone payments not made within the time period specified in Section 5.3.1, shall bear interest
at a rate of [***] percent ([***]%) per month from the due date until paid in full or, if less, the
maximum interest rate permitted by Applicable Laws. When made, any such



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



79









 







overdue royalty or milestone payment shall be accompanied by, and credited first to, all
interest so accrued.




          5.4.4 Payments. All payments made by ELAN hereunder shall be made by wire transfer
from a banking institution in the United States in US Dollars in accordance with instructions given
in writing from time to time by ARCHEMIX.




          5.4.5 Taxes. Any income taxes or other taxes which ELAN is required by law to pay or
withhold on behalf of ARCHEMIX with respect to milestones, royalties and any other monies or other
transfer for value payable or provided to ARCHEMIX under this Agreement shall be deducted from such
milestones, royalties and any other monies due to ARCHEMIX under this Agreement. Any such tax
required to be paid or withheld shall be an expense of and borne solely by ARCHEMIX. ELAN shall
provide ARCHEMIX with documentation of such withholding in a manner that is satisfactory for
purposes of reporting to the U.S. Internal Revenue Service. Payments made by either Party for
goods and services provided by the other Party under this Agreement are exclusive of Value Added
Tax, sales tax or any other similar or substitute tax which will be additionally payable by the
Party receiving the goods or services in the event that Value Added Tax, sales tax or any other
similar or substitute tax applies to any of these payments; provided, that the Party providing the
goods or services will issue to the other Party an appropriate invoice to support any such charge.
ELAN shall submit to ARCHEMIX reasonable proof of payment of the withholding taxes contemplated by
this Section, together with an accounting of the calculations of such taxes, within [***] days
after which such withholding taxes are remitted to the proper authority. The Parties will
cooperate reasonably in completing and filing documents required under the provisions of any
applicable tax laws or under any other Applicable Law, in connection with the making of any
required tax payment or withholding payment, or in connection with any claim to a refund of or
credit for any such payment. The Parties will cooperate to minimize such taxes in accordance with
Applicable Law.




          5.4.6 Foreign Currency Exchange. All royalties shall be payable in full in the United
States in United States Dollars, regardless of the countries in which sales are made. If, in any
Quarter, Net Sales are made in any currency other than United States Dollars, such Net Sales shall
be converted into United States Dollars as follows:



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



80









 









(A/B), where




A = foreign “Net Sales” (as defined above) in such Quarter expressed in such foreign
currency; and




B = foreign exchange conversion rate, expressed in local currency of the foreign country per
United States Dollar (using, as the applicable foreign exchange rate, the average of the
daily closing rates published in the eastern edition of The Wall Street Journal under the
heading “Money Rates,” or any other mutually agreed upon source, for such Quarter).



6. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION. 




     6.1 Confidentiality.



          6.1.1 Confidentiality Obligations. ARCHEMIX and ELAN each recognizes that the other
Party’s Confidential Information and Proprietary Materials constitute highly valuable assets of
such other Party. ARCHEMIX and ELAN each agrees that, subject to Section 6.1.2, it will not
disclose, and will cause its Affiliates and Sublicensees not to disclose, any Confidential
Information or Proprietary Materials of the other Party and it will not use, and will cause its
Affiliates and Sublicensees not to use, any Confidential Information or Proprietary Materials of
the other Party except as expressly permitted hereunder; provided that such obligations shall apply
during the Term and for an additional [***] years thereafter.




          6.1.2 Limited Disclosure. ARCHEMIX and ELAN each agrees that disclosure of its
Confidential Information or any transfer of its Proprietary Materials may be made by the other
Party to any employee, consultant or Affiliate of such other Party to enable such other Party to
exercise its rights or to carry out its responsibilities under this Agreement; provided that any
such disclosure or transfer shall only be made to Persons who are bound by written obligations as
described in Section 6.1.3. In addition, ARCHEMIX and ELAN each agrees that the other Party may
disclose its Confidential Information (a) on a need-to-know basis to such other Party’s legal and
financial advisors, (b) as reasonably necessary in connection with an actual or potential (i)
permitted sublicense of such other Party’s rights hereunder, (ii) debt or equity financing of such
other Party or (iii) Change of Control involving such other Party, (c) to any Third Party that is
or may be engaged by such other Party to perform services in connection



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



81









 







with the Research Program, and (d) for any other purpose with the other Party’s written
consent, not to be unreasonably withheld, conditioned or delayed; provided, that, (A) in the case
of subsections (b)(i) and (iii) and (c) above, the other Party and the applicable Third Party first
enter into a Confidentiality Agreement with terms no less stringent than those contained in the
Confidentiality Agreement between the Parties, and (B) in the case of subsections (a) and (b)(ii)
above, the other Party uses good faith efforts to enter into a Confidentiality Agreement with the
applicable Third Party with terms no less stringent than those contained in the Confidentiality
Agreement between the Parties. Further each Party agrees that the other Party may disclose such
Party’s Confidential Information or Proprietary Materials (A) as reasonably necessary to file,
prosecute or maintain Patent Rights, or to file, prosecute or defend litigation related to Patent
Rights in accordance with this Agreement; (B) as necessary to Develop and Commercialize
Collaboration Aptamers under this Agreement; and (C) as required by Applicable Laws; provided,
that, in the case of any disclosure under this clause (B), the disclosing Party shall (1) if
practicable, provide the other Party with reasonable advance notice of and an opportunity to
comment on any such required disclosure and (2) if requested by the other Party, cooperate in all
reasonable respects with the other Party’s efforts to obtain confidential treatment or a protective
order with respect to any such disclosure, at the other Party’s expense. ELAN hereby agrees that
ARCHEMIX shall have the right to disclose to any Third Parties all ARCHEMIX Confidential
Information that relates to the IL-23 Program in existence as of the Effective Date substantially
in the form, and containing the same and no additional content, as the information previously
disclosed in writing by ARCHEMIX to ELAN on June 12, 2006 (but without any ARC numbers or other
sequence identifiers or any oligonucleotide sequences), subject to the execution by such Third
Parties of a confidential disclosure agreement containing terms consistent with those customarily
used by ARCHEMIX in such agreements.




          6.1.3 Employees and Consultants. ARCHEMIX and ELAN each hereby represents that all of
its employees and consultants, and all of the employees and consultants of its Affiliates, who
participate in the activities of the Collaboration or have access to Confidential Information or
Proprietary Materials of the other Party are or will, prior to their participation or access, be
bound by written obligations to maintain such Confidential Information or Proprietary



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



82









 







Materials in confidence and not to use such information except as expressly permitted
hereunder. Each Party agrees to use, and to cause its Affiliates to use, reasonable efforts to
enforce such obligations.




     6.2 Publicity. The Parties acknowledge that the terms of this Agreement constitute
Confidential Information of each Party and may not be disclosed except as permitted by Section
6.1.2. However, notwithstanding anything to the contrary in Section 6.1, ARCHEMIX, upon the
execution of this Agreement, shall issue a press release with respect to this Agreement, in the
form attached here to as Schedule 7, and either Party may make subsequent public disclosure
of the contents of such press release without further approval of the other Party. After issuance
of such press release, except as required by Applicable Laws, neither Party shall issue a press or
news release or make any similar public announcement (it being understood that publication in
scientific journals, presentation at scientific conferences and meetings and the like are intended
to be covered by Section 6.3 and not subject to this Section 6.2) related to the Research Program
without the prior written consent of an authorized representative of the other Party. Further,
ARCHEMIX shall not issue any press or news release or make any similar public announcement as to
the Development Program; provided that notwithstanding the foregoing, either Party shall be
expressly permitted to publicly announce (i) the occurrence of any clinical milestone event under
Section 5.3.1, so long as neither the amount of the milestone payments associated with the
achievement of such milestone event nor any other financial arrangements hereunder are disclosed
and (ii) any expansion by the Parties of the Research Program and/or any extension of the Research
Program Term, requiring, in each case, an amendment to this Agreement.



     6.3 Publications and Presentations. Each Party agrees that, except as required by
Applicable Laws, it shall not publish or present, or permit to be published or presented, the
results of or information pertaining to the Research Program or any Development Plan for, or
Co-Development of, a Fully-Exercised Co-Developed Product, without the prior review by and approval
of an authorized representative of the other Party. Further, ARCHEMIX shall not publish or
present, or allow to be published or presented any information pertaining to (a) Development of a
Product that is not a Fully-Exercised Co-Developed Product or (b) any Commercialization activities,
without the prior review by and approval of an authorized


CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



83









 







representative of ELAN. Except with respect to Fully-Exercised Co-Developed Products, ELAN
shall be free to publish and present results of Development, including details regarding the
relevant Lead Compounds, Clinical Candidates and/or Products, in accordance with the remainder of
this Section 6.3.



     The Parties acknowledge that scientific publications and public presentations must be strictly
monitored to prevent any adverse effect from premature publication or dissemination of results of
the activities hereunder. Accordingly, each Party shall provide to the other Party the opportunity
to review each of the submitting Party’s proposed abstracts, manuscripts or public presentations
(including, without limitation, information to be presented verbally to the public) that relate to
the Research Program or any Co-Development Program at least [***] days prior to its intended public
presentation or submission for publication, and such submitting Party agrees, upon written request
from the other Party given within such [***] day period, not to submit such abstract or manuscript
for publication or to make such public presentation until the other Party is given up to [***] days
from the date of such written request to seek appropriate patent protection for any material in
such intended publication or public presentation that it reasonably believes may be patentable.
Once such abstracts, manuscripts or presentations have been reviewed and approved by each Party,
the same abstracts, manuscripts or presentations do not have to be provided again to the other
Party for review for a later submission for publication. Each Party also shall have the right to
require that any of its Confidential Information that is disclosed in any such proposed publication
or public presentation be deleted prior to such publication or presentation. In any permitted
publication or public presentation by a Party, the other Party’s contribution shall be duly
recognized, and co-authorship shall be determined in accordance with customary scientific
standards.



     6.4 Prohibition on Solicitation. Without the written consent of the other Party,
neither Party nor its Affiliates shall, during the [***] or for [***] year thereafter, solicit
(directly or indirectly) any employee of the other Party or its Affiliates who participated in the
Research Program at any time during the Research Program Term. This provision shall not restrict
either Party or its Affiliates from advertising employment opportunities in any manner that does
not directly target the other Party or its Affiliates.


CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



84









 





7. LICENSE GRANTS; EXCLUSIVITY




     7.1 Research and Development Licenses.



          7.1.1 ARCHEMIX License Grants.




               (a) Research Program. Subject to the terms and conditions of this Agreement, ARCHEMIX
hereby grants to ELAN and its Affiliates a co-exclusive (together with ARCHEMIX), royalty-free
license in the Territory during the Term, under the Licensed Technology and Licensed Patent Rights,
including ARCHEMIX’ interest in the Joint Technology and Joint Patent Rights, to make and use
Collaboration Aptamers for the sole purpose of conducting ELAN Research Activities. The foregoing
license shall include the right to grant sublicenses as provided in Section 7.3.



               (b) Development Program. Subject to the terms and conditions of this Agreement,
ARCHEMIX hereby grants to ELAN and its Affiliates an exclusive (except to the extent necessary for
ARCHEMIX to conduct Development Activities and to Co-Develop Co-Developed Products), royalty-free
license in the Territory during the Term, under the Licensed Technology and Licensed Patent Rights,
including ARCHEMIX’ interest in the Joint Technology and Joint Patent Rights to make and use
Collaboration Aptamers for the sole purpose of Developing such Collaboration Aptamers (including,
but not limited to, the right to manufacture or have manufactured such Collaboration Aptamers,
subject to Section 4.5) in the Territory. The foregoing license shall include the right to grant
sublicenses as provided in Section 7.3.



               (c) License to Certain Program Technology for Use Outside the Collaboration. Subject
to the terms and conditions of this Agreement, ARCHEMIX hereby grants to ELAN and its Affiliates a
non-exclusive, royalty-free license, with the right to grant sublicenses, in the Territory under
ARCHEMIX Program Technology and Patent Rights Controlled by ARCHEMIX claiming ARCHEMIX Program
Technology to research, develop, make, use, sell, offer for sale and import products that are not,
and that do not contain, Aptamers, for any and all uses outside of the ARCHEMIX Field. For
purposes of clarity, ELAN shall have no right pursuant to the foregoing license to develop, make,
use or sell Aptamers, or to grant a


CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



85









 




sublicense to a Third Party to develop, make, use or sell Aptamers, for any use within the
ARCHEMIX Field, except as expressly granted otherwise herein.




          7.1.2 ELAN Grants.




               (a) Research Program. Subject to the terms and conditions of this Agreement, ELAN
hereby grants to ARCHEMIX and its Affiliates a non-exclusive, royalty-free license in the Territory
during the Research Program Term, without the right to grant sublicenses, under ELAN Technology,
ELAN Patent Rights, ELAN Product Technology and ELAN Product Patent Rights and ELAN’s interest in
Joint Technology and Joint Patent Rights, for the sole purpose of conducting the Research Program.



               (b) Development Program. Subject to the terms and conditions of this Agreement, ELAN
hereby grants to ARCHEMIX and its Affiliates a non-exclusive, royalty-free license in the Territory
during the Term, without the right to grant sublicenses, under ELAN Technology and ELAN Patent
Rights, ELAN Product Technology and ELAN Product Patent Rights and ELAN’s interest in Joint
Technology and Joint Patent Rights for the sole purpose of conducting ARCHEMIX Development
Activities and Co-Development of Co-Developed Products.



               (c) License and Rights to Certain Program Technology for Use Outside the
Collaboration. Subject to the terms and conditions of this Agreement, ELAN hereby grants to
ARCHEMIX and its Affiliates a non-exclusive, royalty-free license in the Territory, with the right
to grant sublicenses under ELAN Patent Rights and ELAN Joint Product Patent Rights that cover
Aptamer-Generic Technology, to research, develop, make, use, sell, offer for sale and import
products that are, or that contain, Aptamers other than Program Aptamers, for any and all uses
within the ARCHEMIX Field. Further, the Parties shall discuss in good faith the grant of a license
on commercially reasonable terms under ELAN Product Patent Rights that cover Aptamer-Generic
Technology and are not ELAN Joint Product Patent Rights as follows: if at any time during the
Term, ARCHEMIX desires to obtain a license under such ELAN Product Patent Rights, ARCHEMIX shall
give written notice to ELAN (the “License Notice”), whereupon the Parties shall negotiate in good
faith with respect to a license on commercially reasonable terms for a period of up to [***] days
from the date of the License Notice. If the


CONFIDENTIAL



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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Parties do not agree upon the terms with respect to a license within the [***] day negotiation
period, ELAN shall thereafter have no obligation to ARCHEMIX with respect to such ELAN Product
Patent Rights.




               (d) Terminated Program Aptamers. Subject to the terms and conditions of this
Agreement, ELAN hereby grants to ARCHEMIX and its Affiliates an exclusive, royalty-bearing license
in the Territory, with the right to grant sublicenses, under (i) ELAN Program Technology and (ii)
ELAN’s interest in Joint Technology, to research, develop, have developed, make, have made, use,
distribute for sale, sell, offer for sale, import and have imported Terminated Program Aptamers.
Such license is subject (i) in accordance with Section 7.1.2(f), to the payment by ARCHEMIX to ELAN
of payments in the amounts and at the rates set forth in Sections 5.3 and 5.4 (including without
limitation Section 5.4.1(c)) for any such Terminated Program Aptamer for which IND Acceptance had
occurred by the time it became a Terminated Program Aptamer and any Product Derived therefrom that
is Commercialized by ARCHEMIX, its Affiliates or Sublicensees for the remainder of the applicable
Royalty Term, and (ii) to ARCHEMIX agreeing to pay all amounts due to Third Parties by ELAN under
agreements between ELAN and such Third Parties with respect to ARCHEMIX’ practice of the foregoing
license; provided, that all such payments shall be deemed to be Third Party Payments for purposes
of Section 5.4.1(c).



               (e) Rejected Program Targets. Subject to the terms and conditions of this Agreement,
ELAN hereby grants to ARCHEMIX and its Affiliates an exclusive (even as to ELAN), royalty-bearing
(as described below) license in the Territory, with the right to grant sublicenses, under ELAN
Program Technology and ELAN’s interest in Joint Technology, to research, develop, make, have made
and use any Rejected Program Targets solely to develop, make, use, sell, offer for sale and import
Aptamers binding to such Rejected Program Target, subject to the payment by ARCHEMIX to ELAN, in
accordance with Section 7.1.2(d) and 7.1.2(f), of payments in the amounts and at the rates set
forth in Sections 5.3 and 5.4 (including without limitation Section 5.4.1(c)) for any Terminated
Program Aptamer for which IND Acceptance had occurred by the time it became a Terminated Program
Aptamer, and any



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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Products Derived therefrom, that are Developed and Commercialized by ARCHEMIX, its Affiliates
or Sublicensees, for the remainder of the applicable Royalty Term.




               (f) Payment of Royalties and Milestones and Other Obligations to ELAN. In calculating
the payments due to ELAN for the licenses granted in Section 7.12(d) and (e), and related matters,
the terms of Sections 5.3 and 5.4 and all related obligations (including the right to offset
payments in accordance with Section 5.4.1(c)) shall apply mutatis mutandis to each such Terminated
Program Aptamer and Product Derived therefrom.



     7.2 Commercialization License. Subject to the terms and conditions of this Agreement,
ARCHEMIX hereby grants to ELAN and its Affiliates an exclusive, royalty-bearing license during the
Term under Licensed Technology and Licensed Patent Rights, including ARCHEMIX’ interest in Joint
Technology and Joint Patent Rights, for the sole purpose of Commercializing Products (including,
but not limited to, the right to make, use, sell, have sold, offer to sell, distribute for sale,
import, have imported, make or have made Products, subject to Section 4.5) in the Territory. The
foregoing license shall include the right to grant sublicenses as provided in Section 7.3.



     7.3 Right to Sublicense. ELAN shall have the right to grant sublicenses under the
licenses granted to it in Sections 7.1 and 7.2, except that ELAN shall not have the right to grant
sublicenses under Section 7.1 and 7.2 with respect to any Fully-Exercised Co-Developed Product for
the relevant Co-Development Territory(ies), Indication and/or formulation absent prior consent from
ARCHEMIX, which shall not be unreasonably withheld, conditioned or delayed. It shall be a
condition of any such sublicense that such Sublicensee agrees to be bound by all terms of this
Agreement applicable to the conduct of ELAN Research Activities, Development and/or
Commercialization of Products in the Territory (including, without limitation, Article 6). ELAN
shall provide written notice to ARCHEMIX of any proposed sublicense with respect to a
Fully-Exercised Co-Developed Product at least [***] days prior to execution of such sublicense and
shall provide copies to ARCHEMIX of all sublicenses (with financial and other confidential terms
redacted) within [***] business days after execution thereof. ELAN shall not be relieved of its
obligations pursuant to this Agreement as a result of such sublicense.


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     7.4 No Other Rights. ELAN shall have no rights to use or otherwise exploit ARCHEMIX
Technology, ARCHEMIX Patent Rights, ARCHEMIX Confidential Information or ARCHEMIX Proprietary
Materials, and ARCHEMIX shall have no rights to use or otherwise exploit ELAN Technology, ELAN
Product Technology, ELAN Patent Rights, ELAN Joint Product Patent Rights, ELAN Product Patent
Rights, ELAN Confidential Information or ELAN Proprietary Materials, in each case, except as
expressly set forth in this Agreement. Notwithstanding anything to the contrary set forth herein,
(a) ELAN is not granted the right to practice the SELEXTM Process or to use the SELEXTM Technology to
identify or modify Aptamers, (b) ELAN is not granted the right to research, develop, make, have
made, use, offer for sale, distribute for sale, sell, import and have imported Diagnostic Products;
provided that, ELAN may use In Vitro Diagnostics solely to research and Develop (including
manufacture and use) Collaboration Aptamers; (c) neither Party shall have, nor grant to any Third
Party, any rights to research, develop, make, use, sell, offer for sale or import the IL-23 Aptamer
designated as [***] and described in Schedule 9; provided, that, notwithstanding the
foregoing, ELAN and ARCHEMIX may each use ARC2350 solely for purposes of the Research Program
during the Research Program Term, and (d) ARCHEMIX shall be free to conduct research and
development activities with respect to Aptamers other than Collaboration Aptamers.



     7.5 Exclusivity.



          7.5.1 ARCHEMIX. During the Term, ARCHEMIX shall not, and shall cause each of its
Affiliates to not, conduct any activity, either on its own, or with, for the benefit of, or
sponsored by any Third Party, that is designed to research, develop or commercialize, or grant any
license or other rights to any Third Party to utilize, any Proprietary Materials, Technology or
Patent Rights Controlled in whole or in part by ARCHEMIX or any of its Affiliates for the purpose
of researching, developing or commercializing any Aptamer or any other molecule or product binding
to (a) a Program Target, (b) any Collaboration Aptamer or Aptamer Derived therefrom, except as
provided under this Agreement. By way of example, with respect to the IL-23 Program Target,
ARCHEMIX will not perform the SELEXTM Process against (i) [***], or the [***] of the [***] or (ii)
the [***] or the [***]. For purposes of clarity, and without limiting the generality of the
foregoing, there shall be no restriction on ARCHEMIX under this Section 7.5.1



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of the Securities Act.



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with regard to Terminated Program Aptamers, or Rejected Program Targets; provided, however,
that this sentence shall not be deemed to confer upon ARCHEMIX any license under any ELAN Patent
Rights, ELAN Product Patent Rights or other proprietary rights that ELAN may now or in the future
Control in respect of any Target or other technology not expressly licensed to ARCHEMIX pursuant to
this Agreement.




          7.5.2 ELAN. During the Term, ELAN shall not, and shall cause each of its Affiliates
to not conduct any activity, either on its own, or with, for the benefit of, or sponsored by any
Third Party, that is designed to research, develop or commercialize, or grant any license or other
rights to any Third Party to utilize any Technology or Patent Rights Controlled by ELAN or any of
its Affiliates for the purpose of researching, developing or commercializing, any Aptamer binding
to a Program Target or any Aptamer Derived therefrom that binds specifically to the relevant
Program Target, except as provided under this Agreement.




8. INTELLECTUAL PROPERTY RIGHTS




     8.1 ARCHEMIX Intellectual Property Rights. ARCHEMIX shall have sole and exclusive
ownership of all right, title and interest on a worldwide basis in and to any and all ARCHEMIX
Technology and ARCHEMIX Patent Rights.



     8.2 ELAN Intellectual Property Rights. ELAN shall have sole and exclusive ownership
of all right, title and interest on a worldwide basis in and to any and all ELAN Technology, ELAN
Product Technology, ELAN Patent Rights and ELAN Product Patent Rights.



     8.3 Joint Technology Rights. ELAN and ARCHEMIX shall jointly own all Joint Technology
and Joint Patent Rights. Notwithstanding anything to the contrary contained in this Agreement or
under Applicable Law, except to the extent exclusively licensed to one Party under this Agreement
or otherwise prohibited hereby, the Parties hereby agree that either Party may use or license or
sublicense to Affiliates or Third Parties all or any portion of its interest in Joint Technology,
Joint Patent Rights or jointly owned Confidential Information or Proprietary Materials for any
purposes without the prior written consent of the other Party, without restriction and without the
obligation to provide compensation to the other Party, except as otherwise provided herein.


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     8.4 Patent Coordinators. ARCHEMIX and ELAN shall each appoint a patent coordinator
reasonably acceptable to the other Party (each, a “Patent Coordinator”) to serve as such Party’s
primary liaison with the other Party on matters relating to patent filing, prosecution, maintenance
and enforcement. Each Party may replace its Patent Coordinator at any time by notice in writing to
the other Party. The initial Patent Coordinators shall be:



     For ARCHEMIX: John Harre



     For ELAN: [***]



     8.5 Inventorship. In case of a dispute between ARCHEMIX and ELAN over inventorship
and, as a result, whether any particular Technology is ARCHEMIX Technology, ELAN Technology, ELAN
Product Technology or Joint Technology, such dispute shall be resolved by patent counsel who (and
whose firm) is not at the time of the dispute, and was not at any time during the [***] years prior
to such dispute, performing services for either of the Parties, such patent counsel to be selected
by mutual written agreement of the Patent Coordinators. The fees for, and expenses of, such patent
counsel shall be shared equally by the Parties.



     8.6 Cooperation. Each Party shall cooperate with the other Party to effect the intent
of this Article 8, including without limitation by executing documents and making its employees and
independent contractors available to execute documents as necessary to achieve the foregoing
allocation of ownership rights.



9. INTELLECTUAL PROPERTY




     9.1 Patent Filing, Prosecution and Maintenance.



          9.1.1 ELAN’s Prosecution Rights.




     (a) Subject to Sections 9.1.4 and 9.1.5, ELAN, acting through patent counsel or agents of its
choice, shall be responsible for the preparation, filing, prosecution and maintenance in the
countries listed on Schedule 9, at its sole cost and expense, of (a) Program
Aptamer-Specific Patent Rights, (b) all Patent Rights that cover (1) ELAN Product Technology, (2)
Joint Technology, and (3) ELAN Program Technology, and (c) ELAN Joint Product Patent



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Rights, but in each case excluding Aptamer-Generic Patent Rights; provided that, ARCHEMIX,
acting through patent counsel or agents of its choice, shall have the right but not the obligation,
for each Program Target, to prepare on ELAN’s behalf and with ELAN’s approval the first patent
application disclosing the corresponding Collaboration Aptamers. ELAN shall have no right or
responsibility with respect to the preparation, filing, prosecution and/or maintenance of any
claims within the Licensed Patent Rights that relate to a Terminated Program Aptamer or its
manufacture or its formulation or a method of its delivery or of its use. ELAN shall nationalize
such filings in the European Patent Office and the other countries or regional offices listed on
Schedule 9 and shall validate such filings in all EPO contracting states and the
contracting states of any other regional offices identified on Schedule 9 and, at ELAN’s
sole discretion, in any other country. At ELAN’s request, ARCHEMIX shall cooperate with ELAN in
all reasonable respects in connection with such preparation, filing, prosecution and maintenance of
such Aptamer-Specific Patent Rights, including but not limited to obtaining assignments to reflect
chain of title consistent with the terms of this Agreement, gaining United States patent term
extensions, supplementary protection certificates and any other extensions that are now or become
available in the future wherever applicable to Licensed Patent Rights. For purposes of clarity,
notwithstanding anything to the contrary herein, ELAN shall have no rights to prepare, file,
prosecute and/or maintain any Patent Rights included in the SELEXTM Portfolio or the Aptamer-Generic
Patent Rights.




               (b) ELAN, at its sole expense and acting through patent counsel or agents of its choice, shall
be responsible for the preparation, filing, prosecution and maintenance of all Patent Rights
covering ELAN Background Technology.



               (c) ELAN, at its sole expense and acting through patent counsel or agents of its choice, shall
be responsible for the preparation, filing, prosecution and maintenance of all IL-23 Patent
Applications.



          9.1.2 ARCHEMIX Prosecution Rights.




               (a) Program Technology. ARCHEMIX, at its sole expense and acting through patent
counsel or agents of its choice, shall be responsible for the preparation, filing, prosecution and
maintenance of all Patent Rights that cover (1) only Aptamer-Generic



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Technology and (2) ARCHEMIX Program Technology that are not part of Aptamer-Specific Patent
Rights or Aptamer-Generic Patent Rights. At ARCHEMIX’ request, ELAN shall cooperate with and
assist ARCHEMIX in all reasonable respects, at ARCHEMIX’ expense, in connection with such
preparation, filing, prosecution and maintenance of such Aptamer-Generic Patent Rights, including
but not limited to obtaining assignments to reflect chain of title consistent with the terms of
this Agreement, gaining United States patent term extensions, supplementary protection certificates
and any other extensions that are now or become available in the future wherever applicable.




               (b) ARCHEMIX Background Technology. Subject to Section 9.1.1(c), ARCHEMIX, at its
sole expense and acting through patent counsel or agents of its choice, shall be responsible for
the preparation, filing, prosecution and maintenance of all Patent Rights covering ARCHEMIX
Background Technology.



          9.1.3 Joint Prosecution. Notwithstanding anything to the contrary in Section 9.1.1(a)
or 9.1.2(a), unless the Parties otherwise agree, the Parties, acting through patent counsel or
agents of its choice, shall be jointly responsible for the preparation, filing, prosecution and
maintenance of all Patent Rights that cover Program Technology and that contain one or more claims
that cover both Aptamer-Specific Patent Rights and Aptamer-Generic Patent Rights as follows: (a)
ELAN shall be responsible for the preparation, filing, prosecution and maintenance of any such
claims that are Aptamer-Specific Patent Rights; (b) ARCHEMIX shall be responsible for the
preparation, filing, prosecution and maintenance of any such claims that are Aptamer-Generic Patent
Rights; (c) the Parties shall discuss in good faith whether and how to pursue those claims for
which they have primary responsibility under this Section 9.1.3 in separate patent applications;
(d) each Filing Party shall provide the Non-Filing Party and its patent counsel with an opportunity
to consult with the Filing Party and its patent counsel regarding the filing and contents of any
application, amendment, submission or response filed pursuant to this Section 9.1.3; and (e) each
Party shall be responsible for all expenses incurred by it for the preparation, filing prosecution
and maintenance of any Patent Rights for which it has primary responsibility pursuant to this
Section 9.1.3.



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          9.1.4 Information and Cooperation. Each Party that has responsibility for filing and
prosecuting any Patent Rights under this Section 9.1 (a “Filing Party”) shall (a) regularly provide
the other Party (the “Non-Filing Party”) with copies of all patent applications filed hereunder for
Program Technology and other material submissions and correspondence with the patent offices, in
sufficient time to allow for review and comment by the Non-Filing Party; and (b) provide the
Non-Filing Party and its patent counsel with an opportunity to consult with the Filing Party and
its patent counsel regarding the filing and contents of any such application, amendment, submission
or response, and the advice and suggestions of the Non-Filing Party and its patent counsel shall be
taken into consideration in good faith by such Filing Party and its patent counsel in connection
with such filing. Each Filing Party shall pursue in good faith all reasonable claims and take such
other reasonable actions, as may be requested by the Non-Filing Party in the prosecution of any
Patent Rights under this Section 9.1; provided, however, if the Filing Party incurs any additional
expense as a result of any such request, the Non-Filing Party shall be responsible for the cost and
expenses of pursuing any such additional claim or taking such other activities. In addition, ELAN
(a) agrees that if ARCHEMIX claims any action taken under Section 9.1.1(a) or (c) would be
detrimental to Patent Rights covering ARCHEMIX Background Technology (including without limitation
the SELEXTM Portfolio), ARCHEMIX shall provide written notice to ELAN and the Patent Coordinator
shall, as promptly as possible thereafter, meet to discuss and resolve such matter and, if they are
unable to resolve such matter, the Parties shall refer such matter to a mutually agreeable outside
patent counsel for resolution.




          9.1.5 Abandonment. If a Filing Party decides to abandon or to allow to lapse any of
the Patent Rights covering any Program Technology for which it has responsibility, it shall inform
the Non-Filing Party of such decision promptly and, in any event, so as to provide the Non-Filing
Party a reasonable amount of time to meet any applicable deadline to establish or preserve such
Patent Rights in such country or region. The Non-Filing Party shall have the right to assume
responsibility for continuing the prosecution of such Patent Rights in such country or region and
paying any required fees to maintain such Patent Rights in such country or region or defending such
Patent Rights, through patent counsel or agents of its choice, which shall be at



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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the Non-Filing Party’s sole expense. The Non-Filing Party shall not become an assignee of any
such Patent Rights as a result of its assumption of any such responsibility. Upon transfer of such
responsibility under this Section 9.1.5, the Filing Party shall promptly deliver to the Non-Filing
Party copies of all necessary files related to the Patent Rights with respect to which
responsibility has been transferred and shall take all actions and execute all documents reasonably
necessary for the Non-Filing Party to assume such responsibility.




     9.2 Legal Actions.



          9.2.1 Third Party Infringement.




               (a) Notice. In the event either Party becomes aware of (i) any possible infringement
of any Licensed Patent Rights, ELAN Patent Rights, ELAN Product Patent Rights, ELAN Joint Product
Patent Rights or Joint Patent Rights through the Development or Commercialization of an Aptamer
covered by the Program Aptamer-Specific Patent Rights, or (ii) the submission by any Third Party of
an abbreviated new drug application under the Hatch-Waxman Act for a product that includes an
Aptamer covered by the Program Aptamer-Specific Patent Rights (each, an “Infringement”), that Party
shall promptly notify the other Party and provide it with all details of such Infringement of which
it is aware (each, an “Infringement Notice”).



               (b) ELAN Right to Enforce.



                    (i) Enforcement of Section 9.1.1(b) Patent Rights. In the event that any Infringement
relates to any Patent Rights covering ELAN Background Technology, ELAN shall have the sole right
but not the obligation to enforce such claim.



                    (ii) Enforcement of Sections 9.1.1(a) and (c) Patent Rights and Certain 9.1.3 Patent
Rights. In the event that any Infringement relates to any Patent Right that ELAN is
responsible for prosecuting pursuant to Sections 9.1.1 and/or 9.1.3, ELAN shall have the first
right (but not the obligation) to enforce such claim, which may include the institution of legal
proceedings or other action; provided that, notwithstanding the foregoing, ELAN shall not admit the
invalidity or unenforceability of any Licensed Patent Rights without ARCHEMIX’ prior written
consent.



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     ELAN shall keep ARCHEMIX reasonably informed on a quarterly basis, in person or by telephone,
prior to and during any such enforcement. ARCHEMIX shall assist ELAN, upon request and at
ARCHEMIX’ expense in taking any action to enforce any such Patent Rights and shall join in any such
action if deemed to be a necessary party. ELAN shall incur no liability to ARCHEMIX as a
consequence of such litigation or any unfavorable decision resulting therefrom, including any
decision holding any such claim invalid, not infringed or unenforceable. All costs, including
without limitation attorneys’ fees, relating to such legal proceedings or other action shall be
borne by ELAN. If ELAN does not take commercially reasonable steps to abate the Infringement of
such Patent Rights within [***] days from any Infringement Notice (or [***] days in the case of an
Infringement resulting from the submission by any Third Party of an abbreviated new drug
application under the Hatch-Waxman Act), then ARCHEMIX shall have the right and option to do so at
its expense. For purposes of clarity, notwithstanding anything to the contrary herein, ELAN shall
have no rights to enforce any (1) ARCHEMIX Patents Rights covering the SELEXTM Process or SELEXTM
Technology, or (2) the SELEXTM Portfolio.



               (c) ARCHEMIX Right to Enforce.



                    (i) Enforcement of Section 9.1.2(b) Patent Rights. In the event that any Infringement
relates to any Patent Rights covering ARCHEMIX Background Technology, ARCHEMIX shall have the sole
right but not the obligation to enforce such claim.



                    (ii) Enforcement of Section 9.1.2(a) Patent Rights and Certain 9.1.3 Patent Rights.
In the event that any Infringement relates to any Patent Right that ARCHEMIX is responsible for
prosecuting pursuant to Sections 9.1.2 and/or 9.1.3, ARCHEMIX shall have the first right (but not
the obligation) to enforce such claim, which may include the institution of legal proceedings or
other action.



     ARCHEMIX shall keep ELAN reasonably informed on a quarterly basis, in person or by telephone,
prior to and during any such enforcement. ELAN shall assist ARCHEMIX, upon request and at ELAN’s
expense in taking any action to enforce any such Patent Rights and shall join in any such action if
deemed to be a necessary party. ARCHEMIX shall incur no liability to ELAN as a consequence of such
litigation or any unfavorable decision resulting therefrom,



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including any decision holding any such claim invalid, not infringed or unenforceable. All
costs, including without limitation attorneys’ fees, relating to such legal proceedings or other
action shall be borne by ARCHEMIX. If ARCHEMIX does not take commercially reasonable steps to
abate the Infringement of such Patent Rights within [***] days from any Infringement Notice (or
[***] days in the case of an Infringement resulting from the submission by any Third Party of an
abbreviated new drug application under the Hatch-Waxman Act), then ELAN shall have the right and
option to do so at its expense.



               (d) Representation of Either Party. Each Party shall have the right to be represented
by counsel that it selects in any legal proceedings or other action instituted under this Section
9.2.1 by the other Party.



               (e) Cooperation by the Parties. In any action, suit or proceeding instituted under
this Section 9.2.1, the Parties shall cooperate with and assist each other in all reasonable
respects. Upon the reasonable request of the Party instituting such action, suit or proceeding,
the other Party shall join such action, suit or proceeding and shall be represented using counsel
of its own choice, at the requesting Party’s expense. If a Party with the right to initiate legal
proceedings under Section 9.2.1 lacks standing to do so and the other Party has standing to
initiate such legal proceedings, then the Party with standing shall initiate such legal proceedings
at the request and expense of the other Party.



               (f) Allocation of Recoveries. Except as provided in subsection (g), any amounts
recovered by ELAN pursuant to actions under Section 9.2.1(b), whether by settlement or judgment,
shall be allocated in the following order: (i) first, to reimburse ELAN and ARCHEMIX for their
reasonable out-of-pocket expenses in making such recovery (which amounts shall be allocated pro
rata if insufficient to cover the totality of such expenses); and (ii) second (A) with respect to
actual damages, then, to ELAN and ARCHEMIX [***] ELAN’s historic profits or Net Sales of the
Product or Products affected by the Infringement bears to ARCHEMIX’ historic royalties hereunder in
respect of such Net Sales, in each case as determined in good faith, and (B) with respect to
punitive, special or consequential damages, [***] percent ([***]%) to ELAN. Any amounts recovered
by ARCHEMIX pursuant to actions under Section 9.2.1(b) shall be allocated in the following order:
(X) first, to reimburse



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ARCHEMIX and ELAN for their reasonable out of pocket expenses in making such recovery (which
amounts shall be allocated pro rata if insufficient to cover the totality of such expenses); and
(Y) then, [***]% to ARCHEMIX.




               (g) Recoveries Applicable to Co-Developed Products. Any costs incurred or amounts
recovered by either Party pursuant to actions under Section 9.2.1 with respect to any Infringement
relating to a Co-Developed Product in the relevant Indication, formulation and Co-Development
Territory(ies) shall be treated as expenses and revenues subject to the sharing of costs and
expenses under Section 4.11 and Schedule 4.



          9.2.2 Defense of Claims.




               (a) Notice. In the event that a Third Party alleges that the conduct of the Research
Program or the Development, Co-Development or Commercialization of a Lead Compound, Clinical
Candidate, Product or Co-Developed Product infringes a Third Party’s patent, the Party becoming
aware of such allegation shall promptly notify the other Party hereof, in writing, reasonably
detailing the claim.



               (b) Third Party Suit Relating Primarily to Program Targets or Proprietary Chemistry.



                    (i) In the event that any action, suit or proceeding is brought against either Party or any
Affiliate or Sublicensee of either Party alleging the infringement of the Patent Rights of a Third
Party relating specifically to the Program Targets by reason of activities conducted pursuant to
this Agreement, (A) ELAN shall have the right and obligation to defend such action, suit or
proceeding at its sole expense; (B) ARCHEMIX or any of its Affiliates or Sublicensees shall have
the right to separate counsel at its own expense in any such action, suit or proceeding and, if
such action, suit or proceeding has been brought against ARCHEMIX or any of its Affiliates or
Sublicensees, ARCHEMIX may elect to defend itself at its sole expense; and (C) the Parties shall
cooperate with each other in all reasonable respects in any such action, suit or proceeding.
Settlement costs, royalties paid in settlement of any such suit, and the payment of any damages to
the Third Party shall be borne solely by ELAN, provided that, if the action, suit or proceeding
relates to a Co-Developed Product, such costs,


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royalties and damage payments was well as the Parties’ attorneys’ fees and expenses, shall be
subject to the sharing of costs and expenses under Section 4.11 and Schedule 4.




                    (ii) In the event that any action, suit or proceeding is brought against either Party or any
Affiliate or Sublicensee of either Party alleging the infringement, by reason of activities
conducted pursuant to this Agreement, of the Technology or Patent Rights of a Third Party relating
specifically to the use of Proprietary Chemistry in (A) the Research Program or any Product
independent of any challenge to the right to practice the SELEXTM Process or SELEXTM Technology or
the SELEXTM Portfolio, (B) the Development of any Clinical Candidate, or (C) the Commercialization,
including without limitation the manufacture, use or sale, of any Product, and provided that
then-available, suitable non-proprietary molecules, methods and/or processes present a reasonable
alternative equivalent to such Proprietary Chemistry in the opinion of an independent, neutral
Third Party selected by mutual agreement of the Parties, ELAN shall have the right and obligation
to defend and resolve such action, suit or prosecution at its sole expense, provided that, if the
action, suit or proceeding relates to a Co-Developed Product, such costs, royalties and damage
payments as well as the Parties’ attorneys’ fees and expenses, shall be subject to the sharing of
costs and expenses under Section 4.11 and Schedule 4.



               (c) Third Party Suit Relating Primarily to the use of the SELEXTM Process or the SELEXTM
Technology. In the event that any action, suit or proceeding is brought against either Party
or any Affiliate or Sublicensee of either Party alleging the infringement of the Patent Rights of a
Third Party by reason of the use of the SELEXTM Process or the use of the SELEXTM Technology
(excluding in either case any action, suit or proceeding based solely on the use of Proprietary
Chemistry) in the conduct of the Research Program (i) ARCHEMIX shall have the right and obligation
to defend and resolve such action, suit or proceeding at its sole expense; and (ii) ELAN or any of
its Affiliates or Sublicensees shall have the right to separate counsel at its own expense in any
such action, suit or proceeding and, if such action, suit or proceeding has been brought against
ELAN or any of its Affiliates or Sublicensees, ELAN or its Affiliate or Sublicensee may elect to
defend itself at its sole expense. Settlement costs, royalties


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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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paid in settlement of any such suit, and the payment of any damages to the Third Party shall
be borne solely by ARCHEMIX.




               (d) Cooperation in Defense. The Parties shall cooperate with each other in all
reasonable respects in any action, suit or proceeding under this Section 9.2.2. Each Party shall
provide the other Party with prompt written notice of the commencement of any such suit, action or
proceeding, or of any evidence or allegation of infringement of which such Party becomes aware, and
shall promptly furnish the other Party with a copy of each communication relating to the alleged
infringement that is received by such Party. The Party that is a party to the action, suit or
proceeding shall not admit the invalidity of any patent within the Licensed Patent Rights, Joint
Patent Rights, ELAN Joint Product Patent Rights, ELAN Product Patent Rights or ELAN Patent Rights,
nor settle such action, suit or proceeding in a manner that adversely affects the other Party’s
rights under this Agreement, without the written consent of the other Party, which consent shall
not be unreasonably withheld, delayed or conditioned.



               (e) Third Party Suit Relating to Other Infringement. In the event that any action,
suit or proceeding is brought against either Party or any Affiliate or Sublicensee of either Party
alleging the infringement of the Patent Rights of a Third Party other than as provided above, then
at the request of the Party against whom the action, suit or proceeding is brought, the other Party
shall provide reasonable assistance to such Party and shall join such action, suit or proceeding if
deemed a necessary party. The Parties shall share equally in the litigation expenses, including
settlement costs, royalties paid in settlement of any such suit, and the payment of any damages to
the Third Party.



     9.3 Trademark and Copyright Ownership Prosecution, Defense and Enforcement. ELAN
shall own and be responsible for the filing, prosecution, maintenance, defense and enforcement of
all Product Trademarks and copyrights created during the Research Program, Development and/or
Commercialization at ELAN’s expense; provided that any such expenses incurred with respect to
Product Trademarks and copyrights for Co-Developed Products shall be treated as Commercialization
Costs subject to the cost-sharing mechanism set forth in Section 4.11 and Schedule 4.


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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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     9.4 Third Party Licenses. If either Party believes that there exists an issued Third
Party patent in the absence of a license to which the conduct of the Research Program, the
Development of a Clinical Candidate or the Commercialization of a Product would infringe a valid
claim under such Third Party patent (a “Blocking Third Party Patent”), it shall notify the JMC and
the other Party. The JMC shall discuss in good faith whether, and on what terms, a Blocking Third
Party Patent should be licensed for the purposes of this Agreement. Subject to the next sentence
of this Section 9.4, (a) any decision with respect to the license of a Blocking Third Party Patent
with respect to the SELEXTM Process or the SELEXTM Technology shall be an ARCHEMIX Decision; and (b)
any decision with respect to the license of such Blocking Third Party Patent that covers the
composition of matter of a Co-Developed Product shall be an Excepted Decision and (c) any decision
with respect to the license of such Blocking Third Party Patent not covered by (a) or (b) above
shall be an ELAN Decision. If, in making any such ARCHEMIX Decision, ARCHEMIX concludes that a
license to such Blocking Third Party Patent is not necessary and ELAN disagrees with such ARCHEMIX
Decision, ELAN shall have the right to (a) enter into a license for itself under such Blocking
Third Party Patent, or (b) terminate this Agreement pursuant to Section 10.2.1. If, in making any
Excepted Decision, the JMC is unable to reach a determination with respect to any issue relating to
a proposed license agreement, then such issue shall be evaluated in accordance with the procedures
set forth in Section 2.1.5. If such issue cannot be resolved pursuant to Section 2.1.5, then
neither Party shall proceed with the activities in the conduct of the Research Program to the
extent doing so would infringe such Blocking Third Party Patent.



10. TERM AND TERMINATION




     10.1 Term. This Agreement shall commence on the Effective Date and shall continue in
full force and effect until the end of the Research Program Term and, if ELAN is Developing a Lead
Compound or Clinical Candidate or Commercializing a Product as of the end of the Research Program
Term, thereafter until (a) such time as ELAN is no longer Developing at least one (1) Lead Compound
or Clinical Candidate or (b) if, as of the time ELAN is no longer Developing at least one (1) Lead
Compound or Clinical Candidate, ELAN is Commercializing a


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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
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Product, such time as all Royalty Terms for all Products have ended, unless earlier terminated
in accordance with the provisions of this Article 10 (the “Term”).




     10.2 Termination. This Agreement may be terminated at any time by either Party as
follows:



          10.2.1 Unilateral Right to Terminate. ELAN may terminate this Agreement at any time
(a) prior to the expiration of the Research Program Term upon not less than ninety (90) days’
written notice to ARCHEMIX upon the occurrence of any of the following events: (i) if ELAN
determines in good faith and in its reasonable discretion that, due to [***] or [***], the Research
Program, Development and/or Commercialization is likely to fail to result in any Collaboration
Aptamers suitable for Development or Commercialization on a commercially reasonable basis; (ii) if
ELAN determines in good faith and in [***], or is [***] by any [***], to [***] the [***] or [***]
of any [***] or [***] to [***] or [***] with [***] to such[***] or [***], or any [***] by such
[***] or [***]; (iii) if ELAN [***] in [***]and in [***] that (A) a [***] have a [***] for a
[***]ARCHEMIX or ELAN of [***] with [***] to any [***] or[***], the [***] of the [***] or the
[***], or ELAN’s [***] of a [***]t, and (B) either (1) [***] into a [***] of the [***] or [***]
and/or [***] a [***] with [***], (2) such [***] or [***] otherwise not [***], (3) it would be
commercially inadvisable to [***] such [***] or [***] or (4) such [***] or [***] only on [***]are
not commercially reasonable; or (iv) if ELAN [***] ARCHEMIX [***] not to [***] a [***] to a [***]
with [***] to the [***] or the [***]; and (b) at any time on and after the expiration of the
Research Program Term upon not less than ninety (90) days’ written notice to ARCHEMIX.




          10.2.2 Termination for Breach. Except as set forth herein, either Party may terminate
this Agreement, effective immediately upon written notice to the other Party, for a material breach
by the other Party of this Agreement that remains uncured [***] days ([***] days in the event that
the breach is a failure of a Party to make any payment required hereunder) after the non-breaching
Party first gives written notice to the other Party of such breach and its intent to terminate this
Agreement if such breach is not cured. Notwithstanding the foregoing, for any breach by ELAN of
its obligations under Section 4.6.2(a), the foregoing notice and cure periods shall apply, but
ARCHEMIX shall have the right to terminate only ELAN’s license with



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respect to the relevant Collaboration Compounds, IL-23 Aptamers and/or Products binding to the
relevant Program Target for which ELAN failed to meet its diligence obligations, as provided in
Section 10.3.3, and this Agreement shall otherwise remain in full force and effect.




          10.2.3 Termination for Insolvency. In the event that either Party files for
protection under bankruptcy laws, makes a general assignment for the benefit of creditors, appoints
or suffers appointment of a receiver or trustee over its business, files a petition under any
bankruptcy or insolvency act or has any such petition filed against it which is not dismissed or
stayed within [***] days of the filing thereof, then the other Party may terminate this Agreement
effective immediately upon written notice to such Party. In connection therewith, all rights and
licenses granted under this Agreement are, and shall be deemed to be, for purposes of Section
365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual property” as
defined under Section 101 (35A) of the United States Bankruptcy Code. Upon the bankruptcy of any
Party the non-bankrupt Party shall further be entitled to a complete duplicate of (or complete
access to, if duplication is impossible) any such intellectual property and all embodiments
thereof, which shall promptly be delivered the non-bankrupt Party upon written request. The
Parties shall retain and may fully exercise all of their respective rights, remedies and elections
afforded by and under the Bankruptcy Code.




     10.3 Consequences of Termination of Agreement. In the event of the termination of
this Agreement pursuant to Section 10.2, the following provisions shall apply, as applicable;
provided that, after termination of this Agreement, all disputed matters shall immediately be
referred to the President of ARCHEMIX and the President (US) of ELAN, or their designees, who shall
promptly initiate discussions in good faith to resolve such disputed matters. If any disputed
matter is not resolved by these individuals within [***] days after the date of such referral, then
either Party may seek any remedy, at law or in equity, that may be available.



          10.3.1 Termination Pursuant to Section 10.2.1. If this Agreement is terminated by
ELAN pursuant to Section 10.2.1:




               (a) all licenses granted to ELAN under Article 7 to any Collaboration Aptamers shall
immediately terminate and all such Collaboration Aptamers shall become Terminated Program Aptamers
upon the effective date of termination; provided, that, if ELAN is


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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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then Commercializing any Product, ELAN shall have the right to dispose of all partially or
previously Made Products within a period of [***] days following the effective date of the notice
of termination, subject to the terms of this Agreement, including the payment of royalties and the
rendering of reports related thereto;




               (b) all of the Parties’ obligations under Section 7.5 shall immediately terminate;



               (c) the licenses granted by ELAN to ARCHEMIX pursuant to Section 7.1.2(c) as of the date of
the notice of termination shall survive; provided, that, any license granted with respect to such
rights shall be subject to the Parties having agreed upon commercially reasonable terms as
described in Section 7.1.2(c);



               (d) the licenses granted by ELAN to ARCHEMIX pursuant to Section 7.1.2(d) shall survive,
subject to the payment by ARCHEMIX to ELAN of (i) for any Terminated Program Aptamer for which IND
Acceptance had not occurred by the date of termination and any Products Derived therefrom that are
Developed or Commercialized by ARCHEMIX, its Affiliates or licensees anywhere in the Territory in
accordance with Section 10.4, the R&D Costs incurred by ELAN and directly attributable to the
research and Development of such Terminated Program Aptamer; provided, that, such R&D Costs shall
not be payable by ARCHEMIX until [***] days from the date of First Commercial Sale of the Product
Derived from such Terminated Program Aptamer, and (ii) for any Terminated Program Aptamer for which
IND Acceptance had occurred by the date of termination and any Products Derived therefrom that are
Developed or Commercialized by ARCHEMIX, its Affiliates or licensees anywhere in the Territory in
accordance with Section 10.4, subsequent milestones in the amounts set forth in Section 5.3 and
royalties at the rates set forth in Section 5.4;



               (e) the licenses granted by ELAN to ARCHEMIX in Section 7.1.2(e) shall survive, subject to the
payment by ARCHEMIX to ELAN of (i) for any Terminated Program Aptamer for which IND Acceptance had
not occurred by the date of termination, and any Products Derived therefrom, that are Developed or
Commercialized by ARCHEMIX, its Affiliates or licensees anywhere in the Territory in accordance
with Section 10.4, the R&D Costs incurred by ELAN and directly attributable to the research and
Development of such Terminated



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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Program Aptamer; provided, that, such R&D Costs shall not be payable by ARCHEMIX until [***]
days from the date of First Commercial Sale of the Product Derived from such Terminated Program
Aptamer and (ii) for any Terminated Program Aptamer for which IND Acceptance had occurred by the
date of termination and any Products Derived therefrom that are Developed or Commercialized by
ARCHEMIX, its Affiliates or licensees anywhere in the Territory in accordance with Section 10.4,
subsequent milestones in the amounts set forth in Section 5.3 and royalties at the rates set forth
in Section 5.4;




               (f) each Party shall promptly return all Confidential Information and Proprietary Materials of
the other Party that are not subject to a continuing license hereunder; provided that each Party
may retain one copy of the Confidential Information of the other Party in its archives solely for
the purpose of establishing the contents thereof and ensuring compliance with its obligations
hereunder;



               (g) upon written notice from ARCHEMIX, ELAN shall, as soon as reasonably practicable after
ARCHEMIX’ request: (i) use Commercially Reasonable Efforts to grant to ARCHEMIX an exclusive,
worldwide, royalty-bearing license on commercially reasonable terms under all Product Trademarks,
if any; (ii) transfer to ARCHEMIX all of its right, title and interest in all Regulatory Filings,
Drug Approval Applications and Regulatory Approvals then in its name and Controlled by ELAN that
are applicable to such Terminated Program Aptamers, if any, subject to payment by ARCHEMIX to ELAN
of the costs of preparing such Regulatory Filings and Drug Approval Applications, preparing for
Commercialization of the relevant Product(s) and obtaining Regulatory Approvals therefor; (iii)
subject to subsection (ii), notify the applicable Regulatory Authorities and take any other action
reasonably necessary to effect such transfer; (iv) subject to subsection (ii), provide ARCHEMIX
with copies of all correspondence between ELAN and such Regulatory Authorities relating to such
Regulatory Filings, Drug Approval Applications and Regulatory Approvals, to the extent Controlled
by ELAN; (v) subject to subsection (ii), unless expressly prohibited by any Regulatory Authority,
endeavor, after full discussion of the facts and circumstances, to transfer control to ARCHEMIX of
all clinical trials of such Terminated Products being conducted as of the effective date of
termination by or on behalf of ELAN and continue to conduct such trials, at



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.



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ARCHEMIX’ sole expense, for up to [***] months to enable such transfer to be completed without
interruption of any such trial, to the extent ELAN is not restricted from doing so under its
agreements with any Third Party or by Applicable Law; (vi) use Commercially Reasonable Efforts to
assign (or cause its Affiliates to assign) to ARCHEMIX all agreements to which it or its Affiliate
is a Party with any Third Party with respect to the conduct of clinical trials for such Terminated
Program Aptamers including, without limitation, agreements with contract research organizations,
clinical sites and investigators, unless such assignment is not allowed under any such agreement or
unless such agreements relate also to products other than Collaboration Aptamers (in which case
ELAN shall cooperate with ARCHEMIX in all reasonable respects to secure the consent of such Third
Party to such assignment or an alternative mechanism for transferring ELAN’s rights under such
agreement to ARCHEMIX); (vii) subject to ELAN’s retention of adequate supplies to the extent
required by Applicable Laws and for use as reference standards or as an in vitro research tool for
assay validation but not for (A) the development or commercialization of Aptamers, or (B) target
validation or library screening; provided, that under no circumstances shall ELAN file for any
Patent Rights covering or publicly disclose any Technology produced as a result of any of the
permitted uses described above, provide ARCHEMIX at ARCHEMIX’ sole cost, including reimbursement
for all Manufacturing Costs and other related expenses, with all further supplies of such
Terminated Program Aptamers in the possession of ELAN or any Affiliate of ELAN, or, if ELAN then
possesses the right to do so, of any ELAN independent contractor (including Sublicensees); (viii)
provide ARCHEMIX with copies of all reports and data generated or obtained by ELAN or its
Affiliates pursuant to this Agreement that relate to any such Terminated Program Aptamers that have
not previously been provided to ARCHEMIX, to the extent then Controlled by ELAN; and (ix) reimburse
ARCHEMIX for all internal and out-of-pocket costs incurred by ARCHEMIX in continuing the research,
Development and/or Commercialization of all Terminated Program Aptamers for a period of up to
thirty (30) days after the effective date of termination; and




               (h) if ELAN is, as of the effective date of termination, then manufacturing or is then having
manufactured by an independent contractor other than a Sublicensee any such Terminated Program
Aptamers or any intermediate thereof, then: (i) ELAN


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shall, if requested by written notice from ARCHEMIX, use Commercially Reasonable Efforts to
supply ARCHEMIX with its reasonable requirements for all such Terminated Program Aptamers and
intermediates for up to [***] months following such termination at a transfer price equal to ELAN’s
Manufacturing Cost for the supply of such Terminated Program Aptamers or intermediate, plus [***]
percent ([***]%); provided that such requirements do not exceed in any material respect the volume
of Terminated Program Aptamers that ELAN is manufacturing or having manufactured as of the
effective date of such termination; and (ii) if ARCHEMIX so requests, within [***] days after such
request, ELAN shall provide to ARCHEMIX or its designee all information in its Control that is
necessary for the manufacture of each such Terminated Program Aptamers or intermediate in the
manner ELAN is then manufacturing or having manufactured such Terminated Program Aptamer (such
information to be deemed ELAN Confidential Information).




          10.3.2 Termination by ELAN Pursuant to Section 10.2.2 or 10.2.3. If this Agreement is
terminated by ELAN pursuant to Section 10.2.2 or 10.2.3:




               (a) all licenses granted by ARCHEMIX to ELAN pursuant to Article 7 shall survive, subject to
ELAN’s continued payment of all milestone, royalty and other payments under and in accordance with
this Agreement with respect thereto and the compliance by ELAN with its obligations under Sections
5.3, 5.4, 7.1.2(d), 7.1.2(f), 9.1 and 9.2 and Articles 6, 8 and 12 with respect thereto;



               (b) all of the Parties’ obligations under Section 7.5 shall immediately terminate;



               (c) the licenses granted by ELAN to ARCHEMIX pursuant to Section 7.1.2(c) with respect to ELAN
Joint Product Patent Rights shall survive and any license agreements negotiated by the Parties
pursuant to Section 7.1.2(c) shall survive in accordance with their respective terms;



               (d) the licenses granted by ELAN to ARCHEMIX pursuant to Section 7.1.2(d) shall survive as to
any aptamers that were or became Terminated Program Aptamers as of the effective date of such
termination, subject to the payment by ARCHEMIX to ELAN of



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
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subsequent milestones in the amounts set forth in Section 5.3 and royalties at the rates set
forth in Section 5.4, for any Terminated Program Aptamers for which IND Acceptance had occurred by
the date of termination and for any Products Derived therefrom that are Developed or Commercialized
by ARCHEMIX, its Affiliates or licensees anywhere in the Territory in accordance with Section 10.4,
and the compliance by ARCHEMIX with its obligations under Sections 5.3, 5.4, 7.1.2(d), 7.1.2(f),
9.1, 9.2 and 11.4 and Articles 6, 8 and 12 with respect thereto;




               (e) the licenses granted by ELAN to ARCHEMIX in Section 7.1.2(e) shall survive as to any
aptamers that were or became Terminated Program Aptamers as of the effective date of such
termination, subject to the payment by ARCHEMIX to ELAN of milestones in the amounts set forth in
Section 5.3 and royalties at the rates set forth in Section 5.4 for any Terminated Program Aptamers
for which IND Acceptance had occurred by the date of termination and for any Products Derived
therefrom that are Developed or Commercialized by ARCHEMIX, its Affiliates or licensees anywhere in
the Territory in accordance with Section 10.4, and the compliance by ARCHEMIX with its obligations
under Sections 5.3, 5.4, 7.1.2(d), 7.1.2(f), 9.1, 9.2 and 11.4 and Articles 6, 8 and 12 with
respect thereto; and



               (f) each Party shall promptly return all Confidential Information and Proprietary Materials of
the other Party that are not subject to a continuing license hereunder; provided that each Party
may retain one copy of the Confidential Information of the other Party in its archives solely for
the purpose of establishing the contents thereof and ensuring compliance with its obligations
hereunder.



     10.3.3 Termination by ARCHEMIX Pursuant to Section 10.2.2. If this Agreement is
terminated by ARCHEMIX pursuant to Section 10.2.2, then the provisions of Section 10.3.1 shall
apply; provided, however, that, notwithstanding the foregoing, ARCHEMIX shall have no obligation to
make any payment to ELAN of R&D Costs incurred by ELAN with respect to any Terminated Program
Aptamer that is Developed and Commercialized by ARCHEMIX, its Affiliates and Sublicensees for which
IND Acceptance had not occurred by the date of termination, and any Products Derived therefrom,
that are Developed or Commercialized by ARCHEMIX, its Affiliates or licensees anywhere in the
Territory with respect to any



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
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Terminated Program Aptamer that is Developed and Commercialized by ARCHEMIX, its Affiliates
and Sublicensees .




          10.3.4 Termination by ARCHEMIX Pursuant to Section 10.2.3. If this Agreement is
terminated by ARCHEMIX pursuant to Section 10.2.3, the provisions of Section 10.3.1 shall apply,
provided, however, that ELAN shall have no obligation to continue to conduct any clinical trials as
provided in Section 10.3.1 or to manufacture Terminated Program Aptamers.




          10.3.5 Payment of Royalties by ARCHEMIX. In calculating the milestone and royalty
payments due to ELAN for the licenses granted in Sections 10.3.1 and 10.3.2, the terms of Sections
5.3 and 5.4 shall apply mutatis mutandis to each such Terminated Program Aptamer and product
Derived therefrom. Such royalties shall be payable for the relevant Royalty Term (determined as if
such Product were a Royalty-Bearing Product).




          10.3.6 Definition of R&D Costs. For purposes of this Sections 10.3 and 13.2.1(b)
only, the term “R&D Costs” means, with respect to a Terminated Program Aptamer and/or a Rejected
Program Target or Target, as the case may be (a) [***] costs paid to a Third Party for specific
external research or Development activities applicable to such Terminated Program Aptamer or
Rejected Program Target or Target, and (b) [***] costs, determined by multiplying the applicable
FTE Rate by the number of FTE hours utilized by both Parties in the relevant period on activities
directly relating to the research or Development of such Terminated Program Aptamer in accordance
with the Annual Research Plan and/or or Annual Development Plan or relating to the development by
ARCHEMIX of the Rejected Program Target or Target, as the case may be.




          10.3.7 Surviving Provisions. Termination or expiration of this Agreement for any
reason shall be without prejudice to the rights and obligations of the Parties provided in Sections 3.4.1(a), 4.11.6(b), 4.12(b), 5.2.1,
5.2.3, 5.4.1(e), 5.4.2, 7.4, 8.1, 8.2, 8.3, 8.5, 8.6, 9.1, 9.2, 10.3 (and, if applicable, 4.5(j)),
13.1, 13.3, 13.4 and Articles 6 and 12 (including all other Sections or Articles referenced in any
such Section or Article and including Article 1), all of which shall survive such termination or




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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
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expiration; and any other rights or remedies provided at law or equity which either Party may
otherwise have. Further, any other provisions of this Agreement that by their nature would
reasonably be expected to survive, shall also survive such termination or expiration.




11. REPRESENTATIONS AND WARRANTIES 




     11.1 Mutual Representations and Warranties. ARCHEMIX and ELAN each represents and
warrants to the other, as of the Effective Date, as follows:



          11.1.1 Organization. It is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction of its organization, and has all requisite power and
authority, corporate or otherwise, to execute, deliver and perform this Agreement.




          11.1.2 Authorization. The execution and delivery of this Agreement and the
performance by it of the transactions contemplated hereby have been duly authorized by all
necessary corporate action and will not violate (a) such Party’s charter documents, (b) any
agreement, instrument or contractual obligation to which such Party is bound in any material
respect, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction,
decree, determination or award of any court or governmental agency presently in effect applicable
to such Party.




          11.1.3 Binding Agreement. This Agreement is a legal, valid and binding obligation of
such Party enforceable against it in accordance with its terms and conditions and it has all rights
necessary to grant to the other Party the rights it purports to grant under this Agreement.




          11.1.4 No Inconsistent Obligation. It is not under any obligation, contractual or
otherwise, to any Person that conflicts with or is inconsistent in any respect with the terms of
this Agreement or that would impede the diligent and complete fulfillment of its obligations
hereunder.




     11.2 Additional Representations of ARCHEMIX. ARCHEMIX further represents and warrants
to ELAN, as of the Effective Date, as follows:



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          11.2.1 Licensed Patent Rights. All Licensed Patent Rights listed on Schedule
3 are existing and, to ARCHEMIX’ Knowledge, no Licensed Patent Rights listed on Schedule
3 are invalid or unenforceable. ARCHEMIX has the right to enforce the Licensed Patent Rights
listed on Schedule 3.




          11.2.2 Claims or Judgments. There are no claims, judgment or settlements against
ARCHEMIX pending, or to ARCHEMIX’ Knowledge, threatened, that invalidate or seek to invalidate the
Licensed Patent Rights listed on Schedule 3.




     11.3 Acknowledgments of ELAN. ELAN acknowledges that the licenses granted to ELAN
hereunder are subject to certain limitations and restrictions set forth in the ARCHEMIX-Gilead
License Agreement and the URC License Agreement and agrees that ELAN shall comply with the terms of
the ARCHEMIX-Gilead License Agreement and the URC License Agreement that ARCHEMIX is subject to
thereunder. In connection therewith, ELAN hereby acknowledges and agrees that (a) it may not use
the SELEXTM Process or the SELEXTM Technology as described in the SELEXTM Portfolio for any reason,
including without limitation (i) to research, make, use, sell, offer for sale, import or export any
Aptamers for In Vitro Diagnostics, In Vivo Diagnostic Agents or Radio Therapeutics or (ii) develop,
modify, manufacture, have manufactured, export, import, use, sell or offer to sell (A) any Aptamer
other than a Collaboration Aptamer, or (B) any Excluded Aptamer and/or any product containing an
Excluded Aptamer; (b) under the ARCHEMIX-Gilead License Agreement and under the URC License
Agreement, ARCHEMIX’ rights in the SELEXTM Process or the SELEXTM Technology as described in the
SELEXTM Portfolio may revert to Gilead if ARCHEMIX, its Affiliates and all assignees and
sublicensees cease reasonable efforts to develop the commercial applications of products and
services utilizing the SELEXTM Process or the SELEXTM Technology; (c) in the event of any termination
of the URC License Agreement, the licenses granted to ELAN hereunder shall remain in full force and
effect in accordance with Section 3.4 of the URC License Agreement; provided, that, ELAN is not
then in breach of this Agreement and ELAN agrees to be bound to UTC as the licensor under the terms
and conditions of the URL License Agreement as described in the SELEXTM Portfolio and (c) in the
event of any termination of the ARCHEMIX-Gilead License Agreement, the licenses granted to ELAN
hereunder shall remain



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Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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in full force and effect in accordance with Section 2.3 of the ARCHEMIX-Gilead License
Agreement; provided, that ELAN agrees to be bound to Gilead as the licensor under the terms and
conditions of the ARCHEMIX-Gilead License Agreement and provided that if the termination of the
ARCHEMIX-Gilead License Agreement arises out of the action or inaction of ELAN, Gilead, at its
option, may terminate such license.




     11.4 Acknowledgement of ARCHEMIX. ARCHEMIX hereby acknowledges and agrees that the
expiration or termination of any agreement between ARCHEMIX and a Third Party that provides for the
license or assignment to ARCHEMIX of Technology that is sublicensed to ELAN pursuant to this
Agreement shall not affect any other licenses by ARCHEMIX to ELAN pursuant to this Agreement, so
long as ELAN complies with the applicable terms of this Agreement.



12. INDEMNIFICATION




     12.1 Indemnification of ELAN by ARCHEMIX. Except as provided in Section 12.4,
ARCHEMIX shall indemnify, defend and hold harmless ELAN, its Affiliates, their respective
directors, officers, employees and agents, and their respective successors, heirs and assigns
(collectively, the “ELAN Indemnitees”), against all liabilities, damages, losses and expenses
(including, without limitation, reasonable attorneys’ fees and expenses of litigation or
settlement) (collectively, “Losses”) incurred by or imposed upon the ELAN Indemnitees, or any one
of them, resulting from claims, suits, actions, demands or judgments brought or initiated by, or
awarded to, a Third Party (collectively, “Claims”), arising out of or in connection with (i) the
activities carried out by, through or on behalf of ARCHEMIX pursuant to this Agreement (other than
Co-Development), (ii) the research, development, manufacture, use, sale, development,
commercialization, import or distribution of any Terminated Program Aptamer or Rejected Program
Target by or through ARCHEMIX or any of its Affiliates, Sublicensees, distributors or agents and
(iii) the ARCHEMIX-SomaLogic Agreement brought by, on behalf of or through SomaLogic, Inc. and/or
any of its Affiliates, directors, officers, employees, agents and licensees and its and their
respective successors, heirs and assigns, arising out of or in connection with any research or
Development (including manufacturing and use) with respect to In Vitro Diagnostics conducted by, on
behalf of or through any of the ELAN Indemnitees or ARCHEMIX



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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Indemnitees, or any of their licensees, for purposes of the Collaboration in the ARCHEMIX
Field, except in each case to the extent such Losses result from Claims arising out of or in
connection with a breach of this Agreement by, or the gross negligence or willful misconduct of,
any of the ELAN Indemnitees; provided that, with respect to any Claim for which ARCHEMIX has an
obligation to any ELAN Indemnitee pursuant to this Section 12.1 and ELAN has an obligation to any
ARCHEMIX Indemnitee pursuant to Section 12.2, each Party shall indemnify each of the other Party’s
Indemnitees for its Losses solely to the extent of such Party’s responsibility, relative to the
other Party, for the facts underlying the Claim.




     12.2 Indemnification of ARCHEMIX by ELAN. Except as provided in Section 12.4, ELAN
shall indemnify, defend and hold harmless ARCHEMIX, its Affiliates, their respective directors,
officers, employees and agents, and their respective successors, heirs and assigns (collectively
the “ARCHEMIX Indemnitees”), against any Losses incurred by or imposed upon the ARCHEMIX
Indemnitees, or any one of them, resulting from Claims arising out of or in connection with (i) the
activities carried out by, through or on behalf of ELAN pursuant to this Agreement (other than
Co-Development and manufacture and supply of Product by ARCHEMIX) and (ii) the use, sale,
manufacture (other than by any ARCHEMIX Indemnitee), development, commercialization, distribution,
promotion or import of any Product (other than a Co-Developed Product) by ELAN or any of its
Affiliates, Sublicensee, distributors or agents, except in each case to the extent such Losses
result from Claims arising out of or in connection with (a) a breach of this Agreement by, or the
gross negligence or willful misconduct of, any of the ARCHEMIX Indemnitees; or (b) any action, suit
or proceeding brought against ELAN alleging (i) the infringement of the Patent Rights or the
misappropriation of the trade secrets of a Third Party with respect to the use by ARCHEMIX of the
SELEX Process or the SELEX Technology that is covered by Section 9.2.2(c), (ii) the infringement of
the Patent Rights of a Third Party that exist as of the Effective Date solely in connection with
the research, Development or Commercialization by ELAN of any IL-23 Aptamer (but not including any
such Patent Rights that cover the manufacture, formulation or delivery of any such IL-23 Aptamer
and/or any component of a Product other than such IL-23 Aptamer ), or (iii) any Claim arising out
of or in connection with the ARCHEMIX-Somalogic Agreement or brought by, on



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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behalf of or through SomaLogic, Inc. and/or any of its Affiliates, directors, officers,
employees, agents and licensees and its and their respective successors, heirs and assigns, arising
out of or in connection with any research or Development (including manufacturing and use) with
respect to In Vitro Diagnostics conducted by, on behalf of or through any of the ELAN Indemnitees
or ARCHEMIX Indemnitees, or any of their licensees, for purposes of the Collaboration in the
ARCHEMIX Field; provided, further, that, with respect to any Claim for which ARCHEMIX has an
obligation to any ELAN Indemnitee pursuant to Section 12.1 and ELAN has an obligation to any
ARCHEMIX Indemnitee pursuant to this Section 12.2, each Party shall indemnify each of the other
Party’s Indemnitees for its Losses solely to the extent of such Party’s responsibility, relative to
the other Party, for the facts underlying the Claim.




     12.3 Indemnification of Gilead and UTC by ELAN. If, and solely to the extent, legally
required by the ARCHEMIX-Gilead License Agreement, ELAN shall indemnify, defend and hold harmless
Gilead, its Affiliates and UTC and any of their respective directors, officers, employees and
agents (each, a “Gilead Indemnitee”), from and against any Losses that are incurred by a Gilead
Indemnitee as a result of any Claims, to the extent such Claims arise out of the possession,
research, development, manufacture, use, offer for sale, sale or other commercialization,
distribution, administration, storage or transport, by ELAN or its Affiliates or Sublicensees of
(a) any Aptamers or Licensed Products, or (b) any other products, services and activities developed
by ELAN relating to the Covered Intellectual Property, including any Licensed Products, Aptamers or
Documentation (as such terms are defined in the ARCHEMIX-Gilead License Agreement).



     12.4 Co-Developed Products. Notwithstanding Sections 12.1 and 12.2, after a
Collaboration Aptamer becomes a Co-Developed Product, and for so long as it remains a Co-Developed
Product, any Losses resulting from Claims arising out of or in connection with the research,
Development, manufacture (other than by any ARCHEMIX Indemnitee) or Commercialization of such
Co-Developed Product in the applicable Indication, formulation and Co-Development Territory(ies)
shall be included in the calculation of costs to be shared pursuant to Section 4.11, and not
separately subject to indemnification by a Party pursuant to this Article



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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12; provided however, that notwithstanding the foregoing, Sections 9.2.1, 9.2.2 and 12.1(iii)
shall still apply.




     12.5 Conditions to Indemnification. A Person seeking recovery under this Article 12
(the “Indemnified Party”) in respect of a Claim shall give prompt notice of such Claim to the Party
from which recovery is sought (the “Indemnifying Party”) and, if the Indemnifying Party is not
contesting its obligation under this Article 12, shall permit the Indemnifying Party to control any
litigation relating to such Claim and the disposition of such Claim; provided that, the
Indemnifying Party shall (a) act reasonably and in good faith with respect to all matters relating
to the settlement or disposition of such Claim as it relates to the Indemnified Party or Person,
(b) use counsel that does not have any conflict of interest in such representation, and (c) not
settle or otherwise resolve such Claim without the prior written consent of the Indemnified Party
(which consent shall not be unreasonably withheld, conditioned or delayed). Each Indemnified Party
or Person shall cooperate with the Indemnifying Party in its defense of any such Claim in all
reasonable respects and shall have the right to be present in person or through counsel at all
legal proceedings with respect to such Claim. In no event shall the Indemnifying Party settle any
Claim, other than for a monetary settlement, in a manner that would adversely affect the other
Party without such other Party’s written consent, not to be unreasonably withheld, conditioned or
delayed.



     12.6 Warranty Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER
SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR
OF FITNESS FOR A PARTICULAR PURPOSE OR NON-VIOLATION OF THIRD PARTY PROPRIETARY RIGHTS. IN
ADDITION, NEITHER PARTY MAKES ANY WARRANTIES AS TO THE VALIDITY OR ENFORCEABILITY OF THE PATENT
RIGHTS LICENSED BY SUCH PARTY TO THE OTHER PARTY.



          12.6.1 No Warranty of Success. Nothing contained in this Agreement shall be construed
as a warranty on the part of either Party that (a) the Research Program will yield any
Collaboration Aptamer or otherwise be successful, (b) any Development Program will yield a




CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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Product or otherwise be successful or (c) the outcome of the Research Program or any
Development Program will be commercially exploitable in any respect.




     12.7 Limited Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF
ITS AFFILIATES UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY SPECIAL, PUNITIVE, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOST PROFITS OR LOST REVENUES,
WHETHER UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE
THEORY. This Section 12.7 is not intended to limit either Party’s obligations or rights under
Sections 12.1 through 12.5.



13. MISCELLANEOUS




     13.1 Mediation. If any dispute, controversy or claim arises between the Parties
relating to any Excepted Decision that cannot be resolved pursuant to Section 2.1.5, the Parties
agree to consider attempting to resolve such dispute, controversy or claim (except as to any issue
relating to intellectual property) by non-binding mediation administered by the American
Arbitration Association in accordance with its commercial mediation rules. Any other disputes, and
any disputes not resolved after mediation, may be submitted for resolution by a court of competent
jurisdiction



     13.2  Change of Control.



          13.2.1  ARCHEMIX Change of Control.




               (a) Notice. If ARCHEMIX enters into an agreement that results or that, if the
transaction contemplated thereby is completed would result, in a Change of Control of ARCHEMIX,
ARCHEMIX shall provide ELAN with prompt written notice describing such Change of Control in
reasonable detail (the “ARCHEMIX Change of Control Notice”). The ARCHEMIX Change of Control Notice
shall be provided by ARCHEMIX prior to execution of such agreement, if permitted under Applicable
Laws and not prohibited by the terms of any agreement between ARCHEMIX and any Third Party, and
otherwise as soon as practicable



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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thereafter and, in any event, not later than promptly following the consummation of the
transaction contemplated by such agreement.




               (b) Change of Control Involving Competitive Entity. If the Change of Control that is
described in the ARCHEMIX Change of Control Notice results or, if completed, would result, in a
Competitive Entity becoming an Affiliate of ARCHEMIX, then, (i) a Target proposed by ELAN for
inclusion in the Research Program shall only be refused by ARCHEMIX or the acquirer under Section
3.5.1(b)(4) on and after the date of the consummation of the Change of Control if ARCHEMIX has been
researching and/or developing aptamers against such Target (including the conduct of the SELEXTM
Process) for a period of not less than [***] months; provided, that, if any such Target is included
in the Research Program, ELAN first reimburses ARCHEMIX for all R&D Costs incurred by ARCHEMIX in
researching and/or developing aptamers against such Target; and (ii) within either [***] days after
such ARCHEMIX Change of Control Notice is provided by ARCHEMIX if such notice is provided prior to
the Change of Control becoming effective, or [***] days after such ARCHEMIX Change of Control
Notice if such notice is provided after the Change of Control is effective, ELAN shall have the
right, in its sole discretion, to provide written notice to ARCHEMIX, (x) if the ARCHEMIX Change of
Control Notice is provided prior to expiration of the Research Program Term, to terminate the
Research Program (including ELAN’s obligation to fund FTEs pursuant to Section 5.4); and/or (y) if
the ARCHEMIX Change of Control Notice is received at any time during the Term, (A) to terminate
ARCHEMIX’ participation in any Development Program pursuant to Article 4 (including ARCHEMIX’ right
to participate in the JPT and JMC); and/or (B) to the extent not exercised as of the date that the
ARCHEMIX Change of Control Notice is given, to terminate ARCHEMIX’ right to exercise any
Co-Development Option. If ELAN should fail to give such notice to ARCHEMIX within such [***] day
or [***] day period, as applicable, ELAN shall have no further rights to take such actions as set
forth in (x) and (y) under this Section 13.2.1 as a result of the Change of Control described in
the ARCHEMIX Change of Control Notice.



               (c) Change of Control Involving Competitive Program. If the Change of Control that is
described in the ARCHEMIX Change of Control Notice involves a Third Party



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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that has a Competitive Program, ARCHEMIX shall so notify ELAN and provide to ELAN a
description of the nature of such Competitive Program; provided, that, the existence of such
Competitive Program following such Change of Control shall not be deemed to be a breach of this
Agreement. The Parties shall then promptly meet to discuss whether, notwithstanding any provision
hereof, such Competitive Program would continue following such Change of Control. In any such
meeting the Parties will review any restrictions applicable to such Competitive Program that may
prevent its combination with the Collaboration, and other issues that may impact the potential
combination of such Competitive Program with the Collaboration. If ELAN determines, in its sole
discretion, that such Competitive Program should be combined with the Collaboration, then within
[***] days the Parties shall agree upon an appropriate amendment to this Agreement such that each
chemical compound or product that is part of the Competitive Program would be deemed to be a
Collaboration Aptamer whether or not such chemical compound or product meets standards or criteria
hereunder for Collaboration Aptamers. The Parties’ rights and obligations under this Agreement
then would apply in all relevant respects to any such deemed Collaboration Aptamers (including
without limitation, the payment of the milestones and royalties set forth in this Agreement). If
ELAN determines, in its sole discretion, that it does not desire to combine such Competitive
Program with the Collaboration, then it will so notify ARCHEMIX and ARCHEMIX shall have thirty (30)
days during which it would determine whether to divest itself of the Competitive Program. If
ARCHEMIX notifies ELAN within such time frame that it will divest itself of the Competitive
Program, then it shall do so as promptly as practicable while maintaining separate teams working on
such Competitive Program and the Collaboration. If within such [***] day period ARCHEMIX does not
respond in writing to ELAN, or ARCHEMIX notifies ELAN that it will not divest itself of such
Competitive Program, then ELAN shall have the right to either (A) terminate that portion of the
Research Program related to the Program Target(s) involved in the Competitive Program, including a
permanent reduction in all Research Program funding and FTE support related thereto to a rate of
[***] FTEs per Program Target (notwithstanding Section 5.2.1), or (B) terminate this Agreement, in
which case the consequences of termination shall be as set forth in Section 10.3.2. In the event
ELAN elects either option (A) or (B), above, such Program Target shall not be deemed a Rejected
Program Target, nor shall Aptamers binding to that Program Target be




CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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deemed Terminated Program Aptamers or otherwise revert or be licensed to ARCHEMIX as a result
of such election.




          13.2.2 ELAN Change of Control.




               (a) Notice. If ELAN enters into an agreement that results or, if the transaction
contemplated thereby is completed, would result in a Change of Control, ELAN shall provide ARCHEMIX
with prompt written notice describing such Change of Control in reasonable detail (the “ELAN Change
of Control Notice”). The ELAN Change of Control Notice shall be provided by ELAN prior to
execution of such agreement, if permitted under Applicable Laws and not prohibited by the terms of
any agreement between ELAN and any Third Party, and otherwise as soon as practicable thereafter
and, in any event, not later than promptly following the consummation of the transaction
contemplated by such agreement.



               (b) Change of Control Involving Competitive Program. If the Change of Control that is
described in the ELAN Change of Control Notice involves a Third Party that has a Competitive
Program, ELAN shall so notify ARCHEMIX and provide to ARCHEMIX a description of the nature of such
Competitive Program; provided that, the existence of such Competitive Program following such a
Change of Control shall not be deemed to be a breach of this Agreement. The Parties shall then
promptly meet to discuss whether, notwithstanding any provision hereof, such Competitive Program
would continue following such Change of Control. In any such meeting the Parties will review any
restrictions applicable to such Competitive Program that may prevent its combination with the
Collaboration, and other issues that may impact the potential combination of such Competitive
Program with the Collaboration. If ELAN determines, in its sole discretion, that such Competitive
Program should be combined with the Collaboration, then within [***] days the Parties shall agree
upon an amendment to this Agreement such that each chemical compound or product that is part of the
Competitive Program would be deemed to be a Collaboration Aptamer, whether or not such chemical
compound or product meets standards or criteria hereunder for Collaboration Aptamers. The Parties’
rights and obligations under this Agreement then would apply in all relevant respects to any such
deemed Collaboration Aptamers (including without limitation, the payment of the milestones and
royalties set forth in this Agreement.) If ELAN determines, in its sole discretion, that it does
not



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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desire to combine such Competitive Program with the Collaboration, then ELAN would have an
additional [***] days during which it would determine whether to divest itself of the Competitive
Program or terminate this Agreement pursuant to Section 10.2.1. If ELAN notifies ARCHEMIX in
writing that it will divest itself of the Competitive Program within such time frame, then it shall
do so as promptly as practicable while maintaining separate teams working on such Competitive
Program and the Collaboration. If ELAN does not notify ARCHEMIX in writing that ELAN will
terminate this Agreement or divest itself of such Competitive Program within such [***] day time
period, then, unless otherwise agreed to by ARCHEMIX, the Aptamers binding specifically to the
relevant Program Target that were identified or used in the Research Program shall be deemed to be
Terminated Program Aptamers for purposes of this Agreement.




     13.3 Notices. All notices and communications shall be in writing and delivered
personally or by courier, by electronic or facsimile transmission or mailed via certified mail,
return receipt requested, addressed as follows, or to such other address as may be designated from
time to time:



	 	 	 
	If to ELAN:

	 	If to ARCHEMIX:
	 
	 	 
	Elan Pharma International, Limited

	 	Archemix Corp.
	Monksland, Athlone

	 	300 Third Street
	County Westmeath

	 	Cambridge, MA 02142
	Ireland
	 	 
	 
	 	 
	Tel: 011 353 9 064 95000

	 	Tel: (617) 621-7700
	Fax: 011 353 9 064 92427

	 	Fax: (617) 621-9300
	Attention: VP Legal

	 	Attention: Chief Executive Officer
	 

	 	Attention: General Counsel
	 
	 	 
	With a copy to:

	 	With a copy to:
	 
	 	 
	Elan Pharmaceuticals, Inc.

	 	Mintz, Levin, Cohn, Ferris, Glovsky
	800 Gateway Boulevard

	 	and Popeo, P.C.
	South San Francisco, CA 94080

	 	One Financial Center
	Tel: 650 877 0900

	 	Boston, Massachusetts 02111
	Fax: 650 553 7165

	 	Attention: Jeffrey Wiesen, Esq.
	Attention: Sr. V.P. Legal

	 	Tel: (617) 542-6000
	 

	 	Fax: (617) 542-2241






CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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In addition, all notices to the JPT or JMC shall be sent to each Party’s designees at such Party’s
U.S. address stated above or to such other address as such Party may designate by written notice
given in accordance with this Section 13.3.




     Except as otherwise expressly provided in this Agreement or mutually agreed in writing, any
notice, communication or document (excluding payment) required to be given or made shall be deemed
given or made and effective upon actual receipt or, if earlier, (a) three (3) business days after
deposit with an internationally-recognized overnight express courier with changes prepaid, or (b)
five (5) business days after mailed by certified, registered or regular mail, postage prepaid, in
each case addressed to a Parties at its address stated above or to such other address as such Party
may designate by written notice given in accordance with this Section 13.3.



     13.4 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of Delaware (USA), without regard to the application of principles of
conflicts of law.



     13.5 Binding Effect. This Agreement shall be binding upon and inure to the benefit of
the Parties and their respective legal representatives, successors and permitted assigns.



     13.6 Headings. Section and subsection headings are inserted for convenience of
reference only and do not form a part of this Agreement.



     13.7 Counterparts. This Agreement may be executed simultaneously in two or more
counterparts, each of which shall be deemed an original and both of which, together, shall
constitute a single agreement.



     13.8 Amendment; Waiver. This Agreement may be amended, modified, superseded or
canceled, and any of the terms of this Agreement may be waived, only by a written instrument
executed by each Party or, in the case of waiver, by the Party or Parties waiving compliance. The
delay or failure of either Party at any time or times to require performance of any provisions
shall in no manner affect the rights at a later time to enforce the same. No waiver by either Party
of any condition or of the breach of any term contained in this Agreement, whether by conduct, or
otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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continuing waiver of any such condition or of the breach of such term or any other term of
this Agreement.




     13.9 No Third Party Beneficiaries. Except as set forth in Sections 12.1 and 12.2, no
Third Party (including, without limitation, employees of either Party) shall have or acquire any
rights by reason of this Agreement.



     13.10 Purposes and Scope. The Parties hereto understand and agree that this
Collaboration is limited to the activities, rights and obligations as set forth in this Agreement.
Nothing in this Agreement shall be construed (a) to create or imply a general partnership between
the Parties, (b) to make either Party the agent of the other for any purpose, (c) to alter, amend,
supersede or vitiate any other arrangements between the Parties with respect to any subject matters
not covered hereunder, (d) to give either Party the right to bind the other, (e) to create any
duties or obligations between the Parties except as expressly set forth herein, or (f) to grant any
direct or implied licenses or any other right other than as expressly set forth herein.



     13.11 Assignment and Successors. Neither this Agreement nor any obligation of a Party
hereunder may be assigned by either Party without the consent of the other, which shall not be
unreasonably withheld, conditioned or delayed, except that each Party may assign this Agreement and
the rights, obligations and interests of such Party, in whole or in part, to any of its Affiliates,
to any purchaser of all of its assets or all of its assets to which this Agreement relates or to
any successor corporation resulting from any merger, consolidation, share exchange or other similar
transaction. Any attempted assignment in violation of this Section 13.11 shall be void and of no
effect.



     13.12 Divestment Offer. If at any time during the Term, ELAN is ordered by a court or
administrative agency of competent jurisdiction to divest itself of any project involving any
Collaboration Aptamer, ELAN shall give written notice to ARCHEMIX (the “Divestment Opportunity
Notice”) specifying the status of development of the particular Collaboration Aptamers that are the
subject of such order (the divestment of such Collaboration Aptamers, a “Divestment Opportunity”).
ARCHEMIX shall have sixty (60) days following the date that the Divestment Opportunity Notice is
given by ELAN (the “Divestment Opportunity Notice Period”) to give written notice to ELAN that it
wishes to enter into negotiations with ELAN with



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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respect to such Divestment Opportunity (a “Divestment Opportunity ROFN Notice”); provided
that, if ARCHEMIX determines not to give a Divestment Opportunity ROFN Notice prior to expiration
of the Divestment Opportunity Notice Period, it shall in good faith provide written notice to ELAN
that it declines to enter into negotiations, promptly upon such determination. If ARCHEMIX gives
written notice within the Divestment Opportunity Notice Period that it wishes to enter into
negotiations with ELAN, the Parties shall negotiate in good faith with respect to a definitive
written agreement with respect to the Divestment Opportunity for a period of up to ninety (90) days
from the date such notice is given. If the Parties do not agree upon and execute a definitive
written agreement with respect to the Divestment Opportunity within the ninety (90) day negotiation
period, ARCHEMIX shall set forth in writing its final offer with respect to such Divestment
Opportunity within five (5) days after expiration of such ninety (90) day negotiation period (the
“Final Offer”). If ELAN does not accept such Final Offer within thirty (30) days, then ELAN shall
have no further obligation to ARCHEMIX with respect to such Collaboration Aptamers; provided,
however, that during the one (1) year period following the date upon which ARCHEMIX submitted to
ELAN its Final Offer, ELAN shall not enter into any agreement with any Third Party with respect to
the Divestment Opportunity on terms which, taken as a whole, are less favorable to ELAN than the
Final Offer, without first offering to ARCHEMIX again the Divestment Opportunity on the terms such
Divestment Opportunity would be available to such Third Party. After such one-year period, ELAN
shall have the unencumbered right to negotiate and execute an agreement with any Third Party for
the Divestment Opportunity.




     13.13 Force Majeure. Neither ELAN nor ARCHEMIX shall be liable for failure of or
delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach
of its obligations, if such failure or delay is due to a Force Majeure. In event of such Force
Majeure, the Party affected shall use reasonable efforts to cure or overcome the same and resume
performance of its obligations hereunder.



     13.14 Interpretation. The Parties hereto acknowledge and agree that: (a) each Party
and its counsel reviewed and negotiated the terms and provisions of this Agreement and have
contributed to its revision; (b) the rule of construction to the effect that any ambiguities are



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





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resolved against the drafting Party shall not be employed in the interpretation of this
Agreement; and (c) the terms and provisions of this Agreement shall be construed fairly as to each
Party, regardless of which Party was generally responsible for the preparation of this Agreement.
In addition, unless a context otherwise requires, wherever used, the singular shall include the
plural and the plural the singular and the use of any gender shall be applicable to all genders.




     13.15 Integration; Severability. This Agreement and the Confidentiality Agreement by
and between the Parties with an effective date of March 15, 2005 is the entire agreement with
respect to the subject matter hereof and supersedes all other agreements and understandings between
the Parties with respect to such subject matter. If any provision of this Agreement is or becomes
invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it
is the intention of the Parties that the remainder of the Agreement shall not be affected.
Exhibits A and B and Schedules 1 through 9 attached hereto are incorporated by reference
herein.



     13.16 Equitable Relief. The Parties acknowledge that under this Agreement each Party
holds a complex series of technology rights and licenses, as well as research, Development,
Commercialization and related financial rights and obligations, the breach of which would not be
adequately compensated in money damages alone. The Parties therefore agree that in the event of
such breach, each shall be entitled to seek remedies in the nature of specific grants of licenses
or assignments from the other Party and other forms of specific performance. Further,
notwithstanding anything to the contrary in this Agreement, if approved by a court of competent
jurisdiction, the Parties shall have the right to obtain injunctive relief for breaches of this
Agreement by one Party which have the potential to cause irreparable injury to the other Party.
Examples of such breaches include, without limitation, breaches of confidentiality obligations,
misappropriation of trade secrets, and use of technology outside the scope of the exclusivity under
Section 7.5 and/or the licenses granted herein.



     13.17 HSR Filing. If ELAN determines in good faith that an HSR Act filing is
required with respect to this Agreement, each Party shall, within [***] days after the execution
date of this Agreement (or such later time as the Parties mutually agree in writing), file with the
Federal Trade Commission and the Antitrust Division of the Department of Justice in the U.S. and
any



CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





124









 







appropriate governmental authorities outside the U.S. any filing required of a licensor and
licensee under the HSR Act, in connection with the transactions contemplated hereby. In such
event, this Agreement shall not take effect unless and until it has been approved by all
appropriate governmental authorities, or the period for review by such authorities has lapsed
without comment. The Parties shall cooperate with each other to the extent necessary in the
preparation of any such filing. ARCHEMIX shall be responsible for paying any fees required to be
paid to governmental authorities in connection with its filings as a licensor, ELAN shall be
responsible for paying any fees associated with its filings as a licensee and each Party shall bear
its own expenses, including but not limited to legal fees associated with preparing any such
filing. Neither Party shall be required in connection with any filing under the HSR Act to resort
to or respond to litigation, agree to hold separate or divest any business or assets or otherwise
materially change its business if doing so is a condition of approvals of the transaction
contemplated hereby.




[Remainder of page intentionally left blank.]




CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





125









 








     IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly
authorized representatives.



	 	 	 	 	 	 	 
	 	 	ARCHEMIX CORP.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	 	 	 
	 

	 	Name:
	 	 

	 	 
	 

	 	Title:
	 	 

	 	 
	 

	 	 	 	 

	 	 
	 
	 	 	 	 	 	 
	 	 	ELAN PHARMA INTERNATIONAL, LIMITED	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	 	 	 
	 

	 	Name:
	 	 

	 	 
	 

	 	Title:
	 	 

	 	 
	 

	 	 	 	 

	 	 






CONFIDENTIAL



Portions of this Exhibit were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential treatment under Rule 406
of the Securities Act.





126









 








EXHIBIT A




ANNUAL RESEARCH PLAN



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.





A-1









 








EXHIBIT B




ANNUAL DEVELOPMENT PLAN



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.





B-1









 








SCHEDULE 1




PROGRAM TARGETS (as of the Effective Date)




Designation of components or subunits of the initial Program Targets




	 	 	 
	Designated Program Target	 	Designated Program Target Partner
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]





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.





S-1-1









 








SCHEDULE 2




EXCLUDED TARGETS



[***]



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.




S-2-1









 





SCHEDULE 3




LICENSED PATENT RIGHTS




	 	 	 	 	 	 	 	 	 	 	 
	Mintz Ref. No.	 	Archemix Ref. No.	 	Status	 	Filing Date	 	Country	 	Title
	[***]

	 	[***]
	 	[***]
	 	[***]
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	[***]

	 	[***]
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	 	[***]
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	[***]

	 	[***]
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	[***]

	 	[***]
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	[***]

	 	[***]
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	 	[***]
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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.





S-3-1









 






	 	 	 	 	 	 	 	 	 	 	 
	Mintz Ref. No.	 	Archemix Ref. No.	 	Status	 	Filing Date	 	Country	 	Title
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	[***]
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	[***]

	 	[***]
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	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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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.





S-3-2









 






	 	 	 	 	 	 	 	 	 	 	 
	Mintz Ref. No.	 	Archemix Ref. No.	 	Status	 	Filing Date	 	Country	 	Title
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]




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.





S-3-3









 






	 	 	 	 	 	 	 	 	 	 	 
	Mintz Ref. No.	 	Archemix Ref. No.	 	Status	 	Filing Date	 	Country	 	Title
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	[***]

	 	[***]
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	[***]

	 	[***]
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	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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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.





S-3-4









 






	 	 	 	 	 	 	 	 	 	 	 
	Mintz Ref. No.	 	Archemix Ref. No.	 	Status	 	Filing Date	 	Country	 	Title
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	[***]

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	[***]

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	[***]

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	[***]

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	[***]

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	[***]

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	[***]

	 	[***]
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	[***]

	 	[***]
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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.




S-3-5









 






	 	 	 	 	 	 	 	 	 	 	 
	Mintz Ref. No.	 	Archemix Ref. No.	 	Status	 	Filing Date	 	Country	 	Title
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
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	[***]

	 	[***]
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	[***]

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	[***]

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	[***]

	 	[***]
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	[***]

	 	[***]
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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.





S-3-6









 








	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

	 	[***]
	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
	 	[***]
	 	[***]
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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.





S-3-7









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
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	 	[***]
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	 	[***]
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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.





S-3-8









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

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	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
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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.





S-3-9









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
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	 	[***]
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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.





S-3-10









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

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	[***]

	 	[***]
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	 	 	 	[***]
	 	[***]
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	 	 	 	[***]
	[***]

	 	[***]
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	 	[***]
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	 	[***]
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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.





S-3-11









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
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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.





S-3-12









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

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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.





S-3-13









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

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	 	[***]
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	 	[***]
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	 	[***]
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	 	[***]
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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.





S-3-14









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

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	 	[***]
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	 	 	 	[***]
	[***]

	 	[***]
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	 	[***]
	 	 	 	[***]
	 	[***]
	 	[***]
	 	 	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	 	 	[***]
	 	[***]
	 	[***]
	 	 	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
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	 	[***]
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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.





S-3-15









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
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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.





S-3-16









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Country	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMATTERNO	 	ID	 	TYPE	 	SERIALNO	 	PATENTNO	 	TITLE	 	STATUS	 	FILE	 	ISSUE	 	CLIENT
	[***]

	 	[***]
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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.





S-3-17









 








SCHEDULE 4




CALCULATION OF OPERATING INCOME




     “Commercialization Cost” means the sum of direct and allocated FTE Costs for (a)
Development Costs and Personnel Costs related to the Co-Development of a Development Lead or
Clinical Candidate, (b) Promotion Expense; (c) Pre-Marketing Expenses; (d) Distribution Expenses;
(e) Working Capital Charges; (f) Sales and Marketing Expenses; (g) Post-Approval Research and
Regulatory Expenses; (h) License Fees and (i) any other out-of-pocket cost or expense stated to be
a Commercialization Cost in this Agreement or under the Product Commercialization Plan. For
purposes of clarity, Commercialization Cost shall not include any internal and out-of-pocket costs,
expenses and fees incurred in prosecuting, and maintaining, the Product Trademark, Licensed Patent
Rights, ARCHEMIX Patent Rights and/or ELAN Patent Rights covering a Co-Developed Product.



     “Cost of Goods” means the fully absorbed Manufacturing Costs attributable to the
manufacture of a Co-Developed Product calculated in accordance with GAAP and consistent with the
Product Commercialization Plan and includes, without limitation, the costs of all Third Party
manufacturing, direct material, direct labor, direct services costs, and manufacturing overhead
consumed (including depreciation), provided or procured by manufacturing facilities in the
manufacture of Co-Developed Product. Cost of Goods shall exclude Commercialization Cost.



     "Distribution Expenses” means actual shipping and warehousing costs and billing,
receiving, collection and other costs incurred in distribution of a Co-Developed Product, including
without limitation related Personnel Costs, inventory management agreements, core distribution
agreements and similar agreements.



     “General Public Relations” means any public relations activity (including a press
release or image piece) which (i) promotes generally the business of a company or deals in a
general manner with the activities of such company in a general pharmaceutical market; and (ii)
mentions in an incidental manner the fact that such company or its Affiliates markets or sells one
or more of the Co-Developed Products or provides other incidental information concerning one or
more of the Co-Developed Products. Announcements related primarily to this Agreement or


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.





S-4-1









 







that concern primarily the relationship of either Party to each other are not General Public
Relations and must be agreed upon by both Parties in writing prior to release.




     “License Fees” means all upfront payments, milestone payments, license fees, royalties
or other payments, payable to any Third Party by either Party under any Third Party license
agreement, to the extent such payments are attributable to a Co-Developed Product. If the rights
under any Third Party license agreement are also attributable to products other than Co-Developed
Products in the applicable Indication, formulation and Co-Development Territory(ies), then only an
equitable portion of any amounts payable under it shall be allocated to Co-Developed Products as
License Fees.



     “Manufacturing Cost” means, with respect to any Collaboration Aptamer or Combination
Product, or any intermediate or component thereof, manufactured by or on behalf of a Party, such
Party’s fully-burdened costs (including the costs associated with product testing and release
activities) of producing and packaging such Collaboration Aptamer or Combination Product in bulk or
finished form, determined in accordance with GAAP, including the sum of the following components:
(a) direct costs, including manufacturing, Personnel Costs and materials directly used in
production and packaging, and the cost of excess capacity reserved for production and packaging,
thereof; (b) overhead costs attributable to the cost of goods under the foregoing clause (a),
including quality assurance and manufacturing Personnel Costs, depreciation, return on capital
assets and other operating and administrative costs of the manufacturing and quality departments
and occupancy costs which are allocable to company departments based on space occupied or
headcount, or other activity-based method; and (c) any other reasonable and customary out-of-pocket
costs borne by such Party for the testing, transport, customs clearance, duty, insurance and/or
storage of such Collaboration Aptamers and Combination Products.



     “Net Income (Loss)” means, with respect to a Co-Developed Product, Net Sales minus the
sum of (a) Cost of Goods of such Co-Developed Product and (b) Commercialization Costs applicable to
the Co-Developed Product, in each case, incurred in that Calendar Quarter for that Co-Developed
Product.



     In calculating Net Income (Loss) for purposes of this Agreement, the following principles
shall apply:


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.





S-4-2









 








     1. There shall be no double counting of any costs or expenses or of any revenues, and to the
extent a cost or expense has been included in one category or sub-category, it shall not be
included in another; similarly, to the extent any revenue has been taken into account in one
category or sub-category it shall not be taken into account in another.



     2. When allocating costs and expenses under this Agreement, each Party shall utilize the same
policies and principles as it utilizes consistently within its group and business units when making
internal cost allocations.



     3. To the extent an item of income or revenue is received by a Party or a cost or expense is
incurred by a Party, and is necessary and specifically and directly identifiable, attributable and
allocable to the Commercialization of a Co-Developed Product and is not otherwise accounted for in
the calculation of Net Income, such Party shall credit such income or revenue and shall be
permitted to charge such cost or expense to the Net Income.



     4. All costs and expenses shall be determined, and all calculations shall be made, in
accordance with GAAP.



     “Net Sales” has the meaning provided in Section 1.



     “Operating Income (Loss)” means the Net Income (Loss) derived in any Calendar Year.



     “Personnel Costs” means the reasonable costs of employment of personnel employed by or
under contract to a Party including, but not limited to, salaries, benefits (including the costs of
cars or allowances therefore), travel, lodging, meals and office and computing supplies.



     “Post-Approval Research and Regulatory Expenses” means, on a Co-Developed
Product-by-Co-Developed Product basis, costs directly attributable to (a) research and development
of a Co-Developed Product after it has received Commercialization Regulatory Approval (including,
without limitation, Phase IV clinical studies and clinical studies in support of additional
indications or labeling changes for such Co-Developed Product) and (b) complying with regulatory
reporting obligations, including, without limitation, Personnel Costs for (a) and (b).



     “Pre-Marketing Expenses” means those expenses incurred on a Co-Developed
Product-by-Co-Developed Product basis in preparation for the Commercialization of a Co-Developed
Product (other than research and Development expenses) before Commercialization Regulatory


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.





S-4-3









 







Approval including, without limitation, costs incurred for education, public relations,
relationships with opinion leaders and professional societies, market research, pharmacoeconomics
studies, and establishment of the Co-Developed Product supply chain.




     “Product Trademark” has the meaning provided in Article 1.



     “Promotion Expense” means the advertising and promotion of Co-Developed Products
through any means, including, without limitation, (i) television and radio advertisements; (ii)
advertisements appearing in journals, newspapers, magazines or other media; (iii) seminars and
conventions; (iv) packaging design; (v) professional education programs; (vi) samples (including
related costs for manufacturing, shipping, and use taxes), visual aids and other selling materials;
(vii) hospital formulary committee presentations; and (viii) presentations to state and other
governmental formulary committees; provided, however, that Promotion Expense shall exclude
detailing and General Public Relations. With regard to advertising and promotion that include
products other than Co-Developed Products, the JMC shall determine the percentage of such
advertising and promotion that will be deemed Promotion Expense for the purposes of this Agreement.



     “Sales and Marketing Expenses” means those expenses directly allocable, on a
Co-Developed Product-by-Co-Developed Product basis, to the marketing, promotion and/or selling of
such Co-Developed Product, including both FTE Costs (e.g., Personnel Costs as well as compensation
provided to Third Parties (e.g., consultants, agency fees and meeting costs)). Sales and Marketing
Expenses shall include, without limitation, costs for: (a) activities related to obtaining
reimbursement from payers, (b) market research and data, (c) preparing and reproducing promotional
materials, (d) professional education, (e) public relations, (f) sales calls, (g) pharmacoeconomics
studies, (h) manufacturing and distributing samples, and (i) conducting seminars, attending
conventions and industry meetings, and establishing relationships with opinion leaders and
professional societies.



     “Working Capital Charges” means internal working capital finance charges for carrying
Product in inventory, and receivables in respect 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.





S-4-4









 








SCHEDULE 5




EXCLUDED 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.





S-5









 








SCHEDULE 6




CLINICAL CANDIDATE SELECTION CRITERIA




A. IL-23 Clinical Candidate Selection Criteria 





	 	•	 	[***] data from [***] of [***] (or less [***] by a [***]
	 
	 	•	 	Evidence of [***] with [***] aptamer or [***] with [***] aptamer [***] of aptamers
[***] and [***] with the [***]
	 
	 	•	 	[***] at [***], to be [***] the [***] as [***] in [***]
	 
	 	•	 	[***] after [***] in [***], with [***]
	 
	 	•	 	With [***] in [***] of [***] in [***] of [***] at [***], which would [***] in [***]
than [***]
	 
	 	•	 	[***] at [***] in [***] at [***] and [***]
	 
	 	•	 	[***] of [***] in [***]
	 
	 	•	 	[***] and [***] must [***] that can [***] though [***] or [***] or [***]
	 
	 	•	 	[***] from a [***] of [***] in a rodent and a [***] a [***] by the [***] for the
[***]
	 
	 	•	 	[***] from a [***] of [***] at [***]
	 
	 	•	 	[***] with [***]




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.





S-6









 








SCHEDULE 7




FORM OF PRESS RELEASE




Archemix Announces Strategic Alliance with Elan to

Discover and Develop Aptamer Therapeutics



CAMBRIDGE, Mass., June xx 2006—Archemix Corp announced today a multi-year, multi-product alliance
with Elan Corporation, plc (NYSE:ELN) focused on the discovery, development and commercialization
of first in class aptamer therapeutics to treat autoimmune disease. The companies will seek to
develop aptamer therapeutics to IL-23, a cytokine that has emerged as a mediator in the chronic
autoimmune inflammatory diseases, and additional protein targets. The collaboration combines
Archemix’s extensive expertise in aptamer therapeutics with Elan’s experience and leadership in the
development and commercialization of new therapies for autoimmune diseases.



Under the terms of the agreements Archemix will receive an upfront payment of $7 million. Depending
upon the number of successfully products commercialized under the collaboration Archemix is
eligible to receive development and sales milestone in excess of $350 million. Archemix is also
entitled to receive a royalty on any in-market products developed under the collaboration. Other
financial terms were not disclosed. Archemix also has an option to participate in the
co-development of some products that may emerge from this collaboration.



“We selected Elan from a number of potential pharmaceutical partners because of its demonstrated
expertise in the clinical and regulatory landscape of autoimmune disease,” said Dr. Errol De Souza,
President and CEO of Archemix. “Our robust intellectual property position in aptamer therapeutics
uniquely positions Archemix to be a product development engine, developing a portfolio of aptamers
for both acute and chronic disease. Aptamers are poised to become the next generation of
therapeutics and we are extremely pleased to be working with a company of Elan’s caliber on their
development.”



Kelly Martin, Elan’s President and CEO, commented, “We are pleased and enthusiastic about joining
forces with Archemix to seek to further expand patient/physician treatment choice in autoimmune
diseases. By combining our strengths this collaboration can accelerate the development of new
therapies for chronic, debilitating diseases with continued unmet medical needs.”




About Interleukin 23



Interleukin 23, or IL-23, is a cytokine that has emerged as a mediator in the chronic autoimmune
inflammatory diseases such as Multiple Sclerosis, Crohn’s Disease, Psoriasis, and Rheumatoid
Arthritis. Preclinical results have demonstrated that IL-23 exerts its pro-inflammatory effects
principally at the site of inflammation. It is hypothesized that specific blockade of IL-23 may
control clinical symptoms at the level of the inflamed tissue without generally suppressing the
patient’s immune system, thus preserving the body’s ability to fight infection. The current anti-



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.





S-7









 







cytokine treatments for autoimmune disorders have a number of disadvantages, including an increased
risk of infection, increased chances of developing lymphoma, renal toxicity and limited efficacy.
Archemix’ aptamers are first-in-class therapeutics for autoimmune diseases that exert their action
by specifically inhibiting IL-23 in the target tissue.




About Aptamers



Aptamers are single-stranded nucleic acids that form well-defined three-dimensional shapes,
allowing them to bind to target molecules in a manner that is conceptually similar to antibodies.
Aptamers combine the optimal characteristics of small molecules and antibodies, including high
specificity and affinity, chemical and biological stability, low immunogenicity and the ability to
target protein-protein interactions. In contrast to monoclonal antibodies, aptamers are chemically
synthesized rather than biologically expressed, potentially offering a significant cost advantage.
As therapeutic agents, aptamers have demonstrated clinical biological efficacy and typically have
excellent, tunable pharmacokinetic properties.




About Archemix



Archemix Corp. is a privately-held biopharmaceutical company based in Cambridge, Massachusetts.
The company’s mission is to develop aptamers as a class of directed therapeutics for the prevention
and treatment of human disease. Because of their unique properties and proven efficacy, aptamers
are a superior alternative to biologics and small molecules and will be a major class of drugs for
the treatment of unmet medical needs.



Archemix’s aptamer expertise is complemented by a robust patent estate comprised of over 220 issued
and 230 pending patents covering the identification, composition and use of therapeutic aptamers.
In addition to the company’s core aptamer generation technology, Archemix possesses strong
expertise in both preclinical and clinical drug development. Further information on Archemix can be
found at http://www.archemix.com.



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.





S-7









 








SCHEDULE 8




REGIONAL OFFICES OR COUNTRIES IN WHICH

PATENT APPLICATIONS ARE TO BE NATIONALIZED

OR OTHERWISE PROSECUTED, FILED AND MAINTAINED




	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]	 	 
	[***]

	 	[***]
	 	[***]	 	 





In addition, any country not listed above in which ELAN customarily pursues patent protection for a
commercial product, taking into account all relevant factors (include, as applicable and without
limitation, stage of development, mechanism of action, efficacy and safety relative to competitive
products in the marketplace, actual or anticipated Regulatory Authority approved labeling, the
nature and extent of market exclusivity (including patent coverage and regulatory exclusivity),
cost and likelihood of obtaining Commercialization Regulatory Approval, actual or projected
profitability and availability of capacity to manufacture and supply for commercial sale.



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.





S-8









 








SCHEDULE 9




Structure 1:




[***]




Structure 2:




[***]




          wherein the 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.





S-9