Exhibit 10.41 COLLABORATIVE RESEARCH AND LICENSE AGREEMENT between ARCHEMIX CORP. and ELAN PHARMA INTERNATIONAL, LIMITED June 30, 2006 CONFIDENTIAL Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.
TABLE OF CONTENTS 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.
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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.
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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.
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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.
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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 SELEX99 process and SELEX99 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.
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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 SELEXd4 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.
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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 SELEX99 Process and SELEX99 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.
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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.
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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.
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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 SELEX99 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.
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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.
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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.
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" 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 ...
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