Collaborative Research And License Agreement BY And Between Archemix Corp. And Takeda Pharm

Exhibit 10.40 EXECUTION COPY COLLABORATIVE RESEARCH AND LICENSE AGREEMENT between ARCHEMIX CORP. and TAKEDA PHARMACEUTICAL COMPANY LIMITED June 11, 2007 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.


TABLE OF CONTENTS Page 1. DEFINITIONS 1 2. ADMINISTRATION OF THE COLLABORATION 19 2.1 Joint Steering Committee 19 2.2 Joint Project Team 21 3. RESEARCH PROGRAM 24 3.1 Objectives of the Research Program 24 3.2 Annual Research Plans 24 3.3 Conduct of Research Program 25 3.4 Records 26 3.5 Selection of Program Targets 27 3.6 Identification of Optimized Lead Compounds 28 3.7 Supply of Proprietary Materials 29 3.8 Research Program Term 29 3.9 Evaluation of Program Aptamers for Satisfaction of OLSC Prior to Expiration of Research Program Term 29 3.10 Evaluation of Program Aptamers for Satisfaction of OLSC After Expiration of Research Program Term 29 4. DEVELOPMENT PROGRAM; COMMERCIALIZATION OF PRODUCTS 29 4.1 Objectives of the Development Program 30 4.2 Responsibility for Development and Commercialization of Products 30 4.3 Technical Assistance 30 4.4 Development and Commercialization Obligations 30 4.5 Cooperation 31 4.6 Exchange of Reports; Information; Updates 31 4.7 Product Recalls 32 5. PAYMENTS 33 5.1 Upfront Technology Access and License Fee 33 5.2 R&D Funding 33 5.3 Milestone Payments 34 5.4 Payment of Royalties; Royalty Rates; Accounting and Records 36 6. TREATMENT OF CONFIDENTIAL INFORMATION; PUBLICITY; NON-SOLICITATION. 40 6.1 Confidentiality 40 6.2 Publicity 41 6.3 Publications and Presentations 41 6.4 Prohibition on Solicitation 42 7. LICENSE GRANTS; ASSIGNMENT; EXCLUSIVITY 42 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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Page 7.1 Research and Development Licenses 42 7.2 Commercialization License 47 7.3 Right to Sublicense 48 7.4 Right to Subcontract 48 7.5 No Other Rights 48 7.6 Exclusivity 48 8. INTELLECTUAL PROPERTY RIGHTS 49 8.1 ARCHEMIX Intellectual Property Rights 50 8.2 Program Generic Patent Rights 50 8.3 TAKEDA Intellectual Property Rights 50 8.4 Program Aptamer-Specific Patent Rights 50 8.5 Joint Technology Rights 50 8.6 Patent Coordinators 50 8.7 Inventorship 51 8.8 Technology Disputes 51 8.9 Cooperation 51 9. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS 51 9.1 Patent Filing, Prosecution and Maintenance 51 9.2 Legal Actions 54 10. TERM AND TERMINATION 59 10.1 Term 59 10.2 Termination 59 10.3 Consequences of Termination of Agreement 60 10.4 Surviving Provisions 63 11. REPRESENTATIONS AND WARRANTIES 63 11.1 Mutual Representations and Warranties 63 11.2 Acknowledgment and Covenants of TAKEDA 63 11.3 Representations and Warranties of ARCHEMIX 64 12. INDEMNIFICATION 65 12.1 Indemnification of TAKEDA by ARCHEMIX 65 12.2 Indemnification of ARCHEMIX by TAKEDA 65 12.3 Indemnification of [***] and [***] by TAKEDA 66 12.4 Conditions to Indemnification 66 12.5 Warranty Disclaimer 66 12.6 No Warranty of Success 67 12.7 Limited Liability 67 13. MISCELLANEOUS 67 13.1 Dispute Resolution 67 13.2 Litigation; Jurisdiction 67 13.3 Notices 67 13.4 Governing Law 68 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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Page 13.5 Binding Effect 68 13.6 Headings 68 13.7 Counterparts 68 13.8 Amendment; Waiver 68 13.9 No Third Party Beneficiaries 69 13.10 Purposes and Scope 69 13.11 Assignment and Successors 69 13.12 Force Majeure 69 13.13 Interpretation 69 13.14 Integration; Severability 69 13.15 Further Assurances 70 List of Schedules Schedule 1 Optimized Lead Compound Selection Criteria Schedule 2A Program Targets Schedule 2B Target Replacement List Schedule 3 Licensed Patent Rights Schedule 4 Excluded Aptamers Schedule 5 Form of Press Release Schedule 6 Program Chemistry Schedule 7 Ligands to Program Targets/Pre-approved Replacement 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.

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COLLABORATIVE RESEARCH AND LICENSE AGREEMENT This COLLABORATIVE RESEARCH AND LICENSE AGREEMENT (this " Agreement" ) is entered into as of June 11, 2007, by and between Archemix Corp., a Delaware corporation with offices at 300 Third Street, Cambridge, MA 02142 (" ARCHEMIX" ), and Takeda Pharmaceutical Company Limited, a Japanese corporation with a principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan (" TAKEDA" ). Each of TAKEDA and ARCHEMIX is sometimes referred to individually herein as a " Party" and collectively as the " Parties." WHEREAS, ARCHEMIX has developed and controls certain technology, patent rights and proprietary materials related to (a) the identification and optimization of aptamers using its proprietary SELEX Process and SELEX Technology (each as defined herein), and (b) the use of such aptamers for treating, preventing or delaying the onset or progression of human diseases or conditions; and WHEREAS, TAKEDA is engaged in the research, development and commercialization of human therapeutics; and WHEREAS, the Parties desire to enter into a collaboration for the purposes of identifying aptamers against certain identified targets, and developing and commercializing human therapeutic products Derived (as defined herein) from such aptamers. NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereto, intending to be legally bound, hereby agree as follows: 1. DEFINITIONS Whenever used in this Agreement with an initial capital letter, the terms defined in this Section 1 shall have the meanings specified. 1.1 " Adverse Event" means any event temporally related to the administration of a Product that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization, prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered an Adverse Event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. 1.2 " Affiliate" means, with respect to any Person, any other Person that, directly or indirectly through one or more affiliates, controls, or is controlled by, or is under common control with, such Person. For purposes of this definition, " control" means (a) ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, (b) status as a general partner in any partnership, or (c) any other arrangementPortions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.


whereby a Person controls or has the right to control the board of directors of a corporation or equivalent governing body of an entity other than a corporation. 1.3 " Annual Net Sales" means, with respect to any Fiscal Year, the aggregate amount of the Net Sales for such Fiscal Year. 1.4 Annual Research Plan" means, with respect to the Program Targets, the written plan describing the research activities to be carried out by each Party during each Fiscal Year of the Research Program Term in conducting the Research Program pursuant to this Agreement with respect to such Program Targets, as such written plan may be amended, modified or updated, as further described in Section 3.2. 1.5 " Applicable Laws" means Federal, state, local, national and supra-national laws, statutes, rules and regulations, including any rules, regulations, guidance, guidelines or requirements of Regulatory Authorities, national securities exchanges or securities listing organizations, that are in effect from time to time during the Term and apply to a particular activity hereunder. 1.6 " Aptamer" means (a) any naturally or non-naturally occurring oligonucleotide identified by ARCHEMIX that binds to a Target with high specificity and affinity and (b) any oligonucleotide Derived from any such oligonucleotide that has such high specificity and affinity. 1.7 " Aptamer-Antidote Combination Product" means [***] of the [***] of (a) [***] aptamer [***], or [***] and (b) a [***] the [***] of such[***]. 1.8 " ARCHEMIX Additional Activities" means any activities, other than ARCHEMIX Research Activities, that (a) TAKEDA reasonably requests in writing that ARCHEMIX perform and (b) ARCHEMIX is reasonably capable of providing. For purposes of clarity, such ARCHEMIX Additional Activities shall include, and unless otherwise agreed by the Parties in writing, be limited to: (i) the use by TAKEDA of certain ARCHEMIX employees and/or long-term consultants of ARCHEMIX to provide advice with respect to issues with respect to which ARCHEMIX has expertise or experience [***], without [***] with[***]and/or [***] and (ii) the transfer by ARCHEMIX to TAKEDA of methods and protocols Controlled by ARCHEMIX that may reasonably assist TAKEDA in the Development and/or Commercialization of Products. 1.9 " ARCHEMIX Background Technology" means any Technology that is used by ARCHEMIX, or provided by ARCHEMIX for use, in the Research Program and/or the Development Program that is (a) Controlled by ARCHEMIX as of the Effective Date or (b) conceived or first reduced to practice by employees of, or consultants to, ARCHEMIX after the Effective Date other than in the conduct of ARCHEMIX Research Activities and/or ARCHEMIX Additional Activities. For purposes of clarity, (i) ARCHEMIX Background Technology shall include any Technology described in (a) and (b) of this Section 1.9 that is an improvement upon the SELEX Process and/or SELEX Technology and (ii) ARCHEMIX Program Technology or ARCHEMIX' s interest in Joint Technology shall not include ARCHEMIX Background Technology.Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.

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1.10 " ARCHEMIX Decision" means a decision with respect to the following issues: (a) the manner by which ARCHEMIX conducts the [***] against [***]; (b) whether ARCHEMIX is to incur any [***] under the Research Program except for [***] that are included in any Annual Research Plan by mutual agreement of the Parties and without TAKEDA exercising the deciding vote under Section 2.1.6 to cause its inclusion; (c) whether ARCHEMIX is [***] any ARCHEMIX Additional Activities; (d) whether ARCHEMIX is to incur any [***] in the performance of [***] and/or ARCHEMIX Additional Activities except for [***] that are included in the Annual Research Plan by mutual agreement of the Parties and without TAKEDA exercising the deciding vote under Section 2.1.6 to cause its inclusion; and (e) the number of FTEs to be provided by ARCHEMIX in each Annual Research Plan to the extent such number of FTEs exceeds [***] FTEs per Fiscal Year. 1.11 " ARCHEMIX-Gilead License Agreement" means the License Agreement between Gilead Sciences, Inc. and ARCHEMIX dated October 21, 2001, as amended. 1.12 " ARCHEMIX Patent Rights" means any Patent Rights Controlled by ARCHEMIX that contain one or more claims that cover ARCHEMIX Technology. 1.13 " ARCHEMIX Program Technology" means (a) any oligonucleotide of an Enriched Pool that is not a Program Aptamer; (b) any Program Technology, other than Program Aptamer-Specific Technology, that is conceived or first reduced to practice by employees of, or consultants to, ARCHEMIX, alone or jointly with any Third Party; and (c) any Program Technology, regardless of whether conceived or first reduced to practice by employees of, or consultants to, ARCHEMIX, TAKEDA, or both Parties, alone or jointly with any Third Party, that is an improvement to the SELEX Process or SELEX Technology. 1.14 " ARCHEMIX Research Activities" means all activities specified to be conducted by ARCHEMIX in any Annual Research Plan (or amendment thereto) that are (a) approved by the JPT and the JSC and (b) to the extent involving matters that are ARCHEMIX Decisions, approved by ARCHEMIX in accordance with Section 2.1.6. 1.15 " ARCHEMIX Technology" means, collectively, ARCHEMIX Background Technology and ARCHEMIX Program Technology. 1.16 " Challenge" means any formal written filing with a government patent agency or court of law in any country made independent of and not in response to a material breach of this Agreement where such filing calls into question the validity or enforceability of any Royalty Triggering Patent Rights scheduled according to Section 9.2.4, including without limitation by (a) filing a declaratory judgment action in which any Royalty Triggering Patent Rights are alleged to be invalid or unenforceable; (b) citing prior art pursuant to 35 U.S.C. a7301, filing a request for re-examination of any Royalty Triggering Patent Rights pursuant to 35 U.S.C. a7302 and/or a7311, or provoking or becoming party to an interference with an application for Licensed Patent Rights pursuant to 35 U.S.C. a7135; or (c) filing or commencing any re-examination, opposition, cancellation, nullity or similar proceedings against any Royalty Triggering Patent Right in any country. Notwithstanding the foregoing, any action with respect to the Prosecution of Patent Rights taken by a Party in accordance with Section 9.1 shall not be deemed to be a Challenge for purposes of this Agreement.Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.

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1.17 " Change of Control" means, with respect to a Party, (a) a merger, consolidation, share exchange or other similar transaction involving such Party and any Third Party which results in the holders of the outstanding voting securities of such Party immediately prior to such merger, consolidation, share exchange or other similar transaction ceasing to hold more than fifty percent (50%) of the combined voting power of the surviving, purchasing or continuing entity immediately after such merger, consolidation, share exchange or other similar transaction, (b) any transaction or series of related transactions (other than an investment transaction by an entity not engaged in the pharmaceutical or biotechnology business, the purpose of which is to raise capital for a Party) in which a Third Party, together with its Affiliates, becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party' s assets which relate to this Agreement. 1.18 " Collaboration" means the alliance of ARCHEMIX and TAKEDA established pursuant to this Agreement for the purposes of identifying, researching, Developing and Commercializing Products in the Field in the Territory. 1.19 " Collaboration Aptamer" means, collectively, all Program Aptamers and Optimized Lead Compounds. 1.20 " Combination Product" means a combination or bundled product that is sold together in a single package or as a unit at a single price by TAKEDA, its Affiliates or Sublicensees and that includes: (a) a Product; and (b) a Supplemental Product. 1.21 " Commercialization" or " Commercialize" means any and all activities directed to the commercialization of a Product after Commercialization Regulatory Approval has been obtained, including marketing, manufacturing for commercial sale, promoting, detailing, distributing, offering to sell and selling a Product, importing a Product for sale, conducting post-marketing human clinical studies and interacting with Regulatory Authorities regarding the foregoing. When used as a verb, " to Commercialize" and " Commercializing" means to engage in Commercialization and " Commercialized" has a corresponding meaning. 1.22 " Commercialization Regulatory Approval" means, with respect to any Product, the Regulatory Approval required by Applicable Laws to sell such Product for use in the Field in a country or region in the Territory. " Commercialization Regulatory Approval" shall include, without limitation, the approval of any Drug Approval Application. For purposes of clarity, " Commercialization Regulatory Approval" in the United States shall mean final approval of an NDA for the first Indication or sNDA for an additional Indication permitting marketing of the applicable Product in interstate commerce in the United States, " Commercialization Regulatory Approval" in the European Union shall mean marketing authorization for the applicable Product pursuant to Council Directive 2001/83/EC, as amended, or Council Regulation 2309/93/EEC, as amended and " Commercialization Regulatory Approval" in Japan shall mean final approval of an application submitted to the Ministry of Health, Labor and Welfare and the publication of a New Drug Approval Information Package permitting marketing of the applicable Product in Japan, as any of the foregoing may be supplemented or amended from time to time.Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.

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1.23 " Commercially Reasonable Efforts" or " Commercially Reasonable" means (a) with respect to the manner by which ARCHEMIX performs (i) the activities assigned to ARCHEMIX in the Research Program and (ii) ARCHEMIX Additional Activities, if any, efforts and resources that are comparable to those undertaken by ARCHEMIX in pursuing the research, discovery, development and intellectual property protection of proprietary materials and the development of product candidates, as applicable, that are not subject to the Collaboration and that are at an equivalent stage of research, development or commercialization and have similar market potential and are at a similar stage in their lifecycle, and (b) with respect to activities of TAKEDA in the Research Program, and the Development and/or Commercialization of a particular Product, the efforts and resources comparable to those undertaken by TAKEDA in pursuing intellectual property protection, development and commercialization of similar products that are not subject to the Collaboration, taking into account the product' s stage of development and/or commercialization, risks and probabilities of success, market potential, and stage in their lifecycle. For purposes of (a) and (b) above, all relevant factors as measured by the facts and circumstances at the time such efforts are due shall be taken into account, including, as applicable and without limitation, mechanism of action; efficacy and safety; product profile; actual or anticipated Regulatory Authority approved labelling; and the nature and extent of market exclusivity (including patent coverage, proprietary position and regulatory exclusivity; cost, time required for and likelihood of obtaining Commercialization Regulatory Approval; competitiveness of alternative products and market conditions; actual or projected profitability and availability of capacity to manufacture and supply for commercial sale). 1.24 " Competitive Program" means any research, development or commercialization activity that involves an aptamer that targets a Program Target for use in the Field. 1.25 " Confidential Information" means all information, Technology and Proprietary Materials disclosed or provided by or on behalf of one Party (the " disclosing Party" ) to the other Party (the " receiving Party" ) or to any of the receiving Party' s employees, consultants, Affiliates or sublicensees (or Sublicensees, as the case may be); provided, that, none of the foregoing shall be Confidential Information if: (A) as of the date of disclosure, it is known to the receiving Party or its Affiliates as demonstrated by contemporaneous credible written documentation, other than by virtue of a prior confidential disclosure to such receiving Party; (B) as of the date of disclosure it is in the public domain, or it subsequently enters the public domain through no fault of the receiving Party or its Affiliates; (C) it is obtained by the receiving Party from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the disclosing Party or its Affiliates; or (D) it is independently developed by or for the receiving Party or its Affiliates without reference to or use of any Confidential Information of the disclosing Party as demonstrated by contemporaneous credible written documentation. The foregoing notwithstanding (i) all tangible embodiments of ARCHEMIX Technology shall be ARCHEMIX Confidential Information, (ii) all tangible embodiments of TAKEDA Technology shall be TAKEDA Confidential Information, and (iii) all tangible embodiments of Joint Technology shall be ARCHEMIX Confidential Information and TAKEDA Confidential Information. Notwithstanding anything herein to the contrary, the terms of this Agreement shall constitute Confidential Information of each Party. 1.26 " Control" or " Controlled" means (a) with respect to Technology or Patent Rights, the possession by a Party of the right to grant a license or sublicense to such Technology or PatentPortions 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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Rights as provided herein without the payment of additional consideration to, and without violating the terms of any agreement or arrangement with, any Third Party and without violating any Applicable Laws and (b) with respect to Proprietary Materials, the possession by a Party of the right to supply such Proprietary Materials to the other Party as provided herein without the payment of additional consideration to, and without violating the terms of, any agreement or arrangement with any Third Party, and without violating any Applicable Laws. 1.27 " CTN" means the notification submitted to the Japanese Ministry of Health, Labor and Welfare prior to the Initiation of a clinical trial in Japan. 1.28 " Derived" means identified, obtained, developed, created, synthesized, generated, designed or resulting from, based upon, containing or incorporating; conjugated to or complexed with (whether directly or indirectly, or in whole or in part). 1.29 " Development" or " Develop" means, with respect to each Product on or after the selection of the Optimized Lead Compound from which such Product is Derived, all non-clinical and clinical activities performed in order to obtain Regulatory Approval of such Product, in accordance with this Agreement up to and including the obtaining of Commercialization Regulatory Approval of such Product. For purposes of clarity, these activities include, without limitation, in vivo animal efficacy testing, preclinical safety testing, test method development and stability testing, regulatory toxicology studies, formulation, process development, manufacturing, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control development, statistical analysis and report writing, clinical trial design and operations, preparing and filing Drug Approval Applications, and all regulatory affairs related to the foregoing. When used as a verb, " Developing" means to engage in Development and " Developed" has a corresponding meaning. 1.30 " Development Program" means the Development activities to be conducted during the Term with respect to each Product on or after the selection of the Optimized Lead Compound from which such Product is Derived with the objective of developing such Product. 1.31 " Diagnosis" means (a) the determination or monitoring of (i) the presence or absence of a disease, (ii) the stage, progression or severity of a disease or (iii) the effect on a disease of a particular treatment; and/or (b) the selection of patients for a particular treatment with respect to a disease. 1.32 " Diagnostic Product" means In Vitro Diagnostics, In Vivo Diagnostic Agents and any other aptamer product used for Diagnosis. For purposes of clarity, the term Diagnostic Product shall not include a product used for the delay of onset or progression of, or treatment or prevention of, an Indication. 1.33 " Discontinued Competitive Target" means any Program Target so designated by TAKEDA pursuant to Section 7.6.1(b) following a Change of Control of ARCHEMIX. 1.34 " Drug Approval Application" means, with respect to a Product in a particular country or region, an application for Commercialization Regulatory Approval for such Product in such country or region, including, without limitation: (a) an NDA or sNDA; (b) a counterpart ofPortions 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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an NDA or sNDA in any country or region in the Territory (including, without limitation, a CTN); and (c) all supplements and amendments to any of the foregoing. 1.35 " E5 Country" means each of the [***] and [***]. 1.36 " Effective Date" means the date first set forth above. 1.37 " Enriched Pool" means a pool of oligonucleotides used to perform the SELEXProcess against a Program Target in the performance of the Research Program that (a) has undergone [***] and (b) wherein, [***] with [***] of [***] (e.g., [***] and [***] of the applicable Program Target, [***]% of the input pool of [***] is [***] in the [***] by the Program Target and the [***]fraction of the [***] pool is at least [***] [***]relative to the [***] fraction for the [***] (i.e., [***]) pool of [***]. 1.38 " Excepted Decision" means any of the following decisions requiring the unanimous approval of all members of the JSC: (a) any decision as to whether a milestone has been achieved under this Agreement for which a milestone payment is payable; and (b) any decision as to the appropriate method of determining royalties for a Combination Product pursuant to the last sentence of Section 5.4.1(h). 1.39 " Excluded Aptamer" means any Aptamer listed on Schedule 4 attached hereto. 1.40 " Exclusivity Term" means, (a) with respect to each Program Target, the period commencing on the Effective Date and continuing until the later of (i) the third anniversary of the Effective Date, and (ii) such date as TAKEDA is no longer either (A) evaluating Collaboration Aptamers directed to such Program Target pursuant to Section 3.10; (B) Developing and/or Commercializing a Product directed to such Program Target in any country in the Territory, or (C) providing the R&D Funding contemplated by Section 5.2 applicable to such Program Target, and (b) with respect to each Pre-approved Replacement Target, the period commencing on the Effective Date and continuing until the second anniversary of the Effective Date. 1.41 " Failed Compound" means any Collaboration Aptamer directed against a Failed Target. 1.42 " Failed Target" means any Program Target as to which the JSC determines that [***] is unable or unlikely to identify an [***] against such Program Target. For purposes of clarity, a Failed Target shall no longer be considered a Program Target for purposes of this Agreement once such Program Target becomes a Failed Target. 1.43 " FDA" means the United States Food and Drug Administration or any successor agency or authority thereto. 1.44 " FDCA" means the United States Federal Food, Drug, and Cosmetic Act, as amended. 1.45 " Field" means the treatment, prevention, cure or delay of onset or progression of all human therapeutic Indications. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act.

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