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EXHIBIT 2.1 Asset Purchase Agreement

Asset Purchase Agreement

EXHIBIT 2.1
Asset Purchase Agreement | Document Parties: SANGAMO BIOSCIENCES INC | Edwards Lifesciences LLC You are currently viewing:
This Asset Purchase Agreement involves

SANGAMO BIOSCIENCES INC | Edwards Lifesciences LLC

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Title: EXHIBIT 2.1 Asset Purchase Agreement
Governing Law: Delaware     Date: 12/28/2006
Industry: Biotechnology and Drugs     Law Firm: Cooley Godward Kronish LLP;Gibson, Dunn & Crutcher LLP     Sector: Healthcare

EXHIBIT 2.1
Asset Purchase Agreement, Parties: sangamo biosciences inc , edwards lifesciences llc
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Exhibit 2.1

Asset Purchase Agreement

     THIS ASSET PURCHASE AGREEMENT (the “ Agreement ”) is entered into as of December 1, 2006 (the “ Signing Date ”) by and between Sangamo BioSciences, Inc., a Delaware corporation (“ Sangamo ”) and Edwards Lifesciences LLC, a Delaware limited liability company (“ Edwards ”). Sangamo and Edwards are referred to individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

     WHEREAS, Sangamo and Edwards are parties to the License Agreement (defined below) and the Research Funding Agreement (defined below);

     WHEREAS, the Parties now desire to terminate the License Agreement and their respective obligations under the Research Funding Agreement; and

     WHEREAS, Edwards desires to transfer to Sangamo, in some cases, and revert back to Sangamo, in other cases, and Sangamo desires to acquire from Edwards, Edwards’ right, title and interest in and to Edwards’ assets relating to the Products (defined below), as more specifically set forth below.

AGREEMENT

     NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained in this Agreement, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

     The following terms, when capitalized, shall have the following meanings (such meanings to be equally applicable to both the singular and plural forms of the terms defined) as used in this Agreement:

      1.1      “ Assets ” has the meaning set forth in Section 3.1.

      1.2      “ Affiliate(s) ” means, with respect to any person, any person which, directly or indirectly through the ownership of equity securities or through other arrangements, either controls, is controlled by or is under common control with, such person. A person shall be deemed to be in control of another entity if it owns or controls at least fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority); provided , however , that a person shall not be deemed to be in control of an entity in which a person owns a majority of the ordinary voting power to elect a majority of the board of directors or other governing board but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect.

      1.3      “ Assigned Copyrights ” has the meaning set forth in Section 3.1(a)(iii).

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      1.4      “ Assigned Data ” has the meaning set forth in Section 3.1(b).

      1.5      “ Assigned Equipment ” has the meaning set forth in Section 3.1(j).

      1.6      “ Assigned Government Licenses ” has the meaning set forth in Section 3.1(f).

      1.7      “ Assigned Intellectual Property ” has the meaning set forth in Section 3.1(a).

      1.8      “ Assigned Know-How ” has the meaning set forth in Section 3.1(a)(ii).

      1.9      “ Assigned Materials ” has the meaning set forth in Section 3.1(c).

      1.10    “ Assigned Patent Rights ” has the meaning set forth in Section 3.1(a)(i).

      1.11    “ Assigned Trademarks ” has the meaning set forth in Section 3.1(a)(iv).

      1.12    “ Assumed Contracts ” has the meaning set forth in Section 3.1(h).

      1.13    “ Assumed Liabilities ” has the meaning set forth in Section 3.3(b).

      1.14    “ Assumption Agreement ” has the meaning set forth in Section 6.6(c).

      1.15    “ Breach ” means, with respect to a representation, warranty, covenant, obligation or other provision, an inaccuracy in or breach (including any inadvertent or innocent breach) of, or any failure (including any inadvertent failure) to comply with or perform, such representation, warranty, covenant, obligation or other provision.

      1.16    “ Claim Notice ” has the meaning set forth in Section 11.1(c).

      1.17    “ Clinical Trial ” means a clinical trial conducted by or on behalf of Edwards or its Affiliates or pursuant to an Edwards Contract, in each case in which a Product is administered to a human.

      1.18    “ Clinical Trial Materials ” means all Products and placebo for the Products manufactured by or on behalf of Edwards or its Affiliates that are for use in preclinical studies or Clinical Trials primarily relating to the Products, whether in bulk, formulated or finished form and whether in existence on the Signing Date or manufactured between the Signing Date and Closing Date.

      1.19    “ Clinical Trial Study Reports ” means all reports or summaries of all data, records and documents resulting from the Clinical Trials.

      1.20    “ Closing ” means the closing of the transactions contemplated by this Agreement.

      1.21    “ Closing Date ” means the date on which the Closing shall take place at the Palo Alto office of Cooley Godward Kronish LLP, commencing at 10:00 a.m. local time, which date shall be the earliest of: (a) one (1) business day after the date on which the last of the conditions specified in Article 10 to be satisfied or waived has been satisfied or waived, (b) the date specified in Sangamo’s written notice to the Escrow Agent pursuant to Section 10.3, or (c) such other date as the Parties may agree upon in writing.

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      1.22    “ Common Stock ” means the common stock, par value $0.01 per share, of Sangamo.

      1.23    “ Company ” means Sangamo for the purposes of Section 5.2.

      1.24    “ Confidential Information ” means all proprietary and confidential information, including Know-How, disclosed by one Party to the other Party pursuant to, or in connection with this Agreement, the License Agreement or the Research Funding Agreement, including any information disclosed in contemplation of this Agreement prior to the Closing Date, regardless of the form or manner of disclosure. “Confidential Information” shall not include information: (a) of which the Party receiving such information was rightfully in possession prior to disclosure, as evidenced by appropriate contemporaneous documentation; (b) that was independently developed by employees or agents of the Party receiving the information without the benefit of Confidential Information provided by the Party disclosing the information, as evidenced by appropriate contemporaneous documentation; (c) that the Party receiving the information rightfully receives from a Third Party not owing a duty of confidentiality to the Party disclosing the information; (d) that is or becomes publicly available without fault of the Party receiving the information; (e) that is published incident to patent application prosecution; or (f) that the Parties agree in writing will not be treated as Confidential Information.

      1.25    “ Contract ” means any written, oral, implied or other agreement, contract, understanding, arrangement, instrument, note, guaranty, indemnity, representation, warranty, deed, assignment, power of attorney, certificate, purchase order, work order, insurance policy, benefit plan, commitment, covenant, assurance or undertaking of any nature.

      1.26    “ Damages ” means any loss, damage, injury, decline in value, Liability, claim, demand, settlement, judgment, award, fine, penalty, Tax, fee (including any reasonable legal fee, expert fee, accounting fee or advisory fee), charge, cost (including any reasonable cost of investigation) or expense of any nature.

      1.27    “ Dispute ” means any claim, dispute or controversy of whatever nature arising out of or relating to this Agreement, including the performance or alleged non-performance of a Party of its obligations under this Agreement.

      1.28    “ Edwards Confidential Information ” means (a) all Confidential Information disclosed by Edwards to Sangamo, except for the Assigned Patent Rights, Assigned Know-How, Assigned Data, Assigned Materials, Clinical Trial Materials, Technical Documents, Government Files and Financial Materials, and (b) the terms of this Agreement, the License Agreement and the Research Funding Agreement.

      1.29    “ Edwards Contracts ” means the Contracts listed on Schedule [1.29] .

      1.30    “ Edwards Indemnitees ” means the following Persons: (a) Edwards; (b) Edwards’ current and future Affiliates; (c) the respective Representatives of the Persons referred to in clauses “(a)” and “(b)” above; and (d) the respective successors and assigns of the Persons referred to in clauses “(a)”, “(b)” and “(c)” above.

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      1.31    “ Encumbrance ” means any lien, pledge, hypothecation, charge, mortgage, security interest, encumbrance, equitable interest, claim, lease, license, covenant, infringement, interference, order, right of first refusal, reservation, limitation, impairment, imperfection of title, and condition or restriction of any nature that has an adverse effect on the title, ownership, possession, use, exercise or transfer of any asset, including any restriction on the receipt of any income derived from any asset; except Permitted Encumbrances and any of the foregoing or other matters, individually or in the aggregate, that are not materially adverse to, or materially interfere with, the use of the asset as they are currently or contemplated to be used or their adequacy for such use.

      1.32    “ Entity ” means any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, cooperative, foundation, society, political party, union, company (including any limited liability company or joint stock company), firm or other enterprise, association, organization or entity.

      1.33    “ Escrow Account ” has the meaning set forth in Section 2.1.

      1.34    “ Escrow Agent ” has the meaning set forth in Section 2.1.

      1.35    “ Escrow Agreement ” has the meaning set forth in Section 2.1.

      1.36    “ Escrowed Agreements ” has the meaning set forth in Section 2.1.

      1.37    “ Excluded Assets ” has the meaning set forth in Section 3.2.

      1.38    “ Exchange Act ” means the Securities Exchange Act of 1934, as amended.

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

      1.40    “ FDA Transfer Letter ” has the meaning set forth in Section 6.8(b).

      1.41    “ Financial Materials ” has the meaning set forth in Section 3.1(i).

      1.42    “ GAAP ” means United States generally accepted accounting principles.

      1.43    “ Government Files ” means any filings made by or on behalf of Edwards or its Affiliates with any Governmental Authority with respect to the IND or primarily related to any Product.

      1.44    “ Government License ” means a regulatory approval or license, or investigational applications, issued, granted, allowed or given by or under the authority of any Governmental Authority or pursuant to any law, rule or regulation throughout the Territory and required for, and used primarily in connection with, the clinical testing in humans of the Product anywhere in the Territory. For clarity, the IND shall constitute a Government License.

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      1.45    “Governmental Authority ” means any United States, state, local or foreign governmental entity or municipality or subdivision thereof or any authority, department, commission, board, bureau, agency, court or instrumentality.

      1.46    “ IND ” has the meaning set forth in Section 6.8(b).

      1.47    “ Indemnitee ” means either Sangamo Indemnitee or Edwards Indemnitee, as applicable.

      1.48    “ IRB ” means an institutional review board.

      1.49    “ Key Employees ” has the meaning set forth in Section 6.5.

      1.50    “ Know-How ” means all non-publicly available knowledge, data (including pharmacological, toxicological, preclinical and clinical test data, and analytical and quality control data), information, assay protocols, methods, results or ideas that (a) is necessary to research, develop or manufacture a Product, (b) was made, conceived or reduced to practice pursuant to the License Agreement, in the course of manufacturing a Product or pursuant to a Clinical Trial, or (c) was used by or on behalf of Edwards or its Affiliates prior to the Closing Date in the course of researching, developing, or manufacturing a Product.

      1.51    “ Know-How Transfer ” has the meaning set forth in Section 6.4.

      1.52    “ Knowledge of Edwards ” means the actual knowledge of the individuals listed on Schedule [1.52] .

      1.53    “ Knowledge of Sangamo ” means the actual knowledge of the individuals listed on Schedule [1.53] .

      1.54    “ Legal Requirement ” means any federal, state, local, municipal, foreign or other law, statute, legislation, constitution, ordinance, code, edict, decree, proclamation, treaty, convention, rule, regulation, ruling, directive, pronouncement, determination, decision, opinion or interpretation issued, enacted, adopted, passed, approved, promulgated, made, implemented or otherwise put into effect by or under the authority of any Governmental Authority.

      1.55    “ Liability ” means any debt, obligation, duty or liability of any nature (including any unknown, undisclosed, unmatured, unaccrued, unasserted, contingent, indirect, conditional, implied, vicarious, derivative, joint, several or secondary liability), regardless of whether such debt, obligation, duty or liability would be required to be disclosed on a balance sheet prepared in accordance with GAAP and regardless of whether such debt, obligation, duty or liability is immediately due and payable.

      1.56    “ License Agreement ” means that certain License Agreement by and between Sangamo and Baxter Healthcare Corporation (Edwards’ predecessor in interest), dated as of January 11, 2000, including all amendments thereto.

      1.57    “ Mutual Release Agreement ” has the meaning set forth in Section 2.1.

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      1.58    “ Net Sales ” means the gross sales price of a Royalty Product sold by Sangamo, its Affiliates, sublicensees or assignees of the Sangamo IP (or Affiliates of such sublicensees or assignees) to a Third Party, less the following to the extent borne by the seller and not taken into account in determining gross sales price: (a) deduction of cash, trade and quantity discounts actually given; (b) discounts, refunds, rebates, chargebacks, retroactive price adjustments, and any other allowances actually given which effectively reduce the net selling price, including institutional rebates or discounts such as those actually provided to Medicare, Medicaid, the Department of Defense or any similar organization in the United States or otherwise; and (c) credits and allowances for product returns actually made; (d) any other adjustments required by generally accepted accounting principles in the United States. Net Sales shall exclude samples distributed in the usual course of business. In the event a Royalty Product is sold as a part of a combined product that contains other active ingredient(s), Net Sales shall be calculated by multiplying the Net Sales of the combined product by the fraction A over B, in which A is the sales price of the Royalty Product portion of the combined product when such Royalty Product is sold separately, and B is the sales price of the combined product. In the event that there is no separate sales price of the Royalty Product, Net Sales allocable to the Royalty Product shall be reasonably and mutually determined by Sangamo and Edwards.

      1.59    “ Patent ” means all United States patents, applications for patents, including any divisionals, continuations, continuations-in-part (to the extent claiming subject matter disclosed in the parent application), continued prosecution applications, provisional applications for patent, and any patents issuing therefrom, and any reexaminations, reissues, extensions, and patent term restorations and any foreign equivalents thereof filed anywhere in the Territory.

      1.60    “ Permitted Encumbrances ” means (a) Encumbrances for Taxes not yet due and payable or that are being contested in good faith by appropriate proceedings, (b) any mechanics’, carriers’, workmen’s, repairmen’s or other similar liens arising or incurred in the ordinary course of business, and (c) any liens arising under original purchase price, conditional sales contracts and equipment leases with Third Parties entered into in the ordinary course of business.

      1.61    “ Person ” means any individual, Entity or Governmental Authority.

      1.62Product ” means a pharmaceutical product that comprises zinc finger DNA binding proteins or nucleic acids that encode zinc finger DNA binding proteins for the activation of VEGF genes or VEGF receptors. For the avoidance of doubt, a pharmaceutical product shall not be Product if the zinc finger DNA binding protein contained in or encoded by such product primarily targets and activates a gene other than VEGF or a VEGF receptor.

      1.63    “ RAC ” means the Recombinant DNA Advisory Committee of the National Institutes of Health, or any successor thereto.

      1.64    “ Register ”, “ registration ”, and “ registered ” refers to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of effectiveness of such registration statement.

      1.65    “ Registrable Securities ” means any and all of the Shares issued to Edwards hereunder; provided , however , that such term shall not include any shares of Common Stock which have been previously registered or which have been sold to the public either pursuant to a registration statement or Rule 144.

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      1.66    “ Regulatory Approval ” means all approvals (including pricing and reimbursement approvals), product and/or establishment licenses, registrations or authorizations of any regional, federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the sale of Products in a regulatory jurisdiction.

      1.67    “ Related Party ” means each of the following: (a) each individual who is, or who has at any time been, an officer of Edwards; (b) each member of the family of each of the individuals referred to in clause “(a)” above; and (c) any Entity (other than Edwards) in which any one of the individuals referred to in clauses “(a)” and “(b)” above holds or held (or in which more than one of such individuals collectively hold or held), beneficially or otherwise, a controlling interest or a material voting, proprietary or equity interest.

      1.68    “ Representatives ” means officers, directors, employees, agents, attorneys, accountants, advisors and representatives.

      1.69    “ Required Third Party Consent ” has the meaning set forth in Section 6.6(a).

      1.70    “ Research Funding Agreement ” means that certain Research Funding Agreement by and between Sangamo and Baxter Healthcare Corporation (Edwards’ predecessor in interest), dated as of January 11, 2000, including all amendments thereto.

      1.71    “ Royalty Indication ” means diabetic neuropathy, intermittent claudication, critical limb ischemia, ischemic cerebral vascular disease (excluding hemorrhagic stroke), peripheral artery disease and ischemic heart disease.

      1.72    “ Royalty Product ” means a Product that is sold in any Territory for treatment of one or more Royalty Indications.

      1.73    “ Rule 144 ” means Rule 144 as promulgated by the SEC under the Securities Act, as such Rule may be amended from time to time, or any similar successor rule that may be promulgated by the SEC.

      1.74    “ Sangamo Confidential Information ” means (a) all Confidential Information disclosed by Sangamo to Edwards pursuant to the License Agreement, Research Funding Agreement or this Agreement, including Sangamo Materials and sequence information relating thereto, (b) the terms of this Agreement, the License Agreement and Research Funding Agreement, and (c) after the Closing Date, the Assigned Patent Rights (but only to the extent such Assigned Patent Rights relate to unpublished patent applications or are otherwise not publicly available), and that portion of the Assigned Know-How, Assigned Data, Assigned Materials, Clinical Trial Materials, Technical Documents, Government Files and Financial Materials that are not publicly available as of the Signing Date.

      1.75    “ Sangamo Indemnitees ” means the following Persons: (a) Sangamo; (b) Sangamo’s current and future Affiliates; (c) the respective Representatives of the Persons referred to in clauses “(a)” and “(b)” above; and (d) the respective successors and assigns of the Persons referred to in clauses “(a)”, “(b)” and “(c)” above.

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      1.76    “ Sangamo IP ” means any and all intellectual property rights licensed to Edwards pursuant to the terms of the License Agreement.

      1.77    “ Sangamo Materials ” means the materials and information transferred to Edwards by Sangamo under the License Agreement, and all copies, progeny and derivatives thereof.

      1.78    “ Sangamo Party ” has the meaning set forth in Section 4.2.

      1.79    “ Sangamo SEC Documents ” has the meaning set forth in Section 9.5.

      1.80    “ Sausalito Facilities ” means the leased facility of Edwards located at One Harbor Drive, Suite 209, Sausalito, California 94965.

      1.81    “ SEC ” means the U.S. Securities and Exchange Commission.

      1.82    “ Securities Act ” means the Securities Act of 1933, as amended.

      1.83    “ Shares ” has the meaning set forth in Section 5.1(a).

      1.84    “ Tax ” means any tax (including any income tax, franchise tax, capital gains tax, estimated tax, gross receipts tax, value-added tax, surtax, excise tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax, property tax, business tax, occupation tax, inventory tax, occupancy tax, withholding tax or payroll tax), levy, assessment, tariff, impost, imposition, toll, duty (including any customs duty), deficiency or fee, and any related charge or amount (including any fine, penalty or interest), that is, has been or may in the future be (a) imposed, assessed or collected by or under the authority of any Governmental Authority, or (b) payable pursuant to any tax-sharing agreement or similar Contract.

      1.85    Technical Documents means all scientific and technical information and documentation that is primarily related to the research, development or manufacture of any Product and that is in embodied in documents or computer files owned or controlled by Edwards or its Affiliates as of the Closing Date or during the Transition Period, including: laboratory notebooks, technical documentation, manufacturing documentation, quality records, specifications, data, vector maps, protocols, manuals, reference materials, and application notes; detailed restriction maps and complete sequence information for each plasmid and nucleic acid included in the Assigned Materials; full descriptions of all cell lines included in the Assigned Materials; detailed cell transfection protocols; protocols for administering Product to humans, animals or cells; protocols detailing methods, assays, processes, and procedures (including standard operating procedures) for manufacturing or testing any Product.

      1.86    “ Termination Agreement ” has the meaning set forth in Section 2.1.

      1.87    “ Territory ” means all countries of the world.

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      1.88    “ Third Party ” means any person or entity other than Sangamo or Edwards and their respective Affiliates.

      1.89    “ Transactional Agreements ” means the Assumption Agreement, the Mutual Release Agreement, the Termination Agreement and the Escrow Agreement.

      1.90    “ Transition Period ” means the period from the Signing Date through the Closing Date.

      1.91    “ VEGF ” means vascular endothelial growth factors.

ARTICLE 2

SIGNING DATE ACTIVITIES

      2.1      Signing Date . On the Signing Date, each Party shall duly execute the Termination Agreement, Mutual Release Agreement, Assumption Agreement and FDA Transfer Letter, in the forms attached hereto as Exhibits A , B , C and D , respectively (the “ Escrowed Agreements ”), and shall deposit the executed Escrowed Agreements into an escrow account (the “ Escrow Account ”) to be held and distributed by the escrow agent (the “ Escrow Agent ”) on the Closing Date in accordance with the terms of the Escrow Agreement dated as of the Signing Date by and among the Parties and the Escrow Agent, in the form attached hereto as Exhibit E (the “ Escrow Agreement ”). In addition, on the Signing Date, Sangamo shall deposit the Shares into the Escrow Account pursuant to Section 5.1 of this Agreement.

ARTICLE 3

PURCHASE AND SALE OF ASSETS

      3.1      Purchase and Sale of Assets . Subject to the terms and conditions set forth herein, on the Closing Date, Edwards shall sell, assign, transfer, convey, grant and deliver to Sangamo, and Sangamo shall purchase, acquire and receive from Edwards, good and valid title and all other rights and interests in and to the Assets, free and clear of any Encumbrances. For purposes of this Agreement, “ Assets ” means the following assets:

               (a)   Intellectual Property .

                     (i)     Patent Rights . All Patents listed on Schedule 3.1(a)(i) (collectively, the “ Assigned Patent Rights ”).

                     (ii)    Know-How . All Know-How owned by Edwards or its Affiliates as of the Closing Date that is primarily related to a Product (collectively, the “ Assigned Know-How ”).

                     (iii)   Assigned Copyrights and Other Related Proprietary Rights . All copyrights, copyright registrations or copyright applications listed on Schedule 3.1(a)(iii) (collectively, the “ Assigned Copyrights ”).

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                     (iv)   Trademarks . All trademarks, design marks, service marks, trade names and trade dress (including registrations and applications for the foregoing) listed on Schedule 3.1(a)(iv) (collectively, the “ Assigned Trademarks ”).

The Assigned Patent Rights, Assigned Know-How, Assigned Copyrights and Assigned Trademarks shall be referred to collectively as the “ Assigned Intellectual Property .”

               (b)   Data . All data (including raw data, data files and summaries, including the Clinical Trial Study Reports) owned by Edwards or its Affiliates as of the Closing Date that were generated in the course of a Clinical Trial or other research on or testing of any Product by or on behalf of Edwards or its Affiliates (collectively, the “ Assigned Data ”).

               (c)   Materials . All biological or chemical materials (including DNA, RNA, plasmids, vectors, cell lines, proteins, antibodies, assays, poloxymers) owned by Edwards or its Affiliates as of the Closing Date which (i) have been used by Edwards or its Affiliates during the term of the License Agreement primarily in the research, development or manufacture of the Products, but excluding all non-proprietary materials, such as reagents and other consumables that are generally available; or (ii) have been derived from any Sangamo Materials and any and all progeny, derivatives, replications, variants, and recombinants thereof, including those generated by recombinant genetic engineering methods (collectively, “ Assigned Materials ”).

               (d)   Clinical Trial Materials . All Clinical Trial Materials owned by Edwards or its Affiliates as of the Closing Date.

               (e)   Technical Documents . All Technical Documents owned by Edwards or its Affiliates as of the Closing Date.

               (f)   Government Licenses . All Government Licenses owned by Edwards or its Affiliates on the Closing Date and all applications therefor and related correspondence (collectively, the “ Assigned Government Licenses ”).

               (g)   Government Files . All Government Files owned by Edwards or its Affiliates on the Closing Date.

               (h)   Contracts . All rights of Edwards or its Affiliates under the Edwards Contracts listed on Schedule 3.1(h) (the “ Assumed Contracts ”).

               (i)   Financial Materials . Any and all copies owned by Edwards or its Affiliates as of the Closing Date of final market research analyses prepared on behalf of Edwards or its Affiliates, relating primarily to the Products (collectively, the “Financial Materials” ).

               (j)   Personal Property . All personal property physically located at the Sausalito Facilities, including equipment, owned by Edwards on the Closing Date and used by or on behalf of Edwards solely with respect to the Product (the “ Assigned Equipment ”).

      3.2      Excluded Assets . Anything in Section 3.1 to the contrary notwithstanding, the Assets do not include any assets, rights or interests of Edwards (collectively, the “ Excluded Assets ”) not specifically set forth in Section 3.1, including:

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               (a)    Contracts or agreements with any Third Party that are not Assumed Contracts;

               (b)    Edwards facilities that are not Sausalito Facilities;

               (c)    Employment agreements;

               (d)    Intellectual property and rights thereto that were developed, conceived, reduced to practice or otherwise acquired prior to the date of the License Agreement or, except as described in Section 7.5, that are developed, conceived, reduced to practice or otherwise acquired after the Closing Date;

               (e)    Corporate records (formation documents, stock records, board resolutions and minutes, and the like); and

               (f)    laboratory and refrigerated storage equipment at Edwards’ facilities located in Irvine, California.

      3.3      Assumed Liabilities .

               (a)    Other than as specifically set forth in this Section 3.3, Sangamo shall not assume any Liabilities of Edwards whatsoever, whether relating to the Assets or otherwise.

               (b)    Notwithstanding Section 3.3(a), at and following the Closing Date, Sangamo shall assume and agree to honor, pay and discharge when due the following Liabilities of Edwards (the “ Assumed Liabilities ”):

                     (i)      all Liabilities of Edwards under the Assumed Contracts to be performed on or after, and in respect of periods following, the Closing Date;

                     (ii)     all Liabilities of Edwards under the Assigned Government Licenses to be performed on or after, and in respect of periods following, the Closing Date; and

                     (iii)    all other Liabilities arising out of or related to the Assets, in respect of periods following the Closing Date;

provided , however , that notwithstanding the foregoing, and notwithstanding anything to the contrary contained in this Agreement, the Assumed Liabilities shall be limited to Liabilities that:

                     (1)      arise on or after the Closing Date;

                     (2)      do not arise from or relate to any Breach by Edwards of any provision of any of the Assumed Contracts; or

                     (3)      do not arise from or relate to any event, circumstance or condition occurring or existing on or prior to the Closing Date that, with notice or lapse of time, would constitute or result in a Breach of any of the Assumed Contracts.

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      3.4    Taxes . Edwards and Sangamo shall each bear and pay one-half of any sales taxes, use taxes, transfer taxes, documentary charges, filing fees, recording fees or similar taxes, charges, fees or expenses that may become payable in connection with the sale of the Assets to Sangamo. The Parties shall reasonably cooperate to file all requests for certifications of sales and use tax due, including pursuant to Section 6812 of the California Revenue and Taxation Code.

      3.5      Allocation . As soon as reasonably practicable after the Signing Date, but in any event prior to the Closing Date, the Parties shall prepare and mutually agree to a statement setting forth the Parties’ determination of the manner in which the consideration paid by Sangamo with respect to the Assets is to be allocated among the Assets, which statement shall be attached hereto as Schedule 3.5 . The allocation prescribed by such statement shall be conclusive and binding upon the Parties for all purposes. The Parties shall not file any Tax Return or other document with, or make any statement or declaration to, any Governmental Authority that is inconsistent with such allocation.

ARTICLE 4

INTELLECTUAL PROPERTY RIGHTS

      4.1      Trademarks . Edwards shall not adopt, use or register any trademark or service mark confusingly similar to any Assigned Trademark, in any context on the Internet or elsewhere in any country.

      4.2      Edwards Covenant Not to Assert . Edwards agrees, effective as of the Closing Date, that neither it nor any of its Affiliates (and in each case such entity’s successor or assign) shall assert or enforce against Sangamo, its Affiliates, or any licensee, sublicensee, manufacturer or distributor (and in each case such entity’s successor or assign) (each a “ Sangamo Party ”), any intellectual property owned by or exclusively licensed to Edwards or its Affiliates as of the Closing Date that would be infringed, misappropriated or otherwise violated by any Sangamo Party’s manufacture, use, development, import, offer for sale, or sale of the Products within the Territory. The Parties acknowledge and agree that the covenant set forth in this Section 4.2 shall be limited to the Products and shall not, under any circumstances, extend to any medical devices including, catheters or delivery systems, whether or not sold in combination with the Products.

ARTICLE 5

PAYMENTS

      5.1      Stock Escrow .

               (a)    As partial consideration for the sale, assignment, transfer, conveyance, grant and delivery by Edwards of the Assets, the other rights and licenses granted by Edwards hereunder, and the covenants, agreements and releases made by Edwards, all to or in favor of Sangamo, and in addition to assuming the Assumed Liabilities, Sangamo shall issue and deliver to Edwards 1,000,000 shares of Common Stock (the “ Shares ”) as follows: On the Signing Date, Sangamo shall deposit the Shares into the Escrow Account, to be held and distributed by the Escrow Agent to Edwards on the Closing Date in accordance with the terms of the Escrow Agreement.

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               (b)    Edwards understands that the Shares issued pursuant to Section 5.1(a) will not have been registered under the Securities Act nor qualified under the blue sky laws of any state, and that the Shares are being offered and sold to Edwards pursuant to an exemption from such registration and qualification based in part upon the representations of Edwards contained herein. Edwards acknowledges the certificate representing the shares shall contain an appropriate legend regarding the foregoing. Edwards acknowledges and agrees with Sangamo that it is acquiring the Shares for investment for its own account and not with a view to, or for resale in connection with, the distribution or other disposition thereof in violation of applicable securities laws.

               (c)    Edwards represents and warrants to Sangamo that it is an “accredited investor,” as defined in Rule 501 under the Securities Act, and has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of an investment such as the Shares.

               (d)    Edwards acknowledges to Sangamo that it is fully aware of the applicable transfer restrictions of the Shares. Edwards understands that there are substantial risks pertaining to the making of an investment in the Shares hereunder.

      5.2      Registration Rights .

               (a)   Form S-3 Registrations . In case the Company shall receive from Edwards a written request that the Company effect a registration statement on Form S-3 with respect to all or a part of the Registrable Securities, the Company shall use commercially reasonable efforts to file, as soon as practicable but not later than twenty (20) business days from the date of receipt by the Company of the Notice of Registration (as defined below), with the SEC a registration statement on Form S-3 covering the resale of such Registrable Securities in a manner consistent with the method or plan of distribution requested and shall use commercially reasonable effort to cause such Registration Statement to be declared effective by the SEC as soon as practicable. Any request for such registration by Edwards (a “ Notice of Registration ”) shall specify (i) the amount of Registrable Shares proposed to be registered; and (ii) the intended method or methods and plan of distribution thereof. In addition, Edwards shall provide to the Company all information and materials reasonably requested by the Company in order to permit the Company to comply with all applicable SEC requirements. The Company shall not be obligated to file or effect any such registration pursuant to this Section 5.2(a):

                     (i)      if Form S-3 is not available for such offering;

                     (ii)     if Edwards proposes to sell less than 200,000 shares of Registrable Securities and such other securities (if any);

                     (iii)    if the request is made by Edwards prior to six (6) months after the Closing Date;

                     (iv)     if the Company has, within the twelve (12) month period preceding the date of such request, already effected one (1) registration on Form S-3 for Edwards pursuant to this Section 5.2(a);

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                     (v)      for any Registrable Securities that have been sold to the public;

                     (vi)     if all the Registrable Securities are eligible for resale during a three (3) month period pursuant to Rule 144 under the Securities Act;

                     (vii)    if the sale of Registrable Securities pursuant to the method and plan of distribution requested in the Notice of Registration is not permissible under applicable law and the requirements of the Form S-3; or

                     (viii)    in any particular jurisdiction in which the Company would be required to qualify to do business or to execute a general consent to service of process in effecting such registration, qualification or compliance.

               (b)   Suspension of Registration Rights . Notwithstanding anything to the contrary contained herein, the Company shall not be obligated to file or effect the Registration Statements, or to file any amendment or supplement thereto, and may suspend the right of Edwards to make sales pursuant to an effective Registration Statement, at any time when the filing thereof at the time requested, or the offering of securities pursuant thereto, (i) would, in the good faith judgment of the Company and its counsel, materially and adversely affect a pending or proposed acquisition, merger, recapitalization, consolidation, reorganization, joint venture, divestiture, tender offer, financing or similar transaction of the Company or one of its Affiliates, or negotiations, discussions or pending proposals related thereto or (ii) would materially and adversely impact the Company and its Affiliate, including by requiring, in the good faith judgment of the Company and its counsel, the disclosure of an event or state of facts relating to the Company or its Affiliates which is material to the Company and the disclosure of which could be adverse to the Company, provided that the Company may not suspend the rights to make sales pursuant to this Section 5.2(b) for more than an aggregate of ninety (90) days, and provided further that Sangamo shall not defer its obligation in this manner more than twice in any twelve (12) month period.

               (c)   Expenses . All expenses incurred in connection with a registration pursuant to Section 5.2(a), including all registration, filing and qualification fees, printers’ and accounting fees, fees and disbursements of counsel for the Company, and the reasonable fees and disbursements of one counsel for Edwards (but excluding underwriters’ discounts and commissions), shall be borne by the Company. Edwards shall bear all discounts, commissions or other amounts payable to underwriters or brokers in connection with such offering.

               (d)   Obligations of the Company . Whenever required to effect the registration of any Registrable Securities under this Agreement, the Company shall use commercially reasonable efforts to do the following as expeditiously as reasonably possible:

                     (i)      Prepare and file with the SEC a registration statement with respect to such Registrable Securities and cause such registration statement to become effective, and, upon the request of Edwards, keep such registration statement effective for up to ninety (90) days.

                     (ii)     Prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Securities Act with respect to the disposition of all securities covered by such registration statement.

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                     (iii)    Furnish to Edwards such number of copies of prospectus, including a preliminary prospectus, in conformity with the requirements of the Securities Act, and such other documents as Edwards may reasonably request in order to facilitate the disposition of Registrable Securities owned by it that are included in such registration.

                     (iv)     Use reasonable efforts to register and qualify the securities covered by such registration statement under such other securities or Blue Sky laws of such jurisdictions as shall be reasonably requested by the Edwards, provided that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business or to file, a general consent to service of process in any such states or jurisdictions.

                     (v)      Notify Edwards at any time when a prospectus relating thereto is required to be, delivered under the Securities Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing.

                     (vi)     If the registration of Registrable Securities covers an underwritten offering, furnish, at the request of Edwards, on the date that such Registrable Securities are delivered to the underwriters for sale (1) an opinion, dated as of such date, of the counsel representing the Company for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering and reasonably satisfactory to the lead underwriter, addressed to the underwriters and (2) a “comfort” letter dated as of such date, from the independent certified public accountants of the Company, in form and substance as is customarily given by independent certified public accountants to underwriters in an underwritten public offering and reasonably satisfactory to the lead underwriter, addressed to the underwriters.

               (e)   Rule 144 Reporting . With a view to making available the benefits of certain rules and regulations of the SEC which may at any time permit the sale of Registrable Securities to the public without registration, after such time as a public market exists for the Common Stock of the Company, the Company agrees to:

                     (i)      Make and keep public information available, as those terms are understood and defined in Rule 144 under the Securities Act;

                     (ii)     Use reasonable, diligent efforts to file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act; and

                     (iii)    So long as Edwards owns any Registrable Securities, to furnish to Edwards forthwith upon request a written statement by the Company as to its compliance with the reporting requirements of said Rule 144, and of the Securities Act and the Exchange Act, a copy of the most recent annual or quarterly report of the Company, and such other reports and documents of the Company as Edwards may reasonably request in availing itself of any rule or regulation of the SEC allowing Edwards to sell any such securities without registration.

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      5.3      Royalties .

               (a)    As additional partial consideration for the sale, assignment, transfer, conveyance, grant and delivery by Edwards of the Assets, the other rights and licenses granted by Edwards hereunder, and the covenants, agreements and releases made by Edwards, all to or in favor of Sangamo, and in addition to assuming the Assumed Liabilities, subject to the terms and conditions of this Agreement, Sangamo shall pay Edwards a royalty equal to:

                     (i)      Five percent (5%) of the Net Sales of each Royalty Product sold by Sangamo or its Affiliate for use in a Royalty Indication; and

                     (ii)     The greater of (i) five percent (5%) of the Net Sales of each Royalty Product sold by a sublicensee for use in a Royalty Indication or (ii) twenty-five percent (25%) of the royalty payment received by Sangamo from its sublicensee on account of a Royalty Product sold by such sublicensee for use in a Royalty Indication.

               (b)    The parties acknowledge and agree that, with respect to any unit of Royalty Product sold for use in a Royalty Indication, Sangamo shall only owe royalties pursuant to Section 5.3(a)(i) or Section 5.3(a)(ii), but not both.

               (c)    Subject to this Section 5.3 and Section 5.4, the royalty obligations of Sangamo and its Affiliates, sublicensees and successors in interest set forth in Section 5.3(a) shall be perpetual and apply to the Territory.

               (d)    Each Product sold by Sangamo or its Affiliate or sublicensee in a particular country shall be presumed to be sold for the indication(s) for which it has received Regulatory Approval in such country. Such presumption may be overcome if a Party, at its sole expense, procures and provides the other Party with commercially reasonable evidence of off-label sales of such Product in such country during the relevant period. Written notice and evidence shall be promptly provided to the other Party upon learning of any such off-label sales of the Product. Such evidence shall be based upon prescription data products or services or other relevant pharmaceutical sales tracking research services (including, for example, use of random sampling, use of data regarding distribution channels as a proxy for indication-specific sales and development of mathematical models for approximating indication-specific sales) generally recognized in the pharmaceutical industry as being reliable in the tracking of sales of pharmaceutical products of similar nature and prescribed by similar physicians. For example, if Edwards timely provides Sangamo with such commercially reasonable evidence that twenty percent (20%) of Sangamo’s sales in the United States in a particular calendar quarter, of a Product that has only been approved for indications that are not Royalty Indications, are sold for use in a Royalty Indication, then Sangamo shall pay royalties pursuant to Section 5.3(a)(i) with respect to such twenty percent (20%) of such sales by Sangamo with respect to that particular Product in the United States during such calendar quarter.

      5.4      Maximum Royalties . The total royalties paid by Sangamo pursuant to Section 5.3 shall not exceed:

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               (a)    $20,000,000 in any calendar year; or

               (b)    $100,000,000 in the aggregate.

Sangamo’s obligation to make royalty payments to Edwards shall terminate with respect to a particular calendar year once Sangamo has paid Edwards $20,000,000 in royalties pursuant to Section 5.3 with respect to such calendar year. Sangamo shall not have any further obligation to make royalty payments to Edwards once Sangamo has paid Edwards a total of $100,000,000 in royalties pursuant to Section 5.3 during the term of this Agreement.

      5.5      Royalty Reports and Payments . Within sixty (60) days after the end of each calendar quarter prior to the termination of Sangamo’s royalty obligations pursuant to Section 5.4(b), Sangamo shall deliver to Edwards a true and accurate report of Net Sales of Product sold by Sangamo and its Affiliates and sublicensees (to the extent that Sangamo has such sublicensee information, provided that Sangamo shall use commercially reasonable efforts to obtain such information, and while Sangamo may delay payment due to unavailability of information, it shall nevertheless promptly make payments once such information is available) during such calendar quarter and the royalty payments received by Sangamo with respect to sublicensee’s sales of Royalty Products during such calendar quarter, accompanied by all royalties due under Section 5.3 for such calendar quarter. In addition, within such sixty (60) day period after the end of each calendar quarter for which royalty payments are due pursuant to this Agreement, Sangamo shall deliver to Edwards a true and accurate true-up report of all royalty payments not timely made pursuant to Section 5.3.

      5.6      Payment Method . All payments due to Edwards under this Agreement shall be made by Sangamo in the United States in U.S. Dollars by wire transfer to a bank account designated by Edwards.

      5.7      Exchange Rate . With respect to sales of Royalty Products made in a currency other than U.S. dollars, for the purposes of calculating royalties due under Section 5.3, Net Sales will be determined in the original currency and then converted into U.S. dollars based on the rate of exchange published in the Wall Street Journal for the last business day in the relevant calendar quarter.

      5.8      Withholdings . All taxes, assessments and fees of any nature levied or incurred on account of any royalty payments accruing under this Agreement, by national, state or local governments, will be assumed and paid by Sangamo, except taxes levied thereon as income taxes to Edwards, and if such taxes are required to be withheld by Sangamo by the applicable national, state or local Governmental Authority, then Sangamo shall deduct such taxes from such payments due to Edwards and shall pay such taxes on the account of Edwards, and shall secure and provide to Edwards a receipt of such payment, together with copies of all pertinent communications from or with such Governmental Authority with respect thereto. Sangamo agrees to reasonably cooperate with Edwards in any effort by Edwards in claiming any exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.

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      5.9      Records; Audit . Sangamo will maintain, and cause its Affiliates and sublicensees to maintain, complete and accurate records of all sales and other dispositions of Royalty Products prior to the termination of Sangamo’s royalty obligations pursuant to Section 5.4(b), including the amounts which are relevant to the calculation of Net Sales under this Agreement, and such records shall be retained and open during reasonable business hours for a period of three (3) years from the creation of individual records for examination or for a longer period of time, if required by applicable law, and not more often than once each calendar year, by an independent certified public accountant that is selected by Edwards and reasonably acceptable to Sangamo for the sole purpose of verifying the correctnes


 
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