EX-10 12 filename12.htm EXECUTION COPY TECHNOLOGY LICENSING AGREEMENT
Exhibit 10.8
EXECUTION COPY
TECHNOLOGY LICENSING AGREEMENT
This Technology Licensing Agreement (“Agreement”) is effective as of the Effective Date and is by and between Dow Global Technologies Inc. and/or The Dow Chemical Company (hereinafter both are referred to as “Dow”), both Delaware corporations having their principal offices at either 0000 Xxx Xxxxxx, Xxxxxxx, XX, 00000 XXX or 0000 Xxx Xxxxxx, Xxxxxxx, XX, 00000 XXX and Pfenex Inc., a Delaware corporation (hereinafter “Pfenex”) having a principal place of business at 0000 Xxxxxxx Xxxxx, Xxx Xxxxx, XX.
WHEREAS, Dow has certain rights to a certain series of patents related to RNA viruses;
WHEREAS, Dow has certain rights to a certain series of patents related to the ARC technology;
WHEREAS, Pfenex desires to take a license to such intellectual property as further defined below.
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ARTICLE 1 | DEFINITIONS |
1.01 Affiliates: “Affiliates” shall mean any entity that, directly or indirectly through one or more intermediates, controls, is controlled by or is under common control with either Dow or Pfenex, where “controls”, “controlled by”, and “is under common control” means ownership, directly or indirectly, of fifty percent (50%) or more of the voting equity interest in the entity or the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of that entity, whether through ownership or voting securities, by contract or otherwise.
1.02 ARC Products: “ARC Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the ARC Patents.
1.04 Assets: “Assets” shall mean collectively the RNA Virus Patents, the Oral Immunization Patents, the Production Techniques Patents, the ARC Patents and the rights granted to Pfenex under Section 2.01.05.
1.05 Control: “Control” in the context of intellectual property rights, shall mean rights to intellectual property sufficient to grant the applicable license or sublicense under this Agreement without violating the terms of any written agreement with any Third Party in effect as of the Effective Date. “Controlled” and “Controlling” shall have their correlative meanings.
1.06 Effective Date: “Effective Date” shall mean November 30, 2009.
1.07 Field: “Field” shall mean any and all applications for therapeutic purposes in humans for any and all indications, including, for the avoidance of doubt, vaccines. For
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the purposes of this definition, “therapeutic purposes” shall mean, with respect to a particular indication, human diagnostics, prophylaxis, cure, reduction, mitigation, prevention, slowing or halting the progress of, or otherwise management of such indication.
1.08 Net Sales: “Net Sales” shall mean the sales revenues actually received by Pfenex from sales of the applicable Product (as set forth in Article 3) to Third Party customers, less: (a) Customary trade, quantity or cash discounts, credits and rebates (including, without limitation, credits, rebates and other discounts made or given with respect to Federal, state or foreign governmental programs (including, without limitation, Medicaid and Medicare) public or private hospitals and managed care entities or patient care organizations), and non-affiliated brokers’ or agents’ commissions actually allowed and taken; (b) Amounts repaid or credited by reason of rejection or return, including chargebacks, refunds or rebates (including expenses related to disposal); (c) Fees payable to purchasers, sales agents, distributors, group purchasing organizations or government agencies; (d) costs of insurance, packaging, storage and transportation from the place of manufacture to the customer’s premises; (e) provisions for uncollectible accounts determined in accordance with generally accepted accounting practices, consistently applied to all products of Pfenex; and/or (f) Taxes levied on and/or other governmental charges made as to production, import, export, sale, receipt, value-add, transportation, delivery, custom duties or use and paid by or on behalf of Pfenex for the RNA Virus Products, and less the sum of the following a) sales taxes, tariff duties and/or use taxes; b) direct, external out-of-pocket expenses incurred by Pfenex; and c) amounts rebated, credited or refunded on returns for the Oral Immunization Products.
1.09 Oral Immunization Products: “Oral Immunization Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the Oral Immunization Patents.
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1.11 Parties: “Parties” shall mean collectively Pfenex and Dow.
1.12 Party: “Party” shall mean either Pfenex or Dow as the case may be.
1.13 Patents: “Patents” shall have the meaning set forth in the Technology Assignment Agreement.
1.14 Product(s): “Product” shall mean individually the RNA Virus Products, the Oral Immunization Products, the Production Techniques Products or the ARC Products, and “Products” shall mean collectively the RNA Virus Products, the Oral Immunization Products, the Production Techniques Products and the ARC Products.
1.15 Production Techniques Products: “Production Techniques Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the Production Techniques Patents.
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1.17 RNA Virus Products: “RNA Virus Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the RNA Virus Patents.
1.19 Third Party: “Third Party” shall mean any person, organization, firm, corporation, partnership or entity other than Pfenex, Dow and their respective Affiliates.
1.20 Valid Claim: “Valid Claim” shall mean a claim of an issued, unexpired Patent within the RNA Virus Patents, the Oral Immunization Patents, the Production Techniques Patents or the ARC Patents, as the case may be, which: (a) has not been held unpatentable, invalid or unenforceable by a court or other government agency of competent jurisdiction in a decision from which no appeal can or has been taken; and (b) which has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise.
1.21 All capitalized terms used in this Agreement that are not explicitly defined herein shall have the corresponding meanings set forth in the Contribution, Assignment and Assumption Agreement, the Technology Assignment Agreement or the Grant-Back and Technology License Agreement.
ARTICLE 2 | TRANSFER AND LICENSE OF ASSETS |
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(b) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above; and (c) otherwise exploit the RNA Virus Patents. The license/sublicense set forth in this Section 2.01.01 shall be exclusive (even as to Dow) in the Field.
2.01.05 To the fullest extent Dow has or may receive rights under Section 4.7 of the License Agreement between DGTI and Diversa Corporation dated December 30, 2003 (“Diversa Agreement”), Dow hereby grants to Pfenex:
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2.01.05.01 A perpetual, worldwide, royalty-free, non-exclusive license or sublicense in the Field, as applicable, with the right to grant and authorize sublicenses in accordance with Section 2.02, under any DIVERSA patents or patent applications which have a priority date after December 19, 1997, and which are listed in the Diversa Agreement as may be amended, and which contain teachings or claims which both i) are directed to Pseudomonas organisms and ii) include information derived from the use of the TDCC Technology and/or Sequestered Information, in each case to: (a) make, have made, use, sell, offer for sale, import or otherwise exploit any product and (b) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above. This license shall not include DIVERSA Genes, DIVERSA intellectual property directed to the functional applications of the protein or the use of the Gene with any other organism.
2.01.05.02 A worldwide, royalty-free, immunity in the Field from suit under any DIVERSA patents as set forth in the Diversa Agreement directed to the use of the genus Pseudomonas as an expression system. This immunity from suit does not extend to DIVERSA Genes, DIVERSA intellectual property directed to the functional applications of the proteins or the use of the Gene with any genus other than Pseudomonas.
2.01.05.03 For the purposes of this Section 2.01.05 the terms “DIVERSA,” “TDCC Technology,” “Sequestered Information,” “DIVERSA Genes” and “Gene” shall have the meanings set forth in the Diversa Agreement.
2.01.05.04 Prior to, or shortly after the Closing Date, Dow shall use reasonable efforts to cause Dow AgroScience (“DAS”) to obtain from Diversa (or its successor-in-interest) sufficient rights to effectuate the grant of rights from Dow to Pfenex in Sections 2.01.05.01 and 2.01.05.02, in writing, signed by the authorized representatives of the applicable parties.
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ARTICLE 3 | Royalties |
3.02.01 A minimum payment due December 31st of each year of [*], such payment obligation commencing at the end of the first full year during which Pfenex has made such commercial sales of an Oral Immunization Product. The payments made by Pfenex to Dow under this Section 3.02.01 shall be creditable against the running royalty rate owed by Pfenex to Dow under Section 3.02.02.
3.02.02 A running royalty, which shall equal the lesser of: (A) [*] of the Net Sales of such Oral Immunization Products or (B) the royalty percentage of the Net Sales of such Oral Immunization Products owed by Dow to Washington University pursuant to the Washington University ’96 Agreement; wherein such royalty payments shall be due December 31st of each year in which such sale is made.
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3.02.03 Within thirty (30) days after the end of each Contract Year prior to First Commercial Sale (“Contract Year” and “First Commercial Sale” shall have the meanings ascribed to them in the Washington University ’96 Agreement), an annual maintenance royalty of [*] which will be fully creditable against the royalties owed under Section 3.02.02. The payment obligation set forth in this section 3.02.03 shall commence in January 2010.
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component(s) or services(s) were not made during the previous calendar quarter, then the Net Sales shall be as reasonably allocated by Pfenex between such Product and such other product(s), component(s) or service(s) based upon their relative importance and proprietary protection.
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ARTICLE 4 | CONSIDERATION FOR THE ASSETS |
4.01 In consideration for Dow’s license/sublicense under the Assets and other intellectual property hereunder, Pfenex shall issue to Dow shares of Series A-1 Preferred Stock of Pfenex as set forth in that certain Contribution, Assignment and Assumption Agreement by and between Dow and Pfenex of even date herewith.
ARTICLE 5 | PFENEX REPRESENTATIONS AND WARRANTIES |
5.01 Pfenex is a corporation duly organized and validly existing under the laws of the State of Delaware.
5.02 Pfenex has all the necessary power and authority to execute deliver and perform this Agreement, and no approvals or consents of anyone other than the signatories below are necessary in connection with the execution and delivery of this Agreement.
5.03 This Agreement has been duly executed and delivered by Pfenex and constitutes a legal, valid and binding obligation of Pfenex enforceable in accordance with its terms.
5.04 To the extent required of the licensee under the Washington University ’96 Agreement or under the Agreement between Agrigenetics and University of Wisconsin dated December 23, 1982 (“Wisconsin Agreement”), Pfenex shall provide activity reports to Washington University under the Washington University ’96 Agreement or to University of Wisconsin under the Wisconsin Agreement. Such activity reports shall comply with the format specified under the Washington University ’96 Agreement and shall include details about its activities and progress made, the status of any licensed products under development and/or planned for development, the tasks necessary to develop or complete the development and introduction of products to market, the estimated time schedules for product development, clinical trials, market testing, and regulatory approval, or the Wisconsin Agreement, as applicable. Upon delivery of such activity reports, Pfenex shall provide notice to Dow indicating that Pfenex has delivered the applicable activity report. Pfenex will use diligent efforts to bring a product to market using the RNA Virus Patents and the Oral Immunization Patents. Failure to use diligent efforts may result in a loss of license to the RNA Virus Patents and the Oral Immunization Patents.
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ARTICLE 6 | DOW REPRESENTATIONS AND WARRANTIES |
6.01 The Dow Chemical Company and Dow Global Technologies Inc. are corporations duly organized and validly existing under the laws of the State of Delaware.
6.02 The Dow Chemical Company and Dow Global Technologies Inc. have all the necessary power and authority to execute deliver and perform this Agreement, and no approvals or consents of anyone (except certain additional Dow personnel) other than the signatories below are necessary in connection with the execution and delivery of this Agreement.
6.03 To the best of its knowledge as of the Effective Date, Dow has all rights to grant the licenses or sublicenses to the Assets, subject to Permitted Liens (as that term is defined in the Contribution, Assignment and Assumption Agreement and Schedule 1.17 therein) , and other performance promised to Pfenex under this Agreement and has good title to all information and materials which are included in the rights and intellectual property transferred to Pfenex pursuant to this Agreement, free and clear of any liens, judgments, encumbrances or adverse claims. For clarity, Dow will not, during the term of this Agreement, grant any rights to any Third Party that are inconsistent with the rights granted to Pfenex under this Agreement.
6.04 To the best of its knowledge as of the Effective Date, Dow is not aware of any claims, demands or actions alleging that any of the Assets licensed or sublicensed in this document are invalid or unenforceable. This provision does not include a representation or warrantee by Dow that any or all of the patent rights will grant or issue as valid patents.
6.05 To the best of its knowledge as of the Effective Date, Dow has not received any notice claiming that the Assets violate or infringe any intellectual property rights of any Third Party.
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6.06 With regards to Third Party Agreements:
6.06.01 As of the Effective Date, Exhibit 6.06.01 of this Agreement lists all the agreements between Dow and Third Parties pursuant to which Dow has in licensed, has gained Control of or acquired any Patents within the Assets (each, a “Third Party Agreement”);
6.06.02(i) Dow has previously provided to Pfenex a redacted (all material terms for the purposes of this Agreement have not been deleted) copy of each Third Party Agreement as the same is in effect as of the Effective Date, (ii) each Third Party Agreement is in full force and effect as of the Effective Date and Dow shall maintain each Third Party Agreement in full force and effect and enforce each Third Party Agreement to its fullest extent, in each case in accordance with its terms and conditions during the term of the Agreement subject to Section 5.04, (iii) as of the Effective Date, no notice of default or termination has been received or given by Dow under any Third Party Agreement, and (iv) during the term of this Agreement, Dow shall not amend or otherwise modify any Third Party Agreement to license out such technology in the Field, or allow any Third Party Agreement to be terminated, unless Pfenex fails to comply with the terms of such Third Party Agreement, without the prior consent of Pfenex; and
6.06.03 In the event of any notice of breach by Dow or its Affiliates, as applicable, of any Third Party Agreement the termination of which will or is likely to adversely affect Pfenex’s rights or obligations under this Agreement, Dow shall as promptly as reasonably practicable notify Pfenex in writing and Pfenex shall have the right, but not the obligation, to cure such breach on behalf of Dow or its Affiliates, as applicable. In the event of any notice of breach by the counterparty of any Third Party Agreement in a manner that will or is likely to adversely affect Pfenex’s rights or obligations under this Agreement, Dow shall immediately notify Pfenex.
6.07 Except for the express warranties in this article, Dow makes no representations or warranties, express or implied, either in fact or by operation of law, regarding without limitation, the validity or scope of any patent rights conveyed or including, without limitation, performance, merchantability, fitness for a particular purpose, or the non-infringement of third party intellectual property rights.
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ARTICLE 7 | PATENT PROSECUTION AND ENFORCEMENT |
7.01 Patent Prosecution and Maintenance.
7.01.02 In the event Dow decides to abandon an application or patent within the Production Techniques Patents that relates to the Field, Dow shall provide Pfenex fifteen (15) business days notice in which Pfenex will have the right to Prosecute and Maintain any such application or patent at its own cost. For the purposes of 7.01.02, “abandon” will include abandoning the Prosecution and Maintenance of a particular Patent without filing a divisional, continuation, continuation-in-part or foreign counterpart for such abandoned Patent.
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7.02.03 Cooperation. Without limiting any rights of comment and review in Section 7.02.02, the Party initiating or defending any Enforcement Action pursuant to this Section 7.02 shall keep the other Party reasonably informed of the progress of any such Enforcement Action, and such other Party shall have the right to participate with counsel of its own choice and at its own expense. Notwithstanding the foregoing right to participate in any Enforcement Action, the Parties shall assist one another and cooperate in any such Enforcement Action, as reasonably requested by the Party initiating such Enforcement Action, at such Party’s expense.
ARTICLE 8 | NOTICES |
8.01 Any notice or other communication required or permitted to be given by either party under this Agreement shall be given in writing and shall be effective when delivered, if delivered by hand, reputable courier service, facsimile with confirmation of transmission, email with confirmation of receipt or five days after mailing if mailed by registered or certified mail, postage prepaid and return receipt requested, addressed to each party at the following addresses or such other address as may be designated by written notice by either Party:
If to Pfenex:
Chief Executive Officer
0000 Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Fax: 000-000-0000
Email: [To be designated by written notice to Dow]
If to Dow:
The Dow Chemical Company
0000 Xxxxxxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000
Attention: General Patent Counsel
Fax: 000-000-0000
Email: xxxxxxxxxx@xxx.xxx and xxxxxxx@xxx.xxx
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ARTICLE 9 | TERM AND TERMINATION |
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ARTICLE 10 | MISCELLANEOUS |
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conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties. Except for assignments expressly permitted under this Section 10.01, any attempted assignment or transfer of this Agreement shall be null and void.
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Section shall give the other Party written notice and full particulars of such force majeure event. Both Pfenex and Dow shall use reasonable business efforts to mitigate the effects of any force majeure on their respective part.
10.06 Choice of Law; Submission to Jurisdiction: All questions with respect to the construction of this Agreement and the rights and liabilities of the Parties hereto shall be determined in accordance with the laws of the State of New York applicable to business arrangements entered into and performed entirely within the State of New York. The Parties hereto irrevocably (a) submit to the exclusive personal jurisdiction of any state court or federal court in the State of New York in any suit, action or other legal proceeding relating to this Agreement; (b) agree that all claims in respect of any such suit, action or other legal proceeding may be heard and determined in, and enforced in and by, any such court; and (c) waive any objection that they may now or hereafter have to venue in any such court or that such court is an inconvenient forum.
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[REMAINDER OF THIS PAGE LEFT BLANK INTENTIONALLY]
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THE DOW CHEMICAL COMPANY | ||
By: | /s/ Xxxxxxxx Xxxx | |
Name: | Xxxxxxxx Xxxx | |
Title: | Corporate Vice President and Treasurer | |
DOW GLOBAL TECHNOLOGIES INC. | ||
By: | /s/ Xxxx X. Xxxxxxxx | |
Name: | Xxxx X. Xxxxxxxx | |
Title: | President | |
PFENEX INC. | ||
By: | /s/ Xxxxxx Xxxxxx | |
Name: | Xxxxxx Xxxxxx | |
Title: | President |
[Signature Page to Technology License Agreement]
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Appendix A
RNA Virus Patents:
Xxxxxxxx | MODIFIED PLUS STRAND RNA VIRUSES; (from Univ Wisconsin) | 2/14/1984 | XX0000000 | |||
Xxxxxxxx | Subgenomic promoter | 3/7/1985 | US5466788 | |||
Xxxxxxxx | RNA transformation vector | 3/7/1985 | US5500360 | |||
Xxxxxxxx | Hybrid RNA virus | 2/9/1987 | US5602242 | |||
Xxxxxxxx | Hybrid RNA virus | 2/9/1987 | US5627060 | |||
Xxxxxxxx | Plant tissue comprising a subgenomic promoter | 8/25/1994 | XX0000000 | |||
Xxxxxxxx | Subgenomic promoter | 8/25/1994 | US5670353 | |||
Xxxxxxxx | Plasmid encoding hybrid RNA virus | 2/9/1987 | US5804439 | |||
Xxxxxxxx | RNA transformation vector | 3/7/1985 | US5846795 |
and any foreign counterpart thereof.
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Appendix B
Oral Immunization Patents:
Xxxxxxx & Cardineau | Oral Immunization By Transgenic Plants | US5654184 | ||||
Xxxxxxx & Xxxxxxxxx | Oral Immunization By Transgenic Plants | US5679880 | ||||
Xxxxxxx & Cardineau | Oral Immunization By Transgenic Plants | US5686079 |
and any foreign counterpart thereof.
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Appendix C
Production Techniques Patents:
62339A | PCT PCT | OVER-EXPRESSION OF EXTREMOZYME GENES IN PSEUDOMONADS AND CLOSELY RELATED BACTERIA | 2/13/2002 | WO2003068926 WO2003068948 PCT/US02/004294 | ||||
USA | 10/504,505 | |||||||
Australia | 2003215197 | |||||||
Brazil | PI0307630 | |||||||
Canada | 0000000 | |||||||
Xxxxx | 03808240.3 | |||||||
EPO | 03711011.1 | [Validation in progress] | ||||||
Xxxxx | 0000/0000 | |||||||
Xxxxx | 2003-568041 | |||||||
Mexico | PA/A/04/007886 | |||||||
61727A | USA | LOW-COST PRODUCTION OF PEPTIDES | 5/22/2002 | US20050227321 PCT/US03/12407 | ||||
PCT | ||||||||
Australia | 2003228637 | |||||||
Canada | 2482995 | |||||||
China | 03814541.3 | |||||||
EPO | 03726398.5 | [Validated in GB, FR, DE, NL, XX] | ||||||
Xxxxx | 000/0000 | |||||||
Xxxxx | 2003-586175 | |||||||
S. Korea | 2004-7017047 | |||||||
61957A | PCT | PROCESS FOR REMOVING WATER FROM AQUEOUS SOLUTIONS OF PROTEINS | 2/27/2004 | WO2005092915 | ||||
USA | 10/590095 | |||||||
EPO | 05713770.5 | Validated in GB, DE, FR, | ||||||
62644A | PCT | METHOD FOR THE EXTRACTION OF INTRACELLULAR PROTEINS FROM A FERMENTATION BROTH | 2/27/2004 | WO2005087791 PCT/US05/005309 | ||||
USA | 60/548403 | |||||||
EPO | 05723333.0 | |||||||
USA | 10/590185 | |||||||
65217 | USA | CONTINUOUS OSMOTIC SHOCK PROCESS FOR RELEASE OF PROTEINS FROM BACTERIA | 1/12/2007 | US Application No: 12/013042 |
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AU | 2008205632 | |||||||
CA | PCT/US08/000426 | |||||||
CH | PCT/US08/000426 | |||||||
EP | 08724501.5 | |||||||
IN | PCT/US08/000426 | |||||||
JP | PCT/US08/000426 | |||||||
SINGAPORE | 200904693-9 | |||||||
SOUTH KOREA | PCT/US08/000426 |
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Appendix D
ARC Patent
US Patent No: 7,338,794 entitled “Amended recombinant cells for the production and delivery of gamma interferon as an antiviral agent, adjuvant and vaccine accelerant” and any foreign counterpart thereof.
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Exhibit 6.06.01
Third Party Agreements
1. License Agreement between Mycogen Corporation and The Dow Chemical Company dated January 1, 2001.
2. Agreement between Agrigenetics and University of Wisconsin dated December 23, 1982.
3. License Agreement between Washington University and Agrigenetics dated December 30, 1996.
4. ARC Technology License Agreement between Dow Global Technologies Incorporated and Dow AgroSciences LLC dated November 30, 2009.
5. Agreement between DAS and Dow granting rights under Section 4.7 of the Diversa Agreement.
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