Creating a Global Culture of Stewardship Chris Holdgreve, ETS Executive Director

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1 Creating a Global Culture of Stewardship Chris Holdgreve, ETS Executive Director

2 Biotechnology Plant Product Stewardship Product Development Seed or Plant Production Marketing & Distribution Crop Production Crop Utilization Research & Discovery Plant Product Life Cycle Product Discontinuation 2

3 Biotechnology Plant Product Stewardship Stewardship is a life cycle approach to product management. It is the responsible way to manage biotechnology-derived plant products from their discovery and development, to their use and eventual discontinuation. Quality Management comprises the systems and processes to establish stewardship and maintain quality in each phase of the product life cycle. 3

4 Benefits of Stewardship Enhances the marketability of biotech products Reduces the potential for trade disruptions Contributes to the industry s freedom to operate Facilitates the availability of the latest technological advances Maintain the durability of products 4

5 Excellence Through Stewardship Excellence Through Stewardship (ETS) is a global organization that promotes the universal adoption of stewardship programs and quality management systems for the full life cycle of biotechnology-derived plant products. 5

6 African Agricultural Technology Foundation AgReliant Genetics ArborGen Inc. Agritech Rural BASF Plant Science Bayer CropScience, LP Beijing Origin State Harvest Biotechnology Limited BioAgilytix Labs Ceres, Inc. CIAT (International Center for Tropical Agriculture) CIMMYT (International Maize and Wheat Improvement Center) Curimapu DBN (Beijing Dabeinong Technology Group Co., Ltd.) Dow AgroSciences LLC DuPont Genective ETS Regular Members INDEAR (Instituto de Agrobiotecnologia Rosario S. A.) KWS Limagrain Mahyco (Maharashtra Hybrid Seeds Co. Ltd.) Monsanto Company Pannar Seed Pinto Piga Seeds S & W Seed Company Semillas del Sur Semillas Tuniche Simplot Plant Sciences Sinobioway Sociedad Exportadora Importadora Hortisem LTDA. Syngenta 3rd Millennium Genetics As of August 20, 2015 Refer to for the most up-to-date list of members. 6

7 Excellence Through Stewardship Components Objectives, Principles and Management Practices Guides, Training, Communications and Technical Resources 3 rd Party Audit Process 7

8 ETS Audit Program Auditable Elements General Product Stewardship Maintaining Plant Product Integrity Product Launch Stewardship Product Discontinuation Incident Response Management Resistance Management (Pest / Weed) 8

9 The Accord Managing Off-Patent Technologies Provides a legally binding framework for patent expiration and beyond, and encourages negotiations pre-patent expiration U.S. cultivation and export market authorizations only Covers Signatories events patented and commercialized in the United States within 4 years of patent expiration Encourages participation in ETS to provide appropriate stewardship Two agreements: Generic Event Marketability and Access Agreement (GEMAA) Data Use and Compensation Agreement (DUCA) 9

10 The Accord Fundamentals Transparency Unique private sector solution Binding contract Entire value chain can participate Promotes continued innovation through strong IPR Communication Access Importance of Trade Commitment to maintain trade and stewardship post patent Brings focus to importance of global regulatory reform Promotes Business Opportunities Framework to access to events Provides access to information for business decisions Promotes negotiation Predictable process 10

11 Two Agreements - the GEMAA and the DUCA Shared Principles, Commitments & Inclusive Governance GEMAA DUCA Access to information Access to the generic event Commitment to maintain trade Commitment to stewardship Built on negotiation and, if necessary, arbitration Obligation to engage in good faith negotiations prepatent expiration Process for discontinuation, commitment to maintain trade 4 years post last sale of the event Overseen by Committee of Signatories, that can include members of the value chain 11

12 Relationship between GEMAA and DUCA Differences between GEMAA and DUCA GEMAA: Access to Proprietary Regulatory Property(PRP) not required flexibility to maintain trade independently GEMAA DUCA DUCA: Access to PRP required Mandatory, predictable and structured negotiation for data compensation 12

13 Interest for growers The Accord gives farmers confidence that if they grow seed products containing generic events trade and product stewardship will be maintained post patent expiration Provides transparency, e.g. advanced public notice of when the patents will expire Provides a framework for negotiations and if necessary arbitration 13

14 Interest for seed companies Advanced public knowledge of patent expiration Access to the generic event in a usable form Predictable process for negotiation Predictable regulatory costs Ability to share costs associated with maintaining global authorizations 14

15 Interest for grain trade and other stakeholders Confidence that trade and stewardship will be maintained Knowledge of who is responsible for maintaining trade and stewardship A commitment to a process for product discontinuation, including advanced notice of discontinuation Facilitates information sharing among signatories and the public 15

16 Current Situation The agricultural biotech industry is maturing notice received for the expiration of the first two patents in 2014 However, most patents likely won t begin to expire until after 2021 The Accord is a package, both agreements provide value and confidence to the value chain that trade will be maintained and those that want generic events will have access ETS is updating its Guide for Product Discontinuation to include stewardship of off-patent technologies 16

17 Thank you!

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