EXELA Designing the Microbial Research Commons 1 Industrial Perspective: Development of an MTA harmonious with a Microbial Research Commons Stephen J. M c Cormack, PhD National Academy of Sciences October 8, 2009

EXELA Commercial Application of Microbial Resources Microbes have had commercial and “societal” value for millennia Since the initiation of modern biotechnology; microbes and microbial collections have formed the underpinning of basic research and of billion dollar products We have just “scratched the surface” of the commercial potential of microbes Global standards or principles are applied to the characterization, access and licensing of these microbes and collections

EXELA Industrial Benefits to Liability Rules Postulate: Diverse licensing strategies and techniques have elevated the transaction costs and other barriers for relatively simple collaborative research projects. Liability rules: Access to all microbial resources and collections will eliminate any of the competitive advantage from sequestering materials and data from other organizations. Caveat: a substantial amount of the data and collections are in private organizations and companies

EXELA Case Study: American Type Culture Collection ATCC is an independent, private, non-profit 501(c)(3) biological resource center (BRC) and World Federation of Culture Collections (WFCC) organization. – As a biological resource center – As a research organization To provide reliable, qualified and low priced biological materials for the advancement of basic research

EXELA Case Study: ATCC History Established in 1925 when a committee of scientists recognized a need for a central collection of microorganisms that would serve scientists all over the world. ATCC began at the McCormick Institute in Chicago and moved to Georgetown University in Washington, DC in first patent culture deposit 1981 accepts patent materials from any country that has signed the Budapest Treaty 1997 initiates the first of the ATCC Special Collections and moved to Manassas, Virginia

EXELA ATCC Mission # 1 “ATCC is a global nonprofit bioresource center and research organization that provides products, technical services and educational programs to private industry, government and academic organizations. Our mission is to acquire, authenticate, preserve, develop and distribute biological materials, information, technology, intellectual property and standards advancement and application of scientific knowledge.”

EXELA ATCC Mission # 2 “To acquire, authenticate, preserve, develop and distribute biological resources and knowledge to scientific researchers. We strive to be the preferred provider of high-quality biological reference standards which, along with products and services developed in-house, enable science to touch people’s lives.”

EXELA ATCC Collection Collection Holdings 3,400 human, animal and plant cell lines 8 million cloned genes microorganism collection – 18,000 strains of bacteria – 2,000 different types of animal viruses – 1,000 plant viruses – 49,000 yeast and fungi strains – 2,000 strains of protists. Research and Development Standards and Services Distribution and Technical Support

EXELA Value Add Proposition ATCC Special Collections: – Johns Hopkins University – MR4 (Malaria) – Mantle Cell Lymphoma Cell Bank – National Park Service – NIH Human Microbiome Project – Yeast Genetic Research

EXELA Disincentive to Research Commons Sequestering of biological resources and data allows for a “perceived” monopoly on the downstream application of research discoveries The academic research group or commercial firm could then take advantage of all the value of this data and collection without any competition Only when sharing and distribution will provide a greater possible “upside” to the owner then the material and data will be disseminated

EXELA Commercial licensing program:  Sterility testing  Vaccine manufacture  Food & beverage manufacture — yogurt, soda, infant formula  Product testing  Clinical diagnostics  Wastewater treatment and septic additives  Contract pharmaceutical manufacture  Drug development  Contract research — drug discovery, preclinical services, screening  Medical devices  Nutraceuticals  Gene expression databases  Genome sequencing instrumentation  Government contracts  High-throughput technologies  Proficiency testing  Research reagents and tools  Stem cell R&D  Toxicology testing  Veterinary pharmaceuticals

EXELA Model MTA: Definition of Commercial Use “Commercial Use” means the sale, license, lease, export, transfer or other distribution of the Biological Materials to a third party for financial gain or other commercial purposes and/or the use of the Biological Material: (a) to provide a service to a third party for financial gain; (b) to produce or manufacture products for general sale or products for use in the manufacture of products ultimately intended for general sale, (c) in connection with ADME testing; ATCC Standard MTA

EXELA Model MTA: Definition of Commercial Use “Commercial Use” cont’d (d) in connection with drug potency or toxicity testing which does not include either screening multiple cell lines for potential inclusion in a screening assay system or screening multiple compounds in a system for internal research purposes only; (e) in connection with proficiency testing service(s), including but not limited to, providing the service of determining laboratory performance by means of comparing and evaluating calibrations or tests on the same or similar items or materials in accordance with predetermined conditions; or ATCC Standard MTA

EXELA Model MTA: Definition of Commercial Use “Commercial Use” cont’d (f) for research conducted under an agreement wherein a for-profit entity receives a right whether actual or contingent to the results of the research. Conclusion: the definition of Commercial Use is not very simple in application or determination ATCC Standard MTA

EXELA ATCC Technologies Available for Licensing Master cell banks of Vero cells for vaccine manufacture Mycoplasma detection kit Speciation kit Materials in ATCC special collections Pre-1980 cell lines in ATCC collection (not subject to the terms and conditions of Bayh-Dole)

EXELA Considerations: Liability Rules If WFCC organizations pursue value-add research and bundling strategies the collections will move up the value chain towards approaching commercial products -this may invalidate such a liability rule approach Culture collections should not deviate from their purpose of basic accessioning of biological material for preservation, maintenance and distribution

EXELA Semicommons: commercial and non-commercial value in the same application  Sterility testing  Vaccine manufacture  Food & beverage manufacture — yogurt, soda, infant formula  Product testing  Clinical diagnostics  Wastewater treatment and septic additives  Contract pharmaceutical manufacture  Drug development  Contract research — drug discovery, preclinical services, screening  Medical devices  Nutraceuticals  Gene expression databases  Genome sequencing instrumentation  Government contracts  High-throughput technologies  Proficiency testing  Research reagents and tools  Stem cell R&D  Toxicology testing  Veterinary pharmaceuticals

EXELA Pushing the limits of liability rules In certain cases the mere characterization of a microbe can create immediate commercial potential for products (e.g. H1N1) The microbes or microbial collections should meet certain non-commercial qualifications for entry into the Microbial Commons Discoveries and advances in scientific understanding will continually move the line for what is eligible under the liability rules.

EXELA Conclusions Commercial Use of Microbial Cultures is very difficult to define because the value changes over time and subjective to begin with at the time of appraisal A multifaceted system may be required to form a Microbial Commons that will enable broad and effective access to data and biological materials The WFCC and ECCO will have to continue to leads with MTA agreements that will form the core of these Microbial Commons