Partnerships

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Vitesse Biologics, Inc.

Shire Plc (Shire), Mayo Clinic and Velocity Pharmaceutical Development, LLC (VPD) formed Vitesse Biologics in May 2015 to focus on the identification and development of early stage therapeutics in the areas of immunology, hematology and rare diseases. The collaboration model, which represents a new method of drug development, was intentionally designed so each company is incentivized to advance promising therapies quickly to clinical proof of concept. Each partner provides its recognized expertise to enhance the target optimization, compound development and product development process.

The creation of Vitesse provides Shire a unique opportunity to incubate early stage R&D targets to accelerate the identification and development of novel treatments that have the potential to greatly contribute to the unmet needs of patients. Mayo Clinic and VPD bring world-class experience and expertise to the company in each of the critical innovation and operational disciplines required to bring promising molecules into human trials. Mayo Clinic's research background and clinical trial capabilities, coupled with VPD's unique management models and drug candidate sourcing capabilities make them ideal partners for this venture.

PARTNERS

Shire recently combined with Baxalta, is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, under-diagnosed, and potentially life-threatening.

The Mayo Clinic is a world-class medical research and education organization that brings research capabilities and experience. Mayo Clinic works with the partners to select the top candidates and executes the Phase I clinical trial processes.

Velocity Pharmaceutical Development (VPD) is a pharmaceutical development organization with extensive experience advancing promising drug candidates to clinical proof of concept using a highly virtual management model. VPD works with the partners to select promising drug candidates and provides management support, to include identification of promising early stage treatment compounds and designing and executing pre-clinical protocols, including toxicology, pharmacology and efficacy.

MANAGEMENT

Under the terms of the agreement, a steering committee comprised of Shire, Mayo Clinic and VPD approves candidate selection. Shire provides global commercialization and biologic development and manufacturing capabilities; Mayo Clinic researchers execute the Phase I clinical trials in-kind, which helps reduce costs associated with early-stage research; and VPD provides project management support, which includes identification of promising early stage compounds. VPD leads the design and execution of pre-clinical protocols with selected studies being carried out at the Panorama Research Institute. Shire will have an exclusive option to acquire the products upon completion of Phase I trials.

Shire, Mayo Clinic and VPD will jointly be involved in the governance of Vitesse as equity owners and in-kind collaborators in the business.

SHIRE'S OPTION FOR COMMERCIAL DEVELOPMENT

Shire will work with partners to select a number of candidates and will also provide global commercialization and biologic development and manufacturing capabilities that include production development, analytical development, process development, formulation optimization and stability studies.

Shire is involved in the early-stages of development for all products produced by Vitesse and will have exclusive rights to acquire the compounds following the completion of Phase I trials for continued development. These compounds are expected to strengthen the Shire pipeline in immunology, hematology and orphan. Should Shire choose not to exercise the option to purchase compounds developed by Vitesse following Phase I trials, those compounds are available for purchase by other companies.

Vitesse is headquartered in South San Francisco, CA. The San Francisco Bay Area is an ideal location to tap into the deep scientific knowledge of the area.