`Case l:14—cv—OOl13—RGA—MPT Document 276-3 Filed 09/24/15 Page 1 of 4 Page|D #: 9309
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`Case 1:14-cv-00113-RGA-MPT Document 276-3 Filed 09/24/15 Page 2 of 4 PageID #: 9310
`Case 1:14—cv—OO113—RGA—MPT Document 276-3 Filed 09/24/15 Page 2 of 4 Page|D #: 9310
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`Ap1'.ir'20]5
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`Paul E Jansen, PE
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`L ummnr 0 Skills: Strong drug)’ biologics device development experience (registration, CMC.
`manufacturing- qualit_v_. business development). Demonstrated success in cross cultural work
`environments (Japan & EU) and excellent proj cct management skills. Demonstrated ability to
`think strategically, creatively and tactically ensuring that plans translate into coordinated action.
`Strong leader, having developed and led through nian_v difficult situations. Excellent relationship
`skills. Highly respected by peers. Gets results through people (intenially and frorn alliances).
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`Experience/A ceorgglishmenis:
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`June 201 4 — Present Scmofi
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`I
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`aVP Medical Devices Development: Responsible for all medical device and drug device combination
`product development from ideation through proof of concept as pan of the ne\vl_v created Device
`Development Unit. Includes management of FP. Competitive Intelligence. Patient Insights, External
`opporiiuiities Technolog_v development and Early Stage product development. Lead a team located in
`Boston and Frankfurt.
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`J’rd_t' 2006 — May 20!-if Sanofl-A ventis
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`0 Global Head Medical Devices Development: Major Accomplisliments: Successful launch of multiple
`drug device combination products and BGM systems._ desig_r_i_and impleinentation of devices
`organization (pow 145 pepple strong in EU and U31. several strategic alliances signed. successful
`completion o_f_patent litigation cases. Creation of a portfolio of 1000+ patent families. Global
`responsibilit_v for devices development including device research. development and inclustrialization.
`business development and post marketing activities. Member of several senior level governance
`committees. Secretary-General Medical Devices Board.
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`April’ 1991 —.hme 2006 Eli Lr'I{v and Company
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`0 CO0: Project Leader Exenatide (Byetta) Global Brand Team: Mriigygtccoimlislimeiils: Member
`of the 2tl05f6 Global Brand Team of the Year and Alliance of the Year. Responsible for leadership of
`the development programs for alternative deliver)-' of cxenatide. This included clinical. toxicology.
`device. CM&C. manufacturing (including Facility construction}. The projects are highl_v leveraged
`with multiple partners. As a result a significant portion of the responsibility included alignment of
`strategy and negotiation with the partners. Member of the Global Brand {B_vctta_) Leadership Team.
`0 Global Supply Chain Steward; Parenteral Network;_l\1ajor Accomplishments: Successful launch
`of Alimta. Z.}_'prexa 1M and l-lunialmpe Reconstitution Device. Develop_r_rient of_and implementation of
`process ir_i_iprevement plan resulgipg in in_ip_roved efficiencies. Creation and implementation of gI_p_bal
`S&0P process for the parenteral network: freeze dried products. Turnaround of manufacturipg
`relationship at DSM. Most improved alliance in 2003. Responsible for management of global
`network of parenteral manufacturing nodes, successful launch of new products. Also responsible for
`third party manufacturing operations related to the parenteral network.
`0 C00 Prozac Global Product Team; Major Accoiitplislutietitsi Divestiture of Sarafeln brand in US.
`2002 sales 10% over plan. IC‘.l-I Harmonization of label in EU. approval of multiple indications in US.
`Responsible for development and implementation of brand strategy for Prozac globally and Affiliate
`Sales support. Responsible for implementation of all R&D activities related to Prozac. Responsible for
`business operations of the Prozac franchise which includes Prozac daily. Prozac Weekly and Sarafem
`(for PMDD) brands.
`Project Leader Prozac Japan; Major Accoiuplislunents: Preparation of .l—NDA. completion of
`bridging clinical prograni. Responsible for successful developnient of Prozac in Japan. Managed and
`lead a complex team located in Japan UK. Canada and USA. Conducted three clinical trials in support
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`0
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`Cl" Pain’ Jansen, PE
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`I (#3
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`PTX-692.0001
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`Case 1:14-cv-00113-RGA-MPT Document 276-3 Filed 09/24/15 Page 3 of 4 PageID #: 9311
`Case 1:14—cv—00113—RGA—MPT Document 276-3 Filed 09/24/15 Page 3 of 4 Page|D #: 9311
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`of J-NDA submission and established strong relationships with key opinion leaders in Japan to support
`approval. Lead CLCR (Lilly — Chugai joint venture), and all development, medical and regulatory
`functions for the development program.
`0 Manager Marketed Products, Pharmaceutical Delivery Systems (PDS); Major Accomplishments:
`Successful introduction of devices for Human Growth Hormone and Insulin devices in Europe Japan
`and US participant in ISO expert group which developed and had published a global pen injector
`standard. Responsible for Supply and Continuous Improvement of all marketed delivery products.
`Also responsible for PDS site support services and processes. A highly integrated and leveraged
`enviromnent. Extensive contact with third party suppliers and manufacturers.
`0 Manager, Pharmaceutical Delivery Systems; Major Accomplishments: Successful development
`implementation of strategic device plan three successful re-certifications of ISO 9001 quality system
`Launches of Insulin and Human Growth Hormone Devices. Responsible for all PDS work processes
`(drug delivery device design, development, manufacturing implementation, quality control and quality
`assurance). Lead development teams resulting in successful launch of Owen Mumford, BD Classic 3.0
`and Humatropen devices. PDS leverages and integrates medical and device technologies with
`formulation and container requirements into delivery systems which satisfy the needs of Lilly's global
`patients and health care professionals
`0 Manager, Lilly Analytical and Bioanalytical Laboratories; Major Accomplishment: Secured
`mandate and funding to expand lab capabilities Responsible for both labs operating in Canada -
`bioanalytical and analytical. Responsible for recmiting and development of all staff, capital purchases,
`and expense management. Responsible for ensuring all operating and procedural systems for long
`term operation are in place. Liason with Sunnybrook Hospital to seek out further business
`development/ collaboration opportunities. Ensure appropriate use of resources to maximize
`laboratories corporate contribution to accelerating the time to get a product to market. Developed,
`gained approval for and implemented bioanalytical laboratory including 4 LC — Mass Spectrometers.
`0 Manager, Lilly Analytical Research Laboratory; Major Accomplishments: Built on success of lab
`successfullv integrated labs into Lillv Research Labs with Corporate Labs. Responsible for recmiting
`and development of all staff, capital purchases, and expense management. Responsible for ensuring all
`operating and procedural systems for long term operation are in place. Liaison with Sunnybrook
`Hospital to seek out further business development/ collaboration opportunities. Ensure appropriate use
`of resources to maximize laboratories corporate contribution to accelerating the time to get a product to
`market.
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`0 Manager, Customer Support Operations, MDD (Medical Device & Diagnostics) Companies;
`Major Accomplishment: Successfullv creating the MDD entities from multiple companies and
`optimizing effectiveness and efficiency of the operations. Responsible for all aspects of operation of
`MDD Companies operating in Canada including Customer Service, Regulatory Affairs (compliance
`and approval), Technical and Field Service, Systems and support staff. Integrated all Techrncal/Field
`Service units under one umbrella group. Implemented after hour service for MDD Companies. Co-
`ordinated installation of call management system for Customer Service group. Implemented new MDD
`Company products and systems as they were introduced to Canada.
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`July I987—April 1991 Philips Electronics
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`0 Manager, Customer Support Centre; Responsibilities included after sales support activities
`including training, documentation, hardware and software support, dispatch and call management.
`Developed and implemented service automation plans. Managed a staff of 27 with accountability for
`top and bottom line results.
`0 Manager Central Support Operations; Responsible for all service automation development and
`implementation, dispatch (7 day a week, 24 hours a day), call management and office automation
`software support. Chairman of Service Quality Committee. Secretary of service management team.
`Accountable for top and bottom line results. Staff of 17.
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`PTX-692.0002
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`Case 1:14-cv-00113-RGA-MPT Document 276-3 Filed 09/24/15 Page 4 of 4 PageID #: 9312
`Case 1:14—cv—00113—RGA—MPT Document 276-3 Filed 09/24/15 Page 4 of 4 Page|D #: 9312
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`April 2015
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`July 1986 — July I987Husky Injection Molding
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`0 Global Parts and Service Manager; Directed $15 million per armum service and parts operation
`through an international staff of 40. Corporate staff in Head Office, Parts Centre in Buffalo, NY and
`service technicians throughout North America. Fully accountable for P & L. Operation included
`logistics, materials management, warranty administration, training, documentation and field service.
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`April 1983 — July 1986 Philips Electronics
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`0 Branch Service Manager and Manager Employee Relations; Responsibilities included all aspects
`of personnel with the exception of compensation. As Branch Services Manager, responsible for $2.5
`million service (sales) revenue in Toronto and Northern Ontario. Supervised staff of 35. Negotiated
`and sold service agreements, invoiced as required and managed spares inventory. Branch considered a
`business unit with full P&L accountability.
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`July 1978 —April 1983 Fiberglas Canada (division Owens Corning)
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`0 Manager Training and Development, Supervisor Product Development, Product Development
`Engineer; Responsibilities included product and process development of GLASCAD exterior
`sheathing. Promoted to supervisor of several projects. Promoted and transferred to Toronto to
`implement T&D function. Developed and conducted numerous sales, management and technical
`training courses across Canada.
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`Education:
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`1974 — 1978
`1992 — 1995
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`University of Toronto B.Sc, Mechanical Engineering
`University of Toronto MSc Biomedical Engineering (1 course outstanding and not completed
`due to relocation to US)
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`Outreach Activities:
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`ISO TC 84 — Vice Chair & Working Group Convener WG15, Visiting Lecturer Tufts University
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`Hobbies: Skiing, cycling, hockey, curling, reading, traveling, hiking, swimming, soapstone carving
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`References.‘ Available upon request
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`CVPaul Jansen, PE
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`3 of 3
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`PTX-692.0003