UPS – GDP - CEIV September 21st, 2016 HPCLC

Healthcare Compliance at UPS UPS Healthcare Introduction UPS and Regulatory Compliance GDP CEIV

Building the logistics of healthcare at UPS UPS acquires Livingston Healthcare Services UPS opens healthcare campus in Burlington, ON Healthcare Strategy develops Temperature True UPS opens healthcare distribution facility in Roermond, the Netherlands UPS acquires Pieffe in Italy UPS acquires CEMELOG in Hungary UPS opens UPS Packaging Center in Venlo, NL Select Healthcare Milestones UPS opens healthcare distribution campus global air hub UPS opens healthcare distribution facility in Puerto Rico UPS opens healthcare distribution in Asia UPS expands suite of shipping solutions for healthcare customers, including UPS Proactive Response® UPS acquires Polar Speed in the UK and Poltraf in Poland UPS started our focus on the Healthcare sector in 2000 with the acquisition of a Canadian company called Livingston. Overall it has been a long 14 year journey in expanding our HC Compliant footprint, adding Healthcare expertise, and adding capabilities especially around temperature sensitive shipping. But our story in Europe has been a bit different. For us here it started in 2010, only 4 short years ago…and it has been an intense 4 years for some of us. From 1 (40K sm) Healthcare compliant facilities to 14 (>130k sm) Through organic efforts and through the acquisition of 3 great companies that have local knowledge and a strong culture. Launched UPS Temperature True – containing Temperature sensitive AF and Ocean freight services (including the innovative PP360 Active container) Launched Proactive Response – A proactive monitoring and intervention service for HV and Thermal passive systems Created Healthcare dedicated sales and solutions teams – to understand requirements better We have expanded our capabilities in Europe to move Biologics and dry ice to 11 new countries in Europe now serving 50 countries And although we are proud of these accomplishments we know we have more to do, customers have told us so; Need to better align our strengths with customer needs to maximize value Need to be more flexible during solution development And we take these seriously…and will continue to listen and focus on delivering value.. 2001 2005 2006 2008 2009 2010 2011 2012 2013 2014 2015

Healthcare Services Overview Our specialized distribution, customer care and transport solutions allow you to maximize supply chain efficiency, meet regulatory requirements and protect your products from temperature excursions. Warehousing 49 global locations Over 6 million sqft GDP & GMP licences Temperature control Inventory management Labelling and kitting Order to cash services Product verification Small Package • In-Room Delivery • UPS Proactive Response • UPR Secure • Temperature loggers • Signed Document Return • Temperature Sensitive Packaging • Preferred Customer Associate Program Returns Portfolio Freight Forwarding UPS Temperature True Quality assurance Temperature loggers Temp. Sens. Packaging (active/ passive cont.) Proof of performance reporting Cooling and re-icing Contingency planning Network of control towers

Healthcare Compliance at UPS UPS Healthcare Introduction UPS and Regulatory Compliance GDP CEIV

UPS & Regulatory compliance Robust Healthcare Quality System for 3PL and Temperature True, implemented globally Continually monitors the evolving healthcare regulatory environment for impact on UPS as a 3PL and a transportation provider Collaborating with healthcare clients, anticipating changing needs and expectations Evolving regulations and their interpretation continue to challenge UPS, Pharma Shippers and the industry

Healthcare Compliance at UPS UPS Healthcare Introduction UPS and Regulatory Compliance GDP CEIV

Good Distribution Practices (GDP) is one of GxP The purpose of the EU Good Distribution Practices (GDP) is to ensure control over the distribution chain to maintain the quality and integrity of the distributed medicinal products.

Healthcare Compliance Culture GDP Healthcare Compliance Culture People Process Premises Proof Quality System Training People Clear and Specific operating procedures and quality system SOPs Ensuring our facilities meet a standard – sanitation and pest control, segregation, special handling and processing areas, temperature monitoring and control as required Evidence to support all the activities (documentation, self assessments, quality agreements, contracts, qualified vendors etc.)

GDP Compliant Space Active container charging area Container handling system Temperature control monitor Temperature registration system

GDP UPS provides multiple modes of transportation for the Healthcare industry In 2007 UPS Healthcare Strategy launches a Healthcare exclusive forwarding product – UPS Temperature True Healthcare Compliance oversight established Dedicated team devises, implements and governs the UPS Temperature True Quality System This team supports all UPS transportation products on Healthcare Compliance matters How best to or should UPS pursue GDP certification?

Healthcare Compliance at UPS UPS Healthcare Introduction UPS and Regulatory Compliance GDP CEIV

CEIV Challenges For providers with formalized systems in place, is a validation warranted Clients aren’t demanding a certification How widely will the validation be accepted Will possession of the certification displace client audits Scalability For providers with multiple locations – may struggle with cost / benefit or ROI Cost of maintaining the certification Benefits Based on GDP, IATA and Pharmaceutical engagement Rigorous program Aligns stakeholders in the supply chain Defines a consistent standard that can be duplicated globally Provides the model for supply chain partners that do not have a formalized program Existing programs are improved or validated Provides confidence for the healthcare industry that is looking for leadership in transportation