BIO PHARMA & HEALTHCARE DIVISION CAPABILITIES & IQP PARTNERSHIP

CAVALIER PHARMA LOGISTICS VISION

● Cavalier Pharma-Logistics is a trusted and critical service provider to pharmaceutical companies engaged in the movement of pharmaceutical products.

● We excel in the global shipping of time and temperature-sensitive drugs, clinical trial supplies, vaccines and dangerous goods.

● Through our specialized services and attention to detail we provide unique customer specific solutions enabling our customers to have peace of mind and visibility to there supply chain and product while in our care.

CAVALIER PHARMA LOGISTICS VISION

● To be a Global Service Provider of choice.

● Provide logistics competency to the pharmaceutical industry.

● Help our customers create and sustain a valuable advantage within their industry.

● To seek the ultimate goal of providing added value and mentoring long term business partnerships.

WHAT IS DRIVING TODAY’S SUPPLY CHAIN, THE GLOBAL INDUSTRY TRENDS AND WHAT ARE THE GEOGRAPHICAL CHALLENGES?

Cavalier offers a clear and precise strategy when handling your global clinical logistics.

● Our goal is to improve your supply chain efficiencies.

● Cavalier seeks and develops practices that minimize cost and risk.

● We understand Global Regulation and know how to deal with issues and processes around the world.

● Cavalier knows the critical requirements of being a good clinical supply chain partner.

A SUSTAINABLE COMPETITIVE ADVANTAGE

INTRODUCTION TO IQP

The ORCA system has been introduced as a reusable logistics asset within the IQP certification scheme

● Offers GDP compliance

● World class temperature controlled distribution performance and operational simplicity.

● The Intelsius Qualified Partner (IQP) certification program provides a quality management framework that will enable you reuse the ORCA with assurance and maximize the performance of your logistics asset.

● The Qualified Intelsius Partner Program is designed to enable maximum performance from your ORCA systems every time.

● Giving our customers, confidence that their payload will arrive intact every time.

● A turn key cold chain solution delivers on time and at temperature !

COMPARISON

PROPOSITION TO THE MARKET

• Traditionally packaging and logistics have been considered as separate purchases.

• This has led Pharmaceutical companies controlling the packaging assets and then outsourcing the movement of the product.

• In order to get the benefit of the higher performance and cost savings, the ORCA must be reused – this means someone has to take charge of tracking and managing the asset.

• Pharmaceutical companies do not wish to do this, but it suits the core competencies of logistics companies.

THE BENEFIT OF THE IQP

Partnering in the IQP ,we can assuage any quality fears within pharmaceutical companies that are natural when outsourcing activities.

• The IQP now offers a new solution to old problems.

• The program offers benefit from economies of scale

• By performing the process for multiple companies we gain benefits they cannot achieve individually.

CAVALIER PACKAGING SOLUTIONS

ORCA°

CAVALIER PACKAGING SOLUTIONS: TECHNOLOGY

• Vacuum Insulation Technology (VIP) A vacuum insulated panel (VIP) is a form of thermal insulation consisting of a nearly gas-tight enclosure surrounding a rigid core, from which the air has been evacuated.

• Advanced Plant-based Phase Change Material (PCM) A phase-change material (PCM) is a substance with high heat fusion which, melts and solidifies at a certain temperature, capable of storing and releasing large amounts of energy. Heat is absorbed or released when the material changes from solid to liquid and vice versa.

• Thermochromic Labels Thermochromic is the property of substances to change colour due to a change in temperatures.

CAVALIER PACKAGING SOLUTIONS: ADVANTAGES

● Outperforms the competition every time

● 2-8° C / CRT / -80° C available

● ISTA Certified Laboratory

● Qualified against all recognized thermal challenges

● Smart inventory

● Universal pack-out

● Thermo chromic Labels to show ready to use

● Packing instructions printed inside every lid

● 3D Barcode to get packing instructions through smart phone

● Reusable solution

● IATA Time & Temperature Label pre-printed

CAVALIER PACKAGING SOLUTIONS: ADVANTAGES

● Outperforms the competition every time

● 2-8° C / CRT / -80° C available

● ISTA Certified Laboratory

● Qualified against all recognized thermal challenges

● Smart inventory

● Universal pack-out

● Thermo chromic Labels to show ready to use

● Packing instructions printed inside every lid

● 3D Barcode to get packing instructions through smart phone

● Reusable solution

● IATA Time & Temperature Label pre-printed

BIO PHARMA HEALTHCARE SERVICE CENTER The cGMP storage and distribution facilities located in Maryland and Los Angeles are temperature controlled with Validated Controlled Ambient Temperature Storage (15°c – 30°c) of Scheduled Pharmaceuticals, Reagents, Life Science.

• Validated -20 °c and -80 °c uprights.

• Validated 2 °c to 8 °c & ambient storage

• 43,000 square feet secure pharma grade facility.

• A 100kVA natural gas generator provides redundant power.

• Three kit assembly rooms for specific packaging.

• Operating the facilities under cGMP guidelines, 21 CFR Parts 210-880

• Supported by audit ready SOPs for all processes.

• The Maryland facility is licensed by the DEA for storage of Schedule 3-5 Pharmaceuticals.

• Over 1,000 icage pallet positions.

THE

● The Pharma Logistics Network has been established by industry professionals to meet the growing and recognized need for a truly professional Global Association of specialist forwarders where capability, resources, and infrastructure are in place to meet the most demanding client needs in the Pharmaceutical Industry with particular emphases on Bio Pharma Cold Chain requirements.

● There will be just one accredited and approved member in each major strategic location and beyond to ensure that the Pharmaceutical Industry has a truly independent, focused, and specialized core of Forwarding Companies that don’t just say “yes we can do this” but have the experience, dedication, and credentials to do the job and have met an exacting membership criteria.

GLOBAL PLATFORM

A consistent approach to cold chain distribution based upon a global platform

CAVALIER PHARMA NETWORK:

CO

LD C

HA

IN L

OG

ISTI

CS • Temperature

Controlled Solutions

• Multi use package lease

• Clinical Trial Logistics

• Pharma IT Platforms

GLO

BA

L C

OM

PET

ENC

Y

• Cold Chain Services

• Dedicated support teams

• GxP Protocol and Process

• Global Visibility

WA

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SE

• Regional Cold Chain facilities

• Pharma Logistics trained experts

• Pharma Grade Cold Storage GMP

• Risk Management competencies

• Global Footprint

GLO

BA

L FO

RW

AR

DIN

G S

PEC

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• Pharma specific SOP library

• Dedicated Process

• Dedicated People

• Data Device Option

• Validated packing solutions

A consistent approach to cold chain distribution based upon a global platform

GOOD DISTRIBUTION PRACTICE (GDP)

● Applies to all drugs including active pharmaceutical ingredients, excipients, intermediates and finished goods.

● The pharmaceutical industry operates at a high level of quality assurance, achieving specific objectives by observing Good Manufacturing Practice.

● Policy ensures that products released for distribution are of the appropriate quality.

● With such protocol in mind, a level of quality exists throughout the distribution network so that authorized medicinal products are distributed without any alteration.

● With this in mind we can acknowledge the intricacies of this practice and demonstrate our complete understanding of parameters, required to be a considered reliable and trustworthy resource for the transportation of pharmaceutical products.

THE CAVALIER SEVEN PILLARS OF GDP ST

AB

ILIT

Y

Storage Temperature

Shipping Temperature

Testing to support

temperature for

distribution

DIS

TRIB

UTI

ON

CO

NT

RO

L M

AN

AG

EMEN

T

Qualification Training

Premises & Equipment

Material Handling

Storage & Inventory Control

Transport

Product Distribution

Protection

Exception

PER

FOR

MA

NC

E M

AN

AG

EMEN

T

Reporting Metrics

Self Inspection

Review Meetings

Supply Chain

Partner Management

SELE

CTI

ON

Quality Audit

Quality Agreement

SOP

Continuous Business Review

QU

ALI

FIC

ATI

ON

VA

LID

ATI

ON

Passive Ship systems

Ambient Temp Profile

Active Ship systems

Facility Qualification

WMS validation

Distribution Validation

Plan

CO

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OU

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PR

OV

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Industry

Regulatory

Validation

IMP

OR

T &

EX

PO

RT

CO

MP

LIA

NC

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Customs

Document Control

Track & Trace

CAVALIER BIOPHARMA & HEALTHCARE LOGISTICS: PROCESS MANAGEMENT

● We assist with the development and implementation of complex multi-country pharma logistics solutions

● With infrastructure in place we ensure and support outstanding customer service to our global customers at all times

A group created to work toward and demonstrate core competencies in Strategic Account Management.

CAVALIER CONCEPT: THE KEY SUCCESS OF OUR PROGRAM

● Worldwide functionality

● A dedicated Cavalier Manager to serve customer requirements

● A clearly defined and agreed-upon process for customer development and management

● A pro-active approach, with a strategic focus on Client relationship

● Over 50 years of industry specific expertise

● Leveraged by a value driven process

● Strong link to operational excellence

WHY CAVALIER?

● By reviewing best practice and implementation of agreed upon logistical solutions we add significant value through: › Thought Leadership

› Solution design and optimization

› Investment in tools and techniques that provide efficiencies of scale and savings

● The Supply Chain technology we have invested in enables us to provide to you a best in class global service.

Cavalier Logistics enables our customers to concentrate upon their day-to-day business and competencies.

CONTINUOUS PERFORMANCE MANAGEMENT

● Manage Customer Satisfaction

● Deliver Value through Customer Focus

● Report Management

● Agreed KPI Review

● Continuous Process Improvement

Cavalier Logistics offers customer-specific program management. It is a globally integrated solution, designed to focus on the delivery of critical information.

SUPPLY CHAIN METHODOLOGY

A call, email, online booking or fax is received requesting a collection. At this time we are given the pieces, weight, dims, and final destination

The paperwork is received with the full information including the

temperature requirements - HAWB is updated. The booking is made

with the Preferred Airline AWB ETD ETA & Cut-off at airline confirmed

The special temperature handing instructions of the shipment is

noted on the MAWB. Export Alert is sent to the local office that is

clearing the shipment. The export alert includes: header, MAWB,

manifest, HAWB Invoice

On Green Light notification Driver dispatched to Origin to pick up

shipment

Shipment tendered to the airline for the flight prior to cut-off

1 hour after flight departure, a check is done with the airline to confirm shipment departed on intended flight and shipment

departed as booked

Local office/partner confirms arrival of shipment with the airline, and any special handling/storage instructions are being followed as

specified on the airline AWB

After customs clearance, the shipment is collected from the

airline warehouse

Depending on cold chain instructions, the shipment is either returned to the destination office

for processing or delivered straight away

Shipment sent out for delivery

LONG TERM PARTNERSHIP: COLLABORATION

● We know you expect the best and we aim to please.

● We are proud to have earned a reputation for being flexible to our customer needs.

● We achieve this by listening to and working with our customers.

● Open and trusting relationships only strengthen the success of such endeavors.

● Our goal is to develop flourishing business relationships.

Our commitment is simple but focused - We firmly believe in healthy partnership. We concentrate on competencies that enhance our ability to be a competitive logistics provider.

CAVALIER : CONTACT INFORMATION

Stephen D. Winyard e: swinyard@cavlog.com t: +609 954 4409 Robbie Neilson e: rneilson@cavlog.com t: +703 733 4010 Clifford W. Wyllie e: cwylllie@cavlog.com t: +301 252 2222