Quotation No. L150073 - test - Contact

Quotation No. L150073

September 9th, 2015

For

AAI/CML Pharmaceuticals 2320 Scientific Park Drive

Wilmington, NC 28405

To the attention of: Aaron Turner Email: [email protected]

Phone: (800) 575-4224

Vial Line - Cartons Laetus S-TTS Serialization Solution

Your contact for Laetus is: Chris Nerreau

Telephone: (973) 983-2700 Fax: (973) 983-2711

Mobile: (804) 564-2207 Email: [email protected]

AAI/CML Pharmaceuticals September 10th, 2015

Quotation No. L150073 of 16

Executive Summary

AAI/CML Pharmaceuticals requires a solution which provides serialization of carton unit of sales to the pallet level on a vial line located at the Wilmington, NC facility. Carton Unit of Sale (Serialization & Pre-printed)

Serialization of carton unit of sale.

Aggregation of serialized carton to bundle

Aggregation of serialized bundles to cases.

Aggregation of serialized cases to pallets.

_ _ _ _ _ _ _ _ _ _ _ _

The proposed Laetus Secure Track and Trace solution (S-TTS) will contain a Laetus PLANT site level management solution. This PLANT site level solution will be installed and reside on a AAI/CML Pharmaceuticals provided hardware server platform. The Laetus PLANT site level solution will communicate with a Laetus supplied LINE level controller hardware and software platform. The LINE level controller will distribute data across Laetus supplied industrial PC controlled camera systems and or any manual packing stations that host Laetus ‘unique CELL technology and software.

Batch, recipe, and serialization criteria will be prepared in the Laetus PLANT site level management solution and downloaded to the Laetus LINE management controller. Upon batch start the Laetus S-TTS software will perform the aggregation of carton unit of sales to the pallet level.

Company Overview

Laetus GmbH belongs to the Coesia Group, being a family-held industrial group having a broad multinational portfolio. This portfolio consists of business units in the packaging, printing, and packaging security industries making Coesia a leading provider in different packaging sectors throughout the world.



Food and beverage;

Cigarette assembly and packing;

Chemical

Hygiene disposables packing;

Cosmetics

Printing and packaging security systems, vision inspection and track and trace systems for the pharmaceutical and cosmetic industries;

Gears and transmissions for high performance applications in the automotive industry;

Conveying & material handling

Fig. 1 The Coesia Group companies

Coesia has manufacturing factories in 9 countries (Italy, France, Germany, Spain, Sweden,

Switzerland, China, USA, Brazil), and a total of 36 operating units worldwide, and a turnover in 2014 of $1.4 Billion, with a total of 6000 employees.



Fig. 2 Coesia Worldwide

Laetus Vision

For more than 40 years, Laetus' objective has been to work with the pharmaceutical industry to

improve patient security when using pharmaceutical products. Our focus in this regard is on the first component that patients encounter—the packaging. We use ultra-modern technology developed in accordance with GMP standards to guarantee the quality and the identity of pharmaceutical packaging. By ‘Identity’ we mean that the packaging, package insert and pharmaceutical product all go together. Whether primary or

secondary packaging, mix-ups and quality defects must always be detected and prevented. Our range of services covers development, consultation, implementation and on-site services. This is the ideal foundation for providing all-inclusive turnkey solutions, and helps us achieve our overall objective of providing streamlined collaborative support for our customers. Christoph Staub, Managing Director of Laetus GmbH, believes that “our customers’ loyalty continually motivates us not only to create innovative developments, but also to provide

uncompromising reliability. Complete control is not achieved until every last risk has been detected and averted. Our mission ‘in Laetus vertitas’ therefore reflects our commitment to maintaining an open, honest relationship with our customers and continually reviewing our services.”



“With six branches around the world, our company’s international presence guarantees comprehensive support for our customers; from the initial planning discussion to assistance during the production stage, through to service and support during operations.” Whether through its own branches or its contract partners, Laetus is a reliable partner in any global location in which products are produced in line with the GMP standard.

From simple checks of the packaging identity through to complete track and trace solutions that monitor the security of pharmaceutical products from the production stage to their use by patients, the Laetus product range fulfills all the necessary requirements for ensuring the security of pharmaceutical products and their packaging.

Laetus Worldwide

Fig. 3 Laetus worldwide

Within its organization, Laetus established in 40 years a fast and efficient worldwide customer support, from order handling, production, installation, training, after sales services, to the hotline. The experienced Laetus team works worldwide “hand in hand” to ensure a seamless flow of information, material and knowledge. Seeing our customers as a partner we deeply involve them into our organization, giving the best and excellent support worldwide, nearly everywhere in the local language. Frequent training of all Laetus employees guarantees that everybody is

always up-to-date to provide the best service we can offer. Where Laetus or Coesia are not directly present with local subsidiaries, we are working together with distributors and agents. Most of them are cooperating for decades with Laetus and are offering also an experienced technical support for the Laetus equipment and solutions. Find more information about Laetus worldwide at



http://www.laetus.com/en/service/contact-us/laetus-worldwide.html

Project Statement

This proposal is to meet the AAI/CML Pharmaceuticals requirement for serialization and aggregations of carton unit of sales to the pallet level on packaging Line. The offered S-TTS

solution also includes the requirement for pre-printed cartons. The following offer is based on a site visit that included an overview of the packaging line, and a discussion concerning the serialization requirements. An AAI/CML Pharmaceuticals generated URS has been received and reviewed by Laetus for this project.

Laetus System Architecture

With its modular design, the Secure Track & Trace Software (S-TTS) meets all requirements of international product traceability regulations. Our 3-level system

architecture starts with the control of a single CELL followed by multi-level aggregation through the complete packaging line, all the way to warehousing. S-TTS is ready to cope with all requirements and can easily be configured and adapted.

PLANT Management Software / Business Infrastructure (Level 3)

PLANT management is the highest software level of Secure Track & Trace System (S-TTS). It hosts the main S-TTS database containing among others production data, device formats, line configurations, and recipe management. S-TTS PLANT is the point of manual order creation or gateway to automatically order data from an ERP System. User management functions are also located on the S-TTS PLANT level with the option of connectivity to active directory integration. Serial codes generated internally or provided by third parties such as SAP or China code lists, etc. is maintained in the embedded code pools.

LINE Management Software (Level 2)

LINE software controls configurations, CELL synchronizations, multi-level aggregations and re-work procedures. Order data and lists of serial codes for the complete LINE configuration are supplied by the PLANT software and sent to the packaging LINE management. The serial codes are stored on the LINE together with the order data. The LINE manager distributes codes to the CELLs, where the codes are verified and sent back to the LINE with their verification result and status. At the end of an order, all codes used are sent back to the PLANT, together with

http://www.laetus.com/en/service/contact-us/laetus-worldwide.html



statistics, counters and the aggregation list. This level enables easy management of multiple batches and ensures secure productivity. As batch data and serial codes are stored at LINE level during production; execution of batches is independent from network connectivity to the PLANT. Upload of batch data to the higher PLANT level can occur at the end of batch or while the batch is still running depending on requirements.

CELL Management Software (Level 1)

CELL management offers flexible solutions for packaging processes. The software utilizes predefined CELL types combining the benefits of fast and easy integration with defined standard qualification procedures. At this level marking, identification, verification, checking and aggregation of the products takes place with the list of codes sent from the LINE manager.

*** For further information on our system solutions please ask for your copy of our document

“Laetus_SecureTrack&Trace_Technical Information.pdf”. In this document you will find answers to all of your Track & Trace system requirements. ***

Laetus Supplied Hardware

Commander 312

The Commander Operator panels offer easy user interfaces with

PC hardware in a compact and efficient unit. The high resolution touchscreen ergonomic design offers extremely reliable operation. The Commander’s hardware allows it to act as a Line Server in addition to a standard general purpose HMI.

Compact Controller

The compact controller processing device is an industrial PC that offers state of the art hardware that runs Laetus multipurpose software applications for reliable and high speed performance needed on modern packaging lines. With offerings up to Intel core i7 processors, Laetus can supply the right hardware for any application. These compact industrial units also act as the backbone for our cell architecture by providing a hardware platform for a software cell level.



iCam Cameras

Laetus iCam camera systems are designed and optimized for the inspection needs in a packaging process or production line. The iCam is perfectly suited to identify defects at the highest

production line speeds. With a wide array of camera resolutions available and rapid digital picture technology allows for the perfect solution for every inspection use. These cameras have a wide variety of applications such as multi-line OCV/OCR, 1D/2D inspection with verification, and data comparison of barcode and human readable text.

MV-70 Compact Carton Marking Conveyor

Mark & Verify pack handling system with classic top / bottom conveyor. The MV-70 pack handling system is the perfect solution to prepare a packaging line for almost any required marking of folded boxes. It can also be hand fed. The flexible design allows the use of multiple marking technologies within just one machine. The machine can be configured for up to two printing positions (front, back side), with simultaneous use. The

MV-70 is very compact, allowing it to be easily integrated into existing lines or used in a hand pack operation.

CS-60 Commander Station

The CS-60 is a mobile work station for data input and data output, and can be supplemented with various printers, hand scanners, IPC Systems, and a stack light indicator light pole. The front of the work station has a compartment to house a hand scanner device, and there is a storage compartment on the backside for supplies such as label rolls and printer supplies. The working area has enough work space for manual packing operations, and a table top printer. Being casters are incorporated on the work station; the work station can be located or moved to different positions in the manual packing area,



IM-400 Automated Manual Aggregation Station

The IM-400 mobile manual packing station from Laetus is a variable solution for aggregation as well as de- and re-aggregation on the packaging line, in the warehouse or in the delivery chain for such purposes as repackaging.

It comes with a scanner surface for multiple or single code entry, as well as a hand scanner that can read both individual product codes and label codes for the aggregation list. The IM-400 convinces with its ease of integration into the Laetus Secure Track & Trace solution. It shines with a secure, timely data flow into the current data systems of all well-known manufacturers, ensuring up-to-date data at all times



Laetus Solution Pricing SW: Software HW: Hardware SER: Services

PLANT Enterprise License (Level 3)

Description Qty. Unit Price Total Price

PLANT Level Management Solution (Level 3)

S-TTS PLANT enterprise License

Laetus USC extended number generator

Multi line production

SQL Server License

SW N/C

N/C

Installation on non-Laetus server hardware with basic configuration.

SER

Documentation set SER

Validation services SER

Subtotal PLANT Level Solution N/C

Installed on customer hardware, required once per site.

One software installation on server included

Can be interfaced to enterprise system in the future, optional.

Single LINE Server (Level 2)


LINE Level Management Solution

S-TTS LINE Enterprise License

Serialization/Aggregation

Rework

SW $44,987 $44,987

Documentation set SER

Validation Services SER

Subtotal LINE Level Solution $44,987

One required per packaging line.



MV-50 Top Printing TIJ Carton Marking Conveyor (CELL 1)


MV-70-C Carton Marking Conveyor

PrintSpect MV-70-C (Type B) Carton Marking Conveyor Complete with Integrated Coder HR Jet Printer.

HW $102,028 $102,028

Coder HR Jet Print Driver & Artwork Software SW

Commander HMI, wt28c, Camera, cables, HW

Barcode & OCV/OCR Dongle license SW

1D/2D Handheld Scanner (Wireless), incl. base station, USB cables, power cables.

HW

UPS DC24V, 6A, USB, Industrial Ethernet 8 port Switch

HW

Standard Line Control Bundle, incl. Disk Cloning tool, Remote Access, USB memory Stick, 2x Ethernet cable

HW

Documentation Set SER

Engineering Services SER

MV-70-C Machine Price $102,028

IMV CELL Carton to Bundle Aggregation (CELL 2)


Automatic Bottle to Bundle (Auxiliary Code)

IMV-370 Carton to Bundle Aggregation Unit with eject bin

HW $233,269 $233,269

IMV CELL software, OCV/OCR, barcode, camera software tools.

HW

Commander 132M HMI, Cell & Inspect hardware controllers, 1 x icam, 2 x wt880 Cameras P/S, Ethernet switch, cameras, cables, complete mounting hardware for HMI and Cameras. 1D/2D Handheld Scanner (Wireless), incl. base station, USB cables, power cables.

HW

Cabinet on Wheels (1000mm x 600mm x 300mm)

prepared for mounting of components, internal & external connections

HW

FlexLink Conveyor with Plexi Cover HW


Subtotal Automatic IMV Solution Bundle $233,269



Bundle to Case to Aggregation (CELL 3)



CS-60 Hand Packing Station, Commander 312S Touchscreen monitor, mounting brackets and cabling

HW $50,667 $50,667

Zebra Printer 110xi4, Nice Label Suite HW

Wireless Hand Scanner HW


CS-60 Engineering Services SER

Subtotal Commander Station Solution $50,667

Case to Pallet Aggregation (CELL 4)



CS-60 Hand Packing Station, Commander 312S Touchscreen monitor, mounting brackets and cabling

HW $50,667 $50,667

Zebra Printer 110xi4, Nice Label Suite HW

Wireless Hand Scanner HW Documentation Set SER

CS-60 Engineering Services SER

Subtotal Commander Station Solution $50,667

AAI/CML Pharmaceuticals Engineering Investment


AAI/CML Pharmaceuticals Total S-TTS Site Engineering

Engineering Services SER $64,000 $64,000

Total S-TTS Engineering Investment $64,000

Laetus requires a separate purchase order number for engineering services.



AAI/CML Pharmaceuticals Total Investment (Level 1 & 2)


AAI/CML Pharmaceuticals Total S-TTS Investment

LINE Level (Level 2) SW $44,987 $44,987

CELL 1,2,& 3 (Level 1) SW/HW $342,198 $436,631

Total S-TTS Investment Line (Level 1 & 2) $481,618

Laetus Options

Go Live Support


Go Live Support

Go Live support for production start-up period (1 shift per day)

1 $1,500. $1,500.

Project Assumptions

The customer will nominate a site technical Project Manager who is familiar with the facility and processes. This person will be the single point of contact per site for the Laetus Project Manager and Service engineers.

The customer will ensure that all necessary site requirements; such as power supply,

cabinet space and workspace; are available and ready prior to the start of Laetus site activities. For the period of the installation of the system the customer will ensure unrestricted availability of the machine as well as sufficient sample material for all relevant formats needed for testing.

The customer will handle the necessary hardware modification for electrical & mechanical modifications on the existing machines. These machine modifications must be completed prior the Laetus site installation. Any necessary firmware updates

on existing machines / devices shall fall under the responsibility and be performed by the customer. Laetus is responsible for its scope of supply, and not responsible for third party hardware or software.

The required hardware for PLANT Control will be provided by the customers IT support.

The offered software for PLANT and LINE Control will be installed and configured by

Laetus.



Expenditures which go beyond two (2) standard format changes within the documentation are invoiced to the client separately.

Changes in machine arrangement (mill, saw, weld, etc.) are to be made by the

customer. The acquirement of additional machinery or format parts falls under the responsibility of the customer.

Expenditures for which Laetus is not responsible (e.g. waiting periods, repeat travel time, etc.), will be invoiced to the customer separately.

Project management costs and other services are calculated based on assumptions and may be subject to change during the project planning phase after receipt of order.

The Project will be executed according to a mutually agreed Project Plan & Quality Plan.

The customer will ensure that required machine modifications and information requests identified / created by Laetus during the Design Phase will be made / provided by the involved OEM machine suppliers. This means for example required machine IO Signal information from/ to the Laetus system. The customer shall provide the contact details of the responsible contact person at the OEM.

In case of S-TTS testing of the PLANT level software (pre FAT, FAT) at OEM site,

customer IT provides to OEM site the necessary test environment which Laetus can use free of charge during the tests.

Any changes to the production line, new brackets, and alterations to frames that are required for the operation of the system will be the responsibility of the customer. The costs for such engineering will be borne by the customer and all such engineering work will be completed prior to the arrival of the commissioning engineers.

Before the start of the project, all necessary drawings of all potential types must be provided by the customer. This must be done within 2 weeks after date of order confirmation.

Sales Terms

Pricing

The above prices are in US Dollars.



Validity

60 days, thereafter Laetus. Reserves the right to modify prices and deliveries quoted.

Delivery Conditions

FOB Allentown, PA (Not to exceed $5,000)

Delivery Date

Estimated 4-5 months after full execution of this agreement, receipt of order, down payment, signed functional specification and clarification of all technical and commercial information.

Payment

30% upon execution of this Contract and placement of purchase order 30% upon completion of design PID and layout drawings, net 30 30% upon shipment or shipment ready to shipment, net 30 10% upon installation completion, net 30 *New Customers Only: Above payment terms will be pending credit approval subject prior to order acceptance. Please submit a bank reference as well as three trade references.

Orders

Laetus requires that our customers’ issue an original signed approved Purchase Order that references the Quotation No. and pricing. All purchase orders should be mailed to:

Flexlink Systems Inc. d.b.a. Laetus

335 Chambers Brook Road Branchburg, NJ 08876

** Only upon receipt of original purchase order will processing be finalized.



Other

Samples of all packaging materials for this application will be required to determine feasibility of the project with the above quoted components.

Signatures

____________________________________ Jeff O’Neill

Quotation No. L150073 - test - Contact

Documents

Transcript of Quotation No. L150073 - test - Contact