REGISTERED OFFICEHaemopharm Healthcare S.r.l.I - 23035 Sondalo (SO)Via Stelvio, 12

HEAD OFFICE/FACTORYI - 23030 Tovo di Sant’Agata (SO)Str. Provinciale per Vervio, 8TEL +39 0342 771017FAX +39 0342 771018info@haemopharm.it

COMMERCIAL OFFICEI - 20135 Milano (MI)Viale Lazio, 26TEL +39 02 5513513FAX +39 02 55191982haemopharm.it

innofamily since 70’sa Paolo Gobbi Frattini CompanyHAEMOPHARMTM

innofamily since 70’sa Paolo Gobbi Frattini CompanyHAEMOPHARMTM

Haemopharm: Unique in its field

Milestones

CE Marks

Patents

Trademarks

Brand Essence - Strategic Guidelines

The ability to innovate and compete globally

Competitive assets - Certifications

Products overview

Contract Manufacturing Production Services andConsultancy & Customized solutions

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Index

Haemopharm is a pioneer company in the manufacturing and commercialization of flexible bags for sterile solutions and for dialysis. Asserting itself among the leading companies in the international market, it offers a wide range of innovative PVC and PVC-free bags and components for the infusion field, entirely designed by the company. Born in the 70’s, on the foundations of the Gobbi Frattini family company, and already present in the medical devices field, Haemopharm owes its success to a balanced synergy between its coherence to its own values, linked to tradition, and its constant impulse for innovation. Today, Haemopharm continues to invest in research of new technologies, and is present in the critical care, life sciences, drug administration and specialty care fields, through the development of new patented systems for drug delivery.

Haemopharm is a globalized company, present in more than 23 countries including Germany, Spain, UK, France, Switzerland, USA, Canada, Australia, Saudi Arabia and Korea, importing raw materials mainly from the USA and the Netherlands.

Haemopharm’s emphasis on excellence has differentiated it in the marketplace. This is evident in all aspects of the company, from superior quality control, a must for Haemopharm, its proprietary software that continuously monitors the essential production parameters of the automatic lines, through high quality flexible bag manufacturing for many medical applications and bag filling with fluids, and finally, to its specialization in the stem cells collection field.

“From industrial research, to treatment”: Haemopharm is a unique entrepreneurial structure, due to its Clinical Division, the St. Agatha Medical Center, which faithfully represents the company’s DNA and its natural tendency for a tight collabora-tion with the medical-scientific world.

Haemopharm:Unique in its field

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Renzo Gobbi Frattini

The Family Company starts its activity as a forerunner in the automatic production of medical devices

Constitution of the Paolo Gobbi Frattini Company

Production Site license authorization for Medical-Surgical systems defined "Plastic Infusion sets for infusion and dialysis solutions", N. 800.5.OFF.820.3704

Commercial office establishment in Milan

Ministry of Health Registration N. 15.828 of Combiset 2G, Infusion Set for infusion and dialysis solutions

Production site licensing for Medical-Surgical systems "Plastic containers and tubular systems for infusion solutions, dialysis solutions, blood, and blood derivatives" N. 800.5.OFF.820.2525

Ministry of Health Registration N. 14.928 of the Medical-Surgical empty bag system Autobag for infusion and dialysis solutions

Ministry of Health licensing N. 35243 for thecommercialization of infusion and dialysis solutions listed in the national galenic formulary

Ministry of Health licensing for the commercialization of the cumulative package 001 AC PRIMINGLineTM

Na-Cl 0.9% solution in double bags for priming inhaemodialysis, and infusion set Combiset 2G

Marketing Authorization licensing by the Ministry of Health for infusion and dialysis solutions packaging in bags, glass bottles and vials

Haemopharm Healthcare S.r.l. company constitution

Extension (900.2/16.SO.7.3934) of the Ministry of Health registration N. 14.928 of the Medical-Surgical empty bag system Autobag for drug reconstitution, called SHARPbagTM

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1978

1985

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1988

1989

1993

1995

1996

1997

Milestones

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Extension (900.2/16.SO.7.3934) of the Ministry of Health registration N. 14.928 of the Medical-Surgical empty bag system Autobag for peritoneal dialysis system, called PERILineTM

Ministry of Health Registration N. 14.928 of the Medical-Surgical empty bag system NUTRILine infusion set and bags for parenteral/enteral nutrition

UNI EN ISO 9002 certification, cert. n. 9120.PGBF

Inauguration of the new plant in Tovo di S.Agata (Province of Sondrio)

Establishment of the Biofluids Division, for drug manufacturing and bag filling in Tovo di S. Agata

ISO 9001:2000 certification, cert. n. IT-1562

Marketing Authorizations for hemofiltration solutions in Austria N. 1-26257, 1-26258, 1-26259 e 1-26260

UNI EN ISO 13485:2004 certification, cert. n. 5783-M

Constitution of the pharmaceutical companyQuatalia Science d.o.o. in Belgrade, Serbia

Registration at the Colombian Ministry of HealthN. 2010DM-0005986 of the medical device NUTRILine, infusion set and bags for parenteral/enteral nutrition

Registration at the Venezuelan Ministry of Health N.30061090 of the medical device NUTRILine, infusion set and bags for parenteral/enteral nutrition

Opening of the Clinical Division Medical CenterSt. Agatha S.r.l.

Gold winner at the “CPhI Pharma Awards for Best Innovation 2012” for the product NIV

TM, “Needle free Vial closure system”

1997

1998

1999

2002

2003

2006

2011

2012

Milestones

98 CPhI Pharma Awards Winner 2012

NUTRILine Sterile bag for parenteral and enteral nutrition

PERILineTM Patient set for peritoneal dialysis

SAFE 2TM Bag for cryopreservation of stem cells

Bag for stem cells collection, sterile

COMBYLine, HAEMOLine, FLOWLine, UROLine Medical devices for infusion and transfusion, sterile

Sterile and apyrogenic solutions for washing and irrigation

Solutions for continuous renal replacement therapy, sterile

SANO3 Set for auto hemo-infusion with Ozone, sterile

Breathchoice Double bag for lactose intolerance breath test

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2006

2007

2008

2011

CE Marks

1110

Developed by Renzo Gobbi Frattini

Automatic machine for the manufacturing of medical empty bags

Automatic machine for the manufacturing of infusion sets

Intravenous flow regulation system

Machine for the automatic production and packing of infusion sets (registered under the name Paolo Gobbi Frattini)

Developed by Paolo Gobbi Frattini

PERIGlass, sterile environment connection device for CAPD catheter

SHARPBagTM, bag for drug reconstitution

Connection device for CAPD catheter

HFLine , double bag for hemofiltration

SANO3, kit for oxygen-ozone therapy

Washout, device for wound washing

NIPTM, needlefree connector

BREATHchoice, double bag for lactose intolerancebreath test

FILLchoiceTM dose, bag for dosed drug reconstitution

FILLchoiceTM smart, three-way bag for drug reconstitution

NIVTM, perforable hermetic needlefree closure for Vial

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1982

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1991

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1999

2003

2007

2008

2011

2012

Patents

1312

Trademark registration N. 00685903 UROPoketTM

Trademark registration N. 674438 PRIMINGLineTM

Trademark registration N. MI95C 007726 PERILineTM

Trademark registration N. M216C 009280 SHARPbagTM

Trademark registration N. 003460805 HAEMOPHARMTM

Trademark registration EU N. 009099615 FillchoiceTM

Trademark registration USA N. 3977292 FillchoiceTM

Trademark registration N. 010123602 TissuechoiceTM

by Paolo Gobbi Frattini and Siad Healthcare

Trademark registration N. 010123644 SteamchoiceTM

by Paolo Gobbi Frattini and Siad Healthcare

Trademark registration N. 010485118 NIPTM

Trademark registration N. 010957587 NIVTM

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2011

2012

Trademarks

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In a market globalization scenario, a unique brand development is essential, capable of enhancing the primal core, represented by the institutional logo Paolo Gobbi Frattini Company, as well as by the trademark Haemopharm, always a synonym for complete solutions, innovative and safe, in the flexible bags and drug delivery systems fields.

The essence of Haemopharm is framed in its slogan Innofamily since 70’s, which fully expresses the company’s vocation and the foundation on which it is positioned. An entrepreneurial spirit, constantly oriented towards excellence, in which the innovation capability is the strategic asset of the company for more than 30 years of history. Paolo Gobbi Frattini and his family, owners of 100% of the company, are present and active in the Group, guaranteeing the long term perspective which facilitates commu-nication, accelerates the decision-making procedures and contributes to the client's satisfaction.

“The customer must be confident”. Those simple words express the company’s belief, founded on respect for the individuals in commercial relations, on integrity and on ethical values of a culture deeply rooted towards client orientation, reliability and credibility.

Haemopharm’s success is tightly correlated to its international-ization strategy and to its abilities, being a forerunner in the Flexible Bags field, as well as in their filling. Its expansion is included in a wider growth logic, oriented towards offering a modern and dynamic organization, capable of competing globally and being the first to reach specialist market areas with high quality products.

Finally, the company’s mission is to consolidate its own leader-ship technologically, developing numerous patents and following a sustainable growth, as a partner of choice for big international entities.

Brand Essence

StrategicGuidelines

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The global competitive ability of Haemopharm is an aspect of crucial importance to its customers, who are increasingly sensitive regarding the launch of new partnerships with operators in the sector, who not only can offer an excellent product, but are also able to guarantee an extensive presence worldwide. Haemopharm has developed over the years many strategic commercial agreements, thanks to which it is now present and active in many countries across Europe, North and South America, Australia and the Far East. Particularly in Serbia, it operates with Quatalia Science d.o.o., a pharmaceutical company which completes the Group’s offer, thanks to numerous Marketing Authorizations, especially for oncological treatment, antibiotics and medical devices. With headquarters in Belgrade, it has been established to consolidate local business and to facilitate the emerging markets penetration.

The ongoing process for acquisition of FDA Certifications, necessary for the commercialization of medical devices in the USA, represents moreover an important step in Haemopharm’s development strategy.To imagine, to experiment, to innovate: these are the key words of our Research & Development department, which is continu-ously committed to consolidating strong international relations with prestigious opinion leaders in the medical-scientific field, for the benefit of our patients’ better quality of life. Both Haemopharm and Quatalia have their own Regulatory Affairs departments, in charge of supervising the Marketing Authorization procedures, through dossiers preparation for drugs, and technical files for the CE marked medical devices.

The ability toinnovate andcompete globally

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The competitive advantage, that turned Haemopharm into a solid industrial entity in its field, remains in the possibility to develop flexible bags in different formats, ideal for many pharmaceutical and medical applications.

A high level of specialization, made possible by an exclusive and proprietary technology, qualifies Haemopharm as a leader in the delivery systems field. The modular management of production assures, through an innovative and versatile process, a high product reliability and constant performance levels.

A total quality approach: choosing the best raw materials, manufactured by the leading companies and certified by the biggest international pharmacopoeias, is combined with the production of closed circuit infusion systems. A must in the sector, thanks to which it is possible to perform drug administration in maximum safety conditions, excluding any possibility of external contamination.

All of Haemopharm products are CE marked, since safety is an essential value for the company. Moreover, the company daily gives its full attention to efficacy and quality of its production processes: the parameters of every system are constantly monitored by the proprietary software system for quality control, and all the procedures are UNI EN ISO 13485:2012 and UNI EN ISO 9001:2008 certified. Finally, the productive and analyti-cal stages take place in a Clean Room and controlled environ-ment in many classifications, in compliance with cGMP and with UNI EN ISO 14644-1-2-3-4-5-6-7 procedures, and are constantly verified with audit methods.

Competitive assets

Certifications

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Haemopharm offers a few product categories:

FLEXIBLE BAGS PVCPVC DEHP free PVC FREE MULTI COMPARTMENTCOMPONENTS

STERILE PRODUCTS AND FILLED BAGS DIALYSIS – Device with fluidsENTERAL/PARENTERL NUTRITIONCELL FREEZING PACKSWOUND CARE – Device with fluidsOZONE THERAPY – Device with fluidsDRUG RECONSTITUTION – Device with fluidsCOMPOUNDING PHARMACYINFUSION SETSNEEDLELESS SYSTEMS

COMPONENTS NEEDLEFREE CONNECTORSNEEDLEFREE STOPPERSBREAKABLE CONNECTORSEXTENSION SETS

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Productsoverview

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Another asset of Haemopharm is represented by Contract Manufacturing, intended as a possibility to provide finished products through local filling of bags, making use of a network of partners around the world.

In the course of time, the company has consolidated an innova-tive supply model, which translates into many advantages for the client's benefit. Haemopharm is actually the only company which can offer the combination of specialization in empty bags production of very high quality, and a strong expertise in the finished products marketing at the same time, assuring a significant reduction of logistic costs and delivery times, thanks to the possible availability of local Marketing Authorizations.

The positive correlation between company culture, and achieved performances, is also proven by the capability of offering consul-tancy and customization services.Haemopharm supports its clients from the feasibility assessment, according to the therapeutic requirements, through research and design of special solutions, until their final fulfillment.

The internal management of all manufacturing procedures, from moulds' preparation to sterilization process, is translated moreover into a significant working time reduction and to a bigger flexibility in the prototyping and customized production realization.

ContractManufacturingProductionServices

Consultancy &Customized solutions

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