Updated Joint Environmental Statement

Updated joint environmental statement

in accordance with Regulation (EC) No 1221/2009 (EMAS)

Initial review: 22/12/2016

with the environmental performance indicators of 2016 for the sites in Wedel, Germany - with the properties: Theaterstr. 6, Theaterstr. 1, Rosengarten 25, von Linné Str. 14, Feldstr. 170 and Tinsdaler Weg 183 Tornesch, Germany

Lyon, France Rome, Italy Brno, Czech Republic Jorvas, Finland Warsaw, Poland Algés, Portugal Bratislava, Slovakia Varberg, Sweden Stirling, United Kingdom

2017 2 Updated environmental statement 2017 Table of contents

Preface 4 1 Company Profile 5 1.1 medac stands for a human-centred perspective 5 1.1.1 Diagnostics 5 1.1.2 Therapeutics 5 1.2 Sites 6 1.2.1 Wedel 6 1.2.2 Tornesch 6 1.2.3 International 7 2 Structure of the enviromental management system 9 2.1 Responsibilities 9 2.2 Documentation 9 2.3 Compliance with legislation 9 2.4 Emergency precautions 10 2.5 Integration of medac employees 10 3 Environmental policy 11 4 Environmental aspects and impacts 12 4.1 Emissions, mobility and traffic 12 4.2 Waste 17 4.3 Resources/material efficiency 20 4.4 Energy 23 4.5 Procurement 28 4.6 Biodiversity 28 4.7 Water 30 4.8 General aspects 32 5 Update of the environmental goals 33 Statement of Validation 38 Contact 39 Certificates 40

Updated environmental statement 2017 3 Preface

medac GmbH is active in the field of medicinal therapies for autoimmune and oncological diseases. It follows that we have to deal with the subject and the people involved in a responsible manner. In some cases, our medicinal products will help in the long term but in other cases, we have to accept the fact that our help is restricted to palliative measures. This tension, which is a part of our daily working lives, calls for a conscientious handling of resources of all kinds. This applies to ethical and economical necessities in equal part, and they are not mutually exclusive.

At the same time, we are well aware that a profit-based approach and technological dealings always go hand in hand with ecological interference and intrusion into nature. Thus, in order to use resources considerately, appropriate environmental protection concepts are necessary.

We have attempted to meet this challenge with the appropriate measures. In this updated environmental statement we have described the foundations of our company’s environmental management system and defined the areas of responsibility, tasks, structures and processes of that system. The statement is supplemented by additional applicable documents. Every employee of our company is obliged to take the procedures and responsibilities defined in this document, which are also part of our Code of Conduct, into consideration in his or her daily work, in accordance with the responsibility we have taken on for our products, their therapeutic use and for our environment in general.

CEO Administration, Finance & HR

Jörg Hans

Managing Director Managing Director Managing Director Managing Director Managing Director International Sales Quality Organisation Product Development Oncology Germany Therapeutic Areas & & Supply Chain Autoimmune Germany

Dr. Ulrich Kosciessa Dr. Rainer Dickhardt Nikolaus Stolberg Jens Denker Heiner Will

4 Updated environmental statement 2017 1 Company profile

1.1 medac stands for a human-centred perspective As a global pharmaceutical company based in Germany, we have been aware of the special requirements we face ever since our foundation in 1970 as a company specialising in the production and distribution of products for the treatment and diagnosis of oncological, urological and autoimmune diseases. We assume responsibility for our actions and harness our cumulative expertise to provi- de safe products of impeccable quality for patients, doctors, laboratory personnel and hospitals. medac supplies the German and many international markets with niche therapeutic products in the fields of oncology, urology and autoimmune diseases. With our own Diagnostics section we com- plement the company’s organisation.

1.1.1. Diagnostics medac offers both diagnostics and therapeutics from our own development and production. In the area of personalised medicine, this means that we have the best prerequisites for the development and continuous improvement of active substances. Precise, patient-specific diagnostics are crucial for optimising therapeutic measures and the best possible treatment outcome. The medac Diagnostics division counts 44 employees who are responsible for the development, production and marketing of in vitro diagnostics (IVD). These are standardised methods and reagents used in specialised laboratories for the testing of patient samples and the identification of diseases. Blood, cerebrospinal fluid (CSF), urine and tissue samples are assayed here. medac specialises in the diagnosis of infectious diseases, tumours, and in life science research and undertakes these services for registered laboratory physicians, hospital laboratories and research organisations.

1.1.2. Therapeutics For the past 40 years, the pharmaceutical company medac has offered innovative and tried-and- tested therapeutics in the fields of oncology, haematology, urology, rheumatological and dermato- logical autoimmune diseases, and neurosurgery. Good tolerance at maximum efficacy is the de- cisive factor here. In addition, medac supplies products that alleviate side effects of anticancer treatments such as dryness of the mouth or hand-foot syndrome. medac’s portfolio also features an anticoagulant for the medicinal dissolution of blood clots (fibrinolysis). In addition to the wide range of established therapeutics, medac attaches great importance to researching and further developing medicinal products used for the treatment of orphan indications. Here, the focus is on providing tangible help and on the welfare of the patient.

Updated environmental statement 2017 5 1.2 Sites

1.2.1 Wedel In 1999 we moved from Hamburg’s city centre to a company-owned building at Theaterstr. 6 in Wedel/Schleswig-Holstein. Besides offices, the packaging department and a laboratory for quality control are located at Theaterstr. 6. Here, employees can have lunch at the company-owned restaurant Jungfernstieg. Further offices are located at the properties at Theaterstr. 1, Rosengarten 25, von-Linné-Str. 14, Feldstr. 170, and Tinsdaler Weg 183 in Wedel. Altogether, close to 900 people work at the Wedel sites.

1.2.2 Tornesch Since 2010, we have been running a centre for logistics, quality control, and the development, manufacturing and support of diagnostics that meets the highest process and safety standards at the Tornesch site. In addition, part of the metex® PEN production has been allocated here since July 2016. In Tornesch, 120 employees are in charge of an efficient production process to ensure the great importance medac places on a consistently high quality standard is met. Since July 2017, at this site, too, the employees can eat at a company-owned restaurant, the Essbar, which was formerly operated by the company Eurest.

Tornesch Logistics centre at Wilfried-Mohr-Str. 1-5 120 employees

Wedel Theaterstraße 6 449 employees

Wedel Wedel Feldstraße 170 Theaterstraße 1 199 employees 32 employees

Wedel Wedel Rosengarten 25 von-Linné-Str. 14 96 employees 53 employees

Wedel Tinsdaler Weg 183 62 employees

6 Updated environmental statement 2017 1.2.3 International Specialised sales and marketing teams are in charge of introducing medac products to the relevant markets – in Germany and world-wide, with the help of our local subsidiaries and branches:

Subsidiaries: • medac s.a.s, Lyon, France (12 employees) • medac Pharma S.r.l., Rome, Italy (15 employees) • medac Pharma LLP, Stirling, United King- dom (22 employees)

Affiliates: • Brno, Czech Republic & Bratislava, Slovakia (13 employees) • Jorvas, Finland (7 employees) • Warsaw, Poland (37 employees) • Algés, Portugal (6 employees) • Varberg, Sweden (12 employees)

In addition to the international sites listed above, which are subject to the field of application of the environmental management system (EMS) according to DIN EN ISO 14001:2015 but are not subject to EMAS III registration, medac also has representative offices in Kazakhstan, Russia and the Ukraine, subsidiaries in the USA and Japan, and owns shares in the companies oncomed manufacturing a.s. and ONCOTEC Pharma Produktion GmbH. There, too, the same high standards and expectations as at our other sites apply when it comes to our work. The representative offices, the US and Japanese subsidiaries, oncomed manufacturing a.s., and ONCOTEC Pharma Produktion GmbH, however, are not subject to the field of application of our environmental management system.

Updated environmental statement 2017 7 Development of staff numbers 2015 to 2016 medac’s staff numbers once again grew by around 6 % in 2016.

medac staff numbers

Employees [number] 2015 2016 Trend Theaterstr. 6 470 449  Theaterstr. 1 32 32  Rosengarten 25 94 96  Feldstr. 170 207 199  von-Linné-Str. 14 43 53  Tinsdaler Weg 183 0 1 62  Tornesch 122 120  Rome (IT) 13 15  Lyon (FR) 5 12  Brno & Bratislava (CZ/SK) 13 13  Jorvas (FI) 6 7  Warsaw (PL) 30 37  Algés (PT) 7 6  Varberg (SE) 12 12  Stirling (UK) 18 22  Total staff numbers 1,072 1,135  (+ 5.88 %)

1 Lease of the office spaces in Tinsdaler Weg only started in 2016.

8 Updated environmental statement 2017 2 Structure of the environmental management system

To comply with the demanding requirements of medicinal product and medical device regulations, all processes and procedures at medac are highly structured and reviewed internally on more than once. Thanks to Good Manufacturing Practice (GMP), DIN EN ISO 13485, an established quality management system and other quality assurance systems for development, production, storage and sales, we are already in possession of a management system where the requirements of the two environmental management standards DIN EN ISO 14001:2015 and Regulation (EC) No. 1221/2009 (EMAS III) have already been implemented. This helps us compile and evaluate all company processes that may have an impact on the environment. The annual assessment of direct and indirect environmental effects is based on their respective relevance and in how far they can be controlled. With this in mind, our key environmental aspects are currently air/emissions, waste, resources, energy, procurement and mobility.

2.1 Responsibilities In order to strengthen the enforcement of our EMS, medac employs a full-time environmental management representative (UMB), Lena Sander, who reports directly to the CEO/Managing Director Administration, Finance & HR. The tasks of the UMB include the controlling and coordination of the EMS and the compilation and preparation of the environmental statement. Ms Sander has been on maternity leave since February 2017; in the meantime her responsibilities are assumed by Swantje Thiele, PhD, as deputy UMB.

2.2 Documentation The central documentation of the EMS is done electronically. All important documents are stored on the medac server and can be accessed by every employee. In addition, the environmental policy and programme can be accessed via the company’s intranet. The employees at medac’s international sites are kept up-to-date by regular e-mails and can ask the UMB for access to all the documents. In addition, the environmental policy and environmental statement are publicly accessible on the internet on medac’s website. Since uploading the environmental statement to the homepage at the beginning of May 2017, the German version of the environmental management site was visited 17 times and the environmental statement was downloaded seven times; the international site had 137 visitors and the English version of the environmental statement was downloaded twice (as of 23/11/2017).

2.3 Compliance with legislation We comply with legislation relating to the environmental impact. New or amended laws, regulations, directives or provisions are analysed in medac’s electronic regulation manager by the Safety, Health and Environment team (SHE team). The team’s experts assess and interpret the resulting changes in regular workshops, initiate the required procedures if necessary, and determine duties for complying with and implementing those requirements.

All authorisations relevant to our company were identified and entered in the list of relevant authorisations. Important conditions imposed by the authorisations, and compliance with which must be regularly inspected, were entered in the list of recurring due diligence. During the internal audits, no infringements of the regulations relevant to us could be found.

Updated environmental statement 2017 9 2.4 Emergency precautions We reduce the potential for operational malfunctions resulting in environmental pollution with the help of comprehensive environmental and health protection, safety and quality concepts. Emer- gency plans, predetermined containment action and regular training courses help reduce potential effects in case of emergency. In order to ensure that all machines and devices are in proper working order and to reduce environmental risks, we have also established an electronic system for the planning, management and control of regular maintenance work (CAFM1 software KeyLogic).

We run an active hazardous substance management, i.e. we handle hazardous substances in an environment-oriented and responsible manner; this includes checking whether hazardous substances can be substituted. We keep an up-to-date hazardous substance register for all hazardous materials in use at our company with the help of a database (ChemSich). Those employees that have to deal with hazardous substances in their working environment are regularly trained in the handling of those materials. Additionally, there are designated cleaning teams for the logistics areas. In case of spillage of medicinal products, the designated employees are informed immediately and they proceed to seal off, clean and then release again the contaminated areas.

During the reporting period, there were no instances of significant environmental impact at any of the sites, and we were not informed of any complaints concerning the environment. For all possible, conceivable accidents or incidents we have available alarm plans, fire protection systems and special emergency plans.

2.5 Integration of medac employees The integration of all medac employees into the continuous environmental improvement process takes place via two means:

• Direct contact to the UMB and regular information published on the intranet • medac’s own suggestion scheme “Environmental ideas“: All submitted ideas are considered and implemented, if applicable, by the UMB.

Moreover, from July 2016 to the end of February 2017 the UMB has published the weekly environment newsletter “Tips for having a green week” which provides employees with information on current environmental topics and tips for improving sustainability in everyday life. Since the end of February 2017, the deputy UMB has also provided information on current environmental topics, such as the introduction of waste separation in the staff kitchens, on the intranet.

1 CAFM computer-aided facility management

10 Updated environmental statement 2017 3 Environmental policy

The basis for our environmental management system is the voluntary commitment of our company to environmental protection. This commitment is reflected in our environmental policy and is communicated to all employees of the company as well as to external parties.

With this, we aim to achieve the following: As a responsible, forward-looking pharmaceutical company we strive for an economical use of natural resources. We will take reasonable and practical steps to minimise or eliminate negative effects on the environment and the climate. We implement current regional, national and international standards consistently and minimise the risks for mankind and the environment by complying with and regularly reviewing the relevant laws, regulations and rules (see index of legal provisions) as well as our internal quality management systems. Through targeted measures we aim for a continuous improvement of our performance concerning labour, health and environmental protection and try to conciliate economics and ecology.

This results in the following environmental guidelines:

1. In order to continuously improve our environmental performance, activities which may have a negative impact on the environment will be measured and evaluated within an environmental management system. 2. Our aim is to continuously reduce the consumption of resources and energy within our means and, wherever possible, to cut air, soil, water or waste water emissions and reduce waste in such a way that we contribute to a more sustainable future. 3. medac promotes environmental awareness and the environmental responsibility of its staff. Each individual employee of medac can and should act in an environmentally responsible and resource-conserving way within his area of responsibility and control. Beyond that, each employee is encouraged to share any possible concerns regarding environmental topics.

Our environmental policy is assessed at regular intervals. This is part of the annual environment audit and the management review. Based on the results of the first environmental audit and the responsibility vis-a-vis the environment and society set out in medac’s environmental policy, the environmental team developed a range of tangible measures that have been summarised in medac’s first environmental programme. In the future, measures will be agreed and documented on an annual basis. Suggestions for improvements by employees will be taken into account for this. The most important environmental targets are summarised in the environmental statement according to the respective environmental aspects.

Updated environmental statement 2017 11 4 Environmental aspects and impacts

We identify the environmental impact resulting from our activities, products and services and determine those environmental aspects that do or could have a significant impact on the environment. Once all direct and indirect environmental aspects have been recorded, we evaluate their relevance to the environment and our potential to control them with the help of defined criteria. Air/emissions, waste, energy, procurement, and mobility were identified as important environmental aspects during the first environmental audit. At the international sites, the environmental impact is very low as they solely operate as marketing and sales units.

For our rented properties at Theaterstr. 1, von-Linné-Str. 14, Feldstr. 170, Tinsdaler Weg 183, and the subsidiaries and international affiliates, it was not always possible to compile data on environmental performance as, for example, waste disposal is organised by the landlord and the actual volume of waste is not recorded, or because utilities are paid on account and the actual invoices do not allow a deduction of the precise consumption figures. In those cases, a footnote indicates which sites or properties are not included in the data provided. If, on the other hand, a certain environmental aspect is only relevant for a few sites or properties, only those sites or properties are listed where this environmental aspect applies.

4.1 Emissions, mobility and traffic

medac’s fleet is responsible for the most significant direct air emissions, CO2 and particulate matter, in the course of private and business trips. 2015 saw the consumption of 586,355 litres of diesel

and 30,179 of super petrol, and thus the emission of 1,504 tons of CO2 and 138 kg of particulate matter. In 2016, consumption could be reduced to 522,759 litres of diesel und 21,201 litres of super petrol, 1 resulting in decreased emissions of 1,328 tons of CO2 and 121 kg of particulate matter . The reduction in fuel consumption was achieved by the replacement of around a third of all fleet vehicles in 2016. Models with outdated technology were replaced with newer, more economical models. Furthermore, 2016 also saw a slightly lower mileage of the fleet vehicles.

We will succeed in reducing CO2 emissions even further by assessing whether electric bicycles and electric cars could be used in Wedel and Tornesch, with the successful introduction of a day event on the occasion of the “car-free day” on 22/09/2017; by establishing measures for determining a set of data to be collected regularly concerning the environmental aspects of the fleet vehicles, and with a project to determine the potential for savings on emissions caused by fleet traffic. The first electric car (BMW i3) was put into operation as a pool car for the Infrastructure department in mid-April 2017.

Compared to 2015, the number of business trips taken by train was reduced by 8.5 % from 1,783 to 1,631, while the number of flights was increased by 5.3 % from 2,172 to 2,288. In 2016, the train trips taken as part of the Deutsche Bahn long-distance transport amounted to 635,897 passenger kilometres; in 2015 in comparison they amounted to 686,515 passenger kilometres. The medac staff travels under the bahn.business scheme in Deutsche Bahn trains using 100 % green electricity. By using renewable energies, fossil fuels are replaced accordingly and direct emissions can be avoided right from the start 2. The flights taken were overwhelmingly for the purpose of business trips to the subsidiaries and business partners in overseas.

1 As all company cars are also used for private trips and the fuel used on those occasions is mostly not tallied separately from fuel during business trips, that fuel consumption is not included in the total amount of emissions. 2 Source: Deutsche Bahn certificates for medac from 01/01 – 31/12/2015, and 01/01/ – 31/12/2016.

12 Updated environmental statement 2017 Other air emissions are caused by the transport of cytostatics and cisplatin from the Tornesch site to the specialist disposal firms by two different disposal companies. In 2017, we evaluated whether we could use only one disposal service for the collection of this waste in the future to even further reduce CO2 emissions but had to dismiss this idea for economic reasons.

Furthermore, the coolants used in the chillers at Theaterstr. 6 and in Tornesch could be harmful to the climate in case of leakage. In 2015, 30.9 kg of R134a (tetrafluorethane) had to be replenished, and 76.0 kg in 2016. Thus, 441.87 tons of CO2 equivalents in 2015 and 1,086.8 tons in 2016 may have been emitted because of coolant leakage. In 2016, more coolant needed to be replenished than in 2015 because a leakage was detected during a maintenance check. After thorough inves- tigation, this leakage could be isolated exlusively to the cooling appliance within one cold storage cell. Remedial maintenance consisted in replacing the appliances within the cold storage cell with ones made from stainless steel to guarantee tightness in the long term. Through the use of stainless-steel appliances the risk of new leakages was reduced compared to the conventional appliances. As part of the repair work, the coolant in the affected part of the site needed to be drained and then replenished, which explains the high amount of coolant used for refilling. In the long term, a cooling alternative that is less harmful to the climate is envisaged. medac’s location in Wedel and Tornesch as well as the large commuting area explain the fact that many employees travel to work by car. We encourage the work commute by public transport through subsidising the “HVV Profi Card” (job ticket by Hamburg’s public transport service). We like to encourage our employee’s mobility awareness, which is why we have implemented activities to support carpooling and cycling to work (bicycle stands). In our travel guideline, employees are already advised to choose the train over the aeroplane for business trips within Germany. In 2017, the “car-free day” event, which took place on 22 September, was organised for all employees in Wedel and Tornesch. A number of booths providing individual mobility and commuting advice and information on the health benefits of doing without a car were set up to make employees more aware and to promote a climate-conscious commute.

Noise emissions are caused by the lorries delivering and collecting goods as well as the monthly test runs of the emergency generators at Theaterstr. 6 and in Tornesch. In addition, noise emissions are caused by employees arriving at and departing from work at all sites and properties. An investi- gation of acoustics for the medac logistics centre in Tornesch in 2009 by the company Lärmkontor GmbH found that noise emission was by 10 dB(A) lower than the imission guide values defined by the TA Lärm (German Technical Guidelines for noise reduction).

The production processes do not produce dust. Only the lorry and passenger car traffic may produce particulate matter as well as normal amounts of road dust.

Updated environmental statement 2017 13 Our goals

Reduced emission of air pollutants through the following measures: • Examination of the possibility to buy coolants with less impact on the climate (Wedel & Tornesch)  30/09/2017 The check has taken place (as of 28/08/2017): The coolant used by medac, R134a, is already the least harmful to the climate out of the available fluorised hydrocarbon coolants. All coolants that are superior from an environmental perspective do not achieve the necessary cooling effect and/or are not compatible with the equipment installed currently by the company Trane. Further- more, Trane has not released the use of alternative coolants in the equipment installed at medac so that there is currently no possibility to change the status quo.  1

• Examination of the possibility to pool the collection of cytostatic medicinal products and cisplatin waste (Tornesch)  30/09/2017 Examination has taken place: Unfortunately, it is not possible to only use one service for collection, as the disposal service used for the cytostatic waste cannot realise the collection of out-of- date but still ready-for-sale goods or of cisplatin. This is carried out by a different company which in turn, however, cannot collect cytostatic waste. 

• Introduction of a “car-free day” (all locations)  30/09/2017 A car-free day event took place for the employees in Wedel and Tornesch on 22/09/2017. 

• Check whether electric bikes could be introduced for transit between the medac site in Tornesch and the train station (Tornesch)  30/09/2017 The check has taken place (as of 30/09/2017): Using electric bikes for transit between the Tor- nesch site and the train station in Tornesch is currently not possible due to the local circumstan- ces. However, we are currently assessing whether bikes can be used for transit between the different Wedel sites. So far, three workshops have taken place on this in 2017.  1

• Definition of a set of data to be collected regularly concerning the environmental aspects of fleet vehicles (Wedel & Tornesch)  30/09/2017 On 25/08/2017 fleet management provided the current summary of the medac fleet containing all reference figures that are relevant to the environment. We are currently collaborating with the IT department on generating a database for the assessment and analysis of data sets concerning the environmental aspects of the fleet vehicles. In the future we can then regularly draw data sets concerning environmental aspects of the fleet vehicles directly from the database. 

1  Goal was achieved. Achievement of goal still in progress.

14 Updated environmental statement 2017 • Identification of the potential to reduce emissions of air pollutants by the fleet (Wedel & Tornesch)  30/09/2017 The first electric car (BMW i3) was put into operation as a pool car for the Infrastructure department in mid-April 2017. Following a trial phase, a decision will be made on whether more electric cars will be introduced at medac. In addition, the first electric-mobility meeting with representatives of the city of Wedel and the Stadtwerke Wedel (municipal utilities Wedel) on the introduction of electric vehicle charging stations took place at the beginning of 2017. Using the data on the medac fleet provided by the fleet management, we will also analyse where we see potential for savings. 

Core indicators

Core indicators/key figures 2015 2016 Trend

Total annual emissions of greenhouse gas in CO2 equivalents per employee 5.9 6.8  (+ 15.25 %) [t/quantity]

Total annual emissions into the air (NOx, SO2, PM) per employee 0.0054 0.0058  (+7.41 %) [t/quantity]

Emissions by medac

1 Emissions of CO2 equivalents [t] 2015 2016 Trend Electricity 3,833.39 2 3,512.34 3  Natural gas 1,040.06 4 983.90 5  Liquid gas/propane 1.04 1.11  Diesel (emergency generator) 9.81 9.10  Fuel oil (emergency generator) 0 6 5.67  Loss of coolant 441.87 1,087 

Total annual emissions of greenhouse 5,326 5,599  (+ 5.13 %) gas

1 The calculation was performed based on CO2 emission factors from the following sources: for Germany: GEMIS database 4.93 (2015) For electricity at the international branches: Covenant of mayors for local sustainable energy/Intergovernmental Panel on Climate Change (IPCC) 2 without von-Linné-Str. and Stirling, UK 3 without Tinsdaler Weg and von-Linné-Str. 4 without von-Linné-Straße 5 without Tinsdaler Weg, von-Linné-Str., France, Finland, Sweden, Portugal and Poland 6 In 2015, diesel instead of fuel oil was used for the emergency generator at Theaterstr. 6.

Updated environmental statement 2017 15 Emissions by medac

Emissions [t] 2015 2016 Trend

1 SO2 1.8 2.0  NOX 3.5 3.7 1 

PM (particulate matter) 0.3 0.3 1 

Annual total emissions into the 5.5 5.9 1  (+7.27 %) atmosphere

Development of the core indicators for emissions, mobility and traffic from 2015 to 2016 When compared, the core indicators for the fields of emissions, mobility and traffic show the following development: Both core indicators on total annual emissions have increased compared to the previous year. This increase is due to the large amounts of coolant that had to be replenished during the 2016 repairs where the applicance in the cold storage unit was replaced by stainless-steel

models. When looking at the inidividual emissions as CO2 equivalents, it is clear that there is a decreasing trend in the area of electricity and natural-gas consumption in noteworthy dimensions. This is largely due to an increase of around 30 % in the use of renewable energies in the electricity mix. Also, less natural gas was used in 2016, leading to lower emissions.

1 without Tinsdaler Weg and von-Linné-Str.

16 Updated environmental statement 2017 4.2 Waste The main waste fractions of non-hazardous waste at the sites in Wedel and Tornesch were residual waste and used paper/cardboard packaging. Hazardous waste other than cytotoxic and cytostatic agents were mainly organic and inorganic laboratory chemicals, waste whose collection and disposal is subject to special requirements in order to prevent infection, other halogenated solvents and mixtures of solvents, used electrical and electronic appliances as well as absorbent and filter materials.

In order to minimise the used electrical appliances waste, old devices in working order are prepped by the IT department in Wedel and Tornesch and are either sold to staff or donated to welfare services. Broken appliances are collected together with the used electrical appliance waste and disposed of in accordance with the regulations.

Additionally, reusable transport boxes are used in the packaging department whenever possible and when in compliance with drug safety. The international branches, too, are working proactively to prevent waste, for example by strict waste separation in Jorvas; in Warsaw, folders are reused in order to keep the amount of residual waste low.

In some staff kitchens, waste separation is not yet implemented. There, potential for avoiding waste and more efficient recycling was realised through more targeted and improved separate collection of waste types, which in turn makes the recycling of the materials possible. Thus, the waste-bin concept in the staff kitchens was optimised in 2017 and separation of the waste according to residual waste, recyclable material (plastic, packaging, composite materials, metal, etc.), cardboard/paper and, depending on the site (e.g. in Tornesch), even organic waste, was introduced successfully. Further, a concept for the implementation of the current German Commercial Waste Ordinance (Gewerbeabfallverordnung) was drawn up. This includes the separation of commercial waste according to recyclable foils, plastic and paper in the logistics area in Tornesch. This concept is an interim solution until the recycling depot in Tornesch has been realised and reconstructed accordingly. If applicable, the amount of residual waste will be reduced in other areas in the future as well. In addition, employees were and are regularly trained in waste prevention and separation through waste training sessions, the environment newsletter and articles on the intranet. This also serves to motivate the staff to reduce waste amounts even further. Food waste from the two company restaurants in Wedel and Tornesch is collected separately and picked up by the BioCycling GmbH for generation of energy. The company uses the waste to produce renewable energy in bio gas plants for use in the electricity and community heating grid.

For the shipping cartons and the styrofoam brought into circulation by us, medac has joined the dual system and thus meets the legal requirements.

Updated environmental statement 2017 17 Our goals Reduction of the residual waste ratio by 2 %: • Optimisation of the waste-bin concept in the offices and staff kitchens (Wedel & Tornesch)

 30/09/2017 In 2017, separation of the waste according to residual waste, recyclable material (plastic, packaging, composite materials, metal, etc.), cardboard/paper and, depending on the site (e.g. in Tor- nesch), even organic waste, was introduced successfully in the offices and staff kitchens in Wedel and Tornesch. In how far the introduction of waste separation in the staff kitchens will have led to a reduction in the amount of residual waste will only become apparent in the following year. 

• Raising awareness of staff (all sites)  30/09/2017 The staff was made aware of the topics waste separation and waste avoidance through the environment newsletter and several intranet articles on the introduction of waste separation at the different sites. 

Core indicators

Core indicators/key figures 2015 2016 Trend

Total annual generation of hazardous waste 36.17 61.90  (+71.14 %) per employee [kg/quantity]

18 Updated environmental statement 2017 Different types of waste 1,2 Waste 2015 2016 Trend Theaterstr. 6 Paper, cardboard, cardboard packaging/ 54,075 36,125  department store waste [t] Slurry/sludge [m³] 17 14  Residual waste (mixed municipal waste for 233,200 228,800  disposal) [l] 3 Medicinal products (other than cytotoxic and 5.0 0.0  cytostatic medicinal products; 20 01 31) [kg] Styrofoam [t] 63.0 55.0  Punching waste [t] 20.1 23.0  Plastics [t] 30.1 17.1  Hazardous waste [t] 6.9 9.2  Theaterstr. 1 Residual waste [l] 3 29,700 28,600  Rosengarten 25 Residual waste [l] 3 116,600 114,400  Feldstr. 170 Residual waste [l] 3 116,600 114,400  von-Linné-Str. 14 Residual waste [l] 3 58,300 57,200  Tornesch Paper, cardboard, cardboard packaging/ 61 64.3  department store waste [t] Waste (not specified otherwise) [t] 4 2.2  Slurry/sludge [m³] 13 13.0  Mixed packaging/residual waste [t] 31 32.5  Hazardous waste [t] 28.1 53.3 

Development of the core indicators for waste from 2015 to 2016 Generally, in 2016 a decreasing trend in the amount of waste became apparent. Only the core indicator of the amount of hazardous waste per employee increased by 71 % in 2016 as a large number of defective cytostatic batches occurred and had to be disposed of compared to the previous year. Therefore, in Tornesch in particular, a large amount of special disposals were necessary. In 2016,f staf numbers increased as well. In how far the introduction of waste separation in the staff kitchens will have led to a reduction in the amount of residual waste will only become apparent in the following year. 1 Due to the diversity of the waste units, no indicator of the total annual volume of waste can be given. 2 The collected waste is not measured or is disposed of directly by the landlord at the other sites/properties. 3 Estimate based on the cycle of collection and the size of the container.

Updated environmental statement 2017 19 4.3 Resources/material efficiency For the production and packaging of medicinal products, many resources are used but due to strict legal requirements and long marketing authorisation procedures there is very little room to minimise the resources used. Due to the variety and heterogeneity of the used materials, the low possibility of influence by the environmental management system and due to confidentiality, these resources are not specified in this environmental statement.

In order to ensure the best possible quality of our products during transportation and to protect them against external influences, the packaging needs to be exceptional. 32,600 kg of paper, cardboard and cardboard boxes, and 7,100 kg of plastic materials were used for this purpose in 2015. In 2016, we recorded an increase to 36,070 kg of paper, cardboard and cardboard boxes, and to 10,080 kg of plastic. This increase is due to increased production at the German sites in 2016.

In the management area, the paper consumption (2016: 5,692,302 sheets of paper, i.e. approx. 5,015 sheets per employee per year, which is an increase of around 5 % compared to 2015) will be examined in order to determine measures to reduce the paper consumption. Duplex printing set as default printing option is not possible due to GMP requirements. The employees, however, have been made aware in the environment newsletter and an intranet article on saving paper of the ad- vantages of duplex and multi-paged printing of non-GMP-relevant documents and of avoiding the unnecessary printing of documents, in particular of e-mails. At the site in Rome, the receipt of fax documents has already been digitised and the “paperless office” project will be developed further for Wedel and Tornesch. Beyond that, we are currently looking into the use of more environmentally friendly paper certified with the Blue Angel eco-label. Currently, medac is already using FSC-mix certified paper.

The external cleaning company has been ordered to use cleaning agents and paraphernelia spa- ringly and responsibly and, where possible, to consider using more eco-friendly alternatives. In the sanitary areas, paper towels are used. Electricity and fuel consumption are described in the chapter „Energy“.

Our goals Reduction of paper consumption by 2 % by the end of the 2017/18 financial year compared to the rate at the end of the 2015/16 financial year by the following measures: • Further development of the project “paperless office” (Wedel & Tornesch)  31/03/2018 The project “digital mail room” has been launched. Following the reasonably complex development of a concept and the creation of a superordinate process for the digital initial processing of invoices, the project has now entered the technical implementation stage. Digitalisation of outgoing invoices is also currently being realised. In addition, as part of the project to introduce a Ma- nufacturing Execution System (MES) which was launched in 2014, the paper-less documentation of all production processes was pursued so that these will only be processed electronically in the future. The manufacturing instructions are thus released through an electronic workflow and the review of the packaging record takes place according to the Review by Exception principle in the final expansion stage of the MES. This helps reduce manual checking and enables concentrating on evaluating special incidents occurring during the production of a batch. 

20 Updated environmental statement 2017 • Information for employees: “Avoid unnecessary printouts of e-mails” (all sites)  31/03/2018 Employees were provided with the information in the environment newsletter and a separate intranet article on saving paper. In addition, on 17/11/2017 all employees in Tornesch and Wedel were provided with clip labels with the motto “Save Paper. Save Energy” that can be attached to e.g. computer monitors and that serve as visual reminders. 

• Communicate to staff: “Use duplex printing whenever possible” (all sites)  31/03/2018 Has been communicated to staff in the environment newsletter and a separate intranet article on saving paper on 08/06/2017. 

Core indicators

Core indicators/key figures 2015 2016 Trend

Paper/employee [A4 sheet/quantity] 5,061 5,015  (- 0.91 %)

Material consumption

Packaging material [kg] 2015 2016 Trend Paper, cardboard and cardboard 32,600 36,070  boxes (Wedel & Tornesch) Plastics (Wedel & Tornesch) 7,100 10,080  Total packaging material 39,700 46,150  (+ 16.25 %)

Updated environmental statement 2017 21 Paper consumption [A4 sheet] 2015 2016 Trend Wedel & Tornesch (DE) 5,184,905 5,431,152  Rome (IT) 58,099 52,000  Lyon (FR) 30,000 25,000  Brno & Bratislava (CZ/SK) 12,500 12,500  Jorvas (FI) 2,250 10,000  Warsaw (PL) 70,000 106,250  Algés (PT) 24,100 32,500  Varberg (SE) 23,000 4,900  Stirling (UK) 20,000 18,000  Total paper consumption 5,424,854 5,692,302  (+ 4.93 %)

Development of the core indicators for resources/material efficiency from 2015 to 2016 Paper consumption in A4 sheets per employee stayed nearly the same as in the previous year, with a slight decreasing trend. However, total paper consumption rose by about 5 % because of risen staff numbers. The increase in packaging material in 2016 at the respective production sites is due to increased production and more extensive requirements regarding the safe packaging of products.

22 Updated environmental statement 2017 4.4 Energy medac is not an energy-intensive company, however here, too, there is still potential for saving. With the introduction of the environmental management system, the opportunity was taken to record and evaluate the energy sources and the most important energy consumers in more detail, and to assess them in terms of optimisation potential. As a first measure, we have tackled the improvement of data collection: All energy and environmental data is collected annually by the respective responsible employees and evaluated by the UMB. Some energy-efficient measures had already been implemented in the construction of the administration building, such as movement-sensitive lighting in the rest rooms. At the site in Rome, the outdoor lighting was equipped with daylight sensors.

In 2016, a total of 6,075,483 kWh of electricity were used at all sites. This is equal to an annual electricity consumption of approx. 5,956 kWh per employee. The main energy consumers are the ventilation and lighting at Theaterstr. 6, and the ventilation and cooling in Tornesch. We were able to use 365 MWh self-generated electricity from our combined heat and power plant (CHP) in Tornesch and fed 1 MWh into the public grid.

Employees were made aware of energy-saving measures in the environment newsletter. Further- more, from October 2017 onwards, the main consumers at the sites with packaging departments, storage units and laboratory duties will be compiled with the help of an energy adviser to reduce energy consumption and to enable them to be used in a more energy-efficient manner. In 2017, we also checked whether a more precise control of the lighting is possible. Additionally, on 25/03/2017, medac took part in the Earth Hour 2017 event organised by the WWF (World Wildlife Fund): All lights were switched off for the duration of the Earth Hour at medac headquarters in Theaterstr. 6 and at medac’s logistics centre in Tornesch as a sign for more sustainability, for more protection of the environment and the climate, and to raise staff’s awareness of these issues. All employees were informed about medac’s participation in this global event via the intranet and encouraged to save energy and to take part from home.

The Tornesch, Rome (IT), Brno/Bratislava (CZ/SK), and Stirling (UK) sites as well as the properties at Rosengarten 25, Theaterstr. 1 and Theaterstr. 6 are heated with natural gas. In 2016, 4,881,194 kWh of natural gas were used for this purpose.

In 2016, 81,214 m³ of compressed air were generated at the Wedel site through the use of approx. 34,000 kWh of electricity. At the Tornesch site, compressed air is generated, too. However, the compressed air consumption cannot be read out through the compressor control. In Tornesch, an estimated 42,924 kWh per year are used to generate the compressed air.

Additionally, 374 kg of propane gas were used for operating the forklifts at Theaterstr. 6 in 2016.

Updated environmental statement 2017 23 Our goals Reduce consumption of electricity by 2 % by the end of the 2017/18 financial year compared to the end of the 2015/16 financial year through the following measures: • Assessment of the potential for more precise control of lighting (Wedel & Tornesch)  31/03/2018 It has been assessed whether the lighting systems can be controlled more precisely. Principally, it is possible to retrofit the systems with more energy-saving controls. Currently, suppliers of such systems are being contacted in order to develop relevant concepts. Following cost-benefit analysis these could be included in budget planning as projects within the energy management which has been under development together with an external energy adviser since October 2017. Additionally, environmental and energy-management concerns are taken into consideration for all repair measures as part of daily facility management. For example, if light switches stop working they are replaced by presence or motion detectors whenever possible. At Thea- terstr. 6, presence detectors have already been installed in some of the rest rooms and common rooms in the packaging department. 

• Increase of employee awareness of how to save energy (all sites)  31/03/2018 Employees were encouraged to save energy and given information on how to do so in the environment newsletter in 2016 and in a separate intranet article on 16/11/2017. In addition, all employees in Tornesch and Wedel were provided with clip labels with the motto “Save Paper. Save Energy.” that can be attached to e.g. computer monitors and that serve as visual reminders. 

• Identification of options for reducing energy consumption • Development of ideas in a workshop • Introduction of a measurement concept (all sites)  31.03.2018 The foundations for introducing a measurement concept are being developed together with an external energy adviser since October 2017. At the same time, the main consumers are to be compiled. Due to a lack of resources, it has not been possible to do so until now. 

Core indicators

Core indicators/key figures 2015 2016 Trend

Total energy consumption 10,934 10,824  (-1.01 %) [kWh/quantity]

24 Updated environmental statement 2017 Total consumption of renewable 2015 2016 Trend energy [MWh]

Wedel 1,205 1 1,285 1  Tornesch 746 1,130 

Share of annual total consumption 17 % 22 %  (+ 29.4 %) (Wedel 1 & Tornesch)

medac’s energy consumption

Electricity [MWh] 2015 2016 Tendenz Theaterstr. 6 2,416 2,370  Theaterstr. 1 19 19  Rosengarten 25 415 441  Feldstr. 170 134 143  Tornesch 2,953 2,994  Rome (IT) 13 34  Lyon (FR) 12 12  Brno & Bratislava (CZ/SK) 13 13  Jorvas (FI) 10 6  Warsaw (PL) 12 15  Algés (PT) 7 8  Varberg (SE) 15 12  Stirling (UK) 0 2 8  Total electricity consumption 6,018 6,075  (+ 0.95 %)

1 without Tinsdaler Weg and von-Linné-Str. 2 advance payment; not recorded

Updated environmental statement 2017 25 Natural gas [MWh] 2015 2016 Trend Theaterstr. 6 2,057 2,404  Theaterstr. 1 49 59  Rosengarten 25 100 120  Tornesch 2,919 2,244  Rome (IT) 25 22  Brno & Bratislava (CZ/SK) 18 18  Stirling (UK) 18 15  Total heat energy consumption 5,185 4,881  (- 5.86 %)

Other energy consumption [MWh] 2015 2016 Trend Fuel for emergency generators Diesel (Theaterstr. 6) 23 0  Fuel oil (Theaterstr. 6) 0 21  Diesel (Tornesch) 17 37  Fuel for fleet Diesel (Wedel & Tornesch) 5,805 5,175  Petrol (Wedel & Tornesch) 270 190 

Propane gas for forklifts (Theaterstr. 6) 4.5 4.8  Total other energy consumption 6,119 5,428  (- 11.29 %)

Total direct energy consumption 2015 2016 Trend [MWh]

All sites 11,251 11,041  (- 1.87 %)

Electricity generated by combined 2015 2016 Trend heat and power plant [MWh]

Tornesch 748 365  (- 51.20 %)

26 Updated environmental statement 2017 Development of the core indicators for energy 2015 to 2016 Total energy consumption was kept at the same level as the previous year with a slight decreasing tendency. Thanks to an increase in the ratio of renewable energies in the electricity mix by the supplier, the total consumption of renewable energies increased in 2016. This resulted in an overall improved

CO2 balance for the company. As diesel was used instead of fuel oil for the emergency generator at Theaterstr. 6 in 2015, the fuel oil consumption increased at that site in 2016 with a corresponding decrease in diesel consumption. In 2016, the performance of the CHP in Tornesch was lower by about half than in 2015 because the plant could not be operated throughout the whole year due to maintenance and reconstruction work. This included replacement of the absorber and the buffer tank, which had become too small, with a bigger one. The new buffer tank resulted in the cold management not working properly and having to be recalibrated, which in turn caused further delay to the CHP resuming operations.

Updated environmental statement 2017 27 4.5 Procurement We continuously evaluate the quality of our suppliers through aspects such as delivery reliability or complaints processing but also by “grading” the quality of the documents supplied.

Our goals Increased use of sustainable goods and services through the following measures: • Evaluation of in how far environmental and social aspects can be taken into consideration when selecting goods and services (all sites)

 31/03/2017 It was agreed that the external insurance broker will be reminded annually to check for the option of taking out sustainable insurance policies where possible. Evaluation has still to take place for other areas (e.g. purchasing department, kitchens). Initial meetings with the supplier qualification unit of the quality management and the purchasing department on this topic have taken place in 2017. Currently, an extended supplier questionnaire is being drawn up as part of the medac quality management system (planned introduction: beginning of 2018). 

4.6 Biodiversity We plant the grounds and patios at the properties that we own. The planting provides shelter, nes- ting grounds and food for birds as well as for butterflies, bees and other insects.

Core indicators

Core indicators/key figures 2015 2016 Trend Land use per employee [m²/quantity] 32.70 33.12  (+ 1.28 %)

28 Updated environmental statement 2017 Land use [m²] 2015 2016 Trend Theaterstr. 6 17,483 17,483  Theaterstr. 1 269 269  Rosengarten 25 868 868  Feldstr. 170 440 440  von-Linné-Str. 14 718 718  Tinsdaler Weg 183 0 1 2,099  Tornesch 13,652 13,652  Rome (IT) 360 360  Lyon (FR) 217 230  Brno & Bratislava (CZ/SK) 160 225  Jorvas (FI) 91 91  Warsaw (PL) 382 727  Algés (PT) 170 170  Varberg (SE) 150 165  Stirling (UK) 100 100  Total land use 35,059 37,597  (+ 7.24 %)

Development of the core indicators for biodiversity from 2015 to 2016 Due to an expansion of sales activities in France, Czech Republic/Slovakia, Poland and Scandina- via additional office space needed to be leased resulting in an increase of land use. In Wedel, too, a new office site was leased at Tinsdaler Weg 183.

1 The office spaces at Tinsdaler Weg 183 have only been rented since 2016.

Updated environmental statement 2017 29 4.7 Water Water is used at medac in the sanitary facilities, laboratories, employee kitchens and the staff restaurants and, to a small extent, for irrigation. When building the administration building and the logistics building, water-saving devices such as toilets with a water-saver button were installed as standard. Fresh water is obtained from the communes and waste water is passed into the public sewer system. In 2016, 12,590 m³ of fresh water were consumed in Wedel and Tornesch. This corresponds to the consumption of approximately 143–217 households (average consumption in Germany: 58–88 m³ of water per 2-person household per year 1) and is therefore within the normal range. Water is a precious commodity; therefore employees are encouraged to use water economically. Core indicators

Core indicators/key figures 2015 2016 Trend

Water consumption per employee 12.7 2 14.9 3  (+ 17.32 %) [m³/quantity]

Water consumption

Water consumption [m³] 2015 2016 Trend Theaterstr. 6 5,449 5,466  Theaterstr. 1 216 275  Rosengarten 25 737 754  Tornesch 5,382 6,095  Rome (IT) 87 102  Jorvas (FI) 0 9  Warsaw (PL) 0 355  Algés (PT) 0 27  Varberg (SE) 0 263  Total water consumption 11,871 13,346  (+ 12.43 %)

1 Source: http://www.energiesparen-im-haushalt.de/energie/tipps-zum-energiesparen/hoher-wasserverbrauch/wasserverbrauch- personenhaushalt.html 2 only for Germany (excluding Feldstr., Tinsdaler Weg and von-Linné-Str.) and IT 3 excluding Feldstr. 170, Tinsdaler Weg, von-Linné-Str., FR, UK, and CZ/SK

30 Updated environmental statement 2017 Waste water

Waste water [m³] 2015 2016 Trend Theaterstr. 6 5,603 5,502  Theaterstr. 1 217 270  Rosengarten 25 737 697  Tornesch 5,382 6,095  Total waste water 11,939 12,564  (+ 5.23 %)

Development of the core indicators for energy 2015 to 2016 The increase in water consumption, in particular for Tornesch, is probably due to increased water consumption by the evaporation cooling plant necessitated by the warmer temperatures during the summer of 2016 as compared to 2015. The increased water and waste water consumption at Theaterstr. 1 when compared to the previous year is due to the meeting room being used more frequently by staff from other sites, though staff numbers working there have stayed the same. In conclusion, it can be stated that the growth in staff numbers led to an increase in the consumption of drinking water and sanitary waste water in 2016. Furthermore, in 2016 we received consumption figures for the sites in Finland, Poland, Portugal and Sweden for the first time. In 2015, the properties’ landlords only provided an annual statement of utilities using flat rates where water consumption was not listed in detail.

Updated environmental statement 2017 31 4.8 General aspects After the first environmental audit, we decided to regularly collect and analyse environmentally relevant data, such as fuel use, in order to record and evaluate our environmental impact even better in the future. Moreover, we started a company suggestion scheme for environmental ideas. Since its introduction in July 2016, 72 ideas on how medac could reduce environmental impact have already been collected. Altogether, 112 environment-related ideas have been submitted by staff to the Environmental Management since January 2016 (date: 15/11/2017). Furthermore, medac representatives from the Environmental Management and the technical projects and constructions division of the Facility Management, amongst others, took part in the 3rd Wedel Climate Conference (3. Wedeler Klimaschutzkonferenz) at the beginning of October 2017. In four workshops, the participants joined representatives from business, politics and administration, and Wedel citizens to come up with tangible ideas for the implementation of local climate protection projects1.

Our goals Improvement of the data situation through the following measure: • Definition of a set of data to be collected regularly concerning environmental aspects at medac (all sites)  31/03/2017 On 25/08/2017 fleet management provided the current summary of the medac fleet containing all reference figures that are relevant to the environment. We are currently collaborating with the IT department on generating a database for the assessment and analysis of data sets concerning the environmental aspects of the fleet vehicles. 

Setting up a “green letter box” through the following measure: • Establishing a company suggestion scheme to collect ideas for reducing harmful effects on the environment (Wedel & Tornesch)  30/07/2016 The e-mail address “[email protected]” was set up and announced via e-mail and on the intranet to all medac employees in Germany. The submitted ideas are collected and administered by the environmental management representative or her deputy, respectively. 

1 Source: https://www.wedel.de/rathaus-politik/newsdetail/news/klima-konkret.html

32 Updated environmental statement 2017 5 Update of the environmental goals Based on the results of the environmental audits, the external audits of the environmental management system and the responsibility vis-a-vis the environment and society set out in the environmental policy, a range of tangible annual measures were developed and have been summarised in medac’s environmental programme. Suggestions for improvements by employees were taken into account for this as well.

The following table depicts medac’s first environmental programme from 2016 and the current status of the measures (date: 15/11/2017):

Key area: Air/emissions and mobility Status: For details, see

Goal: Reduced emission of air pollutants Measures: 1. Examination of possibility to buy coolants with less impact on the  P. 14 climate (Wedel & Tornesch) 2. Examination of the possibility to pool the collection of cytostatic  P. 14 medicinal products and cisplatin waste (Tornesch) 3. Introduction of a “car-free day” event (all locations)  P. 14 4. Check whether electric bikes could be introduced for transit  P. 14 between the medac site in Tornesch and the train station (Tornesch) 5. Definition of a set of data to be collected regularly concerning the  P. 14 environmental aspects of fleet vehicles (Wedel & Tornesch) 6. Identification of the potential to reduce emissions of air pollutants  P. 15 by the fleet (Wedel & Tornesch)

Key area: Waste

Goal: Reduction of the residual waste ratio by 2 % Measures: 1. Optimisation of the waste-bin concept in the offices and staff  P. 18 kitchens (Wedel & Tornesch) 2. Raising awareness of staff (all sites)  P. 18

Key area: Resources/material efficiency S. 14

Goal: Reduction of paper consumption by 2 % by the end of the 2017/18 financial year compared to the rate at the end of the 2015/16 financial year

Measures: 1. Further development of the project “paperless office”  P. 20 (Wedel & Tornesch) 2. Information for employees: “Avoid unnecessary printouts of  P. 21 e-mails” (all sites) 3. Communicate to staff: “Use duplex printing whenever possible”  P. 21 (all sites)

Updated environmental statement 2017 33 Key area: Energy Status: For details, see

Goal: Reduce consumption of electricity by 2 % by the end of the 2017/18 financial year compared to the end of the 2015/16 financial year Measures: 1. Assessment of the potential for more precise control of lighting  P. 24 (Wedel & Tornesch) 2. Increase of employee awareness of how to save energy (all sites)  P. 24

3. Identification of options for reducing energy consumption  P. 24

Key area: Procurement

Goal: Increased use of sustainable goods and services Measure: Evaluation of in how far environmental and social aspects can be  P. 28 taken into consideration when selecting goods and services (all sites)

General measures S. 14

1st goal: Improvement of the data situation

Measure:

Definition of a set of data to be collected regularly concerning  P. 32 environmental aspects at medac (all sites)

2nd goal: Setting up a “green letter box”

Measure:

Establishing a company suggestion scheme to collect ideas for  P. 32 reducing harmful effects on the environment (Wedel & Tornesch)

 Goal was achieved.  Achievement of goal still in progress.

34 Updated environmental statement 2017 medac environmental programme 2018 The updated environmental programme for 2018 includes the following measures: Responsible for the Key area: Air/emissions and mobility Budget Deadline implementation Goal: Reduced emission of air pollutants Measures: 1. Check whether medac could offer a company bicycle leasing Compensation & / 10/2018 scheme Benefits 2. Annual analysis and examination of the potential to reduce Fleet management / 10/2018 emissions of air pollutants by the fleet (Wedel & Tornesch) 3. Implementation of the Federal Immission Control Act (Bundes- FM T/G € 5,000 10/2018 Immissionsschutzgesetz, BImSchG) (Wedel and Tornesch) Key area: Waste Goal: Reduction of the residual waste ratio by 2 % in comparison to the calendar year 2016, i.e. less than 31.38 t of residual waste in Tornesch, and less than 476.476 L of residual waste in Wedel (without von-Linné-Str. and Tins- daler Weg) during the calendar year 2018 Measures: approx. 1. Introduction of an organic waste bin at Theaterstr. 6 (Wedel) Waste management 02/2018 € 750 2. Implementation of the current German Commercial Waste approx. Waste management 10/2018 Ordinance (Gewerbeabfallverordnung) (Wedel and Tornesch) € 16,800 3. Continue raising awareness of staff: Waste management / The goal for the key area “Waste” will be communicated to the environmental / 10/2018 employees and they will be asked to help achieve it. management

Key area: Resources/material efficiency Goal: Reduction of paper consumption by 2 % in comparison to the calendar year 2015 (=v 103,698 sheets of A4 paper), i.e. consumption of less than 5,081,207 sheets of A4 paper during the calendar year 2018 (Wedel/Tornesch) Measures: 1. Further development of the project “paperless office”: 1. Introduction of the electronic signature (e-signature) at IT / 1 04/2018 medac in 2018 2. Introduction of the electronic IT authorisation application IT / 1 12/2018 form (e-authorisation) at medac in 2018 3. Introduction of the Electronic Trial Master File (eTMF) at Max Horneck (Clinical / 1 02/2018 medac in 2018 Data Management and eClinial Systems)

2. Introduction of MES (Manufacturing Execution System) in 2018; Michail Herrmann this is estimated to save ~300,000 sheets of paper per year (Production Support, / 1 12/2018 project leader) 3. Introduction of sub-project 1 of the “digital mail room” project: Sven Schneider Digital initial processing of invoices (Facility Management / 1 07/2018 Infrastructure) 4. Introduction of digital invoices for the pharmaceutical wholesale Customer Service / Sönke Lorenzen sector. At the same time, the electronic dispatch of invoices in 1 PDF format will be promoted to customers as an alternative. (IT Applications and / 10/2018 Development) 1 For this measure, the respective responsible persons or departments have already applied for a budget independent of the environmental programme. Thus, the costs are not listed here again.

Updated environmental statement 2017 35 Responsible for the Key area: Energy Budget Deadline implementation

1st goal: Reduction of electric energy consumption by 2 % (=v 114,616 kWh) in comparison to the amount at the end of the financial year 2015/16, i.e. energy consumption of less than 5,616,196 kWh during the financial year 2017/18 (Wedel/Tornesch, without von-Linné-Str. and Tinsdaler Weg) Measures: 1. Creation of a more energy-efficient lighting concept in Tornesch for the - large logistics hall (dispatch) / 1 12/2018 FM technical projects - small logistics hall (incoming/outgoing goods area) approx. 12/2018 and constructions € 2,000 - laboratory areas approx. 12/2018 € 2,000

2. Implementation of a more energy-efficient lighting concept for the FM technical projects / 1 12/2018 large logistics hall (dispatch) in Tornesch and constructions

3. Raising awareness of staff concerning the saving of energy: Environmental Check whether this has already made a difference for the financial / 04/2018 management year 2017/18 and led to a reduction by 2 % at the office sites.

2nd goal: Collection of inventory data concerning the energy sector and determination of initial actions Measure: Compilation of the main consumers with the help of an external FM technical projects € 30,000 10/2018 energy adviser and constructions

Key area: Procurement

1st goal: Increased use of sustainable goods when procuring office supplies, in the kitchens and for the catering Measure: Analysis of the status quo and potential for optimisation... Annet Gerberding ...when procuring office supplies (Facility Management / 10/2018 Infrastructure) ...in the kitchens Ute Hacke (kitchens) / 10/2018 Manuela Dilling ...for the catering / 10/2018 (catering) 2nd goal: Increased use of sustainable services when booking hotels Measure: Analysis of the status quo and potential for optimisation when book- Travel management / 10/2018 ing hotels

1 For this measure, the respective responsible persons or departments have already applied for a budget independent of the environmental programme. Thus, the costs are not listed here again.

36 Updated environmental statement 2017 Responsible for the General measures Budget Deadline implementation 1st goal: Improvement of the data situation

Measures: see above Collection of inventory data in the energy sector and continuous data FM technical projects (€ 30,000 10/2018 maintenance and constructions in total) Annual analysis of the data situation concerning the medac fleet Fleet management / 10/2018 Annet Gerberding Analysis of the data situation concerning the procurement of office (Facility Management / 10/2018 supplies Infrastructure) Analysis of the data situation concerning the kitchens Ute Hacke (Services) / 10/2018 Manuela Dilling / Ute Analysis of the data situation concerning the catering / 10/2018 Hacke (Services) Analysis of the data situation concerning the booking of hotels Travel management / 10/2018

2nd goal: Assessment of the ideas received by employees via the environmental suggestion scheme

Measure:

Creation of a concept for the analysis, assessment and processing Environmental of the suggestions and ideas; formation of an “environment team” if management / / 10/2018 applicable. “Environment team”

Updated environmental statement 2017 37 Statement of Validation

38 Updated environmental statement 2017 Contact For further information and questions, comments and criticism, please contact the Environmental Management Representative, Lena Sander, and her deputy, Swantje Thiele, PhD, at any time.

Lena Sander Environmental Management Representative Safety Health Environment (SHE)

E-mail: [email protected] Phone: +49 4103 8006-8109 Fax: +49 4103 8006-8474

Theaterstr. 6 22880 Wedel Germany www.medac.de

Swantje Thiele, PhD Deputy Environmental Management Representative; Junior Manager Product Safety Safety Health Environment (SHE)

E-mail: [email protected] Phone: +49 4103 8006-8427 Fax: +49 4103 8006-8474

Theaterstr. 6 22880 Wedel Germany www.medac.de

Updated environmental statement 2017 39 Certificates

EMAS III Certificate

40 Updated environmental statement 2017 Updated environmental statement 2017 41 DIN EN ISO 14001:2015 Certificate

Number 94023

Valid from 12.12.2016

Valid until 11.12.2019 Page 1 of 3

Kiwa International Cert GmbH certifies that the company

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6 22880 Wedel

for the scope design, manufacture and sales of therapeutic substances and diagnostics; oncology, urology and autoimmune diseases marketing and sales of pharmaceutical products

has implemented and applies an environmental system, which is in compliance with the requirements of ISO 14001:2015

This is a multi-site certification. Additional site details are listed on subsequent pages.

Kiwa International Cert GmbH Kiwa International Cert GmbH

Managing Director Technical Manager

Kiwa International Cert GmbH Grüner Deich 1 20097 Hamburg Germany Telefon +49 (0)40 30 39 49 60 Telefax +49 (0)40 30 39 49 79 e-mail: [email protected] www.kiwa.de

42 Updated environmental statement 2017

Number 94023

Valid from 12.12.2016

Valid until 11.12.2019 Page 2 of 3

medac Gesellschaft für klinische Spezialpräparate mbH

for the scope design, manufacture and sales of therapeutic substances and diagnostics; oncology, urology and autoimmune diseases (valid for all sites on page 2) several sites: medac Gesellschaft für medac Gesellschaft für klinische Spezialpräparate mbH klinische Spezialpräparate mbH Tinsdaler Weg 183 Rosengarten 25 22880 Wedel 22880 Wedel medac Gesellschaft für medac Gesellschaft für klinische Spezialpräparate mbH klinische Spezialpräparate mbH von-Linné-Str.14 Feldstraße 170 22880 Wedel 22880 Wedel

medac Gesellschaft für medac Gesellschaft für klinische Spezialpräparate mbH klinische Spezialpräparate mbH Wilfried-Mohr-Straße 1-5 Theaterstraße 1 25436 Tornesch 22880 Wedel

Kiwa International Cert GmbH Grüner Deich 1 20097 Hamburg Germany Telefon +49 (0)40 30 39 49 60 Telefax +49 (0)40 30 39 49 79 e-mail: [email protected] www.kiwa.de

Updated environmental statement 2017 43 Nummer 94023

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medac Gesellschaft für klinische Spezialpräparate mbH

for the scope marketing and sales of pharmaceutical products (valid for all sites on page 3)

several sites: medac s.a.s medac Pharma S.r.l. 23 rue Pierre Gilles de Gennes Via Viggiano, 90 69007 Lyon, France 00178 Rome, Italy

medac GmbH – organizační složka medac GmbH sivuliike Suomessa Cervený kopec 4 Jorvas Hitech Center 639 00 Brno, Tschechische Republik Hirsalantie 11 02420 Jorvas, Finnland

medac GmbH Sp. z o.o. medac GmbH Oddział w Polsce Sucursal em Portugal ul. Postępu 21 B Alameda António Sérgio nº. 22 - 6º.C 02-676 Warschau, Polen 1495-132 Algés, Portugal

medac Gesellschaft für klinische Spezialpräparate m.b.H. organizačná zložka Slovensko Štúrova 4 811 02 Bratislava, Slowakai

medac Scandinavia (Sweden, Denmark, Norway, Iceland) Box 120 / Kungsgatan 32 432 23 Varberg, Schweden

medac GmbH Scion House Stirling University Innovation Park Stirling FK9 4NF, Großbritannien

Kiwa International Cert GmbH Grüner Deich 1 20097 Hamburg Germany Telefon +49 (0)40 30 39 49 60 Telefax +49 (0)40 30 39 49 79 e-mail: [email protected] www.kiwa.de

44 Updated environmental statement 2017

Theaterstraße 6 22880 Wedel · Germany www.medac.de