Data protection

1.1.  Introduction

As website operators, we also process personal data. In the following, we would like to give you an overview of these processes as well as of your rights and other important information that must be provided in accordance with the General Data Protection Regulation (GDPR). When you visit our website, you can access, save and print out the following data protection information at any time.

1.2.  Person Responsible

The person responsible for data processing within the meaning of the General Data Protection Regulation is:
Life Molecular Imaging GmbH represented by Managing Directors Dr. Ludger Dinkelborg and Michel Jongens
Tegeler Strasse 6-7
13353 Berlin
Email: info@life-mi.com Telefon: +49 30 461 124603

1.3.Data Protection Officer

Our data protection officer monitors data protection at our company. You can contact him if you have any questions about data protection with us or about your data processed by us:

UIMC DR. VOSSBEIN GmbH & Co KG
Unternehmens- und Informations-Management Consultants Otto-Hausmann-Ring 113
42115 Wuppertal
Tel.: +49 (0)202 9467726200
Fax: +49 (0)202 94677269200

1.4.  What data do we process when you visit our website and why do we do this?

Visiting our website is generally possible without the direct provision of personal data. You do not have to log in with your name etc. during your visit. However, there are also situations in which personal data is processed:

The internal section of our website can only be accessed after registration. If you have permission to access this section, you will find further information on data processing in the internal section. If you do not have the permission and enter personal data in the registration form, this data will be processed. In this case, we process your data to verify access permission and protect our infrastructure from attacks.

If you enter your data in our contact form (usually your contact data and your requests to us), we process these data – exclusively – for your request. For this purpose, the data is required.

If the data is required for contacting you in order to fulfil a contract with you or if a contract is intended to be concluded with you, this will result in the legality of the data processing. If mere contact remains, this results from the protection of legitimate interests. Because it is in our interest to answer your request and you have made this request, so we can assume that you have nothing against this processing. However, there is also data that you automatically transmit to us when you visit our website. This is your IP address. Without the IP address, we cannot display the website in your browser. Furthermore, when you access our website via a link, your browser transmits the so-called referrer. Here we see which link you clicked on. You can prevent this by not calling up our page via a link, i.e. clicking on a link, but by entering the website address directly in your browser. You also provide us with technical data about your browser and your computer: which browser, which operating system you are using, how large your monitor is, etc.

On the one hand we process this data (the IP address) to display the website to you. On the other hand, we log the visited websites (your IP address is shortened and thus made anonymous) in order to statistically evaluate the visits and improve our site: Which areas of our website are popular, which are less. We also evaluate the referrer in this way to optimize advertising that links to our

website. Especially with the referrer, it is possible that personal data from you is integrated here and is thus transmitted to us. We have no influence on this and do not evaluate this data on a personal basis. Displaying the website to you and optimizing the website is our legitimate interest.

We also do not pass your data on to third parties. However, there are a few exceptions: You have asked us to pass the data on,

You have asked us for something for which it is necessary to pass on the data, it is necessary for legitimate reasons to pass on the data. In this case, our data protection officer will consider whether you might have anything against it. If, at our customary discretion you would have nothing against it, we may pass the data on. One example is a criminal attack on our servers. Here we may pass on the temporally relevant sections of the log files to the investigating authorities. The only one who will object is the criminal assailant. And criminals are not protected in their actions.

And there is the exception that we are legally obliged to transmit the data.

We would like to ask you not to provide us with more data than is necessary for the respective matter. This helps us to comply with the principle of data minimisation and earmarking. Data that are not (no longer) necessary for a matter are generally deleted in a timely manner. Please note that we endeavour to secure all types of data transmission using SSL encryption. However, this safeguard is not complete, so the risk of unintentional disclosure of data cannot be completely excluded. Auto- matic decision making such as profiling does not take place.

1.5.  And what about cookies etc.?

Cookies are small text files which are stored on your system and whose content is transmitted back to us. They can serve various purposes. For example, you can manage a shopping basket, or you can be recognized as a recurring website visitor.

There are other techniques that offer comparable functions: IDs in the URL or “browser fingerprinting”.

We use these techniques for technical reasons for administration, e.g. to save the settings you have made (e.g. the display font size).

We also use these techniques to recognize a visitor during his visits to improve our website: If visitors visit us regularly, we obviously have a good offer – if they only visit our website once and do not come back, then we have to do something. These data are not personal, we cannot identify you as a visitor here. You can prevent the creation of cookies by a certain setting of your browser. You can usually find information on this in your browser’s instructions. By preventing the creation of cookies, some functions of our website may fail.

1.6.  Website Analysis: WordPress.com-Stats

This website uses WordPress.com-Stats, a tool for statistical analysis of visitor access, operated by Automattic Inc, 60 29th Street #343, San Francisco, CA 94110-4929, USA, using tracking technology from Quantcast Inc, 201 3rd St, Floor 2, San Francisco, CA 94103-3153, USA. WordPress.com-Stats uses “cookies”, which are text files placed on your computer, to help the website analyse how users use the site. The information generated by the cookie about your use of this website is stored on a server in the USA. The IP address is made anonymous immediately after processing and before it

is stored. You may refuse the use of cookies by selecting the appropriate settings on your brows- er, however please note that if you do this you may not be able to use the full functionality of this website.

You can object to the collection and use of data by Quantcast with effect for the future by setting an opt-out cookie in your browser by clicking on the link “Click here to opt-out”: http://www.quantcast. com/opt-out. If you delete all cookies on your computer, you must set the opt-out cookie again.

1.7. Third-party services and content

We use a link to the service provider LinkedIn (https://www.linkedin.com/company/life-molecular-imaging/). If you use the link, you will be forwarded to our company’s profile on LinkedIn. LinkedIn thus receives information that you have previously visited our homepage. The collection of personal data and the extent to which it is collected also depends on whether you are logged in to LinkedIn at the same time. If this is the case, LinkedIn may be able to link your usage behaviour to your person.

The operator of the website is: LinkedIn Ireland Unlimited Company, Wilton Plaza, Wilton Place, Dublin 2, Ireland. The terms of use for LinkedIn can be found at www.linkedin.com/legal/user-agreement. Detailed information on the handling of personal data via LinkedIn can be found at www.linkedin.com/legal/privacy-policy.

1.8. Your rights as a data subject

You have the comprehensive right to information from us at any time as to whether and which of your personal data is processed or disclosed by us or another party for which purposes. You have the right at any time to have incorrect data corrected and unlawfully processed data deleted immediately. Furthermore, you can request the restriction of the processing of your personal data if on the one hand the continuation of the processing no longer appears legal but on the other hand an immediate deletion is not yet required (e.g. if the correctness is disputed but this has yet to be checked). If the processing is based on your consent, you can revoke this at any time – of course only for the future. You also have the right to data transferability and the right of appeal to the following supervisory authority:

Berlin Commissioner for Data Security and Freedom of Information Friedrichsstraße 219

10969 Berlin
Tel.: +49 30 13889-0
Fax: +49 30 2155050
Email: mailbox[at]datenschutz-berlin.de

1.9.  Changes

Legal, economic and technical developments may make it necessary to adapt this data protection information. We will make the updated version available to you promptly on our website.

1.10.   Text of Article 13 of the GDPR (General Data Protection Regulation):

Information to be provided where personal data are collected from the data subject

Where personal data relating to a data subject are collected from the data subject, the controller shall, at the time when personal data are obtained, provide the data subject with all of the following information: the identity and the contact details of the controller and, where applicable, of the con- troller’s representative; the contact details of the data protection officer, where applicable;

the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; the recipients or categories of recipients of the per- sonal data, if any; where applicable, the fact that the controller intends to transfer personal data to a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46or 47, or the second subpara- graph of Article 49(1), reference to the appropriate or suitable safeguards and the means by which to obtain a copy of them or where they have been made available. In addition to the information referred to in paragraph 1, the controller shall, at the time when personal data are obtained, pro- vide the data subject with the following further information necessary to ensure fair and transparent processing: the period for which the personal data will be stored, or if that is not possible, the crite- ria used to determine that period; the existence of the right to request from the controller access to and rectification or erasure of personal data or restriction of processing concerning the data sub- ject or to object to processing as well as the right to data portability;

where the processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; the right to lodge a complaint with a supervisory authority;

whether the provision of personal data is a statutory or contractual requirement, or a requirement necessary to enter into a contract, as well as whether the data subject is obliged to provide the per- sonal data and of the possible consequences of failure to provide such data;

the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the signifi- cance and the envisaged consequences of such processing for the data subject.

Where the controller intends to further process the personal data for a purpose other than that for which the personal data were collected, the controller shall provide the data subject prior to that further processing with information on that other purpose and with any relevant further information as referred to in paragraph 2.

Paragraphs 1, 2 and 3 shall not apply where and insofar as the data subject already has the information

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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