Imprint

Otsuka Novel Products GmbH
Erika-Mann-Str. 21
80636 München (Munich), Germany
Tel.: + 49 89 2060205-50
Fax: + 49 89 2060205-55
Email: reception@otsuka-onpg.com

Managing Director: Robert Dornheim
Commercial register: HRB 190185, Munich Local Court
VAT identification number: DE 275782318

General Terms and Conditions of Sale

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We confirm your order subject to the exclusive application of our general terms and conditions of sale.

§ 1 Application

(1) These terms and conditions of sale shall apply exclusively. Differing or contrary terms shall not apply except if expressly agreed upon in writing.
(2) These terms and conditions of sale shall also govern all future transactions between the parties and shall also apply if we perform delivery despite our knowledge of differing or contrary terms.
(3) These terms and conditions of sale shall only apply vis á vis entrepreneurs, governmental entities, or special governmental estates within the meaning of sec. 310 para. 1 BGB (German Civil Code).
(4) The order can only be fulfilled if the ordering party can provide all documents necessary proving it is allowed to handle prescription medicines. The purchaser ensures and warrants in particular that he is eligible for the purchase of prescription medicines pursuant to § 47 German Drug Act (Arzneimittelgesetz, AMG).

§ 2 Offer, Acceptance

Insofar as the order constitutes an offer within the meaning of § 145 BGB we are entitled to accept the offer within two weeks and in accordance with § 1 (4).

§ 3 Prices, Payment

(1) Prices are CPT place of the consignee, exclusive of the respective statutory VAT and exclusive of costs for packaging and transportation, except as otherwise expressly agreed upon.
(2) The purchase price is due and payable net within 30 days from the date of the invoice. From the due date, default interest in the amount of 8% above the respective base interest rate p. a. shall accrue. We reserve all rights to claim further damages for delay.

§ 4 Offset, Retainer

The purchaser shall be entitled to offset only insofar as the purchaser’s counterclaim is acknowledged, undisputed or assessed in a legally binding judgement. The purchaser is entitled to claim retainer rights only to the extent such rights are based on the same transaction.

§ 5 Delivery and Resale

(1) Delivery is conditioned upon timely and proper performance of all duties of the purchaser. Defences based on non-performance of the contract are reserved.
(2) In case of default in acceptance or other breach of duties to cooperate by the purchaser we are entitled to claim any resulting damage including but not limited to additional expenses, if any. Further damages are reserved. In this case, the risk of loss or damage to the goods passes to the purchaser at the time of such default or breach of duty to cooperate.

§ 6 Passing of Risk, Shipment

If the purchaser demands shipment of the goods the risk of loss or damage to the goods passes to the purchaser upon dispatch.

§ 7 Retention of Title

(1) We reserve title to the delivered goods until all claims which exist against the purchaser based on the business relationships at the time the contract is concluded have been fulfilled. This shall also apply to any future claims that we acquire from the ongoing business relationship with the purchaser.
(2) In case the purchaser culpably violates the contract, in particular in the event of default in payment, we are entitled to take back the goods. Taking back the goods does not constitute a withdrawal from the contract, unless we explicitly declared a withdrawal in writing.
(3) The purchaser shall handle the goods with due care and maintain suitable insurance.
(4) The purchaser has no permission to resell goods subject to the above retention of title.
(5) We undertake to release the securities we are entitled to upon the purchaser’s request if the realisable value of the securities exceeds the claims to be secured by more than 15%. The selection of the securities to be released shall be at our discretion.

§ 8 Warranty

(1) Precondition for any warranty claim of the purchaser is the purchaser’s full compliance with all requirements regarding inspection and objection established by sec. 377 HGB (German Commercial Code).
(2) Warranty claims shall be time-barred after 12 months of the passage of risk.
(3) In case of non-conformity of the goods the purchaser is entitled to alternative performance in the form of subsequent improvement or delivery of conforming goods. If such alternative performance has failed, the purchaser is entitled to reduce the purchase price or to withdraw from the contract.
(4) The above limitations of warranty do not apply to damages according to the 16th section of the AMG.

§ 9 Liability

(1) In case of intent or gross negligence on our part or by our agents or assistants in performance we are liable according to the provisions of applicable law; the same applies in case of breach of fundamental contract obligations (an obligation which must be fulfilled to enable a due performance of the contract and on whose fulfilment the contractual partner generally relies and may rely). To the extent the breach of contract is unintentionally our liability for damages shall be limited to the typically predictable damage.
(2) Our liability for culpable damage to life, body or health as well as our liability under the Product Liability Act shall remain unaffected.
(3) The above limitations of liability do not apply to a liability according to the 16th section of the German Drug Act (Arzneimittelgesetz, AMG).
(4) Any liability not expressly provided for above shall be disclaimed.

§ 10 Applicable law, Jurisdiction

(1) This contract shall be governed by the laws of the Federal Republic of Germany (excluding the Convention on Contracts for the International Sale of Goods).
(2) Place of performance and exclusive place of jurisdiction for all disputes arising out of or in connection with this contract shall be Munich, Germany.

Copyright

Rights for all content contained in this website—information including but not limited to text, trademarks, logos, and graphics, features including but not limited to software and icons, and editing and placement of the content—belong to Otsuka Novel Products GmbH or are used with legitimate rights. Under copyright laws, it is strictly forbidden for you to use or duplicate the contents of this website, without the company’s permission, for anything other than your own personal, non-commercial use.

Disclaimer

As a content provider pursuant to Sec. 7 para. 1 of the German Telemedia Act (Telemediengesetz, TMG) Otsuka Novel Products GmbH (“ONPG”) is, in accordance with statutory laws, responsible for its “own content” provided at www.otsuka-onpg.com.

A distinction must be made between this own content and cross-references (“links”) to content from other providers. In this respect, ONPG provides “third-party contents” which are available for use through these cross-references and are respectively marked as “[external]” or available over a new browser window.

When the links were first inserted the third party contents were checked to see whether they might cause a liability under civil or criminal law. However, it cannot be ruled out that contents are subsequently changed by the respective providers. ONPG does not continuously check the contents for changes (to which the links refer) that could constitute a new liability. If, in your opinion, the linked external pages are in breach of applicable law or contain otherwise inappropriate content, please inform us via reception@otsuka-onpg.com.

Our Internet pages contain general information about ONPG, our products and our services. They are not intended to give medical or other advice or instructions regarding the products and services offered by ONPG. For specific inquiries concerning our products and services, please contact ONPG directly.

 

Otsuka Novel Products GmbH

Privacy Notice (last updated 25 November 2020)

 

About this notice

This website is operated by Otsuka Novel Products GmbH, Erika-Mann-Str. 21, 80636 Munich, Germany (hereinafter referred to as “ONPG”).

For the purposes of this notice, ONPG will be the controller, meaning ONPG determines how and to what extent your personal data will be processed (the controller is also referred to in this notice as “ONPG”, “we”, “our” and “us”).

This notice explains how and why we use your personal data, e.g. when we provide you with information you have requested from us, within the framework of any agreement pursuant to which you provide services to ONPG, or when you simply use our websites and other digital platforms. In all cases, ONPG understands and respects your privacy and acknowledges that in particular the information about an individual’s health and healthcare is confidential and sensitive.

In this notice, when we talk about personal data we mean any information that relates to an identifiable natural person – in this case, you.

You should read this notice, so you know what personal data we collect about you, what we do with it and how you can exercise your rights in connection with it. You should also read any other privacy notices that we give you, that might apply to our use of your personal data in specific circumstances from time to time. If you have any questions about this notice, you can contact ONPG’s Data Protection Officer, by writing to the “Legal & Compliance Department” at the address for ONPG provided above, or by emailing privacy@otsuka-onpg.com.

In summary…

  • We use your personal data within the framework of any agreement pursuant to which you provide services to ONPG, when you use our websites and other digital platforms, to provide you with information, where you have requested them, manage our business, recruit new staff, comply with our legal obligations, and improve and monitor the performance of our digital platforms
  • We have measures in place to safeguard your personal data when we transfer it outside the European Union
  • We take steps to minimise the amount of personal data we hold about you and to keep it secure
  • We delete your personal data when we no longer need it, and we have policies in place to govern when that is
  • You have a number of rights in relation to your personal data
  • We are happy to answer your questions about any of the above – please just send them to privacy@otsuka-onpg.com.

Who are you?

We process personal data for different purposes, depending on who you are. To find out for what specific purposes we process your personal data, you may choose from the below.

I am…

Quickly find what you’re looking for by clicking the links below:

1. Our data protection responsibilities

2. What types of personal data do we collect and where do we get it from?

3. What do we do with your personal data, and why?

4. Who do we share your personal data with, and why?

5. Where is your personal data transferred to?

6. How do we keep your personal data secure?

7. How long do we keep your personal data for?

8. What are your privacy rights and how can you exercise them?

1. Our data protection responsibilities

ONPG is a “controller” in relation to its use of your personal data. This is a legal term – it means that we make decisions about how and why we use your personal data and, because of this, we are responsible for making sure it is used in accordance with applicable data protection laws. We are required by law to give you the information in this notice.

2. What types of personal data do we collect and where do we get it from?

2.1 The personal information we process about you broadly falls into six main categories: (i) Contact Information; (ii) Agreement Information; (iii) Candidate Information; (iv) Browsing Information; (v) Medical Information and (vi) Customer Information.

2.2 We collect your personal information from limited sources. The table below sets out the different types of personal information that we collect and the sources we collect it from.

CategoryType of personal dataCollected from
Contact Information
  • Name
  • Address
  • Telephone number
  • Organisation details (eg your place of work, practice, professional area, job title and organisation contact information)
  • You
Agreement Information
  • Contact Information (see above)
  • Details relating to the services you provide to us, including service related communications with you
  • Information about other people (eg your customers and/or staff, your employer) that you share with us in connection with your services
  • Information you provide us when you interact with ONPG (eg for a conference, patient cohort, order)
  • Billing and payment information
  • You/your organisation’s banking details
  • You

 

Candidate Information
  • Contact Information (see above)
  • Details you include in your application, eg CV, references, certificates
  • You
  • Publically available resources
Browsing Information
  • IP address
  • You and your use of our digital platforms
Medical Information
  • Contact Information (see above)
  • Information you disclose during your query (adverse event, quality complaint, medical information)
  • You
Customer Information
  • Contact Information (see above)
  • Agreement Information (see above)
  • Details relating to the services provided by us to you, including service related communications with you

 

  • You

2.3 Please note that if you do not provide us with your Contact Information we will not be able to provide you with any information you request, and if you do not provide us with your Contact Information, Agreement Information or Candidate Information, we will not be able to interact or contract with you.

3. What do we do with your personal data, and why?

3.1 We use your personal data for a number of different purposes. We must always have a “lawful basis” (ie a reason, prescribed by law) for processing your personal data. The table below sets out the purposes for which we process the different categories of your personal data and the corresponding lawful basis for that processing. For some processing activities, we consider that more than one lawful basis may be relevant – depending on the circumstances.

3.2 Website visitors

Category of informationPurposes of processing Lawful basis
Contact InformationResponding to your enquiriesTo perform a contract with you
Legitimate interests (It’s important that we can respond to your enquiries)
Browsing InformationMonitoring and producing statistical information regarding the use of our platforms, analysing and improving their functionality, including data security. This is done by placing cookies on your device.Legitimate interests (We need to perform this limited routine monitoring to make sure our platforms work properly) and your consent (for non-essential cookies)
Contact Information
Medical Information
Handling your enquiry or notification
Processing associated safety information
To perform a contract with you
To comply with a legal obligation
Legitimate interests (ensure the safety of our products)

3.3 Healthcare professional

Category of informationPurposes of processing Lawful basis
Contact InformationResponding to your enquiriesTo perform a contract with you
Legitimate interests (It’s important that we can respond to your enquiries)
Agreement InformationTo be able to keep accurate records of ONPG’s communications with you.  In addition, we may need the information you provide to comply with our regulatory monitoring and reporting obligations.To perform a contract with you
To comply with a legal obligation
Agreement InformationDisclosure of payments according to regulatory requirementsConsent
Agreement InformationTo understand how our products impact your patients, to track and respond to safety concerns and to further develop and improve our products and services.  For example, we may create a record about you to decide whether to invite you to participate in various programs, panels of experts or surveys about our products or services.Legitimate interests (we need to use certain personal data for our business development strategies; we have a legitimate interest in making sure that we are continuously improving our product offering)
Agreement InformationCompliance with our legal obligations where data related to safety or pharmacovigilance is concerned, including those related to adverse events, product complaints and patient safety.To comply with a legal obligation
Contact Information, Medical InformationHandling your enquiry or notification
Processing associated safety information
To perform a contract with you
To comply with a legal obligation
Legitimate interests (ensure the safety of our products)

3.4 Job applicants

Category of informationPurposes of processing Lawful basis
Candidate InformationProcessing of this personal data is required to enable ONPG to administer the recruiting process, including the set-up of an electronic job applicant HR file, managing your application, organizing interviews – in short, the processing is necessary for us to entering into a contract with you.To perform a contract with you
Candidate InformationWe may also share your personal data with other ONPG group companies to consider you for future job openings and will retain your data for a limited period of time beyond an unsuccessful application for this purpose.Legitimate interests (It is our interest to consider you for other vacancies, now and in the future)

3.5 Website visitors, healthcare professionals and job applicants

Category of informationPurposes of processing Lawful basis
All InformationEstablishing and enforcing our legal rights and obligations and monitoring to identify and record fraudulent activity; Complying with instructions from law enforcement agencies, any court or otherwise as required by law; resolving any complaints from or disputes with you.To comply with a legal obligation

3.6 Requestor

Category of informationPurposes of processing Lawful basis
Contact Information, Medical InformationHandling your enquiry or notification
Processing associated safety information
To perform a contract with you
To comply with a legal obligation
Legitimate interests (ensure the safety of our products)

3.7 Customer

Category of informationPurposes of processing Lawful basis
Contact InformationResponding to your requests
Performing obligations by us to you (eg orders and other enquiries)
To perform a contract with you
Legitimate interests (It’s important that we can respond to your enquiries)
Agreement InformationTo be able to keep accurate records of ONPG’s communications with you.  In addition, we may need the information you provide to comply with our regulatory monitoring and reporting obligations.To perform a contract with you
To comply with a legal obligation
Customer InformationPerforming obligations by us to you (eg orders and other enquiries)
Processing information associated with your request to comply with our regulatory monitoring and reporting obligations
To perform a contract with you
To comply with a legal obligation
Contact information,
Medical Information
Handling your enquiry or notification
Processing associated safety information
To perform a contract with you
To comply with a legal obligation
Legitimate interests (ensure the safety of our products)

 

3.8 Cookies and similar technologies

In order to improve the appearance of our Website and to allow the use of certain functions, we use “cookies”. Cookies are small text files that are stored on your computer. Please visit our Cookies Policy to read more on which cookies we set.

 

4. Who do we share your personal data with, and why?

4.1 Sometimes we share your personal data with third parties, including the following:

4.1.1. other Otsuka companies where necessary for the purposes described above. We are joint controllers with Otsuka Pharmaceutical Europe Ltd, Gallions, Wexham Springs, Framewood Road, Wexham, Bucks, SL3 6PJ for the processing of medical information data. If you would like to receive the essence of the arrangement please contact us.

4.1.2 courts, where we are asked to respond to a court order or other binding requests;

4.1.3 regulatory authorities and law enforcement agencies, where necessary for any investigations or to respond to enquiries in relation to our compliance with applicable law or regulations; and

4.1.4 professional advisors (such as lawyers and accountants).

These organisations will also use your personal data as a “controller” – they will have their own privacy notices which you should read, and they have their own responsibilities to comply with applicable data protection laws.

4.2 We also ask third party service providers to carry out certain business functions for us. These include:

4.2.1 IT support, cloud platform and data hosting providers who help us with the operation of our websites, mobile applications, document and workflow management systems and other systems and applications;

4.2.2 Service providers assisting us in the organisation of customer services and/or with respect to storage and logistics of products;

4.2.3 Service providers assisting us in the organisation (monitoring and reporting) of pharmacovigilance related matters;

4.2.4 Service providers assisting us in the organisation of events, arranging travel logistics and bookings;

4.2.5 Third parties assisting on the collection and disclosure of transfer of value information to the public;

4.2.6 Communication service providers, including companies who send out surveys and communications on our behalf; and

4.2.7 survey providers who help collate feedback for us.

We will have in place an agreement with our service providers which will restrict how they are able to process your personal data and impose appropriate security standards on them.

 

5. Where is your personal data transferred to?

5.1 Since ONPG is part of a global company, we will sometimes need to transfer your personal data outside the European Union, in particular to the US and our headquarters in Japan. We will only make that transfer if:

5.1.1 that country ensures an adequate level of protection for your personal data;

5.1.2 the recipient or recipient country is subject to an approved certification mechanism or code of conduct with binding and enforceable commitments which amount to appropriate safeguards for your personal data;

5.1.3 we have put in place appropriate safeguards to protect your personal data, such as a contract with the person or entity receiving your personal data which incorporates specific provisions as directed by the European Commission;

5.1.4 the transfer is permitted by applicable laws; or

5.1.5 you explicitly consent to the transfer.

5.2 If you would like to see a copy of any relevant provisions, please contact us.

 

6. How do we keep your personal data secure?

6.1 We will put in place appropriate security measures to protect your personal data from unlawful or unauthorised processing and accidental loss, destruction or damage.

6.2 However please note that, in relation to any personal data you submit to us online, we cannot guarantee the security of data sent to us in this way. Transmission of data over the internet is at your own risk.

 

7. How long do we keep your personal data for?

7.1 We will only retain your personal data for a limited period of time, and for no longer than is necessary for the purposes for which we are processing it for. This will depend on a number of factors, including:

7.1.1 any laws or regulations that we are required to follow;

7.1.2 whether we are in a legal or other type of dispute with each other or any third party;

7.1.3 the type of information that we hold about you; and

7.1.4 whether we are asked by you or a regulatory authority to keep your personal data for a valid reason.

 

8. What are your privacy rights and how can you exercise them?

8.1 Where our processing of your personal data is based on your consent (see table at paragraph 3 above), you have the right to withdraw your consent at any time. If you do decide to withdraw your consent we will stop processing your personal data for that purpose, unless there is another lawful basis we can rely on – in which case, we will let you know.

8.2 Where our processing of your personal data is based on the legitimate interests (see table at paragraph 3 ‎0above), you can object to this processing at any time. If you do this, we will need to show either a compelling reason why our processing should continue, which overrides your interests, rights and freedoms or that the processing is necessary for us to establish, exercise or defend a legal claim.

8.3 You have the right to (subject to certain limitations):

8.3.1 access your personal data and to be provided with certain information in relation to it, such as the purpose for which it is processed, the persons to whom it is disclosed and the period for which it will be stored;

8.3.2 require us to correct any inaccuracies in your personal data without undue delay;

8.3.3 require us to erase your personal data;

8.3.4 require us to restrict processing of your personal data;

8.3.5 receive the personal data which you have provided to us, in a machine readable format, where we are processing it on the basis of your consent or because it is necessary for your contract with us (see table at paragraph 3 above) and where the processing is automated; and

8.3.6 object to a decision that we make which is based solely on automated processing of your personal data.

8.4 Please contact us at privacy@otsuka-onpg.com if you would like to exercise any of your privacy rights.

8.5 We also encourage you to let us know if you have any concern about how we are processing your personal data so we can try to resolve your concerns. However, if you consider that we are in breach of our obligations under data protection laws, you are always entitled to submit a complaint with the competent supervisory authority.

8.6 We may decide to change this notice. If the change is fundamental or may significantly affect you, we will provide you with the updated notice in advance of the change actually taking effect. We encourage you to review the content of this notice regularly.

 

Information current as of 30-12-2020
Reference ONP-COP-2000001