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General Terms & Conditions

General Terms & Conditions of Diagenom GmbH

Diagenom GmbH (hereafter also referred to as “Diagenom”) with main office in Rostock operates a medical diagnostics laboratory for human genetics with the areas of cytogenetics and molecular biology. Diagenom does not normally work for consumers. Consequently, these General Terms & Conditions do not apply to consumers. Pursuant to Section 13 of the German Civil Code (BGB), consumers are every natural person who concludes a legal transaction for a purpose that can be attributed neither to his commercial nor freelance professional work. You can find an overview of the offered analyses in the request forms at www.diagenom.de.

1           Area of Validity

1.1         These General Terms & Conditions in their respective current version apply to all services to be provided to customers by Diagenom. Deviating agreements for individual cases only apply to the respective contract and not to future agreements. Insofar as nothing to the contrary has been agreed, every one of our employees with corresponding qualified training is authorized to process the respective order.

1.2         In the sense of these conditions, the following definitions apply:

1.2.1        Customer: the medical person responsible pursuant to Section 3 No. 5 of the Genetic Diagnosis Act (GenDG)

1.2.2        Patient: the person concerned in the genetic analysis

1.2.3        Specimen: the biological material pursuant to Section 3 No. 10 of the Genetic Diagnosis Act (GenDG)

1.2.4        Analysis: the genetic analyses of the Patient specimen submitted by the Customer

2           Contract Conclusion/Contractual Partner 

2.1         Insofar as nothing to the contrary is agreed upon in writing, the contractual partner of Diagenom is the Customer.

2.2         Analyses can be requested by a sending a filled-out request form or informally via fax, e-mail or telephone call to Diagenom. Diagenom normally informs the Customer via e-mail, fax or letter within two workdays about the fee for the Analysis or rejects the Analysis request.

2.3         A contract is concluded if the Customer:

–           confirms the proposed fee via e-mail, fax, telephone call or letter within one week after receipt of the quote or

–           sends in the specimen, and Diagenom starts with the analysis

2.4        The Customer can send specimens for Analysis without having previously submitted an Analysis request in the sense of Clause 2.2. In this case, Diagenom shall try to process the Analysis order as fast as possible. The contract is considered concluded when Diagenom starts with the Analysis or confirms the order. As fee, Diagenom normally charges the fixed price for such Analyses. However, Diagenom reserves the right to reject individual Analyses. In particular, an Analysis request can be rejected if Diagenom cannot perform the ordered Analysis due to technical reasons or due to its operational capacity. In this case, the Customer shall be informed as quickly as possible.

3           Customer’s Duties to Cooperate

3.1         In order for Diagenom to be able to perform Analyses in line with agreements, the Customer is required to cooperate. The Customer is obligated to send Diagenom the required genetic specimens safely, on time, at the Customer’s own cost and in a condition that allows Analysis. The Customer shall disclose all required contact data to Diagenom, especially in the case of a request in the sense of Clause 2.3. Diagenom only compares the correct allocation of the material to the contents of the request form unless, in consideration of the conditions of an individual case, there is due cause to do otherwise.

3.2         If the Customer sends unusable Specimens for Analysis, Diagenom shall be released of its duty to perform. Diagenom shall inform the Customer about this without undue delay. In this case, Diagenom is empowered to charge the costs that the Customer caused Diagenom in an appropriate amount, in particular those that were incurred up until the time that the unusability was determined and the Sample was disposed of.

4           Performance Obligations of Diagenom

4.1         The Analysis scope is set and limited in the order submitted.

4.2         Diagenom only performs the Analyses of the submitted Specimen stipulated in the order on principle; without an express order, no screening is performed with respect to all diagnosable diseases. Should Diagenom detect findings other than those in the order by chance, Diagenom shall inform the Customer of such.

4.3         Diagenom shall be released from its performance obligations for the duration of a legal workers’ strike or lockout or force majeure unless Diagenom is to be held responsible for such.

5           Performance Obligations of the Customer/Payment Methods/Default

5.1         The Customer is obligated to pay the agreed-upon fee for Analyses.

5.2         After performance of the Analysis, payment can be via invoice. Before the Analysis, payment can be per advance payment to the bank account of Diagenom or via a crossed cheque sent with the Specimen.

5.3         The invoices are due on the date cited in the invoice; if no date is set, payments are due 21 (twenty-one) days after invoice receipt.

5.4         In the case of a delay in payment, Diagenom is empowered to charge interest on arrears in the amount of eight percent above the basic interest rate.

6           Consent for the Analysis

6.1        The Customer shall ensure separately for each Analysis order that he is authorized by the Patient to request such an Analysis and has obtained written consent for the Analysis. To this end, the Customer shall provide Diagenom with a copy of the written consent of the Patient with the Analysis request.

6.2         The Customer shall inform Diagenom about revocation of consent without undue delay.

7           Participation of Third Parties

Diagenom collaborates with additional specialists (e.g., specialist doctors, experts, laboratories and test facilities) to ensure Analysis quality insofar as the Customer has not prohibited forwarding of Specimens and data to third parties. This prohibition can be announced via telephone call, fax, e-mail, etc. at any time. If additional costs arise for the Customer due to collaboration with third parties, Diagenom shall consult and agree upon this collaboration with the Customer in advance.

8           Communication

In the area of human genetics, particularly personal, private and highly sensitive data are processed. Diagenom communicates with Customers in various ways, especially via the Internet, by regular mail, per e-mail, fax and telephone. Insofar nothing to the contrary is agreed upon, Diagenom may use any of these communication forms. Diagenom cannot assume any responsibility for risks due to use of these communication forms.  If the Customer wants a specific form of communication, the Customer shall inform Diagenom of this in writing at the earliest time possible. Insofar as the Customer does not request a specially protected communication form, the Customer shall release Diagenom for all claims in this connection presented by the Patient or a third party.

9           Data Protection/Handling Specimens and Analysis Results

9.1        Diagenom considers the careful and conscientious handling and protection of Patient data and Specimens to be of great importance. Diagenom only collects the information required for performing the Analysis and the contract. The information collected is only forwarded to a third party if the Patient consents or if Diagenom is obligated to forward it due to a law or a agency/legal directive.

9.2         All Specimens sent to Diagenom for Analyses are destroyed without undue delay as soon as they are no longer required for the Analyses unless the Patient consents to their storage and use for purposes of quality assurance in encoded (pseudonymised) form.

9.3       Diagenom shall store the results of Analyses in compliance with the relevant legal provisions, especially Section 12 of the Genetic Diagnosis Act (GenDG).

10        Liability

10.1     Liability of Diagenom for contractual violations as well as offences is limited to malicious intent or negligence. The following exceptions apply to the above limitation of liability:

10.2     If a guaranteed characteristic is lacking, Diagenom shall be liable for all damages caused by such.

10.3     In the case of slight negligence, Diagenom is liable unlimitedly in the case of death and injury to body or health or violation of an essential contractual obligation. If Diagenom is behind with its performance due to slight negligence, if the performance of Diagenom has become impossible, or if Diagenom has breached a duty essential to the contract, the liability is limited to the property and asset damage arising from such to the damage that is foreseeable and typical for this type of contract. An essential contractual duty is such a duty whose fulfilment makes the proper execution of the contract possible in the first place, whose violation endangers achievement of the contract purpose, and whose observance the Customer may regularly trust. This especially includes the obligation of Diagenom to perform the analysis in line with recognised rules of science.

10.4     For damages, which were caused by Diagenom through malicious intent or negligence, Diagenom is liable at most in the amount of the insurance amount cited below in Clause 11. This limitation of Diagenom does not apply if Diagenom is guilty of malicious intent or negligence, slightly negligent personal injury, loss of life or health or the violation of an essential contractual obligation as designated in Clause 10.3.

10.5     Insofar as employees of Diagenom work externally to their plant grounds, they are not liable for damages caused by a failure to sufficiently make land or premises safe for persons or vehicles unless the obligation to make land or premises safe for persons or vehicles is the responsibility of Diagenom.

10.6     Diagenom is not liable for damages due to the fact that the Customer did not fulfil his own obligations to cooperate, especially those cited in Clause 3.

10.7     Diagenom is not liable for damages due to force majeure or unavoidable events.

11        Insurance Policy

11.1     A globally applicable liability insurance policy has been concluded for damages caused by Diagenom.

11.2    Damages to persons and property are insured for an insurance sum of €5,000,000. Economic losses are insured for an insurance sum of €1,000,000.

11.3      As an exception to the provision above, the insurance amount for the USA, US territories and Canada is €100,000.

12        Offsetting, Retention Rights and Assignment

The Customer may only offset counter-claims if they have become legally enforceable or are not disputed. A retention right can only be enforced if it concerns the same matter. The rights due the Customer from this contractual relation cannot be transferred without the prior written consent of Diagenom.

13        Court of Jurisdiction and Applicable Law

13.1     The law of the Federal Republic of Germany applies exclusively.

13.2     Insofar as the Customer is a businessman, legal entity of public law or a special fund under public law or does not have its main office in Germany, the main office of Diagenom is the sole place of jurisdiction. Diagenom can enforce its demands at courts of the place of jurisdiction of the Customer. The sole place of jurisdiction is not affected by such.

14        Final Provisions

14.1     Insofar as a written contract is concluded with the Customer, all changes, supplements and ancillary agreements, especially information and promises made by employees involved in the order as well as third parties contracted by us (e.g. experts) with respect to these General Terms & Conditions and/or separately concluded contracts must be made in writing. Changing or cancelling this requirement for the written form also requires written agreement of the parties.

14.2     Should individual provisions above be or become null and void, the validity of the rest of the provisions shall not be affected by this. Null and void provisions shall be replaced by provisions that come closest to the intended economic objective of the contract and which do justice to the interests of both parties.

14.3     The English version of these General Terms and Conditions shall serve as a translation. The German version of the General Terms and Conditions shall prevail.

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