General Terms and Conditions for the Participation in Ring Trials of Berufsverband Deutscher Humangenetiker e.V.

1. General, scope

(1) Berufsverband Deutscher Humangenetiker e.V. (BVDH) offers ring trials under www.bvdh-ringversuche.de according to the applicable guidelines of the German Medical Association (Bundesärztekammer) or their application by analogy.

(2) These General Terms and Conditions shall apply exclusively; any general terms and conditions of the Participant shall not apply, even if BVDH has not contradicted them in the particular case.

(3) Only the present version in the German language shall apply.

(4) Any statements of legal relevance shall be made in writing.

2. Registration

(1) Enrolment for a ring trial requires the successful registration of the Participant under www.bvdh-ringversuche.de. All laboratories worldwide that routinely perform human genetic diagnostics may participate.

(2) When registering, the Participant shall be obliged to provide truthful and complete information. The Participant itself shall enter any significant changes in the user account immediately and without being asked to do so.

(3) Personal access data will be generated by the Participant itself when registering. The Participant is obliged to keep its registration data for the user account secret and store them such that any access by unauthorised persons is prevented.

3. Enrolment in a ring trial

(1) The Participant shall declare its interest in the participation in a ring trial by enrolling under www.bvdh-ringversuche.de. The Participant will receive an automated email which confirms the receipt of the enrolment by BVDH, but which does not yet mean acceptance of the contract. A contract shall be deemed concluded upon the dispatch of the ordered samples (acceptance of enrolment).

(2) Upon expiry of the enrolment period, the entitlement to acceptance of enrolments or changes to the contract shall lapse. BVDH is entitled to cancel or postpone the ring trial prior to its commencement.

(3) The current prices published at the time of enrolment under www.bvdh-ringversuche.de shall apply. All prices shall be understood plus the legal VAT, unless stated otherwise.

4. Performance of the ring trials

(1) BVDH uses subcontractors for providing services when performing the ring trials. In the event of subcontracting, the services will be provided by subcontractors who are bound by instructions and obliged to maintain confidentiality.

(2) BVDH shall send samples to be analysed by the Participant within the scope of participation in the ring trial by mail or courier on the dates specified in the enrolment procedure at BVDH’s expense if sent within Germany and at the Participant’s expense if sent outside Germany (costs passed on). The risk of loss or damage of the samples shall pass on to the Participant as soon as BVDH has handed over the sample to the companies designated to carry out shipment, unless BVDH has culpably breached its duty of care during dispatch. If the sample material is lost or damaged, a complaint shall be submitted immediately. If possible, BVDH shall provide a replacement sample. The costs for the second shipment shall be borne according to the costs-by-cause principle.

(3) In addition or alternatively to the sent sample material to be analysed, the ring trial will be performed using materials or questions provided by the ring trial management on the website www.bvdh-ringversuche.de (e.g. data sets, images, texts). To this end, it is necessary that the Participant logs on to the website with its user account and downloads data, if appropriate. Deadlines and periods will be announced in the enrolment process.

(4) The Participants are required to upload the analysis results to their user account and, if appropriate, also enter data regarding participation there. The deadline for submitting the analysis results will be announced in the enrolment process. Technical problems shall be reported to the Coordination Office immediately.

(5) BVDH will check the uploaded and entered analysis results and send the Participant a certificate or confirmation of participation. A certificate about the successful participation in the ring trial will be issued only for analysis results transmitted on time – provided the other requirements are fulfilled.

(6) Invoices shall be issued after shipment of the ring trial samples or activation of the analysis task. Certificates or confirmations of participation will not be sent until after the invoice has been paid. BVDH shall be free to demand advance payment from individual Participants.

(7) After receipt of the ring trial results, any objections or complaints may be submitted in text form to the Quality Assurance Coordination Office (BVDH, Koordinationsstelle Qualitätssicherung, Feldstr. 30, 52249 Eschweiler, Germany, brandt@bvdh.de) or the Head Office (BVDH, Linienstr. 127, 10115 Berlin, info@bvdh.de) within a period of 4 weeks. After this period has expired, any claims of the Participant in this regard shall be excluded.

5. Liability

Claims for damages - irrespective of their legal ground - against BVDH, its legal representatives, vicarious agents and subcontractors shall only exist under fault-based liability for wilful intent and gross negligence. Any liability of BVDH for negligent breaches of duty – except in the case of a breach of a material contractual obligation – shall be excluded. Liability shall be limited to typically foreseeable damage. Otherwise, any liability of BVDH shall be excluded. This exclusion of liability shall not apply to injury to life, body or health and to the extent the damage is based on an intentional or grossly negligent breach of duty.

6. Confidentiality, data protection

(1) The parties to the contract undertake to keep confidential any information and documents of the other party designated as confidential or resulting from the circumstances to be treated as confidential, as well as its trade and business secrets.

(2) BVDH collects, processes and uses personal data of the Participants to the extent necessary for the performance and evaluation of the ring trials and the issuance of the certificates or confirmations of participation. To this end, also subcontractors and automatic data processing systems are used in compliance with data protection requirements.

(3) The Participants consent to the processing and use of their sent analysis results for the purpose of quality assurance. The analysis results will be transmitted in pseudo-anonymised form to the other Participants of the respective ring trial. The consent is given on a voluntary basis and may be revoked by the Participant towards BVDH at any time with effect for the future.

(4) You can find our privacy policy under www.bvdh-ringversuche.de/index/datenschutz.

7. Choice of law, place of jurisdiction

(1) The contract will be governed by the law of the Federal Republic of Germany. The application of international private law and the UN Convention on International Contracts for the Sale of Goods is expressly excluded.

(2) The place of performance and jurisdiction shall be Berlin. BVDH shall be entitled to sue the Participant at the place of performance or the Participant’s general place of jurisdiction. If one provision of these General Terms and Conditions is invalid, this shall not affect the validity of the remaining provisions.