General Terms & Conditions

§ 1 Scope

(1) These General Business Terms shall apply exclusively to all deliveries and services of ‘benefits’ for the entire business transactions between ‘benefits’ and the customer in addition to the individual contractual agreements. They shall also apply to all future deliveries and services and offers of ‘benefits’, even if they are not agreed separately once again. Deviating terms and conditions of the customer are not recognised. Neither shall they become contents of the contract by acceptance of the order.

(2) All offers of ‘benefits’ are without obligation and non-binding insofar as they have not explicitly been marked as binding or include a certain acceptance deadline.

§ 2 Duties of the contractual partners

(1) The type and scope of the services owed by the consultant are oriented to the individual contractual agreements and the statutory regulations at the time when the contract was concluded.

(2) Insofar as not explicitly agreed otherwise in writing the consultant owes the performance of services, not however a success. The consultant shall only owe legal services according to the individual contractual agreements insofar as they as a secondary service belong to the job or activity profile of the consultant within the meaning of § 5 Par. 1 Legal Services Act.

(3) If the consultant or the customer become aware of changes to the legal position after conclusion of the contract, which have implications on the services to be provided by the consultant (e.g. changes to the regulations of the Eudralex, in particular Notice to Applicants (NTA), Clinical Trial Directive, Variation Regulation, scientific or regulatory guidelines, etc.; regulations for the paediatric development of drugs, development of Orphan Drugs or so-called ‚Advanced Therapies’, as well as relevant national laws or regulations), the contractual partners shall inform each other immediately and agree upon an extension or change to the scope of services which becomes necessary hereby.

(4) The customer shall carry out all measures which are necessary for the provision of the services by the consultant in time, in particular submit corresponding declarations and make documents and information available.

§ 3 Place and time of the consultant’s activity

(1) The consultant shall independently determine his place of work, his time of work and the manner of the work at his dutiful discretion. The consultant shall be available if the personal presence of the consultant in business premises of the customer should be necessary in an individual case.

(2) The parties shall coordinate on dates for this purpose. The consultant shall provide the consultancy service himself, by own employees or by third parties commissioned and monitored by him.

§ 4 Property to documents

(1) Reports, expert’s opinions and other documents as well as presentations, templates, samples and all other objects, which the consultant makes available to the customer with the provision of the contractual service, shall remain the property of the consultant and are to be returned to the consultant upon request, by no later however than at the end of the contract. The consultant reserves all rights hereto, in particular copyrights. They may not be made accessible to third parties or used outside of the purpose, for which they were handed over to the customer. This shall in particular apply to those documents which are marked as confidential.

(2) Before each forwarding of documents to third parties the customer has to obtain the explicit written consent of the consultant.

§ 5 Official or court proceedings

If the consultant is obliged to make statements as a witness relating to matters which were the object of a consultant service provided by him in the event of court or official proceedings, the expert shall receive the difference between the witness’ fee and the remuneration rates agreed in the individual consultancy agreement from the customer.

§ 6 Service deadlines and dates

Agreed delivery and service deadlines are approximate deadlines insofar as the delivery date was not explicitly agreed as binding. It shall begin with the start of the contract, no earlier however than after the receipt of all information, which is necessary for the consultancy service and has to be made available by the customer.

§ 7 Offsetting, rights to retention

(1) The customer can only declare the offsetting against undisputed or recognised claims or claims which have been determined final and binding. The assignment of claims directed against the consultant requires the consent of the consultant.

(2) The customer can only exercise a right of retention because of claims from the same contractual relationship. The pre-requisite is further that these claims are undisputed, have been recognised or are determined final and binding.

§ 8 Statute-of-limitations

(1) The statute-of-limitations for possible claims because of defects is one year. The statute-of-limitations according to sentence 1 shall also apply to all existing claims for damages against the consultant irrespective of whether they are associated with a defect and irrespective of the legal basis of the claim.

(2) The statute-of-limitations shall not apply in the event of wilful intent, malicious non-disclosure of a defect or assumption of a guarantee of condition. It shall further not apply in case of claims for damages owing to the injury to life, the body or the health or freedom of a person, with claims from the Product Liability Act, in case of grossly negligent breach of duty or with the culpable breach of essential contractual duties.

(3) The execution of the subsequent satisfaction by the consultant does not include in case of doubt any recognition within the meaning of § 212 No. 1 BGB [German Civil Code]. Subsequent satisfaction measures shall inhibit the statute-of-limitations which applies to the original service claim by the duration of the executed subsequent satisfaction measure. The statute-of-limitations shall not begin to apply new hereby.

(4) Incidentally the statutory regulations apply.

§ 9 Liability for damages

(1) The liability of the consultant for damages, no matter for what legal reason, is limited according to the following regulations:

(2) The consultant shall not be liable in the event of simple negligence of his employees or other vicarious agents insofar as it does not concern a breach of essential contractual duties.

(3) Insofar as the consultant according to Par. (2) above is liable for damages with respect to the reason, this liability is limited to damages, which the consultant foresaw as a possible consequence of a breach of contract after the conclusion of the contract or which he should have foreseen with the application of the customary care and attention. Indirect damages and follow-up damages, which are the consequence of defects to the object of delivery and service, are in addition only capable of compensation insofar as such damages are typically to be expected with the use of the object of delivery and service as intended.

(4) In the event of a liability for simple negligence the obligation for compensation of the consultant for property damages and thus resulting further financial losses is limited to an amount of € 2,000,000.- per damaging event (in line with the current sum insured of the employer’s liability insurance of the consultant). This limitation shall also apply if it concerns a breach of essential contractual duties.

(5) The afore-mentioned liability exclusions and limitations shall apply in the same scope for the benefit of the employees and other vicarious agents of the consultant.

(6) The limitations of this § 8 shall not apply to the liability of the consultant owing to wilful conduct, to guaranteed condition features as well as owing to the injury to life, the body and the health or according to the Product Liability Act.

(7) § 377 HGB [German Commercial Code] shall apply accordingly to service and work services of the contractor. The report of a defect shall not release the customer from his payment obligation.

§ 10 Data protection
Personal data will be processed by the consultant in accordance with the following information concerning the processing of personal data by “benefits”, which can be found at “Information on processing of personal data by benefits” below. The customer will disclose this information to those of his colleagues and external consultants to whom he is transferring the task of collaborating with the consultant within the scope of the consulting services to be delivered by the consultant.

§ 11 Miscellaneous

(1) There are no oral or written collateral agreements. Amendments or addendums to the contract are only effective if they have been concluded in writing or reciprocally confirmed in writing.

(2) Should one provision of the contract be or become invalid in whole or in part this shall have no effect on the validity of the other provisions of the contract. The invalid provision shall be replaced by the provision which is permitted by law, which shall as far as possible correspond with that which was intended. This shall also apply in the event of an unintended loophole in the regulations.

(3) German law shall apply exclusively to this contract. The exclusive place of jurisdiction for all disputes in connection with this contract is Munich.

Information on processing of personal data by benefits

1. Name and contact details of the person responsible for processing (“Controller”)

This data privacy policy applies to the processing of data by benefits – tailor-made regulatory consulting under the ownership of Beate R. Schmidt, Hebelstr. 9, 68161 Mannheim (hereinafter “benefits”), in relation to the present or future provision of consulting services by benefits; with respect to the processing of data on the website, the data privacy policy described therein applies.

2. Collection and retention of personal data, as well as the nature, purpose and use of such data benefits collects the following information from clients

  • Title, first name, last name, job title if applicable, address;
  • Telephone number (landline and/or mobile phone), telefax number, email addresses of individuals named above
  • Information necessary for delivering the services according to the consultancy agreement

Benefits also collects this information from legal representatives and those members of the client’s staff and advisers to whom the client has transferred the task of working with the consultant within the context of the services to be delivered by the consultant, and from the competent members of staff at authorities with whom benefits communicates in the context of providing consultancy services.

Such data will be collected:

  • at the request of the customer for carrying out the requisite pre-contractual activities
  • for delivering the agreed consultancy services
  • to permit consultancy services to also be delivered in the future
  • for communicating with the customer and the individuals named above in relation to delivering the consultancy services
  • for invoicing and tracking payments
  • for fulfilling legal obligations
  • for handling potential liability claims and asserting potential claims against customers

Art. 6 (1) subpara. 1 lit. c GDPR serves as the legal basis for processing insofar as benefits is required to retain data in accordance with tax and commercial retention and documentation duties (arising from the Commercial Code [HGB], Tax Code [StGB] or Fiscal Code [AO]). Art. 6 (1) subpara. 1 lit. b GDPR serves as the legal basis for processing the data mentioned above.

Art. 6 (1) subpara. 1 lit. f GDPR serves as the legal basis for retaining information from clients, their legal representatives and those members of the client’s staff and advisers with whom benefits is or shall be communicating within the framework of the consultancy agreement, as well as competent members of authorities with whom benefits is or shall be communicating within the framework of deliv-ering the consultancy services. The overriding interest of benefits lies in the need to remain in constant contact with the client, his legal representatives, appointed staff and advisers, and the competent members of the authorities for the purpose of delivering the agreed consultancy services.

Benefits shall erase the collected personal data once the purpose for their processing has been fulfilled. This is the case if data are pro-cessed in accordance with Art. 6 (1) subpara. 1 lit. c GDPR and the legally stipulated documentation and retention period has expired. Data processed in accordance with Art. 6 (1) subpara. 1 lit. f GDPR will be erased by benefits as soon as these individuals leave the cli-ent’s company or the authority or move into a role where the consultancy services delivered by benefits no longer necessitate constant contact with the individuals in question.

Personal data are processed by benefits in accordance with Art. 6 (1) subpara. 1 lit. a GDPR provided the individuals in question have given consent for the purposes and the duration for which the consent has been granted. The consent may be revoked at any time with-out affecting the legality of the processing undertaken on the basis of the consent until such time that it is revoked.

3. Transfer of data to third parties

The customer’s personal data will not be disclosed to third parties for purposes other than those listed below. The personal data of the client will be disclosed to third parties only if necessary in accordance with Art. 6 (1) subpara. 1 lit. b GDPR for executing the consultancy agreement with the client. This includes, in particular, disclosing the details of the client’s respective contacts to government agencies and sharing the details of the contacts at competent authorities with the client. The disclosed data may be used by the third-party solely for the specified purposes.

4. Rights of the data subject

Subjects whose data are processed by benefits are entitled

  • to revoke any consent given to benefits as defined by Art. 7 (3) GDPR. Consequently, benefits may not continue to process the data in the future if such processing was based solely on this consent.
  • to request information on the personal data processed by benefits as defined by Art. 15 GDPR.
  • to request immediate rectification or supplementation of their personal data stored by benefits as defined by Art. 16 GDPR.
  • to request erasure of their personal data stored by benefits as defined by Art. 17 GDPR, unless the processing is necessary for exer-cising the right of freedom of expression and information, for compliance with a legal obligation, for reasons of public interest, or for establishing, exercising or defending legal claims.
  • to request restriction of processing of their personal data as defined by Art. 18 GDPR insofar as the user contests the accuracy of such data, the processing is unlawful but the data subject opposes erasure and benefits no longer requires the data but they are re-quired by the data subject for establishing, exercising or defending legal claims, or the data subject has objected to processing pur-suant to Art. 21 GDPR.
  • to request, in accordance with Art. 20 GDPR, provision of their personal data in a structured, commonly used and machine-readable format or to request transmission of the data to another controller.
  • to lodge a complaint with a supervisory authority as defined by Art. 77 GDPR. As a rule, the data subject has the right to lodge a complaint with the supervisory authority responsible for his or her habitual residence or place of work, or the principal place of busi-ness of benefits.

5. Right to object

Where personal data are processed on the grounds of legitimate interests as defined by Art. 6 (1) subpara. 1 lit f GDPR, the data subject has the right, in accordance with Art. 21 GDPR, to object to processing on grounds relating to his or her particular situation. In the event of objection, an email addressed to shall suffice.

6. Effective date and amendments to this data privacy policy

This data privacy policy was last updated in June 2018.

In the event of changes to the services offered by benefits or amendments to legal or official provisions, it may be necessary to modify this data privacy policy. The latest version of the data privacy policy can be retrieved and printed from