General Terms and Conditions
(as of 16 November 2021)
1. Scope
1.1 The following General Terms and Conditions (hereinafter referred to as “GTC”) apply to all legal transactions of GRÜNEWALD GmbH (hereinafter referred to as “Contractor”) with its contractual partner (hereinafter referred to as “Client”) (together also referred to as the “Parties”). Deviating general terms and conditions of the Client shall not apply unless the Contractor has expressly agreed to them in writing. The Contractor’s GTC shall also apply exclusively if the Contractor, being aware of conflicting or deviating terms and conditions of the Client, performs services for the Client without reservation.
1.2 The Contractor provides consulting and services in the field of MDR, GMP and regulatory compliance exclusively for the medical device, pharmaceutical, and biotechnology industries, i.e. for entrepreneurs within the meaning of Section 310 (1) BGB (German Civil Code).
2. Scope of Services and Reporting Obligation
2.1 The specific description of the consulting and services to be provided results from the offer, the annexes thereto, and any service descriptions of the Contractor. All such documents are integral parts of the consulting and service agreement concluded between the Parties.
2.2 The Contractor’s consulting services shall be deemed rendered when the necessary analyses, resulting conclusions, and recommendations have been prepared and explained to the Client. It is irrelevant whether or when the conclusions or recommendations are implemented.
2.3 Events of force majeure that significantly hinder or temporarily make the Contractor’s performance impossible, or impediments due to a lack of cooperation by the Client, entitle the Contractor to postpone performance for the duration of the impediment and a reasonable start-up period thereafter. Force majeure shall include labor disputes and similar circumstances, insofar as they are unforeseeable and severe. The Parties shall notify each other immediately of the occurrence of such circumstances.
2.4 At the Client’s request, the Contractor shall provide information on the status of contract performance. If the Contractor is to prepare a comprehensive written report or a report in text form, particularly for submission to third parties, this must be agreed upon separately and remunerated accordingly.
3. Changes to the Contract
3.1 Changes and additions to the contract require written agreement.
3.2 As long as the changes have not been set out in writing, the Contractor shall continue the work without regard to the requested changes.
3.3 The Contractor is obliged to take the Client’s requests for changes into account, provided this is reasonable in terms of effort and scheduling within the Contractor’s operational capacities. Any additional costs incurred shall be remunerated in accordance with Sections 4.7 and 4.8 of these GTC.
4. Remuneration
4.1 The agreed remuneration stated in the order confirmation shall apply. Payments are due no later than fourteen days after invoicing without any deduction, unless otherwise agreed in writing in the contract or an existing framework agreement between the Client and the Contractor. The Client shall be in default if payment is not made upon a reminder from the Contractor or, if the due date is calendar-based, upon non-payment at the agreed time. From the date of default, the Contractor is entitled to default interest of 10 percentage points above the applicable base interest rate. The right to claim further damages remains unaffected.
4.2 According to Section 611 BGB, the Contractor is obliged to compensate its employees’ travel time as working time. The Contractor shall charge the Client only 50% of the hourly rate as travel time.
4.3 For travel by car, the Contractor shall charge €0.30 per kilometer from the Contractor’s registered office. For train travel, second-class tickets will be invoiced upon proof, and for air travel, economy class tickets.
4.4 If the Client changes or cancels orders, work, plans, etc., or changes the conditions for performance, the Client shall reimburse the Contractor for all costs incurred and indemnify the Contractor against all liabilities to third parties.
4.5 If the Client withdraws from the contract before work commences, the Contractor may claim a cancellation fee of up to 10% of the agreed fee.
4.6 All amounts payable by the Client are subject to statutory VAT at the applicable rate.
4.7 If additional work becomes necessary during the project term, it must be requested in writing by the Client and confirmed in writing by the Contractor.
4.8 Additional work carried out by the Contractor at short notice in order to prevent damage to the Client (e.g., disproportionate project delays or safety deficiencies) shall be reported to the Client without delay for retroactive approval.
4.9 Third-party costs, expenses, and outlays shall be reimbursed to the Contractor separately against submission of appropriate receipts.
5. Duties of Cooperation by the Client
5.1 The Client shall support the Contractor to the best of its ability in a spirit of trustful cooperation and shall create all conditions necessary for proper execution of the contract; in particular, the Client shall provide in good time all documents and information necessary and relevant for the execution of the assignment. The Client shall inform the Contractor without delay of any circumstances that arise during the course of the project and may affect performance.
5.2 At the Contractor’s request, the Client shall confirm in writing the correctness and completeness of the documents, information, and oral statements provided.
5.3 The Client undertakes not to employ or commission any employees or former employees of the Contractor involved in the execution of the assignment for a period of 24 months after termination of cooperation.
5.4 Employees assigned to the project may be taken over by the Client within the period specified in Section 5.3, provided a one-time payment of 30% of the agreed gross salary is made to the Contractor upon commencement of employment.
5.5 Direct contractual commissioning of a Contractor’s employee by the Client is only permitted with the Contractor’s approval. In case of violation, a commission of 15% of the agreed net service amount shall be payable to the Contractor.
6. Liability of the Contractor
6.1 The Contractor shall only be liable for damages caused intentionally or by gross negligence by the Contractor or its vicarious agents.
6.2 Liability for simple negligence exists only in cases of breach of essential contractual obligations or in cases of injury to life, body, or health. In such cases, liability is limited to typical foreseeable damages that were known at the time of contract conclusion or at the time of the breach at the latest. Liability for atypical damages is excluded.
6.3 The coverage amounts of the Contractor’s business liability insurance are €5 million per claim for personal injury, property damage, and financial loss.
6.4 The Client’s contractual claims for damages against the Contractor shall become time-barred two years after the claim arises.
7. Confidentiality and Data Protection
7.1 The Contractor undertakes to treat all information obtained as a result of this contract, in particular company data, balance sheets, plans, documents, etc., as strictly confidential for an unlimited period of time and to obligate its employees and any third parties engaged by it to the same level of confidentiality.
7.2 The Client agrees that the contents of the contract and services created under this contract may be electronically stored and processed by the Contractor in compliance with data protection regulations. Both Parties undertake not to disclose electronically stored or other data to third parties.
8. Protection of Intellectual Property
8.1 Reports, documents, plans, drafts, schedules, and calculations prepared by the Contractor may only be used for the contractually agreed purposes. Any use outside the scope of the contract, in particular publication, requires the Contractor’s prior written consent. This also applies if the service provided is not subject to specific statutory rights, in particular copyright.
8.2 In the event of a breach of Section 8.1, the Contractor shall be entitled to an additional fee in an amount reasonable under the circumstances.
9. Contract Term and Notice Periods
Unless otherwise agreed, the contract may be terminated by either Party with 14 days’ notice to the end of the month. The right to immediate termination for good cause remains unaffected. Termination must be made in text or written form.
10. Retention of Documents
10.1 Until full settlement of its claims, the Contractor shall have a right of retention to the documents provided to it.
10.2 After settlement of its claims arising from the contract, the Contractor shall, at the Client’s request, return all documents handed over by the Client or a third party for the purpose of executing the order. This does not apply to correspondence between the Parties or to simple copies of reports, organizational charts, drawings, schedules, calculations, etc. prepared in the course of the contract, provided the Client has received the originals.
10.3 The Contractor’s obligation to retain documents expires six months after delivery of a written request for collection, otherwise three years, and for documents retained under Section 10.1, five years after termination of the contractual relationship.
11. Miscellaneous; Final Provisions
11.1 The Client is not entitled to assign its claims from the contract to third parties.
11.2 Offsetting or asserting a right of retention by the Client is only permissible with or in the case of recognized or legally established counterclaims.
11.3 Amendments and additions to these terms and conditions or the contract must be made in writing and must be expressly identified as such. This also applies to any waiver of the written form requirement.
11.4 The exclusive place of jurisdiction for all disputes arising from or in connection with the contractual relationship between the Parties is D-64625 Bensheim.
11.5 Unless otherwise specified in the contract and these GTC, the place of performance is D-64625 Bensheim.
11.6 If a version of these GTC in another language exists, it is provided for information purposes only. The German version alone shall be legally binding.
11.7 The legal relations between the Parties shall be governed exclusively by the substantive law of the Federal Republic of Germany, excluding the UN Convention on Contracts for the International Sale of Goods (CISG).