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General Services Agreement (General Terms of Business) of Vali Consulting GmbH (Status: 01.06.2023)
 
1. Scope of application
 
  1. These General Terms of Business shall apply to all our business relations with our Sponsor’s or Sponsor’s monitor’s concerning a single project or writing of scientific documents (project(s)) performed for the contracting company (Sponsor or Sponsor’s monitor) by Vali Consulting GmbH (hereinafter referred to as Vali), Arheilger Weg 19a, D-64380 Rossdorf. The General Terms of Business shall only apply if the Sponsor or Sponsor’s monitor is an entrepreneur (§ 14 BGB, Bürgerliches Gesetzbuch, German Civil Code), a legal person under public law or a special fund under public law.
  2. Our General Terms of Business shall apply in their respective version as a framework agreement also for future contracts with the same Sponsor or Sponsor’s monitor, without Vali having to refer to them again in each individual case; in case of modification Vali shall inform the Sponsor or Sponsor’s monitor immediately of any changes to our General Terms of Business.
  3. Our General Terms of Business shall apply exclusively; any terms and conditions of the Sponsor or Sponsor’s monitor which conflict with or deviate from our General Terms of Business shall not be recognised unless their validity is expressly agreed to in writing. Deviating conditions of the Sponsor or Sponsor’s monitor are hereby expressly contradicted. Our General Terms of Business shall also apply even if Vali carries out the project without reservation knowing that the Sponsor or Sponsor’s monitor's terms and conditions conflict with or deviate from our General Terms of Business.
  4. Individual agreements made with the Sponsor or Sponsor’s monitor (including collateral agreements, amendments and modifications) shall in any case take precedence over these General Terms of Business. A written contract or our written confirmation shall be significant for the content of such agreements.
  5. Legally relevant declarations and notifications to be made to Vali by the Sponsor or Sponsor’s monitor after conclusion of the contract (e.g. setting of deadlines, notifications of defects, declaration of withdrawal or reduction) must be made in writing to be effective.
  6. References to the validity of statutory provisions shall only have a clarifying meaning. Even without such clarification, the statutory provisions shall therefore apply, unless they are directly amended or expressly excluded in these General Terms of Business.
 
2. Scope and execution of the engagement; Project manager or expert
 
  1. Vali will perform a project according to detailed written description in the contract. Each contract will specify the project design, information desired, estimated duration of the project and all other matters pertinent to completion of the project. Object of the engagement is both the agreed service – not a particular economic result – and/or a work service.
  2. The contract will appoint a project manager to be responsible for the completion of the project and a representative of Sponsor or Sponsor’s monitor (Project monitor or monitoring Scientist). If not otherwise agreed in the contract all communications between Sponsor or Sponsor’s monitor and Vali regarding the conduct of the project shall be addressed to or routed through the project manager and Sponsor or Sponsor’s monitor’s representative. Neither the project manager nor the Sponsor’s or Sponsor’s monitor’s representative are authorized to make any amendments to the conditions of this General Terms of Business unless this is explicitly provided for in the contract.
3. Project Performance
 
  1. Vali shall perform the project(s) as an independent contractor of Sponsor or Sponsor’s monitor and shall have complete and exclusive control over its employees and agents
  2. Vali will use its best efforts according to the present state of science to provide all technical equipment and staff needed to complete the project as described in the contract, if appropriate, and in accordance with the terms of this agreement.
  3. Vali may employ external consultants, experts and laboratory or field capacity for specific needs of the project. Vali shall be responsible for the work of its external resources and its employees done in performance of its obligations in the same way as for its own work.
 
4. Changes in Performance
 
  1. The Sponsor or Sponsor’s monitor may request changes to the content and scope of the project(s). This also applies to partial services already performed and delivered.
  2. The Sponsor or Sponsor’s monitor shall, if the requested changes are not only insignificant, determine the time delays and the additional expenditure occurring as a result of the requested changes and the parties shall agree on corresponding contractual adjustments. If the parties fail to reach agreement, Vali shall be entitled to reject the change request.
  3. Vali shall not be entitled to claim additional remuneration for changes in remuneration for changes in project(s) for which the Sponsor or the Sponsor’s monitor is not responsible.
  4. All changes in performance shall be regulated in a written supplementary agreement prior to the start of the execution, in which the additional remuneration and any changes in the time schedule shall be recorded.
 
5. Project Data
 
  1. The Sponsor or Sponsor’s monitor will provide Vali free of charge with sufficient data with which the project shall be performed
  2. If delays in the agreed commencement or performance of the project occur because of Sponsor’s or Sponsor’s monitor’s inability to supply Vali with information or data required to begin, perform or complete the project, Vali may reallocate resources being held for performance of the project without incurring liability to Sponsor or Sponsor’s monitor.
     
6. Results of projects
 
  1. Vali will prepare the results of all projects in Vali´s standard report format, unless otherwise specified in the contract. Vali will provide a draft report on completion of the project to the Sponsor or Sponsor’s monitor. The report and therefore the performance of Vali shall be deemed accepted if the Sponsor or Sponsor’s monitor has not refused the acceptance of the report within 60 days after dispatch of the draft. The refusal of acceptance must specify at least one defect in the report. Vali commits itself to point out to the customer the effect of a missing statement with the dispatch of the report. On receipt of Sponsor’s or Sponsor’s monitor’sapproval or 60 days after dispatch of the draft, whichever is sooner, Vali will provide one original of the final report.Vali will not publish any report or data prepared by Vali for Sponsor without prior written consent of the Sponsor. This consent shall not be unreasonably withhold.
 
7. Use of names
 
Neither party shall use the name of the other party or the names of any of its staff for any advertising, promotional or other public purposes without the prior written consent of such party.
 
8. Regulatory Affairs
 
Vali will perform all projects in accordance with all applicable current government regulatory requirements concerning current guidelines appropriate to the project, as specified in the  contract.
 
9. Confidentiality
 
  1. Vali shall keep confidential and shall not disclose to any third party at any time any information received in confidence from Sponsor or Sponsor’s monitor relating to any of Sponsor’s studies or the project(s) (hereinafter referred to as “Confidential Information”).
  2. The obligation of confidentiality shall not apply to the extent that
    1. the Confidential Information concerned is publicly known at the time it is made available by the Sponsor or Sponsor’s for a reason other than a breach of this Agreement;
    2. the Confidential Information concerned becomes available to Vali by means of a source other than the Sponsor or Sponsor’s monitor, provided that Vali has no reason to believe that such source is itself prevented from disclosing the Confidential Information by a legal or contractual obligation;
    3. the Sponsor or Sponsor’s monitor has permitted Vali to disclose certain Confidential Information to a third party by prior written consent;
    4. the Confidential Information was obtained from Vali without Vali itself using or referring to Confidential Information;
    5. the Confidential Information was already lawfully in the possession of Vali prior to its provision by the Company; or
    6. Vali is obligated to disclose Confidential Information due to the order or direction of a competent court, a competent authority, or a mandatory provision of law.
    7. In all other respects, Section 5 GeschGehG (Geschäftsgeheimnisgesetz) shall remain unaffected by this Agreement.
 
10. Retention of data; Retention of confidential information
 
  1. Upon written request of the Sponsor or Sponsor’s monitor, Vali shall within fourteen (14) days return to the Sponsor or Sponsor’s monitor or destroy all physical and/or electronic reproductions and copies of Confidential Information, including data produced by Vali, which contain or allow conclusions to be drawn about Confidential Information (no matter onwhich carrier medium they are embodied), at the Sponsor or Sponsor’s monitor option, and shall immediately confirm to the Company in writing the complete return or destruction.
  2. Upon termination of this Agreement, the Parties shall release or delete any Confidential Information in their possession to the other Party upon request of such Party.
  3. Excluded from the aforementioned release obligations is confidential information for which there is an ongoing legal obligation to retain data. The same applies, if the storage is necessary for organisational or archival reasons in order to ensure compliance with this Agreement by Vali, if the data is part of data backups as a part of customary backup processes, or if storage is required by official or judicial order.
 
11. Privacy
 
  1. The Parties shall comply with the applicable data protection provisions applicable to them in each case.
  2. If and to the extent that Vali has access to personal data of the sponsor or sponsor’s monitor in the course of providing the service, the parties shall conclude a corresponding order processing agreement prior to the start of the processing and attach it to this agreement as an annex. In this case, Vali will process the relevant personal data solely in accordance with the provisions set forth therein and in accordance with the instructions of the sponsor or sponsor’ monitor.
 
12. Inventions;
 
Vali is not developing any new inventions within the scope of the project for which intellectual property rights could be established.
 
13. Warranty
 
In the case of work services, Vali shall be liable for material defects and defects of title in accordance with the provisions of the German Civil Code (BGB) for the contract for work and services, but the client shall first assert the rights to subsequent performance. If this is unsuccessful, the Sponsor or Sponsor’s monitor shall be entitled to the further defect rights (self-execution, withdrawal, reduction, compensation).
 
14. Claims for damages; Indemnities
 
  1. Vali shall be liable for damages - regardless of the legal basis - in the event of intent and gross negligence. In case of simple negligence Vali shall only be liable
    1. for damages resulting from injury to life, body or health
    2. for damages resulting from the violation of an essential contractual obligation (an obligation whose fulfilment makes the proper execution of the contract possible in the first place and on whose compliance the contractual partner regularly relies and may rely); in this case, however, our liability is limited to the compensation of the foreseeable, typically occurring damage;
    3. for damages resulting from the delay in performance insofar as a fixed delivery date was contractually agreed;
    4. to the extent that liability results from a mandatory and non-negotiable liability standard, such as in particular under the Produkthaftungsgesetz (German product liability act);
    5. insofar as Vali has assumed a guarantee for the quality of the goods or the procurement risk.
2. Vali shall indemnify Sponsor or Sponsor’s monitor from any claims by Vali ´s employees or others arising out of Vali ´s negligent acts giving rise to any personal injury, death or property damage occurring during the conduct of the project.
3. Sponsor or Sponsor’s monitor shall indemnify Vali from any claim for personal injury, death or property damages arising out of a failure to warn Vali of any dangerous property of the test material or any other item supplied to Vali by Sponsor or Sponsor’s monitor. Sponsor or Sponsor’s monitor shall indemnify Vali from any claim or expense arising out of Sponsor or Sponsor’s monitor’s use of the project or its use or marketing of any substance tested by Vali.

4. The above provision shall also apply in the event of a breach of duty by our legal representatives and employees. The aforementioned limitations of liability apply equally to claims for reimbursement of expenses by the Sponsor or Sponsor’s monitor. Such claims of the Sponsor or Sponsor’s monitor are limited to the amount of the interest the Sponsor or Sponsor’s monitor has in the fulfilment of the contract.
 

15. Deadlines and delay; Force Majeure
 
  1. The estimated delivery time or date of execution shall be given in the contract. A binding delivery time or date of execution, which can lead to a delay in delivery or execution has to be explicitly agreed on.
  2. The occurrence of a delay in delivery or execution shall be determined in accordance with the statutory provisions. In any case, a reminder from the Sponsor or Sponsor’s monitor is required.
  3. If delays in the agreed commencement or performance of the project occur because of Sponsor’s or Sponsor’s monitor’s inability to supply Vali with information or data required to begin or perform the project(s) (5.1), Vali shall be released from the accepted delivery and performance obligation for the duration and to the extent of their occurrence.
  4. Events of force majeure and other circumstances for which Vali is not responsible and which make the timely execution of project(s) wholly or partially impossible shall release Vali from the accepted delivery and performance obligation for the duration and to the extent of their occurrence, unless Vali has assumed a delivery guarantee or the procurement risk or manufacturing risk. This applies in particular in the event of energy and raw material shortages, industrial disputes, pandemics, epidemics, diseases which result in special containment measures such as the imposition of a quarantine, official decrees, traffic or operational disruptions, for example due to fire, water and machine damage. The same shall apply if external consultants and laboratory or field capacity do not supply Vali, do not supply Vali on time or do not supply Vali properly due to events of force majeure or due to the other aforementioned reasons despite proper congruent coverage. Vali shall notify the Sponsor’s or Sponsor’s monitor’s immediately of the occurrence and termination of the delays and shall use our best endeavours to remedy the event on which the force majeure is based and to limit its effects as far as possible. If such a disruption lasts longer than three months, the Sponsor or Sponsor’s monitor shall be entitled to withdraw from the contract in accordance with the statutory provisions. Further rights of the Sponsor or Sponsor’s monitor, in particular claims for damages, do not exist in this case.
  5. Deliveries that are made before the delivery time stated in our order confirmation are permissible, provided that no recognisable interest of the Sponsor or Sponsor’s monitor is opposed.
 
16. Termination of Project(s)
 
  1. Sponsor or Sponsor’s monitor may at any time terminate any project prior to completion by giving written notice to Vali. In such event, Vali shall immediately comply with such notice to terminate work on the project and use its best effort to reduce cost to Sponsor or Sponsor’s monitor. Sponsor or Sponsor’s monitor shall pay Vali all of its cost incurred or irrevocably obligated, plus a pro rata portion of applicable profits determined in accordance with Vali ´s ordinary accounting system computed to the date of termination.
  2. The termination of this agreement shall not relieve either party of its obligations to the other in respect of confidentiality of information, consents for advertising purposes and publications, indemnification and compensation for services performed.
 
17. Compensation, retention
 
The Sponsor or Sponsor’s monitor shall only be entitled to compensation and retention if his counterclaims have been legally established or are undisputed or acknowledged by Vali.
 
Furthermore, he is only entitled to exercise a right of retention insofar as his counterclaim is based on the same contractual relationship.
 
18. Place of jurisdiction, applicable law
 
  1. The conclusion of the contract as well as the contractual relations between Vali and the Sponsor or Sponsor’s monitor are exclusively subject to the law of the Federal Republic of Germany. The application of the UN Convention on Contracts for the International Sale of Goods is excluded.
  2. Place of jurisdiction for all disputes arising from the contractual relationship is the registered office of Vali. However, Vali shall also be entitled to take legal action at the Sponsor or Sponsor’s monitor's place of business.
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