License Terms for MassPrep® Control
Effective: April 2026
Preamble
The following terms and conditions of Chromsystems Instruments & Chemicals GmbH, Am Haag 12, 82166 Gräfelfing, Germany (hereinafter: “CS”) apply to all agreements regarding the use of the MassPrep® Control software (hereinafter: “License Terms”) by customers of CS (hereinafter: “Customer”), whether the Customer uses the MassPrep® Control software themselves (hereinafter: “End Customer”) or the Customer, as a CSauthorized reseller, makes the MassPrep® Control software available to its customers for use (hereinafter: “Reseller”).
These License Terms also apply to all future business relationships insofar as they concern the MassPrep® Control software, even if they are not expressly agreed upon again. CS reserves the right to modify the License Terms in a reasonable manner. CS hereby rejects all deviating, conflicting, or supplementary terms and conditions of purchase, license terms, or other general terms and conditions of the customer; such terms and conditions of the customer shall apply only if they have been expressly acknowledged in writing by CS.
§ 1 Subject Matter of the Agreement, MassPrep® Control Software, Components
(1) The subject matter of the contract is the MassPrep® Control software (hereinafter: “MassPrep® Control” or “Software”) as well as the MassPrep® AddOns (hereinafter: “AddOn(s)”).
The Software provides a generic functional framework that is extended by methodspecific AddOns and enables different Chromsystems assays to be efficiently and standardizedly implemented on the MassSTAR or MassPrep® platform.
(2) MassPrep® Control is part of a modular overall system consisting of
a) the MassSTAR, MassPrep®, or MassPrep® Duo (hereinafter collectively: “robot”),
b) several assays, including the respective associated MassPrep® AddOns, as well as
c) the MassPrep® Control itself.
(3) The robot is supplied by the manufacturer with CEIVD conformity. Likewise, Chromsystems assays, including the MassPrep® AddOns, are CEIVD compliant.
(4) The MassPrep® Control does not have CEIVD conformity; it does not serve a specific medical purpose but functions exclusively as supporting, generic control and execution software.
Any future changes to the regulatory classification, such as those resulting from an adjustment to the intended use, an expansion of functionality, or changes in legal requirements, do not affect the validity and continued existence of the agreements with the customer.
(5) The complete system is intended for automated sample preparation for diagnostically relevant applications. In conjunction with a suitable analytical measurement system (e.g., HPLC or LCMS/MS instrument, including method setup), the complete system enables the user to perform automated preparation of human samples, for example to determine vitamin status, drug levels, metabolic markers, or endogenous substances.
(6) Furthermore, for the intended use of the software, reference is made to the user documentation for MassPrep® Control, which is available at https://chromsystems.com/en/downloadcenter/instruction-manuals.html.
(7) CS provides the customer with MassPrep® Control, a software solution for which the configuration and user documentation were selected and implemented by CS without consultation with the customer. CS is not obligated to provide any features of the contractual software solution beyond the functionality defined herein; specific customer requests are only binding if they are additionally agreed upon in writing.
CS also provides the customer with
- the setup and commissioning (including IQ/OQ) of the software within the Customer’s IT infrastructure,
- training and implementation support as part of the installation, as agreed in the contract, as well as
- additional services to be agreed upon on a casebycase basis
Services that have not been agreed upon are not part of the business relationship with the customer.
§ 2 Provision and data backup by the customer
(1) The customer is obligated to back up any data stored on their computer, as well as data on other components of their software /hardware infrastructure with which the computer communicates, prior to installing MassPrep® Control, and in particular to protect such data from damage and loss. The customer remains obligated to back up their data regularly on their own.
(2) The customer is advised that they are solely responsible for securing their software/hardware infrastructure against viruses and other malicious programs, as well as for protecting it against unauthorized access.
(3) The customer is obligated to report security incidents to CS.
(4) The installation of MassPrep® Control takes place after running the installer, which is provided by CS via a USB drive or as a download.
(5) The Customer shall provide CS—to the extent technically possible—with remote access, which will be used for error analysis and troubleshooting, as well as for addon installation and updates. Remote access is provided with the user rights described in the user documentation and under the technical requirements specified therein. If remote access is not technically possible, the customer shall grant CS the necessary physical access to its IT infrastructure for the aforementioned purposes.
(6) The Customer is advised that the installation and proper operation of MassPrep® Control require a compatible version of the Microsoft Windows operating system as well as the other software components specified in the user documentation.
§ 3 Contract Performance, Customer Data and Its Use, Indemnification
(1) CS’s services are designed and intended for natural or legal persons who enter into the respective contract for the use of MassPrep® Control for a purpose attributable to their commercial or selfemployed professional activity. Any other use is excluded. The customer shall immediately notify CS if these conditions are not met and shall indemnify CS against any rights and claims of third parties against CS arising from the failure to meet the conditions upon first request.
(2) The customer is solely responsible for the validation and maintenance of addons developed by the customer or third parties for Laboratory Developed Tests (LDTs).
(3) Under the concluded contract, CS acquires the irrevocable right, for the term of this contract, to collect, process, and otherwise use contact data transmitted by the customer/end customer for the purpose of performing this contract, in particular for transmission to external service providers within the European Union and the EFTA states that CS utilizes in the performance of this contract (including, but not limited to, data centers).
The customer/end customer hereby grants their consent in this regard.
Furthermore, CS acquires from the concluded contract the irrevocable right, for the term of this contract, to collect, process, and otherwise use the content data transmitted by the customer/end customer, in particular technical parameters of MassPrep® Control as well as the other components of the overall system described in § 1 (2) (hereinafter: “Components”), for the purposes of this contract, in particular to perform the necessary backups during the term of the contract, as well as to improve the functions and services offered by the software and the components. This data may also be transferred to external service providers within the European Union and the EFTA states (including data centers) for the performance of this contract.
(4) CS is granted the following rights irrevocably, free of charge, and with worldwide validity, both for CS and for its affiliated companies within the meaning of Article 3(3) of Annex I to COMMISSION REGULATION (EU) No. 651/2014 of June 17, 2014 (General Block Exemption Regulation):
CS may collect, process, and use data generated in connection with the use of MassPrep® Control and its components, or data entered by a user (hereinafter: “usage data”), in pseudonymized form for any purpose beyond the scope of the contract. These purposes include, among other things, the improvement or expansion of the functionalities of MassPrep® Control and other CS products, as well as for statistical, analytical, and internal purposes of CS.
The end customer hereby grants his consent in this regard and ensures access for CS.
The end customer further warrants that they are authorized to grant the collection, processing, and usage rights described in the preceding provisions of this Section 3 and that they have not entered into any agreements that conflict with this.
(5) CS customers undertake to comply with all applicable data protection regulations and to ensure that the processing of personal and nonpersonal data by them and by their own customers is lawful. They are obligated to ensure that the necessary consents for the processing of data are lawfully obtained before services under this Agreement are utilized.
(6) The CS customer indemnifies CS against all claims by third parties arising from a breach of data protection obligations, in particular the obligations described above in accordance with this Section 3, by the customer or by its authorized users.
§ 4 Fees and Terms of Payment
(1) CS charges the fee specified for the agreed configuration in accordance with the concluded contract.
(2) In addition, services are billed according to the compensation model agreed upon in the respective individual contract. Depending on the customer’s selection, compensation may take the form of a subscription with regular payments, a onetime usage fee, or a component of a contractually agreedupon service—such as a price per diagnostic, service, or maintenance package. The amount and due date of the remuneration are governed exclusively by the terms and conditions set forth in the respective individual contract and the contractual clauses incorporated therein, as well as the currently valid price list.
(3) If the customer defaults on payment, CS is entitled to charge statutory default interest, suspend the use of MassPrep® Control and the other contractually agreed components, or, in the event of a repeat offense, terminate the contract without notice. Upon request, the customer must confirm receipt of the invoice and the date of receipt in writing.
(4) All claims by CS become due immediately if the terms of payment are not met or if CS becomes aware of circumstances that are likely to reduce the customer’s creditworthiness. In such cases, CS is also entitled to perform any outstanding services only against advance payment or to demand appropriate security.
§ 5 Setoff, Right of Retention
(1) The customer is entitled to setoff only with respect to claims that have been legally established, are undisputed, or have been acknowledged by CS.
The customer’s claim under the law of unjust enrichment to reclaim the excess portion of the fee paid remains unaffected by this.
(2) The customer may assert a right of retention only on the basis of counterclaims arising from the same legal relationship.
§ 6 Customer’s Liability, breach of contract, indemnification
(1) The customer undertakes, in particular, to respect and comply with the statutory provisions regarding data protection, copyright, trade secrets, trademark law, the law against unfair competition, and related areas of law, as well as the (fundamental) right to the protection of general personality rights, when using MassPrep® Control.
(2) The Customer warrants that it is authorized to use the data and information collected and stored by it in connection with the performance of the Agreement and, in the case of end customers, the use of MassPrep® Control and other components.
This applies in particular to the required consent of patients and other persons who hold rights to this data and information, as well as to the sample material examined using MassPrep® Control, and to special categories of personal data within the meaning of Article 9 of the EU General Data Protection Regulation (GDPR) or to the required consent for the processing of nonnonpersonal data in accordance with the principles of the EU Data Act (Regulation (EU) 2023/2854).
The Customer shall indemnify CS against all claims by third parties, including costs, arising from alleged violations of personal rights or other rights. The Customer shall bear all potential liabilities, in particular those resulting from claims by third parties and the associated costs.
(3) MassPrep® Control and the other components of the overall system may be used exclusively for the purpose described in § 1(5); any other use is prohibited. In all other respects, the provisions of § 7(6) through (8) apply.
(4) Any disadvantages and additional costs arising from a breach of these contractual obligations shall be borne by the customer.
§ 7 Right of use of the customer and its authorized users, intellectual property rights
(1) The software made available to the customer is legally protected. The copyright, patent rights, trademark rights, and all other related rights in the software, as well as in other items and services that CS makes available to the customer in the context of contract initiation and performance, are exclusively vested in CS in the relationship between the contracting parties. To the extent that rights are vested in third parties, CS holds the corresponding exploitation rights.
(2) CS grants the customer—in the case of a fixedterm license agreement, solely for the duration of the agreement—a personal, nonexclusive, nontransferable, and nonsublicensable right to use MassPrep® Control as well as any other agreedupon components and the associated user documentation for the agreedupon use within the agreedupon scope for one workstation of the end customer. The right of use applies only to one workstation.
This right of use also includes use by authorized users who are employed by or work as freelancers for the end customer.
(3) To the extent permitted by applicable law, the End Customer and the Authorized User are not permitted, among other things, without the written consent of CS, to decompile, disassemble, decode, analyze, reverse engineer, or otherwise decode the Software or to integrate it into a website; to modify or edit the Software, or to create derivative works, extensions, or translations based on the Software; to distribute or disclose the Software, or to permit its use by a third party, in particular a service provider; or to disclose, transfer, or otherwise make available to third parties any trade secrets contained in the system. Provisions to the contrary under these license terms remain reserved.
(4) The End Customer warrants that every authorized user complies with the regulations governing the proper use of the software and the other agreedupon components in accordance with these license terms.
(5) With the exception of the limited right of use granted in these license terms, no further rights—in particular, no copyrights, patents, or other industrial property rights, nor any rights to trade secrets relating to the software—are granted to the end customer or the authorized user.
(6) Use of the software beyond the scope permitted under this Agreement is not permitted. The Customer is not authorized to use the software at other workstations, to allow others to use it, to allow third parties to use it, or to make it accessible to third parties; in particular, the Customer is not permitted to reproduce or sell the software, any part thereof, or any rights thereto. The Customer must also pay the fees if a third party uses the Software, provided that the Customer is responsible for such use. Third parties in the aforementioned sense do not include the authorized users described in paragraph 2 above.
(7) CS is entitled to review the customer’s conduct if there are indications of violations by the customer of the obligations under this Section 7.
(8) CS is entitled, in the event of serious breaches of the customer’s obligations, to prohibit further use, to revoke and withdraw the granted right to use the software with immediate effect and to block access, to claim further license payments, and to assert claims for damages and further rights against the customer, for example due to breach of contract and/or infringement of copyrights.
The provisions regarding confidentiality, copyright protection, restrictions on use, and limitations of liability and warranty shall remain in effect even after the termination of the contract, to the extent permitted by law. Usage fees already paid will not be refunded.
§ 8 Contract Term, Termination, Withdrawal
(1) Contracts for the use of MassPrep® Control and components of the overall system may be concluded as a onetime exchange contract (e.g., purchase contract) or as a usage contract for a fixed term, limited or unlimited; the details thereof are set forth in the individual contract or in the offer and order confirmation.
If a usage agreement is concluded for a fixed term, ordinary termination during the term is excluded. If a usage agreement is concluded for an indefinite term, it may be ordinarily terminated with three months’ notice to the end of a calendar month.
(2) The right to terminate the agreement for cause remains unaffected.
(3) Any termination must be in writing to be effective.
(4) CS reserves the right to withdraw from concluded contracts until the services or deliveries owed by CS have been provided if CS becomes aware of reasons relating to the customer that call into question the proper performance of the contract, such as lack of creditworthiness or conduct by the customer in breach of the contract. In this case, the customer is only entitled to reimbursement for services already rendered by them; any further claims, in particular claims for damages, are excluded.
§ 9 Customer’s Obligations to Cooperate in PostMarket Surveillance, Reports, and Feedback
(1) The customer agrees to actively support CS in all measures to monitor the safety and performance of MassPrep® Control and components of the overall system after they have been placed on the market (postmarket surveillance) in accordance with these license terms.
This includes, in particular,
a) the immediate reporting of all incidents, serious nearmisses, or other safetyrelated events that come to the customer’s attention and that impair the functionality, use, or distribution of MassPrep® Control and components of the overall system;
b) the forwarding of complaints, feedback, or other comments from users, patients, or third parties that indicate risks, side effects, or quality defects in the services;
c) the submission of all information relevant to the assessment of product safety and performance, to the extent that such information is available to the customer or comes to the customer’s attention;
d) cooperation in the implementation of recalls, safety corrective actions, or measures ordered by authorities, to the extent necessary to comply with legal or regulatory requirements.
(2) The notifications and statements referred to in paragraph 1 above must be sent in writing (e.g., via email) to support@chromsystems.com immediately upon becoming known.
(3) The customer’s statutory reporting obligations or other (cooperation) obligations toward government agencies or other third parties remain unaffected. The customer is obligated to independently comply with all legal obligations applicable to them.
§ 10 Liability
(1) Claims by the customer for reimbursement of expenses or damages, regardless of the legal basis, are limited to damages caused by CS or one of its vicarious agents or contractors
- intentionally,
- grossly negligently, or
- in the case of material contractual obligations, through slight negligence
Material contractual obligations in this sense are those obligations of CS intended to fulfill the customer’s rights under the content and purpose of the concluded contract, as well as those obligations whose fulfillment is essential for the proper performance of the concluded contract and on whose compliance the customer regularly relies and has relied.
The complete freedom from errors of the provided software is not an essential contractual obligation. Due to possible data, hardware, and operating configurations, as well as potential operating errors, malfunctions may occur.
Data loss cannot be completely ruled out either.
In particular, CS is not liable for a malfunction that does not significantly impair the technical availability of the software. CS is liable for data loss only in accordance with paragraph 5 below. CS is not liable for disruptions in the customer’s IT infrastructure.
(2) Liability is limited to damages that were foreseeable at the time of contract conclusion or, at the latest, at the time the breach of duty occurred, as damages typical for comparable transactions of this kind, unless CS is liable for intent or gross negligence.
(3) Liability for the functionality of the software provided by CS is limited to the amount of the usage fee for 12 months as stated in the currently valid price list, assuming monthly payment.
(4) Liability for consequential damages or lost profits is excluded.
(5) CS shall be liable for the loss of data only if such loss could not have been avoided by the customer taking appropriate data backup measures. If the customer’s data sets change, the customer must also perform a data backup immediately in this regard. Furthermore, any liability of CS for data loss is subject to limitations up to the amount of the agreedupon or by CS invoiced remuneration.
(6) The limitations of liability in paragraphs 1 through 5 above do not apply in cases of injury to life, limb, or health; in cases of liability under the Product Liability Act; or in cases of other further mandatory statutory liability.
§ 11 Statute of Limitations
(1) Claims for defects shall become timebarred within twelve months of the installation and commissioning of the software; otherwise, upon delivery.
(2) Claims for damages, insofar as they are not related to a defect, shall become timebarred within one year from the end of the year in which the claim arose and the customer became aware of the circumstances giving rise to the claim or, in the absence of gross negligence, should have become aware of them.
(3) The provisions in the preceding paragraphs 1 and 2 do not apply if the claims are based on an intentional or grossly negligent breach of duty by CS, in the event of injury to life, limb, or health, in the event of liability under the Product Liability Act, or in the event of any other further mandatory statutory liability. In all other respects, § 444 BGB remains unaffected.
§ 12 Data Processing, Separate Liability and regulatory requirements
(1) To the extent that the Customer transmits personal data, CS shall perform the contractual services exclusively in compliance with the legal requirements of the GDPR and the Federal Data Protection Act (BDSG); to the extent that the Customer transmits nonpersonal data, CS shall perform the contractual services exclusively in compliance with the legal requirements of the EU Data Act.
(2) The customer remains responsible for compliance with the provisions of the GDPR, the BDSG, and the EU Data Act, as well as other relevant data protection regulations, if and to the extent that the customer acts as a data controller for the processing of its personal data and that of patients; CS assumes no responsibility in this regard for the processing of personal or nonpersonal data.
(3) The customer is solely responsible for complying with all applicable legal and regulatory requirements regarding information security. This includes, in particular, where applicable to the customer, the requirements set forth in the Act on the Federal Office for Information Security (BSIG) and any subsequent amendments thereto.
(4) Likewise, the customer is obligated to independently verify whether and to what extent Directive (EU) 2022/2555 (NIS 2 Directive) and its national implementation, in particular through the NIS 2 Implementation and Cybersecurity Strengthening Act (NIS2-UmsuCG), apply to them. The Customer shall ensure that it fulfills all obligations arising therefrom.
(5) If the Customer fails to comply with the obligations set forth in paragraphs 3 and 4 above, the Customer shall indemnify CS against all resulting claims, damages, costs, or disadvantages, to the extent that CS is not responsible for them. This applies in particular if violations by the Customer vis-à-vis authorities or third parties are attributable to a lack of or insufficient implementation of legal requirements.
§ 13 Retention and Deletion of Data
(1) The preceding provisions of Sections 3 and 6 apply to the collection, processing, and use of data by CS.
(2) Upon termination of the contractual relationship, CS will block personal data and then delete it.
Data is generally deleted within 6 months of the date of termination of the contract (hereinafter: “standard period”)
(3) In particular with regard to personal data, statutory retention and documentation obligations may exist that exceed the standard period, especially under the German Commercial Code (HGB) and the German Fiscal Code (AO). These obligations are not exhaustive; the periods provided for therein may extend up to ten years after the termination of the contractual relationship, so that the standard period may be exceeded in these cases.
(4) To the extent that specific legal provisions require it, particularly for the preservation of evidence within the context of statutes of limitations, the data may also be stored for a longer period. Pursuant to Sections 195 et seq. of the German Civil Code (BGB), the standard statute of limitations is three years; however, in certain cases, statutes of limitations of up to 30 years may apply.
§ 14 Disclosure, Sale, and Transfer to Third Parties
(1) Any transfer, resale, rental, lending, or other provision of the software, the license, or parts thereof by the end customer to third parties is expressly prohibited without the prior written consent of CS.
(2) In the event of violations of the obligations set forth in paragraph 1 above, CS may terminate the contract without notice and claim damages.
§ 15 Written Form
The written form requirement under these license terms is also satisfied by a declaration bearing a signature, at least by way of an electronic signature within the meaning of Article 3(10) of the European eIDAS Regulation (i.e., data in electronic form that is attached to or logically associated with other electronic data and that the signatory uses to sign), e.g., DocuSign.
Telecommunication transmissions, such as email without a corresponding signature, do not satisfy the written form requirement within the meaning of these license terms.
§ 16 Final Provisions
(1) German substantive law shall apply exclusively, to the exclusion of international conventions (e.g., CISG).
(2) Munich is agreed upon as the place of performance and exclusive venue.
(3) Only the German version of these license terms, as available at www.chromsystems/de/massprepcontrollicence, is legally binding. The same applies to any amendment or supplement to these license terms, provided that a German version exists and no other agreement has been made.
(4) The assignment of rights and claims arising from this contract requires the prior express consent of the other contracting party.
(5) Should individual provisions be wholly or partially invalid, this shall not affect the validity of the remaining provisions of these license terms. The contracting parties shall replace the invalid provision with a provision that most closely approximates the economic purpose of the invalid provision. The same applies to any gaps in these license terms.
(6) Amendments and supplements must be made in writing; this applies in particular to any amendment of this formal requirement.
Appendix – Service Level Agreement (SLA)
§ 1 Subject Matter
The following provisions of this Service Level Agreement (SLA) govern the support services provided by CS in the event of a defect in MassPrep® Control or AddOns for the duration of the contractual relationship. Upon termination of the contractual relationship, CS is no longer obligated to provide support services, except in cases of consequential damages resulting from the defect.
§ 2 Warranty, Support
(1) In the event of a defect, the customer is entitled to rectification of the service. This applies primarily if a functionality of MassPrep® Control or AddOns, as contractually agreed, is not present or cannot be executed, and CS is responsible for this.
(2) For the respective version of MassPrep® Control or AddOns provided, CS warrants that the (main) functions specified in the respective product description are fulfilled.
However, due to the wide variety of data, hardware, and operating configurations that arise in practice, as well as user errors, complete freedom from errors cannot be guaranteed in this regard. Data loss cannot be completely ruled out either. The customer acknowledges this.
(3) The customer must therefore back up their data at regular intervals. They shall retain the necessary documentation for any potential data recovery in the event of data loss.
(4) The customer must report any defects to CS immediately.
§ 3 Availability
(1) CS will provide warranty and maintenance services for the software during the following service hours:
Monday through Friday (excluding public holidays applicable at the company’s headquarters) from 9:00 a.m. to 4:00 p.m.
(2) During service hours, CS will respond to a defect reported by the customer within 24 hours (response time). The response time does not apply outside of service hours.
§ 4 Troubleshooting
(1) CS will resolve any malfunctions that occur, at its discretion, by taking one or more of the following measures:
- Developing and providing the customer with instructions for troubleshooting,
- Providing patches or additional bug fixes to the customer,
- Delivering a software version that no longer contains the error.
(2) CS will provide the services listed above via remote maintenance or remote diagnosis; only if, in CS’s discretion, troubleshooting in this manner is not possible will CS provide support services onsite at the customer’s location.
(3) The customer is not authorized—after a bug occurs—to perform updates, upgrades, or bug fixes without instructions from CS.
(4) The customer is obligated—to the extent technically feasible—to provide CS with remote access to verify an error reported by the customer and to resolve it, as well as to create a complete backup copy of all data and databases prior to CS accessing the system. If remote access cannot be provided, the customer will incur additional costs for the verification and resolution of an error reported by the customer.
(5) A malfunction to be rectified by CS does not exist in the case of disruptions to data transmission outside the data network operated by CS, e.g., due to line failure or disruption at other providers or telecommunications providers, or a breach of contract regarding the use of the provided system capacities, e.g., due to an excessive number of accesses by the customer.
§ 5 Fault Reporting
(1) Errors in the software must be reported at a minimum via email to support@chromsystems.com . The report must describe the error in a comprehensible manner (in particular, the conditions under which it occurs, symptoms, and effects) so that the error can be reproduced.
(2) The customer must also, to the extent reasonable, take measures that facilitate the identification of errors and their causes. In particular, the customer shall provide CS with the necessary information in this regard.
(3) The warranty obligation does not apply if the customer has not used the service provided by CS in accordance with its intended purpose.
(4) The customer’s right to damages is governed by the provisions of Section 10 of the License Terms; Section 444 of the German Civil Code (BGB) remains unaffected.
(5) Beyond the statutory provisions, the customer is entitled to a right of withdrawal and a claim for damages in lieu of performance due to a breach of nonperformancerelated obligations pursuant to Section 241(2) of the German Civil Code (BGB) only if the customer has previously issued a written warning to CS and CS has nevertheless failed to remedy the breach of duty.
§ 6 Compensation
No separate remuneration shall be charged for the provision of services under this SLA. However, if the Customer has reported a malfunction to CS and an investigation reveals that the malfunction was caused by a circumstance for which the Customer is responsible, CS may invoice the Customer for the services rendered to identify the malfunction, unless the Customer could not have recognized, even with the exercise of due diligence, that the malfunction was caused by a circumstance for which the Customer is responsible.