GTC

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General Terms of Delivery and Payment

General Terms and Conditions

I. Scope of application

  1. These General Terms and Conditions (“GTC”) apply to all contracts between BIOTYPE GmbH (“BIOTYPE”) and its contractual partners concerning (a) the delivery of devices and systems including agreed installation, commissioning and other ancillary services, (b) the delivery of consumables, reagents, test kits and other products, (c) the provision and licensing of software, (d) maintenance, consulting, training, support and other services, and (e) development, manufacturing and other contract services, in particular CDMO services – collectively the “Services”. The delivered products including software are hereinafter also referred to as the “Goods”.
  2. These GTC apply exclusively to entrepreneurs within the meaning of Section 14 of the German Civil Code (BGB), legal entities under public law and special funds under public law. Consumers are not supplied.
  3. Once these GTC have been incorporated into a contract, they shall also apply to future contracts between BIOTYPE and the contractual partner concerning similar Services, unless otherwise agreed.
  4. Individual agreements between BIOTYPE and the contractual partner take precedence over these GTC. Conflicting or deviating terms and conditions of the contractual partner shall only become part of the contract if BIOTYPE expressly consents to their application in text form. This also applies if BIOTYPE performs the Services without reservation in knowledge of such terms and conditions.

II. Products and intended use

  1. The products offered by BIOTYPE may in particular be in-vitro diagnostic medical devices (“IVD”), products intended for research use only (“RUO”), laboratory and analysis devices, consumables, reagents, test kits or software.
  2. The classification, intended purpose and intended use of a product are determined by the product information applicable from time to time, in particular the labelling, the instructions for use (“IFU”), the technical documentation and other information provided by BIOTYPE.
  3. The contractual partner shall use the products exclusively in accordance with their intended use and the applicable product information and shall comply with the statutory and regulatory requirements applicable thereto.
  4. Any use outside the intended use is within the contractual partner’s sphere of responsibility and is permitted only to the extent legally permissible. Statutory claims of the contractual partner based on defects or breaches of duty for which BIOTYPE is responsible remain unaffected.
  5. RUO products are intended exclusively for research purposes. They are not intended for diagnostic, therapeutic or other medical purposes and must not be used for such purposes. When passing RUO products on to third parties, the contractual partner shall ensure that this intended purpose and the relevant product information are complied with.

III. Offer and conclusion of contract

  1. Orders and inquiries of the contractual partner are non-binding. A contract is concluded upon BIOTYPE’s order confirmation or upon fulfilment of the order by BIOTYPE.
  2. Offers made by BIOTYPE are subject to change and non-binding unless expressly designated as binding.
  3. BIOTYPE reserves all ownership rights, copyrights and other proprietary rights in offers, illustrations, drawings, calculations, technical documents and other documentation. Any disclosure to third parties requires BIOTYPE’s prior consent, unless mandatory statutory provisions or the purpose of the contract require otherwise.
  4. Rights to use software provided by BIOTYPE are governed exclusively by Section VIII of these GTC and, where applicable, by a supplementary end-user licence agreement (“EULA”).

IV. Prices and terms of payment

  1. The prices stated in BIOTYPE’s offer or order confirmation apply. Unless otherwise agreed, prices are ex works including standard packaging, plus statutory value added tax.
  2. Additional costs for special transport conditions, in particular refrigerated transport, transport with dry ice or dangerous-goods transport, shall be borne by the contractual partner unless already included in the offer or order confirmation.
  3. Unless otherwise agreed, invoices are due for payment immediately without deduction. Any cash discount requires an express agreement. Receipt of payment by BIOTYPE is decisive for the timeliness of payment.
  4. In the event of default in payment, the statutory provisions apply. BIOTYPE is entitled to make further deliveries and services conditional upon settlement of due claims or upon a reasonable advance payment or provision of security.
  5. The contractual partner may set off only counterclaims that are undisputed or have been established by final and binding court decision. This does not apply to counterclaims that are legally connected with the respective claim. The contractual partner may exercise a right of retention only insofar as its counterclaim is based on the same contractual relationship.

V. Delivery, performance, transfer of risk and shipping

  1. Delivery and performance dates are binding only if expressly agreed as binding.
  2. Delivery and performance periods do not commence until all technical and commercial questions have been clarified and the contractual partner has performed the acts of cooperation incumbent on it.
  3. If BIOTYPE is unable to meet a binding delivery or performance period for reasons for which BIOTYPE is not responsible, in particular due to force majeure, official measures, industrial action, disruptions at upstream suppliers or other interruptions of the supply chain, the period shall be extended by the duration of the impediment plus a reasonable start-up time.
  4. BIOTYPE shall inform the contractual partner without undue delay of any material delivery or performance disruptions that are not merely temporary.
  5. If an impediment pursuant to Clause 21 lasts for more than three months, both parties are entitled to withdraw from the contract with respect to the Services affected by the impediment if the continued performance of the contract is unreasonable for them due to the duration and effects of the impediment. Any consideration already provided will be refunded without undue delay.
  6. The occurrence of a delay in delivery or performance is determined in accordance with the statutory provisions.
  7. BIOTYPE is entitled to make partial deliveries and render partial services insofar as this is reasonable for the contractual partner.
  8. Risk passes to the contractual partner in accordance with the statutory provisions. In the case of a sale involving carriage, risk passes to the contractual partner, to the extent legally permissible, upon handover of the Goods to the carrier.
  9. At the request and expense of the contractual partner, BIOTYPE will take out transport insurance, provided such insurance is available and obtainable on reasonable terms.
  10. If shipment or acceptance is delayed for reasons for which the contractual partner is responsible, BIOTYPE shall store the Goods at the contractual partner’s cost and risk. BIOTYPE’s statutory rights arising from default of acceptance or debtor’s default remain unaffected.
  11. If the contractual partner is in default of acceptance or culpably breaches other duties to cooperate, BIOTYPE may claim compensation for the resulting damage and any necessary additional expenses in accordance with the statutory provisions.

VI. Operation, maintenance and consumables

  1. The contractual partner shall operate, maintain, clean and calibrate devices in accordance with the applicable instructions for use and the technical specifications of BIOTYPE or the respective manufacturer. Prescribed maintenance, inspection and calibration intervals must be observed.
  2. BIOTYPE recommends concluding a separate maintenance contract and offers corresponding maintenance services on request. The conclusion of a maintenance contract is not a condition for the validity of the supply or other contract. Without a maintenance contract, the contractual partner is responsible for the professional maintenance and proper upkeep of the device.
  3. The contractual partner may only use consumables, reagents and test kits that are intended for the respective product according to the applicable product information or that have been expressly approved or validated by BIOTYPE as compatible. Insofar as the respective product is expressly intended for use with components not supplied or approved by BIOTYPE, their use remains permissible.
  4. The use of other products is within the contractual partner’s sphere of responsibility. Claims for defects and liability claims remain unaffected insofar as the contractual partner proves that the use of the product concerned did not cause the defect or damage claimed. In all other respects, the provisions of Sections IX and X apply.

VII. Consulting, CDMO and other services

  1. The nature and scope of consulting, training, support, validation, development, manufacturing and other services, including CDMO services, are determined by the respective offer, order confirmation, service description or separately agreed contract.
  2. Separately agreed quality agreements, framework agreements, quality assurance agreements, service descriptions or other individual agreements take precedence over these GTC in the event of a conflict.
  3. Unless a specific result has been expressly agreed, BIOTYPE owes the diligent performance of the agreed activity in accordance with the contractually agreed requirements and the state of science and technology applicable at the time of performance, but not the achievement of a specific economic, technical or scientific result.
  4. If the production or achievement of a specific result has been expressly agreed, the rights and obligations of the parties are determined by the provisions agreed for this purpose in the individual contract and, supplementarily, by the statutory provisions governing the respective type of contract, where applicable.
  5. The contractual partner shall provide BIOTYPE in good time with all information, documents, materials, samples, specifications and access required for the performance of the Services and is responsible for their accuracy, completeness, suitability and legal permissibility.
  6. Delays and additional expenses resulting from late, incomplete or defective cooperation by the contractual partner shall be borne by the contractual partner insofar as the contractual partner is responsible for them.
  7. Pre-existing knowledge, processes, data, methods, know-how and intellectual property rights (“Background IP”) of the parties remain the property or legal entitlement of the respective party. Rights in work results, inventions, data, processes, software, documentation and other know-how created in the course of development services, as well as their use and exploitation, are governed by the respective individual contract.
  8. Unless otherwise provided in the individual contract, the contractual partner receives a non-exclusive right to use the work results handed over to it, to the extent required for the contractual use of the work results.

VIII. Software

  1. For software provided by BIOTYPE, in particular device software, analysis software and cloud-based applications including updates, documentation and configuration files, BIOTYPE grants the contractual partner a non-exclusive right to use the software within the contractually agreed scope.
  2. The right of use is limited in particular with regard to the agreed number of devices, users and licences. The software is licensed, not sold.
  3. Where BIOTYPE provides a separate end-user licence agreement (“EULA”) for a specific software, such EULA applies in addition. Individually negotiated provisions of the EULA and deviations expressly agreed in the individual contract take precedence over these GTC in the event of a conflict, unless expressly agreed otherwise in the individual contract. A EULA merely provided as a standard EULA does not take precedence over these GTC unless expressly agreed otherwise.
  4. The contractual partner may use the software only within the contractually intended scope. In particular, the contractual partner may not modify, reproduce, sublicense, rent out or lease the software or make it available to third parties for use, and may not circumvent any technical protection or licensing mechanisms, unless mandatory statutory provisions permit otherwise. By way of derogation from sentence 2, insofar as the contractual partner acts as a distributor authorised by BIOTYPE, it may make the software available to its customers and end users and grant them the contractually intended rights of use within the scope and for the term of its distribution or reseller agreement with BIOTYPE, provided that it passes on the software unaltered and in full and obliges the recipients, prior to such transfer, to comply with the applicable terms of use and the relevant EULA. Any broader or deviating provisions of a distribution or reseller agreement between BIOTYPE and the contractual partner remain unaffected and take precedence over this clause in the event of a conflict.
  5. Mandatory statutory rights of the contractual partner, in particular under Sections 69d and 69e of the German Copyright Act (UrhG) regarding the reproduction, adaptation and decompilation of the software, remain unaffected.
  6. The contractual partner is responsible for the proper installation, configuration and intended use of the software as well as for appropriate IT security measures and regular data backups, insofar as the relevant services and measures are not to be provided by BIOTYPE under the respective contract.
  7. The contractual partner shall review and validate analysis results and other results generated by the software within its area of professional responsibility. The software and its results do not replace a professional assessment by suitably qualified personnel.
  8. BIOTYPE is entitled to further develop, update and technically modify the software, provided that the contractually agreed use is not materially impaired thereby.
  9. An entitlement to specific future functionalities, further developments or support services, or to the permanent availability of cloud-based applications, exists only insofar as this has been expressly agreed. BIOTYPE’s obligation to provide the cloud-based application during the agreed term of the contract remains unaffected.
  10. Sections IX and X apply accordingly to defects of the software and to liability for the software.

IX. Defect claims

  1. Defect claims of the contractual partner require that the contractual partner has duly complied with its obligations to inspect and give notice of defects pursuant to Section 377 of the German Commercial Code (HGB), insofar as Section 377 HGB is applicable.
  2. Defect claims do not exist if one of the following circumstances is present and, in the circumstances of the individual case, is capable of having caused the defect claimed: (a) use outside the intended use or contrary to the product information, (b) improper maintenance, cleaning, calibration or other handling, (c) modifications, repairs or other interventions by persons other than BIOTYPE or service providers authorised by BIOTYPE, or (d) other circumstances within the contractual partner’s sphere of responsibility; this does not apply if BIOTYPE is responsible for the circumstance in question or if the contractual partner proves that the defect exists independently thereof.
  3. In the case of justified notices of defects, BIOTYPE shall first provide subsequent performance. In accordance with the statutory provisions, BIOTYPE is entitled to choose between rectification of the defect and delivery of a replacement.
  4. The contractual partner shall give BIOTYPE the time and opportunity required for subsequent performance. If subsequent performance fails or if the statutory requirements are met, the contractual partner is entitled to the further statutory defect rights, in particular price reduction, withdrawal from the contract and damages in accordance with these GTC.
  5. The limitation period for defect claims is one year. It commences, in the case of the delivery of goods, upon their delivery; in the case of work performances (Werkleistungen), upon acceptance; and in the case of the provision of software, upon its initial provision. In the case of work performances for which the statutory limitation period does not commence upon acceptance, the shortened limitation period commences at the statutory commencement of the limitation period. For cloud-based applications provided on an ongoing basis during the term of the contract and for other software provided for a limited period or on an ongoing basis, the statutory limitation provisions apply. For consulting, training, support or other services for which no specific result is owed, the statutory limitation periods apply.
  6. The shortening of the limitation period pursuant to Clause 56 does not apply to claims based on intentional or grossly negligent breach of duty, claims for injury to life, body or health, claims under an assumed quality or durability guarantee, claims under the Product Liability Act (Produkthaftungsgesetz) or claims under the statutory supplier’s recourse, in particular pursuant to Sections 445a, 445b and 478 BGB. In these cases, the statutory limitation periods apply. Furthermore, the shortening does not apply in the case of fraudulent concealment of a defect or to defect claims pursuant to Section 438 (1) nos. 1 and 2 BGB and Section 634a (1) no. 2 BGB. In these cases, too, the statutory limitation periods apply.

X. Liability

  1. BIOTYPE is liable without limitation in accordance with the statutory provisions for damage resulting from injury to life, body or health, for damage based on an intentional or grossly negligent breach of duty, for damage within the scope of an assumed quality or durability guarantee, and for claims under the Product Liability Act (Produkthaftungsgesetz) as amended from time to time.
  2. In the case of a simply negligent breach of material contractual obligations, BIOTYPE is liable only for the damage typical for this type of contract and foreseeable at the time of conclusion of the contract. Material contractual obligations are obligations whose fulfilment is essential for the proper performance of the contract and on whose observance the contractual partner may regularly rely.
  3. In all other respects, BIOTYPE’s liability for simple negligence is excluded.
  4. The foregoing limitations of liability apply accordingly in favour of the legal representatives, employees and vicarious agents of BIOTYPE.
  5. Mandatory statutory liability remains unaffected.

XI. Regulatory requirements and product responsibility

  1. Medical devices and in-vitro diagnostic medical devices are subject to the applicable statutory and regulatory requirements, in particular Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), each as amended, including the applicable transitional and grandfathering provisions.
  2. Insofar as BIOTYPE is the manufacturer of a product, BIOTYPE fulfils the statutory and regulatory obligations incumbent on it as manufacturer.
  3. Insofar as BIOTYPE distributes products of a third-party manufacturer, BIOTYPE fulfils the obligations incumbent on it by law in its specific function, in particular as distributor, importer or other economic operator. BIOTYPE assumes further responsibility for the manufacture, conformity or regulatory characteristics of the third-party manufacturer’s product only where this has been expressly agreed or is required by law. Statutory provisions under which BIOTYPE assumes manufacturer obligations as a result of its specific activities remain unaffected.
  4. These GTC do not limit any statutory or regulatory obligations of BIOTYPE.
  5. The contractual partner shall observe the labelling, instructions for use and other product information applicable to the respective product.
  6. The contractual partner may not remove, alter or obscure CE markings, UDI, batch or serial numbers or other regulatory-relevant information.
  7. When passing products on to third parties, the contractual partner shall pass on the product information required for this purpose and shall not make any statements regarding the intended purpose, safety, performance or regulatory classification of the product that deviate from the information provided by BIOTYPE or the respective manufacturer.
  8. The contractual partner shall inform BIOTYPE without undue delay of any serious incidents, safety-relevant events, significant product defects or other circumstances of which it becomes aware and which may require a regulatory report, safety measure, corrective action or other response. Complaints and other product-related objections shall be reported to BIOTYPE without undue delay insofar as they may be relevant to the assessment of the circumstances referred to in sentence 1; otherwise, they shall be reported within a reasonable period. The contractual partner shall support BIOTYPE in the investigation and handling thereof to a reasonable extent. The contractual partner’s own statutory reporting, documentation and cooperation obligations remain unaffected. Notification to BIOTYPE does not replace any legally required report to a competent authority.
  9. The contractual partner shall obtain, at its own expense, the permits, authorisations or other approvals required for its purchase, transport, storage, use or resale of the Goods, insofar as obtaining them is incumbent on the contractual partner.
  10. The contractual partner shall comply with the applicable export control, sanctions and import regulations.

XII. Retention of title

  1. The tangible goods delivered by BIOTYPE remain the property of BIOTYPE until full payment of all claims of BIOTYPE arising from the business relationship with the contractual partner (“Reserved Goods”).
  2. In the event of conduct by the contractual partner in breach of contract, in particular default in payment, BIOTYPE is entitled, in accordance with the statutory provisions, to take back the Reserved Goods. Taking back the Reserved Goods constitutes a withdrawal from the contract only if BIOTYPE expressly declares this.
  3. The contractual partner shall treat the Reserved Goods with care and insure them at its own expense against fire, water and theft damage at replacement value to an appropriate extent, insofar as such insurance is customary and reasonable for the goods concerned.
  4. The contractual partner is entitled to resell and use the Reserved Goods in the ordinary course of business as long as it is not in default of payment. Pledges and transfers by way of security are not permitted.
  5. The contractual partner hereby assigns to BIOTYPE by way of security the claims arising from the resale of the Reserved Goods in the amount of the invoice value of the Reserved Goods. BIOTYPE accepts the assignment.
  6. The contractual partner remains authorised to collect the assigned claims. BIOTYPE is entitled to revoke this authorisation if the contractual partner fails to duly meet its payment obligations.
  7. Any processing, combination or mixing of the Reserved Goods is carried out for BIOTYPE. If a new item is created by processing, combination or mixing with other items, BIOTYPE acquires co-ownership of the new item in the proportion of the invoice value of the Reserved Goods to the value of the other items at the time of the processing, combination or mixing.
  8. In the event of third-party access to the Reserved Goods, in particular seizures, the contractual partner shall point out BIOTYPE’s ownership and inform BIOTYPE without undue delay.
  9. Upon request of the contractual partner, BIOTYPE is obliged to release securities insofar as their realisable value exceeds the claims of BIOTYPE to be secured by more than 10%. The selection of the securities to be released is at BIOTYPE’s discretion.

XIII. Confidentiality

  1. The parties shall treat as confidential all confidential information obtained in the course of the business relationship, in particular trade secrets, technical documents, specifications, data, processes and development results, and shall use such information exclusively for the performance of the respective contract.
  2. The confidentiality obligation does not apply to information that is demonstrably publicly known or becomes publicly known without breach of a confidentiality obligation, was already lawfully known to the recipient, was lawfully disclosed to the recipient by an authorised third party without a confidentiality obligation, or was developed by the recipient independently and without use of confidential information.
  3. Statutory disclosure obligations and separately agreed confidentiality agreements remain unaffected. In the event of a conflict, separately agreed confidentiality agreements prevail.

XIV. Data protection and processing of personal data pursuant to the transparency requirement under Art. 12 et seq. GDPR

  1. BIOTYPE processes personal data in accordance with the applicable data protection laws, in particular the General Data Protection Regulation (GDPR) and the German Federal Data Protection Act (BDSG).
  2. Details of the processing of personal data are set out in BIOTYPE’s privacy policy as amended from time to time.
  3. Insofar as BIOTYPE processes personal data on behalf of the contractual partner, the parties will conclude a separate agreement pursuant to Art. 28 GDPR before the processing begins, insofar as such an agreement is required by law.
  4. Controller within the meaning of the GDPR and the BDSG
    BIOTYPE GmbH, Dresden
  5. Data protection officer of the company
    Steve Vetter, Vetter Consulting,
    Oschatzer Str. 46, 01127 Dresden
  6. Right to lodge a complaint
    Pursuant to Art. 77 GDPR, every data subject has the right to lodge a complaint with the supervisory authority of the federal state. The State Data Protection Commissioner can be reached by e-mail at: saechsdsb@slt.sachsen.de.

XV. Applicable law, place of jurisdiction and place of performance

  1. All legal relationships between BIOTYPE and the contractual partner are governed by the laws of the Federal Republic of Germany, excluding the United Nations Convention on Contracts for the International Sale of Goods (CISG).
  2. If the contractual partner is a merchant (Kaufmann), a legal entity under public law or a special fund under public law, the exclusive place of jurisdiction for all disputes arising from or in connection with the contractual relationship is the registered office of BIOTYPE. However, BIOTYPE is also entitled to bring an action against the contractual partner at the contractual partner’s general place of jurisdiction.
  3. The place of performance for the obligations under the contractual relationship is, to the extent legally permissible, the registered office of BIOTYPE.