GTC

General Terms of Delivery and Payment

General Terms and Conditions

I. Scope of application

1. The following Terms and Conditions apply to all contracts concluded between BIOTYPE GmbH (hereinafter also referred to as "BIOTYPE" or "we") and its contractual partners for the delivery of goods, in particular a MODAPLEX system (hereinafter also referred to as the "MODAPLEX"), including the related installation, maintenance and other ancillary services that are fundamentally necessary as well as the ordering of additional equipment, consumables or molecular test kits required for the use of the MODAPLEX (hereinafter also referred to collectively as the "Goods") from BIOTYPE to the contractual partner, provided that these General Terms and Conditions (GTC) are expressly included in the contract.
2. All agreements made between the contracting parties and BIOTYPE for the execution of the respective contract are set out in writing in the contracts with our contracting parties. Agreements made between the contracting parties in individual cases (including collateral agreements, supplements and amendments) shall in any case take precedence over these General Terms and Conditions insofar as they contradict these General Terms and Conditions.
3. These General Terms and Conditions shall also apply to all future contractual relationships for the delivery of Goods between the contractual partners and us which are based on the relevant contractual relationship which has included these General Terms and Conditions or which are directly related to it, even if they are not expressly agreed again.
4. Differing conditions of the contractual partner, which we have not explicitly accepted, shall not be binding, even if we do not explicitly reject them. The following General Terms and Conditions shall also apply, even if we, while knowing of conflicting or differing conditions of the contractual partner, unconditionally execute an order from the contractual partner.
5. Our offers shall be directed at commercial customers only. Consumers as defined by Section 13 German Civil Code [§ 13 BGB – Bürgerliches Gesetzbuch] shall not receive any deliveries.

II. Offer and conclusion of contract

1. An order or other contact made by the contractual partner to BIOTYPE with regard to the delivery of Goods, in particular a MODAPLEX, shall not be qualified as an offer to conclude a contract, but shall be processed by BIOTYPE after appropriate examination by submitting its own offer for acceptance by the contractual partner and with information on the inclusion of these General Terms and Conditions and – in the case of delivery of a MODAPLEX – of the additional maintenance contract required between us and the contractual partner with regard to the MODAPLEX in accordance with Section V Number 5 of these General Terms and Conditions.
2. Other offers are subject to change and non-binding unless we have expressly designated them as binding.
3. We reserve our property rights, copyrights and other (in particular intellectual) property rights to all Goods, illustrations, calculations, drawings and other documents. The contractual partner may only pass these on to third parties with our written consent, irrespective of whether we have marked them as confidential or not. In particular – in the event of the delivery of a MODAPLEX – any source codes or software programs incorporated in or forming part of the MODAPLEX shall remain our property. These shall be made available to the contracting party by means of a non-exclusive license to use these source codes and software in the MODAPLEX devices (but without any right of reproduction). These license rights shall expire if the contracting party is no longer entitled to possession of the MODAPLEX supplied or if one of the parties declares its withdrawal from this contract. The license may not be assigned or otherwise transferred by the contracting party without our prior written consent; however, it may be assigned by way of sublicense to the contracting party's clients who have purchased the MODAPLEX containing the software, on condition that the contracting party also complies with the terms of these General Terms and Conditions and that we are immediately notified of the name of this sublicensee at the time of assignment of a sublicense. We are entitled to revoke this license if the contractual partner violates one of the conditions regulated herein.

III. Terms of payment

1. Our prices apply ex works including packaging, unless otherwise specified in BIOTYPE's offer or order confirmation. In case of a delivery with dry ice, the contractual partner shall bear the incremental costs.
2. Our prices do not include the statutory value added tax. The tax will be shown separately on the invoice at the statutory rate on the date of invoicing.
3. A discount deduction is only permitted in the case of a special written agreement between us and the contractual partner. The purchase price is due for payment net (without deduction) immediately upon receipt of the invoice by the contractual partner, unless the order confirmation specifies a different payment term. Payment shall only be deemed to have been made as soon as we can dispose of the payment amount. In the case of payment by check, payment shall only be deemed to have been made when the check has been successfully cashed.
4. If the contractual partner defaults on a payment, the statutory provisions shall apply. In addition, we reserve the right to stop the delivery of Goods in the process of being delivered and to withhold shipments in whole or in part if the contractual partner fails to make a payment to us when due or otherwise fails to fulfill its obligations under these General Terms and Conditions.
5. The contractual partner is only entitled to set-off, even if notices of defects or counterclaims are asserted, if the (counter-)claims have been legally established in court or recognized by us or are undisputed. The contractual partner is only authorized to exercise a right of retention if his (counter-)claim is based on the same contractual relationship.

IV. Delivery and performance time, delay in delivery

1. Delivery dates or deadlines that have not explicitly been agreed on to be binding, shall be strictly non-binding. The delivery deadline stated by us shall only start once all technical issues regarding the Goods to be delivered have been settled. Likewise, the contractual partner must also have fulfilled all obligations imposed on him properly and on time.
2. If we are unable to meet binding delivery deadlines for reasons for which we are not responsible (non-availability of the service), we shall inform the contractual partner of this immediately and at the same time inform him of the expected new delivery deadline. If the service is still not available within the new delivery deadline, we are entitled to withdraw from the contract in whole or in part; we will immediately reimburse any consideration already provided by the contractual partner. Non-availability of the service is to be assumed, for example, in the event of late delivery by our supplier, if we have concluded a congruent hedging transaction, or in the event of other disruptions in the supply chain, for example, due to force majeure or if we are not obliged to procure personally in individual cases.
3. The conditions for our delay in delivery shall be determined in accordance with the statutory provisions. In any case, however, a reminder from the contractual partner is required.
4. 4. In the event of culpable delay in delivery, the contractual partner may demand lump-sum compensation for the damage caused by the delay. The lump-sum compensation shall amount to 0.5 % of the net price (delivery value) for each completed calendar week of delay but shall not exceed a total of 5 % of the delivery value of the Goods delivered late. We reserve the right to prove that the contractual partner has suffered no damage at all or only significantly less damage than the lump sum regulated above.
5. The rights of the contractual partner pursuant to Section VI of these General Terms and Conditions and our statutory rights, in particular concerning an exclusion of the obligation to perform (e.g. due to impossibility or unreasonableness of performance and/or subsequent performance), shall remain unaffected.
6. 6. We shall be entitled to make partial deliveries and render partial services at any time, which shall be invoiced and paid for separately, insofar as this is reasonable for the contractual partner.
7. If the contractual partner enters into default of acceptance, we shall be entitled to demand compensation for the resulting damage and any additional expenditures. The same applies in case the contractual partner culpably violates his obligation to cooperate. Upon entering into default of acceptance respectively payment, the risk of incidental deterioration and accidental loss shall pass to the contractual partner.

V. Transfer of risk, shipping, packaging, maintenance contract/special duty of use of the contractual partner

1. The loading and shipping shall be conducted without insurance and at the risk of the contractual partner. We shall endeavor to take into account the contractual partner’s wishes and interest regarding the shipping method and the shipping route; additional costs resulting from such considerations – even in case of a carriage paid delivery has been agreed – shall be borne by the contractual partner.
2. We do not take back any transport packaging or any other packaging materials in accordance with the Packaging Ordinance [Verpackungsverordnung]. This shall not apply to palettes. The contractual partner shall take care of the disposal of the packaging materials at his own expense.
3. If the shipping is delayed by request or by the fault of the contractual partner, we shall store the Goods at the contractual partner’s risk and expense. In this case the notification of the readiness for shipping shall be considered equal to the event of shipping.
4. At the request and expense of the contractual partner, we will insure the delivery by means of a transport insurance.
5. In the event of delivery of a MODAPLEX, the contractual partner is informed that the operation of the MODAPLEX requires regular, careful and professional maintenance and undertakes to have the device serviced and maintained by us continuously at intervals of 6 months after delivery. The parties shall conclude a separate maintenance contract for this purpose. The conclusion of the contract concluded on the basis of these General Terms and Conditions for the delivery of a MODAPLEX is subject to the condition precedent of the conclusion of the aforementioned maintenance contract. In the event of invalidity or premature termination of the maintenance contract, BIOTYPE shall be entitled to terminate the contract concluded on the basis of these General Terms and Conditions and, if applicable, to demand the return of the MODAPLEX. In this case, the MODAPLEX property shall be returned to BIOTYPE.
6. In the case of delivery of a MODAPLEX, the contractual partner also undertakes to operate the MODAPLEX exclusively with consumables/test kits purchased from BIOTYPE. In the case of test kits developed by the contractual partner within the framework of the open platform concept, PCR reagents from other manufacturers may also be used with the MODAPLEX.

VI. Defects in material and title, liability, approvals

1. Claims for defects on the part of the contractual partner shall only exist if he has duly and, in particular, immediately fulfilled his obligations to inspect and give notice of defects in accordance with § 377 of the German Commercial Code [HGB – Handelsgesetzbuch]. In the case of delivery of a MODAPLEX, such claims for defects shall also only exist if the contractual partner has concluded a corresponding maintenance contract with us in accordance with Section V Number 5 of these General Terms and Conditions and has used only BIOTYPE consumables/test kits for the MODAPLEX.
2. In case of legitimate notices of defects, we shall be obligated to provide subsequent performance – under exclusion of the contractual partner’s right to rescind the contract or reduce the purchase price (reduction) –, unless we are entitled to deny the subsequent performance due to statutory regulations. The contractual partner must grant us an appropriate time limit for providing the subsequent performance. We may choose whether we wish to provide subsequent performance by means of correction of the defect (subsequent correction) or by way of a new delivery. In case of subsequent correction, we shall bear the necessary additional expenses, insofar as these do not result from the fact that the contractual object is located at a place other than the place of performance. If the subsequent performance ends in failure, the contractual partner may choose to demand a reduction of the purchase price (price reduction) or declare his withdrawal from the contract. The subsequent correction shall be deemed to have failed with the second unsuccessful attempt to fulfill the contract, insofar as further correction attempts appear appropriate due to the subject matter of the contract and can be reasonably expected from the contractual partner. The contractual partner may only exercise his claims for damages due to a defect in accordance with the following conditions once the subsequent performance has finally failed. The contractual partner’s right to assert further claims for damages in accordance with the following conditions shall remain unaffected thereby.
3. Any warranty claims on the part of the contractual partner shall expire one year following the delivery of Goods to him, unless we have fraudulently concealed the defect; in this case, the statutory regulations shall apply. Our obligations in accordance with Section VI Number 4 and Section VI Number 5 shall remain unaffected.
4. Pursuant to the statutory provisions, we shall be obligated to take back the Goods or reduce the purchase price (price reduction) even without the generally required setting of a deadline if the contractual partner’s buyer as a end consumer of a new movable article sold (purchase of consumer goods, [Verbrauchsgüterkauf]) could demand from the contractual partner that he takes back the Goods or reduces the purchase price (price reduction) due to the defect of the Goods or if the contractual partner is rightfully confronted with such a claim for recourse resulting from it. We shall further be obligated to reimburse the contractual partner for any expenses, in particular expenses for transport, travel, work and material, which he had to bear based on his relationship with the aforementioned end consumer in connection with subsequent performance caused by a defect of the Goods that had already existed at the time the risk passed from us to the contractual partner. The claim is excluded if the contractual partner has not properly, and in particular not immediately, fulfilled his duties of inspection and notification of defects in accordance with Section 377 HGB (German Commercial Code).
5. The obligation pursuant to Section VI Number 4 shall be excluded, insofar as the defect was caused by advertising statements or other contractual agreements that did not originate from us, or if the contractual partner has granted the end consumer a special guarantee. The obligation shall also be excluded if the contractual partner himself was not obligated to fulfil the warranty rights against the end consumer due to statutory regulations or if the aforementioned notification regarding a claim brought against him was not made. This shall also apply if the contractual partner has assumed warranties towards the end consumer, which exceed the statutory scope.
6. Irrespective of the following limitations of liability, we shall be liable pursuant to the statutory provisions regarding any harm to life, body and health that was caused by negligent or intentional violations of obligations by us, our legal representatives or our vicarious agents as well as regarding any damage included in the liability in accordance with the Product Liability Act [Produkthaftungsgesetz]. We shall also assume liability for damage that is not yet covered by Sentence 1 and that was caused by intentional or grossly negligent violations of obligations as well as fraudulent intent on the part of us, our legal representative or our vicarious agents in accordance with the statutory provisions. In this case, however, the liability for damages shall be limited to the foreseeable damage that typically occurs, unless we, our legal representatives or our vicarious agents have acted with intent. Insofar as we have assumed a quality and/or durability guarantee regarding the Goods or parts thereof, we shall be held liable within the scope of this guarantee. However, we shall only be liable for damages that may be attributed to the absence of the guaranteed quality and/or durability but which do not effect the Goods directly, if it is evident that the risk of such a damage is included in the quality and/or durability guarantee.
7. We shall also be liable for damages caused by simple negligent breach of such contractual obligations, the fulfillment of which is essential for the proper performance of the contract anyway and on whose compliance the contractual partner regularly relies on and may rely on (essential contractual obligations). However, we shall only be liable for direct damages and only insofar as the damages are typically associated with the contract and are foreseeable.
8. Any further liability is excluded regardless of the legal nature of the claim asserted; this also applies in particular to claims in tort or claims for reimbursement of useless expenses instead of contract performance. Insofar as our liability is excluded or limited, this shall also apply to the personal liability of our employees, workers, staff, representatives and vicarious agents.
9. The contractual partner’s claims for damages arising from defects expire one year starting from the delivery of the Goods. This shall not apply in case of harm to life, body or health caused by us, our legal representatives or our vicarious agents or in case we, and our legal representatives acted with intent or gross negligence, or if our simple vicarious agents acted with intent.
10. The contractual partner shall obtain at its own expense all licenses, permits, approvals or other authorizations from state authorities or other entities that are required for the purchase, transport, storage, use or sale of the Goods by the contractual partner and, if necessary, provide us with evidence of this upon request.

VII. Retention of title

1. Until all obligations, including all current account receivables, which we are entitled to now and in the future, have been fulfilled, the delivered Goods shall remain our property (reserved Goods). In case of acts in violation of the contract on the part of the contractual partner, e.g. default in payment, we shall have the right to reclaim the reserved Goods after having set a reasonable deadline. Should we take back the reserved Goods, this shall be deemed a withdrawal from the contract. If we seize the reserved Goods, this shall be deemed a withdrawal from the contract. We shall be entitled to utilize the reserved Goods after taking them back. Following the deduction of a reasonable amount for the utilization costs, the utilization proceeds shall be offset against the amounts owed to us by the contractual partner.
2. The contractual partner shall handle the reserved Goods carefully and adequately insure them at his own expense and at the original value against damage due to fire, water and theft. Necessary maintenance and inspections are to be conducted by the contract partner in good time and at his own expense.
3. The contractual partner shall be entitled to sell and/or use the reserved Goods during the ordinary course of business, for as long as he is not in default of payment. Pledging and transferring by way of security are not permitted. The contractual partner fully assigns by way of security all claims arising from the resale or another legal reason (insurance, torts) regarding the reserved Goods (including all current account receivables) to us. We are hereby accept the assignment. We revocably authorize the contractual partner to collect for his account in its own name the claims assigned to us for the purpose of invoicing. This direct debit authorization shall be subject to revocation at any time if the contractual partner does not properly meet its payment obligations. Furthermore, the contractual partner shall not be allowed to claim assignments for the purpose of debt collection by way of factoring, unless the obligation of the factor is established at the same time, which stipulates that we shall directly receive consideration in the amount of the claim as we still have claims against the contractual partner.
4. The processing or remodeling of the reserved Goods shall be carried out by the contractual partner in any case on our behalf. Insofar as the reserved Goods are processed together with other items that do not belong to us, we shall acquire joint ownership of the new object in proportion to the value of the reserved Goods (final invoice amount, incl. value-added tax) and the other processed items at the time of processing. The provision regarding the reserved Goods shall also apply to new, by means of processing, created products. In case of an inseparable mixing of the reserved Goods with other items that do not belong to us, we shall acquire joint ownership in proportion to the value of the reserved Goods (final invoice amount, incl. value-added tax) and the other, blended items at the time of the mixing. If the item of the contractual partner is considered to be the main item after the mixing took place, the contractual partner and we agree that the contractual partner shall assign joint ownership of the item to us. We hereby accept the assignment. Our subsequently realized sole respectively joint ownership of an item shall be kept safe by the contractual partner on our behalf.
5. In case third parties accessing (in particular in case of seizure) the reserved Goods, the contractual partner shall inform the third party of our ownership and report to us immediately, so that we may exercise our ownership rights. Insofar as the third party is unable to reimburse us for the judicial costs or extrajudicial costs incurred in this connection, the contractual partner shall be liable for these.
6. We shall be obligated to release securities that we are entitled to insofar as the realizable value of our security exceeds the claim to be secured by more than 10 %. We shall have the right to choose, which security to be released.

VIII. Place of performance, place of jurisdiction, applicable law

1. The place of performance and jurisdiction for all deliveries and payments (including actions regarding checks and bills of exchange) as well as any disputes that might arise between us and the contract partner from the contracts concluded between us and the contract partner shall be our registered office. However, we are also entitled to bring an action against the contract partner at his place of residence and/or place of business.
2. The relations between the contracting parties shall be exclusively governed by the applicable laws of the Federal Republic of Germany. The application of the United Nations Convention on Contracts for the International Sale of Goods [UN-Kaufrecht] shall be excluded.

IX. Information on the compilation and processing of personal data pursuant to the requirement of transparency in accordance with Art. 12 et. seqq. General Data Protection Regulation [Datenschutz-Grundverordnung – DSGVO]

1. Specification of purpose
   BIOTYPE compiles and processes personal data for the purpose of entering into business relationships and the performance of contracts. Affected are all data categories relevant for the performance of pre-contractual and contractual obligations. Personal data shall only be disclosed to third parties if this is necessary to fulfill the business objective. The disclosure of personal data to third parties in third countries with an uncertain data-protection level (generally countries outside the European Union), which have no part in the business objective shall not take place or shall only take place with the consent of the data subject. The compilation, processing and use of personal data shall be conducted to the extent that is legally permissible pursuant to Art. 5 and 6 DSGVO. If personal data are collected from the data subject, the data subject shall be entitled to the right of transparent information pursuant to Art. 12 et. seqq. DSGVO and in accordance with Section 32 BDSG [Bundesdatenschutzgesetz]. In general, only this information is processed and used that is necessary for the fulfillment of the operational tasks by the company and is directly connected to the purpose of the processing. In this case, the special conditions for the compilation, processing and use of the particular categories of personal data pursuant to Art. 9 DSGVO and Sections 22 et. seqq. BDSG shall be taken into account. The compilation and processing of sensitive data pursuant to the DSGVO shall only be permitted within the scope of the principle of reservation of authorization or upon presentation of a legal basis.
2. The rights of data subjects
   Pursuant to Art. 15 et. seqq. DSGVO, data subjects shall have the right to disclosure, correction, erasure, limitation and objection to the compilation and processing of their personal data. Pursuant to Art. 13 Subsection 2 Point c DSGVO, data subjects shall further have the right to withdraw their consent regarding the future compilation and processing of personal data if the data processing is based on Art. 6 Subsection 1a or Art. 9 Subsection 2a DSGVO. The legitimacy of the data processing done based on the consent given until its withdrawal shall remain unaffected. However, a withdrawal of consent as well as the non-provision of the required data usually leads to the purpose, for which the data were or would have to be collected, being impossible to achieve. In order to exercise these rights, the written form is required. For this purpose, please contact BIOTYPE at Datenschutz@mdx-group.com.
3. Erasure of personal data
   Personal data shall be erased once the purpose for their storage ceases to exist and no legal norm (e.g., statutory retention period) requires the data to be kept. The stipulations of Art. 17 DSGVO in conjunction with Section 35 BDSG shall apply. Insofar as the erasure for statutory and/or contractual reasons, or for reasons related to commercial and/or tax law is impossible, the processing of personal data of the data subject can be restricted at his/her request. In order to exercise this right, the written form is required.
4. The data subject's right to data portability
   The company shall ensure the rights to data portability pursuant to Art. 20 DSGVO. Any data subject shall have the right to receive a copy of his/her personal data in a common, machine-readable data format.
5. Controller within the meaning of the DSGVO and the BDSG
   BIOTYPE GmbH, Dresden, Germany
6. Data Protection Supervisor of the BIOTYPE
   Hermann. J. Janz, c/o Janz Consulting, Schevenstr. 18, 01326 Dresden, Germany
7. Right to file a complaint
   All data subjects shall have the right of complaint with the state’s supervisory authority pursuant to Art. 77 DSGVO. You may contact the State Data Protection Commissioner via email: saechsdsb@slt.sachsen.de.