1 Definitions
1. In these general sale and supply conditions the following terms shall have the meaning set out below.
SkylineDx: (i) SkylineDx B.V. a company organized and existing under the laws of the Netherlands, having its registered office at Lichtenauerlaan 40, 3062ME Rotterdam, the Netherlands, registered with the Commercial Register under number 58599797, (ii) SDx Diagnostic Services B.V. a company organized and existing under the laws of the Netherlands, having its registered office at Lichtenauerlaan 40, 3062ME Rotterdam, the Netherlands, registered with the Commercial Register under number 81566425 and (iii) the private company SkylineDx USA, Inc. having its registered office at 3030 Bunker Hill Street Suite 230, San Diego CA 92109, the United States of America.
Agreement: means an agreement setting out the scope and terms of the defined Services and Deliverables agreed between SkylineDx and Customer.
Customer: the legal entity purchasing Services and Deliverables from SkylineDx.
Customer Data: any and all data and other information from the Customer required by SkylineDx and necessary for the Services and delivery of the Deliverables
Deliverables: a report describing the test results generated by SkylineDx pursuant to Services as further described in the offers made by SkylineDx to the Customer or the Agreement between SkylineDx and the Customer.
(EU) Data Protection Laws: the applicable laws and regulations regarding Personal Data, including without limitation, the General Data Protection Regulation (Regulation (EU) 2016/679).
(US) Data Protection Laws: the applicable laws and regulations regarding Personal Data, including without limitation, as applicable, the US Health Insurance Portability and Accountability Act (HIPAA).
Personal Data: any information relating to an identified or identifiable natural person, as defined in the EU & US Data Protection Laws.
Services: all activities (including diagnostic services) which are subject to any offer, proposal, agreement or any other contract between SkylineDx and the Customer.
(EU) Services: means the Services performed by a Dutch entity of SkylineDx.
(US) Services: means the Services performed by the US entity of SkylineDx for a Customer that is not located in the European Economic Area (EEA).
Samples: means any biological material sample from a human being including but not limited to DNA, RNA, cultured cells, small tissue biopsies, bone marrow and blood plasma provided to SkylineDx by the Customer.
SkylineDx Materials: any materials, data, information, software, equipment or other resources owned by or licensed to SkylineDx and made available to Customers pursuant to facilitating the use of the Deliverables.
2 Applicability
1. The General Service Terms and Conditions shall cover and form part of all offers, agreements and other acts, either made orally, in writing, electronically or in any other form, concerning the sale and supply by SkylineDx of Services and Deliverables to Customer (or, on behalf of the Customer, directly to any end-user in connection with such sale and supply of Services and Deliverables).
2. Deviations from the General Service Terms and Conditions shall only apply if and to the extent that they have been explicitly agreed upon in writing between SkylineDx and the Customer.
3. SkylineDx explicitly rejects the applicability of any general conditions used by the Customer, unless confirmed otherwise in writing.
4. If and to the extent that any provision contained in these General Service Terms and Conditions should prove not valid for whatever reason, the other provisions of General Service Terms and Conditions shall remain in full force and effect.
3 Offer and agreement
1. All offers made by SkylineDx shall be without any obligation, unless explicitly stated by SkylineDx that the offer is binding.
2. All binding offers are valid for the period mentioned in the offer concerned. If no period is mentioned, the offer will be valid for fourteen (14) calendar days after the date mentioned in the offer.
3. An Agreement shall have been concluded as soon as the Customer accepts SkylineDx’ binding offer in writing.
4. SkylineDx is entitled to request that the Customer places orders for Services and Deliverables having a certain minimum quantity or value.
4 Prices, fees and variations
1. All prices and fees mentioned in SkylineDx’ offers are in dollars when it applies to the US Services and in euros when it applies to the EU Services, unless explicitly otherwise stated in the offer and/or Agreement.
2. All prices and fees are excluding value-added tax (VAT), any other sales tax, duty, inspection or testing fee and any other taxes or government levies, as well as costs for transport and delivery, unless explicitly otherwise stated.
3. SkylineDx is at any time authorized to adjust its prices and fees with respect to new orders for Services and Deliverables for such new orders.
4. If, in agreement with the Customer, deviations from the original Agreement are made, the costs deriving from such deviations will be invoiced to the Customer against the prices and fees that apply at such moment.
5 Payment
1. Unless otherwise agreed between SkylineDx and Customer, SkylineDx’ invoices must be paid within 30 (thirty) calendar days after the date of invoice. Unless otherwise agreed between SkylineDx and Customer.
2. All payments by the Customer to SkylineDx shall first be applied against the oldest of any outstanding invoices, irrespective of any other indication by the Customer.
3. Customer shall not be entitled to any postponement of payment of SkylineDx’ invoices, neither to any set-off or reduction outside the scope of its rights in this respect under mandatory law.
4. SkylineDx is entitled at all times to require payment in advance by Customer and to postpone the rendering of Services and delivery of Deliverables until such payment in advance has been received. Furthermore, SkylineDx is entitled to require security from the Customer for the fulfilment of its payment obligation in any form, to be indicated by SkylineDx, such as a bank guarantee. In such event, the Services and Deliverables will only be delivered after such security has been obtained.
5. If the Customer fails to pay an invoice within the payment term, Customer is in default without a warning or notice of default being required.
6. From the day on which the Customer shall be in default until the day of payment in full, interest shall accrue on the outstanding amount at the statutory rate.
7. If Customer continues to be in default in his obligation to pay the outstanding invoice with accrued interest, SkylineDx is at liberty to instruct a debt-collector agency and/or lawyer to collect Customer’s debt.
8. All collection costs incurred by SkylineDx in respect of such collection, both in law (judicial costs) as well as out of law (extra judicial costs) shall be for the Customer’s sole account. The amount of the collection costs shall be determined at least 15% (fifteen per cent) of the principal sum due by Customer to SkylineDx.
6 Delivery and retention of title
1. SkylineDx shall use commercially reasonable efforts to deliver the Services and Deliverables within the agreed term, but delivery times are estimates only and SkylineDx shall not be liable for any damages suffered by Customer in the event that, despite SkylineDx’ reasonable efforts, the Services and Deliverables are not delivered within such agreed term.
2. Deliverables shall be delivered FCA SkylineDx (Incoterms 2020). Risk of loss or damage with respect to the Deliverables shall pass to Customer when SkylineDx hands over the Deliverables to the Customer or the courier selected by Customer.
3. SkylineDx retains title to the Deliverables, until payment has been received in full, including accrued interest and costs referred to in article 5 of these General Service Terms and Conditions.
4. All Deliverables shall be suitably packed in SkylineDx’ standard shipping materials in accordance with relevant regulatory packaging requirements and marked for delivery to Customer.
7 Complaints
1. Immediately upon receipt of the Deliverables by the Customer, the Customer will inspect all Products or Deliverables, whatever is the case, for possible defects or other shortcomings
2 Any claims for incomplete Services and Deliverables or otherwise incorrect deliveries must be reported in writing to SkylineDx within fourteen (14) calendar days from the date of receipt of the Deliverables. In absence of timely complaints, the Deliverables will have deemed to have been received in good condition and accepted by Customer.
3. If Customer is of the opinion that any Services and Deliverables delivered by SkylineDx does not meet the agreed conditions, Customer must notify SkylineDx thereof in writing within fourteen (14) calendar days of delivery. In absence of timely complaints, the Services and Deliverables are deemed to have been supplied in conformity to the agreed conditions.
4. For any valid complaint made regarding Services and Deliverables, SkylineDx shall at its option, replace the Service and Deliverable with an identical or substantially similar Service and Deliverable, or credit Customer for the amount paid for the Service and Deliverable. The foregoing shall be Customer’s sole and exclusive remedy for damaged, defective or missing Services and Deliverables, except for the express warranty rights stated under article 8.
5. All of Customer’s objections against any of SkylineDx’ invoices must be notified in writing to SkylineDx within 14 (fourteen) calendar days after the date of invoice, after which term the amount concerned is considered to be acknowledged for payment in due time.
8 Services and Deliverables Warranty, limitation of liability and indemnification
1. Subject to article 8.3, SkylineDx warrants that the Services and Deliverables meet the agreed specifications for the Services and Deliverables as described in the Agreement and comply with the legal requirements, provided that the Deliverables are used by or on behalf of Customer in accordance with the instructions for use provided by SkylineDx (“Services and Deliverables Warranty”).
2. SkylineDx’ specifically disclaims all implied warranties of title, non-infringement, merchantability and fitness for a particular purpose.
3. The Services and Deliverables Warranty granted by SkylineDx under article 8.1 will forthwith cease to have effect if Customer has not used the Deliverables in accordance with instructions for use provided by SkylineDx.
4. SkylineDx shall use reasonable efforts in performing the Services and delivery of Deliverables but does not make any warranties, express or implied, by operation of law or otherwise, other than set out in Article 8.1.
5. The liability and indemnification obligation of SkylineDx in relation to the Services and Deliverables will be limited to compensation of the direct damages. Any liability of SkylineDx for special, punitive, consequential or indirect damage, including but not limited to loss of profits, loss of turnover, loss of prospective profits or anticipated sales or goodwill is excluded. The liability of SkylineDx shall, save for wilful misconduct, never exceed the amount which is paid out in the matter concerned under the professional liability policy entered into by SkylineDx, to be increased by the amount of the deductible which according to the terms and conditions of the insurance policy will not be for the account of the insurer. Information about the professional liability insurance will be provided on request. This clause does not apply for death or personal injury to the extent that SkylineDx can by law not exclude or limit its liability for such damages.
6. Customer agrees to indemnify, defend and hold SkylineDx harmless against any and all claims and/or damages resulting from the use of the Services and Deliverables by Customer, its officers, employees or agents in breach or non-compliance with these General Service Terms and Conditions, particularly but not limited to Customer’s obligations under Article 9 hereof. The obligations set out herein shall survive the expiration or termination of ant agreement between SkylineDx and Customer.
7. SkylineDx will take reasonable steps to destroy any remaining Samples in accordance with relevant legislation (if applicable). At Customer’s request, SkylineDx will return all Samples to Customer, at Customer’s expense.
9 Customer Obligations
1. Customer will provide SkylineDx in due time with all Samples and Customer Material and other information required by SkylineDx the performance of the Services and delivery of the Deliverables. Customer warrants that all such data and information is correct and complete, and that it is entitled to provide SkylineDx with such information for the delivery of Services and Deliverables. Customer indemnifies SkylineDx against all third parties’ claims in this respect.
2. Customer will use the Services and Deliverables in strict accordance with received training, applicable instructions, warning and other information in user manuals or Service and Deliverable documentation, and in the manner and for the purpose for which they were intended. Pursuant to the foregoing, Customer shall not use the Services and Deliverable after the expiry date.
3. Customer shall give and make no other warranty or representation to third parties (including patients) relating to the quality, reliability, fitness for purpose or any other feature of the Services and Deliverables than those given by SkylineDx. If Customer unilaterally extends any additional warranty, Customer shall indemnify SkylineDx for any liability caused by such additional warranty.
4. Customer may not assign, transfer or otherwise dispose of any of its rights or sub-contract, transfer or otherwise dispose of any of its obligations under any agreement with Skyline Dx without SkylineDx’ prior written consent.
10. A Data protection EU
- If any of the Customer Data or Samples provided by Customer consist of patient samples containing personal data, Customer guarantees that with regard to such samples, all applicable European regulations for the protection of privacy have been observed. Customer furthermore guarantees that SkylineDx is entitled to process such samples for the purposes agreed with Customer, who will indemnify SkylineDx against any third parties’ claims in this respect. SkylineDx agrees to observe all applicable European privacy regulations as well.
- Insofar as SkylineDx processes Personal Data in providing the Services and Deliverables the parties agree that SkylineDx shall process Personal Data in compliance with the obligations of data processors under the GDPR and other European Data Protection Laws.
- In relation to the processing of the Personal Data, SkylineDx shall implement and maintain, at its cost and expense, technical and organisational Measures.
- In the event necessary under the GDPR and/or other EU Data Protection Laws, Customer and SkylineDx shall enter into a data processing agreement that sets out the tasks of Customer and SkylineDx.
10. B Data protection US
- If any of the Customer Data or Samples provided by Customer consist of patient samples containing personal data, Customer guarantees that with regard to such samples, all applicable US regulations for the protection of privacy have been observed. Customer furthermore guarantees that SkylineDx is entitled to process such samples for the purposes agreed with Customer, who will indemnify SkylineDx against any third parties’ claims in this respect. SkylineDx agrees to observe all applicable US privacy regulations as well.
- Insofar as SkylineDx processes Personal Data in providing the Services and Deliverables the parties agree that SkylineDx shall process Personal Data in compliance with the obligations of data processors under US law, if applicable.
- In relation to the processing of the Personal Data, SkylineDx shall implement and maintain, at its cost and expense, technical and organisational Measures.
11 Confidentiality
1. Both SkylineDx and Customer undertake to observe strict confidentiality with regard to all confidential information they receive from each other. They shall also impose this confidentiality obligation on their employees as well as to third parties who have been contracted by them in connection with any agreement between SkylineDx and Customer.
2. Information will in any event be regarded as confidential if either SkylineDx or Customer indicates such information as confidential.
3. The confidentiality obligations referred to in articles 11.1 and 11.2 above shall not apply or cease to apply to information regarding which the receiving party can prove by documentary evidence that:
(a) it was in the public domain prior to disclosure to the receiving party;
(b) it was in its possession prior to the disclosure to the receiving party without any obligation of confidentiality;
(c) after disclosure to the receiving party, it became part of the public domain by publication or otherwise through no act or omission of the receiving party;
(d) after disclosure to the receiving party, it has been lawfully provided by a third party, meaning that this third party was not under any confidentiality obligation regarding the information supplied to the receiving party.
12 Intellectual Property and license
1. SkylineDx or its licensors own all right and title to any intellectual property rights regarding its Services and Deliverables, such as but not limited to the copyright with respect to the software and the trademarks owned by SkylineDx. The supply of the Deliverable does not grant any right or title to such intellectual property rights to the Customer.
2. Customer is not entitled to disassemble, decompile, reverse engineer, modify intellectual property owned by SkylineDx.
3. The delivery of any Products and/or Services does not imply any transfer or license of intellectual property rights.
4 The Customer is prohibited from removing or changing any copyright or other notices of SkylineDx or its suppliers. Customer may not use SkylineDx’ name and/or logo in any manner other than as identified in any agreement between Customer and SkylineDx, without first obtaining written permission from SkylineDx
13 Termination
1. Each of SkylineDx and Customer is entitled to terminate an agreement in place between them with immediate effect and without any judicial intervention being required if:
(a) its counterpart has not, not timely or not properly fulfilled its obligations hereunder and, such default can either not be cured or, if curable, has not been cured within sixty (60) calendar days after receipt of written notice thereof from the other party, all without prejudice to the right of the terminating party to claim the damages it has suffered as a result of the termination of this agreement; or
(b) its counterpart files for bankruptcy or suspension of debts (surséance), a petition for bankruptcy has been filed against it, passes a resolution for its liquidation, if a liquidator is appointed in respect of its assets or if the counterparty makes an assignment for the benefit of its creditors, or deceases.
2. The termination of an agreement between SkylineDx and Customer does not release Customer from any payment obligation regarding any Services and Deliverables and the installation thereof (if applicable).
3. The provisions regarding Service and Deliverable warranty, limitation of liability and indemnification (8), confidentiality (11), intellectual property rights (12), and disputes (14.A & 14.B) shall survive termination of these General Service Terms and Conditions and any related agreement.
14. A Disputes related to EU Services
1. These General Conditions as well as any related agreement between SkylineDx and Customer concerning the delivery of Services and Deliverables are governed by the laws of the Netherlands.
2. Any disputes following from or arising in connection with these General Service Terms and Conditions and any related agreement between SkylineDx and Customer shall exclusively be settled by the competent court of Rotterdam, the Netherlands.
14. B Disputes related to US Services
- These General Conditions as well as any related agreement between SkylineDx and Customer concerning the delivery of Services and Deliverables are governed by the laws of the State of Delaware.
- Any disputes following from or arising in connection with these General Service Terms and Conditions and any related agreement between SkylineDx and Customer shall exclusively be settled by the competent court (Court of Chancery) of Delaware, The United States of America.
