General terms and conditions


of
SkylineDx Holding BV, SkylineDx BV, Rotterdam, the Netherlands and SkylineDx USA, Inc. San Diego, United States of America (together “SkylineDx”)

 

1. Definitions

In these General Term and Conditions the following definitions are being used, singular as well as plural. ”General Conditions”: these general supplier terms and conditions, irrespective of the form in which these general terms and conditions are presented to the Contracting Party. “SkylineDx”: the private company with limited liability SkylineDx Holding B.V. and SkylineDx B.V., having its registered office at Lichtenauerlaan 40, 3062 ME Rotterdam, the Netherlands and the private company SkylineDx USA, Inc. having its registered office at 3030 Bunker Hill Street Suite 201, San Diego CA 92109, the United States of America. “Contracting Party”: the party, either acting in the course of a business or profession or as a private person, to whom the offer of SkylineDx is submitted, or with whom SkylineDx has entered into an agreement or to whom the Products or Services are or will be delivered or are or will be executed. “Products”: all movable assets (including diagnostic kits) which are subject to any offer, proposal, agreement or any other contract between SkylineDx and the Contracting Party. “Services”: all activities (including diagnostic services) which are subject to any offer, proposal, agreement or any other contract between SkylineDx and the Contracting Party. “Service deliverables”: a report describing the test results generated by SkylineDx pursuant to Services.

 

2. Applicability

The General Conditions shall cover and form part of all offers, proposals, agreements and other acts, either made orally, in writing, electronic or in any other form, concerning the delivery by SkylineDx of Products and/or Services to or on behalf of the Contracting Party. The General Conditions also apply to Products and/or Services partly or wholly obtained by SkylineDx from a third party and which are, either processed or not, delivered to the Contracting Party, as well as to Products and/or Services required for the execution of the offer, proposal, agreement or any other legal act delivered to the Contracting Party on SkylineDx’ instruction. Deviations from the General Conditions shall only apply if and to the extent that they have been explicitly agreed upon in writing between SkylineDx and the Contracting Party. SkylineDx explicitly rejects any applicability of any general (purchase) conditions used by the Contracting Party. If and to the extent that any provision contained in these General Conditions should prove not valid for whatever reason, the other provisions of these General Conditions shall remain in full force and effect.

 

3. Offer and agreement

All offers by SkylineDx shall be non-binding unless explicitly otherwise stated in writing. All offers are valid for the period as mentioned in the offer concerned. If no period is mentioned, the offer will be valid for fourteen (14) days after the day on which the offer was submitted. All instructions are accepted and carried out exclusively by SkylineDx, with the exclusion of Article 7:404 and 7:407 (2) Dutch Civil Code. Third parties cannot derive any rights from the work carried out and from the ensuing results. An agreement shall have been concluded as soon as SkylineDx accepts the Contracting Party’s order by e-mail or written confirmation or on the moment SkylineDx starts executing the Contracting Party’s order.

 

4. Prices, fees and variations

All prices and fees mentioned by SkylineDx are in Euros, unless explicitly otherwise stated. All prices and fees are excluding value-added tax (VAT), any use tax, sales tax, excise 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. SkylineDx is at any time authorized to adjust its prices and fees. Unless agreed upon in writing that prices and fees are valid for a fixed period, all announced adjustments will enter into force 1

(one) month after the announcement thereof. If the Contracting Party does not agree to any announced adjustment in SkylineDx’ prices and fees, the Contracting Party may terminate the agreement with SkylineDx in writing within 14 (fourteen) days after such announcement. The termination will have effect from the date the adjustment of the prices and fees enters into force. If in consultation with the Contracting Party deviations from the original agreement will be made, the costs deriving from such variations will be invoiced to the Contracting Party against the prices and fees that apply at such moment.

 

5. Delivery

Transfer of ownership of Products and/or Services shall occur on a “FOB Delivered” basis upon the signature of an authorized SkylineDx representative accepting delivery. Delivery and/or performance of Products and/or Services must be completed within the term stated in the Contract. SkylineDx reserves the right to terminate or dissolve the Contract, with immediate effect, by giving written notice to Contracting Party without liability in the event of, and Contracting Party agrees to indemnify SkylineDx against any loss or liability incurred by SkylineDx as a result of, Contracting Party’s failure to fulfill its obligation to deliver the Products and/or Services within the term specified.

 

6. Packaging

Contracting Party shall provide proper and adequate packaging in accordance with prevailing commercial best practices to ensure that Products shipped to SkylineDx will be free of damage. SkylineDx shall reserve the right to reject any and all shipments deemed by SkylineDx to have been inadequately packaged.

 

7. Inspection

SkylineDx shall have 90 days after receipt of Products and/or Services to accept or reject them as non- conforming with the Contract as determined by SkylineDx acting reasonably. SkylineDx’ failure to reject any Products and/or Services within such time frame shall be deemed acceptance thereof.

Rejected Products and/or Services shall be returned to Contracting Party, transportation charges for the account of Contracting Party, or promptly corrected by Contracting Party at Contracting Party’s sole cost, as applicable. SkylineDx may reject the Product and/or Services in whole or in part. Contracting Party agrees that SkylineDx’ payment under the Contract shall not be deemed acceptance of any Product and/or Services delivered or performed thereunder. Acceptance shall not relieve Contracting Party of its warranty obligations or liability for latent defects.

 

8. Payment

The Contracting Party will pay SkylineDx’ invoices within the term specified on the invoice concerned. If no term has been specified, the invoice must be paid within 30 (thirty) days after the date of invoice. All payments by the Contracting Party to SkylineDx shall first be applied against the oldest of any outstanding invoices, irrespective of any other indication by the Contracting Party. The Contracting Party shall not be entitled to any postponement, set-off or reduction outside the scope of its rights in this respect under mandatory law. SkylineDx is entitled at all times to require payment in advance by the Contracting Party, for example by way of a direct debit mandate issued in favor of SkylineDx and to postpone delivery until such payment in advance has been received. Furthermore SkylineDx is entitled to require security from the Contracting Party for the fulfillment of its payment obligation in any form, to be indicated by SkylineDx, such as a bank guarantee. In such event, the Products and/or Services will only be delivered after such security has been obtained. If the Contracting Party fails to pay an invoice within the term of payment, the Contracting Party is in default without a warning or notice of default being required. From the time at which the Contracting Party shall be in default until the day of payment in full, interest shall accrue on the outstanding amount at the statutory rate. If the Contracting Party continues to be in default in his obligation to pay the outstanding invoice with accrued interest, SkylineDx can place the matter in the hands of a lawyer or a debt-collector agency. All collection costs incurred by SkylineDx in respect of such collection, both in court (judicial costs, including all attorney’s fees and court costs) as well as out of court (extra judicial costs)

shall be for the Contracting Party’s sole account. The amount of the collection costs shall be determined at least 35% (thirty-five percent) of the principal sum.

 

9. Warranties

Contracting Party expressly warrants (garandeert) that all Products and Services delivered or performed under a Contract will be (a) merchantable (Products only); b() free from defects in material and workmanship; (c) fit and sufficient for purposes intended; (d) in strict conformance to applicable specifications, (e) provided in a timely, professional and competent manner and in accordance with all applicable laws and regulations (including applicable insider trading, anti-bribery and privacy-laws).

All warranties (garanties) specified herein or in the Contract shall be in addition to any other warranties (garanties), express or implied or arising by operation or law, custom or usage. This warranty shall survive SkylineDx’ inspection, acceptance and payment.

SkylineDx’ continued use of Products and/or Services after notifying Contracting Party of their failure to conform to the Contract or breach of warranty will not be considered a waiver of SkylineDx’ right to a remedy.

 

10. Performance, risk and retention of title

Immediately upon receipt of the Products or the Service deliverables by the Contracting Party, the Contracting Party will inspect all Products or Service deliverables, whatever is the case, for possible defects or other shortcomings. All items and Service deliverables delivered to the Contracting Party will remain SkylineDx’s property, until the Contracting Party has fully paid all amounts due for any Products and/or Services delivered by SkylineDx, with accrued interest and costs, as meant in article 5. Insofar it has been explicitly agreed upon in writing that any rights will be granted or transferred, such rights will at all times be granted or transferred under the condition that the payments concerned will be timely and fully made. SkylineDx shall perform the Services professionally and to the best of its abilities. However, the Contract Party acknowledges that SkylineDx cannot guarantee that the Services will always be performed to a result or a correct result.

 

11. Samples

Samples shall be shipped to SkylineDx at the Contracting Party’s responsibility. SkylineDx shall be entitled to reject samples for diagnostic services if, in SkylineDx ́s sole discretion, the samples are not appropriate and/or the quality of these samples is not sufficient. The samples that may be rejected by SkylineDx include but are not limited to samples that (i) are not bone marrow, (ii) samples with a delivery time longer than 24 hours for the MMprofiler and longer than 48 hours for the AMLprofiler after aspiration of the Bone Marrow sample (iii) samples that have been shipped or stored under inappropriate environmental conditions (iv) samples yielding less than 10x 106 (ten million) mononuclear cells in case of AML (v) samples yielding less than 1 μg (one micro gram) RNA for AML (vi) samples yielding less than 1x 106 (one million) plasma cells for MM (vii) samples yielding less than 500 ng (five-hundred nano gram) RNA for MM (viii) samples smaller than 5 ml (five milliliter) for both AML and MM and (ix) samples from which the RNA quality is insufficient (x) the plasma cell % in the bone marrow sample is less than 5%. In case the root cause of the failure occurred under the responsibility of SkylineDxDx (during sample processing), the analysis will not be charged and the samples will be returned to the Contracting Party free of charge. In case the root cause of the failure occurred under the responsibility of the Contracting Party (the costs incurred by SkylineDx (e.g. analysis of the sample and shipment costs) will be charged to the Contracting Party.

 

12. Complaints

All of Contracting Party’s objections against any of SkylineDx’s invoices or a directly debited amount must be notified in writing to SkylineDx within 14 (fourteen) days after the date of invoice or the date of direct

debit, after which term the amount concerned is considered to be acknowledged. If the Contracting Party is of the opinion that any Product or Service delivered by SkylineDx does not meet with the agreed conditions, the Contracting Party must notify SkylineDx thereof in writing within 14 (fourteen) days of delivery, or 14 (fourteen) days from the day the Contracting Party could reasonably be aware of the alleged shortcoming. Contracting Party shall inspect Products upon delivery. Any claims for damaged, missing or defective Products must be reported in writing to SkylineDx within 14 (fourteen) business days from the date of receipt of the Products otherwise the Products will be deemed to have been received in good condition and accepted by the Contracting Party. Contracting Party must promptly return a rejected Product to SkylineDx, unused and in a condition no worse than that delivered to Contracting Party and in the Product’s original containers and packing material. SkylineDx may refuse any Product not timely rejected in writing. For any valid claim made, SkylineDx shall, at its option, repair the Product or replace the Product with an identical or substantially similar Product. The foregoing shall be Contracting Party’s sole and exclusive remedy for damaged, defective or missing Products.

Contracting Party shall inspect reported results from diagnostic services upon delivery. Any claims for incorrect or missing reported results must be reported in writing to SkylineDx within 14 (fourteen) business days from the (expected) date of receipt of the reported results otherwise the reported results will be deemed to have been received in good condition and accepted by the Contracting Party. For any valid claim made, SkylineDx shall, at its option, and to the extent sufficient sample material is (made) available, reanalyze the sample and generate new reported results. The foregoing shall be Contracting Party’s sole and exclusive remedy for incorrect or missing reported results.

 

13. Intellectual Property and Trade secrets

All intellectual property rights regarding the Products and/or Services as well as all designs, software, documentation and all other materials developed and/or used for the preparation or execution of the agreement between SkylineDx and the Contracting Party, or deriving there from, are the exclusive ownership/property of SkylineDx or its suppliers and/or licensors. The delivery of any Products and/or Services does not imply any transfer or license of intellectual property rights. The Contracting Party will not disclose, copy or make available to third parties any Product or result of a Service, without SkylineDx’s prior written consent. The Contracting Party is prohibited from removing or changing any copyright or other notices of SkylineDx or its suppliers.

Contracting Party may not use SkylineDx’ name and/or logo in any manner other than as identified in the Contract without first obtaining written permission from SkylineDx

 

14. Obligations of the Contracting Party

The Contracting Party will at all-time timely and completely provide SkylineDx with all data and other information required by SkylineDx and necessary for the delivery of the Products and/or Services. The Contracting Party warrants that the information as meant in this article 11 is correct and complete, and that it is entitled to provide SkylineDx with such information for the delivery of the Products and/or Services. The Contracting Party indemnifies SkylineDx against all third parties’ claims in this respect. If any of the data provided by the Contracting Party must be considered to be personal data, including, but not limited to, protected health data, the Contracting Party guarantees that with regard to such data, all applicable laws and regulations for the protection of privacy have been observed and that SkylineDx is entitled to use and process such data. The Contracting Party indemnifies SkylineDx against any third parties’ claims in this respect. If and to the extent that the Contracting Party provides SkylineDx with such personal data, the Contracting Party herewith explicitly authorizes SkylineDx to keep and to process such data, insofar this is reasonably necessary in connection with the execution of the agreement between the parties. SkylineDx will strictly observe all applicable privacy laws and regulations.

The Contracting Party shall pass on to each of its clients the limitations on warranty specified in the agreement between SkylineDx and the Contracting Party. The Contracting Party has no authority to

modify SkylineDx ́s warranty and shall indemnify SkylineDx for any unauthorized modification. The Contracting Party shall give and make no other warranty or representation on behalf of SkylineDx ́ Products and/or Services as to quality, reliability, fitness for purpose or any other feature of the products and/or Services than those given by SkylineDx to the end user as set forth in the warranty literature applicable to the specific Product and/or Service, if any. If the Contracting Party unilaterally extends any additional warranty, the Contracting Party shall indemnify SkylineDx for any liability caused by such additional warranty. The Contracting Party is not allowed to re(sell) or (re)distribute any Product or Service purchased from SkylineDx unless explicitly permitted otherwise. The Contracting Party agrees to use SkylineDx’s Products strictly in accordance with applicable instructions, warnings and other information in user manuals and other Product or Service documentation, and in the manner for which they were intended.

Contracting Party 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 the Contract without SkylineDx’ prior written consent.

 

15. Confidentiality

All information given by SkylineDx to Contracting Party or otherwise obtained by Contracting Party relating to the business or operations of SkylineDx or SkylineDx Entities shall be treated by Contracting Party as confidential and Contracting Party shall not disclose the same to the third parties without SkylineDx’ prior written consent. The foregoing shall not apply to confidential information which (i) is in or enters the public domain other than by breach of these obligations, (ii) is obtained from a third party lawfully, (iii) is or has been independently generated by Contracting Party without use of SkylineDx information, or (iv) is properly disclosed pursuant to a statutory obligation, the order of a court of competent jurisdiction or that of a competent regulated body. SkylineDx information is and shall remain the property of SkylineDx and Contracting Party shall not use such information for any other purpose other than where strictly necessary for the provision of Products and/or Services in accordance with the Contract.

 

16. Sole Recourse

Notwithstanding any other provision of the Contract, Contracting Party’s recourse with respect to any matter (including any obligation of SkylineDx hereunder) shall be limited to the assets of SkylineDx and Contracting Party shall have no recourse against, and shall bring no claim against any other SkylineDx Entity.

 

17. Limitation liability SkylineDx

SkylineDx shall use reasonable efforts in producing the Products and performing the Services but does not make any warranties, express or implied, by operation of law or otherwise, with respect to the functionalities of the Products and/or the Services. Without limiting the foregoing, SkylineDx’ specifically disclaims all implied warranties of title, non-infringement, merchantability and fitness for a particular purpose. The liability of SkylineDx due to an attributable failure to perform under the agreement 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 willful 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.

 

18. Indemnity

To the fullest extent permitted by law, Contracting Party agrees to indemnify and hold harmless (vrijwaart) SkylineDx, its affiliates and the other members of the SkylineDx group of companies, and their respective assignees, subcontractors, members, shareholders, directors, officers, managers, partners, employees and losses, including reasonable attorneys’ fees and expenses, that arise from Contracting Party’s negligence, wrongful acts or omissions (onrechtmatige daad), or breach obligations of the terms (toerekenbare tekortkoming) of a Contract. The obligations set out herein shall survive the expiration or termination of the Contract.

 

19. Authority

For the avoidance of doubt, the parties confirm that (i) an electronic version of any part of the Contract (including, but not limited to) these General Conditions) is deemed to be in writing; and (ii) where either party has used an electronic signature (or equivalent) to indicate their acceptance of the terms of the Contract the parties agree that such electronic signature is a valid means of establishing the authenticity and integrity of the signature for the purposes of binding the parties.

 

20. Termination

SkylineDx has the right to terminate or dissolve the Contract, with immediate effect by giving written notice to Contracting Party without liability in the event of, and Contracting Party agrees to indemnify SkylineDx against any loss or liability incurred by SkylineDx as a result of, Contracting Party’s breach thereof, when Contracting Party has failed to remedy such breach within 10 days after receipt of a written notice requiring it to be remedied.

SkylineDx has the right to terminate the Contract, without liability, without cause, by giving 20 days’ written notice to Contracting Party.

SkylineDx has the right to terminate the Contract, with immediate effect, by giving written notice to Contracting Party without liability in the event Contracting Party’s files for bankruptcy or suspension of debts (surceance), 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 Contracting Party makes an assignment for the benefit of its creditors, or if the Contracting Party dies.

 

21. Disputes

The Contract shall be governed by the laws of The Netherlands, without regard to conflicts of law principles. Any disputes that may arise in connection with a Contract or these General Conditions, including any disputes regarding the applicability of these General Conditions, shall be submitted exclusively to the competent court in Rotterdam, The Netherlands, without prejudice to the right of appeal and that of appeal to the Supreme Court.

 

Version January 2019