REMARK: THIS PROPOSAL CONTAINS STRICTLY CONFIDENTIAL INFORMATION AND IS INTENDED FOR THE INTERNAL USE OF THE CUSTOMER. NO INFORMATION DISCLOSED IN THIS PROPOSAL MAY BE DISCLOSED –
AUX1810 – valid as from 1-Dec-2021.
These General Terms and Conditions ;͞GTC shall apply to all quotations and contracts regarding the provision of study-related services by Masterfilter NV (hereafter Masterfilter NV) to the exclusion of any other general terms and conditions. Any derogation or variation to these GTC should be agreed in writing and signed by a duly authorized representative of Masterfilter NV .
By signing or accepting a quotation, issuing a purchasing order, or otherwise ordering or requesting Masterfilter NV’ services, the customer confirms his agreement with these GTC. It is understood that any communication of other terms and conditions (as they might appear in customer’s documents cannot be deemed to have been accepted by Masterfilter NV unless the applicable written requirement for derogations and variations to the GTC as mentioned above has been met.
Upon prior notification to the Customer, Masterfilter NV may involve its subcontractors in the performance of the study-related services requested by the customer.
Study outlines in any quotation are provided for guidance and information purposes only. Customized protocols can be provided on receipt of detailed information on the test material and special test requirements.
All prices are mentioned in EUR, VAT exclusive. Except if specified otherwise, any quotation will remain in effect for 6 weeks, unless amended or revoked by Masterfilter NV.
The quoted price does not encompass any services not expressly included in the study quotation document. Masterfilter NV will be entitled to invoice additional fees for additional or special requests (including special report or protocol formats) by the customer or if the customer does not respect its obligations under the present GTC. Certain causes that can give rise to additional fees are expressly mentioned in these GTC. These mentions are non-exhaustive.
Additional fees will be established according to the applicable Masterfilter NV’ commercial rates or estimated at the reasonable discretion of Masterfilter NV.
Unless otherwise agreed in writing, non routine study reports (e.g. Extractables & Leachables Studies) will be invoiced after delivery of the draft report. Test Result Reports, Certificates of Analysis and GLP studies will be invoiced after delivery of the final report, unless otherwise set forth in the proposal.
Notwithstanding the foregoing, in case serious doubts arise about the solvency or liquidity of the customer, Masterfilter NV is entitled to invoice the total price of the study and the fees for additional requests to the customer at any time, and to suspend any further performance until such invoices, which shall be immediately payable, are paid. These serious doubts will, inter alia, exist if the customer files for bankruptcy, for judicial reorganisation or similar insolvency proceedings, or if a trustee, liquidator, a court-mandated agent or similar is appointed to administrate the customer’s activities and or assets.
In other cases, the invoices have to be paid by the customer within 30 days after the invoice date. Any late payment shall give rise to a contractual penalty of 15% of the invoiced amount, with a minimum of 250 EUR, to cover the costs of the extrajudicial recovery process, as well as interests at a rate of 12% per year.
All non-public information disclosed by one party to the other in relation to the study, including but not limited to samples, product plans, formulas, experimental designs, analytical approaches, methodologies, processes, test protocols, SOPs, validation files or materials received or reviewed during onsite audits, shall be considered ͞Confidential Information and is the exclusive property of the disclosing party. Subject to the exceptions set forth below, each party agrees that all information communicated to it by the other party shall be received in strict confidence, shall be used only for the purposes of the study-related services and shall not be disclosed by such party, its agents or employees without the prior written consent of the disclosing party, except as may be necessary by reason of legal or regulatory requirements beyond the receiving party’s reasonable control. In addition, Confidential Information cannot be shared, copied, transmitted to any third parties or exploited by the receiving party without the disclosing party’s prior written authorization. The receiving party guarantees that identical confidentiality obligations shall be respected by all persons and entities involved in the study or its results by or on behalf of the receiving party ;the ͞involved parties .
The obligations of confidentiality shall not apply to information that: (i) is or becomes available to the public through no act or omission by the receiving party; (ii) was already known by the receiving party at the time of the disclosure, as evidenced by the receiving party’s written records existing prior to the date of disclosure by the disclosing party; (iii) is lawfully obtained from a person or entity who is lawfully entitled to disclose the information; or (iv) is developed independently by the receiving party or its affiliates by personnel not having access to the disclosing party’s confidential information.
Masterfilter NV will maintain all data and documentation from the studyin a secure area reasonably protected from fire, theft and destruction. Archives of documents will be retained for a period of 10 years, unless otherwise specified by mutual agreement or matter of law or regulation. No intellectual property rights or licenses implied or otherwise, shall be granted by Masterfilter NV to the customer.
The customer warrants and guarantees to hold all intellectual property rights required to perform the study and grants a temporary license to Masterfilter NV to that extent. The customer shall indemnify and hold Masterfilter NV harmless from and against all claims, losses, damages, costs and expenses related to intellectual property infringement in connection with the study.
The scheduling of a study requires that: (1) a signed study quotation has been received by Masterfilter NV; (2) the customer has issued a purchasing order; (3) unless it has been agreed that a study protocol is not necessary for the study, the study protocol has been completed by Masterfilter NV and has been accepted by the customer and (4) all of the study-related articles have been received by Masterfilter NV. Masterfilter NV may dispense certain of these requirements at its own discretion.
The customer can request for a test and/or report to be completed in less time than standard turnaround time ;a ͞STAT request , which must be communicated to a Masterfilter NV Service Representative. Typical STAT fees range from 50% - 100% in addition to the original study price. Masterfilter NV will attempt to accommodate these customer requests, however scheduling will be dependent on current lab resources. The customer must provide a purchase order for STAT processing fees.
The customer will provide Masterfilter NV with (1) the samples; (2) the study materials, including all documentation, toolkits, supplies and equipment necessary or useful in order to safely and efficiently perform the study; (3) any relevant occupational safety information that is known or reasonably acquirable by the customer, including a Material Safety Data Sheet (MSDS) and (4) the supplies and equipment as agreed in the study quotation. The aforementioned items and all other items provided by the customer in relation to a study shall be collectively referred to as study-related articles.
All study-related articles should be provided by the customer to Masterfilter NV within an agreed time span after acceptance of the quotation document in sufficient amounts in order to be able to start the study. Delays in providing the study-related articles will also delay the study process, meaning that the customer will be liable for all additional costs and expenses incurred. Masterfilter NV will use the study-related articles according to the customer’s specifications and according to the reasonable or customary methods for the type of study and services requested by the customer. This may involve the study-related articles’ destruction or alteration, without giving rise to any right of the customer to be compensated.
The customer guarantees that the study-related articles (1) do not differ from what has been agreed upon; (2) are in a condition that makes the study possible without difficulty; (3) do not pose any hazard that Masterfilter NV has not been expressly informed about prior to issuing its quotation; (4) are delivered in accordance with regulatory requirements and (5) have been subjected to all reasonable protective measures (including those related to packaging) by the customer.
If the aforementioned obligations with regards to the study-related articles are not respected by the customer, Masterfilter NV is entitled to charge the customer additional fees for the additional delays and/or difficulties encountered and the customer will be liable for all additional charges and expenses incurred as a result. At its discretion, Masterfilter NV may also terminate the contract for serious breach of contract. The customer shall indemnify and hold Masterfilter NV harmless for all damages, costs, and claims relating to study-related articles that do not conform, or have not been delivered according to the requirements of the present clause.
After completion of the study, a final report, either a test result report or a study report, will be issued to the customer. ISO/IEC 17025 reports can be obtained upon explicit request of the customer. Customer-specific formats or changes to Nelson Labs standard format will give rise to additional fees. Format requirements must be disclosed during protocol development and prior to start of the study.
Masterfilter NV will only issue a draft report if this was expressly agreed or if it is customary for the type of study ordered. If a draft report is issued the customer has up to 14 days to make comments. Multiple draft revisions will give rise to additional fees. Masterfilter NV will work closely with the customer to ensure the report is acceptable to both parties. If after 14 days, no new comments or other remarks regarding the draft report have been made, Masterfilter NV will issue a final report.
A final report will only be modified upon written request by the customer, at which point a study amendment will be issued, giving rise to additional fees.
Customer may use the final report for substantiation of marketing claims, regulatory submissions and similar uses as long as the final report is used and presented in its entirety or summarized data is represented as stated in the final report. However, use of the company name, its trade names (including Nelson Laboratories, and Nelson Labs), or other mentions that could be understood as referring to Masterfilter NV or companies in the same corporate group ;together the ͞proprietary names , is restricted and may only be used by way of reference to the report, e.g. ‘Study performed at Masterfilter NV, Leuven, Belgium’. No use of the proprietary names or logo otherwise is permitted. No use of the proprietary names that may be interpreted as an endorsement of the customer or the customer’s products services is permitted.
CONDITIONS OF USE OF THE FIT SCREENING DATA IN COMMUNICATION WITH THIRD PARTIES. Lhasa, the company which developed and distributes the Derek Nexus Software, has put restrictions on communications of the results of the Derek assessments ;the ͞FIT Screening Data . The FIT Screening Data can be included in submissions to regulatory authorities (e.g. FDA, EMA), however, the FIT Screening Data cannot be used in any other communication (e.g. scientific articles, presentations, etc.) with third parties without the prior written approval of Masterfilter NV and Lhasa.
The initial and return shipment of all study-related articles and of the study output to and/or from the Masterfilter NV test facilities is the responsibility of the customer. The customer will be solely responsible for the fulfilment of customs and other transport- related formalities and shall be responsible for paying all transport charges, customs duties, taxes and other costs related to these shipments. The customer is responsible for losses or damage during the shipping process.
The customer will ensure that the shipping documents accompanying a shipment of study-related articles allow them to be identified easily, or the study may be delayed. Customer should clearly label study- related articles as ͞Not For Human Use on all shipping documents and with a clear indication: no commercial value – only for testing purposes. Hazardous substances or materials require notification of planned shipment date and submission (or availability) of appropriate documentation (i.e. MSDS) to (or for) Masterfilter NV at 7 days before their arrival at Masterfilter NV’ facilities. If applicable, the customer shall ensure that the ADR and other regulations in relation to the transport of dangerous goods are respected.
Samples and other study-related articles will be stored until 2 months after delivery of the final report. For leachables studies with multiple time points, they will be stored until 2 months after the final report of the next time point ;for example: ϯ months’ time point samples will be removed Ϯ months after the final report of the ς months’ time point). Samples can be stored over a longer period if the customer has indicated this at the start of the study, and such storage will give rise to additional fees that will be invoiced at the end of the study.
If the customer does not arrange for return shipment prior to the expiration of the storage period, the study-related articles can be disposed of. Masterfilter NV is entitled to charge additional fees for the disposal of hazardous goods or goods that are difficult to dispose of.
Any study needs information on the product to be tested before the project can be initiated. The information, supplied by and under the responsibility of the customer, is critical to the soundness of the results obtained. Due to the high costs involved with the consequence of a modification of these data of entry after the study initiation, including but not limited to data reinterpretation and report modification, an additional cost might be requested to the sponsor for any data of entry modification. The extent of this additional cost will depend on the impact of the modification requested.
Masterfilter NV makes no qualifications or guarantees regarding the study outcome. The customer is advised to verify the intended testing plan with its own regulatory personnel. Masterfilter NV cannot and will not guarantee that a specific test material will be accepted or rejected by any regulatory body. Masterfilter NV will perform the study as specified by the customer and according to the study protocol or specification and the data generated. Masterfilter NV has no knowledge if test materials or finished products have been previously qualified and relies on the information provided by the customer. Masterfilter NV does not assume any liability for any actual or perceived failure of the study.
Masterfilter NV shall only be liable for cases of wilful misconduct or gross negligence. If Masterfilter NV can legitimately be held liable under these GTC for its performance of the study, Masterfilter NV can choose, at its discretion, to either re-conduct the parts of the study and/or redraft the parts of the final report that are affected or to offer (retroactively or prior to payment) a proportional reduction of the price for the relevant study. This shall be the sole and final remedy of the customer to the exclusion of any type of claim for damages suffered as consequence of the performance of the study.
Masterfilter NV shall not be liable for consequential and indirect damage, loss of profits, loss of revenue, loss of anticipated savings, production losses, loss of clients, loss of orders, loss of goodwill, loss of contracts, loss of business opportunities, delays, reputational damage, damage caused by the implementation or the exploitation of the study or its results, for claims introduced by third parties against the customer and for damage to or loss of study-related articles or study output.
In any case Masterfilter NV liability towards the customer shall be limited to the amount of the price quotation.
Any claim against Masterfilter NV shall expire if it is not notified by registered letter within 2 months after the cause for the claim becomes or should have become apparent to the customer. Any right to introduce a court claim against Masterfilter NV shall be forfeited if such court claim is not initiated within one year after the cause for the claim became apparent, and in any case within three years after the delivery of the final report.
In case of serious breaches of contract by the customer, Masterfilter NV may terminate the contract by sending a written notice. Any breach of contract by the customer, regardless of its nature, shall be considered a serious breach of contract if it has not been remedied within 15 days of having been informed of the breach of contract by Masterfilter NV by written notice.
Any quotation by Masterfilter NV and any contract concluded between Masterfilter NV and the customer shall be governed by Belgian law.
The courts of Leuven, Belgium shall have exclusive international and territorial jurisdiction for any dispute arising out of or in connection to this quotation or the contract arising from it.
If certain provisions or parts of provisions in these GTC should be deemed invalid, the other provisions or parts of provisions will remain in force. Any invalid provision will be replaced by a provision that matches the economic consequences and the intentions behind the invalid provisions as closely as allowed by the applicable mandatory law.