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The mAbXmise quantification kits are intended to monitor the concentration of therapeutic monoclonal antibodies (mAbs) in samples from patients treated with these mAbs. The kit is a quantitative assay. The test can be performed on plasma (EDTA, heparin or citrate collection tubes) and serum. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product.


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mAbXmise monoclonal antibodies quantification kits are In Vitro Diagnostic Medical Devices for laboratory professional use and CE-IVD labeled for Europe by BSI. Assay results are intended to be used by healthcare professionals. The kits are designed to perform absolute quantification by LC-MS (Liquid Chromatography – Mass spectrometry) of specific therapeutic monoclonal antibodies (mAbs) in a patient sample. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product. The products are non-refundable. The mAbXmise Kit described has not been cleared by any regulatory entity for diagnostic purposes outside of Europe. Proteomics mAbXmise Kits are not available for sale in all countries.


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GENERAL TERMS AND CONDITIONS OF SALES OF GOODS

General terms and conditions of sales of goods
2024

SECTION 1. DEFINITIONS – The following terms commencing with a capital letter shall have the meaning attributed to them below throughout this Agreement, unless stipulated to the contrary. Agreement: these General Terms and Conditions of Sales, together with any Purchase Order, and, as the case may be, the Specific Terms and Conditions of Licensing accepted by the Customer. In case of discrepancies, the descending order of priority shall be as follow: Purchase Order, General Terms and Conditions of Sales,. Confidential Information: any information in connection with the Agreement, in whatever form, without limitation – documents, data, formulae, know-how, processes, computer applications, specifications, studies, photographs, Intellectual Property Rights, patents, designs, models, prototypes, samples, plans, workshops or any other oral or written information of a commercial, technical, scientific or financial nature – disclosed by one Party (the ‘Disclosing Party’) to the other Party (the ‘Receiving Party’). Consumable: any consumable purchased by Customer to PROMISE. Customer: any company with registered office in any country of the European Union, ordering Supplies to Promise under these General Terms and Conditions. Data Contact : shall have the meaning set forth in section 12. FCPA and SAPIN II : shall have the meaning set forth in section 9. Intellectual Property Rights: all rights and titles in connection with any patent, copyright, design, model, trademark, trade or manufacturing secret or Confidential Information arising from laws and regulations and all rights to file applications for such titles. Promise: Promise Proteomics SASU, a French simplified joint stock company with a sole shareholder, with a share capital of 50 000 €, having its registered office at 7 Parvis Louis Néel, MINATEC BHT-52 A, 38040 Grenoble CS20050, France, registered with the Grenoble Trade and Companies Registry under number 433 546 504. Party(ies): shall refer individually to the Customer or Promise, and collectively to the Customer and Promise.Price: shall have the meaning set forth in section 5. Purchase Order: the purchase order issued by the Customer, or the purchase order completed on the Website by the Customer, in order to be supplied in Supplies by Promise. Samples Preparation Protocols: they constitute Confidential Information belonging to Promise. Supply(ies): (i) any stable-isotopically-labelled (SIL) protein identified on the Website, that is produced by Promise and supplied by the latter to the Customer; or (ii) the labelled antibody derived from an antibody identified on the Website, that is produce by Promise and supplied by the latter to the Customer. Website: Promise’s website under url http://www.promise-proteomics.com where the Supplies are available for sale

 

SECTION 2. PURPOSE – ACCEPTATION – ORDERING – These General Terms and Conditions apply to all Supplies offered by Promise. The applicable General Terms and Conditions shall be those in effect on the date the Customer either (i) purchases Supplies through Promise’s Website by completing a Purchase Order or (ii) issues a Purchase Order in accordance with pricing mentioned on Website. The act of placing a Purchase Order entails unconditional acceptance of these General Conditions of Sale. They shall take precedence over any other document produced by the Customer, in particular any general terms and conditions of purchase, except with Promise’s prior, written agreement to the contrary. In the event of a contradiction between these General Terms and Conditions and a specific agreement entered into between Promise and the Customer, the specific agreement shall take precedence. Any modification of a Purchase Order by the Customer after its submission to Promise shall be subject to acceptance by the latter. Promise reserves the right to refuse any modified Purchase Order or Purchase Order issued by a Customer for which there are legitimate grounds for thinking that the latter will be unable to pay the full amount of the Price or fulfil the Agreement. Where applicable, such refusal shall not constitute a refusal of sale and may not give rise to any form of compensation for the Customer. Any Purchase Order shall be issued at least fifteen (15) days prior to expected delivery date.

 

SECTION 3. DELIVERY – Purchase Orders shall be deemed firm once Promise issues an email confirming such Purchase Order and shipment date. The shipment date confirmed by Promise shall under no circumstances be binding, and Promise reserves the right to delay any shipment for a maximum of five (5) working days. Promise shall incur no liability in this respect. Promise shall inform the Customer of any delay in the shipment of Supplies ordered as soon as possible. The shipment date is to be considered as the “delivery date” under this Agreement. The Supplies ordered and purchased by the Customer and any Consumables purchased shall be delivered on the date contractually defined in the email of confirmation issued by Promise, FCA Grenoble (France) (incoterms ® ICC 2020). All delivery, insurance and tax costs, including customs duties, shall be borne in full by the Customer. Supplies shall be accompanied by a delivery note.

 

SECTION 4. QUALITY OF THE SUPPLIES – Supplies must satisfy the characteristics indicated on the product sheet shown on the Website. In the event of a disagreement concerning the quality of a batch of Supplies delivered by Promise, the Parties shall analyse the problem together with the aim of finding an amicable solution. Should the disagreement persist, such problem shall be referred to an independent laboratory appointed by mutual consent within one (1) month of the Parties becoming aware of the disagreement. The Parties hereby agree to accept the laboratory’s conclusions, whatever they may be. If the laboratory considers that the quality of the batch of Supplies complies with that described in the product sheet, all costs and fees in connection with the expert assessment shall be borne in full by the Customer . In the opposite case, the costs and fees shall be borne in full by Promise. Unless the Parties agree to the contrary, any batch of Supplies presenting a quality defect shall be replaced promptly by Promise at the latter’s expense, provided that (i) the quality defect has been acknowledged by Promise or determined by expert assessment as indicated above and (ii) the Customer’s written complaint, including specifics regarding the quality defect, is addressed to Promise in a timely manner once the Customer becomes aware of said defect. Where possible, the Customer shall return the defective batch, minus quantities withheld for the purpose of the expert assessment, to Promise. Any reimbursement or other form of compensation for a defective Supply is expressly excluded.

 

SECTION 5. PRICE – TERMS OF PAYMENT – The pricing list in euros, exclusive of VAT, is available on the Website. The pricing list is FCA Grenoble (France) (Incoterms ® ICC 2020). The price of Supplies ordered to Promise shall be defined in consideration of the pricing list and quantities being ordered. Costs for shipping and insurance are added in consideration of the place of destination indicated by the Customer : the Customer will have the information concerning such cost before finalizing its purchase of the Supplies. Such cost together with the price of Supplies constitute the “Price’ of corresponding Purchase Order. In case of Purchase Order through Website, payment shall take place by credit card through Website before delivery. In case of Purchase Order transmitted to Promise, the latter shall transmit its invoice to the Customer at the time of delivery of the Supplies. All invoices shall be due by the Customer thirty (30) days from the invoice date, invoice being sent on shipment date. Any delay in the payment of all or part of an invoice shall automatically give rise to the payment of a fixed charge of forty (40) euros to cover debt collection costs. In addition to paying the invoice concerned by the delay, the Customer shall also pay late payment interest calculated on the amount due, at the following rate: interest rate published by the European Central Bank + 10 points.

 

SECTION 6. TRANSFER OF RISK AND TITLE – INTELLECTUAL PROPERTY – Transfer of risk is made according to the FCA incoterms ICC 2020 ®, i.e. at time of delivery in Grenoble (France). The Customer shall obtain title to the Supplies upon receipt by Promise of payment of the corresponding Price of purchase. The Supplies do not constitute medication and may under no circumstances be administered to humans. Any publication or communication project concerning the Customer’s projects mentioning its use of the Supplies must mention that they are the property of Promise and bear the following information: © PROMISE – 2014 – Year of purchase – All rights reserved.

 

SECTION 7. CONFIDENTIALITY – The Confidential Information shall be deemed confidential, unless that expressly identified as non-confidential by the Disclosing Party. The Parties shall keep all Confidential Information strictly confidential and use it solely as required in order to execute the Agreement and/or use the Supplies, in accordance with the provisions contained in this Agreement. Confidential Information may only be disclosed to employees having a need to know such Information in order to use the Supplies and who shall be bound by this confidentiality obligation or by an equivalent confidentiality obligation. Information which the Receiving Party can demonstrate constitutes one of the following exceptions shall not be considered as confidential: i)- Information known to the Receiving Party prior to receiving it from the Disclosing Party; ii)- Information in the public domain at the time of its transmission but not as a result of any breach of this Agreement; iii)- Information received by a Party from a third party having the right to possess it and not bound by a confidentiality obligation; iv)- Information developed independently by the Receiving Party, without using said Information; or v)- Information the disclosure of which is required or ordered by a court or government authority, provided that the Receiving Party first makes every effort to obtain an injunction preserving the confidentiality of the Confidential Information and provided that the Receiving Party gives the Disclosing Party reasonable notice that said disclosure is to take place, thereby offering the latter the option of intervening in order to protect the confidentiality of the Confidential Information. This confidentiality obligation shall remain in effect throughout the entire term of the Agreement and for seven (7) years after the end of the Agreement.

 

SECTION 8. INSURANCE – GUARANTEE – LIABILITY – FORCE MAJEURE – COMPENSATION – Promise hereby certifies that it has taken out all necessary insurance policies covering the financial consequences arising from its liability for any damage resulting from its actions or negligence in performing the Agreement, according to normal standards within its profession. The Supplies are delivered by Promise to the Customer ‘AS IS’, i.e. without any form of guarantee that they are intended or suitable for any specific purpose. The only guarantee from Promise is the guarantee that Supplies are in conformity with specifications of their product sheet as available on the Website. The Customer shall use the Supplies solely for its R&D activities or pharmacological studies, at its own risk, and acknowledges that Promise may under no circumstances be held liable for any direct or indirect harm resulting from use of the Supplies, in full or in part, the results of such use or incorrect use of the Supplies. In particular, the Customer shall not administer Supplies to humans, as said Supplies do not constitute medication but an R&D reagent. In view of the foregoing, Neither Party shall be held liable in the event of non-performance or poor performance of the Agreement due to force majeure. In this respect, ‘force majeure’ means any eternal, unforeseeable and irresistible event within the meaning of article 1218 of the French civil code and the case law of French courts. The Parties expressly acknowledhe and agree that epidemic of COVID-19, its variants and their consequences are recognized as constituting a force majeure event. The respective obligations of either Party hereunder shall be suspended during the time and to the extent that such Party is prevented from complying therewith by a force majeure event provided that such Party shall have given written notice thereof, specifying the nature and details of such event and the probable extent of the delay to the other Party.In case of a force majeure event, the time for performance required by either Party under this Agreement shall be extended for any period during which the performance is prevented by the event. However, the other Party may terminate this Agreement by notice if such an event prevents performance continuously for more than three (3) months. Promise shall hold the Customer harmless from and against any infringement proceedings brought by a third party based on its exploitation of the Intellectual Property Rights pertaining to the Supplies, provided such exploitation complies with the provisions of this Agreement. Promise’s liability, for whatsoever reason, is limited to direct damage incurred by the Customer and, in any event, to a total amount that may not exceed fifty thousand (50,000) euros. The Customer shall hold Promise harmless in the event of infringement proceedings concerning Intellectual Property Rights belonging to third parties, unfair competition proceedings and any other civil or criminal liability proceedings brought by a third party, if such proceedings are founded on use of the Supplies and / or the protocols used by the Customer with the Supplies, in breach or in non-compliance with the provisions of this Agreement.

 

SECTION 9. ANTI-BRIBERY AND INFLUENCE PEDDLING – The Customer undertakes to comply with anti-bribery laws and regulations. The Customer especially undertakes not to make, give, provide, offer, or promise, directly or indirectly, any payment, benefit, or other incentive to any person, individual or entity, whatever their position and/or affiliations, at the suggestion, request or direction, or engage in acts or transactions, in order to influence the acts of the above-described persons and/or entities in their official capacity or to induce them to use their influence with a government to obtain or retain business or gain an improper advantage in connection with the Agreement in manner that would be in violation of the applicable domestic anti-bribery legislation of any government, the United Kingdom Bribery Act 2010, the United States Foreign Corrupt Practices Act (“FCPA”), the OECD Convention on Combating Bribery of Foreign Officials in international business transactions. Within the framework of the application of the (French) law of 9 December 2016 on transparency, the fight against corruption and the modernisation of economic life (and called “SAPIN II”), the Customer must inform Promise by registered letter with acknowledgement of receipt, within eight (8) days of any change in its legal situation (such as merger-acquisition, amendment of its articles of association, change in its management). Promise will then have three (3) months to evaluate the consequences of this change and reserves the right to request preventive or corrective actions from the Customer against corruption or to terminate the relationship if the latter refuses or if it presents an excessive risk of corruption.

 

SECTION 10. GOVERNING LAW – DISPUTE RESOLUTION – This Agreement is subject to French law. The Parties shall endeavour to resolve any disagreement or dispute that may arise in connection with this Agreement out of court. In the event of failure to reach an amicable agreement, the Parties mutually agree to refer any dispute arising between them to the competent courts of Grenoble, France.

 

SECTION 11. MISCELLANEOUS – The fact that Promise does not, at any time, avail itself of any one of the clauses of the Agreement, may not be construed as a waiver of its rights subsequently to avail itself of any of the clauses of said Agreement. To the extent possible, each stipulation herein shall be construed in a manner such that it is enforceable and valid under applicable law. If a court of jurisdiction under particular circumstances declares a stipulation void or unenforceable, such stipulation shall remain in effect under any other circumstance.

 

SECTION 12. PRIVACY POLICY – The Customer is informed and accepts that Promise, acting as data controller, collects and processes personal data concerning its contact persons within the Customer (hereinafter, ” Data Contact “) in the context of the management of its relations with the Customer as listed below:

– Performance of the Agreement

– Ensure the follow-up and management of its commercial relations and communication with the Customer;

– Conduct audits (if applicable);

– Administer, manage and defend against legal claims or actions (if applicable);

– Comply with its legal, regulatory and contractual obligations.

Promise will keep the Data Contact for the period necessary to fulfil the purposes specified above, and will archive in compliance with legal and regulatory requirements. In accordance with the applicable regulations on protection of personal data, the Customer contact person has the right of access, rectification and – in the event of legitimate reasons – opposition to the processing of their personal data. The Customer contact person also has a right to the limitation and portability of their data under the conditions provided for by the regulations as well as the right to define directives relating to the fate of their data after their death and the right to file a complaint with the CNIL. These rights can be exercised by contacting Promise’s operational contact or, in case of difficulty: personaldata@aguettant.fr. The Customer undertakes to inform the concerned Contact Person of the existence of these rights and shall obtain the necessary consent from the concerned Contact person for the processing of their personal data. Each Party undertakes to comply with all obligations prescribed by laws and regulations relating to the protection of personal data.