This page contains all the currently applied legal documentation which governs how we manage data and will be updated as amendments are released:
Valid as of 1st January 2023
These General Terms and Conditions (hereinafter referred to as “T&C”) of LumiraDx and its Affiliates (hereinafter referred to as “LumiraDx”) shall apply to all sales and deliveries made by LumiraDx to a customer. A customer acknowledges by placing an order or by accepting product delivery the applicability of the T&C. The T&C shall also apply to all future transactions with the same customer. General terms and conditions of the customer, if any, shall in no event apply even if LumiraDx has not expressly rejected them. These T&C shall apply only vis-à-vis companies, entrepreneurs, public law governed legal persons or public law funds.
2.1 LumiraDx’s offers are nonbinding and subject to change. A contract becomes only effective upon written confirmation of a customer order by LumiraDx. The content of the contract shall be based exclusively on the order confirmation and these T&C. Verbal arrangements of any type are nonbinding and require confirmation in writing by LumiraDx to become binding.
2.2 LumiraDx reserves all rights to the sales documentation (including illustrations, drawings, weight and dimension information) and the samples and designs. They shall not be disclosed to third parties and shall be immediately returned to LumiraDx upon request. Such documents may only be disclosed to third parties upon prior written consent of LumiraDx.
2.3 Members of LumiraDx’s sales organization are not authorized to conclude, amend, terminate agreements or to make binding statements relating to products or other terms and conditions.
3.1 Delivery terms and dates shall only be binding if confirmed in writing by LumiraDx, and if the LumiraDx has been provided timely with all information and documentation required for the delivery, and if agreed down payments have been paid. Any agreed delivery terms shall commence upon the date of the confirmation of order. In case of later order changes, delivery terms shall be extended accordingly.
3.2 Unless otherwise agreed with the customer, LumiraDx will ship the products to the customer. To the extent that regular delivery intervals of reagents have been agreed, LumiraDx shall dispatch them in case of agreed delivery from the German LumiraDx warehouse by the 6th business day of each delivery month.
3.3 In case an event occurs for which LumiraDx bears no responsibility like events that cannot be foreseen, are unavoidable or that are beyond LumiraDx’s sphere of influence including Acts of God, war and natural disasters, LumiraDx shall be released for the period of such event from its obligation to deliver and perform timely. Agreed delivery dates shall be extended by the period of such event; LumiraDx will inform the customer in such case adequately. Either Party may withdraw from a contract if the period for which such event lasts cannot be foreseen or if such event continues for more than two months.
3.4 In case of customer’s (i) default of acceptance or (ii) violation of cooperation obligations LumiraDx shall be entitled to store the products adequately at customer’s risk and costs. Without prejudice to its other rights, LumiraDx shall be entitled to withdraw from the contract if an adequate deadline being set for the acceptance of the products expires unsuccessfully.
3.5 If justified LumiraDx shall be entitled to partial deliveries to the extent reasonable.
4.1 LumiraDx may determine the type of shipment. Except if agreed otherwise, all products will be shipped LumiraDx Ex-Works, LumiraDx’s point of shipment (Incoterms 2010)
4.2 Unless agreed otherwise with the customer, the risk of accidental loss or deterioration by chance transfers to the customer upon LumiraDx having handed over the products to the carrier, shipper or any other person or institution appointed to effect the shipment.
4.3 Insurance shall be obtained only upon request and at the expense of the customer.
4.4 Delivery and insurance charges will be added to the contract price of the goods and shall be payable at the same time and upon the same terms as the contract price of the goods. Delivery and insurance charges will be notified to the customer on or after the contract date.
5.1 Unless a specific product price was agreed upon, LumiraDx’s latest pricelist (as amended from time to time) shall apply. LumiraDx reserves the right for a price adjustment in case a delivery is made later than 4 months as from the contract date for reasons the customer is responsible for.
5.2 Each invoice shall be due for payment into the indicated bank account within 30 days as from the invoice date without deduction. Payment means receipt of payment by LumiraDx. VAT is always applicable unless a valid VAT exemption certificate is provided to the supplier.
5.3 To the extent payment default has not been caused by a reminder of LumiraDx, the customer will be in any case in payment default as from 30 days upon due date and receipt of the invoice.
5.4 In case of payment default LumiraDx may charge interest of 4 % p.a. above base interest rate as set by the Bank of England (as applicable from time to time) per annum. All rights to claim for additional default damages shall remain unaffected.
5.5 If it becomes evident to LumiraDx after conclusion of a contract that the performance capability of a customer is at risk, LumiraDx shall be entitled to deliver open orders only against payment in advance or deposit. If requests for advance payment or deposit are not settled within a reasonable deadline, LumiraDx shall be entitled to withdraw from the contract entirely or partially without prejudice to any of its other rights.
5.6 The customer shall only be entitled to set off its counter-claims if undisputed or having become res judicata.
5.7 The ordering party is only entitled to enforce a right of retention if its counter-claim is based on the same contract and is undisputed or has been recognized by declaratory judgment.
5.8 LumiraDx reserves the right to request advance payments of the invoice amount prior to delivery of the ordered product.
6.1 Customer’s warranty rights shall only exist if a customer has duly performed a reasonable inspection and notified LumiraDx of any identified issues.
6.2 In each case of a customer complaint regarding defects, LumiraDx shall have the right to inspect and examine the respective products. The customer shall grant LumiraDx adequate time and opportunity to do so. LumiraDx may instead request from the customer to return the products at LumiraDx’s costs. In case of a return request, the products must be disinfected and all applicable specific hazard regulations must be observed. If the customer complaint turns out to be unjustified due to intent or gross negligence, the customer shall be obliged to compensate LumiraDx for all the costs caused in this context – e.g. travel and fitter expenses or shipping costs.
6.3 In case of statutory warranty LumiraDx is entitled to rectify defects at its option by means of either free of charge repair or by replacement delivery of a defective item or by free of charge replacement delivery of the entire defective product.
6.4 The customer shall grant LumiraDx adequate time and opportunity to rectify defects.
6.5 If LumiraDx has replaced parts, the ownership of the replaced parts shall transfer to LumiraDx.
6.6 LumiraDx assumes no liability for damages caused by inappropriate or improper use, faulty assembly, faulty commissioning, faulty treatment or faulty installation by the ordering party or resulting from normal wear and tear unless LumiraDx is responsible for such damage.
6.7 Material, shipment and personnel costs caused by a rectification of defects (repair, replacement delivery) shall be borne by LumiraDx provided the notified defect has been established.
6.8 If the rectification of a defect (repair, replacement delivery) fails, the customer, at its option, may withdraw from the contract or request an adequate reduction of the price.
6.9 The warranty limitation period for newly manufactured products shall be 12 months and for used products 6 months as from delivery. Test strips shall be as per product specifications provided.
6.10 All further claims of the customer shall be excluded unless otherwise provided for in Section 7.
6.11 If and to the extent that product labeling / inserts refer for specific products to a longer warranty limitation period than stipulated in Section 6.9, such longer warranty limitation period shall apply in favor of the customer.
6.12 Test strips and consumables have a limited shelf life or, respectively, a expiration date which are indicated on the product packaging and/or in the product information and/or in product manual. Such products may in no event be used after the expiration of the shelf life or, respectively, after expiration date.
7.1 LumiraDx shall be liable
(i) for damages caused intentionally or gross negligent by LumiraDx or its directors or vicarious agents ;
(ii) for damages caused by the violation of essential contractual obligations due to slight negligence, the damage shall however be limited to such damage amount being foreseeable in context with such contract;
(iii) for damages under the regulations of mandatory liability law;
(iv) for personal injuries culpably caused by LumiraDx or its directors or agents.
7.2 LumiraDx shall not be liable for damages if none of the categories set forth in Section 7.1 applies. In particular LumiraDx will not be held liable for the consequences of incorrect modification or treatment of the goods nor – particularly where medical technology devices are concerned – for the damage caused through the use of unsuitable reagents, nor for the consequences of inadequate maintenance on the part of the purchaser or a third party, and not for any defects attributable to normal wear and tear or transport.
7.3 Clauses 7.1 and 7.2 shall apply to all claims for compensation, irrespective of their legal grounds, and in particular also to any liability resulting from tortious acts, a positive violation of contractual duty and fault during contract negotiations.
7.4 The ordering party is obliged to take appropriate action to prevent or mitigate the damage.
8.1 With regards to the use or purchase of software, the terms of the end user agreements (EULA’s) - including but not limited to the LumiraDx Platform Software license - with regards to such software shall apply .
8.2 Customer shall purchase the products for its own use only,and shall not resell or transfer the products to any other party. Customer represents it has evaluated the products and that they are acceptable and clinically suitable for its intended purposes.
8.3 In case of non-payment with regards to LumiraDx products and/or services LumiraDx shall be entitled to suspend or terminate access or use of the LumiraDx Instruments until payment is made.
8.4 Trademarks and Trade Names. All sales and rentals are made with the understanding that LumiraDx trademarks, Trade Names and original packaging will not be misused.
If the customer sells delivered products either in an unchanged form or after having combined them with other goods, the customer shall indemnify LumiraDx internally from product liability claims of third parties to the extent the customer is liable for the default causing liability vis-à-vis third parties.
If the customer determines how LumiraDx shall manufacture products to be delivered by means of instructions, information, documents, drafts or drawings, the customer shall be responsible that the rights of third parties including such as patents, utility models or other intellectual property rights and copyrights will not be violated by LumiraDx. The customer shall indemnify LumiraDx from all claims of third parties, who may enforce them against LumiraDx as a result of such a violation.
11.1 Changes and amendments to the contract and/or these T&C as well as side agreements require written form. This shall also apply to this Section 11.1.
11.2 If a provision of this contract and/or these T&C should be entirely or partially be invalid or ineffective, this shall not affect the validity or effectiveness of the remaining provisions. In this case, the parties are obliged to replace the invalid and ineffective provision with a valid and effective provision which comes as closest as possible to the intended commercial purpose of the invalid or ineffective provision. If and to the extent that terms and conditions including warranties and warranty limitations contained in product labeling and/or product inserts conflict with these T&C, the T&C shall have priority except in cases referred to in Section 6.11.
11.4 This contract shall be governed by and construed in all respects in accordance with the laws of England and Wales and the customer hereby submits for all purposes of and in connection with this contract to the exclusive jurisdiction of the Scottish Courts.
We’re creating an inclusive and equitable workplace where our people feel valued and inspired to do the best work of their careers and empowered to solve some of the biggest challenges in global healthcare.
Our gender pay gap report sets out our key gender pay data and our approach to attracting, rewarding, and recognizing talent.
We recognize closing the gender pay gap is a long-term initiative and we’re committed to monitoring our progress and putting the actions in place that make sure we can sustain it for the future.
Read our full gender pay gap report here:
LumiraDx products may be covered by one or more of the following patents and patent applications:
JP6016168B, US20130309778, CN103097029, IN1657/DELNP/2013, PCT/GB2017/051946, ARP170101903, TW106123057
EP2613881, US9919313, JP6016168B, US9341620 CN103348245m EP2673643, JP5922153, US20130309778, CN103097029, IN1657/DELNP/2013, PCT/GB2017/051946, ARP170101903, TW106123057, CN103097029, IN1657/DELNP/2013, PCT/GB2017/051946, ARP170101903, TW106123057, US20160320374A1, IN5321/DELNP/2013, GB1815278.5
US9848386, US8606338, US8150424, US7937121, US7466979, US7187924
US9848386, US8606338, US8150424, US7937121, US7466979, US7187924
1. Introduction
The LumiraDx Group is committed to maintaining the highest level of ethical standards in the conduct of our business. The foundation of LumiraDx’s business conduct program is this: we will do business legally and ethically in all aspects of our global operations. We believe that integrity is the key to establishing and preserving our good reputation and the delivery of quality services to our customers.
2. The Program
LumiraDx has developed a comprehensive global compliance program (the “Program”). The Program reflects the seven elements of an effective compliance program as set forth in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published in April 2003 by the Office of Inspector General, U.S. Department of Health and Human Service an as made applicable to the medical device industry (“OIG-HHS Guidance”). The Program also requires compliance with voluntary industry guidelines, including the MedTech Europe Code of Ethical Business Practice and the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals.
In accordance with OIG-HHS Guidance, our Program includes the following:
2.1 Written Standards of Business Conduct
The LumiraDx Code of Conduct (the “Code”) aims to provide guidance to enable us to conduct business with the highest standards of ethics and integrity. All directors, officers and employees are required to observe not only the letter but also the spirit of the Code. LumiraDx employees read and certify adherence to the Code annually. LumiraDx also develops and distributes policies and procedures to supplement the Code and support the day-to-day activities of the business.
2.2 Leadership
Our General Counsel serves as our chief compliance officer and is responsible for the development and enhancement of the Program (the “CCO”). The CCO reports compliance matters to the Chief Executive Officer, senior level leadership, and LumiraDx’s Board of Directors and committees. The CO reports directly to the Chief Executive Officer and leads a team of qualified legal and compliance professionals.
The CCO oversees regional Compliance Committees (each, a “Compliance Committee”). The Compliance Committee consists of senior-level leadership and is led by the CCO. The Compliance Committee was established to assist in the implementation of the compliance program. The Compliance Committee holds periodic meetings to discuss matters including the legal and regulatory environment, risk areas and best practices to ensure effective oversight of the Program. The Program includes dedicated legal and compliance support for each of LumiraDx’s businesses.
2.3 Effective Lines of Communication
We encourage our employees to ask questions, raise concerns, and report suspected or actual violations of our Code, policies, and procedures. Our employees have access to an anonymous web-based Ethics and Compliance Hotline, which is available 24 hours a day, seven days a week in multiple languages. Employees also may contact the CCO or Audit Committee directly. All allegations reported are thoroughly investigated and documented. Reports are handled as confidentially as possible.
2.4 Training and Education
LumiraDx employs a robust training program for directors, officers, and employees. LumiraDx mandates training on the Code and related policies and procedures, as well as targeted education and awareness programs that help foster a culture of compliance. LumiraDx training program includes other third parties and business partners, such as international distributors and agents. LumiraDx utilizes a variety of training platforms and mechanisms, including but not limited to interactive web-based modules and in person training sessions.
2.5 Accountability
LumiraDx employees are expected to adhere to our Code and related policies and procedures. Failure to comply with the Code, or failure to report a violation, may result in disciplinary action up to and including termination of employment. The Code prohibits retaliation against any individual filing a good-faith complaint or for participating in the investigation of any such complaint.
2.6 Auditing and Monitoring
The CCO and Compliance Committee utilize results from internal audits and internal monitoring programs to assess the effectiveness of the Program. The CCO and Compliance Committee are committed to enhancing the Program to reflect the evolving needs of the business, as well as changing legal requirements and updated codes of ethics.
2.7 Remediation
Results of investigations, audits, and monitoring are communicated to the CCO, Compliance Committee, and business leaders. The CCO partners with the business to implement corrective actions and make improvements to the Program.
3. Declaration for purposes of the California Act
In connection with its ongoing commitment to compliance, LumiraDx has developed the California Comprehensive Compliance Program pursuant to California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400-119402 (the “California Act”). Our California Program sets forth certain of our policies regarding relationships with California “medical or health professionals” as defined in the California Act.
In accordance with the California Act, LumiraDx has established a specific annual dollar limit of $2,500, which applies to promotional materials, items, and activities provided by an employee of relevant LumiraDx businesses to covered recipients in California.
To the best of its knowledge, LumiraDx declares that as of July 1, 2022, it is in all material respects in compliance with the requirements of the California Act.
To obtain a print version of this document, please contact LumiraDx’s customer service line at 1-888-586-4721.
LumiraDx is an organization with a strong sense of integrity. Doing the right thing, working ethically and with high quality in all we do is at the heart of our values.
To be successful, we must recognize the interests of all of those we work with; our customers, employees, shareholders, investors, and suppliers, as well as the environment and the local communities in which we operate.
Our Code of Conduct contains general guidelines for conducting our business with the highest standards of ethics, integrity and in compliance with the law.
The principles and standards set out in the code are supported by internal policies and processes, which together create a framework to provide clarity on our responsibilities.
All stakeholders, including suppliers, customers and employees, are required to observe not only the guidelines, but also the spirit of our Code of Conduct.
We want our suppliers, customers, stakeholders and employees to feel safe and confident to speak up and raise concerns about anything they see that goes against our values, breaks the law, or breaches regulations or policies.
EthicsPoint is our global whistleblowing platform that enables our people to raise concerns confidentially and anonymously.
EthicsPoint are an independent, third-party provider who support LumiraDx to capture and investigate any concerns raised.
The service is currently online, and we’ll be launching a global telephone hotline in the coming weeks.
Please do not use the EthicsPoint integrity lines for product enquiries or to report adverse events. Visit the Customer Services page for instructions on where to submit questions on these matters.
LumiraDx is committed to the highest standards of professionalism and ethical behaviour in all arms of our business and improving our practices to combat slavery and human trafficking. We recognise that slavery and human trafficking is a real yet hidden issue in our society. We will not tolerate slavery and human trafficking in our business or our supply chain. As a business with core ethical principles, we are committed to acting with integrity in all of our business dealings and relationships and to implementing and enforcing effective systems and controls to ensure that any form of slavery is not taking place in our supply chains or business.
Read our full Modern Slavery Statement here:
Please read all documentation below carefully and to the end before using any LumiraDx technology. The use of our technologies implies acceptance of the license agreements: