EHR Connect Licence and Service Terms
LumiraDx UK Ltd
EHR Connect Licence and Service Terms
Applicable from January 2020
- the software component known as DataView including updates and new releases that may be issued from time to time (“DataView”);
- the middleware component known as EHR Connect including updates and new releases that may be issued from time to time (“EHR Connect”);
- any physical and electronic documentation (“Documentation”); and
- any Implementation Services and Support Services (all as defined below) provided in relation to EHR Connect.
By using DataView, EHR Connect or ticking the “Accept” box, the Organization, and its Users, confirms that it agrees to the terms this Licence. The Organization shall be responsible for ensuring that its Users comply with the terms of this Licence. This Licence includes, in particular, limitations on liability in clause 14.
1.1 The definitions and rules of interpretation in this clause apply in the background and in this Licence:
Acceptance: the acceptance of EHR Connect by the Organization pursuant to clause 5.
Acceptance Certificate: the certificate to be signed by the Organization under clause 5.
Acceptance Date: the date on which the Acceptance Certificate is issued by the Organization under clause 5.
Acceptance Tests: the tests to be carried out on EHR Connect in accordance with clause 5 once the Customisation Services have been performed.
Business Day: a day other than a Saturday, Sunday or public holiday in England when banks in London are open for business.
Confidential Information: any information which has been designated as confidential by either party in writing or that ought to be considered as confidential (however it is conveyed or on whatever media it is stored) including information which would or would be likely to prejudice the commercial interests of any person, trade secrets, Intellectual Property Rights, know-how of either party and all Personal Data and sensitive data within the meaning of the Data Protection Legislation.
Customisation Services: the customisation and related services to be performed by LumiraDx in accordance with clause 4 to modify EHR Connect so that it conforms with the Specification.
Data Protection Legislation: the General Data Protection Regulation ((EU) 2016/679) (“GDPR”) and any national implementing laws, regulations and secondary legislation, the Data Protection Act 2018, the EU Data Protection Directive 95/46/EC, the Regulation of Investigatory Powers Act 2000, the Telecommunications (Lawful Business Practice) (Interception of Communications) Regulations 2000, the Electronic Communications Data Protection Directive 2002/58/EC, the Privacy and Electronic Communications (EC Directive) Regulations 2003 and all applicable laws and regulations relating to processing of personal data and privacy, including where applicable the guidance and codes of practice issued by the Information Commissioner.
Data Controller: has the meaning given to it in the GDPR.
Data Processor: has the meaning given to it in the GDPR.
Documentation: physical and electronic documentation provided by LumiraDx which relates to EHR Connect or DataView.
FOIA: the Freedom of Information Act 2000 and any subordinate legislation made under that Act from time to time together with any guidance and/or codes of practice issued by the Information Commissioner or relevant government department in relation to such legislation.
Implementation Plan: the implementation plan (detailing the tasks, the Milestone Dates and the party assigned to the relevant task) which is agreed between LumiraDx and the Organization and provides an overview of the Implementation Services.
Implementation Services: the Set-up & Configuration Services, Customisation Services and Acceptance Tests.
Initial Term: the initial term set out on the Purchase Order.
Instrument: the diagnostic instrument supplied by LumiraDx to the Organization.
Intellectual Property Rights: patents, utility models, rights to inventions, copyright and neighbouring and related rights, trade marks and service marks, business names and domain names, rights in get-up and trade dress, goodwill and the right to sue for passing off or unfair competition, rights in designs, database rights, rights to use, and protect the confidentiality of, Confidential Information (including know-how and trade secrets), and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.
Organization: the legal entity who requests a licence to use EHR Connect from LumiraDx.
Organization’s Representative: a person duly authorised by the Organization to act on its behalf for the purpose of this Licence.
LumiraDx Group: means LumiraDx, any subsidiary or any holding company from time to time of LumiraDx, and any subsidiary from time to time of a holding company of that company. Each company in the LumiraDx Group is a member of the LumiraDx Group and the term “LumiraDx Group Company” shall be construed accordingly.
Materials: all documents, papers, designs, typographical arrangements, software, and all other materials in whatever form, including hard copy and electronic form, prepared by LumiraDx.
Milestone Date: the date, set out against the relevant task in the Implementation Plan, by which the task shall be completed.
Normal Business Hours: 9.00 am to 5.00 pm local UK time, each Business Day.
Patient(s): an individual or individuals accessing care/medical services from a relevant Organization.
Patient Data: the clinical information (including, but not limited to, Personal Data) collected by the Organization in the course of treating Patients which is processed by EHR Connect.
Personal Data: has the meaning given to it in the GDPR.
Project Manager: LumiraDx’s employee, agent or subcontractor who has overall responsibility for the Customisation Services.
Purchase Order: the purchase order issued by LumiraDx to the Organization, or the third party acquiring the Licence on the Organization’s behalf.
Renewal Term: the renewal term set out on the Purchase Order.
Request for Information: means a request for information or an apparent request under the FOIA.
Services: any services accessible through EHR Connect and the content LumiraDx provides to the Organization, or the third party acquiring the Licence on the Organization’s behalf.
Set-up & Configuration Services: the set-up & configuration services to be performed by LumiraDx in accordance with clause 3.
Specification: the functionality specifications for EHR Connect agreed between LumiraDx and the Organization from time to time and contained in the Statement of Works.
Start Date: the start date set out on the Purchase Order.
Statement of Work: the detailed plan describing the Implementation Services to be provided by LumiraDx, the business requirements, the technical requirements, the assumptions, the risks and the scope of work.
Support Services: the support services to be provided to the Organization in accordance with clause 13.
Trial Period: the period of 6 months during which the Organization may use DataView without charge (unless otherwise agreed).
Trail Start Date: the date on which the Organization enters its connection details into DataView and connects to DataView.
Users: anyone authorised by the Organization to use EHR Connect which includes its employees, agents and independent contractors (namely clinicians).
1.2 Clause, Schedule and paragraph headings shall not affect the interpretation of this Licence.
1.3 The Schedules form part of this Licence and shall have effect as if set out in full in the body of this Licence. Any reference to this Licence includes the Schedules.
1.4 Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms.
2. SCOPE OF THIS LICENSE
2.1 LumiraDx shall:
(a) if applicable and agreed in writing by LumiraDx, prepare the Statement of Work;
(b) if applicable and agreed in writing by LumiraDx, perform the Set-up & Configuration Services;
(c) if confirmed in the Statement of Work, perform the Customisation Services and Acceptance Tests;
(d) supply the Support Services;
(e) if applicable, licence DataView in accordance with clause 6; and
(f) if confirmed in the Purchase Order, licence EHR Connect in accordance with clause 6.
2.2 The Statement of Work (if applicable) shall be agreed in writing between the parties. Once the Statement of Work has been agreed and signed, no amendment shall be made to it except in accordance with clause 4.13, clause 4.14 and clause 4.15.
2.3 The signed Statement of Work shall be part of this Licence and shall not form a separate contract to it.
3. SET UP & CONFIGURATION SERVICES
3.1 The Organization, or the third party acquiring the Licence on the Organization’s behalf, shall:
(a) enter its connection details to enable basic configuration of EHR Connect. If agreed in writing, LumiraDx shall enter the Organization’s connection details on the Organization’s behalf within a reasonable time of receiving such information from the Organization;
(b) if agreed in writing, perform the installation of EHR Connect on the Organization’s equipment;
(c) if agreed in writing, perform basic verification testing to ensure that the organization has entered the correct connection details to enable access to EHR Connect;
(d) at all times co-operate with LumiraDx in relation to the Set-up & Configuration Services; and
(e) provide all information and assistance reasonably requested by LumiraDx to facilitate its performance of the Set-up & Configuration Services.
3.2 LumiraDx shall perform, on the Organization’s behalf:
(a) if confirmed in the Statement of Work, the installation of EHR Connect on the equipment identified on the Statement of Work;
(b) if confirmed in the Statement of Work, basic verification testing, on behalf of the Organization, to ensure that the Organization has entered the correct connection details and is able to access EHR Connect;
(c) any further development services as set out the Statement of Work; and
(d) if confirmed in the Statement of Work, the Customisation Services in accordance with clause 4.
4. CUSTOMISATION SERVICES
4.1 If Customisation Services are confirmed in the Statement of Work, LumiraDx shall perform the Customisation Services set out in this clause 4.
4.2 LumiraDx shall appoint the Project Manager, who shall have the authority to contractually bind LumiraDx on all matters relating to the Customisation Services and the Organization shall appoint the Organization’s Representative, who shall have the authority to contractually bind the Organization on all matters relating to the Customisation Services.
4.3 The Organization Representative shall co-operate with the Project Manager and shall attend a reasonable number of meetings scheduled by the Project Manager and assist LumiraDx on all matters relating to the Customisation Services. If the Organization Representative requests additional meetings with the Project Manager, LumiraDx shall be permitted to charge further fees for these meetings in accordance with its standard rates from time to time in force.
4.4 LumiraDx shall prepare the Implementation Plan in co-operation with the Organization.
4.5 Each party shall use its reasonable endeavours to perform the task allocated to it in the Implementation Plan by the applicable Milestone Date, subject to clause 4.6.
4.6 LumiraDx shall be given an extension of time to complete any of the tasks allocated to it in the Implementation Plan if one or more of the following events occurs:
(a) a variation in the Specification is made and agreed in accordance with clause 4.13, clause 4.14 and clause 4.15 at the Organization’s request;
(b) a force majeure event occurs as described in clause 17; or
(c) a delay is caused in whole or in part by an action or omission of the Organization or its employees, agents or independent contractors.
4.7 If LumiraDx is entitled to an extension of time under clause 4.6, it shall give written notice to the Organization. Such notice shall specify the event relied on and, in the case of a force majeure event under clause 17 shall estimate the probable extent of the delay.
4.8 The Organization Representative and the Project Manager shall use best endeavours to agree in writing, signed by both parties, what extension of time is reasonable in the circumstances. The Implementation Plan shall be deemed amended accordingly.
4.9 LumiraDx warrants that EHR Connect will, when properly used, perform substantially in accordance with the Specification for a period of 60 days from the Acceptance Date or the date on which the Organization connects to EHR Connect in accordance with clause 3.1(a) (whichever is the latter) (Warranty Period).
4.10 If, within the Warranty Period, the Organization notifies LumiraDx in writing of any defect or fault in EHR Connect as a result of which it fails to perform substantially in accordance with the Specification, LumiraDx will, at its sole option, either repair or replace EHR Connect, provided that the Organization makes available all the information that may be necessary to help LumiraDx to remedy the defect or fault, including sufficient information to enable LumiraDx to recreate the defect or fault.
4.11 The warranty at clause 4.9 does not apply the extent of any defect or fault in EHR Connect which is caused by:
(a) use of EHR Connect contrary to LumiraDx's instructions;
(b) a feature of EHR Connect which was specified by the Organization and included in the Specification; or
(c) a modification or alteration of EHR Connect by any party other than LumiraDx or LumiraDx's duly authorised contractors or agents.
4.12 If the Customisation Services are delayed as a result of the acts or omissions of the Organization, LumiraDx shall be entitled to invoice the Organization for the Customisation Services performed up until the date of the delay. If LumiraDx can demonstrate that the delay has resulted in an increase in cost to LumiraDx of carrying out its obligations, LumiraDx may, at its sole discretion, notify the Organization that it wishes to increase the price payable under the Purchase Order by an amount not exceeding any such demonstrable cost.
4.13 If either party identifies a requirement for change, it may, by giving written notice to the other party at any time during the term of this Licence, request a change to the Specification, the Statement of Work, the Implementation Plan, the Implementation Services, the Support Services or any other term of this Licence (“Change Notice”).
4.14 If the Change Notice is sent by:
(a) the Organization, within a reasonable time of receipt of such Change Notice, LumiraDx may, at its standard rates then in force, prepare for the Organization a written estimate of any increase or decrease in the fees set out in the Purchase Order, and of any effect that the requested change would have on the Specification, the Statement of Work, the Implementation Plan, the Implementation Services, the Support Services or any other term of this Licence;
(b) LumiraDx, the Change Notice shall state any increase or decrease in fees set out in the Purchase Order, and of any effect that the requested change would have on the Specification, the Statement of Work, the Implementation Plan, the Implementation Services, the Support Services or any other term of this Licence.
4.15 Within 14 Business Days of receipt of the Change Notice, the other party shall confirm in writing if they accept the requested change. For the avoidance of doubt, the other party may be either the Organization or LumiraDx. If the change is accepted, LumiraDx shall not make the change until the parties have agreed and signed a written agreement (“Change Agreement”) specifying, in particular, any changes to the fees payable under the Purchase Order, the Specification, the Statement of Work, the Implementation Plan, the Implementation Services, the Support Services or any other term of this Licence.
5. ACCEPTANCE TESTS
5.1 If confirmed in the Statement of Work, on completion of the Implementation Plan, LumiraDx and the Organization shall test EHR Connect to ensure that it materially conforms with the Specification (“Acceptance Tests”).
5.2 The procedure in this clause 5 shall be reasonably repeated in respect of any failures of EHR Connect to pass the Acceptance Tests. If retests are required, LumiraDx shall perform a reasonable number of retests (which shall be determined in LumiraDx’s sole discretion) and, if EHR Connect does still not comply with the Specification following the expiry of this retest period, LumiraDx shall be permitted to charge further fees for these retests in accordance with its standard rates from time to time in force or terminate the agreement. If LumiraDx elects to terminate the Licence in accordance with this clause 5.2, the Organization shall be responsible for the payment of all charges incurred by LumiraDx in relation to the Implementation Services performed up until the date of termination.
5.3 Acceptance shall occur when EHR Connect has passed the Acceptance Tests. The Organization shall sign the Acceptance Certificate in respect of the EHR Connect and return it to LumiraDx as soon as reasonably practicable following Acceptance.
5.4 In the event that any Acceptance Tests are not passed, the failures that cause the relevant tests to be failed shall be drawn up and documented by the party responsible for testing (as identified in a Statement of Work) and presented to the other party for discussion on how best to rectify such failures. LumiraDx shall provide the Organization with reasonable assistance to remedy any failures promptly in order to ensure that EHR Connect passes the Acceptance Tests on a retest.
5.5 If such a retest demonstrates that that EHR Connect does still not comply with the Specification, the Organization may, by written notice to LumiraDx, elect at its sole discretion:
(a) to fix (without prejudice to the Organization's other rights and remedies) a new date for carrying out further tests on EHR Connect on the same terms as the retest (except that the reasonable costs which the Organization may incur as a result of such tests shall be reimbursed by LumiraDx);
(b) to accept EHR Connect; or
(c) if LumiraDx is unable to correct the failures within a period of three months from the commencement of the Acceptance Tests, to terminate the Licence provided that the Organization shall be responsible for the payment of all charges incurred by LumiraDx in relation to the Implementation Services performed up until the date of termination.
6. GRANT OF LICENSE
6.1 If Lumira has notified the Organization in writing that it may use DataView, the following terms shall apply:
(a) in consideration of the Organization, and the Users, agreeing to abide by the terms of this Licence, LumiraDx hereby grants to the Organization, and the Users, a non-exclusive, non-transferable right to use DataView for the purpose of evaluating the Instrument or performing clinical trials during the Trial Period only;
(b) the Organization acknowledges and agrees that the licence to use DataView shall commence on the Trial Start Date and, unless otherwise terminated as provided in clause 15.3 or if either party gives prior written notice to the other party, continue until the expiry of Trial Period when it shall terminate automatically without notice. At the expiry of the Trial Period, the Organization may elect to purchase a full licence to use EHR Connect and LumiraDx shall confirm the grant of such licence by issuing a Purchase Order;
(c) the remaining terms of this Licence shall apply to the Organization’s use of DataView.
6.2 If a licence to use EHR Connect is confirmed in the Purchase Order, in consideration of the Organization, and the Users, agreeing to abide by the terms of this Licence, LumiraDx hereby grants to the Organization, and the Users, a non-exclusive, non-transferable right to use EHR Connect, the Services and the Documentation within their Organization for the purpose of connecting to Patient’s electronic health records during the Term of this Licence.
6.3 LumiraDx has the right to remove the functional capability of DataView or EHR Connect (which may include disabling any password) at any time, if in its reasonable opinion the Organization, or the Users, have failed to comply with any of the terms of this Licence.
6.4 The Organization may be provided with updates of DataView or EHR Connect which includes the incorporation of “patches” and corrections of errors from time to time.
6.5 The Organization shall only:
(a) allow Users to use DataView, EHR Connect, the Services and the Documentation if over 18 years of age; and
(b) use the Documentation to support its use of DataView or EHR Connect and the Services as provided in clause 6.5(a).
6.6 The Organization shall not, except as expressly set out in this Licence or as permitted by law:
(a) copy DataView, EHR Connect, the Services or the Documentation;
(b) make available or grant access to DataView, EHR Connect, the Services or the Documentation to anyone outside of the Organization;
(c) rent, lease, sub-license, distribute, loan, translate, merge, adapt, vary or modify DataView, EHR Connect, the Services or the Documentation;
(d) make alterations to, or modifications of, the whole or any part of DataView, EHR Connect, the Services or the Documentation;
(e) subject to the Customisation Services provided by LumiraDx in accordance with clause 4, permit DataView, EHR Connect, the Services or the Documentation or any part to be combined with, or become incorporated in, any other programs or documentation without obtaining the prior written consent of LumiraDx;
(f) disassemble, decompile, reverse-engineer or create derivative works based on the whole or any part of DataView, EHR Connect or the Services;
(g) access all or any part of DataView, EHR Connect, the Services or the Documentation in order to build a product which competes with DataView, EHR Connect or the Services; and
(h) provide or otherwise make available DataView, EHR Connect, the Services or the Documentation in whole or in part (including object and source code), in any form to any person, other than as provided for in this clause 6, without prior written consent from LumiraDx, (together, the “Licence Restrictions”).
6.7 The Organization shall not:
(a) use DataView, EHR Connect, the Services or the Documentation in any unlawful manner, for any unlawful purpose, or in any manner inconsistent with this Licence, or act fraudulently or maliciously, for example, by hacking into or inserting malicious code, including viruses, or harmful data into DataView, EHR Connect, the Services or the Documentation or any operating system;
(b) infringe LumiraDx’s Intellectual Property Rights or those of any third party in relation to its use of DataView, EHR Connect, the Services or the Documentation (to the extent that such use is not permitted by this Licence);
(c) transmit any material that is defamatory, offensive or otherwise objectionable in relation to its use of DataView, EHR Connect, the Services or the Documentation;
(d) use DataView, EHR Connect, the Services or the Documentation in a way that could damage, disable, overburden, impair or compromise LumiraDx’s systems or security or interfere with other users; and
(e) collect or harvest any information or data from DataView, EHR Connect, the Services or the Documentation, (together, the “Acceptable Use Restrictions”).
6.8 LumiraDx shall follow its archiving procedures for Patient Data processed by EHR Connect (as set out in its back-up policy, a copy of which is available on request). In the event of any accidental or unlawful loss, damage, alteration, unauthorised disclosure or access to Patient Data, LumiraDx will notify the Organization without undue delay on becoming aware of the event. The Organization’s sole and exclusive remedy shall be for LumiraDx to use reasonable commercial endeavours to restore the Patient Data from the latest back-up. LumiraDx shall not be responsible for any loss, destruction, alteration or disclosure of Patient Data caused by any third party except for a third party processor engaged by LumiraDx for the processing of Patient Data in accordance with clause 8.6. For the avoidance of doubt, DataView shall not process any Patient Data and LumiraDx shall have no obligation to follow its archiving procedures for data collected by DataView.
7. THIRD PARTY PROVIDERS
7.1 If the Organization uses a third party software system (including middleware) to integrate with EHR Connect, it does so solely at its own risk.
7.2 LumiraDx makes no representation, warranty or commitment and shall have no liability or obligation whatsoever in relation to the third party software system. Any contract relating to the third party software system is between the Organization and the relevant third party provider, and not LumiraDx. The Organization is responsible for reviewing the contract it forms with the third party provider and ensuring that the contract contains all necessary provisions to facilitate the transfer of Patient Data and information to EHR Connect.
7.3 The Organization shall ensure that the third party provider at all times;
(a) maintains the connectivity of the third party software system;
(b) complies with its obligations under the Data Protection Legislation;
(c) enables the transfer of Patient Data to EHR Connect and does not disable EHR Connect; and
(d) implements appropriate technical and organizational measures to ensure a level of security for Patient Data appropriate to the risk.
7.4 The Organisation agrees that LumiraDx shall not be responsible for:
(a) any loss, destruction, alteration or disclosure of Patient Data caused by any third party provider; and
(b) any failure of the third party software system to provide connectivity or to transfer Patient Data.
8. DATA PROTECTION
8.1 Each party shall duly observe all their obligations under the Data Protection Legislation, which arise in connection with this Licence. This clause 8.1 is in addition to, and does not relieve, remove or replace, a party's obligations under the Data Protection Legislation.
8.2 The Organization shall have sole responsibility for the Patient Data. Subject to this clause 8, LumiraDx shall have no rights in the Patient Data.
8.4 The parties acknowledge that for the purposes of the Data Protection Legislation, the Organization is the Data Controller and LumiraDx is the Data Processor of the Patient Data and other related Personal Data provided by the Organization to LumiraDx for processing in accordance with clauses 8.5 and 8.6. Schedule 1 sets out the scope, nature and purpose of processing by LumiraDx, the duration of the processing and the types of Personal Data and categories of Data Subject (as defined in the Data Protection Legislation).
8.5 Notwithstanding the general obligation in clause 8.1, when processing Patient Data:
(a) the Organization shall ensure that the relevant third parties, including, but not limited to Patients, have been informed of, and have given their specific consent to, such use (including the use set out at Schedule 1), processing, and transfer as required by Data Protection Legislation;
(b) LumiraDx shall:
(i) only process that Patient Data on the written instructions of the Organization, which are set out in Schedule 1, unless LumiraDx is required by the laws of any member of the European Union or by the laws of the European Union applicable to LumiraDx to process Patient Data (“Applicable Laws”). Where LumiraDx is relying on Applicable Laws as the basis for processing Patient Data, LumiraDx shall promptly notify the Organization of this before performing the processing required by the Applicable Laws unless those Applicable Laws prohibit LumiraDx from so notifying the Organization;
(ii) ensure that it has in place appropriate technical, contractual and organisational measures to protect against unauthorised or unlawful processing of the Patient Data and against accidental loss or destruction of, or damage to, the Patient Data, appropriate to the harm that might result from the unauthorised or unlawful processing or accidental loss, destruction or damage and the nature of the data to be protected, having regard to the state of technological development and the cost of implementing any measures;
(iii) ensure that all personnel who have access to and/or process Patient Data are obliged to keep the Patient Data confidential;
(iv) assist the Organization, at the Organization's cost, in responding to any request from a data subject and in ensuring compliance with its obligations under the Data Protection Legislation with respect to security, breach notifications, impact assessments and consultations with supervisory authorities or regulators;
(v) notify the Organization without undue delay on becoming aware of a Patient Data breach;
(vi) ensure it does not knowingly or negligently do or omit to do anything which places the Organization in breach of the Organization’s obligations under the Data Protection Legislation;
(vii) maintain complete and accurate written records and information of its Patient Data processing activities to demonstrate compliance with this clause 8; and
(viii) not transfer any Patient Data outside the EEA unless appropriate safeguards have been put in place. The Organization agrees that Personal Data relating to the Organization’s employees, agents or independent contractors may be transferred outside the EEA provided that appropriate safeguards in relation to the transfer are in place and LumiraDx ensures that an adequate level of protection is provided to all Patient Data transferred.
8.6 The Organization consents to LumiraDx appointing third party data providers (which includes any member of the LumiraDx Group) and third party services providers (who may provide telephone support services and technical support services) as a third party processor of Personal Data under this Licence. LumiraDx confirms that it has entered or (as the case may be) will enter with the third party processor into a written agreement substantially on that third party's standard terms of business. As between the Organization and LumiraDx, LumiraDx shall remain fully liable for all acts or omissions of any third party processor appointed by it pursuant to this clause 8.6. For the avoidance of doubt, any third party providers chosen or appointed by the Organization shall not be deemed to be LumiraDx’s appointed third party processor of Personal Data. The Organization agrees that the data processing obligations of the Organization’s appointed third party providers shall be included in the contract the Organization forms with the third party provider.
8.7 The Organization agrees that LumiraDx may utilise anonymised data produced from the Patient Data inputted into EHR Connect by the Organization provided that ISB1523 Anonymisation Standards for Publishing Health Care Data are observed.
9. FREEDOM OF INFORMATION
9.1 LumiraDx acknowledges that the Organization may be subject to the requirements of the FOIA and shall assist and co-operate with the Organization (at the Organization’s expense) to enable the Organization to comply with these information disclosure requirements.
9.2 LumiraDx shall:
(a) transfer any Request for Information to the Organization as soon as practicable after receipt of a Request for Information;
(b) provide the Organization with a copy of all Information in its possession or power in the form that the Organization reasonably requires as soon as reasonably practicable (or such other longer period as the Organization may specify) of the Organization requesting that Information; and
(c) provide all necessary assistance as reasonably requested by the Organization to enable the Organization to respond to a Request for Information within the time for compliance set out in section 10 of the FOIA.
9.3 In no event shall LumiraDx respond directly to a Request for Information.
10. ORGANIZATION'S OBLIGATIONS
10.1 The Organization shall:
(a) treat passwords, or any other information provided as part of LumiraDx’s security procedures, as confidential. The Organization shall not disclose it to any third party;
(b) ensure that all its Users of DataView, EHR Connect act in accordance with this Licence and only use it for the purposes set out in clause 6;
(c) ensure that all its Users of EHR Connect comply with the procedures and guidelines set out in the Documentation (including the user manual) relating to the use of EHR Connect;
(d) at all times co-operate with LumiraDx and provide information reasonably required by LumiraDx, including any test data required for the purpose of performing Acceptance Tests in accordance with clause 5;
(e) supervise and control the use of DataView and EHR Connect in accordance with the terms of this Licence and ensure that DataView and EHR Connect is only used by suitably qualified and trained healthcare professionals;
(f) undertake, and shall procure that all Users undertake, any training requirements specified by LumiraDx from time to time;
(g) immediately notify LumiraDx of any adverse event where DataView or EHR Connect may have been a contributory factor. The Organization further agrees to provide written details of the event and co-operate with LumiraDx in its investigation of the event. The Organization acknowledges and agrees that all communications relating to any adverse event shall be deemed to be Confidential Information and shall be subject to the confidentiality obligations at clause 12;
(h) report all failures, issues or defects in DataView and EHR Connect to LumiraDx. The Organization acknowledges and agrees that the all communications relating to failures, issues or defects in DataView and EHR Connect shall be considered to be Confidential Information and shall be subject to the confidentiality obligations at clause 12; and
(i) not permit any third party to provide technical support in respect of DataView, EHR Connect, the Services or the Documentation.
11. PROPRIETARY RIGHTS
11.1 The Organization acknowledges that LumiraDx, and/or its licensors (who are third party owners of intellectual property rights used in EHR Connect), own all Intellectual Property Rights in DataView, EHR Connect, the Services and the Documentation. This Licence does not grant the Organization any rights to, or in, patents, copyrights, database rights, trade secrets, trade names, trade marks (whether registered or unregistered), or any other rights or licences in respect of DataView, EHR Connect, the Services or any related Documentation, other than the right to use them in accordance with this Licence.
11.2 Notwithstanding clause 11.1, if LumiraDx creates any Materials as part of its performance of the Implementation Services, the Organization acknowledges and agrees that all the Intellectual Property Rights in the Materials are and will remain the exclusive property of LumiraDx.
11.3 The Organization acknowledges that it has no right to have access to DataView, EHR Connect or any of the Materials in source-code form.
12.1 LumiraDx acknowledges that the Patient Data is the Confidential Information of the Organization.
12.2 Subject to clause 12.3, the parties shall keep confidential the Confidential Information of the other party and shall use all reasonable endeavours to prevent their employees, agents and independent contractors from making any disclosure to any person of the Confidential Information.
12.3 Clause 12.2 shall not apply to any disclosure of information:
(a) required by any applicable law, provided that clause 9 shall apply to any disclosures required under the FOIA;
(b) that is reasonably required by persons engaged by a party in the performance of that party's obligations under this Licence;
(c) where a party can demonstrate that such information is already generally available and in the public domain otherwise than as a result of a breach of clause 12.2;
(d) which is already lawfully in the possession of the receiving party, prior to its disclosure by the disclosing party, and the disclosing party is not under any obligation of confidence in respect of that information; or
(e) by a party when the other party has given its prior written consent to disclosure.
13. SUPPORT SERVICES
13.1 During the Term of this Licence, LumiraDx shall endeavour to provide the Organization with support services by telephone (00800 5864 7239) or email (firstname.lastname@example.org) during Normal Business Hours on Business Days to assist with connectivity.
13.2 Support services shall not be provided in respect of the following:
(a) if LumiraDx has installed EHR Connect on any of the Organization’s equipment in accordance with clause 3.2(a), any versions of EHR Connect the other than the current release;
(b) support caused by the Organization’s failure to comply with any support procedure agreed between LumiraDx and the Organization;
(c) advice on the medical treatment of individual Patients; and
(d) if the Organization does not comply with any term of this Licence, which includes any of its responsibilities outlined in the Statement of Work.
14. LIMITATION OF LIABILITY
14.1 The Organization agrees that it assumes sole responsibility for results obtained from the use of DataView, EHR Connect and the Services and for conclusions drawn from such use. LumiraDx shall have no liability for any damage caused by errors or omissions in any information provided by the Organization, or any actions taken by LumiraDx at the Organization's direction. The Organization acknowledges that DataView and EHR Connect were not designed to the Organization’s individual requirements and that it is therefore the Organization’s responsibility to ensure that the facilities and functions of DataView and EHR Connect, as described in the Documentation, meet its requirements.
14.2 DataView, EHR Connect and the Services are intended only as a diagnostic aid and are not a substitute for the expertise and judgement of physicians, pharmacists or other healthcare professionals. All information is provided on the basis that the healthcare practitioners responsible for patient care will retain full and sole responsibility for deciding any treatment to prescribe or dispense for all patients and in particular whether the use of information provided by DataView or EHR Connect is safe, appropriate or effective for any particular patient or in any particular circumstances.
14.3 LumiraDx shall not:
(a) be liable whether in tort (including for negligence or breach of statutory duty), contract, misrepresentation, restitution or otherwise for any loss of income, loss of profits or contracts, loss of business, business interruption, loss of money or anticipated savings, loss of or depletion of opportunity, goodwill, reputation and/or similar losses or loss or corruption of data or information, or pure economic loss, or for any special, indirect or consequential loss, costs, damages, charges or expenses however arising under this Licence; or
(b) be liable for any claim or losses which arise in respect if a feature of EHR Connect which was specified by the Organization and included in the Specification.
14.4 Other than the losses set out in clause 14.3 (for which LumiraDx is not liable), LumiraDx's total aggregate liability in contract, tort (including negligence or breach of statutory duty), misrepresentation, restitution or otherwise, arising in connection with the performance or contemplated performance of this Licence shall be limited to the total licence fees paid to LumiraDx for EHR Connect (as set out on the Purchase Order) during the 12 months preceding the date on which the claim arose or [insert sum] whichever is greater.
14.5 Nothing in this Licence excludes the liability for death or personal injury caused by negligence or for fraud or fraudulent misrepresentation.
14.6 The Organization acknowledges that any Open-Source Software provided by LumiraDx is provided "as is" and expressly subject to the disclaimer in clause 14.7. The terms of an Open-Source Software licence may override some of the terms of this Licence.
14.7 This Licence sets out the full extent of LumiraDx’s liabilities in respect of DataView, EHR Connect, the Services, the Implementation Services, the Support Services and the Documentation. Except as expressly stated in this Licence, there are no conditions, warranties, representations or other terms, express or implied, that are binding on LumiraDx. Any condition, warranty, representation or other term concerning the supply of DataView, EHR Connect, the Services, the Implementation Services, the Support Services or the Documentation which might otherwise be implied into, or incorporated in, this Licence whether by statute, common law or otherwise, is excluded to the fullest extent permitted by law.
14.8 The parties acknowledge and agree that any Milestone Dates in the Implementation Plan or dates provided in relation to the Support Services are approximate only, and that the time is not of the essence. LumiraDx shall not be liable for any delay in delivery of the Implementation Services or the Support Services that is caused by an event, circumstance or cause within the scope of clause 17 or the Organization’s failure to provide LumiraDx with adequate instructions or information.
15. TERM AND TERMINATION
15.1 The Customisation Services shall commence on the Start Date and shall continue, unless terminated earlier in accordance with clause 15.3 until the Implementation Plan has been completed or the Licence has expired or been terminated. For the avoidance of doubt, the Licence shall commence on the Start Date and not the date on which Acceptance takes place.
15.2 This Licence and the Support Services (excluding the trial licence to use DataView set out at clause 6.1) shall commence on the Start Date and shall continue for the Initial Term and, thereafter, shall be automatically renewed for successive Renewal Terms, unless:
(a) the Organization notifies LumiraDx, in writing, at least 30 days before the end of the Initial Term or any Renewal Term; or
(b) otherwise terminated in accordance with the provisions of this Licence,
and the Initial Term together with any subsequent Renewal Term shall constitute the “Term”.
15.3 Without affecting any other right or remedy available to it, LumiraDx may terminate this Licence (which includes the Statement of Work) and the licence to use DataView at clause 6.1 with immediate effect by giving written notice to the Organization if:
(a) the Organization, or its Users, commits a material breach of any term of this Licence (including the Statement of Work) which breach is irremediable or (if such breach is remediable) fails to remedy that breach within a period of 14 days after being notified in writing to do so;
(b) the Organization fails to pay any amount due under the Purchase Order, which includes the payment of the licence fee and any support charges, on the due date for payment;
(c) the Organization, or its Users, breach any of the Licence Restrictions or the Acceptable Use Restrictions;
(d) the Organization suspends, or threatens to suspend, payment of its debts or is unable to pay its debts as they fall due or admits inability to pay its debts or is deemed unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986;
(e) a petition is filed, a notice is given, a resolution is passed, or an order is made, for or in connection with the winding up of the Organization other than for the sole purpose of a scheme for a solvent amalgamation of the Organization with one or more other companies or the solvent reconstruction of the Organization;
(f) an application is made to court, or an order is made, for the appointment of an administrator, or if a notice of intention to appoint an administrator is given or if an administrator is appointed, over the Organization;
(g) a person becomes entitled to appoint a receiver over the assets of the Organization or a receiver is appointed over the assets of the Organization; or
(h) the Organization suspends or ceases, or threatens to suspend or cease, carrying on all or a substantial part of its business.
15.4 On termination of this Licence for any reason:
(a) all the rights granted to the Organization under this Licence shall cease;
(b) the Organization shall immediately pay to LumiraDx all of LumiraDx’s outstanding unpaid licence fees as set out on the Purchase Order;
(c) the Organization acknowledges that the licence fees and other amounts payable in accordance with the Purchase Order are non-cancellable and non-refundable;
(d) the Organization shall immediately cease all activities authorised by this Licence (including its use of DataView, EHR Connect, the Services and the Documentation); and
(e) the Organization shall return and make no further use of the Documentation (and all copies of it) belonging to LumiraDx.
15.5 On termination or expiry of this Licence, the following clauses shall continue in force: clause 1 (Interpretation), clause 12 (Confidentiality), clause 14 (Limitation of Liability) and this clause 15 (Termination).
16. PRECEDENCE OF DOCUMENTS
In the event of, and only to the extent of, any conflict or inconsistency between the terms of this Licence, such conflict or inconsistency shall be resolved according to the following order of priority:
(a) the Purchase Order;
(b) the Statement of Work: and
(c) the terms of this Licence.
17. FORCE MAJEURE
LumiraDx shall have no liability to the Organization under this Licence if it is prevented from, or delayed in performing, any of its obligations under this Licence if such delay or failure results from events, circumstances or causes beyond its reasonable control, including strikes; lock-outs or other industrial disputes; failure of a utility service or transport or telecommunications network or the internet; act of God; war; riot; civil commotion; malicious damage; accident; breakdown of plant or machinery; fire, flood, or storm; default of suppliers or sub-contractors; or interruption or failure of utility service, provided that the Organization is notified of such an event and its expected duration.
No variation of this Licence shall be effective unless it is in writing and signed by the parties (or their authorised representatives).
No failure or delay by a party to exercise any right or remedy provided under this Licence or by law shall constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall prevent or restrict the further exercise of that or any other right or remedy.
20.1 If any provision (or part of a provision) of this Licence is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions shall remain in force.
20.2 If any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted, the provision shall apply with whatever modification is necessary to give effect to the commercial intention of the parties.
21.1 The Organization shall not, without the prior written consent of LumiraDx, assign, transfer, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under this Licence.
21.2 LumiraDx may at any time assign, transfer, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under this Licence.
22. THIRD PARTY RIGHTS
This Licence does not confer any rights on any person or party (other than the parties to this Licence and, where applicable, their successors and permitted assigns and any LumiraDx Group Company) pursuant to the Contracts (Rights of Third Parties) Act 1999.
23.1 Any notice required to be given under this Licence shall be in writing and shall be delivered by hand or sent by pre-paid first-class post or recorded delivery post to the other party at its main trading address or such other address as may have been notified by that party for such purposes.
23.2 A correctly addressed notice sent by pre-paid first-class post or recorded delivery post shall be deemed to have been received at the time at which it would have been delivered in the normal course of post.
24. GOVERNING LAW AND JURISDICTION
24.1 This Licence and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.
24.2 Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with this Licence or its subject matter or formation (including non-contractual disputes or claims).
Processing, Personal Data and Data Subjects
1. Processing by LumiraDx
1.1 Nature and Purpose of processing
LumiraDx, and any member of the LumiraDx Group, may process Personal Data:
- For the purposes of transferring Personal Data from LumiraDx’s online software component known as Connect Manager to the Patient’s electronic health record;
- for data analytics and statistical research to help LumiraDx better understand how its products are used;
- to investigate misuse of the Organization’s account, fraud and debt collection.
- for support, maintenance and patient safety (including the investigation of faults);
- to improve the performance or features of EHR Connect, the Services or the Documentation;
- to provide feedback to the Organization and/or Patient and improve the performance of the service that the Organization provide;
- to improve the understanding, treatment, outcomes and choice for Patients and healthcare professionals; and
- to comply with any relevant statutory or regulatory requirement imposed on LumiraDx from time to time.
1.2 Subject matter and duration of the processing
The subject matter and duration of the processing are set out in the Licence.
2. Types of personal data
- Personal data including patient identification, first name, surname, date of birth and gender; and
- data concerning health, including healthcare conditions affecting Patients and test result information.
3. Categories of data subject