General Terms

Last updated: 21 February 2024

Recitals

1. Client is a manufacturer of medical devices. Client requires one or more specific regulatory approvals to allow it to sell its device to Client’s customers.
2. Scarlet is a certifying organisation, capable of performing conformity assessment activities, and of granting one or more of the specific regulatory approvals that Client requires.
3. Client and Scarlet enter an agreement for the performance of conformity assessment when the specific terms are signed by both parties.
4. The parties wish to enter into this Agreement which sets out the terms and conditions upon which Scarlet will provide such conformity assessment activities to Client.
5. Scarlet’s Product includes a VS Code Extension that communicates with the LSP Server to produce the functionality that allows Scarlet to obtain the data required to perform the conformity assessment.
6. Scarlet’s Product is made available to Client through the Scarlet VS Code Extension in VS Code, which is hosted on Github.
7. Client may have access to Scarlet’s Product prior to this Agreement taking effect. Subject to any conflict(s) between the software licence and the specific and general terms, access to Scarlet’s Product is and continues to be governed by the Software Licence, which the user accepts when they access the Scarlet VS Code Extension.

Agreement

1. This agreement (Agreement) comprises the following, in order of priority:
   1. The specific terms agreed between the Parties (Specific Terms);
   2. These general terms and conditions (General Terms), including Appendix 1; and
   3. The software licence that relates specifically to Client’s use of Scarlet’s Product (Software Licence).
2. The Agreement shall enter into force when the Specific Terms are executed.
3. No other terms, conditions, or requirements, including those contained in any purchase order of Client, shall apply.

Supply of Services

4. Scarlet is an independent, non-governmental, third party certifying organisation.
5. Scarlet follows the requirements of the Relevant Regulation to perform the Services that are agreed with Client in the Specific Terms.
6. Scarlet shall only perform the Services in respect of the Agreed Device(s). Client shall notify Scarlet of any changes to the scope of the Agreed Device(s) and Scarlet shall have discretion to determine whether the new scope is covered by this Agreement. Where it is not covered, the Parties may agree to expand the scope of the Services, which may come at an additional cost to Client.
7. Scarlet does not:
   1. provide any guarantees or warranties in respect of any of Client’s products, systems or services; or
   2. review or evaluate the Agreed Device(s) in any way that is beyond the scope of the Relevant Regulation.
8. Scarlet agrees to perform the Services in a professional manner and with a level of skill and expertise as can be expected from a body performing conformity assessment activities.
9. Scarlet agrees to provide Client written notice of any non-conformity with any Scarlet requirement. Notice of non-conformities will be provided through Scarlet’s Product. Client shall resolve any non-conformities to Scarlet’s satisfaction, before Scarlet provides any Certification in respect of the Agreed Device(s).
10. Upon determination that the Agreed Device(s) are certifiable, and upon receipt of the applicable fees, Scarlet agrees to issue the applicable Certificate.
11. Scarlet shall respond to requests for information from Client according to the timeframes separately agreed with Client in the Service Levels.
12. Scarlet shall have no responsibility, and shall not be liable for, any services provided by Github, VS Code, Amazon Web Services, or any other software provider that Client uses to access Scarlet’s Product.
13. Scarlet reserves the right to refuse, suspend or withdraw access to Scarlet’s Product or other systems operated by Scarlet, in respect of any:
    1. consultant or third party engaged by Client;
    2. employee, agent or officer of Client who, in Scarlet’s reasonable opinion, has or is likely to misuse Scarlet’s Product or systems operated by Scarlet, or misappropriate Scarlet’s Confidential Information.

Client’s obligations

14. Client shall:
    1. commit itself to full compliance with the initial and ongoing certification requirements as notified to Client by Scarlet in Scarlet’s Product;
    2. ensure that the Specific Terms accurately describe Client, the Agreed Device(s) and Client’s operations;
    3. co-operate with Scarlet in all matters relating to the Services;
    4. provide Scarlet with access to Client’s premises, data and/or software as may be required in order to provide the Services including, for example access to allow Scarlet to conduct an audit;
    5. use all reasonable endeavours to assist Scarlet in obtaining all visas, permits and other authorisations required for Scarlet and Scarlet’s people to provide the Services;
    6. notify all of Client’s subcontractors that Scarlet may require access to the subcontractor’s premises, information, data and/or software in connection with the Services, including in the case of an unannounced audit, and procure that Client’s subcontractors consent to such access.
15. Client certifies and represents that it shall comply with all applicable laws and regulations with respect to its activities under this Agreement.

Information and notifications

16. The Parties acknowledge that Scarlet cannot perform the Services and reliably meet its own regulatory obligations without receiving information from Client. Client agrees to supply Scarlet with any information needed for evaluation of the Agreed Device(s), including information about Client’s broader products, systems or services and its Technical Documentation. Unless otherwise advised by Scarlet, all information provided by Client to Scarlet in connection with the Relevant Regulation shall be inputted into Scarlet’s Product.
17. Client represents, warrants and undertakes that, to the best of its information and knowledge, the information given to Scarlet is true and accurate. Client assumes sole responsibility for the truth and accuracy of such information.
18. As a result of information provided by Client or otherwise obtained about the Agreed Device(s) or Client’s broader products, systems or services, Scarlet may identify a safety, compliance, or other issue. Client agrees that, in the event that it is notified of such issue by Scarlet, it will:
    1. address the problem immediately;
    2. make the appropriate notifications; and
    3. take full responsibility for any failures to comply with paragraphs a. and b. of this clause.
19. Client is solely responsible for providing all warnings, instructions, Vigilance Reports and notices of any kind (including in relation to safety) to governmental / regulatory agencies in all relevant jurisdictions, to Scarlet, and to the general public, in a timely manner and within all applicable statutory or regulatory deadlines. Without limiting the foregoing, Vigilance Reports must be provided to both Scarlet and the relevant governmental / regulatory agencies concurrently or in quick succession.
20. Client shall notify Scarlet as soon as possible (and, if planned, well in advance) of any changes to the information or data supplied by Client to Scarlet, within the scope of the Services.
21. Client shall notify Scarlet as soon as possible (and, if planned, well inadvance) of any changes or additions to Client’s:
    1. Agreed Device(s);
    2. quality management systems;
    3. product range;
    4. device design;
    5. intended use of or claims made for a device;
    6. products, systems or services
    to the extent not otherwise covered by this clause;to the extent that the changes could affect Client’s Certification or potential Certification under this Agreement.
22. Client shall notify Scarlet as soon as possible (and, if planned, well in advance) of any material changes to Client’s:
    1. legal, commercial, organisational status or ownership;
    2. organisation and management;
    3. contact address and sites;
    4. organisation, personnel or structure to the extent not otherwise covered by this clause.
23. Client acknowledges that, on receipt of notification under one or both of the preceding two clauses, Scarlet will assess the new information provided by Client, and verify whether the Agreed Device(s) still meet the requirements of the Relevant Regulation, and whether the Authorisations remain valid. Such assessment may come at additional cost to Client.

Confidentiality

24. All Confidential Information shall remain the property of the Party disclosing the Confidential Information, who reserves all rights in connection with the Confidential Information.
25. Each Party receiving Confidential Information from the other Party shall keep all Confidential Information secret and confidential.
26. Each Party receiving Confidential Information from the other Party shall only use or disclose Confidential Information:
    1. to the extent necessary for the purposes of the Agreement; or
    2. to the extent necessary for third party suppliers including, for example, Github, to support the provision of the Services; or
    3. to the extent required by law, any governmental, regulatory or accreditation authority, or court in any jurisdiction; or
    4. with written agreement of the other Party; or
    5. if, in the reasonable opinion of the receiving Party, the health or safety of consumers may be at risk; or
    6. to the minimum extent necessary for a potential acquirer or material investor to evaluate, consider or advance the acquisition.
27. The Party disclosing Confidential Information to a third Party under this Agreement must mark that information as confidential. Such disclosure must be notified to the other Party.
28. Client expressly acknowledges Scarlet’s designation to provide Certification. In some cases, this will be under assessment by a regulatory authority. Client agrees that the regulatory authority may review, witness and analyse the provision of any Servicesand associated data. Client expressly consents that Scarlet may disclose to third parties information about Client’s products or services as directed by the regulatory authority.

Data

29. Both Parties shall abide by and maintain data security measures that are consistent with best industry practice and the GDPR, to protect the other Party’s Confidential Information from unauthorised disclosure or acquisition by an unauthorised person.
30. Data security measures compliant with this Agreement shall include:
    1. encryption of all Confidential Information at rest;
    2. two factor authentication;
    3. data backups;
    4. using data storage providers who are compliant with state of the art information security standards and practice; and
    5. any other measures that would reasonably be expected of a competent operator in Scarlet or Client’s position (as applicable).

Intellectual Property

31. All Intellectual Property Rights in or arising out of or in connection with the Services (other than Intellectual Property Rights in any materials provided by Client) shall be owned by Scarlet. This includes Scarlet’s Product and all content created, developed or built by Scarlet therein. Client may only access and use Scarlet’s Intellectual Property to the minimum extent necessary to receive the Services performed under this Agreement.
32. Client grants to Scarlet a fully paid up, non-exclusive, royalty-free, non-transferable licence to copy and modify any materials provided by Client to Scarlet for the term of the Agreement to the extent required for Scarlet to provide the Services.
33. Neither Party may sub-license, assign or otherwise transfer the Intellectual Property Rights granted in the Agreement.

Registered Symbols, Certificates, Reports

34. Only customers whose Agreed Device(s) have been Certified by Scarlet may use Scarlet’s Registered Symbols, Certificates and Reports (together, the Authorisations). Customers who no longer hold a valid Certificate shall immediately stop using such Authorisations.
35. Authorisations granted to Client shall remain the property of Scarlet. Subject to any decisions to Suspend, Restrict or Withdraw Client’s Authorisation(s):
    1. Authorisations under ISO 13485 are valid for a maximum of three years from the date the Authorisation is granted;
    2. Authorisations under MD Regulation are valid for a maximum of five years from the date the Authorisation is granted.
36. The timeframe for a valid Authorisation may be further restricted by Scarlet, at the time of granting the Authorisation, depending on the novelty, risk classification, clinical evaluation and conclusions from the risk analysis of the Agreed Device(s).
37. Authorisations may automatically renew where Client has paid all necessary fees, the Agreed Device(s) has successfully passed all recertification audits and, in Scarlet’s reasonable opinion, Client is otherwise compliant.
38. Client shall:
    1. inform Scarlet, at least 90 Business Days prior to the expiration of the Authorisation, if Client does not intend to renew such Authorisation;
    2. not make or permit any misleading statements regarding the Authorisations or use of the Authorisations;
    3. not use the Authorisations in a misleading way or for a product, system or service that is not within the scope of the Certification;
    4. amend its website and any other advertising material, to accurately reflect the scope of Authorisation granted;
    5. subject to the process for termination set out in this Agreement, upon termination of the Certification, however determined, discontinue the use of Authorisations and all advertising matters that contain any reference to Client’s Authorisations;
    6. discontinue the use of corresponding Authorisations for the duration of any suspension or part-suspension of Client’s Certification.
39. In addition, and specifically relating to ISO 13485, Client shall:
    1. only use the Registered Symbols in the form in which they are shown in Appendix 1 of these General Terms;
    2. not use the Registered Symbols on a product or product packaging, or in any way that may be interpreted as denoting product conformity.
40. Client shall be permitted to distribute Authorisations provided they are distributed in the same form as provided to Client by Scarlet, unless otherwise approved by Scarlet.

Suspension, Restrictions, Withdrawals

41. Scarlet reserves the right to decline, Suspend, Restrict or Withdraw any Certification that it provides, or may provide, to Client.
42. Scarlet may invoke such right if, in Scarlet’s reasonable opinion, Client, or (any part of) the Agreed Device(s):
    1. persistently or seriously fails to comply with the Relevant Regulation;
    2. persistently or seriously fails to comply with any of the obligations under the Agreement;
    3. raises material safety concerns;
    4. has not been sufficiently audited due to refusal by Client or their subcontractors to grant Scarlet access to premises;
    5. is otherwise threatened to be inaccessible to Scarlet due to Client’s failure to guarantee access to Client’s premises, information, data and/or software;
    6. have had features added or changes made that have not been notified to and approved by Scarlet and, in Scarlet’s reasonable opinion, fall outside of the scope of Certification; or
    7. Client has failed to make full payment by the final deadline according to this Agreement.
43. In addition, Scarlet may Suspend or Withdraw Client’s Certification on written request by Client.
44. Client’s Certification is invalid for any period for which it is Suspended or Withdrawn.
45. Scarlet will restore a Suspended Certification if, in Scarlet’s reasonable opinion, the issue(s) that caused the Suspension has been resolved.
46. Client’s failure to resolve the issue(s) that caused the Suspension in a time specified by Scarletwill result in Withdrawal or Restriction, in accordance with this Agreement, unless otherwise decided by Scarlet.
47. In lieu of declining, Suspending, or Withdrawing Client’s Certification,Scarlet may choose to restrict the scope of Certification to exclude aspects of the Agreed Device(s) that do not meet the requirements (Restriction).
48. In the event of Suspension, Withdrawal, or Restriction, Scarlet shall communicate the decision and rationale to Client and notify any applicable regulatory authorities of the action taken.
49. Client agrees that its Certification of the Agreed Device(s) is automatically invalid if:
    1. Client fails to comply with all Scarlet requirements notified to Client in writing; or
    2. Client provides products, systems or services outside of the scope of the Certificate, whether or not such Certificate has been Restricted.

Appeals

50. There may be instances where Client disagrees with Scarlet’s (or those acting on Scarlet’s behalf) decision to decline, Restrict, Suspend, or Withdraw Certification (Initial Decision).
51. The Initial Decision is made by the Final Reviewer and Decision Maker, who will base their decisions on findings of the Audit Team, their own conclusions, and any other relevant information.
52. The Final Reviewer and Decision Maker has the authority to review and challenge Certification recommendations made by Scarlet’s Audit Team. Certificates are only valid if signed by a director of Scarlet.
53. Client may apply to appeal a decision of the Final Reviewer and Decision Maker using the online form available on Scarlet’s website, but must do so within 15 Business Days of receiving the Initial Decision.
54. On receipt of an application to appeal, a member of Scarlet personnel will conduct an investigation. The investigation shall be completed within 20 Business Days of receipt of Client’s application to appeal.
55. The same member of Scarlet personnel shall appoint two Final Reviewers and Decision Makers to make a decision on the appeal, based on the findings of the investigation. The decision on the appeal shall be made within 5 Business Days of the completion of the investigation.
56. If one or both of the Final Reviewers and Decision Makers making the decision on appeal were involved in the subject matter of the appeal, their decision on appeal shall be subject to further review by Scarlet’s Impartiality Panel, within 10 Business Days of the decision on the appeal being made.
57. The final decision of the appeal shall be recorded in writing and any associated correction or corrective action shall be carried out by Scarlet or the Appellant. The Initial Decision will remain in force pending the outcome of the investigation and/or appeal.
58. If Client has material concerns with the decision of the appeal, Client may convey these concerns to the MHRA or IGJ, as applicable. Scarlet’s decision on appeal is final, unless and until a different decision is reached by the MHRA or IGJ, as applicable.
59. Scarlet is committed to remaining free of discrimination in the submission, investigation and decision on appeals and complaints. Submission, investigation and decision on appeals shall not result in any discriminatory action being taken against the Appellant.

Fees and Payments

60. Scarlet’s fees for providing the Services are set out in the Specific Terms.
61. Scarlet may, from time to time, change its pricing, provided such change in pricing is reasonable. Scarlet shall notify Client at least 2 Calendar Months in advance of Client receiving the Services in respect of which the new pricing applies. On receipt of such notice, Client may terminate the Agreement, by notifying Scarlet of its intention to do so, with 1 Calendar Month’s notice. If Client provides no such notice before receiving the Services in respect of which the new pricing applies, Client is deemed to accept the new pricing, unless otherwise agreed between the Parties in writing.
62. Fees shall be incurred Monthly, from the Effective Date. Scarlet shall invoice Client for the fees Monthly in arrears.
63. Client has one Month to make payment following receipt of the invoice. Scarlet reserves the right to request additional payment for late invoices, by applying interest of 8% above the Bank of England base rate.
64. If any late invoice is not paid, Scarlet may notify Client, in writing, of a final deadline for payment, such deadline not to be less than 1 Month from the date of notification.
65. If Client fails to make full payment by the final deadline, Scarlet reserves the right to discontinue Services, to Suspend Client’s Certification, or to suspend or terminate the Agreement upon notice with immediate effect.
66. If Client reasonably believes an invoice includes a sum which is not valid and properly due:
    1. Client shall notify Scarlet in writing within 5 Business Days of receipt of the disputed invoice;
    2. Client shall pay all amounts specified on the invoice that are not in dispute;
    3. The Parties shall negotiate in good faith to resolve the dispute;
    4. Original payment terms, including timeframes for calculating interest payments, shall run from the date of resolution of the disputed invoice; and
    5. Client’s failure to pay the disputed portion of the invoice shall not be deemed to be a breach of the Agreement.
67. Client is responsible for paying, without any corresponding withholding from Scarlet, any and all taxes and fees that may be imposed by any and all governmental agencies having jurisdiction over Client’s business transactions with Scarlet.

Liability

68. Nothing in this Agreement limits any liability which cannot legally be limited or excluded, including liability for:
    1. death or personal injury caused by negligence;
    2. fraud or fraudulent misrepresentation;
    3. any other liability that cannot be limited or excluded by law.
69. Scarlet’s total liability to Client arising under or in connection with the Agreement will not exceed a one-off amount equal to the annual fees payable by Client in the year in which the cause of action arose.
70. Client may not make any liability claim against Scarlet in relation to any of the following types of loss:
    1. loss of profits;
    2. loss of sales or business;
    3. loss of agreements or contracts;
    4. loss of anticipated savings;
    5. loss of use or corruption of software, data or information;
    6. loss of or damage to goodwill; and
    7. indirect or consequential loss.
71. Unless Client notifies Scarlet that it intends to make a claim in respect of an event within the notice period, Scarlet shall have no liability for that event. The notice period runs from the day the Client ought reasonably to have become aware of its having grounds to make a claim and shall expire three months from that date. Notice must be in writing and identify the event and the grounds for the claim in reasonable detail.

Indemnity

72. Client agrees to indemnify and hold harmless Scarlet against any costs or losses that Scarlet may suffer arising in connection with any claims, allegations, demands, suits, proceedings, investigations, damages, penalties or fines made or imposed against Scarlet or its group companies arising out of or in connection with the Services, including (but not limited to):
    1. any use, misuse, sale or resale of any of Scarlet’s products, systems or services by Client;
    2. any use, misuse, sale or resale of an Agreed Device or of any of Client’s broader products, systems or services by a person other than Scarlet;
    3. a third party’s reliance on a Report disclosed by Client, whether or not disclosed with Scarlet’s prior written consent;
    4. Client’s use or display of any Authorisations given to Client from Scarlet;
    5. an Agreed Device, or Client’s broader products, systems or services not being fit for purpose;
    6. actual or alleged infringements of a third party’s intellectual property rights relating to Scarlet’s use of Client’s information, data, or other assets;
    7. Client’s failure to comply with any regulatory requirement or other obligation related to this Agreement including, but not limited to, rectifying violations, notifications, and Vigilance Reports.
73. This indemnification shall not cover Scarlet to the extent that a claim under it results from Scarlet’s wilful misconduct, recklessness or negligence.

Termination

74. The initial term of this Agreement shall be one year from the Effective Date, with automatic renewal of subsequent one year periods. This Agreement shall not renew automatically if either Party provides notice to the other Party, in writing, of their intention not to renew at least three Months prior to the anniversary of the Effective Date.
75. Either Party may terminate this Agreement by giving the other Party six Months’ written notice.
76. Scarlet may terminate the Agreement with immediate effect if Scarlet ceases to hold the authorisations required to conduct the Services. Scarlet will give reasonable notice, in writing, to Client if it becomes aware of any circumstances that may result in the withdrawal of authorisations that apply to Scarlet.
77. Either Party may terminate the Agreement with immediate effect by giving written notice to the other Party if:
    1. the other Party commits a material breach of the Agreement and such breach is not resolved within 5 Business Days after the infringing Party receives written notice of the breach from the other Party;
    2. the other Party takes any step or action in connection with bankruptcy, liquidation, administration or receivership;
    3. the other Party ceases or threatens to cease to carry on all or substantial parts of its business;
78. Scarlet may terminate this Agreement if Client fails to make payment, in accordance with the process set out in the Fees and Payments provisions of this Agreement.
79. Following a price increase made by Scarlet, Client may terminate the Agreement by giving Scarlet 1 Calendar Month’s written notice, in accordance with the process specified in this Agreement.
80. On termination or expiry of the Agreement, Client shall:
    1. immediately pay Scarlet all amounts owing for Services provided to date;
    2. follow Scarlet’s reasonable directions relating to the return of property, Intellectual Property, access rights to software;
    3. cease all uses of any Authorisations issued by Scarlet immediately, at such time as:
       1. Client makes, or intends to implement a Release in respect of the Agreed Device(s) that is the subject of the Authorisation;
       2. Client is due for a surveillance audit;
       3. Client’s Authorisations otherwise expire; whichever occurs first.
81. Termination of the Agreement shall not affect any rights, remedies, obligations or liabilities of the parties that have accrued up to the date of termination, including the right to claim damages in respect of any breach of the Agreement which existed at or before the date of termination.
82. The clauses of this Agreement that fall within the following headings shall survive any and all terminations of Services or of the Agreement: Confidentiality; Data; Registered Symbols, Certificates and Reports; Liability; Indemnity and clause 31 (Intellectual Property).

Force majeure

83. Neither Party shall be in breach of the Agreement nor liable for delay in performing, or failure to perform, any of its obligations under the Agreement if such delay or failure results from events, circumstances or causes beyond its reasonable control.

Assignment and subcontractors

84. Scarlet has the right to subcontract and otherwise engage third parties for the performance of the Services, to the extent permitted by the Relevant Regulation.
85. Scarlet may assign its rights under the Agreement to another Scarlet group company.
86. Client may not assign, transfer or deal in any manner with its rights and obligations under the Agreement.

Variation

87. Scarlet may update these General Terms as may be required, provided that the current version of these General Terms is made publicly available on Scarlet’s website and changes are notified to Client in writing, before such changes take effect.
88. Variations to the Specific Terms must be agreed between the Parties in writing.

Severance

89. If any provision or part-provision of the Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed deleted, but that shall not affect the validity and enforceability of the rest of the Agreement.

Notices

90. Notices under the Agreement must be in writing and sent by email or delivered to the Party’s address as set out in the Specific Terms.

Jurisdiction and Language

91. The Agreement is governed by the law of England and the English courts have non-exclusive jurisdiction to settle any disputes or claims.
92. In the event of translation of the Agreement, the English version shall prevail.

Counterparts

93. This Agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute an original of this agreement, but all the counterparts shall together constitute the same Agreement.

No partnership or agency

94. This Agreement shall not constitute or imply any partnership, joint venture, agency, fiduciary relationship or other relationship between the Parties, other than the rights and obligations expressly set out in this Agreement.
95. Neither Party shall make or hold itself out as having authority to make any commitments on behalf of the other Party.

Third party rights

96. No person who is not a Party to this Agreement will have any right to enforce it pursuant to the Contracts (Rights of Third Parties) Act 1999.

Entire agreement

97. This Agreement, including the General Terms, the Specific Terms and the Software Licence, constitutes the entire agreement between the Parties and supersedes all prior agreements, understandings, negotiations and discussions, whether oral or written.

Interpretation

The following rules of interpretation apply to this Agreement:

1. headings are for convenience only and do not affect the interpretation;
2. the singular includes the plural and vice versa;
3. the words “such as”, “including”, “for example” and similar expressions are not used as, nor are intended to be interpreted as, words of limitation;
4. a reference to a person shall be interpreted in its broadest sense;
5. a reference to a Party includes its agents, successors and assigns;
6. no rule of interpretation applies to the disadvantage of a party because that party was responsible for the preparation of this Agreement, or any part of it;
7. if a period of time is calculated from a particular day, act or event (such as the giving of a notice), it is to be calculated exclusive of that day, or the day of that act or event;
8. when the day on which something must be done is not a Business Day, that thing must be done on the following Business Day.

Agreed Device(s) is defined in the Specific Terms.

Agreement means the agreement for the provision of services by Scarlet to Client, which includes these General Terms; the Specific Terms separately signed between Scarlet and Client, and the Software Licence, which remains applicable to Client’s use of Scarlet’s Product.

Appellant means Client if and when Client makes an appeal in connection with a decision made by Scarlet under the Agreement.

Audit Team means an individual or set of individuals who have the responsibility for performing audits, reporting audit findings, and making Certification decisions, on behalf of Scarlet.

Authorisations means the documents, information, images, badges and symbols awarded by Scarlet to Client following Certification and shall include Registered Symbols, Certificates and Reports.

Business Day means a day, other than a Saturday, Sunday or public holiday in England, when banks in London are open for business.

Calendar Month means one of the 12 full months named in the calendar, such as January, February, or March.

Certificate means a written document (whether physical or electronic) granted by Scarlet to Client following Certification.

Certification means the approval by Scarlet in respect of the Agreed Device(s), pursuant to the Relevant Regulation and Certify and Certified have corresponding meanings.

Client means the entity executing this Agreement, as specified in the Specific Terms, and includes all officers, directors, employees and agents. In all references to Client in this Agreement, Client is a manufacturer of medical devices.

Confidential Information means information, in whatever form and wherever located, together with any copies, which relates to a party and which would reasonably be regarded as confidential, whether or not marked as such. It shall not include:

1. information which is in the public domain other than as a result of a breach of this Agreement or any separate confidentiality undertaking between the parties;
2. information which the receiving party received, free of any obligation of confidence, from a third party which was not itself under any obligation of confidence in relation to that information, whether before the date of its disclosure by the disclosing party or otherwise; or
3. information which the receiving Party can show by its written or other records was developed or created independently by the receiving party.

Contract Year is defined in the Specific Terms.

Deduction means the percentage reduction in amounts payable by Client to Scarlet as a result of (and the sole remedy in relation to) a breach of Service Levels by Scarlet, in accordance with the Specific Terms.

Technical Documentation means the technical documentation (as the term is used in the MD Regulation), owned by or relating to Client, in respect of which Client requests Services.

Effective Date means the date the Agreement shall take effect, as set out in the Specific Terms.

Final Reviewer and Decision Maker means an individual within Scarlet who is authorised to approve, decline, Restrict, Suspend, Withdraw, or reinstate Client’s Certification.

GDPR means one or both of, as the case may be:

1. EU General Data Protection Regulation (GDPR): Regulation (EU) 2016/679;
2. UK GDPR, as defined in section 3(10) (as supplemented by section 205(4) of the Data Protection Act 2018).

General Terms means these general terms and conditions that apply to Scarlet’s services, as may be amended from time to time.

IGJ means the Dutch Health and Youth Care Inspectorate, a government agency that is responsible for monitoring and supervising compliance of medical devices in the EU alongside oversight counterparts from other European Member States.

Impartiality Panel means a panel made up of independent members, selected by Scarlet to review and advise on risks relating to Scarlet’s impartiality.

Initial Application means, in the context of Scarlet’s Service Level commitments, the first submission of a completed application form from Client to Scarlet to request Services in relation to an Agreed Device.

Initial Decision means the decision by Scarlet to grant, decline, Suspend, Restrict or Withdraw Client’s Certification, in response to an Initial Application.

Intellectual Property Rights means patents, rights to inventions, copyright and related rights, trademarks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off, rights in designs, rights in computer software, 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.

ISO 13485 means ISO 13485:2016, a regulatory standard that relates specifically to quality management systems.

LSP Server means the server that interacts with the VS Code Extension to provide the functionality required for Scarlet to obtain the data from Client, in order to provide the Services.

MD Regulation is defined in the Specific Terms.

MHRA means Medicines and Healthcare products Regulatory Agency, the executive agency responsible for the regulation of medical devices in the United Kingdom.

Month means a period of time between the same dates in successive Calendar Months.

Party means a signatory to the Agreement as identified in the Specific Terms and Parties shall be construed accordingly.

Product Query means a Query related to the use of Scarlet’s Product.

Pricing is the amount payable by Client to Scarlet in consideration for the Services, as set out in the Specific Terms.

Public Health Threat means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

Query means communication from Client to Scarlet that relates to Scarlet’s Product or Services and that falls within the scope of the Service Levels.

Registered Symbols means digital and physical labels on products and processes that indicate compliance with the existing standards and regulations. These include:

1. For ISO 13485:2016 Certification, the symbols shown in Appendix 1;
2. For MD Regulation Certification, the symbols produced by the relevant regulatory authority.

Regulatory Query means a Query related to regulatory requirements.

Release means an update to Client’s Agreed Device(s) that is released by Client to their customers or users of that Agreed Device(s).

Relevant Regulation means one or any combination of, as the case may be, and as may be amended from time to time:

1. ISO 13485:2016;
2. Regulation (EU) 2017/745;
3. Council Directive 93/42/EEC (as modified by Part 2 of Schedule 2A to the Medical Devices Regulations 2002).

Reports means any summary of data, findings, and any other information that relates to an audit or assessment activity conducted by Scarlet as part of the Services, whether in preliminary or final form.

Resolution means a definitive outcome of a Query, as determined by Scarlet in Scarlet’s reasonable opinion.

Resolution of Queries Time means the Service Level commitment by Scarlet in terms of the time taken to respond to a Query, calculated from the first Business Day after Scarlet receives the Query from Client.

Restriction means a reduction in scope of Certification to exclude aspects of the Agreed Device(s) that do not meet requirements.

Scarlet means Scarlet NB B.V, Scarlet NB UK Ltd, or any group company (or group companies), and includes any officers, directors, employees, agents and, if appropriate, subcontractors.

Scarlet’s Product means the software built by Scarlet and made available by Scarlet to Client for the purposes of performing the Services. Scarlet’s Product includes the LSP Server and the VS Code Extension. It shall not include any software that Client requires to accept the Services that is built, hosted or owned by another entity, unless otherwise specified.

Services means the services provided by Scarlet to Client under this Agreement, as set out in the Specific Terms.

Service Levels means commitments by Scarlet to Client in respect of response times and the provision of other services, with corresponding penalties, as set out in the Specific Terms.

Software Licence means the licence governing the use of Scarlet’s Product and accepted by the user at the time of accessing the VS Code Extension.

Specific Terms means the terms separately agreed between Scarlet and Client that, together with the General Terms and Software Licence, form the Agreement.

Submission means a formal exchange of data from Client to Scarlet, through Scarlet’s Product or otherwise, that requires a response from Scarlet and that falls within the scope of the Service Levels.

Submission Processing is the process by which Scarlet assesses a Submission from Client, as set out in the Specific Terms.

Submission Processing Time means the Service Level Commitment by Scarlet in terms of the time taken to respond to a Submission, calculated from the first Business Day after Scarlet receives the Submission from Client.

Suspension means when an Authorisation is temporarily suspended for a period up to a maximum of six months, in accordance with the process in this Agreement.

Uptime Commitment means the commitment by Scarlet to Client about the availability of Scarlet’s Product, as set out in the Service Levels.

VAT means value added tax or any equivalent tax chargeable in the UK, Europe, or elsewhere.

Vigilance Reports means the reports, data and information that Client or its representatives submits, or is required to submit, to a regulatory body following an incident that relates to the Agreed Device(s).

VS Code means Visual Studio Code, a source code editor made by Microsoft, on top of which Scarlet’s Product is built.

VS Code Extension means the extension to VS Code that is built by Scarlet as part of Scarlet’s Product and is made accessible to Client for the purposes of providing the Services.

Withdrawal means when Client’s Authorisation is terminated by any person and for any reason.

Appendix 1

Registration number: [Client to insert]

Registration number: [Client to insert]