Subject: Clarification Request Regarding Addendum Contract to MDR Associated with MDD Devices

Dear Ms. Jaffery,

I hope this email finds you well. We have received the Addendum contract to MDR associated with MDD
devices from the SGS India Office. In reviewing the document, we have encountered certain points that
require clarification, and we would highly appreciate your assistance in resolving these queries.

Regarding the transfer agreement, it is stipulated that DQS will conduct audits and share the audit results
(Non-conformities and Audit reports) with SGS. However, in points 1.5 and 2. of the Addendum contract,
it is clearly stated that audits will be conducted by SGS until 31/12/2028. This appears to be in breach of
the transfer agreement, and it is also unclear whether Xcellance needs to participate in both SGS and DQS
audits.

Furthermore, point 1.6 of the Addendum contract mentions that if the client refuses audit services, SGS
has the right to terminate the proposal. We seek clarification on this point as well. In the event that we
proceed with a CE certification audit for our legacy ESU device as per EU MDR 2017/745, we will
formally communicate this decision to you. We need to understand if the SGS confirmation letter will still
be valid for other legacy devices under these circumstances.

We kindly request your prompt attention to these matters and would appreciate your clarification at your
earliest convenience.

Thank you for your attention to this matter.