Public offer

This document constitutes an official proposal (a public offer) of RegMedGrupp (hereinafter — the Contractor) and contains the essential terms of a contract for the paid provision of consulting services in the field of medical device registration, concluded with any natural or legal person (hereinafter — the Customer) who has accepted these terms.

In accordance with Articles 435 and 437 of the Civil Code of the Russian Federation, this offer is deemed public. Unconditional acceptance (acceptance) of the offer in accordance with Article 438 of the Civil Code of the Russian Federation consists of the Customer's submission of a request via the Site's forms, payment of an issued invoice, or any other implied action evidencing an intention to use the Contractor's services.

1. Terms and Definitions

Site — an Internet resource on which information about the Contractor's services and tools for submitting requests are posted.

Services — consulting and support services in the field of medical device registration, including (but not limited to) audit of the registration dossier, preparation of technical documentation, support of expert review, organization of technical and toxicological testing, clinical evaluation, and registration within the EAEU.

Request — an inquiry from the Customer, submitted via the Site's forms or other communication channels, containing a description of the services of interest and the Customer's contact details.

Parties — the Contractor and the Customer when referred to jointly.

Contract — the agreement concluded between the Parties on the basis of this offer and its acceptance by the Customer.

2. Subject of the Offer

2.1. The Contractor undertakes to provide the Customer with the Services agreed upon by the Parties following the review of the Request, and the Customer undertakes to accept and pay for the Services rendered in the manner and on the terms provided for by the Contract and this offer.

2.2. The list, scope, and cost of specific Services are determined following the review of the Request and are recorded in the commercial proposal sent to the Customer, or in a separate agreement, supplementary agreement, or appendix to the Contract.

2.3. The Services are provided remotely, by means of electronic correspondence, telephone and video conferences, and the transfer of documents in electronic form, unless otherwise provided by a separate agreement.

3. Procedure for Concluding the Contract

3.1. The Customer submits a Request via one of the Site's forms or to the Contractor's email address.

3.2. The Contractor reviews the Request within 24 hours on business days and contacts the Customer to clarify the requirements.

3.3. Following the review, the Contractor sends a commercial proposal containing a list of the Services, timeframes, cost, and other essential terms.

3.4. The Contract is deemed concluded from the moment the parties agree on the terms of the commercial proposal and payment is received in the Contractor's settlement account, unless otherwise provided by a separate agreement.

4. Cost of Services and Payment Procedure

4.1. The cost of the Services is determined individually for each Request and is recorded in the commercial proposal or a separate contract.

4.2. The cost is specified in Russian rubles. Value added tax does not apply, unless otherwise indicated in the commercial proposal.

4.3. Payment is made by non-cash settlement through the transfer of funds to the Contractor's settlement account specified in the invoice.

4.4. The Services are paid for in full or in stages in accordance with the schedule agreed upon by the Parties in the commercial proposal.

4.5. The Customer's payment obligation is deemed fulfilled from the moment the funds are received in the Contractor's settlement account.

5. Rights and Obligations of the Parties

5.1. The Contractor undertakes to

• provide the Services in the scope and within the timeframes agreed with the Customer;
• ensure the confidentiality of all information received from the Customer in the course of providing the Services;
• inform the Customer about the progress of the work, identified risks, and any necessary additional actions;
• deliver to the Customer the results of the Services in the format agreed upon by the Parties.

5.2. The Contractor has the right to

• engage third parties in the provision of the Services while remaining responsible to the Customer for their actions;
• suspend the provision of the Services in the event of the Customer's failure to fulfill payment obligations or to provide the necessary information;
• refuse to provide the Services if violations by the Customer of the requirements of the legislation of the Russian Federation are identified;
• use anonymized information about completed projects for marketing purposes, without disclosing the Customer's confidential information.

5.3. The Customer undertakes to

• provide the Contractor with complete, accurate, and timely information necessary for the provision of the Services;
• pay for the Services in the manner and within the timeframes provided for by the Contract;
• accept the Services rendered in the manner provided for by the Contract;
• promptly inform the Contractor of any changes affecting the progress of the provision of the Services;
• warrant that it holds the rights to the information and materials transferred to the Contractor.

5.4. The Customer has the right to

• require the Contractor to duly fulfill its obligations;
• receive information about the progress of the provision of the Services;
• withdraw from the performance of the Contract in the manner provided for by the legislation of the Russian Federation and this offer.

6. Timeframes for the Provision of Services

6.1. The timeframes for the provision of the Services are agreed by the Parties individually and are recorded in the commercial proposal.

6.2. The timeframe for the provision of the Services may be extended in the following cases:

• the Customer's failure to provide the necessary documents or information in a timely manner;
• changes in regulatory requirements affecting the progress of the provision of the Services;
• delays on the part of state bodies and accredited organizations;
• the occurrence of force majeure circumstances.

7. Confidentiality

7.1. The Parties undertake to keep confidential any information that has become known to them in connection with the performance of the Contract, and not to disclose it to third parties without the prior written consent of the other Party.

7.2. All technical, commercial, organizational, and other information that is not publicly available and that has been received by one Party from the other in connection with the performance of the Contract is deemed confidential.

7.3. The Parties' confidentiality obligations remain in effect for the term of the Contract and for 3 (three) years following its termination.

8. Liability of the Parties

8.1. For the failure to perform or the improper performance of obligations under the Contract, the Parties shall be liable in accordance with the legislation of the Russian Federation.

8.2. The Contractor's aggregate liability under the Contract is limited to the cost of the Services actually rendered.

8.3. The Contractor is not liable for:

• delays and refusals on the part of state bodies, accredited organizations, and other third parties that are beyond the Contractor's control;
• the consequences of the Customer providing incomplete, inaccurate, or untimely information;
• lost profits, indirect damages, and other consequential losses of the Customer.

8.4. The Customer warrants that all materials and information transferred to the Contractor do not infringe the rights of third parties, and is responsible for their accuracy and the lawfulness of their origin.

9. Force Majeure Circumstances

9.1. The Parties are released from liability for the failure to perform or the improper performance of obligations under the Contract if such failure was the result of force majeure circumstances (natural disasters, military actions, acts of state bodies, epidemics, etc.).

9.2. The Party for which it has become impossible to perform its obligations is obliged, within 5 (five) business days of the occurrence of such circumstances, to notify the other Party in writing.

10. Validity Period and Procedure for Amending the Offer

10.1. This offer comes into force from the moment it is posted on the Site and remains in effect until it is revoked by the Contractor.

10.2. The Contractor has the right to amend the terms of the offer unilaterally at any time. The new version of the offer comes into force from the moment it is posted on the Site, unless otherwise provided by the new version.

10.3. Amendments to the offer do not apply to contracts concluded before the amendments came into force.

11. Dispute Resolution Procedure

11.1. The Parties shall endeavor to settle all disputes and disagreements arising in connection with the performance of the Contract through negotiations.

11.2. The pre-trial claim procedure for dispute settlement is mandatory. The period for responding to a claim is 30 (thirty) calendar days from the date of its receipt.

11.3. If a dispute cannot be settled through the pre-trial claim procedure, the dispute is referred for consideration to the court at the Contractor's location in accordance with the applicable legislation of the Russian Federation.

11.4. The norms of the legislation of the Russian Federation apply to relations between the Parties that are not governed by the Contract.

12. Final Provisions

12.1. This offer has been drawn up in the Russian language. In the event of any discrepancy between the Russian version and a foreign-language version, the Russian version shall prevail.

12.2. A court ruling that any provision of the offer is invalid or unenforceable does not entail the invalidity of the other provisions of the offer.

12.3. Documents sent by the Parties by email from the addresses specified in the Contract are deemed by the Parties to have been received and have legal force equal to that of documents in paper form.

13. Contact Information

13.1. All questions related to this offer, its acceptance, and the provision of the Services are to be sent to the following email address: info@regmedgrupp.ru.