1. Introduction

These Website Standard Terms and Conditions contained herein on this webpage, shall govern your use of this website, including all pages within this website (collectively referred to herein below as this “Website”). These Terms apply in full force and effect to your use of this Website and by using this Website, you expressly accept all terms and conditions contained herein in full. You must not use this Website, if you have any objection to any of these Website Standard Terms and Conditions.

This Website is not for use by any minors (defined as those who are not at least 18 years of age), and you must not use this Website if you are a minor.

This online platform shall be used to bring Purchaser and Seller introduced to each other for UKRP (United Kingdom Representative) Services and/or for purchase of UKRP (United Kingdom Representative) Took Kit.

The terms Purchaser (hereinafter refer to as “you”, “your”) and Seller/Freyr (hereinafter referred to as “our”/ “we”/ “us”).

2. Intellectual Property Rights

We own all rights to the intellectual property and material contained in this Website, and all such rights are reserved. Purchaser has a limited access only, subject to the restrictions provided in these Terms, for purposes of viewing and purchasing the tool kit contained on this Website and/or for purposes for availing services of UKRP. The UKRP services and the material contained in the UKRP Tool Kit are confidential material to that of Seller and you shall not share it with any other third party(s).

3. Restrictions

You are expressly and emphatically restricted from all of the following:

  • publishing any Website material in any media;
  • selling, sublicensing and/or otherwise commercializing any Website material;
  • publicly performing and/or showing any Website material;
  • using this Website in any way that is, or may be, damaging to this Website;
  • using this Website in any way that impacts user access to this Website;
  • using this Website contrary to applicable laws and regulations, or in a way that causes, or may cause, harm to the Website, or to any person or business entity;
  • engaging in any data mining, data harvesting, data extracting or any other similar activity in relation to this Website, or while using this Website;
  • using this Website to engage in any advertising or marketing;

Certain areas of this Website are restricted from access by you. Any user ID and password you may have for this Website are confidential and you shall maintain confidentiality of such information.

4. Buyer-seller terms and conditions

Seller Purchaser
In these Website Standard Terms and Conditions, “Our Content” shall mean any product or material we choose to display on this Website. With respect to Our Content, by displaying it, we grant the right to make it viewable to prospect purchasers for their selection to purchase any product or material. UKRP Tool Kit: In these Website Standard Terms and Conditions, “Your Content” shall mean your personal details like your company name, company address, contact name and contact phone number, email address, type of business and the bank details to make payment online while purchasing UKRP Tool Kit displayed on this Website. You are responsible to provide all correct details in order for the delivery of the UKRP Tool Kit in the correct address in a timely fashion. If the details are incorrect due to which products do not reach to the address; then we shall not be liable for any such damage and/or loss caused to the Purchaser.
We reserve the right to remove any of Our Content from this Website at any time, and for any reason, without notice. UKRP Services: In these Website Standard Terms and Conditions, “Your Content” shall mean your personal details like your company name, company address, contact name and contact phone number, email address, product details such as Medical device name (Brand Name), Product Trade Name, Global Medical Devices Nomenclature GMDN code, Description of the GMDN Term, CE marked, CE certificate, UKCA marked, UKCA Certificate, Declaration of Confirmity (DoC), Number of Products [Trade name, Catalogue reference number, MDV Classification, UDI-DI number, UDI-DI (Issuing entity)], Medical Device Technical file and the bank details to make payment online while purchasing UKRP Services. You are responsible to provide all correct details in order for the delivery of the UKRP Services in a timely fashion. If the details are incorrect then we have the right to terminate the UKRP services and shall refund the entire amount paid by you.
  Post payment; before initiating the UKRP services by us; Master Services Agreement and UKRP Agreement between you and us shall be executed which shall be shared by us.

5. No warranties

This Website is provided “as is,” with all faults, and we make no express or implied representations or warranties, of any kind related to this Website or the materials contained on this Website. Additionally, nothing contained on this Website shall be construed as providing consult or advice to you.

6. Limitation of liability

In no event shall we, nor any of its officers, directors and employees, be liable to you for anything arising out of or in any way connected with your use of this Website, whether such liability is under contract, tort or otherwise, and we, including its officers, directors and employees shall not be liable for any indirect, consequential or special liability arising out of or in any way related to your use of this Website.

7. Indemnification

You hereby indemnify us to the fullest extent from and against any and all liabilities, costs, demands, causes of action, damages and expenses (including reasonable attorney’s fees) arising out of or in any way related to your breach of any of the provisions of these Terms.

8. Severability and Waiver

If any provision of these Terms is found to be unenforceable or invalid under any applicable law, such unenforceability or invalidity shall not render these Terms unenforceable or invalid as a whole, and such provisions shall be deleted without affecting the remaining provisions herein. The failure to enforce or to require the performance at any time of any one of the provisions of this Agreement shall not be construed to be a waiver of such provision and shall not affect either the validity of this Agreement or any hereof or in the right of any party thereafter to enforce each and every provision in accordance with the terms of this Agreement.

9. Variation of Terms

We are permitted to revise these Terms at any time as it sees fit, and by using this Website you are expected to review such Terms on a regular basis to ensure you understand all terms and conditions governing use of this Website.

10. Assignment

We shall be permitted to assign, transfer, and subcontract its rights and/or obligations under these Terms without any notification or consent required. However, you shall not be permitted to assign, transfer, or subcontract any of your rights and/or obligations under these Terms.

11. Entire Agreement

These Terms, including any legal notices and disclaimers contained on this Website, constitute the entire agreement between you and us in relation to your use of this Website, and supersede all prior agreements and understandings with respect to the same.

12. Governing Law and Jurisdiction

These above terms and conditions will be governed by and construed in accordance with the laws of the country where the party required to effect the characteristic performance has its habitual residence, seat or place of business, and both seller and purchaser submit to the non-exclusive jurisdiction of that country’s court which will be applicable for the resolution of any disputes.

13. UK RP Project Setup fee includes Technical Service agreements between UKRP and foreign Manufacturer, preliminary review of technical documentation availability, products registration with MHRA.

14. UKRP retainer annual fee to the current budget includes utilization of Freyr name, address and phone number used on the product labels, review of UKRP mailbox and provide a quarterly report. Based on the provided timesheet, all additional product-related operations would be invoiced as an ad-hoc regulatory support quarterly.

15. PMS for products/Vigilance and communication to & from MHRA are not included in the retainer fee and would be invoiced as an ad-hoc, purchased in a block of 4 hours and invoiced on actuals.

16. MHRA portal registration fee of £100 per application (Pass-Through cost). A statutory fee for each registration application.

17. UK importer notification is an additional fee (70 EUR per importer).

18. A Project Specification Agreement needs to be executed between the customer and Freyr Lifesciences Ltd.

19. The yearly fee is payable in advance. Payment terms: 30 days net after date of invoice. This proposal is binding for 4 weeks. All payments are net of any VAT or taxes due. Pass-through cost (except the MHRA fees) is not included in the fees above.

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