Framework Agreement

The following definitions in this section apply in this Framework Agreement:

"Advisory Notice" means notices of Products that need to be corrected in order to be safe and perform as intended, as well as nonconforming Products that cannot be corrected and have to be removed from the market.

"Affiliate" means a legal entity, now or hereafter, directly or indirectly, owned or controlled by, or owning or controlling, or under common control with by one of the Parties, but such legal entity shall be deemed to be an Affiliate only so long as such ownership or control exists. For purposes of this definition "control" of a legal entity shall mean to have, directly or indirectly, the power to direct or cause the direction of the management and policies of a legal entity, whether (a) through the ownership of voting securities entitling to the right to elect or appoint, directly or indirectly, the majority of the board of directors, or a similar managing authority; (b) by contract; or (c) otherwise.

"Applicable Laws" means all laws, statutes, regulations, decisions, rulings, sanctions, governmental and regulatory policies, industry guidelines and/or codes of practice which may from time to time be in force in the Territories and relevant to any rights and/or obligations under and/or the performance of this Framework Agreement.

"Branded Products" means the products set out in Schedule A, as such Schedule may be amended from time to time by the Parties in writing. Such products shall bear Supplier branding on the physical product, packaging and/or associated user manuals.

"Commencement Date" has the meaning given to it in section 2.1..

"Confidential Information" means all information of a confidential nature or which would be deemed confidential by a reasonable business person (however recorded and whether marked as confidential or not) belonging to a party or an Affiliate which is disclosed to or received by the other Party or its Affiliate, whether before or after the Commencement Date, directly or indirectly, in connection with this Framework Agreement, including the terms of this Framework Agreement and any financial, technical, operational, commercial, employee, management, product, price(s) of the products and services provided by Supplier and the Supplier Distributors, and other information and/or data of whatever kind (including all information relating to the trade secrets, operations, manufacture processes, distribution channels, sales, plans, intentions, product information, know-how, designs, market opportunities, transactions, affairs and/or business) of the disclosing party and/or its customers, clients, suppliers and/or Affiliates.

"Contractual Year" means a period of twelve (12) consecutive months beginning on the Commencement Date.

"Delivery Address" means the address that the Products are to be delivered to as set out in the Order Form.

"Field Safety Corrective Action" means any action taken by Supplier to reduce a risk of death or serious deterioration in the state of health associated with the use of a Product that is already placed on the market. Such actions may be notified via a Field Safety Notice.

"Field Safety Notice" means a communication to customers and/or users sent out by Supplier or its representatives in relation to a Field Safety Corrective Action.

"Fixed Exchange Rate" has the meaning to it in section 5.3..

"Government" has the meaning given to it in section (19.3.a).

"Buyer Group" means Buyer and each of its Affiliates from time to time.

"Buyer Online Platform" means any online platform owned by any member of the Buyer Group which offers Product description and related products for sale.

"Buyer Trade Marks" means the trade mark(s) (whether registered or unregistered) which any member of the Buyer Group may permit Supplier to use in respect of the Private Label Products, including the Buyer trademark examples mark, and the product name Private label under which name the Private Label Products will be branded or any other product name belonging to any member of the Buyer Group which the Parties may agree from time to time will be used on or in connection with the Private Label Products.

"Private Label Products" means products set out in Schedule A derived from Supplier's branded Products, as such Schedule may be amended from time to time by the Parties in writing. Such products shall bear the relevant product name set out in Schedule a or such other product name as the Parties may agree from time to time.

"Incident or Near Incident" means any malfunction or deterioration in the characteristics and/or performance of a Product, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.

"Initial Term" has the meaning given to it in section 2.1..

"Intellectual Property Rights" means Patents, utility models, rights to inventions, copyright and neighboring and related rights, rights in software, 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.

"Know-How" means any know-how relating to the Products, including information relating to the design, manufacture, fitting and/or use of the Products, which is supplied to a member of the Buyer Group by or on behalf of Supplier or otherwise in connection with this Framework Agreement.

"Local Agreement" means an agreement between (a) one or more members of the Buyer Group in a particular Territory; and (b) Supplier or a relevant Supplier Distributor, including any variation to any of the terms of this Framework Agreement for a particular Territory.

"Manufacturer's Warranty Period" has the meaning given to it in section 10.1..

"Marketing Materials" means all artwork, content, advertising and promotional materials, produced by or on behalf of a member of the Buyer Group relating to or featuring any of the Products or Supplier Trade Marks and/or their advertisement, including (by way of example only) catalogues, flyers, mail drops, posters, billboards, shop displays, and the content of any advertising to be carried out in the press, on TV, radio and online (including on the websites of members of the Buyer Group and on social media).

"Non-Warranty Faults" has the meaning given to it in section 10.2..

"Official" has the meaning given to it in section (19.3.a).

"Patents" means the patents and other proprietary rights subsisting in and/or related to the Products.

"Personal Data" has the meaning given to it in section 16.5..

"Product Complaint" means any oral, electronic, or written communication that alleges deficiencies related to the identity (labelling), quality, durability, reliability, safety, effectiveness, or performance of a marketed product, including failure of the Product, labelling or packaging to meet specifications, whether or not the Product is related to, or caused the alleged deficiency. A complaint may allege that an adverse event or device malfunction has occurred.

"Products" mean the Branded Products and the Private Label Products.

"Quarter" or "Quarterly" means a period of three calendar months commencing on (a) 1st Quarter: First quarter start date to First quarter end date ; (b) 2nd Quarter: Second quarter start date to Second quarter end date ; (c) 3rd Quarter: Third quarter start date to Third quarter end date ; to (d) 4th Quarter: Fourth quarter start date to Fourth quarter end date .

"Repair Services" means the repair services set out in Schedule A and any other additional services that the relevant Supplier Distributor provides in any particular Territory which are set out in a Local Agreement.

"Specification" means technical details for the Products as set out in product data sheets provided by Supplier which may be updated by the Parties from time-to-time.

"Technical Agreement" means an agreement entered into by the Parties relating to the manufacture, testing and packaging of the Private Label Products.

"Term" has the meaning given to it in section 2.1..

"Territory Notification" has the meaning given to it in section 3.4..

"Territories" means List of initial territories , and each of the Territories shall be a "Territory". Additional territories may be added to this Framework Agreement in accordance with section 3.4..

"User Guides" means the user guides relating to the Products as are supplied by Supplier to any member of the Buyer Group under this Framework Agreement.

"VAT" means value added tax and any similar additional turnover, sales or purchase tax or duty levied in any Territory.

"Warranty" has the meaning given to it in section 10.1..

"Working Day" means a day when banks in the relevant Territory are open for business, other than a Saturday or Sunday.

"Supplier Brand Guidelines" means the brand guidelines relating to the use of the Supplier Branding provided by Supplier to any member of the Buyer Group, as may be updated or amended by Supplier from time to time.

"Supplier Branding" means any trade marks, trade or business names, product names (including the product names set out in Schedule A, logos, designs, get-up and/or other designations owned and/or used by Supplier in any part of the world, including the Supplier Trade Marks.

"Supplier Distributor" means in respect of a Territory, the company appointed by Supplier or a member of the Supplier Group (as such company is set out in the relevant Local Agreement), to receive and fulfil Orders made by any member of the Buyer Group on Supplier's behalf under this Framework Agreement or any Local Agreement and to deal with any Product-related enquiries and provide or facilitate the provision of the Repair Services in that Territory, as the local representative for that Territory.

"Supplier IP" means the Patents, the Supplier Materials, the Supplier Branding and Know-How, together with all and any Intellectual Property Rights which subsist (now or in the future) in the foregoing, and all Intellectual Property Rights which subsist (now or in the future) in and/or relate to the Products.

"Supplier Materials" means all technical and product specifications for the Products, User Guides, operating manuals and instructions relating to the fitting, use, support and/or maintenance of the Products, marketing information and any other information relating to the Products as are supplied by Supplier to any member of the Buyer Group under this Framework Agreement (including Supplier Promotional Materials).

"Supplier Promotional Materials" means promotional materials relating to the Products supplied by Supplier to any member of the Buyer Group from time to time, including brochures, leaflets, posters and in-store display materials.

"Supplier Trade Marks" the trade mark registrations and applications listed in the Exhibit of each Local Agreement and any further trade marks (whether registered or unregistered) that Supplier may, by express notice in writing, permit any member of the Buyer Group to use in the relevant Territory in respect of the Products.

"Supplier Group" means Supplier and each of its Affiliates from time to time.

References to Sections and Schedules are to the sections and schedules of this Framework Agreement. The Schedules form part of this Framework Agreement and shall have effect as if set out in full in the body of this Framework Agreement and any reference to this Framework Agreement includes the Schedules. Section and Schedule headings shall not affect the interpretation of this Framework Agreement.

A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality). Unless the context otherwise requires, words in the singular shall include the plural and vice versa.

Unless expressly stated otherwise, a reference to a statute or statutory provision is a reference to such state or statutory provision as amended, extended or re-enacted from time to time and shall include reference to all related subordinate legislation made from time to time.

Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative only and shall not limit the sense of the words, description, definition, phrase or term preceding those terms.

This Framework Agreement shall commence on Commencement date("Commencement Date") and shall continue in force for a period of Initial term length ("Initial Term"), and shall be automatically renewed for a Renewal term length term unless a Party notifies the other Party in writing of its intention not to renew not less than Non-renewal notice period prior to the expiration of the Initial Term, subject to earlier termination in accordance with the terms of this Framework Agreement (the Initial Term and the continuation of this Framework Agreement thereafter shall together be referred to as the "Term"). Thereafter, any extension period shall be mutually agreed in writing by the Parties.

Each Local Agreement shall commence on the date specified in that Local Agreement and shall continue until the end of the Term. In the event that a member of the Buyer Group or a Supplier Distributor is supplying or buying Products or Repair Services in a Territory under this Framework Agreement or Local Agreement (as applicable), Buyer and Supplier, as applicable, shall be responsible for ensuring that the relevant member of the Buyer Group or relevant Supplier Distributor complies with the terms of this Framework Agreement as though it were a party to it.

This Framework Agreement sets out the basis on which Supplier or the relevant Supplier Distributor agrees to supply Products and Repair Services to any member of the Buyer Group in the Territories, together with a Local Agreement (if any) for the relevant Territory. Any Local Agreement agreed and signed by the Parties in accordance with this Framework Agreement shall be incorporated into this Framework Agreement by reference herein.

This Agreement together with a Local Agreement (if any) shall govern the supply and purchase of the Products and Repair Services to members of the Buyer Group in the relevant Territory governed by such Local Agreement. In the event of any inconsistency or conflict between the terms of this Framework Agreement and a Local Agreement, this Framework Agreement shall prevail.

During the Term of this Framework Agreement, Supplier or a relevant Supplier Distributor shall supply, and members of the Buyer Group shall purchase, such quantities of Products as may be required under section 7.1. in accordance with the terms of this Framework Agreement. The supply of Products, and the provision of Repair Services, shall be fulfilled by the relevant Supplier Distributor for that Territory.

Buyer may, on giving as much written notice to Supplier as is reasonably practicable in the circumstances and in any event not less than New territory notice notice, inform Supplier of their intention to add additional countries to the definition of "Territory" (such notice being a "Territory Notification"). The Parties shall, as soon as reasonably practicable following the issuance of the relevant Territory Notification, enter into good faith negotiations in relation to such matters and shall reflect any agreed changes in a Local Agreement for that Territory.

Each Party agree to comply at all times during the Term with the prevailing code of conduct.

The global Products list and prices are set out in Schedule A of this Framework Agreement.

For the first Contractual Year, for each territory, the relevant Supplier Distributor and the relevant member of the Buyer Group shall carry out a reconciliation of:

The prices set out in Schedule A are exclusive of any applicable VAT. If VAT is chargeable, the relevant member of the Buyer Group shall pay these additional amounts in accordance with Applicable Laws. All payments shall be made without any deduction or withholding of taxes by the relevant member of the Buyer Group. Where tax is required to be withheld in accordance with Applicable Laws, the sum payable by the relevant member of the Buyer Group shall be increased to the extent necessary to ensure that, after the making of such deduction or withholding, the relevant Supplier Distributor receives a net sum equal to the sum which would have received had no such deduction or withholding been made or required to be made.

Supplier shall inform Buyer about planned introductions of new "SUPPLIER" branded products ("Supplier Products") New product notice in advance. On this basis, Supplier and Buyer shall define and mutually agree on a "road map" regarding new or updated Supplier Products, and the key technologies and core features of the Supplier Products. Supplier commits to the development of Supplier Product innovations and to supply the Buyer Group with Supplier Products which are competitive and that offer key selling features to be referenced by the Buyer Group in their correspondence with potential end users. The Parties shall review on a bi-annual basis the roadmap for "the Supplier Products."

Supplier and Buyer agree to develop a range of Private Label Products in accordance with the set out in section 6..

Supplier shall be entitled to make changes to the Specification of any of the Branded Products at any time during the Term, provided such changes do not adversely affect the quality of the Products. Any changes to the Specification for the Private Label Products shall be managed in accordance with the procedure set out in the Technical Agreement.

Unless otherwise mutually agreed by both Parties, subject to sections 4.3. and 6.5., Supplier shall:

Each member of the Buyer Group shall:

If Supplier should decide to introduce a new Products platform (or generally new Products or Product groups) for the Branded Products, Buyer may exchange the unused and sealed predecessor Products of the older platforms (or Products or product groups) with an individual production date not older than Product exchange period against new Supplier Products and deduct the full price previously paid by Buyer for the said predecessor Products (right of exchange) provided always that such predecessor Products have not been phased out by Supplier. For the avoidance of doubt, this section shall not be applicable to Private Label Products.

Supplier shall provide Buyer with an advertising rebate for each Contractual Year for Buyer to carry out its advertising activities for the Products on the terms set out in Schedule A.

The prices and advertising rebate set out in Schedule A are based on the annual estimates provided by Buyer to Supplier in a Contractual Year. In the event that the annual volume purchased by members of the Buyer Group in any Contractual Year deviates significantly from the aforementioned estimates, the Parties shall discuss in good faith and mutually agree to revise the prices and advertising rebate set out in Schedule A for the succeeding Contractual Year (acting reasonably) within Price revision period from the end of the completed Contractual Year.

Each member of the Buyer Group shall be responsible for payment of all invoices for Products ordered by such member in the relevant Territory to the relevant Supplier Distributor under this Framework Agreement or any Local Agreement.

Invoices shall be raised by the relevant Supplier Distributor for the respective Territory. The relevant Supplier Distributor shall be entitled to invoice the relevant member of the Buyer Group for each Order on or at any time after the Order has been shipped to that member of the Buyer Group.

At the beginning of each Contractual Year, the Parties shall agree upon in writing and fix the exchange rate for the next Contractual Year ("Fixed Exchange Rate").

The Fixed Exchange Rate for each Contractual Year shall not be adjusted due to any fluctuation in the foreign currencies exchange rate(s) that occurred during such Contractual Year.

The relevant member of the Buyer Group shall pay all invoices in full and cleared funds within Payment period of the last day of the month in which the invoice was received. Payment shall be made to the bank account nominated by Supplier or the relevant Supplier Distributor (as applicable). The relevant member of the Buyer Group may challenge any invoice within Invoice challenge period from its receipt.

If the relevant member of the Buyer Group fails to pay an invoice which is due and payable in accordance with section 5.6, such member of the Buyer Group shall pay to the relevant Supplier Distributor interest on any overdue amount at the rate of Late payment interest rate per cent (%) per annum from the due date for payment until such time as payment is made.

Buyer hereby grants to Supplier, for the purposes of manufacturing the Private Label Products (including all related packaging/labelling and any Supplier Materials relating to the Private Label Products), a Licence for the Term to use the Buyer Trade Marks as directed by Buyer in accordance with the Trade Mark Licence Agreement and in accordance with the requirements set out in section 6.4.. If Buyer wishes to make any changes to any of the Buyer Trade Marks which are to be used on the Private Label Products and/or their packaging or labelling, it shall give reasonable notice to Supplier of the proposed changes and the Parties shall agree a reasonable timescale in which to implement such changes. Buyer shall indemnify and defend Supplier and any Supplier Distributor against any and all costs, damages, losses, liabilities and expenses (including any reasonable attorneys' fees and costs) arising out of a claim by a third party alleging that the use of the Buyer Trade Marks used by Supplier and any Supplier Distributor in accordance with this Framework Agreement infringes any of its intellectual property rights. In the event that the use of the Buyer Trade Marks used by Supplier and any Supplier Distributor in accordance with this Framework Agreement infringes the intellectual property rights of any third party, Buyer shall purchase from Supplier all the inventory that Supplier and the Supplier Distributors manufacture using the Buyer Trade Marks.

Supplier agrees to assume all regulatory responsibilities as the manufacturer of the Private Label Products. Supplier has the responsibility for the design, manufacture, packaging and labelling of the Private Label Products and any other regulatory requirements as required by the laws or regulations of any Territory.

In relation to Private Label Products, for market approval and introduction, Supplier is responsible for obtaining the local product approval, registration and/or licensing at Buyer's cost. Supplier is responsible for providing Buyer with the necessary data. Buyer shall only start selling the Products to customers when all legal, regulatory, licensing and technical requirements, all requirements of Supplier and compliance with all Applicable Laws have been met.

Buyer shall, and shall ensure that each member of the Buyer Group shall, market and sell the Private Label Products only under the product name set out in Schedule A or such other Buyer Trade Mark as the Parties may agree from time to time, and not in association with, under or in conjunction with any other trade mark, brand or trade name, without the prior written consent of Supplier.

Supplier shall be entitled to display the relevant product names and/or Patent numbers if applicable on the Private Label Products and/or their packaging and/or such other proprietary notices as Supplier may deem appropriate from time to time. Buyer shall not and shall ensure that each member of the Buyer Group shall not, without the prior written consent of Supplier, alter, deface or remove any reference to the relevant product name, Patents or other proprietary notice relating to the proprietary rights in the Private Label Products displayed on the Products or their packaging or labelling.

Unless prevented by Applicable Laws, the labelling and packaging for Private Label Products shall include the statement "Manufactured by Supplier or its Affiliate, Supplier (Address (multi-line)) , and distributed by Buyer" and the notified body of Supplier shall be affixed.

Buyer must inform Supplier in case of label changes or over-labelling done by Buyer or any member of the Buyer Group. Additional labelling application must be communicated to the Supplier.

Unless otherwise agreed in writing between the Parties, Buyer shall ensure that each member of the Buyer Group shall not make the new Private Label Products commercially available before the date that is Commercial availability period after Supplier or the relevant Supplier Distributor launched the equivalent product in that Territory. The relevant member of the Buyer Group and the relevant Supplier Distributor shall use commercially reasonable endeavours to work together to launch the new Private Label Product within the timeline stated or sooner where reasonably possible.

The relevant member of the Buyer Group shall engage the Supplier Distributor in the relevant Territory Launch engagement period before the launch of a new Private Label Product to discuss the details of the launch and the supply of the new Private Label Product. The relevant member of the Buyer Group and the relevant Supplier Distributor shall use all commercially reasonable endeavours to work together to launch the new Private Label Product within the timeline stated or sooner where reasonably possible.

Members of the Buyer Group shall place orders for Products with the relevant Supplier Distributor using the Supplier online ordering platform or any other ordering method as agreed between the Parties. Order is subject to acceptance by Supplier.

During the Term, members of the Buyer Group shall provide Supplier or the relevant Supplier Distributor not less than Quarter forecast period before the beginning of each Quarter with a forecast of the Products the members of the Buyer Group expect to order during that Quarter for each Territory which has in place a fully-signed Local Agreement. Members of the Buyer Group shall act in good faith when forecasting its requirements for Products.

If during a Quarter a member of the Buyer Group considers that it may not meet its forecast or that its forecast may be exceeded for that Quarter, it shall submit a revised forecast as soon as possible.

If Supplier or the relevant Supplier Distributor anticipates that it will be unable to meet the forecasted requirements of the relevant member of the Buyer Group provided in accordance with this section 7, the relevant Supplier Distributor shall inform the relevant member of the Buyer Group as soon as practicable.

Delivery shall be effected:

Supplier shall be responsible for all packaging requirements in accordance with Supplier's standard packaging policy and materials such that Products will be delivered safely and without damage. The Products shall be marked in accordance with any applicable regulations or requirements of the carrier, and properly packed and secured so as to reach the Delivery Address in an undamaged condition. Supplier shall ensure that a delivery note identifying the customer's name shall accompany each delivery and shall be displayed prominently.

. All Products will be supplied by Supplier on a Carriage and Insurance Paid To basis to Buyer or one of its affiliated partner providers. For the shipping cost the prices of the local Supplier Affiliate shall apply.

Risk and title in the Products shall pass to the relevant member of the Buyer Group upon delivery in accordance with section 8.1. or in the case of delivery by instalment upon delivery of each instalment.

Where payment or part payment for the Products has been made prior to delivery, title in the Products purchased shall immediately vest in the relevant member of the Buyer Group and the relevant Supplier Distributor shall identify such Products as the property of the relevant member of the Buyer Group and keep them separate from other goods at all times.

If a carrier is appointed for the delivery of Products, it shall be deemed to be acting on behalf of the relevant Supplier Distributor in carrying out the delivery and not of the relevant member of the Buyer Group.

Supplier shall provide a manufacturer's warranty, covering manufacturing defects or faults arising from normal use, in respect of the relevant Territory. In the event of a fault in a Product covered by the Warranty (other than Non-Warranty Faults set out in section 10.2. below), Supplier or the relevant Supplier Distributor shall repair or replace, as determined by Supplier, the Product in accordance with and subject to the terms set out in the Product Warranty and Returns Terms, and subject to the exclusions in section 10.2.. Repairs or replacements may be made with products or parts that are new, used or refurbished.

As far as permitted by Applicable Laws, Supplier shall not be obliged to repair Products within the Manufacturer's Warranty Period in the event that:

Faults in non-custom Products covered under the Product Warranty and Returns Terms (except for Non-Warranty Faults) reported to Supplier within the Manufacturer's Warranty Period shall be repaired, or Products replaced, by Supplier (or the relevant Supplier Distributor) at Supplier's cost.

All repairs of faults in Products which arise outside the Manufacturer's Warranty Period shall be charged at Supplier's standard service charges as set out in Schedule A (or the relevant Local Agreement). Repairs may be made with products or parts that are new, used or refurbished.

All Warranty returns of Products shall be at the sole cost and risk of the relevant member of the Buyer Group.

To the extent permitted by Applicable Laws, Supplier and the Supplier Distributors makes no warranty other than to Buyer and those members of the Buyer Group with whom it has a contractual relationship and as set forth in this section 10 that such warranty is in lieu of all other warranties, express or implied, including but not limited to any express or implied warranty of merchantability or fitness for particular purposes, and as such constitutes the only warranty made with respect to the Products and Repair Services and any defect, deficiency or nonconformity in any product, service or other item furnished under this Framework Agreement.

Members of the Buyer Group shall promote the Products at their own cost. All advertising carried out by them in relation to the Products shall be at their own cost.

Buyer shall observe all reasonable directions and instructions given to it by Supplier in respect of the use of the Supplier Trade Marks and any Supplier Branding in the Marketing Materials, and the information provided in respect of any of the Products in such Marketing Materials.

Buyer shall ensure that any information provided in relation to the price of the Products, including in any Marketing Materials, is clear and accurate and is not misleading.

Buyer shall ensure that all Marketing Materials used by members of the Buyer Group shall:

Buyer shall ensure that all information provided by Buyer and the members of the Buyer Group in relation to the Products, including in any Marketing Materials, is accurate and correct and conforms to the product data sheets, technical and User Guides and information provided by Supplier.

Buyer shall not, and shall ensure that members of the Buyer Group shall not, without Supplier's prior written consent, make any representations, warranties, guarantees or other commitments with respect to the specifications, features or capabilities of the Products which are inconsistent with those contained in product data sheets provided by Supplier, or make any representations, warranties, guarantees or commitments which extend beyond or which are inconsistent with the terms of any product warranties provided by Supplier in the Product Warranty and Returns Terms in connection with the Products, or otherwise incur any liability on behalf of Supplier.

Buyer shall indemnify and keep Supplier indemnified from and against any liabilities, claims, costs or expenses, damages and losses (including any direct, indirect and consequential losses, and all interest, penalties and legal costs (calculated on a full indemnity basis) and all other reasonable professional costs and expenses) which may be suffered or incurred by Supplier or the Supplier Distributors arising out of or in connection with:

From time to time during the Term, Supplier may provide Supplier Promotional Materials to the Buyer Group, but Supplier shall be under no obligation to specially prepare and/or provide the same. Buyer undertakes to use, and to ensure that its Affiliates shall use, any such Supplier Promotional Materials solely for the purpose of advertising and/or selling the Products in accordance with this Framework Agreement.

Supplier, or the relevant Supplier Distributor, shall provide training for Branded Products to the relevant product dispensers employed or engaged by any members of the Buyer Group in the operation and fitting of the Products in accordance with Supplier prevailing guidelines in the relevant Territory. Training for new Products shall be provided on dates to be agreed by the relevant Supplier Distributor and the relevant Buyer Group member in that Territory.

Buyer, or the relevant member of the Buyer Group, shall provide training for Private Label Products to the relevant Supplier Distributor. Training on new Private Label Products supplied shall be provided on dates to be agreed by the relevant Supplier Distributor and the relevant Buyer Group member in that Territory.

Buyer shall ensure that all product dispensers employed or engaged by any members of the Buyer Group to fit the Products shall be suitably skilled, experienced and qualified to carry out such services.

Any software is licensed, not sold, to Buyer. It is protected by intellectual property laws and treaties worldwide and contains trade secrets in which Supplier and its licensors reserve and retain all rights not expressly granted to Buyer.

Buyer shall have a non-exclusive and non-transferable license to use such software solely in conjunction with the Products and only for the purpose(s) stated in the Product description and in accordance with the User Guides made available by Supplier. Buyer shall not modify, reproduce or copy any such software, or any portions thereof, without Supplier's prior written consent. Except to the extent that the Parties may otherwise agree in writing, Buyer's license to use such software shall terminate upon: (a) discontinuance of use of the hardware delivered hereunder in which such software is initially installed; (b) discontinuance of payment of the applicable periodic license and maintenance fees, if any; or (c) a breach of any of the above-stated license terms. All copies of the software with respect to which the license is terminated shall be returned to Supplier promptly after such termination.

Supplier provides the software "as is" and provides no warranty that the software will be uninterrupted or free from errors. All conditions, warranties or other terms which may be implied or incorporated into this Framework Agreement in relation to the software, whether by statute, common law or otherwise, are hereby excluded, including any implied conditions, warranties or other terms as to satisfactory quality, fitness for purpose or the use of reasonable skill and care.

Supplier grants a non-exclusive, revocable, royalty-free licence to Buyer and its Affiliates during the Term to:

Buyer acknowledges and agrees that, as between the Parties, Supplier absolutely and unconditionally owns the Supplier IP.

Buyer shall ensure that each Affiliate shall strictly comply with all directions and guidelines of Supplier, including Supplier Brand Guidelines, regarding such use of the Supplier Branding.

The benefit of and all goodwill that the Buyer Group may generate or acquire in respect of their use of any Supplier Branding shall at all times enure to Supplier (or, at Supplier's request, its nominee). Other than as expressly set out in this Framework Agreement, Supplier does not grant any right, title or interest in or to any Supplier Branding to Buyer or any of its Affiliates. Buyer shall, at Buyer's own cost and expense, promptly do or ensure to be done all such further acts and things (including the execution of documents) as Supplier may reasonably require in order to give full effect to this section 15.4 and/or in order to maintain the validity and enforceability of any of Supplier's Intellectual Property Rights.

Buyer shall, and shall ensure that each Affiliate shall, market and sell the Branded Products only under the Supplier Trade Marks, and not in association with any other trade mark, brand or trade name, except as permitted in any Brand Guidelines issued by Supplier. Supplier shall include on the Branded Products and/or their packaging the Supplier Trade Marks, together with any Patent numbers where appropriate and such proprietary notices as Supplier may deem appropriate from time to time.

Buyer shall not, and shall ensure that each Affiliate shall not:

Save as expressly provided in section 15.1., Buyer shall not, and shall ensure that each Affiliate shall not, sub-license, transfer or otherwise deal with the rights of use of the Supplier Trade Marks granted under this Framework Agreement.

Buyer acknowledges that the Products are premium products and the value of the Supplier Trade Marks established by Supplier and shall use its best endeavours to uphold and maintain the value of the Supplier Trade Marks and the Products in its promotion, advertising and sale of the Products.

Buyer shall not, and shall ensure that each Affiliate shall not, do or omit to do or allow to be done, anything that could adversely affect the validity or reputation of any of the Supplier Trade Marks or which may weaken, damage or be detrimental to any of the Supplier Trade Marks or the reputation or goodwill associated with the Trade Marks.

Buyer shall promptly give notice in writing to Supplier if it becomes aware of:

In respect of any matter that falls within section 15.10. in relation to the Supplier IP:

To the extent that any matter that falls within section 15.10. relates to the Buyer Trade Marks, such matter shall be dealt with in accordance with the Trade Mark Licence.

Supplier alone is responsible for the registration and maintenance of any marks or designs that relate to the Branded Products. Buyer shall not, and shall ensure that each Affiliate shall not, obtain or try to obtain or register for itself anywhere in the world any trade marks or trade names the same as or similar to the Supplier Trade Marks.

Buyer shall not, and shall ensure that none of its Affiliates shall, use the Supplier Trade Marks as part of the name under which Buyer or any of its Affiliates conducts its business, or any connected business, or under which it sells or services any products (except the Products), or in any other way, except as expressly permitted hereunder.

Each Party undertakes to keep, and shall procure that its Affiliates keep, as confidential all Confidential Information belonging to the other Party and their respective Affiliates and to not, either during or after the Term, use or disclose any such Confidential Information, except with the prior written consent of the other Party or as permitted by this section 16.

Each Party may, strictly for the purposes of performing, implementing and/or exercising that Party's rights and/or obligations under this Framework Agreement and/or seeking professional advice in respect of the same, use the other Party's Confidential Information and/or disclose it under obligations of confidence to that Party's employees, officers, agents, personnel and/or professional advisors. Each Party shall take all reasonable steps and precautions to ensure that the other Party's Confidential Information and that of their Affiliates remains confidential at all times and the persons to whom it makes such disclosures comply with the confidentiality obligations contained in this section 16 as though they were a party to this Framework Agreement. Each Party shall at all times remain primarily responsible for any unauthorised use or disclosure of the other Party's Confidential Information by it and/or any person to whom it has disclosed the same.

The obligations of confidentiality in this section 16 shall not extend to any matter which a disclosing Party can demonstrate:

Neither Party shall make any announcement, press release and/or statement relating to the other Party and/or in connection with this Framework Agreement at any time during or after the Term, except with the prior written agreement of the other Party and/or to the extent required pursuant to any Applicable Law or by an order of a court or governmental body or authority of competent jurisdiction.

Buyer shall not provide Supplier with any personally identifiable information (including but not limited to the name, gender, age, passport number, identity card number, contact information and health information) (collectively "Personal Data"), unless such information is specifically requested by Supplier or required to be provided by Applicable Laws. Buyer represents and warrants that it shall comply with all applicable data protection laws and further represents and warrants that it has obtained and shall have obtained all consents and authorizations necessary by virtue of Applicable Laws or otherwise of all data subjects for Buyer to disclose their personal data to Supplier (including for the purposes set out above). Upon Supplier's request, Buyer shall promptly provide a copy of any data subject's consent for disclosure to Supplier. Where requested by Supplier, Buyer shall enter into a data processing agreement on Supplier's standard terms setting out its obligations in relation to such Personal Data and to enable Supplier to process the Personal Data. Buyer shall indemnify Supplier and its Affiliates against any loss or damage suffered or any costs incurred by Supplier or its Affiliates because of a breach by Buyer of this section 16.5.

This section 16 shall continue in force following termination of this Framework Agreement.

Each Party hereby represents, warrants and undertakes to the other Party that:

Supplier shall be liable under this Framework Agreement only in accordance with the manufacturer's warranty set out in section 10. and returns policy set out in section 11.. Supplier shall have no further liability under this Framework Agreement whatsoever. Supplier's liability to Buyer under this Framework Agreement shall in all circumstances (including breach of contract, tort, negligence, breach of statutory duty, misrepresentation or otherwise) be limited per incident to (a) the value of the affected Products or Repair Services provided by Supplier to Buyer (provided that Buyer has paid for such affected Products or Repair Services to Supplier); or (b) Monetary cap per incident (whichever is lower). Further, in no event shall Supplier's total liability per Quarter exceed an amount equal to Net invoice value cap % of the aggregate net invoice value of Products sold to Buyer in that Quarter. The limitations set forth in this section shall not apply to liability for death or personal injury caused by negligence, liability for fraud or any other liability which cannot be excluded under Applicable Laws.

Under no circumstances whatsoever shall Supplier be liable to Buyer, whether in contract, tort (including negligence) or restitution, or for breach of statutory duty or misrepresentation, or otherwise, for any loss of profit, loss of goodwill, loss of business, loss of business opportunity, loss of anticipated saving, loss or corruption of data or information, procurement of substitute goods and/or services, or any special, indirect or consequential damage suffered by Buyer that arises under or in connection with this Framework Agreement.

Buyer shall remain responsible for all acts and omissions of any member of the Buyer Group as if such acts or omissions were its own.

Buyer represents and warrants that:

Buyer and members of the Buyer Group shall maintain control of records by ensuring the efficient storage of: (a) documentation for traceability, together with invoices, of the sold Products to the end-users; (b) customer complaints or adverse market surveillance information; (c) records and documentation of recalls; (d) samples and sales literature; (e) product registrations in the territories where the Products are sold with applicable government agencies or health authorities; and (f) any registration, approval or filing of these records and documentations. Buyer and members of the Buyer Group shall report to Supplier all information relating to any Incident or Near Incident, Adverse Events, Product Complaints and Device Malfunctions that are brought to its attention involving Products purchased from Supplier or its Supplier Distributors promptly upon their receipt. Incidents are understood to comprise any malfunction or deterioration in the characteristics and/or performance of a Product as well as any inadequacy in the labelling or the instructions for use, which might lead to, or might have led to the death of a patient or user or to a serious deterioration in the patient's or user's state of health.

Buyer and members of the Buyer Group must be able to fully trace any Product within Traceability period Working Days to the end-user.

Buyer and members of the Buyer Group shall forward all Product complaints to Supplier as soon as these are identified and no later than Complaint forwarding periodWorking Days. Such obligation includes any oral, electronic or written complaints of any deficiencies related to labeling, quality, durability, reliability, safety, effectiveness or performance of any Product.

Buyer and members of the Buyer Group are obliged to follow Supplier's vigilance procedures for the devices, and shall inform Supplier immediately of any oral, electronic or written complaints or reports, either from competent authorities or from end-users or others, on Incidents or Near Incidents involving the Products so that Supplier may be able to react appropriately, including notifying national health authorities.

Buyer and members of the Buyer Group acknowledge that Supplier may issue a recall or a Field Safety Corrective Action if a recall of a Product is needed or if Advisory Notice is needed. Buyer and members of the Buyer Group shall comply with all instructions set out in any Field Safety Notice or Advisory Notice and any reasonable requests within Recall compliance period Working Days and Supplier shall bear the costs of such product recall where such recall is not attributable to the negligence of Buyer or the relevant members of the Buyer Group. For the avoidance of doubt, Supplier shall, in its sole discretion, have the final decision as to any recall, Field Safety Corrective Action and any communication made to the public, and it shall be the party to handle such recall or Field Safety Corrective Action, including but not limited to final recall, removal, correction, withdrawal decision, the communication to the competent authorities and notified bodies, the public and surveys, as well as logistic processes regarding the returned Products.

To the extent that Buyer or any member of the Buyer Group outsources any services (including but not limited to installation and/or servicing) to third parties, Buyer or any member of the Buyer Group shall procure that such third party complies with the obligations of this section 18. Supplier shall be notified of any such outsourcing activities prior to commencement of the same and shall be subject to Supplier's prior written consent.

In case any registrations of Products, approvals or permissions are made in Buyer's or any member of the Buyer Group's name (except for Private Label Products), Buyer shall immediately assign and transfer any such registrations, approvals and permissions relating to Supplier or the Products in the Territory to Supplier or its nominee at no cost to Supplier upon termination of these Terms or upon Supplier's written request.

Supplier and the Supplier Distributors have the property right to all registrations of Products with authorities and approvals, permissions etc. from authorities. Buyer and members of the Buyer Group are not authorised to act on Supplier's or any of the Supplier Distributors' behalf in correspondence with any authorities unless a written, duly signed power of attorney is provided by to Buyer for this specific purpose.

In order to ensure the highest quality standards, Buyer and members of the Buyer Group shall use only genuine spare parts provided by the manufacturer for the contractual product.

The Supplier technical documentation (User Guide, safety manual and data sheet) provides Buyer and the members of the Buyer Group with the master user documentation. Buyer and the members of the Buyer Group shall keep the content of this master user documentation in the local user documentation. Buyer and the members of the Buyer Group are responsible to hand over the technical documentation together with the product to the end-customer.

Buyer represents and warrants that it and any party acting on its behalf (including but not limited to its employees, agents and business partners), together with the members of the Buyer Group and any party acting on their behalf (including but not limited to their employees, agents and business partners), shall strictly comply with all applicable laws and regulations, including without limitation any laws and regulations relating to taxation, anti-corruption, anti-bribery, antitrust, anti-money laundering or any other criminal laws, rules or regulations. Buyer shall forthwith, and in any event within Compliance breach period, notify Supplier in writing upon becoming aware that any of the foregoing representations and warranties are no longer true and correct, or upon being requested directly or indirectly by a third party or any Supplier officer or employee to violate any law or regulation in connection with this Framework Agreement or any Local Agreement.

Buyer further represents and warrants that:

Buyer agrees to comply, and will ensure that members of the Buyer Group comply, with the Foreign Corrupt Practices laws and the laws of the country in which any transactions are made or services are provided under this Framework Agreement. Without limiting the generality of the foregoing, Buyer represents and warrants and covenants and agrees as follows:

Buyer and members of the Buyer Group agree to keep, and make available in case of an audit as referenced in section 19.6., books and records that accurately describe in detail all products and services received, and payments made, by Buyer and members of the Buyer Group, as well as evidence of fulfilment of its obligations under this section 19 (including but not limited to having carried out compliance trainings commensurate with Buyer's business).

Buyer and members of the Buyer Group shall provide all such information, documents, confirmations or assurances to Supplier as it may request from time to time to its satisfaction to confirm that Buyer and members of the Buyer Group comply and continue to comply with all Applicable Laws.

Without limiting the generality of section 19.5., Supplier or a third party retained by Supplier shall be entitled to conduct an audit of all Products and services received by Buyer and members of the Buyer Group under this Framework Agreement if (a) Supplier has obtained information which Supplier determines to indicated that Buyer or any members of the Buyer Group may have breached any of its obligations, representations or warranties under this section 19, or (b) the results of Supplier's internal assessments indicate a potential corruption risk. Buyer shall, and shall ensure that members of the Buyer Group, fully cooperate in any audit which may be conducted.

Unless otherwise agreed to in writing by Supplier, all payments made by Buyer and members of the Buyer Group shall be paid by electronic bank transfer. Supplier and the Supplier Distributors will not accept payments from Buyer or members of the Buyer Group in cash or bearer instruments, or from an account in a country other than (a) the country of incorporation of Buyer or the relevant member of the Buyer Group, or (b) the country in which Buyer or the relevant member of the Buyer Group has its principal or substantial place of business. Buyer and the members of the Buyer Group warrant and represent that no payments will be made, directly or indirectly, through any trust, intermediate entity or other third party.

To the extent required by Applicable Laws, Buyer and members of the Buyer Group shall ensure that Products are only assembled using biocompatible materials in accordance with applicable standards and are fitted and sold by trained professionals maintaining all necessary licenses and certifications. Buyer is further not allowed to use CE marking. Supplier may require Buyer and members of the Buyer Group to provide evidence of its compliance with this section if Supplier becomes aware or has reason to suspect non-compliance by Buyer.

Buyer and members of the Buyer Group shall indemnify and hold harmless Supplier and the Supplier Distributors from and against any claim, proceeding, action, fine, loss, cost and damages arising out of or relating to any non-compliance with this section 19 by Buyer and members of the Buyer Group, and Buyer and members of the Buyer Group shall compensate Supplier and the Supplier Distributors for all losses and expenses resulting thereof.

Supplier and the Supplier Distributors shall not be obliged to perform any obligations under this Framework Agreement, and/or may terminate this Framework Agreement, or any other agreement, with immediate effect and without any liability by giving written notice to Buyer or members of the Buyer Group if Supplier or a Supplier Distributor, in its sole discretion, is of the view that: (a) Buyer or a member of the Buyer Group is in breach of any of the warranties, certifications, or representations provided in this section 19; or (b) the performance of this Framework Agreement, in whole or in part, or any transactions governed by this Framework Agreement, would cause Supplier or the Supplier Distributor to breach any term, warranty, condition, or other provision of any contract or undertaking to which the Supplier and/or any of its Affiliates is a party, which exists at the date of this Framework Agreement or which the Supplier enters into after the date of this Framework Agreement; or (c) any transactions contemplated under this Framework Agreement would be in breach of, or otherwise targeted by any laws or regulations, including sanctions and export control laws; or (d) any transactions contemplated under this Framework Agreement could potentially constitute a sanctionable activity under secondary sanctions, or give rise to retaliatory measures by any government or regulatory authority.

Either Party may terminate this Framework Agreement or the relevant Local Agreement with immediate effect by written notice upon the occurrence of one of the following events:

Supplier may terminate this Framework Agreement and/or any relevant Local Agreement with immediate effect by written notice upon the occurrence of one of the following events:

Supplier and the Supplier Distributors shall not be liable for any loss or damage for any delay in delivery or any other failure by Supplier and the Supplier Distributors to perform this Framework Agreement or Local Agreement due to any of the following: any acts of government or public authority; compliance with any governmental or public authority rules or regulations; acts of God or of the public; war; terrorism; civil commotion or riots; civil war; blockades; embargoes; sanctions; calamities; epidemics; pandemics; floods; fires; earthquakes; explosions; storms; strikes; lockouts; labour disputes or unavailability of labour, raw materials, component parts, power, utilities, or supplies; non-performance by suppliers or subcontractors; cyber-attacks, or any other causes beyond the reasonable control of Supplier or the relevant Supplier Distributor. Should such a delay or failure to perform occur, Supplier or the relevant Supplier Distributor may at its sole discretion elect to reasonably extend delivery or production schedules or cancel the order in whole or in part without liability other than to return any pre-payment.

Upon termination of this Framework Agreement (unless agreed otherwise by the Parties in writing):

Sections which expressly or by implication survive termination of this Framework Agreement shall continue in full force and effect.

Termination or expiry of this Framework Agreement, however arising, shall not affect any of the Parties' rights, remedies, obligations or liabilities that have accrued as at termination or expiry.

If any provision or part-provision of this Framework Agreement is or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to or deletion of a provision or part-provision under this section shall not affect the validity and enforceability of the rest of this Framework Agreement.

In entering into this Framework Agreement, each Party acknowledges that it does not rely on and shall have no remedies in respect of any statement, representation, assurance or warranty (whether made innocently or negligently) that is not expressly set out in this Framework Agreement.

Unless expressly stated otherwise in this Framework Agreement, no variation of this Framework Agreement 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 Framework Agreement or by law shall constitute a waiver or abandonment 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.

This Framework Agreement, and any documents referred to in it, including any Local Agreements, constitute the entire agreement between the Parties and supersedes and extinguishes all previous agreements, promises, assurances, warranties, representations and understandings between them, whether written or oral, relating to its subject matter.

Neither Party may assign, transfer, mortgage, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under this Framework Agreement without the prior written consent of the other Party (such consent not to be unreasonably withheld or delayed).

This Framework Agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement.

Subject to section 23.2., no person other than a party to this Framework Agreement may enforce this Framework Agreement.

The Parties agree that:

The Parties shall negotiate in good faith and shall use their respective reasonable endeavours to resolve all disputes arising out of or in connection with this Framework Agreement on an amicable basis. Disputes which cannot be resolved promptly shall be initially referred to a member of the senior management team (in the case of Buyer) and the Supplier senior management rep in the case of Supplier. If they are unable to resolve the dispute within Senior manager escalation period of escalation the dispute shall be referred to the Buyer executive title in the case of Buyer and the Supplier executive title in the case of Supplier. If the Parties are unable to resolve any dispute within Executive escalation period of escalation to their Buyer executive title / Supplier executive title , either Party may refer the dispute to arbitration by notifying the other Party in writing.

If a dispute is referred to arbitration in accordance with section 24.1., it will be referred to and finally resolved by arbitration in Arbitration seat administered by the Arbitration instiution in accordance with the Arbitration Rules of the Arbitration instiution in effect at the time of referral, which rules are deemed to be incorporated by reference in this section. The seat of arbitration shall be Arbitration seat . The tribunal shall consist of Number of arbitrators arbitrators. The language of the arbitration shall be the English language.

Nothing in this section 24 shall prevent the Parties from seeking from any court of competent jurisdiction an interim order restraining the other Party from doing any act or compelling the other Party to do any act.