DEFINITIONS AND INTERPRETATION

In these General Conditions of Sales:

a) Unless the context otherwise requires: “Company” means Medec International bv and includes a successor in title to the business of Medec; “Contract” means a contract under the terms of which the Company is liable to supply goods and or services of any description; “Customer” means the party having the right to enforce the supply by the Company of goods and/or services of any description under the terms of a contract.

b) Words importing one gender shall be treated as importing any gender and the singular number shall include the plural; and

c) The titles to the several conditions are inserted for convenience only and shall not be deemed to form part of the conditions.

d) Sales of the products from the Company to the Customer shall be governed by the Companies general conditions of sale and The United Nations convention on contracts for the international sale of goods (Vienna 1980).

e) Sales of the products and/or services from the Company to the Customer shall be solely government (in form and substance) by and construed in accordance with the laws of Belgium. Any dispute between the Parties arising out of or in relation to the Agreement, shall fall under the exclusive jurisdiction of the Courts of the judicial district of Belgium.

2. CONTRACTS

a) A contract shall not come into existence until the Company dispatches its written acceptance of the Customer’s order, or commences to deliver the goods, whichever shall occur the sooner.

b) The terms and conditions of a contract shall be such as are contained in the Company’s quotation/estimate together with these General Conditions of Sales, and such other terms and conditions as the Company may stipulate or agree, to the exclusion, of all other items and conditions whatsoever, whether express or implied.

c) The terms and conditions of a contract shall be limited to such as are expressed in writing, to the exclusion of all oral expressions whether of advice, opinion or otherwise.

d) Where a term of an estimate or quotation, or any other express term of a contract, is found to be in conflict with any one or more of these General Conditions of Business, the terms of the estimate or quotation, or the other express term of the contract, as the case may be, shall, unless the context otherwise requires, prevail.

e) The Customer acknowledges that he has not been induced to enter into the contract by any representation made by or on behalf of the Company, except such as may be contained in, or endorsed by the terms of the contract.

PRICES, QUOTATIONS AND ESTIMATES

a) Quotations/estimates in writing alone shall bind the Company; they remain valid for three calendar months from their date of issue and then expire, unless renewed in writing by the Company.

b) Unless the Company stipulates, or agrees, otherwise, the Company’s prices are EXW prices conform INCOTERMS 2020

c) The Company’s list prices are subject to alteration without notice.

d) Quoted prices relate to the quantity of goods quoted for, and may not be applicable if a different quantity of goods is ordered.

e) Designs, drawings, illustrations and samples supplied to the Customer remain the property of the Company, may not be copied or reproduced, and are to be returned to the Company within a reasonable time.

3. TAX

Unless otherwise quoted or agreed, the Company’s prices do not include Value Added Tax, or any other tax, levy, duty or surcharge, whether imposed before or after the making of the contract.

4. PAYMENT

a) The Company’s invoices are due for payment strictly in accordance with the terms shown below and on the Acknowledgement of Order and the invoice.

b) An invoice can only be contested in writing within 8 days of the invoice date. When contesting an invoice the date and invoice number must be clearly mentioned. Any attempt at contesting an invoice after this period will not be accepted.

c) Except as the Company’s quotation/estimate may provide, no discounts are allowable, or may be taken, against amounts invoiced by the Company, nor shall the Customer be entitled to any commission or rebate in respect thereof, and this not withstanding any previous course of dealing between the Company and the Customer.

d) When payments of any of the Company’s invoices is overdue, the Company may suspend its performance of the contract to which the invoice relates and/or of any other contract then subsisting between the Company and the Customer for the period until the invoice is paid.

e) Term Description:

a. Prepayment.

b. LC Letter of Credit at sight.

c. Open account (with approval of the credit insurance company).

f) For orders under 500 EURO, Medec will add 50 EURO administration cost.

g) LC has to be conform Medec LC requirements, otherwise the LC can be refused.

h) From the due date of any unpaid invoice, the invoice shall automatically be increased without notice of default with interest at the rate of 8 % per year of the total sum of the unpaid invoice. At the same time a fixed compensation of 10 % of the total sum of the unpaid invoice is owed, with a minimum of 50 euros.

i) The Customer has no rights to lower the payment of the goods delivered at any time before, at or after delivery. Exceeded delivery times, claims or penalties are not of any influence on the value of the goods. Delivered goods have to be paid conform the Companies invoice.

j) A proforma invoice issued by Medec has the same legal rights/value as an invoice.

5. CREDIT LIMITS

a) Where the Company has granted the Customer a credit facility, the Company may withdraw the same without either giving any reason for so doing or thereby incurring any liability to the Customer.

b) If the Customer takes goods from the Company in excess of the Customer’s credit limit, the Company may require payment on demand for such excess goods.

6. DELIVERY

a) Delivery terms are conform INCOTERMS 2020 see: http://www.iccwbo.org. Unless otherwise agreed between both parties in writing, delivery will be EXW. In case of other delivery conditions is the Customer not allowed to claim damages or penalties in connection to the delay in delivery of the goods or services.

b) Delivery dates are quoted in good faith and as accurately as possible but are not guaranteed.

c) When the Company is required to deliver goods, the Company shall have the sole discretion as to the mode of transport to be adopted.

d) Delivery of goods by the Company does not include the provision of labor and equipment for unloading, which the Customer shall be liable to provide, at the Customer’s own cost.

e) When the Company is required to deliver the goods, the Company’s liability for so doing shall be limited to delivering them as near to the place where the goods are required as a safe hard road permits. If, in any particular case, the Company should agree to relax this condition, the relaxation shall be deemed to have been given in consideration of an indemnity from the Customer against all losses, costs, and expenses which the Company may incur or pay as a result of such relaxation.

f) Goods held by the Company pending delivery instructions may be subject to a storage charge.

g) The Company may deliver goods by installments.

h) Unless otherwise agreed, the Customer will be responsible for the goods in case of damage or loss from the point of shipment where the goods leave the premises of the Companies factory.

i) In case of resale of the products, the Customer is solely responsible to comply with all applicable export rules and regulations, including but not limited to the;

a. EU Regulation (EC) No 428/2009 (dual use export control), as amended or replaced from time to time; and

b. The EU Consolidated Financial Sanctions List, as updated from time to time.

The Customer shall defend, indemnify and fully hold harmless, the Company from all costs and claims based on the violation of export rules and regulations by the Customer (or any contract party of the Customer). “

7. CONSEQUENTIAL LOSS

Except where negligence on the part of the Company is shown to have resulted in the death of, or bodily injury to, any person, the Company shall not be liable for consequential loss suffered by the Customer as a result of the Customer having entered into a contract, and the Company’s price levels are set accordingly. If in any case the goods delivered by the Company would cause damages to other goods, the liability of the Company will end at the manufacturer of the goods damaged.

8. TIME FOR PERFORMANCE

a) No provision or stipulation as to the time within which the Company shall perform its obligation under a contract shall be, or be deemed to be, of the essence of the contract.

b) The Company shall not be liable to the Customer if, and to the extent that, the delivery of goods and/or the provision of services is hindered by circumstances outside the Company’s control, which shall be deemed to include, but shall not be limited to, fire, accident, industrial disputes, shortages of material and power and failure on the part of the Company’s suppliers. Both parties agree that Article 33 of the CICG will not apply. No claims can be made.

c) The Customer is not able to cancel or recall its order if the Company cannot meet the estimated time of arrival (expected delivery date) as these are indicative.

9. VARIATION AND CANCELLATION

a) Subject to Condition (c) below, the terms of a contract may not be varied, nor may the contract be suspended or cancelled without prior consent in writing of the Company, which may be given on terms.

b) If the Company’s performance of a contract is interrupted or hindered for any reason other than the default of the Company, the Customer shall be liable to pay the Company a proper price for any additional work or attendance thereby required.

c) The Company reserves the right to vary by way of improvement, the specification of any of its products, and to supply goods to a specification as so varied in fulfillment of any order.

10. NON-DELIVERY AND DAMAGE IN TRANSIT

a) Claims for non-delivery, shortage and damage in transit will be entertained only if the Customer observed whichever of the following procedures is appropriate. Non-delivery – to be notified in writing to both the Company and the carrier within 14 days of the date of the Company’s advice of dispatch. Short delivery and damage in transit – to be notified in writing to both the Company and the carrier within 3 days of receipt of the goods, followed by a detailed claim to be made both against the Company and against the carrier within 14 days of the date of the Company’s advice of dispatch.

b) When delivery is taken without the goods being examined, the Customer must endorse any receipt or acknowledgement of delivery, “not examined”.

c) Goods alleged to have been damaged in transit shall be held by the Customer for inspection by, or on behalf of, the Company and the carrier for a period, if the point of delivery of the goods is within Belgium, of 14 days after delivery to the Company of the Customer’s detailed claim in respect of the damage or, if the point of delivery of the goods is outside Belgium, of 45 days after the delivery of such claim.

11. RETURNS

Goods sold to the Customer may only be returned to the Company provided that the following conditions have been met:

a) The request for a return of material to the Company has to be done within 14 days after delivery at the Customer.

b) In exception to article 39, point 2 of the CICG; the Customer cannot claim any returns if the request for return in writing arrives after 14 days from date of delivery.

c) The written consent of the Company must have been given prior to any return.

d) The goods must be in new and unused condition, of current type or model and not been made or obtained to the Customer’s special order.

e) Return to the Company is made within three months of the invoice date.

f) All goods returned will be subject to the payment of the Company’s handling charge.

12. WARRANTY

Medec warranty

Medec makes no representation, warranty or guarantee, express or implied regarding the products except its standard form of limited warranty (“Limited Warranty”). Medec may in its sole discretion modify its Limited Warranty at any time and from time to time. Beginning on the date of manufacture, as indicated by serial or lot/batch number, to its direct Customer and continuing for the published warranty period, Medec represents that the products are new and warrants that each Product failing to function properly under normal use, due to a defect in materials or workmanship or due to non- conformance to the agreed upon specifications, will be repaired or exchanged, at Medec’s option and expense. The published warranty periods are 12 months for capital equipment, 12 months for vaporizers, 4 months for reusable accessories like: hoses, breathing bags, bellows and masks of rubber or plastic materials. The Customer will obtain a Goods Return Approval Number from the Medec Technical Support Desk prior to returning the nonconforming product freight prepaid, Door to door shipment. Medec will pay for transporting the repaired or exchanged product to Customer. Repaired, replaced or exchanged Product will be warranted for the remainder of the original warranty. The replacement of a part or component during the warranty period does not extend the duration of the warranty. This Limited Warranty extends to Medec’s direct Customer only and is not assignable or transferable.

Disclaimer

Except as set forth in writing in the Limited Warranty, Medec makes no performance representations, warranties, or guarantees, either express or implied, oral or written, with respect to the Products, including without limitation any implied warranty:

a) Of merchantability,

b) Of fitness for a particular purpose, or

c) Of arising from course of performance, course of dealing, or usage of trade.

Voiding the warranty

This warranty does not apply:

a) To damage caused by accident, external factors, abuse, misuse, misapplication or non- Medec products,

b) To service parts,

c) To damage caused by service performed by anyone other than Medec certified personnel,

d) To a product or a part that has been modified without the written permission of Medec,

e) To a product that has not been maintained in accordance with the published service schedule or repaired with the non-original Medec parts or parts which have not been supplied by Medec,

f) To components designated as service items to be replaced by the Customer as part of the published service schedule,

g) If any Medec serial number has been removed or defaced. Product warranty is void if the covers or top cover, or any seal or label is removed or damaged, or a repair attempted,

h) To products for which Medec has not received full payment.

Extending the warranty

Extra years of warranty can be purchased for capital equipment and vaporizers. These extra years of warranty will only be honored when servicing instructions of the manufacturer are rigorously followed.

13. DESCRIPTIVE MATTER

a) Descriptive matter contained in catalogues, brochures and any other publication or display is believed correct and up-to date, but is not warranted so, unless specifically confirmed in writing by the Company.

b) Color indications, whether given by means of the provision of samples or derived from color charts or descriptions, are necessarily approximate, by reason of inevitable variations in the processes of manufacture and reproduction.

14. PASSING OF PROPERTY AND RISK

a) Article 66 to 70 of the CICG are applicable for passing the risk in goods supplied by the Company.

b) Whether or not the risk in goods sold shall have passed to the Customer, the property in goods sold shall be and remain in the Company until the Company has received payment in full for them, together with payment in full for any other goods supplied by the Company to the Customer the price for which is overdue for payment. Pending receipt by the Company of such payments, the Customer shall hold the goods for the Company as fiduciary bailee.

c) When payment for the goods is overdue or the Customer suffers distress or execution to be levied against his or its effects, makes an arrangement or composition with creditors or, being a corporate body, enters into liquidation (otherwise than for the purpose of amalgamation or reconstruction where the corporate body, as amalgamated or reconstructed accepts in full the Customer’s liability to pay for the Goods), or has a receiver appointed for the whole or any part of its undertaking or, being an individual, has a receiving order in bankruptcy made against him, then:

1. If the Customer remains in possession of the goods, whether or not the Customer has sold them, the Company shall be entitled to recover the goods from the Customer: or

2. If the Customer has parted with possession of the goods by way of sale, whether or not the goods have been mixed with or incorporated into other goods, the Customer, having sold them as fiduciary bailee, shall hold in trust for the Company so much of the proceeds of sale of the goods as represents the Customer’s liability to the Company in respect of them.

15. FITNESS FOR PURPOSE

Except where goods are supplied on the express advice of the Company, given in writing, that they are suitable for any particular purpose, it shall not be a term of a contract that goods are sold as fit for any particular purpose, and this notwithstanding that the Company may have, or be deemed to have, knowledge of the purpose for which the goods are required.

16. THIRD PARTY RIGHTS

a) The Company does not warrant, nor shall it be an implied term of a contract, that goods and designs sold or employed by the Company do not infringe the rights of any third party.

b) Where information, instruction or guidance received from the Customer is the direct or indirect cause of any assertion by, or on behalf of a third party, that the Company is in breach of any right of that party, the Customer shall be deemed to have agreed to indemnify the Company against all costs incurred by the Company as a result of such assertion.

17. CUSTOMER INSOLVENCY

Except where payment for goods to be supplied has been made or secured in advance of their delivery to or to the order of the Customer, the Company shall be entitled to withdraw from a contract if and when the Customer suffers distress or execution to be levied against his or its goods or effects, makes an arrangement or composition with creditors, enters into liquidation (otherwise than for the purpose of amalgamation or reconstruction), has a receiver appointed for the whole or any part of its undertaking, or if a receiving order in bankruptcy is made against him. When the Company elects to withdraw from the contract in any such circumstances, the Company shall thenceforth cease to have any liability to the Customer thereunder but shall remain entitled to claim from the Customer a due proportion of the contract price in respect of such part of the contract as the Company shall have performed.

18. COMPLIANCE WITH ANTI-CORRUPTION, ANTI-MONEY LAUNDERING, AND ANTI-TERRORISM LAWS

18.1 Each Party represents, warrants, and undertakes that in connection with the performance of these General Sales Conditions, it will comply with all applicable laws, regulations, and international conventions concerning anti-corruption, anti-money laundering, and counter-terrorism financing, including but not limited to the United States Foreign Corrupt Practices Act (FCPA), the UK Bribery Act 2010, and the relevant regulations promulgated by the Financial Action Task Force (FATF).

18.2 Each Party shall not, directly or indirectly, offer, give, or agree to give any payment, gift, or other benefit to any person or entity, including any government official or employee, political party, or public international organization, for the purpose of influencing any act or decision in order to obtain or retain business or to secure any improper advantage.

18.3 Each Party shall ensure that funds received or paid in connection with these General Sales Conditions are not derived from illegal activities, including but not limited to money laundering, fraud, or terrorist financing.

18.4 Each Party shall promptly notify the other Party if it becomes aware of any breach or suspected breach of this clause or any applicable anti-corruption, anti-money laundering, or anti-terrorism law. In such event, the notifying Party shall have the right to terminate these General Sales Conditions immediately upon written notice without liability.

18.5 Each Party agrees to maintain accurate and complete records of all transactions conducted under these General Sales Conditions, including but not limited to records relating to payments made or received, and to make such records available for inspection by the other Party or its representatives upon reasonable notice.

18.6 Each Party agrees to cooperate fully with any investigation, inquiry, or audit conducted by any regulatory or law enforcement authority concerning potential violations of anti-corruption, anti-money laundering, or anti-terrorism laws in connection with these General Sales Conditions.

18.7 This clause shall survive the termination or expiration of these General Sales Conditions for a period of five (5) years.

19. Medical Device Regulation 2017/745 Art 14

General obligations of distributors or buyers.

When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.

Before making a device available on the market, distributors shall verify that all of the following requirements are met:

the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11)*;

for imported devices, the importer has complied with the requirements set out in Article 13(3)**;

that where applicable, a UDI has been assigned by the manufacturer.

In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.

Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.

Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.

Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.

Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.

Distributor shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributor shall cooperate with the competent authorities, at their request, on any action taken to eliminate the risk posed by devices which they have made available on the market. Distributor shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.

Distributor, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.

* Art 10 (11)

Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

** Art 13 (3)

Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.

20.ETHICAL BUSINESS CONDUCT AND COMPLIANCE

20.1 The Buyer and Seller agree to conduct their business activities in a manner that promotes ethical standards, integrity, and compliance with all applicable laws, including but not limited to laws relating to anti-bribery, anti-corruption, anti-slavery, human rights, labour practices, and environmental protection.

20.2 Each Party shall refrain from engaging in any unethical or illegal business practices, including but not limited to fraud, bribery, kickbacks, or exploitation of vulnerable individuals or groups.

20.3 The Buyer shall ensure that its employees, agents, and subcontractors adhere to similar ethical standards and that adequate measures are implemented to prevent violations of this clause.

20.4 The Buyer shall notify the Seller immediately upon becoming aware of any suspected or actual violation of this clause, including any breach of applicable anti-bribery, anti-corruption, or anti-slavery laws.

20.5 Failure to comply with this clause shall constitute a material breach of these General Sales Conditions, entitling the non-breaching Party to terminate any ongoing or future sales without liability.

20.6 This clause shall survive the termination or expiration of these General Sales Conditions for a period of five (5) years.

21. MISCELLANEOUS

a) The Customer may not assign its rights or liabilities under a contract without the prior consent in writing of the Company.

b) Failure by the Company to enforce a term of a contract as soon as it may be enforced shall not prevent the subsequent enforcement of that or any other term of the contract.

c) The construction, validity and performance of a contract shall be governed by the laws of Belgium.

d) The Belgium Courts shall have exclusive jurisdiction in any dispute or difference arising between the Company and the Customer in relation to a contract.

The obligations under these general sales conditions shall apply not only to distributors but also to any buyer who purchases Medec products, irrespective of whether a formal distributor agreement exists. Any such buyer shall be deemed to have accepted and agreed to comply.