General terms and conditions

General terms and conditions Arega Medical

Article 1 – General

AREGA MEDICAL BV (hereinafter AREGA), with its registered office at Laarstraat 16, 2610 Wilrijk, is registered with the Crossroads Bank for Enterprises (CBE/KBO) under number 078.941.538.

All agreements concluded and orders accepted by AREGA are subject to the following terms and conditions (the ‘GT&C’) unless otherwise agreed in writing and in advance. These GT&C exclude any of the customer’s general or special terms and conditions for all orders place with AREGA. Any special provisions stated on the order form that could conflict with these GT&C shall prevail.

Article 2 – Offers – conclusion of the agreement

2.1. Offers and quotations are made with due reservations, and are in no way binding on AREGA. Offers and quotations remain valid solely for the time stipulated in the offer, i.e. a standard of 30 days following the issue of the offer or quotation. No rights from previous offers or quotations may be derived for future orders.

2.2. Orders, agreements, or other arrangements are only valid when confirmed by AREGA in writing.

2.3. AREGA regards the natural or legal person having entrusted the order to AREGA as its client, unless AREGA has been expressly informed that the person has been commissioned by a third party and, consequently, provided said third party’s name, address and company number to AREGA. Anyone placing an order on behalf of a legal entity is held jointly liable with the former on whose behalf they act.

2.4. Any amendment of the order by the customer must be made in writing and, in principle, gives rise to a new offer or quotation, and this at AREGA’s discretion and resolve. In this case, AREGA is entitled to adjust the delivery period and/or the rate or further amend the order.

Article 3 – Execution of the agreement – delivery

3.1. AREGA exercises due care in executing the assignments entrusted to it and may only be charged with an obligation of effort. Delivery and/or execution deadlines are provided solely for informational purposes and are therefore not binding on AREGA, insofar as these delivery deadlines comply with the legislation applicable to the goods in question, and unless expressly agreed otherwise between the parties. Delivery times are only guaranteed for goods available from stock. However, delivery and/or execution delays may at no time give rise to fines, damages, termination of the agreement or refusal to accept the goods.

3.2. The customer must provide AREGA with all data deemed essential for the execution of the agreement at every stage of the agreement’s execution in timely fashion. Should such essential data fail to be delivered to AREGA in time, AREGA has the right to suspend the execution’s agreement and/or invoice the customer for additional costs incurred by the delay. The customer is liable for the provision of incorrect delivery addresses, which could result in additional charges.

3.3. In principle, delivery is conducted through wholesalers or is delivered directly to the customer according to the European Commission’s Guidelines on Good Distribution Practice for Medicinal Products for Human Use (’Guideline 2013/C 343/01’).

3.4. Partial deliveries and/or execution are admissible. AREGA reserves the right to invoice these partial deliveries and/or performance at the time of their execution.

3.5. All goods-related risks, including transport risks, transfer to the customer on delivery of the goods to the place specified on the order form.

3.6. AREGA reserves the right to terminate the agreement ipso jure and without prior notice of default should there be objective reasons that demonstrate compromise of the customer’s solvency and/or liquidity situation (e.g. due to bankruptcy, judicial settlement, contested bills of exchange, apparent insolvency, payments due AREGA or third parties in arrears, acquisition of collective debt settlement by the customer, etc.).

3.7. Should AREGA take cognisance of circumstances casting reasonable doubt on the agreements’ integrity following confirmation of the order and before or during delivery, it shall be entitled to demand advance payment or security and, where necessary, terminating the agreement without any right of compensation due the customer.

Article 4 – Price

4.1. The agreed prices are only valid for goods deliverable from stock and are based on the purchase price at the time of or acceptance of the offer. Pursuant to 38/7, § 2 of the RD AUR of 14/01/2013, and in view of difficulties with establishing a price variation clause for the goods in question, AREGA expressly reserves the right to increase the agreed price according to the health index trend. Following the offer, the variation clause may be invoked on a recurrent six-monthly basis, based on the following formula: indexed price = starting price * new index/base index. The base index is the health index of the month in which the offer was sent.

4.2. Should the economic balance be disrupted to the detriment of AREGA due to circumstances external thereto, and should the price variation clause provided for in Article 4.1 fail to restore said balance, AREGA shall be entitled to terminate the offer subject to one month’s advance notice.

4.3. All prices are exclusive of VAT and other fees (insurance, transport, etc.), unless explicitly provided otherwise. The customer is liable for VAT. The customer is liable for any increase in the VAT rate or any tax of any other kind occurring between the order and its execution.

4.4. For any goods order valued at a total of less than €350.00 excluding VAT, the customer may be charged additional transport costs of at least €100.00 excluding VAT, unless otherwise agreed in writing. For customers qualifying as a chemist within the meaning of Article 8 of the Consolidation Act of 10 May 2015 on the exercise of the health professions or as a care facility, a minimum order value of €200.00 excluding VAT applies, failing which a transport cost of at least €100.00 excluding VAT may be charged.

Article 5 – Payment

5.1. AREGA’s invoices are payable to the account of its registered office no later than 30 days within receipt of the invoice.

5.2. Any invoice for which the amount has not been settled or settled in full by the due date is automatically subject to a flat-rate compensation of 10% on the amount owed, with a minimum of €100.00. Additionally and ipso jure, a late payment interest equal to the legal interest rate pursuant to the Law of 2 August 2002 on combatting late payment in commercial transactions shall be owed.

5.3. In case of non-compliance with the agreed payment terms, all outstanding invoices and/or debts become immediately due and payable, and AREGA has the right to suspend further deliveries or consider the agreement dissolved without prejudice to its claim for compensation.

5.4. Without prejudice to the provisions of Article 7 and where an AREGA invoice is the subject of dispute, the customer must lodge a substantiated claim by registered letter within 14 calendar days of invoice receipt, and this under penalty of forfeiture.

5.5 AREGA has the right to offset mutual customer assets against debts at any time, even in the event of concurrent liabilities.

Article 6 – Force majeure

6.1. Should AREGA be unable to execute the order due to force majeure, including accidents, illness, fire, war, pandemic, health crisis, strikes, lockouts, riots, supplier delays, lack of transport material, etc., AREGA shall be entitled to terminate the agreement without any additional customer compensation.

6.2. Should AREGA already have partially executed its obligations on occurrence of the force majeure, or should only partial execution of its obligations be possible, AREGA is entitled to separately invoice the work already executed, and the customer is obliged to pay this invoice as though it were a separate agreement.

Article 7 – Liability

7.1. Any immediately perceptible error concerning the delivery or any visible defect affecting all or part of the goods must be established at the time of delivery in the presence of the carrier or its representative so that they are afforded the possibility to contest the claim, and this in writing through the inclusion of provisos on the order form. In any case, any delivery-related complaint must be communicated to AREGA in writing no later than within 14 calendar days, along with any proof of the defect (e.g. photos). Any warranty for visible defects is void should the defects only have appeared after its delivery at the agreed location or should the customer or one of its agents or appointees have already modified or used the goods. Invisible defects must, under penalty of forfeiture, be reported by registered letter within eight (8) calendar days of their discovery. However, the warranty for invisible defects becomes void should the goods already have been modified or used by the customer or one of its agents or appointees, or should the usage instructions not have been followed or should the goods have been used incorrectly.

7.2. Should defects occur and be reported in time with the required evidence to substantiate them, AREGA may repair the defects in accordance with the order form or pay compensation therefor. Should AREGA regard the complaint as unfounded, the goods in question or similar goods will be submitted for inspection to an independent expert, to be appointed by both parties by agreement. The expert’s conclusions are binding on the parties. The losing party shall be held liable for the costs of the expert report. Should the customer return the goods as a result of this complaint, this must be enacted pursuant to Guideline 2013/C 343/01.

7.3. AREGA guarantees the conformity of the goods it delivers in accordance with the agreed specifications. This is AREGA’s sole guarantee. AREGA expressly excludes recourse to any other guarantee, such as but not limited to guarantees concerning the market value of the goods, their suitability for specific use or the infringement of intellectual property rights. The customer expressly waives any recourse to such guarantee.

7.4 The customer indemnifies AREGA against any damage, loss or claim arising from or in connection with the distribution, sale and/or marketing of the goods, the infringement of patents and/or other intellectual property rights, the failure to comply with any legal requirement, regulation and/or registration, or any other shortcoming of the customer, unless the damage, loss and/or liability is due to AREGA’s wilful misconduct or gross negligence.

7.5. The compensation for which AREGA may be held liable based on this agreement shall not exceed 20% of the amounts invoiced to and paid by the customer during the previous contract year, whatever the cause, nature or object of the claim, and subject to the provisions of Article 3.1. Should the client believe itself entitled to such compensation, incontrovertible evidence of the defects and damage must be provided. Withholding or delaying payment of outstanding invoices is prohibited.

7.6. However, AREGA may not be held liable for consequential damage and/or any indirect damage, including loss of use, turnover or profit.

Article 8 – Adverse reactions reporting requirements

8.1. The customer acknowledges and agrees that AREGA must fully and promptly comply with all applicable safety reporting requirements relating to its goods. The customer agrees that if, in relation to the goods in question, it receives information about adverse reactions and/or other specific safety issues, AREGA will be immediately informed in accordance with this article. For the purposes of these GT&C, adverse reactions include exposure during pregnancy, exposure of an infant during breastfeeding, overdose, abuse, misuse, medication errors, lack of efficacy, contamination with infectious agents, drug interactions, occupational exposure, and any other safety information that AREGA may reasonably request. Any information received in relation to adverse reactions must be reported by the customer to AREGA within one (1) working day by contacting AREGA’s local pharmacovigilance officer, Anne-Sophie Gernay, via the contact details below: E-mail: safety@arega.com Telephone: +32 3 808 67 00; 24-hour pharmacovigilance number: +32 3 808 67 00. The customer shall make every effort to at least obtain the informational minimum on the reported adverse reactions (including the nature of the adverse reactions, the medicine used, the person who reported the adverse reactions, and the patient). Where reasonably possible, the customer will notify the person reporting the adverse reactions that the adverse reaction-related details will be transmitted to AREGA and ask whether AREGA may contact them directly. The customer shall provide AREGA with reasonable assistance to facilitate AREGA’s compliance with its legal obligations and requests for information from the competent authorities. Notwithstanding the above, AREGA has the right to amend its instructions regarding the time limit, criteria, and means of notifying adverse reactions-related information, including specific safety issues. The customer will be informed thereof through separate correspondence.

Article 9 – Transfer of rights

9.1. The customer only becomes the owner of the delivered goods on the fulfilment of all its obligations to AREGA. AREGA retains full ownership of the delivered goods until all invoiced costs, any interest, damages, and fees have been paid in full. This retention of title is an essential component of the agreement concluded by the parties, without which AREGA would not have concluded the agreement. Nevertheless, AREGA does sanction the customer’s sale and use of the goods in question in the normal course of the latter’s operations. Customer resale of the unpaid goods automatically transfers the customer’s third-party claims to AREGA, granting the latter direct right of action vis-à-vis the third party.

9.2. Should the customer fail to pay within the contractually agreed period, AREGA may demand the return of the goods and this at the customer’s risk and expense. The goods held in stock by the customer will be considered unpaid goods. In this case, the goods must be returned to AREGA immediately on its demand and at the customer’s expense, without prejudice to AREGA’s right to full compensation. The parties agree that AREGA’s goods are fungible, thus permitting AREGA to invoke its retention of title in respect of any goods held in stock by the customer that are similar to the unpaid goods. During the retention of title period, the customer assumes custodial duties and responsibilities for the delivered goods, undertaking to guard and insure them accordingly against all causes of damage, destruction, theft, fire, loss, etc.

9.3. Notwithstanding the retention of title foreseen, the risk inherent to the goods transfers to the customer on the delivery of the goods to the place agreed in accordance with the order form. Should it be agreed that the customer will collect the goods, then the risk transfers to the customer on its summons to collect the goods. Storage fees may be charged following said summons.

Article 10 – Compliance with anti-corruption law

10.1. The customer is aware that AREGA and the customer are jointly liable for compliance with all applicable anti-corruption laws and regulations (hereinafter: Applicable Anti-Corruption Law). The Applicable Anti-Corruption Law prohibits the direct or indirect corrupt payment, offer or promise of payment, or authorisation of a payment or transfer of specie goods or any other benefit to a civil servant, or to any other person, knowing that all or part of the payment, specie goods, or benefit will be offered, given, promised, or transferred to a civil servant. Part of the Applicable Anti-Corruption Law also prohibits commercial bribery – e.g. the direct or indirect unauthorised payment, transfer of specie goods, benefits, or any undue advantage to a private party with the intent to unlawfully obtain or retain business transactions or unlawfully influence the recipient’s behaviour.

10.2. The customer declares that it has not been convicted by any governmental or judicial authority of violating the Applicable Anti-Corruption Law. Furthermore, the customer declares that no specie goods have been or will be received by it under this agreement or have been or will be used by it for a purpose that contravenes the Applicable Anti-Corruption Law, nor has it acted or will it act to contravene the Applicable Anti-Corruption Law.

10.3. The customer declares that, unless permitted under the Applicable Anti-Corruption Law, it has not made nor will it make payment, authorise the payment or gift of any specie goods to any official for the purpose of (i) influencing any act or decision of such official in their official capacity; (ii) inducing such official to act or neglect to act in breach of said official’s legal duty; (iii) securing an undue advantage, or (iv) inducing such official to use their position to influence any government act or decision related to the activities undertaken as part of this agreement.

10.4. The customer shall fairly and accurately record all agreement-related transactions in its bookkeeping, accounts, and other documents in reasonable detail.

10.5. For the duration of this agreement and a period of three years thereafter, the customer shall provide an AREGA appointed independent auditor with access to all of the customer’s accounting documents, accounts, invoices and relevant files relating to this agreement to verify compliance with the provisions of this article and the requirements of the Applicable Anti-Corruption Law. The customer shall provide its full cooperation with any audit or investigation conducted by AREGA regarding compliance with this agreement or the Applicable Anti-Corruption Law.

10.6. AREGA is entitled to suspend or terminate this agreement as well as all payments under this agreement should it be sincerely convinced that the customer would have acted in breach of this article or the Applicable Anti-Corruption Law.

10.7. The customer guarantees that all statements herein shall remain true and accurate throughout the term of this agreement. Should it become aware of a potential violation of this article or of the Applicable Anti-Corruption Law or any other amendment that would render any of the statements herein inaccurate or incorrect, the customer must notify AREGA immediately. Failure to issue AREGA with such notice under this article is a material breach of this agreement by the customer, entitling AREGA to terminate the agreement.

10.8. This article applies only insofar as the customer is a wholesaler or carries out wholesale activities related to AREGA goods.

Article 11 Privacy

11.1. By contacting or placing an order with AREGA, the customer expressly authorises the processing and use of its personal data for purposes such as administering the customer database, managing orders, deliveries and invoices, solvency monitoring, marketing and advertising. To execute the agreement, AREGA requires the following customer data: name, address, telephone number, e-mail address, and invoicing details. Processing for marketing purposes and personalised advertising is only performed with the customer’s express consent. AREGA is not permitted to transfer the data to third parties without the customer’s explicit consent. The customer has the right to object to direct marketing-related data processing at any time, free of charge. AREGA is responsible for processing this data. The processing of this data is essential for the agreement’s execution and will not be used for other purposes.

11.2. AREGA is obliged to forward the customer’s personal data in certain situations. This occurs when mandated by law, regulation or legal proceedings, or when petitioned by the public authorities in relation to law enforcement, or should AREGA deem it necessary to transmit the customer’s personal data to prevent damages or financial losses, and this in the context of a fraud investigation or investigation into other illegal activities.

11.3. Should AREGA sell or transfer all or part of its business or assets, it reserves the right to simultaneously transfer all personal data of the customer. In such a case, AREGA will undertake what is required to inform the customer thereof and ensure that the new recipient of the personal data also uses it in accordance with this article. In such a situation, the customer must contact the new personal data recipient with any questions in relation thereto.

11.4. The customer has the right to access their data at any time and correct it where necessary.

11.5. AREGA shall ensure appropriate administrative, technical and physical security policies to protect the customer’s personal data from accidental, unlawful or unauthorised destruction, loss, alteration, access, disclosure, or use.

Article 12 – Intellectual property

12.1. The documents provided to the customer before or after the agreement’s conclusion are protected by copyright and remain the property of AREGA. They may not be used, copied or reproduced by the customer without the latter’s consent.

12.2. Full ownership of intellectual rights to the concepts or designs provided by AREGA shall remain with AREGA unless expressly agreed otherwise in writing.

12.3. For promotional purposes, AREGA is entitled at all times to refer to services and/or goods delivered, including the customer’s identity data, as a reference on its website and social media, unless expressly agreed otherwise in writing.

Article 13 – Complaint handling

13.1. All complaints about the agreement’s execution must be submitted by the customer within five (5) working days of the latter’s discovery of the shortcomings, described clearly and in full detail, to AREGA.

13.2. AREGA will sufficiently undertake to respond to complaints lodged within a period of two (2) working days from the date of receipt. Should a complaint reasonably require a foreseeably longer processing time, AREGA will respond within two (2) working days with a notice of receipt and an indication of when the customer can expect a more detailed response.

Article 14 – Miscellaneous and dispute resolution

14.1. These GT&C are without prejudice to AREGA’s exercise of any other legal or contractual rights to which it is entitled.

14.2. The customer is prohibited from transferring its rights and obligations under the agreement concluded with AREGA without the prior written consent therefrom. Any unauthorised transfer automatically becomes null and void.

14.3. Any failure by AREGA to require the execution of the provisions of these general terms and conditions does not imply a waiver or revocation of the application of this or any other provision.

14.4. The invalidity of one or more provisions of these general terms and conditions does not preclude the application of the other provisions. Where required, the provision will be replaced by a valid, enforceable provision acceptable to both parties. Such provision must have an economic effect equivalent to that of the original provision and reflect the parties’ intent expressed therein to the greatest extent possible.

14.5. The relationship between AREGA and the customer is solely governed by Belgian law. Any dispute relating to the interpretation or implementation of these GT&C shall be submitted by AREGA to the courts of the District of Antwerp, Antwerp Division.