General terms and conditions

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General terms and conditions

Article 1 – General

AREGA PHARMA BV (hereinafter AREGA), with its registered office in 2610 Wilrijk, Laarstraat 16, is registered with the Central Enterprise Databank (CED) under the number 0722.544.585.

All agreements entered into and orders accepted by AREGA are subject to the following terms and conditions (the “GTC”), unless agreed upon otherwise in writing and in advance. These GTC are applicable to all orders sent to AREGA, except for any client general and special terms and conditions. Any special provisions that are stated on the order form and that would conflict with these GTC take precedence.

Article 2 – Quotations – Creation of the contract

2.1. Quotations and estimates are made with all rights reserved and without obligation on the part of AREGA. Quotations or estimates are only valid for the time period stated in the quotation, in principle, 30 days after creation of the quotation or the price estimate. No rights can be derived for future orders from quotations or estimates made in the past.
2.2. Orders, agreements or other arrangements are only valid if they have been confirmed in writing by AREGA.
2.3. AREGA considers its client to be the natural person or legal entity that entrusted the order to AREGA, unless it was explicitly communicated that actions are made on behalf of a third party and on the condition that the name, address and company registration number of this third party are communicated to AREGA at that same time. The person who places an order for a legal entity is jointly and severally obligated to the legal entity in whose name he/she acts.
2.4. Each change in the order must occur in writing by the client and, in principle, results in a new quotation or estimate at AREGA’s discretion and decision. In this case, AREGA is entitled to adjust the delivery period and/or rate or modify the order.

Article 3 – Execution of the contract - delivery

3.1. AREGA takes the necessary care in the execution of its entrusted orders and is only obligated to perform its best efforts. The delivery and/or execution periods are only provided as information and are therefore not binding upon AREGA, insofar as these delivery periods are in accordance with the legislation that is applicable to the relevant goods and unless otherwise expressly agreed between parties. Delivery periods are only guaranteed for goods that can be delivered from stock. However, delay in the delivery and/or execution can never lead to a penalty, compensation, dissolution of the contract or refusal to receive the goods.
3.2. At each stage in the execution of the contract, the client provides AREGA in a timely manner with all information that is deemed necessary for execution of the contract. If this required information has not been provided to AREGA in a timely manner, AREGA is entitled to suspend execution of the contract and/or to invoice the client for the additional costs resulting from the delay. Delivery addresses that have been communicated erroneously are the client’s responsibility and may lead to additional costs.
3.3. In principle, the delivery occurs via the wholesaler or directly to the client in accordance with the Guidelines from the European Commission regarding proper distribution practice for medicinal products for human use (“Guidelines 2013/C 343/01”).
3.4. Partial deliveries and/or partial executions are permitted. AREGA reserves the right to invoice these partial deliveries and/or partial executions at the time they are executed.
3.5. All risks regarding the goods, including the risks of transport, transfer to the client at the time the goods are delivered at the location stated on the order form.
3.6. AREGA reserves the right to legally dissolve the contract without prior notice of default if there are objective reasons that demonstrate that the client’s solvency and/or liquidity position has been jeopardised (for example, through bankruptcy, judicial agreement, protested bills, apparent insolvency, overdue payments at AREGA or third parties, obtaining a collective debt settlement by the client, etc.).
3.7. If AREGA learns of circumstances, after the confirmation of the order and before or during the delivery, as a result of which the contracts no longer reasonably appear to be sufficiently insured, then AREGA is entitled to demand payment in advance or sureties, where appropriate, in order to terminate the contract without any right to compensation for the client.

Article 4 – Price

4.1. The agreed upon prices are only valid for goods that can be delivered from stock and are based on the purchase price at the time of the offer or acceptance of the offer. AREGA explicitly reserves the right to increase the agreed upon price if, after acceptance of the offer, one or more of the factors that determine the price undergo an increase (including, but not limited to, the price of the raw materials or a new tax).
4.2. All prices exclude VAT and other costs (insurance, transport, etc.), unless expressly provided to the contrary. The VAT is borne by the client. Any increase in the VAT rate or any other tax of any kind that occurs between the order and the execution will be at the client’s expense.
4.3. For each order of goods for which the total value is lower than €350.00 excluding VAT, additional transport costs of at least €100.00 excluding VAT can be charged to the client unless agreed upon otherwise in writing. For clients who qualify as a pharmacy in the sense of Article 8 of the Coordinated Act of 10 May 2015 regarding the exercise of healthcare professions or as a Care Institution, a minimum order value of €200.00 excluding VAT is applicable, in the absence of which a transport cost of at least €100.00 excluding VAT can be charged.

Article 5 – Payment

5.1. AREGA’s invoices are payable in cash at its registered office, no later than within 30 days after receipt of the invoice.
5.2. Each invoice, for which the amount has not been settled or has not been fully settled by the due date, will be legally increased by a flat rate compensation equal to 10% of the amount due, with a minimum of €100.00. An interest on arrears is also legally owed that is equal to the legal interest rate in accordance with the Act of 2 August 2002 to combat the payment arrears regarding commercial transactions.
5.3. In the event that the agreed upon payment terms are not observed, all outstanding invoices and/or debts become immediately due and payable and AREGA is entitled to suspend further deliveries or to consider the contract as dissolved, without prejudice to its claim for compensation.
5.4. Without prejudice to the provisions in Article 7, the client must protest AREGA’s invoices, in the event of dispute, through a registered letter with reasons within 14 calendar days after their receipt, under penalty of forfeiture.
5.5 AREGA is entitled at all times to compensate credit balances it has from clients with debts to the client, even after concurrence.

Article 6 – Force Majeure

6.1. If AREGA cannot execute the order due to force majeure, which includes accidents, illness, fire, war, pandemic, a health crisis, strikes, lock-outs, riots, delays at suppliers, lack of transportation, etc., then AREGA is entitled to terminate the contract without any further compensation to the client.
6.2. If AREGA has already partially fulfilled its obligations when the force majeure occurs, or can only partially fulfil its obligations, then AREGA is entitled to invoice the already executed items separately and the client is obligated to pay this invoice as if it were a separate agreement.

Article 7 – Liability

7.1. Any immediately observable error regarding the delivery and any visible defect that impairs the goods entirely or partially must be established mutually in writing upon delivery with and in the presence of the carrier or his/her representative by stating reservations on the order form. In any event, each objection regarding the delivery must be communicated in writing to AREGA no later than within 14 calendar days, with any evidence of the defect (for example, a photo). Any indemnification for visible defects lapses if the defects appeared only after delivery at the agreed-upon location or if the goods have already been processed or were processed by the client or one of its agents or appointees. Invisible defects must be reported, under penalty of forfeiture, through a registered letter within eight calendar days after their discovery. However, the indemnification for invisible defects lapses if the goods have already been processed or were processed by the client or one of its agents or appointees or if the instructions for use were not followed or the goods were not handled in the appropriate manner.
7.2. In the event of defects and provided they are reported in a timely manner with the necessary supporting evidence, AREGA can decide to repair the defects in accordance with the order form or pay compensation.
If AREGA deems the complaint to be unfounded, then the goods involved or similar goods will be presented for evaluation by an independent expert to be appointed by both parties in mutual agreement. This expert’s findings are binding upon the parties. The unsuccessful party will bear the costs of the expert evaluation. If the goods are returned by the client as a result of this complaint, then the return must occur in accordance with the Guidelines 2013/C 343/01.
7.3. AREGA is responsible for the conformity of the goods it delivers in accordance with the agreed-upon specifications. This conformance is the only guarantee that AREGA provides. AREGA explicitly excludes any appeal to any other warranty, such as, but not limited to: guarantees regarding the market value of the goods, their suitability for specific use or the infringement of intellectual property rights. The client explicitly waives any appeal to such guarantees.
7.4 The client indemnifies AREGA for all damage, loss or claim resulting 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 non-compliance with a legal requirement, regulation and/or registration, or a different client failure, unless the damage, loss and/or liability is due to AREGA’s intent or gross negligence.
7.5. The compensation for which AREGA can be liable on the basis of this agreement, regardless of the cause, nature or object of the claim, and subject to the provisions in Article 3.1, shall not exceed 20% of the amounts invoiced to the client and paid during the previous contract year. In the event the client is of the opinion that it can claim such compensation, client must prove the defects and its damage in mutual consultation. The client is not permitted to withhold or postpone the payment of outstanding invoices.
7.6. AREGA cannot be held liable, however, for consequential damage and/or any indirect damage, including loss of use, lost sales or lost profit.

Article 8 – Reporting obligations regarding adverse reactions

8.1. The client acknowledges and agrees that AREGA must fully and immediately satisfy all applicable requirements in terms of the safety-reporting obligations regarding its goods. The client agrees that if it receives information about adverse reactions and/or other specific safety issues regarding the relevant goods, client will immediately inform AREGA in that regard in accordance with this Article. For the application of these GTC, adverse reactions include, among other things: exposure during pregnancy, exposure of an infant during breastfeeding, overdose, misuse, incorrect use, medication errors, lack of efficacy, contamination with infectious material, interactions between medicines, occupational exposure and any other safety information that AREGA can reasonably request.

The client must provide AREGA with all information regarding adverse reactions that it receives within one (1) working day by contacting the local AREGA contact person for pharmacovigilance, Dr. Frank Verbeeck, via the following contact data: Email: safety@arega.com; Telephone: +32 3 808 67 00 ; 24h pharmacovigilance number: +32 03 808 67 02. The client does its utmost to obtain at least minimal information about the reported adverse reactions (including the nature of the adverse reactions, the medication that was used, the person who reported the adverse reactions and the patient). If reasonably possible, the client will inform the person who reported the adverse reactions that the information regarding the adverse reactions will be transmitted to AREGA and this person will be asked whether AREGA may contact him/her directly. The client will provide reasonable assistance to AREGA so that AREGA can fulfil its legal obligations and the requests for information from the competent authorities. Notwithstanding the aforementioned, AREGA is entitled to modify its instructions regarding the time frame, criteria and manner of reporting information regarding adverse reactions, including specific safety issues. The client will be informed of these changes via separate correspondence.

Article 9 – Transfer of rights

9.1. The client only becomes owner of the delivered goods starting from the time it has fulfilled all of its obligations towards AREGA. AREGA retains full ownership of the delivered goods up until the time of full payment of its charged prices, possible interest, compensation and costs. This retention of title is an essential part of the agreement entered into between parties, without which AREGA would not have signed the contract. AREGA nevertheless permits the client, in the context of its normal business operations, to use and sell the goods in question. The resale by the client of the unpaid goods legally results in the transfer to AREGA of the client’s claim on the third party, so that AREGA has a direct right of claim against the third party.
9.2. If the client does not pay within the contractually agreed time frame, AREGA can demand the return of the goods at the client’s risk and expense. The goods that the client has in stock are considered to be unpaid goods. The goods must then be returned immediately to AREGA upon request, at the client’s expense, without prejudice to AREGA’s right to full compensation.
Parties agree that the AREGA goods are fungible, so that AREGA is permitted to invoke its retention of title regarding all goods that the client has in stock and that are equivalent to the unpaid goods. During this period of retention of title, the client assumes the duties and responsibility of custodian for the delivered goods and, as a result, client is obligated to safeguard and insure them against all causes of damage, destruction, theft, fire, loss, etc.
9.3. Notwithstanding the specified retention of title, the risk regarding the goods transfers to the client at the time the goods are delivered to the location agreed upon in accordance with the order form. If it has been agreed that the client will pick up the goods, the risk transfers as soon as the client is summoned to pick up the goods. Storage costs can be charged after this summons.

Article 10 – Compliance with anti-corruption legislation

10.1. The client is aware that AREGA and the client are obligated to comply with all applicable anti-corruption laws and regulations (hereinafter: Applicable Anti-Corruption Legislation). The Applicable Anti-Corruption Legislation prohibits the corrupt payment, offer or promise of payment, or authorisation of a payment or transfer of items of value or any other advantage, directly or indirectly, to a civil servant, or to another person, with the knowledge that all or part of the payment, items of value or advantage will be offered, given, promised or forwarded to a civil servant. Some of the Applicable Anti- Corruption Legislation also prohibits commercial bribery, for example, the unlawful payment, transfer of items of value, payment, or any unlawful advantage, directly or indirectly, to a private party with the intention of obtaining or retaining business transactions in an unacceptable manner or to influence the conduct of the recipient in an unacceptable manner.
10.2. The client declares that it has not been convicted by a government agency or by the judicial authority of violating the Applicable Anti-Corruption Legislation. The client also declares that based on this agreement, it does not or will not receive, or does not or will not use, any items of value for a purpose that would violate the Applicable Anti-Corruption Legislation, nor has it performed or will perform any action that violates the Applicable Anti-Corruption Legislation.
10.3. The client declares that, unless permitted under the Applicable Anti-Corruption Legislation, it has not made or will not make any payment, has not provided or will not provide authorisation to pay or gift any items of value, to a civil servant with the purpose of (i) influencing an act or decision by this civil servant in his/her official capacity; (ii) to persuade this civil servant to act or neglect to act contrary to this civil servant’s legal duty; (iii) to secure an unjustified advantage; or (iv) to persuade this civil servant to use his/her influence to affect any governmental act or decision regarding activities that are undertaken in the context of this agreement.
10.4. The client will record all transactions in the context of this agreement in its accounting system, accounts and other documents, in reasonable detail, accurately and honestly.
10.5. For the duration of this agreement and for a period of three years thereafter, the client will provide an independent accountant designated by AREGA with access to all client accounting documents, accounts, invoices and relevant documents relating to this agreement with the purpose of verifying compliance with the provisions of this Article and the requirements of the Applicable Anti-Corruption Legislation. The client will grant its full cooperation to an audit or investigation performed by AREGA regarding the compliance of this agreement or the Applicable Anti-Corruption Legislation.
10.6. AREGA is entitled to suspend or to terminate this agreement, as well as all payments based on this agreement, if it believes in good faith that the client has acted in violation of this Article or the Applicable Anti-Corruption Legislation.
10.7. The client guarantees that all declarations herein remain correct and accurate during the course of this agreement. The client must inform AREGA immediately if it becomes aware of a possible violation of this Article or the Applicable Anti- Corruption Legislation or any other change that would render one of the declarations herein incorrect or inaccurate. Failure to notify AREGA of such a possibility on the basis of this Article is a material violation of this agreement by the client, which entitles AREGA to terminate the contract.
10.8. This Article is only applicable insofar as the client is a wholesaler or performs wholesale activities regarding AREGA goods.

Article 11 – Privacy

11.1. By contacting or placing an order with AREGA, the client explicitly permits the processing and use of its personal data for purposes such as the administration of the client database, the management of the orders, deliveries and invoices, the monitoring of solvency, marketing and advertising. In order to execute the contract, AREGA must have the following client information: name, address, telephone number, email address and billing information. The processing for marketing purposes and individualised advertising only occurs if the client has explicitly provided approval for this purpose. AREGA will not be able to transfer the data to third parties without the client’s explicit consent. The client is entitled at any time to oppose, free of charge, the processing of the data for direct marketing purposes. AREGA is responsible for processing this data.
The processing of this data is necessary for execution of this agreement and shall not be used for other purposes.
11.2. AREGA is obliged to disclose the client’s personal data in specific circumstances. Such circumstances can be if the law, the regulations or a legal procedure requires AREGA to do so or if AREGA is requested to do so by government agencies in the context of enforcing the law or if AREGA holds that it is necessary to forward this client personal data in order to prevent damage or financial losses in the context of an investigation into fraud or other illegal activities.
11.3. If AREGA sells or transfers all or part of its activities or assets, it reserves the right to also transfer all of the client’s personal data. In that case, AREGA will make the necessary effort in order to inform the client of this fact and to ensure that the party that receives the personal data will also use it in accordance with this Article. In this case, the client must contact the recipient of the personal data for further questions.
11.4. The client is entitled to view his/her data at any time and to correct it, if necessary.
11.5. AREGA ensures an appropriate administrative, technical and physical security policy, where the client’s personal data
is protected against accidental, unlawful or unauthorised destruction, loss, alteration, access, disclosure or use.

Article 12 – Intellectual Property

12.1. The documents provided to the client before or after the creation of the contract are copyright protected and remain the property of AREGA. The client may not use, copy or reproduce these documents without consent from AREGA.
12.2. The full ownership of intellectual rights to the concepts or designs provided by AREGA remains with AREGA, unless otherwise expressly agreed in writing.
12.3. AREGA is entitled at any time to refer, as a reference for promotional purposes, on its website and social media to the
services and/or goods provided with statement of the client’s identity, unless otherwise expressly agreed in writing.

Article 13 – Handling of Complaints

13.1. The client must submit to AREGA all complaints, fully and clearly described in writing, regarding execution of the contract within five working days after the client noticed the defects.
13.2. AREGA will make all efforts to respond to complaints submitted within two working days after the date of receipt. If a complaint reasonably requires a foreseeable longer processing time, AREGA will respond within two working days with an acknowledgement of receipt and an indication of when the client can expect a more detailed answer.

Article 14 – Miscellaneous and Resolution of Disputes

14.1. These GTC do not affect AREGA’s exercising of all other legal or contractual rights to which it is entitled.
14.2. The client is prohibited from transferring its rights and obligations under the agreement entered into with AREGA without prior written consent from AREGA. Any unauthorised transfer will be legally void.
14.3. Any failure by AREGA to demand execution of the provisions in these GTC cannot imply any waiver or renunciation of the application of this or any other provision.
14.4. The invalidity of one or more provisions of these GTC does not affect the application of the other provisions. If necessary, the provision will be replaced by one that is acceptable and enforceable according to both parties and that will correspond with the original provision in terms of economic consequences and that will reflect as much as possible the parties’ intent described in the provision.
14.5. Only Belgian law is applicable to the relationship between AREGA and the client. AREGA will submit any dispute regarding the interpretation or execution of these GTC to the Antwerp district courts, Antwerp division.

BE-ARMED-OTC-2020-10-0034


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