GENERAL SALES CONDITIONS OF AMSTELFARMA B.V. V.1/2021

1. General definitions and scope of application

1.1. These General Conditions shall apply to all offers, quotations, supplies and services in the broadest sense to be rendered by the private limited liability company Amstelfarma B.V., having its registered offices at the Zuiveringweg 40 in (8243 PZ) Lelystad, the Netherlands, with Commercial Register number 39064879, (hereinafter to be referred to as "AMSTELFARMA"), as well as to all (additional) agreements between AMSTELFARMA and a customer (hereinafter to be referred to as the "Customer").

1.2. For purposes of these General Conditions the Customer shall be taken to mean: any entity that has entered, or wishes to enter, into an agreement with AMSTELFARMA, in which AMSTELFARMA undertakes to provide pharmaceuticals, (medical) supplies, and other (medical) products and/or services (hereinafter jointly to be referred to as the “products”), as well as any of their legal successors.

1.3. As part of AMSTELFARMA’s customer qualification procedure, the Customer must upon request provide proof that such procedure was followed then to be approved by AMSTELFARMA The Customer shall ensure it supplies pharmaceuticals  products only to persons/organizations who are themselves in possession of a wholesale distribution authorization or who are authorized or entitled to supply pharmaceutical  products to the public according to their national law.

1.4. Any additional and/or derogating conditions, including purchase conditions, of the Customer shall not form part of the agreement between AMSTELFARMA and the Customer and shall not be binding upon AMSTELFARMA, unless AMSTELFARMA has accepted all or part of the Customer’s conditions in writing.

1.5. Any deviations to these General Conditions shall be binding only if and to the extent agreed in writing between AMSTELFARMA and the Customer and only for the offers, quotations, supplies, services and (additional) agreements to which they relate. The other offers, quotations, supplies, services and (additional) agreements shall remain fully governed by these General Conditions.

1.6. In the event that the General Conditions and another agreement contain mutually conflicting clauses, these General Conditions shall prevail.

2. Quotations and orders

2.1. An order shall not come into effect until AMSTELFARMA accepts it in writing by means of an order confirmation, sent after the Customer’s acceptance of the offer, or after the Customer placing an order for delivery. The order confirmation shall be deemed correctly and fully to represent the agreement. Any additional arrangements or amendments shall be binding only if confirmed by AMSTELFARMA in writing. The quantity, description and any specification for the goods shall be those set out in AMSTELFARMA’s sales acknowledgment. Without feedback from the Customer, AMSTELFARMA will assume the order to be correct.

2.2. All intellectual and industrial property rights (including but not limited to copyrights) in manufacturer- or AMSTELFARMA-labelled products supplied, packaging and/or inserts, shall be owned by AMSTELFARMA and/or third parties. The Customer shall not be entitled to use any such packaging and/or inserts without AMSTELFARMA’s explicit written consent.

2.3. The Customer, acting in the course of a profession or business, will not be subject to Articles 6:227b (1) and 6:227c of the Dutch Civil Code

2.4. AMSTELFARMA shall be entitled at any time by notice to the Customer to cancel or refrain from any order in circumstances where it becomes impracticable or uneconomical for AMSTELFARMA to carry out the contract at the offered rate and the customer shall have no claim whatsoever against AMSTELFARMA for any loss, damage, cost or expense that the Customer might incur as a result of AMSTELFARMA cancelling or refraining from the order.

2.5. By placing the order the Customer confirms it holds or will arrange on time the relevant licenses, registrations and permits necessary to purchase and/or import the goods in the country of destination. For delays, please refer to point 4.2

3. Price

3.1. Price quotations made by AMSTELFARMA have a validity of 30 days from the date of the quotation, unless otherwise stated in its offer.

3.2. The price of products to be supplied by AMSTELFARMA is communicated in AMSTELFARMA’s price list. These prices stated shall only serve as guidelines, and the Customer cannot derive any rights from the information in the price list.

3.3. Unless specifically agreed otherwise, all prices quoted by AMSTELFARMA shall be in Euro or US Dollars and exclusive of Dutch VAT (BTW), import duties, and other taxes, levies or rights, costs of packing, costs of loading and unloading, and costs of transport and insurance.

3.4. Unless specifically agreed otherwise, the costs of any third parties engaged in the performance of the agreement shall in no event be deemed to be included in the offers issued by AMSTELFARMA.

3.5. After the agreement has been entered into, AMSTELFARMA may adjust the price or dissolve the agreement if any factors justifying that should occur. Such factors may include, but are not limited to: an increase in the prices of raw materials, labour and production costs, fuel costs, import duties, taxes, currency changes, etc.

3.6. All transport prices quoted shall be based on the prices that apply at the time of the order confirmation. If between the time of the order confirmation and the time of shipment, one or more of the cost factors (including fees, wages, the cost of social measures and/or laws, freight prices and exchange rates, etc.) increase, AMSTELFARMA is entitled to pass on this increase to the Customer. AMSTELFARMA must be able to prove the changes.

3.7. In the event of circumstances that are of such a nature that at the time of concluding the agreement it was not deemed necessary to take into account the risk that could occur, and that cannot be attributed to AMSTELFARMA and that significantly increase the costs of the services being performed, AMSTELFARMA is entitled to an additional payment. Where possible, AMSTELFARMA shall consult in advance with the Customer. In such a case, the additional payment shall consist of the additional costs that AMSTELFARMA has had to incur in order to perform the services, plus an additional payment deemed fair and equitable for the services to be performed by AMSTELFARMA.

4. Delivery Period and Terms

4.1. Unless agreed otherwise in writing, delivery conditions shall be the prevailing Incoterms, clause FCA [location].

4.2. AMSTELFARMA may grant a free storage period never to exceed the period of two weeks, to be agreed from the moment of order readiness, after which AMSTELFARMA will be entitled to charge the customer with a tariff of Euro 7.50 per pallet per week.

4.3. The delivery period shall be determined based on the agreements made between the parties. Any delivery periods stated shall, however, be indications only and shall in no event be deemed to be deadlines, unless agreed otherwise.

4.4. If AMSTELFARMA has stipulated a down payment/advance payment/bank guarantee/letter of credit from the Customer, and AMSTELFARMA has not received this by the agreed date, AMSTELFARMA may adjust the agreed delivery period accordingly.

4.5. As soon as AMSTELFARMA establishes that an expected delivery period will be exceeded, AMSTELFARMA shall contact the Customer in that respect. The Customer’s obligations shall remain unchanged.

4.6. AMSTELFARMA reserves the right within a reasonable tolerance range  to deviate from the agreed quantities for each type of product to be supplied, without any right on the Customer’s part to delivery or return of the discrepancies between the quantity delivered and the quantity agreed, nor shall the Customer be entitled to any damages or dissolution of the agreement. In such event AMSTELFARMA shall adjust the price accordingly – either upward or downward.

4.7. AMSTELFARMA reserves the right to make changes to (the composition of) the products to be supplied by it, if required based on amendments to legislation and/or regulations. AMSTELFARMA warrants that any such changes shall not impair the functional characteristics of such products.

4.8. AMSTELFARMA reserves the right to make partial deliveries, in which event the (payment) terms and conditions set forth below shall also apply to each partial delivery.

4.9. The delivery date specified by AMSTELFARMA is an estimate only. Time for delivery shall not be regarded as the essence of the agreement. AMSTELFARMA will make its best efforts to make the delivery date. Agreed delivery and completion periods can never be regarded as strict deadlines. If AMSTELFARMA does not deliver the products, AMSTELFARMA must be given a written notice of default and granted a reasonable period in which to comply with its delivery obligations.

5. Receipt of Goods by Customer

5.1. The Customer shall take delivery of the products delivered on the agreed date.

5.2. If the Customer fails to take delivery of the products on the agreed date, the Customer shall be in default, without any further notice of default being required, and AMSTELFARMA may, at its option: (i) dissolve the agreement without any judicial intervention being required; (ii) ship the products at the Customer’s expense and risk; (iii) store the products at the Customer’s expense and risk. All costs ensuing from the foregoing circumstances, including but not limited to the costs of storage and possible decrease in revenue, shall be paid by the Customer. The foregoing shall not affect any other rights that AMSTELFARMA may have.

6. Payment

6.1. Unless agreed otherwise in writing, payment of the invoices shall be made by transfer to a bank account designated by AMSTELFARMA in line with agreed payment terms on order confirmation or invoice. Payment shall be made without deduction of any discount, bank charges or setoff. AMSTELFARMA reserves the right to require advance payment, a down payment, a Letter of Credit, or a bank guarantee (the latter two to be issued by an internationally recognized organization). In case of receipt of a signed Purchase Order, AMSTELFARMA will keep stock reserved for 7 days until advance payment or down payment are received. Unless the payment is received within this window, AMSTELFARMA will cancel the order on the 8th day and will not be held responsible to supply in case of shortage.

6.2. Unless it is agreed otherwise in writing, payment of the invoices shall be made by the Customer. If the parties have agreed that payment will be made by a third party, AMSTELFARMA shall remain entitled, if such third party fails in any way whatsoever to perform its payment obligation, to claim payment by the Customer.

6.3. Payment shall not be deemed to have been made until the amount due has been irrevocably credited to AMSTELFARMA’s bank account.

6.4. In the event of failure to pay by the due date, the Customer shall be in default by operation of law as from expiry of the payment term, without further notice of default being required. Late payment entitles AMSTELFARMA to charge past-due interest as set by the Dutch Central Bank (De Nederlandsche Bank N.V.), on the payable amount (including Dutch VAT) from the date of default onward. In addition, AMSTELFARMA will be entitled to charge a collection fee, with a minimum of  EUR 150.

6.5. If the Customer is in default in the performance of any of its obligations, all reasonable costs incurred to obtain payment out of course shall be paid by the Customer, such costs to be set at the amounts calculated on a reasonable basis, without prejudice to AMSTELFARMA’s right to charge the actual costs incurred if such costs exceed the amount calculated.

6.6. Payment of a sum attributable to a certain obligation shall in the first instance go to reduce the costs, subsequently to reduce interest that has fallen due, and finally to reduce the longest outstanding payable invoices and current interest.

6.7. Upon or after entering into the agreement, AMSTELFARMA may require the Customer to provide security with respect to both the payment obligations or other obligations of the Customer, before commencing or continuing work. If the Customer fails to provide security within the term set by AMSTELFARMA, AMSTELFARMA may dissolve the agreement out of court and the Customer shall be liable for all damage resulting from such dissolution.

7. Retention of Ownership

7.1. AMSTELFARMA retains ownership of all products supplied by AMSTELFARMA to the Customer. Ownership of such products shall not pass to the Customer until the Customer has performed all its payment obligations under this and any similar agreements.

7.2. If the Customer has not performed its payment obligations, the Customer may not establish any right of pledge or non-possessory pledge for third parties on the products supplied by AMSTELFARMA, or in any way or under any title whatsoever surrender control of, such products, save as provided in article 7.3. In the event of confiscation of the delivered goods by a (non) governmental organisation or a third party, on any ground whatsoever, the Customer shall immediately notify AMSTELFARMA in writing and shall keep the product in its custody in proper and effective storage until the moment that the relative situation has been clarified and Amstelfarma may have agreed to the dissolution of the product or otherwise. Should the Customer not act in line with these agreed terms and the product is lost or damaged, then Customer will be liable for the (consequential) damages so caused.

8. Complaints

8.1. Upon taking delivery, the Customer shall inspect the products supplied, including packaging, for any visible damage and/or missing items. In case of visible defects, these should be reported in writing to AMSTELFARMA immediately, at least within three (3) days, or the Customer forfeits their rights in this respect. Any visible damage or missing items shall be reported by the Customer on the transport document or the delivery note. Any report must accurately state the nature of, and the ground for, the complaints, otherwise the Customer shall be deemed to have accepted the products delivered. Putting the products into operation shall be deemed to constitute acceptance. Should the Customer observe damage of which the condition is not yet certain, this should also be reported. In no circumstances, except under written protest, should the Customer give clean receipts if they have observed a shipment in potentially damaged condition.

8.2. Complaints for hidden damages or losses should be reported to AMSTELFARMA in writing (giving a clear description of the complaint) within thirty (30) days after arrival at the customer/PR as per the agreed Incoterm. In the event of a complaint about the quality of a product and a potential product defect which is not immediately visible, the Customer shall inform AMSTELFARMA in writing (giving a clear description of the complaint). Any complaints of hidden damage or missing items discovered on opening containers, cases and/or packages should be reported immediately to AMSTELFARMA, at least within thirty (30) days after arrival at the Customer as per the agreed Incoterm, or the Customer forfeits their rights in this respect.

8.3. In the event of a complaint, the Customer shall be under an obligation to make a sample of the concerned products/ batches available to AMSTELFARMA. Moreover, the Customer shall provide its co-operation in an investigation by AMSTELFARMA, if needed.

8.4. A complaint does not entitle the Customer not to perform its (payment) obligations towards AMSTELFARMA nor to invoke suspension of payment.

8.5. The aforementioned terms shall not affect the Customer’s statutory rights in the event of hidden damages or losses to the products delivered.

8.6. If a complaint is filed and justified, AMSTELFARMA shall at its discretion be solely obliged to deliver the missing products, replace the products delivered or take the products back and credit the Customer for the relevant invoice amount. In no event shall AMSTELFARMA be under any other obligation whatsoever, including any obligation to pay any other costs and/or damages.

8.7. If AMSTELFARMA and the Customer do not agree that a quality complaint is justified, then an independent laboratory will be appointed upon mutual agreement by all involved parties. The laboratory will investigate the quality complaint and the outcome shall be accepted by all parties.

8.8. The products may be returned only with AMSTELFARMA’s prior written consent, under conditions subsequently to be determined by AMSTELFARMA. If products are returned without AMSTELFARMA’s consent, shipment and storage of the products shall be at the Customer’s expense and risk. Products may never be destroyed without AMSTELFARMA’s permission.

9. Reporting quality-related product issues

9.1. The Customer shall promptly notify AMSTELFARMA in writing of any incidents and/or (serious) side effects that may occur in relation to any products supplied, also if a complaint is received from an end user. ‘Incidents’ shall be taken to mean any incident in relation to a product that has resulted in death, serious deterioration of the health condition (including but not limited to life-threatening illness or injury; permanent impairment of a bodily function or permanent damage to the body structure; or a situation that requires medical or surgical intervention to prevent permanent impairment of a bodily function or permanent damage to the body structure) or that could have resulted in death or serious deterioration of the health condition. “(Serious) side effects” shall be taken to mean any reaction that may occur in relation to the products supplied that is damaging and unintended and that occurs in dosages normally used.

9.2. The Customer shall promptly report any pharmacovigilance incidents, adverse reactions, special situations (with or without associated adverse drug reactions) for products supplied by AMSTELFARMA Foundation. Furthermore, the Customer shall report all observed pharmacovigilance cases to their health authorities according to their local national laws.

9.3. Furthermore, the Customer shall provide AMSTELFARMA all the support that may reasonably be required of it relating to reporting any incidents and (serious) side effects to the relevant authorities.

9.4. In filing the report, the Customer shall provide AMSTELFARMA with all documentation and other relevant information in connection with the relevant incident and/or (serious) side effect in order to enable AMSTELFARMA fully to perform its obligation to notify the relevant authorities of any such incidents and/or (serious) side effects within good time.

10. Warranty

10.1. AMSTELFARMA warrants that upon delivery, the product is free from any major defects in material and design and satisfies requirements of quantity and quality as shown in the written order confirmation and the applicable product specifications.

10.2. Any documentation, disclaimers and advice in respect of the use and properties of the products supplied, other advice and assistance shall be drawn up and/or provided by AMSTELFARMA to the best of its knowledge and ability. AMSTELFARMA does not warrant the correctness and completeness of the information thus obtained.

10.3. All other (implied) conditions and warranties with respect to the quality of the products or their suitability for their intended use are expressly excluded, unless explicitly agreed otherwise in writing between the parties.

10.4. Any third-party products shall be supplied only subject to the warranty provisions of the relevant third parties, which AMSTELFARMA shall provide to the Customer upon request.

11. Use of products by customer (obligations /indemnifications)

11.1. The Customer shall use the products supplied in accordance with AMSTELFARMA’s (storage) instructions only. In no event shall the Customer use the products supplied in any way that is contrary to, or otherwise derogates from, AMSTELFARMA’s objects, without AMSTELFARMA’s prior written consent.

11.2. If the products supplied – if such products are pharmaceuticals – are not registered in the country of destination, the Customer warrants AMSTELFARMA that it is authorised to distribute such pharmaceuticals there.

11.3. If the products supplied are psychotropic and/or narcotics, the Customer shall, prior to delivery, provide AMSTELFARMA with an original copy of the import license issued by the authorities of the country of destination, for the purpose of AMSTELFARMA’s obtaining an export license.

11.4. The Customer shall indemnify AMSTELFARMA against the consequences of any third party claims, costs and damage ensuing from the Customer’s failure to perform its obligations under this article.

12. Liability

12.1. AMSTELFARMA’s liability to the Customer shall be limited to AMSTELFARMA’s obligations as set forth in articles 8 (Complaints) and 10 (Warranty).

12.2. Save in the event of intentional act or gross negligence on AMSTELFARMA’s part, AMSTELFARMA shall in no event be liable for any damage suffered by the Customer. Furthermore, any liability for indirect damage, consequential damage, nonmaterial damage, business or environmental damage, or damage as a result of liability to third parties, is excluded.

12.3. If and to the extent that, despite the provisions of article 12.2, AMSTELFARMA is subject to any liability on any ground whatsoever, such liability shall be limited to a maximum amount of € 2,500,000 (in words: two and a half million Euro)  per damage event, or to the maximum amount under its insurance coverage, whichever is higher. For purposes of this article, a series of related damage causing events shall be deemed to constitute one (damage) event.

13. Recall

13.1. The Customer agrees to assist AMSTELFARMA in carrying out a recall, if any. To that end the Customer is obliged to keep adequate records for traceability of the products supplied for a period of at least five (5) years after the date of sale or use of the products supplied. The records shall at least contain information about dates of sales or use, quantities, batch numbers and batch specifications and all such other information as may be necessary for a possible recall. AMSTELFARMA shall always be entitled to inspect such records or to receive copies thereof from the Customer.

13.2. In the event of a product recall, the Customer shall render its full cooperation, by following instructions as provided by AMSTELFARMA in a product recall letter, so that this recall can be carried out promptly and effectively. If the Customer fails to render its full and prompt cooperation to the conditions set forth in this article, AMSTELFARMA shall hold the Customer liable for any damage suffered or to be suffered by AMSTELFARMA, including but not limited to damage pursuant to the product liability rules and damage as a result of negligence.

13.3. AMSTELFARMA shall be obliged to compensate the Customer only to the extent that the Customer meets all the requirements set forth in this article. AMSTELFARMA's liability in the event of a recall shall be limited to payment of the price at which the Customer had purchased the products covered by the recall or replacement of such products, all at AMSTELFARMA's sole discretion.

14. Cancellation of orders

14.1. Orders may, in principle, not be cancelled by the Customer. If, however, the Customer cancels all or part of an order, it shall be under an obligation to reimburse all costs reasonably incurred with a view to performance of such order (including costs of preparations, storage, unpacks etc.). Furthermore, the Customer shall compensate any costs ensuing from the cancellation and exchange differences, if any, if AMSTELFARMA has entered into a currency agreement with a bank or another third party in connection with the order.

14.2. Without prejudice to the provisions of article 14.1 in the event of cancellation the Customer shall pay cancellation costs equal to ten percent (10%) of the principal amount, to be increased by VAT (Dutch BTW), when applicable.

15. Termination of the Agreement

15.1. Both the Customer and AMSTELFARMA have the right to dissolve an agreement with immediate effect, without requirement of judicial intervention if the other party is declared insolvent or bankrupt or if the other party has been granted a (provisional) moratorium on payment of its debts, or if the other party, after having been given written notice of default, continues to fail to perform any of its obligations. The terminating party shall not be under any obligation whatsoever to pay damages. The aforementioned grounds shall not be deemed to be exhaustive; other serious grounds may also result in termination of the agreement with immediate effect.

15.2. Article 15.1 shall not prejudice the option of dissolution of the agreement pursuant to law.

15.3. Without prejudice to the provisions of article 15.1, if the Customer fails to perform properly, or in good time, any of its obligations under an agreement with AMSTELFARMA and/or these General Conditions, AMSTELFARMA shall be entitled to suspend all or part of its obligations under the agreement and any directly related agreements, until the Customer has performed its corresponding obligations. In such event the Customer shall be under an obligation to compensate all damage, including damage as a result of lost profits, to be suffered by AMSTELFARMA.

15.4. If the agreement is terminated early by either party, or in the event of suspension of the obligations under the agreement, AMSTELFARMA shall remain entitled to payment of invoices for deliveries made up until that point in time.

15.5. The parties’ rights and obligations as set forth in articles 9 (Reporting Quality-related Product Issues), 11 (Use of Products by Customer (Obligations/Indemnifications)), 12 (Liability), 13 (Recall), and 17 (Confidentiality) shall survive termination of an agreement between the parties.

16. Force Majeure

16.1. AMSTELFARMA shall not be bound to perform any obligation under an agreement if prevented from doing so due to force majeure.

16.2. For the purpose of this article, “force majeure” shall be taken to mean any circumstances of such a nature that, as a result, the performance of an agreement is rendered impossible, and/or disproportionally expensive to such an extent that AMSTELFARMA cannot reasonably be required to continue to perform, or immediately to perform, the agreement.

16.3. Force majeure shall in any event include but not be limited to:

-  war, international conflict, invasion, aggression of a hostile power, restrictive government measures, and similar situations;

- uprising, terrorism, revolution, rebellion, civil war or acts by military/civil militias, and similar situations;

- riots, insurgency, disturbance of public order, strike and lockouts by staff of AMSTELFARMA or third parties engaged by AMSTELFARMA, and similar situations;

- natural disasters, such as earthquakes, flooding, hurricanes, typhoons, extreme weather, volcanic activity, pandemics/epidemics, and similar situations;

- transport problems or obstructions (e.g. harbour, truck and aircraft problems), including delays at country borders, and similar situations;

- unforeseen technical complications and similar situations;

- qualitative rejection by AMSTELFARMA of the products to be supplied;

- a situation where a third-party performance, important to the performance to be rendered by AMSTELFARMA, is not/not properly/punctually rendered to AMSTELFARMA, and similar situations.

16.4. AMSTELFARMA shall notify the Customer in writing of its reliance on force majeure within seven (7) days of the occurrence, with the reasons and circumstances constituting force majeure. The notice referred to in the foregoing sentence shall in any event include (1) the obligations that AMSTELFARMA is unable to perform due to the situation of force majeure, and (2) the expected duration of force majeure.

16.5. If the situation of force majeure has exceeded a period of one hundred and eighty (180) days, either AMSTELFARMA or the Customer may terminate the agreement by dissolution, without any judicial intervention being required. In such event the Customer shall not be entitled to any damages.

16.6. The customer may not dissolve the agreement, unless (1) the Customer can demonstrate that timing of the performance is of the essence to its business operations, and (2) moreover, the situation of force majeure is not expected to end within the foreseeable future (60 days). In such event dissolution shall be effected in writing not later than five (5) days of expiry of the period referred to in 16.5. In such event the Customer shall compensate the damage suffered by AMSTELFARMA as a result of dissolution.

16.7. During the period of force majeure AMSTELFARMA shall take all reasonable measures to arrange termination of the situation of force majeure or to mitigate the adverse effects thereof for the Customer. AMSTELFARMA shall notify the Customer of the measures referred to in the foregoing sentence.

16.8. As soon as the situation of force majeure has ended, AMSTELFARMA shall notify the Customer, stating in any event when AMSTELFARMA will resume delivery.

16.9. If upon occurrence of the situation of force majeure AMSTELFARMA has already performed, or can perform only, part of its obligations, it may invoice the part that has already been delivered or that can be delivered separately. The Customer shall pay such invoice as if it were a separate agreement. In the event of force majeure AMSTELFARMA shall also be entitled to charge the costs to be incurred by it as a result of such situation of force majeure to the Customer, including but not limited to costs of storage, costs as a result of demurrage, and any lower revenue. Any costs ensuing from the foregoing shall, just as any outstanding invoices in that respect, be paid by the Customer before any obligation can arise on AMSTELFARMA's part - after the situation of force majeure has ended - to deliver the relevant products.

16.10. All additional logistic costs caused by force majeure, such as transport and storage charges, warehouse or yard rental, demurrage and standing fees, insurance, removal, etc., shall be borne by the Customer and shall be paid to AMSTELFARMA at the latter's first request. If the Customer consistently imputably fails to fulfil one or more of its obligations under the Agreement, without prejudice to its right to compensation for any damage that may have been suffered, AMSTELFARMA can dissolve the Agreement with immediate effect in full or in part after, by registered letter, it has stipulated a deadline to the Client of at least fourteen days for fulfilment of the obligations and upon expiry of that deadline, the Customer has not yet fulfilled its obligations. If, by stipulating such a period, AMSTELFARMA’s interests in the undisturbed conduct of its business would be impaired disproportionately, AMSTELFARMA may dissolve the Agreement without observing a time limit.

17. Confidentiality

17.1. The Customer is bound to confidentiality regarding information and data received from AMSTELFARMA in the context of an agreement. Information and data shall be deemed to be confidential if so labelled by AMSTELFARMA or if such confidentiality ensues from the nature of the information and/or data, in any event including all information related to incidents and serious side effects as referred to in article 13.

17.2. Article 17.1 shall not apply in the event of information that is in the public domain or that the Customer has lawfully obtained, other than through AMSTELFARMA, or if the Customer is required to disclose confidential information to third parties pursuant to a statutory regulation or in the context of performance of its obligations under the agreement.

18. Assignment

18.1. Without the prior written consent of AMSTELFARMA, the Customer may not assign its rights and/or obligations under an agreement entered into with AMSTELFARMA to any third parties. AMSTELFARMA shall not unreasonably withhold its consent.

18.2. AMSTELFARMA may assign its rights and obligations under the agreements entered into between AMSTELFARMA and the Customer to another (legal) entity, either affiliated with AMSTELFARMA or otherwise, which assignment shall release AMSTELFARMA from its obligations vis-à-vis the Customer. AMSTELFARMA shall notify the Customer of the assignment by registered letter. The Customer hereby agrees with such assignment, if any.

19. Consequences of Voidness or Voidability

19.1. If any provision of these General Conditions should be void or nullified, the other provisions of the General Conditions shall remain in full effect, and the parties shall consult to agree on new provisions to replace the void or nullified provisions, observing the intent of the void or nullified provisions to the extent possible.

20. Applicable Law and Disputes

20.1. The offers, quotations, supplies and (additional) agreements, and performance thereof, as well as these General Conditions themselves, shall be governed by the laws of the Netherlands.

20.2. Any disputes arising as a result of, or in connection with, the agreements with Customers established within the European Union, which are governed by these General Conditions, or the relevant conditions themselves, as well as their construction or performance, either of a factual or of a legal nature, shall be submitted to the competent court in Amsterdam, the Netherlands, to the extent not dictated otherwise by statutory provisions. Any such disputes arising as a result of agreements with Customers established outside the European Union shall be resolved by arbitration in accordance with the arbitration rules of the International Chamber of Commerce (ICC) in Paris, France. The place of arbitration shall be Amsterdam, and arbitration shall be conducted in the English language. The chairman of the ICC shall, at his option, appoint one (1) or three (3) arbitrators, provided that he will consider the interest of the matter in relation to the arbitration costs to be incurred in his decision.

21. Amendment and Location of the Conditions

21.1. AMSTELFARMA may make amendments to these General Conditions, which shall take effect at the announced effective date, save with respect to any orders agreed prior to such date. AMSTELFARMA shall provide the Customer with the amended conditions in good time. If no effective date has been announced, any amendments shall take effect vis-à-vis the Customer as soon as it has been notified or has taken cognizance thereof, save with respect to any orders agreed prior to such date.