Preamble

These are the General Terms and Conditions (GTC) that shall apply to all orders, purchases and sales agreements entered into by Customize Medical. No account can be created without agreeing with these GTC. Without an account, no orders can be placed. The present GTC shall also apply to all agreements between Customize Medical and the Client when services of third parties are involved. Any differing conditions or terms of buyer are herewith objected to and shall not apply unless explicitly agreed upon in writing.

Offers and orders

Offers are free of obligation by both parties and are valid for thirty (30) days. An order is binding only after it has been signed by the Client.

Execution of the Agreement

Customize Medical shall execute the agreement to the best of its ability and in accordance with the requirements of good manufacturing practice. If required for the proper execution of the agreement, Customize Medical shall have the right to have services provided by third parties. The Client shall ascertain that Customize Medical shall be provided in due time with all digital data and other materials that are necessary for the timely execution of the agreement.
Customize Medical can suspend the execution of the agreement belonging to a following step in the production until the Client has approved in writing the results of the stage before.
Unless expressly stated otherwise, all deliveries of goods shall be DAP. Customize Medical’s DAP shall have the meaning assigned to the same in the latest version of INCOTERMS published by the International Chamber of Commerce at Paris, France, at the time of the conclusion of the agreement.
Unless expressly stated otherwise, any times or dates for delivery by Customize Medical are estimates.
Customize Medical shall not be liable for injury, either physical, psychological or financial loss caused by the fact that Customize Medical worked on the basis of incorrect, incomplete, or untimely data procured by the Client.

Changes to the agreement

Customize Medical shall indicate the degree to which any change in the execution of the agreement as requested by the Client will increase the final price. A signed addendum to the agreement will confirm the changes.

GDPR

General Data Protection Regulation (GDPR) applies.
If a judicial decision compels Customize Medical to convey confidential information to third parties designated by law or by the court and Customize Medical cannot for that purpose invoke a legal right to refuse to give evidence or such a right acknowledged or allowed by the competent court, Customize Medical shall not be held to pay damages or compensation and the Client shall not be entitled to demand the dissolution of the agreement on the ground of any damage resulting from said circumstance.

Intellectual property and copyrights

All intellectual property rights resulting from the execution of the agreement (including patent rights, design rights, and copyright) accrue to Customize Medical unless explicitly stated otherwise in the agreement. Insofar as this right can only be obtained by depositing, only Customize Medical has the right to do so.
Customize Medical is not obliged to investigate the existence of rights of third parties, such as patent rights, trademark rights, design rights, copyrights, or portrait rights or to conduct a study into the possibility to develop such rights in favor of the customer, unless expressly stated otherwise in the agreement.
All documents, such as reports, advice, agreements, designs, sketches, drawings, software and prototypes, etc., provided by Customize Medical, may not be reproduced, made public, or brought to the notice of third parties by the Customer, unless the nature of the documents and goods dictate it differently.

Fee and price

Customize Medical and the customer can agree to a fixed price at the time the agreement is concluded.
If no fixed fee has been agreed, the fee or price for Customize Medical services will be determined based on the number of hours spent on the work (calculated following the usual hourly rates of Customize Medical, unless another hourly rate has been agreed) and the overhead and production costs that implied.

Payment

Customize Medical is authorized to invoice each month for work performed and costs incurred in connection with the agreement.The payment must be made within thirty (30) calendar days after the invoice date by transfer to a bank account specified on the invoice.
If Customize Medical has not received the (full) payment after the expiry of the payment term, the Client is legally in default. In that case, the Client will owe an interest equal to the European statutory commercial interest.
All costs and expenses of Customize Medical, such as court costs and extrajudicial and judicial costs and expenses, including the costs of legal assistance, bailiffs, and collection agencies, are at the expense of the customer. The extrajudicial costs are deemed to amount to at least ten percent (10%) of the invoice amount.
Claims relating to an invoice must be submitted within ten (10) days of the invoice date. Then the customer is deemed to agree with the invoice.

Reservation of ownership (retention of title)

All goods delivered by Customize Medical, including designs, sketches, drawings, films, software, (electronic) files, etc., remain the property of Customize Medical until the Client has fulfilled all its obligations under all agreements concluded with Customize Medical.
The Client is not authorized to pledge or encumber the goods that are subject to the retention of title in any way.
If third parties seize delivered goods that are subject to retention of title or wish to establish or assert rights thereon, the client is obliged to report this immediately to Customize Medical.
The Client undertakes to insure and keep insured the goods delivered under retention of title against damage caused by fire, theft, explosion, and water and makes this insurance available for inspection at first request.
Goods delivered by Customize Medical that fall under the retention of title according to this article may only be resold in the context of normal business activities and may never be used as a means of payment.
In the event that Customize Medical wishes to exercise ownership rights mentioned herein, the Client will grant unconditional and irrevocable consent to Customize Medical or third parties appointed by Customize Medical to gain access to all locations where Customize Medical goods can be found and to take them back.

Warranty

Customize Medical guarantees exclusively the construction of the delivered parts of the goods. This guarantee is valid for sixty (60) months from delivery unless otherwise agreed in writing.
The guarantee only applies if the fault is not due to the customer or the patient. The warranty is, at the discretion of Customize Medical, limited to repair by or on behalf of Customize Medical or replacement of the relevant part or item.
The Customer must send the goods that are eligible for repair or replacement to the address indicated by Customize Medical at their own expense and risk. Customize Medical is entitled to charge transport costs to the Customer for sending repaired or replacement goods.

Complaints

The Client must inform Customize Medical in writing of complaints about the work carried out within ten (10) days after the discovery, but no later than within twenty (20) days after completion of the relevant work.
If a complaint proves to be well-founded, Customize Medical will perform the work as agreed, unless this has demonstrably become useless for the Customer and this has been communicated in writing by the Client to Customize Medical.

Liability

Customize Medical cannot be held liable for results that are not achieved because under the agreement it is only obliged to use its best effort. Patient specific implants are made on doctor’s prescription. The physician / surgeon / dentist is responsible for the implant design and the implantation.
Customize Medical is never liable for damage caused by loss of profit or missed savings and indirect damage or consequential damage.
If Customize Medical is liable for direct damage, then this liability is limited to a maximum of the invoiced amounts. The liability of Customize Medical is at all times limited to a maximum equal to the amount of the payment by the professional liability insurer of Customize Medical in the occurring case.
In the case of an assignment with a duration of more than 6 months, the liability in deviation from the provisions is also limited to the part of the price or the fee owed in the last six months.

Indemnification and Warranty Client

The customer indemnifies Customize Medical against claims by third parties with regard to the use of the services of Customize Medical and the use of the delivered goods.
The customer indemnifies Customize Medical against claims by third parties regarding intellectual property rights to material or data provided by the customer, which are used before and during the execution of the agreement.
If the Client provides Customize Medical with information carriers, electronic files or software etc., it guarantees that the information carriers, electronic files or software are free of viruses and defects.

Force Majeure

Customize Medical and the Client are not obliged to fulfill their obligations if they are prevented from doing so by force majeure.
In addition to the provisions of the judicial law in this connection, force majeure in these general terms and conditions is understood to mean any external circumstance, whether intended or not, on which Customize Medical cannot exert any influence but which prevents Customize Medical from fulfilling its obligations. Strikes at the company of Customize Medical are also regarded as a circumstance of force majeure.

Cancellation

Customize Medical and the Customer have the right to cancel the agreement at any time.
If the agreement is terminated prematurely by the Customer, Customize Medical shall be entitled to compensation for the loss of occupancy rate to be demonstrated as a result of the premature termination and the related external costs, unless the termination is based on facts and circumstances that can be attributed to force majeure. In that case, the Client will also be obliged to pay the invoices for the work performed up to that time and related costs and expenses.
If the agreement is terminated prematurely by Customize Medical, it will take care of transferring the work still to be done to third parties together with the Client, unless the termination is based on facts and circumstances that can be attributed to the Client. If the transfer of the work still to be performed entails extra costs for Customize Medical, the aforementioned costs will be charged to the Client.

Suspension and dissolution

Customize Medical is entitled to suspend the fulfillment of the obligations under the agreement or to dissolve the agreement if:
- Client does not or does not fully meet its obligations arising from the agreement;
- After the agreement has been concluded, Customize Medical will be informed of circumstances that give good reason to fear that the client will not fulfill his obligations and the shortcoming justifies the suspension or dissolution;
- Other circumstances arise such that the unaltered maintenance of the agreement can no longer be reasonably demanded.
If the agreement is dissolved, the claims of Customize Medical on the Customer are immediately due and payable.
Customize Medical always reserves the right to claim compensation.

Limitation of action

No action by Client shall be brought unless Client first provides written notice to Customize Medical of any claim alleged to exist against Customize Medical within thirty (30) days after the event complained of first becomes known to Client and an action is commenced by Client within twelve (12) months after such notice.

Applicable law and jurisdiction

The laws of Portugal apply to this agreement excluding principles of conflict of laws. The applicability of the United Nations Convention on Contracts for the International Sale of Goods (CISG) is excluded.
The court in Porto, Portugal, shall have exclusive jurisdiction to hear actions. Nevertheless, Customize Medical shall be entitled to submit the dispute to the court deemed competent by the law.

Patient data regulation

Patient data delivered by the Client. Privacy: all efforts are undertaken to guarantee the privacy of the patient’s information in the framework of the ISO 13485 quality system and other NEN-GDPR that apply.
Personal information will be identified by assigning a unique case number.
By providing the patient data, the Client confirms that the disclosure of any information is done following applicable privacy regulations and legislation and written acceptance of the patient for charging patients data with a third party.

Support devices

The supplied (electronic) devices are intended to support the design and validation process of Customize Medical’s products. Support devices will be delivered after the first patient-specific implant order, if necessary. The devices remain the property of Customize Medical at all time. Customize Medical reserves the right to recall these devices at any time. Customize Medical cannot be held responsible for possible damage caused to or by these devices.