General Terms and Conditions Design My Implants LLC

The General Terms and Conditions (GTC) shall apply to all orders, purchases, and sales agreements entered into by Design My Implants LLC.

The present GTC shall also apply to all agreements between Design My Implants LLC 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.

Exclusivity

The Client understands and agrees that they have hired a Provider exclusive of any other service provider. In order to provide a high level of satisfaction and quality of service, no additional service providers, other than an assistant or third party that Provider hires to complete the Services outlined in this Agreement, are permitted to provide the same or similar services or products, paid or unpaid, at the locations and dates specified in this Agreement.

Offers and orders

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

Execution of the Agreement

Design My Implants LLC shall execute the Agreement to the best of its ability and by the good manufacturing practice requirements. If required for the proper execution of the Agreement, Design My Implants LLC shall have the right to have services provided by third parties. The Client shall ascertain that Design My Implants LLC shall be provided in due time with all digital data and other materials necessary for the timely execution of the Agreement.

Design My Implants LLC 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. Design My Implants LLC DAP shall have the meaning assigned to the same in the latest version of INCOTERMS published by the International Chamber of Commerce in Paris, France, at the time of the conclusion of the Agreement.

Unless expressly stated otherwise, any times or dates for Design My Implants LLC delivery are estimates.
Design My Implants LLC shall not be liable for injury, either physical, psychological, or financial loss caused by the fact that Design My Implants LLC worked based on incorrect, incomplete, or untimely data procured by the Client.

Changes to the agreement

Design My Implants LLC 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.

Intellectual property and copyrights

All intellectual property rights resulting from the execution of the Agreement (including patent rights, design rights, and copyright) accrue to Design My Implants LLC unless explicitly stated otherwise in the Agreement. Insofar as this right can only be obtained by depositing, only Design My Implants LLC has the right to do so.
Design My Implants LLC 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 of developing 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, prototypes, etc., provided by Design My Implants LLC, 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.

GDPR

General Data Protection Regulation (GDPR) applies.
If a judicial decision compels Design My Implants LLC to convey confidential information to third parties designated by law or by the court and Design My Implants LLC cannot for that purpose invoke a legal right to refuse to give evidence or such a right acknowledged or allowed by the competent court, Design My Implants LLC 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 the said circumstance.

Fee and price

Design My Implants LLC and the Customer can agree on a fixed price when the Agreement is concluded.
Suppose no fixed fee has been agreed upon. In that case, the fee or price for Design My Implants LLC services will be determined based on the number of hours spent on the work (calculated by the usual hourly rates of Design My Implants LLC, unless another hourly rate has been agreed) and the overhead and production costs that implied.

Payment

Design My Implants LLC 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 credit card or transfer to a bank account specified on the invoice.
If Design My Implants LLC 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 interest equal to the United States of America statutory commercial interest.

All costs and expenses of Design My Implants LLC, such as court costs and extrajudicial and judicial costs and expenses, including the costs of legal assistance, bailiffs, and collection agencies, are at the Customer’s expense. 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 Design My Implants LLC, including designs, sketches, drawings, films, software, (electronic) files, etc., remain the property of Design My Implants LLC until the Client has fulfilled all its obligations under all agreements concluded with Design My Implants LLC.
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 Design My Implants LLC.
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 the first request.
Goods delivered by Design My Implants LLC that fall under the retention of title pursuant 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 Design My Implants LLC wishes to exercise ownership rights mentioned herein, the Client will grant unconditional and irrevocable consent to Design My Implants LLC or third parties appointed by Design My Implants LLC to gain access to all locations where Design My Implants LLC goods can be found and to take them back.

Warranty

Design My Implants LLC guarantees the construction of the delivered parts of the goods exclusively. This guarantee is valid for a period of 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 Design My Implants LLC, limited to repair by or on behalf of Design My Implants LLC 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 Design My Implants LLC at their own expense and risk. Design My Implants LLC is entitled to charge transport costs to the Customer for sending repaired or replacement goods.

Complaints

The Client must inform Design My Implants LLC in writing of complaints about the work carried out within ten (10) days after the discovery but no later than twenty (20) days after completion of the relevant work.
If a complaint proves to be well-founded, Design My Implants LLC 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 Design My Implants LLC.

Liability

Design My Implants LLC 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 a doctor’s prescription. The physician/surgeon/dentist is responsible for the implant design and the implantation.
Design My Implants LLC is never liable for damage caused by loss of profit or missed savings and indirect damage or consequential damage.
If Design My Implants LLC is liable for direct damage, then this liability is limited to a maximum of the invoiced amounts. The liability of Design My Implants LLC is at all times limited to a maximum equal to the amount of the payment by the professional liability insurer of Design My Implants LLC in the occurring case.
In the case of an assignment with a duration of more than six 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 Design My Implants LLC against claims by third parties concerning the use of the services of Design My Implants LLC and the use of the delivered goods.
The Customer indemnifies Design My Implants LLC against claims by third parties regarding intellectual property rights to material or data provided by the Customer, which is used before and during the execution of the Agreement.
Suppose the Client provides Design My Implants LLC with information carriers, electronic files or software, etc. In that case, it guarantees that the information carriers, electronic files, or software are free of viruses and defects.

Force Majeure

Design My Implants LLC 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 Design My Implants LLC cannot exert any influence but which prevents Design My Implants LLC fulfills its obligations. Strikes at Design My Implants LLC company are also regarded as a circumstance of force majeure.

Cancellation

Design My Implants LLC and the Customer have the right to cancel the Agreement at any time.
If the Agreement is terminated prematurely by the Customer, Design My Implants LLC 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. Suppose the Agreement is terminated prematurely by Design My Implants LLC. In that case, 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 Design My Implants LLC, the aforementioned costs will be charged to the Client.

Suspension and dissolution

Design My Implants LLC is entitled to suspend the fulfillment of the obligations under the Agreement or to dissolve the Agreement if:

• The Client does not or does not fully meet its obligations arising from the Agreement;
• – After the Agreement has been concluded, Design My Implants LLC 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 Design My Implants LLC on the Customer are immediately due and payable. Design My Implants LLC always reserves the right to claim compensation.

Limitation of action

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

Applicable law and jurisdiction

The laws of Texas 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.
In Texas, USA, the court shall have exclusive jurisdiction to hear actions. Nevertheless, Design My Implants LLC shall be entitled to submit the dispute to the court deemed competent by the law.

Patient data regulation

Patient data delivered by the Client. Design My Implants LLC asks the Client that all data be identified by assigning a unique case number and performing anonymization of all data.
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 in accordance with 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 Design My Implants LLC’s products. If necessary, support devices will be delivered after the first patient-specific implant order. The devices remain the property of Design My Implants LLC at all times. Design My Implants LLC reserves the right to recall these devices. Design My Implants LLC cannot be held responsible for possible damage caused to or by these devices.