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Terms & conditions

General Terms and Conditions of PetBioCell GmbH

Effective from: 18.10.2024

Dear pet owner,

in order to begin production of the dendritic cell vaccine for your animal, which is not kept for food production purposes, we require your consent to our General Terms and Conditions. Please read this document carefully before treatment begins.

Information on the Manufacturing Process

  • For the manufacture of the dendritic cell vaccine, it is essential that the blood draw and packaging of the sample at the veterinary practice are carried out exactly according to the instructions provided. Your veterinarian will receive detailed instructions as well as a telephone briefing.
  • The autologous dendritic cell vaccine is manufactured in accordance with the strict criteria of GMP (Good Manufacturing Practice) in PetBioCell GmbH’s cleanroom laboratory.
  • Following manufacture, the vaccine is shipped to the attention of the treating veterinarian.
  • PetBioCell GmbH reserves the right to use any blood components not required for the manufacture of the autologous dendritic cell vaccine for validation and research purposes, in order to further develop the product.

Required Information

By these terms, you undertake to ensure that your veterinarian provides PetBioCell GmbH with all available patient records for the veterinary examination required for diagnosis and treatment decisions.

In order to rule out possible contraindications, monitor the course of the disease, and achieve the best possible conditions for the cultivation of the dendritic cells, it is necessary to inform PetBioCell GmbH, prior to the start of cell therapy, of all medications administered to the patient (including supportive and long-term medication) and treatment measures (e.g. chemotherapy, radiation therapy, blood transfusion), as well as any pre-existing and concomitant conditions.

Prices and Invoicing

The costs incurred for the consultation service, the manufacture and quality control of the vaccine, and the supervision of the entire process by our team were communicated to you individually at the start of the consultation in our information email.

The costs for express transport vary per shipment and by region and can likewise be found in the information email.

Following placement of the order, an order confirmation and an invoice itemizing the agreed services will be sent to you by email.

For deliveries to Switzerland, the invoice for overnight express shipments is issued in three parts to facilitate customs clearance.

The invoice amount in euros (EUR) is due in full, without deduction, immediately upon receipt of the invoice, unless special terms have been agreed in writing, and must be paid no later than the day before the scheduled shipment of the vaccine. The vaccine will only be dispatched once payment has been received.

In addition to the above manufacturing costs, you are responsible for the costs of veterinary care provided by your veterinarian. This includes, for example, the blood draw, examination of the patient, and administration of the cell therapy. Please contact your veterinarian for further information on these costs.

Costs in the Event of Treatment Discontinuation

Should a commissioned treatment be discontinued prior to the start of production—whether due to the patient’s death (from accident or illness), at your request, or for other reasons—you will be reimbursed for any services not yet rendered as of that date (treatment price and transport costs).

In such cases, a processing fee will be charged:

  • EUR 175 (single treatment)
  • EUR 100 (follow-up treatment)
  • EUR 200 (full cycle)

If the patient dies after production has begun, only the transport costs that are no longer incurred will be refunded.

Addendum for EU member states: If a treatment cycle (3 administrations with advance payment) has been selected, discontinuation of treatment after production has begun for the 1st administration will result in a refund of 60%, and after the 2nd administration a refund of 25%, of the treatment price, plus any transport costs not incurred.

Any discontinuation of production must be declared in writing by email to info@petbiocell.de.

Costs in the Event of Insufficient Blood Sample Quality

  • If a blood sample is delivered to PetBioCell GmbH in an unusable condition for reasons not attributable to PetBioCell GmbH, the transport costs already incurred shall be borne in full by you.
  • If the blood draw is repeated at your veterinarian’s practice, you will bear the costs thereof, as well as the costs of delivering the new starter kit or collecting the new blood sample. In this case, PetBioCell GmbH will cover the cost of a new starter kit as a gesture of goodwill.
  • If the blood draw is not repeated, a processing fee of EUR 120 will be charged.
  • The quality of the blood sample is assessed at the start of production. Due to the biological nature of the patient’s blood, it is possible for insufficient sample quality to be identified as early as the incoming inspection (e.g. an insufficient cell count). In such cases, cultivation of the dendritic cells is not possible.
  • Should no new blood draw take place, PetBioCell GmbH reserves the right to charge EUR 200 for the assessment of sample quality.

Costs in the Event of Vaccine Release Failure

PetBioCell GmbH’s obligation is limited to carrying out the manufacture of the vaccine in accordance with standard procedures; PetBioCell GmbH does not guarantee the production of a usable product.

If the manufactured vaccine cannot be released for use in the patient by quality control due to insufficient cell development, this does not release you from your payment obligations.

In this case, the costs of the resulting return transport of the vaccine to the veterinary practice will be reimbursed.

Should you decide to proceed with a new production run, you will bear the costs thereof as well as the costs of the repeat blood draw. In this case, PetBioCell GmbH will cover the cost of a new starter kit as a gesture of goodwill.

The causes of insufficient cell development cannot always be clearly determined, as patient blood is a natural starting material subject to a wide range of biological variability that cannot be fully controlled. On average, this affects approximately 4.7% of all vaccines manufactured.

Tumor Types with an Increased Likelihood of Insufficient Cell Yield

  • Osteosarcoma: 8%
  • Spindle cell sarcoma: 8%
  • Lymphoma: 7%
  • Hemangiosarcoma: 7%
  • Adenocarcinoma: 6%

Should this occur, further internal investigations into the cause of the insufficient cell development will be initiated without delay. This will not result in any additional costs to you.