Pre-implanted Animal Terms and Conditions
1. PRE-ORDER REQUIREMENTS.
- Customers should allow up to two months following the date that the Agreement is signed by both the Customer and DSI and a purchase order is created (and any devices are received by DSI for refurbishment) before the Animals will be ready for shipment.
- DSI’s surgical staff and the Customer’s primary investigator must deem the Animals to be acceptable based on the following criteria.
- The Animals will originate from a mutually agreed upon commercial vendor and will be housed with animals of the same species from an animal vendor that utilizes barrier facilities and provides sentinel data. Isolated housing in a separate animal room may be provided based on availability for an additional fee and must be specifically requested by the customer.
- Surgery will take place in a dedicated operating area.
- No sentinel/surveillance data will be provided, unless pre-arranged with the surgical staff at DSI and paid for by the Customer. Details of this arrangement will be included in a separate attachment.
- DSI does not currently have Animal Welfare Assurance and must be included in the Customer’s Animal Welfare Assurance, if necessary.
- DSI will only guarantee success in wild-type strains of animals with previously described (by DSI) implantations of devices. Any modifications, including the use of transgenic strains or novel implantation sites will constitute model development, in which case the Customer is required to pay DSI per the terms of the Agreement regardless of success. Additional documentation regarding model development will be attached separately.
2. PRODUCT SPECIFICATIONS. Health records from the animals’ place of origin and screen capture images of all appropriate signals will accompany the shipment of the Animals. Prior to shipment, the Animals will be monitored for recovery from surgery, wound healing, and adequacy of device signals. Surgical staples will be removed if appropriate.
3. TITLE/RISK OF LOSS. The Customer shall pay reasonable shipping costs in accordance with its shipping instructions, but DSI shall be responsible for packaging, shipping and safe delivery and shall bear all risk of damage or loss until the goods are delivered to the Customer’s address.
4. DELIVERY. Time is of the essence in the performance of this Agreement. DSI will propose a delivery method prior to shipment and collaborate with the Customer to ensure someone is available to receive the Animals.
A representative for the Customer must be present to receive the Animals, or no guarantees as to the health status of the Animals can be made, and the Customer assumes full responsibility for the status of the Animals at delivery.
5. WARRANTIES. The device will be covered under the warranty described upon the purchase of the device. In the event device failure is suspected, the device must be surgically explanted and returned to DSI for failure analysis. The Customer shall contact DSI Technical Support Services for assistance prior to explanting the device. The Customer must immediately inform the Technical Support Services personnel that the call is regarding an animal that was surgically pre-implanted by DSI. If the issue cannot be resolved, DSI’s Technical Support Services will provide instructions on how to explant the device if necessary and the required documentation for failure analysis. DSI’s Technical Support Services can be contacted at support@datsci.com
6. INSPECTION. Once the Animals are received, the Customer is responsible within the first 24 hour period to assess the Animal’s health status and the device signal quality. The Customer should immediately contact DSI's Technical Support Services (1-800-262-9687) if there are any concerns regarding health status or signal quality and must immediately disclose that the call is regarding surgically pre-implanted animals from DSI. Following the initial 24 hours after Customer receipt of the Animals, the Customer will assume the costs associated with any exchanges or refunds. It will be assumed that the health status of the animals and quality of the signal is acceptable if DSI does not receive notification of an issue from the Customer in a timely manner (within 48 hours of initial receipt of animals), and the customer will then be responsible for any replacement costs associated with said animals.
If replacement of an Animal is required due to health issues or inadequate signal quality, DSI will have 60 days from the receipt of the returned device to provide a replacement Animal, if adequate quarantine space is available. If quarantine space is limited, the Customer may choose to accept a replacement Animal that has not been quarantined or wait for surgical implantation of an animal in the next available quarantine space. The customer will bear all costs of shipping for any replacement animals required.
7. USE OF VASCULAR ACCESS PORT. Vascular access ports (VAP) may be placed upon request. Catheter patency will be verified intermittently throughout the postoperative period until the animal is ready to be shipped. Patency will be verified immediately prior to shipping. Upon receipt of animals, the customer is responsible for verifying catheter patency within three (3) calendar days of arrival at the end facility. The customer should immediately contact the DSI Surgery Team (surgeryteam@datasci.com) if there are concerns about the patency of the VAP catheter. It will be assumed that the VAPs are acceptable if DSI does not receive notification of an issue from the customer in a timely manner (within 3 days of initial receipt of animals), and the customer will then be responsible for any replacement costs associated with said animals. The customer is fully responsible for long-term care and maintenance of VAPs. Improper handling of VAPs increases risk of infection, so aseptic technique and new, sterile supplies MUST be used when flushing and re-locking catheters. DSI is not responsible for infections due to improper VAP maintenance at the customer site.
Surgery as a Service Specific Terms and Conditions
1. PREREQUISITES. The following prerequisites must be met prior to DSI representatives performing surgery for the Customer. If the prerequisites are not met the contract will be null and void, however, if the DSI representative determines this after travel to the Customer’s site, the Customer will still be responsible for paying for the travel costs incurred, and the DSI representative is not required to perform surgery.
- The Customer must provide a written protocol describing the surgery and peri-operative procedures and animal care. DSI’s Institutional Animal Care and Use Committee (IACUC) will review all protocols and have the authority to request protocol modification or deny DSI representative participation.
- The Customer will be responsible for the provision of a designated space (for small animal surgery) or a designated operating room (for large animal surgery) which is appropriate for the conduction of aseptic surgery.
- The Customer will be responsible for the provision of sufficient support staff to prepare the animal(s) fully for surgery, including, but not limited to, peri-operative analgesia and antibiotic administration, anesthesia induction, maintenance, and monitoring, clipping and aseptically scrubbing the surgery sites, surgical assistance, and recovering the animal(s) from anesthesia.
- The DSI representative will be responsible only for the performance of surgery itself.
- The Customer will be responsible for the provision of all of the surgical, anesthetic and personal protective equipment and medications recommended in the DSI Surgical Manual associated with all the surgeries the DSI representative is contracted to perform. If the Customer cannot provide any of the materials, they are required to inform the DSI representative prior to the date of surgery, so they may make alternative arrangements.
2. WARRANTY. DSI shall provide its services and meet its obligations under these terms and conditions in a timely and workmanlike manner, using knowledge and recommendations for performing the services which meet generally acceptable standards in DSI’s community and region, and will provide a standard of care equal to, or superior to, care used by service providers similar to DSI on similar projects.
The customer accepts the potential loss of the animal inherent to veterinary surgery. DSI will not be responsible for animal loss or poor signal quality unless it is a result of an overt surgical error. If surgical error leads to the loss of the animal or an unacceptable signal in the immediate post-operative period, prior to recovery from anesthesia, the DSI surgical representative will perform surgery on an additional animal to replace the instrumented animal lost or with an unacceptable signal. The DSI surgical representative will not perform additional surgery if the loss of the animal or unacceptable signal is the result of anesthetic complications, underlying physiologic or health issues, phenotypic strain variation, insufficient surgical facilities or equipment, or other factors not directly related to surgical technique. No guarantees of successful surgery will be made for novel uses of DSI technology or in atypical species, such as during new model development.
THESE WARRANTY TERMS ARE AN INTEGRAL PART OF DSI'S STANDARD TERMS AND CONDITIONS OF SALE.
Surgical Training Terms and Conditions
1. PREREQUISITES. The following prerequisites must be met prior to DSI representatives performing surgical training at the Customer’s site. [If training is to take place at DSI, the following prerequisites are not required to be met; however, only surgical training procedures approved by DSI’s IACUC may be performed]. If the prerequisites are not met the contract will be null and void. However, if the DSI representative determines this after travel to the Customer’s site, the Customer will still be responsible for paying for the travel costs incurred, and the DSI representative is not required to perform surgical training.
- The Customer must provide a written protocol describing the surgery and peri-operative procedures and animal care. DSI’s Institutional Animal Care and Use Committee (IACUC) will review all protocols and have the authority to request protocol modification or deny DSI representative participation.
- The Customer will be responsible for the provision of a designated space (for small animal surgery) or a designated operating room (for large animal surgery) which is appropriate for the conduction of aseptic surgery.
- The Customer will be responsible for the provision of sufficient support staff to prepare the animal(s) fully for surgery, including, but not limited to, peri-operative analgesia and antibiotic administration, anesthesia induction, maintenance, and monitoring, clipping and aseptically scrubbing the surgery sites, surgical assistance, and recovering the animal(s) from anesthesia.
- The DSI representative will be responsible for surgical training only.
- The Customer will be responsible for the provision of all of the surgical, anesthetic and personal protective equipment and medications recommended in the DSI Surgical Manual associated with all the surgeries the DSI representative will teach. If the Customer cannot provide any of the materials, they are required to inform the DSI representative prior to the date of surgery, so they may make alternative arrangements.
2. WARRANTY. DSI shall provide its services and meet its obligations under these terms and conditions in a timely and workmanlike manner, using knowledge and recommendations for performing the services which meet generally acceptable standards in DSI’s community and region, and will provide a standard of care equal to, or superior to, care used by service providers similar to DSI on similar projects.
The customer accepts the potential loss of the animal inherent to veterinary surgery and anesthesia either during or following the above described surgical training. Due to a potentially increased rate of surgical error during the training period, it will be assumed that no small laboratory animals will be recovered from anesthesia for use in scientific studies, unless documented otherwise. During DSI surgical training on large laboratory animals, DSI will not be responsible for animal loss or poor signal quality unless it is a result of an overt surgical error by a DSI representative during a demonstration surgery. If DSI surgeon error leads to the loss of the animal or an unacceptable signal in the immediate post-operative period, prior to recovery from anesthesia, the DSI surgical representative will perform surgery on an additional animal to replace the instrumented animal lost or with an unacceptable signal. The DSI surgical representative will not perform additional surgery if the loss of the animal or unacceptable signal is the result of customer error, anesthetic complications, underlying physiologic or health issues, phenotypic strain variation, insufficient surgical facilities or equipment, or other factors not directly related to DSI surgeon technique. No guarantees of successful surgery will be made for novel uses of DSI technology or in atypical species, such as during new model development, and no guarantee of customer surgical competency following training will be made.
THESE WARRANTY TERMS ARE AN INTEGRAL PART OF DSI'S STANDARD TERMS AND CONDITIONS OF SALE.
General for All Surgical Service Orders
Services purchased must be used within eighteen (18) months from the date the order is placed or the invoice date if products are purchased along with the services. If the service and/or training has not been completed within eighteen (18) months, and the delay is not caused by DSI, DSI will consider the service and/or training to be closed. If the service and/or training has been previously invoiced, the amount invoiced will be forfeited by the Purchaser. If the service and/or training has not been previously invoiced, the open amount on the order related to the service and/or training services will be cancelled. If the service or training is still desired after the eighteen (18) month time period, it can be purchased at the current price.