Terms for professional orders of FixNip NRI.

These Professional order terms (the "order terms") apply to every order of FixNip NRI that a physician places with MedTechInvest Canada Corp. ("MedTechInvest Canada", "we", "us") through the professional area of fixnip.ca or that we accept in writing. They form the contract of sale together with our order confirmation. The terms of use of the site continue to apply to your use of the site; if they conflict with these order terms, these order terms prevail for the order. Our privacy policy explains how we handle personal information; it is not part of the contract. Any purchase conditions of your practice, clinic or hospital apply only if we have accepted them in writing.

Orders may be placed only by a physician who (a) holds a valid licence from a Canadian provincial or territorial college of physicians, (b) has completed the FixNip training and holds a FixNip certificate number, and (c) orders for use in their own professional practice or in a health care facility where they practise. By placing an order you confirm that these conditions are met, that the information in the order is accurate, and that you act in the course of your profession and not as a consumer. We may verify your licence and certificate with the issuing body and may refuse an order if we cannot confirm them. Orders may not be placed on behalf of a person who does not meet these conditions.

FixNip NRI (model PN-9035) is a Class III medical device licensed by Health Canada under Medical Device Licence No. 116189. The licence holder and manufacturer is FixNip Ltd. (Israel); MedTechInvest Canada is the importer and distributor in Canada. The device is supplied sterile, in single-unit packaging, for single use, and only to licensed health care professionals. The instructions for use supplied with the device (the "IFU") prevail over any description on the site, in these order terms or in our correspondence. Nothing in these order terms is a representation about the safety or effectiveness of the device beyond its labelling and IFU.

Your order, whether placed through the online form or sent to us in writing, is an offer to buy. Typing your name in the signature field and ticking the confirmation box has the effect of your signature. We send you an acknowledgement by e-mail with a copy of the order; the acknowledgement is not an acceptance. The contract is formed when we send you an order confirmation stating the quantity, the unit price, the shipping cost, the expected shipping date and the payment method, or when we ship the device, whichever comes first. We may decline an order in whole or in part, in particular if the licence or certificate cannot be confirmed, if the quantity exceeds what we can supply, if a previous invoice is unpaid, or if the order is inconsistent with the licence conditions of the device; we tell you the reason where we can. You may correct or withdraw an order free of charge at any time before we send the order confirmation, and may cancel it free of charge until we notify you that it has shippedL-33 Provisional. Orders are limited to 50 units per order.

Prices are in Canadian dollars. The unit price is the price stated in our order confirmation; a price entered in the order form is a proposal that we confirm or correct. Unless the confirmation says otherwise, prices exclude shipping, which is charged at the cost of tracked courier delivery stated in the order confirmationL-26 Provisional. The supply of FixNip NRI for medical or reconstructive purposes is a zero-rated supply of a medical or surgical prosthesis under section 25 of Part II of Schedule VI to the Excise Tax Act, so no GST/HST is charged; Quebec sales tax follows the same treatment. If a tax authority determines that tax applies to a supply, the tax is payable in addition to the price. Prices may change; a change does not affect an order that we have already confirmed.

You may pay by bank transfer or wire to the account stated in the order confirmation, by Interac e-Transfer to the address stated there, or by credit or debit card by telephone with our office. Do not send card numbers by e-mail or in a form. Payment is due before shipment, for every order. Please quote the order number with every payment. If a payment is late, we may charge interest at 12 percent per annum (1 percent per month)L-25 Provisional from the due date, suspend further shipments until payment is received, and recover reasonable collection costs. Title to the device passes to you when we have received full payment; the risk passes as set out in section 7.

We ship to addresses in Canada only, by tracked courier, to the shipping address in your order. The expected shipping date in the order confirmation is an estimate; we ship as soon as possible and normally within 5 to 10 business daysL-31 Provisional after the confirmation, or after receipt of payment where payment is due before shipment. Delivery dates are not of the essence unless we have agreed a fixed date in writing. Risk of loss or damage passes to you when the courier delivers the parcel to the shipping address or to a person there who accepts it. If we cannot deliver within 30 days after the expected date, you may cancel the undelivered part of the order and we refund any payment for it; further claims for delay are excluded to the extent permitted by section 12.

Please examine the parcel and the devices on receipt. Report visible transport damage to the courier on delivery and to us within 2 business daysL-27 Provisional; report missing or wrong items within 5 business daysL-27 Provisional after delivery, with the order number, lot number and photographs where possible. We then replace the affected devices or credit them, at our option. Devices that are not reported within these periods are deemed accepted as to visible damage, missing quantities and wrong items; this does not affect claims for defects that a careful inspection could not reveal (section 11).

Each device is supplied sterile in sealed packaging labelled with its name, identifier, lot or control number and expiry date. Store it as stated in the IFU and on the label. Do not use a device whose packaging is opened or damaged or whose expiry date has passed. We deliver devices with a remaining shelf life of at least 12 monthsL-30 Provisional unless we tell you otherwise before you order. We keep, as importer and distributor, the distribution records that the Medical Devices Regulations require so that a device can be recalled completely and rapidly. To make that possible you agree to record, for each implanted device, the lot or control number, the date of the procedure and the patient to whom it was implanted, in your own records, to keep those records for at least the period required by your college and by the Medical Devices Regulations for distribution records (the longer of the projected useful life of the device and two years after shipment), and to give us the lot number and the patient identifier you chose if we ask for them in a recall or safety investigation. Providing a patient identifier with the order is optional and must not contain more than a code or initials.

You may return a device within 14 days after delivery if its sterile packaging is unopened, undamaged and unlabelled by you, if it has been stored as stated in the IFU, and if its remaining shelf life is at least 12 monthsL-30 Provisional. Contact us first for a return number and instructions; returns without a return number are not accepted. We credit the price of accepted returns without a restocking feeL-29 Provisional; the return shipping is at your cost unless the return results from our error. Devices with opened or damaged sterile packaging, devices that have expired, and devices that were delivered more than 14 days before the return cannot be returned, because their sterility can no longer be assured. If we or the manufacturer recall a device or a lot, you will stop using the affected devices, follow the recall instructions and return the devices at our cost; we replace them or refund the price.

We warrant that, at delivery, each device is the licensed product described in the order confirmation, is sterile in its sealed packaging, and conforms to its labelling and IFU. The manufacturer's warranty stated in the IFU or in the manufacturer's written warranty documents applies in addition. To the extent permitted by law, and except as stated in this section and in section 12, all other conditions and warranties implied by statute, common law or usage, including the implied conditions of merchantable quality and fitness for a particular purpose under the Sale of Goods Act, are excluded; because the device is sold under its trade name for the purposes stated in its IFU, no condition of fitness for any other purpose applies. If a device does not conform to this warranty, tell us within a reasonable time after you discover the defect and in any case before the expiry date, keep the device and its packaging for inspection, and we replace the device or refund its price, at our option. The clinical outcome of a procedure depends on factors outside our control, including patient selection, technique and after-care, and is not warranted.

Quebec: the legal warranty of quality in articles 1726 to 1731 of the Civil Code of Québec is excluded only to the extent that article 1732 allows it; we do not exempt ourselves from liability for our own acts or omissions, and the exclusion does not apply to defects of which we were aware or could not have been unaware and which we did not disclose (article 1733).

To the extent permitted by law: (a) our total liability to you arising out of or in connection with an order, whether in contract, extra-contractual liability, tort, negligence or otherwise, is limited to the price paid for the order concerned; (b) we are not liable for loss of profit, revenue, business or goodwill, or for indirect or consequential loss; (c) we are not liable for the consequences of storage, handling or use that does not follow the IFU, of use after the expiry date, of re-sterilization or re-use, or of a procedure performed by a person who is not certified. Nothing in these order terms excludes or limits our liability, or that of FixNip Ltd., for death or bodily injury, for moral injury, for material injury caused intentionally or through gross fault, for fraud, for the liability of a manufacturer, importer or distributor for a safety defect of the device towards a patient or any other person, or for any other liability that cannot be excluded or limited by law. The limitations in this section apply to FixNip Ltd. and to our and its directors, officers, employees and agents in the same way as to us.

You agree (a) to use the device only as stated in its IFU, within its licensed indication, after your own assessment of the patient, and after obtaining the patient's informed consent; (b) to follow the training received in the FixNip Academy and to keep your certification current; (c) not to resell, lend or transfer the device to any other person or facility, and not to export it, without our written consent; (d) to make no statement about the device to patients or the public that is inconsistent with its licence, labelling or IFU, and not to describe it as approved by Health Canada; (e) to report to us at safety@fixnip.ca within 72 hours any incident involving the device that has led, or could lead, to death or a serious deterioration in health, and any other malfunction, complaint or suspected defect as soon as you become aware of it, so that we and the manufacturer can meet our reporting duties to Health Canada (you may also report directly to Health Canada, see report a product problem); (f) to cooperate with any recall or safety investigation; and (g) to confirm, when you provide a patient identifier, that you are authorized to share it with us for the purposes of the order and of traceability. You remain solely responsible for your clinical judgement, patient selection, the procedure and follow-up care.

We use the information in your order to process it, to ship and invoice, to keep the distribution and complaint records required by the Medical Devices Regulations, and to contact you about the order, a recall or a safety matter. Licence and certificate numbers and any patient identifier are stored encrypted; order e-mails do not contain the patient identifier. Ordinary e-mail is not encrypted end to end; do not send patient information by e-mail beyond the identifier the form asks for. Our privacy policy has the details, including retention periods and your rights.

Neither party is liable for a failure or delay caused by events beyond its reasonable control, including regulatory action affecting the device, interruption of supply from the manufacturer, import restrictions, transport disruption, epidemic, strike, or failure of communication networks, provided it informs the other party without delay and resumes performance as soon as it can. Payment obligations for delivered devices are not suspended. If the event lasts more than 60 days, either party may cancel the affected part of the order without liability, and we refund any payment for devices not delivered.

These order terms and each order are governed by the laws of the Province of Ontario and the federal laws of Canada applicable in Ontario, without regard to conflict of law rules and excluding the United Nations Convention on Contracts for the International Sale of Goods. The courts of Ontario have exclusive jurisdiction over any dispute arising out of an order, and each party submits to that jurisdiction; either party may nevertheless seek interim or injunctive relief in any competent court. No limitation or prescription period is shortened or extended by these order terms. If you practise in Quebec, nothing in this section deprives you of the protection of the provisions of Quebec law that apply notwithstanding a choice of law, and the courts of Quebec remain competent where Quebec law so provides. Before starting proceedings, the parties will try to resolve the dispute by discussion between a representative of each party for at least 30 days.

We may change these order terms. The version that applies to an order is the version published on the site on the day you place the order and identified in our acknowledgement and order confirmation; a change does not apply to an order already placed. We inform holders of a professional account by e-mail at least 30 days before a change takes effect, showing the changed clauses.

• Language: these order terms are available in French and in English; both versions have the same value. Les présentes conditions de commande sont offertes en français et en anglais, et les deux versions ont la même valeur. A physician in Quebec receives the French version first and may ask to contract in English.
• Entire agreement: these order terms, the order confirmation and the IFU are the entire agreement about the order; they replace any earlier discussion or document on the same subject. Nothing excludes liability for fraud.
• Severability: if a provision is held invalid, it is reduced or severed to the extent necessary and the remaining provisions stay in force.
• Assignment: you may not assign an order without our written consent; we may assign our rights to an affiliate or successor of our business that assumes our obligations.
• Electronic communications: notices about an order may be given by e-mail to the address of your professional account and satisfy any requirement of a written notice; keep a copy of the order confirmation for your records.
• No waiver: if we do not enforce a provision, we may still enforce it later.
• Interpretation: headings are for convenience; "including" means "including without limitation".

MedTechInvest Canada Corp., 4789 Yonge St., Suite 805, Toronto, ON M2N 0G3, Canada. Orders and invoices: info@fixnip.ca. Safety reports: safety@fixnip.ca.