General Terms and Conditions of Sale of PolyMedics Innovations Inc.

Effective May 2024

1. Agreement

1.1 These General Terms and Conditions of Sale (hereinafter: “GTCS”) of PolyMedics Innovations Inc. (“PolyMedics”, “we” or “us”) apply to all PolyMedics sales of product to the customer. PolyMedics obligation to sell the products to the customer is expressly made conditional on the customer’s acceptance of the GTCS, unless otherwise specifically agreed to by PolyMedics in a signed writing.

1.2 These GTCS shall control the relationship between the parties and shall prevail over any contradictory terms and conditions set forth in a customer’s purchase order or other document. These GTCS constitute the entire agreement regarding the subject matter hereof and supercede all prior or contemporaneous understandings, written or oral.

1.3 Acceptance of our services and deliveries by the customer shall be deemed to be acceptance of the validity of these GTCS.

1.4 Previous agreements and previous versions of our General Terms and Conditions of Sale are superseded by these GTCS and shall be considered null and void.

2. Offer and Conclusion of Contract

2.1 Unless otherwise agreed to, our offers are subject to confirmation and are non-binding. We shall only be bound by a written purchase order issued by an authorized representative of a customer if it has been confirmed by us in writing by way of an order confirmation or if we begin with the performance of the order. Customer must submit to PolyMedics written purchase orders via email for products prior to the shipment of such products. The email address to submit purchase orders to PolyMedics is ORDER.USA@POLYMEDICS.COM. Purchase Orders received by PolyMedics are normally processed on the same day if received by the customer on M-Th, by 3p ET.  Purchase Orders received after 3p ET, or on a Friday, will be processed the following business day.

3. Confidentiality

3.1 During the term of the contract, the customer undertakes to preserve and protect all information which becomes accessible to them in connection with the contract and which is designated as confidential or which should reasonably be known to be confidential or which is recognizable as a business or trade secret due to other circumstances (“confidential information”) and not to disclose any such confidential information to third parties or utilize such information in any way, unless such disclosure or utilization is expressly approved in writing beforehand or required to achieve the purpose of the contract. This confidentiality obligation shall remain in force for five years after the complete fulfillment or termination of the order.

3.2 The customer undertakes to protect business secrets in the same way as other confidential information from being obtained by third parties by means of confidentiality measures appropriate to the circumstances. Confidentiality measures shall at least correspond to the level of care customary in the industry as well as the level of protection that the customer applies to its own business secrets of the same category.

3.3 The above shall not apply to any information which

  • Was already known to the customer before the start of the contract negotiations or which are communicated by third parties as non-confidential, provided that these third parties are not in breach of confidentiality obligations on their part,
  • the customer has developed independently,
  • is or becomes publicly known through no fault or action of the customer or
  • must be disclosed due to legal obligations or orders by a court or a public authority.

In the latter case, the customer shall notify us without undue delay before any disclosure. If the customer claims one of the above exceptions to be applicable, they shall bear the burden of proof in this respect.

4. Prices

4.1 The prices in our current price list are subject to change and are net prices and are always understood to be FOB Destination with shipping and handling paid for by customer. Customer shall provide PolyMedics with a FedEx 3rd Party Account number or shipping charges shall be applied as PrePay-Add-to-Invoice. PolyMedics will ship all orders to the customer via Priority Overnight delivery.  If further morning delivery is required, the customer must specify this request.

4.2 PolyMedics shall include the appropriate sales tax on each invoice as applicable to the address of the customer’s shipping location.  If customer is exempt from sales tax, customer shall provide PolyMedics with a valid copy of the customer’s sales tax exemption certificate prior to sale of products.

4.3 Any discount, free goods or other reduction in price (collectively “Discount”) received as a result of the purchase of products under this Agreement may involve a Discount or other reduction in price under federal law at 42 U.S.C. Section 1320a-7B(b)(3)(A) and regulations issued thereunder. Where applicable, customer is responsible for reporting and/or providing information on all Discounts to reimbursement agencies (including Medicare, Medicaid and other federal health care programs) and other entities in accordance with all applicable laws and regulations including the provisions of the discount safe harbor exception at 42 C.F.R. Section 1001.952(h) (the “Discount Safe Harbor”).  Each Party shall refrain from doing anything that would impede the obligations of the other Party to meet their obligations under the Discount Safe Harbor. PolyMedics will fully and accurately report the Discount on the invoice or statement submitted to the customer.  If the value of the Discount is not known at the time of the sale, PolyMedics must fully and accurately report the existence of a Discount program on the invoice, and when the value of the Discount becomes known (which may not be later than the year following the year in which the Discount was earned), PolyMedics must provide the customer with documentation of the calculation of the Discount identifying the specific goods or Services purchased to which the Discount will be applied.

5. Scope of Delivery, Use of Product, Return of Product

5.1 Our written offer or order confirmation shall determine the scope of our delivery or service. Any collateral agreement and amendment shall require our written confirmation. If our offer or our order confirmation is based on information provided by the customer our offer shall only be binding if this information is correct. If it becomes apparent after conclusion of the contract that the order cannot be carried out in accordance with the customer’s specifications, we shall be entitled to withdraw from the contract if and insofar as the customer is not prepared to accept the alternative solution proposed by us and to bear any additional costs actually incurred.

5.2 Our deliveries are free of defects if they comply with the agreed requirements with regard to quality and instructions for use. Customer agrees to follow user guides, training manuals and other documentation and directions provided by PolyMedics when using the products. Any copying, modification or reverse engineering of the products is strictly prohibited.  Our recommended storage of the PolyMedics product is inside of a refrigerator in order to maintain the product at a controlled temperature below 72° F.  If a refrigerator is not available, the PolyMedics product may be stored at room temperature as long as the room is below 72°F.  Product must be kept away from any heat sources, such windows or direct sunlight.

5.3 If the goods cannot be shipped for reasons for which the customer is responsible, we are entitled to store the goods at the customer’s risk and expense. In such cases, the date of storage shall be deemed to be the delivery date; the warehouse receipt shall replace the shipping documents.

5.4 If the customer is in default of acceptance, we shall be entitled to demand compensation for the resulting damage and any additional expenses.

5.5 We shall be entitled to use subcontractors to fulfill our contractual obligations.

5.6 Delivery and performance periods and dates provided are based on the best possible information but are estimates only. Our delivery periods shall commence on the date of our order confirmation. However, the commencement of the delivery period as well as compliance with delivery dates shall be subject to the customer’s timely and proper performance of its duties of cooperation, the provision of all documents required and the payment of any agreed advance payments if any.

5.7 In the event of force majeure or other extraordinary circumstances for which we are not responsible, including but not limited to epidemics or pandemics, industrial disputes, operational disruptions, civil unrest, official measures, acts of God, shortages of materials, or other unavoidable events beyond the reasonable control of PolyMedics, we shall not be in default. In such case, we shall be entitled to also withdraw from the contract if we are already in default. In particular, we shall not be in default in the event of delays in delivery if these are caused by incorrect or untimely delivery by our suppliers for which we are not responsible. In case of any hindrance of a temporary nature, the delivery periods shall be extended or shall be postponed by the period of such delay as well as a reasonable run-up period.

5.8 Transport insurance for goods to be shipped will only be taken out upon express request of the customer. The transport insurance shall then be taken out in the name and for the account and expense of the customer.

5.9 If upon acceptance of product at the loading docks/delivery point, it is discovered that product is expired, damaged, or not in an acceptable condition, customer may return such product to PolyMedics, at PolyMedics expense, and PolyMedics (a) will reimburse any costs, if any, associated with the product; and (b) if requested by customer, provide customer with a replacement product.  The customer must issue this notification to PolyMedics within 72 hours of original receipt of product shipment. Product is not customarily returned to PolyMedics for normal use.  Product must be maintained at a controlled temperature.

6. Terms of Payment

6.1 Upon shipment of products to customer, PolyMedics will submit to customer an invoice for such products, and customer shall pay all undisputed amounts within 30 days of receipt of PolyMedics invoice. Customer shall remit payment by check or by ACH bank transfer. If customer chooses to remit payment by credit card, a credit card transaction fee will be applied to the invoice.  The current credit card transaction fee is 2.9% + $0.25 per invoice and is subject to change. A service charge of 1.5% per month may be added to all unpaid balances which are 45 or more days old. Delinquent accounts may be served on a COD basis. Accounts delinquent for 90 days may be scheduled for collection.

6.2 Customer may not set off any amounts owed to us under any circumstances.

7. Return Conditions (Outside Warranty)

7.1 Our products are excluded from return except for claims due to defects in the goods or guarantees given by us. If, in exceptional cases, we have expressly agreed to take back the goods in writing, the value to be reimbursed in the event of the goods being taken back shall be based on the age, condition and resale ability of the goods.

7.2 The customer shall bear the risks and costs for the return transportation of goods for which we have exceptionally agreed to take back the goods. In such a case, the customer shall also bear the costs for assessing the quality of the returned goods.

8. Product Recall

8.1 In the event that PolyMedics would need to recall the product: (a) PolyMedics will immediately notify customer by written communication of the decision to recall and a recall plan; and (b) will detail, in the recall plan, the actions to be taken by PolyMedics and customer, notification requirements for the government authorities and responsibilities of PolyMedics and customer in regards to this notification. PolyMedics agrees that if the product is subject to recall per the direction of PolyMedics (or per the direction of an appropriate federal regulatory agency), PolyMedics shall reimburse customer for all shipping and product costs and actual out-of-pocket expenses customer incurs in taking reasonable action in response to the recall.

9. Warranty

9.1 PolyMedics warrants that (i) PolyMedics has good title to products shipped directly to customer, free of all liens, claims and encumbrances; (ii) the products will, at the time of manufacture, conform with the product specifications; (iii) and (iv) PolyMedics has received all regulatory and legal approvals, including FDA clearances and approvals, necessary for the Product to be used as contemplated hereunder. POLYMEDICS MAKES NO OTHER WARRANTIES TO CUSTOMER WITH RESPECT TO PRODUCTS, EXPRESS OR IMPLIED, AND POLYMEDICS SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

9.2 Our acceptance of the goods returned to us by the customer shall not constitute an acknowledgement of the defect unless this is expressly declared by us.

9.3 Any claim of the customer due to defects in the delivery provided by us shall be subject to the following provisions:

9.3.1 If the delivered item is defective, we may initially choose whether we provide subsequent performance by remedying the defect (rectification) or by delivering a defect-free item (replacement delivery).

9.3.2 The customer shall provide us with reasonable time and opportunity for any subsequent performance, in particular, provide us with the goods claimed to be defective for inspection purposes. In the event of a defect, we are entitled to make a subsequent delivery dependent on the customer returning the defective item.

9.3.3 We shall bear the expenses necessary for the purpose of inspection and subsequent performance, in particular any transport, travel, labor, and material costs, if a defect actually exists.

9.3.4 If any claim for rectification of a defect by the customer proves to be unjustified, we shall be entitled to claim reimbursement of the costs incurred from the customer.

10. Damages and Limitation of Liability:

10.1 PolyMedics shall only be liable for


11. Obligations of the Customer, Notification of Incidents

11.1 The customer shall ensure compliance with all relevant provisions for handling of the goods and the safety conditions from the time of delivery of the goods. In particular, the customer shall ensure to comply with the provisions on storage, labeling and expiry periods.

11.2 If the customer becomes aware that a patient or a user of the goods has suffered a deterioration in health in connection with the goods – outside of known adverse reactions – we must be informed of this immediately. Upon request, the customer shall inform us and/or the competent authorities to whom he has delivered the specific goods and other goods from the same batch that we have delivered to them.

12. Governing Law & Compliance

12.1 These GTCS shall be governed by and construed in accordance with the laws of the state of Delaware without regard to its principles of conflicts of laws.

13. Compliance with Laws

13.1 The customer agrees to comply with all applicable laws in connection with the use of products.

14. Waivers

14.1 The failure of PolyMedics to insist upon the performance of any of these terms and conditions or to exercise any rights thereunder shall not be deemed to be a waiver of such terms, conditions or rights in the future, nor shall it be deemed to be a waiver of any other term, condition, or right thereunder.  No terms and conditions other than those stated herein, and no agreement or understanding, in any way purporting to modify these terms and conditions, shall be binding on PolyMedics without PolyMedics written consent.

15. General

15.1 Neither these GTCS nor any rights hereunder shall be assigned or otherwise transferred by customer (by operation of law or otherwise) without the prior written consent of PolyMedics and any unauthorized transfer or assignment shall be void. If any of these GTCS set forth herein are held to be illegal by any court of competent jurisdiction, all remaining terms set forth herein shall remain in full force and effect.  Customer warrants that it will not import, export, or re-export the products in violation of any applicable laws, rules or regulations of any country, state, or jurisdiction.