Terms and conditions

1.Scope and Acknowledgment.

These terms and conditions of sale (the “Terms”) shall apply to all sales of goods and services (“Goods”) by Domico Med-Device, LLC and its Affiliates (“Seller”) to Buyer, and its Affiliates (“Buyer”). For purposes of these Terms, “Affiliates” shall include any entity controlled by or that control Seller or Buyer respectively or are under common ownership of Seller or Buyer respectively

2.Assent to Terms.

The sale of Goods by Seller is expressly conditioned upon the assent by Buyer to these Terms and the rights of the parties shall be governed exclusively by these Terms and any corresponding pricing, manufacturing, supply, or distribution agreement between the parties (each an "Agreement"). Any attempt by Buyer to vary these Terms or any term, condition, or provision in any related Agreement, in any acceptance, acknowledgment, confirmation, purchase order, or otherwise containing additional, different, or inconsistent terms and conditions (collectively “Different Terms”) is hereby expressly objected to and rejected by Seller. Seller’s dealings with Buyer or silence in response to Different Terms proposed by Buyer shall not be deemed acceptance of the Different Terms. No person may modify these Terms without written consent of Seller. No course of dealing or trade usage modifies these Terms. Seller reserves the right to refuse – in writing – any order from Buyer at its sole discretion. To the extent of any inconsistency between these Terms and any term, condition, or provision of any applicable Agreement between the parties, the terms, conditions, or provisions of the Agreement shall control.

3. Shipment and Acceptance.

Shipment (and delivery) of an order on any specified date is subject to the availability of the Goods, and it is understood that any date specified by Seller or Buyer is an estimated and projected shipment date. SELLER SHALL NOT BE LIABLE FOR ANY LOSS, DAMAGE, OR PENALTY FOR DELAY IN SHIPMENT OR FOR FAILURE TO GIVE NOTICE OF ANY DELAY. Failure by Seller to ship Goods by any specified shipment date shall not provide a basis for cancellation of any order. Seller may ship Goods in advance of any shipment schedule. Upon receipt of shipment, it is Buyer’s or Buyer’s agent’s responsibility to fully inspect the Goods for damage or other problems. Buyer shall, within fortyeight (48) hours after receipt of Goods, inspect the Goods and immediately report in writing to Seller any shortages, damages, or defects reasonably observable by proper inspection. Notwithstanding the foregoing, Buyer must (i) report any visible damage to the Goods to the carrier at time of delivery, and (ii) note the damage when signing for the Goods. If Buyer fails to inspect or report any shortages, damages, or defects as required under this section, Buyer shall be deemed to have unqualifiedly accepted the Goods. If Buyer rightfully rejects any Goods under this section, Buyer’s sole remedy shall be to return the Goods pursuant to these Terms and Seller shall replace the Goods with conforming Goods, or reimburse Buyer for the net invoice price of the Goods, in Seller's sole discretion.

4. Delivery Cost and Risk of Loss.

Except as otherwise set forth in any corresponding Agreement or accepted purchase order, delivery of Goods shall be Ex-Works Seller's applicable manufacturing facility (Incoterms, 2010). Seller is not responsible for loading, sorting, or segregating at or beyond Seller's delivery point. Seller reserves the right to make shipment in installments; all such installments are to be separately invoiced and paid for when due per invoice, without regard to subsequent deliveries. Delay in shipment of any installment shall not relieve Buyer of its obligations to accept remaining shipments. Risk of loss and damage to Goods shall pass to Buyer upon delivery of the Goods to Seller's delivery point. It is Buyer’s responsibility to be available at the time of delivery, and the shipping carrier shall determine, in its discretion, whether it will leave the Goods at Buyer’s address without a signature. Goods shall be packaged and labeled in accordance with the standard labeling practices of Seller as required by applicable law. Identification of Goods shall be with Seller's part number. Except as set forth in a related Agreement, special packaging or labeling shall be an additional charge to Buyer.

5. Pricing and Payment.

All prices shall be specified by Seller and are subject to change as set forth in Section 7 herein. Seller reserves the right to invoice at prices in effect at time of shipment if Buyer requests a shipment date more than thirty (30) days after a sales quotation is signed and accepted by Buyer, or thirty (30) days after an order is made by Buyer. All accounts are due and payable net thirty (30) days of purchase and shall be subject to a 1.5% per month late charge on any past due balance. All payments must be made by check, money order, ACH or other approved electronic funds transfer (immediately available funds). Seller retains all rights to extend or remove credit for any reason, and to require Cash-On-Delivery or Cash-In-Advance. Payment shall not be subject to any right of set-off. Seller may require a deposit on special order items. Buyer’s minimum order is $500.00. Orders less than $500.00 will be subject to a $25.00 processing fee. Except as provided otherwise by Seller, all payments must be made in U.S. currency (dollars).

6. Taxes and Other Charges.

All orders by Buyer shall be subject to applicable sales tax unless Buyer files a valid exempt certificate with Seller at the time of signing a sales quotation or making an order. Buyer must re-file the exempt certificate with Seller every calendar year. In addition to the purchase price and sales tax, Buyer shall pay all other taxes (including without limitation, manufacturer's tax, occupation tax, use tax, excise tax, turnover or value-added taxes, medical device tax, duty, custom, inspection or testing fee, or any other tax, fee, interest, or charge of any nature whatsoever imposed by any governmental authority, on or measured by the transaction between Seller and Buyer) or similar charges associated with the purchase of the Goods. In the event Seller is charged for such taxes or other charges, Buyer shall promptly reimburse Seller therefore.

7. Price Adjustments.

Seller may change its prices to Buyer anytime upon not less than sixty (60) days' advance written notice.

8. Right to Assurance.

Whenever Seller in good faith has reason to question Buyer's ability or intent to perform, Seller may demand in writing adequate assurance from Buyer of Buyer's ability or intent to perform, and may suspend performance hereunder pending such assurance, in Seller’s sole discretion. In the event that such a demand is made and such assurance is not given within a reasonable time, Seller may treat that failure as an anticipatory repudiation of the agreement of the parties and exercise any appropriate remedy therefore.

9. Change or Cancellation.

Signed and accepted orders are not subject to change or cancellation, except with Seller’s written consent, which shall not be unreasonably withheld. Buyer shall be responsible for any costs, charges, or fees associated with an order at the time of Seller’s receipt of any purported notice of change or cancellation, up to the full amount of the order. Seller reserves the right to modify, change, or replace Goods from time to time, for any reason, with reasonable notice. Seller may furnish suitable substitutes for materials unobtainable because of priorities or regulations established by governmental authority or non-availability of materials from suppliers upon reasonable notice to Buyer.

10. Warranty/Disclaimers.

Seller warrants to Buyer that: (i) nondisposable/non-expendable/non-consumable Goods manufactured by it and sold to Buyer will be free from defects in materials and workmanship for a period of one (1) year after shipment to Buyer; (ii) disposable/expendable/consumable Goods will be free from defects in materials and workmanship for a period that terminates upon the earlier of (x) sixty (60) days after shipment to Buyer or (y) upon initial use. If, within such applicable period, any such Good shall be proved to Seller's satisfaction to be defective, such Good shall be (i) replaced at Seller's expense or (ii) the amount paid for such defective Good(s) shall be refunded, in Seller’s sole and absolute discretion. Such replacement or refund shall be Seller's sole obligation and Buyer's exclusive remedy hereunder and shall be conditioned upon Seller's receiving written notice of any alleged defect within ten (10) days after its discovery and, at Seller's option, return of such Goods to Seller's facility from which the Goods originally came. THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, AND SELLER EXPRESSLY DISCLAIMS AND EXCLUDES ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR ANY INFRINGEMENT OF THIRD PARTY RIGHTS, OR ANY OTHER WARRANTY ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE. Buyer is solely responsible for determining the appropriate use of the Goods. Seller makes no warranties or representations related to any third party goods or services. Any modification of the Goods or use inconsistent with any instructions related to the Goods by any person or entity other than Seller shall void all Seller’s obligations with respect to the limited warranties and remedies provided herein. The limited warranties provided herein are conditioned upon the proper storage and use of the Goods.

11. Limitation of Liability.

Buyer acknowledges that the price of the Goods is predicated on the enforceability of the following limitation of liability, that the price would be substantially higher if Seller could not limit its liability as herein provided, and that Buyer accepts this limitation of liability in exchange for the lower price. ACCORDINGLY, SELLER SHALL NOT BE LIABLE, WHETHER BASED IN CONTRACT, WARRANTY, INDEMNITY, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR ALTERNATIVE TORT REMEDIES, OR ANY OTHER THEORY OF LAW OR EQUITY, FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING BUT NOT LIMITED TO DAMAGE TO EQUIPMENT, LOSS OF PROFITS OR REVENUE, LOSS OF USE OF PROPERTY, PLANT, EQUIPMENT, SYSTEM, OR DOWNTIME COSTS. SELLER’S TOTAL AGGREGATE LIABILITY HEREUNDER SHALL NOT EXCEED THE PURCHASE PRICE PAID BY BUYER FOR THE SPECIFIC GOODS FROM WHICH ANY CLAIM OR DAMAGES MAY ARISE. Buyer acknowledges and agrees that any claim or cause of action that Buyer may have arising out of or relating to the Goods must be filed on or before one (1) year after such claim or cause of action arises, or forever be barred. Buyer acknowledges that Buyer’s sole and exclusive remedy arising out of or in connection with these Terms or any purchase order or related Agreement between the parties shall be limited solely to the replacement of any defective or non-conforming Good(s), or a refund of the amount of the purchase price, at Seller’s option.

12. Limitation of Damages - Termination of Actual or Perceived Distribution Relationship.

IF BUYER IS A DISTRIBUTOR OR AGENT OF SELLER, SELLER SHALL NOT BE LIABLE FOR DAMAGES OF ANY KIND, INCLUDING WITHOUT LIMITATION INCIDENTAL OR CONSEQUENTIAL DAMAGES, ON ACCOUNT OF THE TERMINATION OR EXPIRATION OF ANY ACTUAL OR PERCEIVED DISTRIBUTION AGREEMENT OR ARRANGEMENT BETWEEN THE PARTIES HERETO. BUYER WAIVES ANY RIGHT IT MAY HAVE TO RECEIVE ANY COMPENSATION OR REPARATIONS ON TERMINATION OR EXPIRATION OF THESE TERMS UNDER THE LAW OF THE APPLICABLE TERRITORY OR OTHERWISE, OTHER THAN AS EXPRESSLY PROVIDED IN THESE TERMS. Except as set forth in any Agreement, this is not an exclusive distribution agreement or arrangement. Buyer may only sell the Goods into territories pre approved by Seller in writing. Upon request, Buyer shall provide documentation establishing the location and name of the customers purchasing Goods from Buyer. Seller shall be not liable to Buyer on account of termination or expiration of these Terms for reimbursement or damages for the loss of goodwill, prospective profits or anticipated income, or on account of any expenditures, investments, leases or commitments made by either Seller or Buyer or for any other reason whatsoever based upon or growing out of any termination or expiration hereof. Buyer acknowledges that(i) Buyer has no expectation and has received no assurances that any investment by Buyer in the promotion of the Goods will be recovered or recouped or that Buyer will obtain any anticipated amount of profits by virtue of these Terms, and (ii) Buyer will not have or acquire by virtue of these Terms or otherwise any vested, proprietary or other right in the promotion of the Goods or in "goodwill" created by its efforts hereunder. THE PARTIES ACKNOWLEDGE THAT THIS SECTION HAS BEEN INCLUDED AS A MATERIAL INDUCEMENT FOR SELLER TO ENTER INTO THESE TERMS AND THAT SELLER WOULD NOT HAVE ENTERED INTO THESE TERMS BUT FOR THE LIMITATIONS AS SET FORTH HEREIN.

13. Compliance with Laws.

Buyer shall obtain all licenses, permits, and approvals required by any government or applicable authority, and shall comply with all applicable laws, rules, regulations, policies, and procedures, and any requirements applicable to the importation, exportation, use, sale, loan, purchase, destruction, and distribution of the Goods. Buyer agrees to comply with all applicable export laws and restrictions and regulations of the United States Department of Commerce or other United States agency or authority.

14. Indemnification.


15. Returns.

Approval for the return of any Goods must be obtained from Seller prior to such return and any returned Goods must be identified by a “Return Authorization Number” provided by the Seller. Buyer should contact a Customer Relations Representative to obtain a Return Authorization Number. If the return of Goods is approved, at Seller’s sole discretion, returned Goods must be securely packaged to reach Seller without damage. Goods may only be returned within thirty (30) days of delivery of the Goods and must have a shelf life of not less than six (6) months upon receipt by Domico. All sterile Goods must be returned in original, unopened, and undamaged packages. Returned Goods will be credited at the net invoice price at the time of purchase. Goods authorized for return other than delivery or shipping error on the part of Seller or defectiveness in materials or workmanship must be returned freight pre-paid, and are subject to a 25% restocking charge. Return of Goods having a remaining shelf life of less than six (6) months is prohibited.

16. Liens and Claims.

To the fullest extent allowable by law, Seller retains all lien rights and claims against property for supplying Goods to Buyer. Buyer shall be fully responsible for all payments and claims if lien rights are found unenforceable for any reason. Upon full payment, Seller will release all lien claims against Buyer. Buyer hereby grants to Seller a security interest in all Goods delivered to Buyer until such time as Seller is paid in full for such Goods.

17. Force Majeure.

Seller shall not be liable for any claim, expense, loss or damage arising from Seller’s delay in performing, or failure to perform, as a result of equipment failures, power failures, strikes, labor disputes, riots, insurrections, civil disturbances, shortages of materials, fires, floods, storms, explosions, acts of god, war, governmental actions, orders of domestic or foreign courts or tribunals, nonperformance by third parties, or any other occurrence or loss beyond the reasonable control of Seller.

18. Waiver.

Failure by Seller to insist upon strict performance of any Terms shall not be considered a continuing waiver of such Terms or any of Seller’s rights hereunder.

19. Successors, Assigns and Affiliates.

These Terms are binding upon and shall inure to the benefit of the parties, their Affiliates, and their respective heirs, executors, legal representatives, successors, and permitted assigns. Buyer may not, directly or indirectly, assign, delegate, transfer, convey, or subcontract all or any portion of its rights, duties, and obligations under these Terms without the prior written consent of Seller, which may be withheld at Seller’s sole discretion, except in the case of an assignment to a subsidiary of Buyer where Buyer remains liable for such subsidiary’s payment and performance.

20. Independent Contractors.

Each of the parties to this order is an independent contractor. Neither party has or will have any power to bind the other party or to assume or create any obligation or responsibility, express or implied, on behalf of the other party. The parties do not intend to create any agency, partnership, joint venture, or like relationship through these Terms. 21. No Third Party Beneficiary. Neither these Terms or any order of Goods is intended to create any right, claim, or remedy in favor of, or impose any obligation upon, any person or entity other than the parties hereto.

22. Severability.

If any section of these Terms is held by a court of competent jurisdiction to be illegal, or unenforceable for any reason, such determination shall not affect the remainder of this order.

23. Electronic Transactions.

The parties intend that these Terms can be electronically submitted and accepted, that the email addresses provided on any attached order or sales documents can be used to provide any required notice or communications, and that the electronic transactions provisions in Wis. Stat. Chapter 137 apply to this quotation.

24. Food and Drug Administration.

Claims and statements made by Seller about specific Goods may not have been evaluated by the United States FDA (Food and Drug Administration). Buyer should consult with a qualified healthcare professional or physician before use of any Goods.

25. Emergency Product Allocation.

In the event of a shortage of any Goods, as determined solely by Seller, Seller shall allocate sales of Goods among purchasers in its sole discretion.

26. Confidentiality.

Buyer acknowledges that, unless and only to the extent Seller specifically agrees to the contrary in advance in writing, these Terms, and all other information as to quantity, cost, and prices charged to Buyer by Seller for Goods, all information relating to marketing, Goods, designs, ideas, sales volume, and data regarding Seller, sketches, specifications, prototypes, models, and samples, or any design or production techniques, and other information identified or reasonably identifiable as confidential or proprietary, shall be maintained in confidence by Buyer (hereinafter the "Confidential Information"). The confidentiality obligations of this section shall not apply to information which (i) Buyer is compelled to disclose by judicial or administrative process; provided that Buyer shall promptly give Seller advance notice of its intention to make such disclosure so that Seller may have the opportunity to prevent or restrict such disclosure if it deems such prevention or restriction in its best interest; (ii) Buyer can show to have been generally available to the public other than as a result of a breach of this section; (iii) Buyer can show was within its legitimate possession prior to the time of disclosure by Seller; or (iv) is disclosed to Buyer by a third party having legitimate possession thereof and the unrestricted right to make such disclosure. Buyer's burden of proof is by clear and convincing evidence with respect to exceptions (i) to (iv) above. This obligation of confidentiality is for five (5) years from the date of the last purchase of the Goods, except for Confidential Information that is defined under the laws of the State of Michigan, U.S.A., as a trade secret, which shall be remain confidential for the maximum period of time allowed under the laws of the State of Michigan, U.S.A. Buyer acknowledges that the Confidential Information of Seller is valuable to Seller, and there is no adequate remedy at law for a breach of these Terms, and Seller will be entitled to an injunction to prevent and restrain the use of Confidential Information other than as authorized herein in addition to any other remedies available at law or equity.

27. No Gratuities or Hidden Payments.

Seller has not paid any gratuities, fees, or payments of any kind to any officer, employee, director, agent, or representative of Buyer to induce an order; and Seller has not made, directly or indirectly, any gift to or bestowed any benefit on any officer, employee, director, agent, or representative of Buyer, or directly or indirectly entered into any business or financial arrangement with any of them to induce an order. Buyer represents, warrants and covenants that it shall not make any payments, in money or other items or services of value to (i) any United States or foreign government official, (b) any foreign political party, (c) any candidate for foreign political office or (d) any other person or entity, with the knowledge that such payment, offer or compromise to pay or provide items or services of value are being made to any such person for the purpose of influencing such person to make one or more business decisions favorable to Buyer. Buyer further represents warrants and covenants that no government official is a principal, owner, officer, employee or agent of any entity that Buyer has an interest in, and not government official has any material financial interest in the business of Buyer. Buyer shall review Seller's Foreign Corrupt Practices Act Policy, to comply with such policy, and to annually certify such compliance by executing a certification presented by Seller from time to time.

28. Indemnification for Intellectual Property Infringement.

As to any Goods Seller furnishes to Buyer manufactured in accordance with drawings, designs, or specifications proposed or furnished by Buyer, or any claim of contributory infringement resulting from the use or resale by Buyer of Goods sold hereunder, Seller shall not be liable. Buyer shall indemnify Seller and hold Seller harmless from and against any and all loss, liability, damage, claim, and expense (including but not limited to Seller's reasonable attorneys’ fees and other costs of defense) incurred by Seller as a result of any claim of patent, trademark, copyright, trade secret, or other intellectual property theft or infringement, or infringement of any other proprietary rights of third parties based on Goods being manufactured and sold by Seller in accordance with drawings, designs, and specifications furnished by Buyer.

29. Intellectual Property.

Seller retains all right, title and interest in and to all design concepts, designs, drawings, specifications, samples, ideas, and materials, including any derivative works and works based on such items, and including all trade secret, trademark, copyright, patent, and all other intellectual property and proprietary rights therein, for anything it creates, develops, prepares, or sells either alone or jointly with any employees, agents, or subcontractors of Buyer, in the course of performing under these Terms (hereinafter the “Work Product”). Buyer agrees that it shall execute and cause its employees, agents, and subcontractors to execute all documents necessary or convenient to allow Seller to perfect Seller's interest in the Work Product. Buyer agrees not to reverse engineer any Work Product.

30. License.

Each party grants to the other party with immediate effect a personal, non-exclusive, limited, and non-sublicensable license to perform the obligations under these Terms or any Agreement. Such limited license shall immediately terminate upon termination or expiration of these Terms or any related Agreement between the parties without further action of either party.

31. Recall Policy Statement.

Seller maintains a recall policy per quality system procedure P0008. This procedure addresses the requirements of Clause 8.5 in EN/ISO 13485 and Section 8.5 in Seller’s QMS Manual, and Part 806 of the FDA 21 CFR regulations. Within this procedure, the Director of Quality Assurance and Regulatory Affairs is responsible for coordination of all information in a potential recall situation as well as defining and monitoring the activities during an actual recall event.

32. Reporting Requirements under Various Health Care Programs.

Buyer acknowledges that Buyer may be obligated by law, including but not necessarily limited to 42 U.S.C. 1320a-7b(b) and 42 C.F.R. 1001.952(h)(1), to report and provide information to government authorities regarding any and all discounts and/or rebates applicable to your acquisition of Goods from Seller.

33. Entire Agreement.

These Terms, when accompanied by a related Agreement between the parties and/or a written quotation from the Seller, shall constitute the final expression of the agreement of the parties and is the complete and exclusive statement of its terms. Catalogues, photographs, drawings, and other illustrations shall not form a part of these Terms or any related Agreement unless expressly agreed to by Seller, in writing.

34. Cumulative Remedies.

No remedy conferred upon Seller is intended to be exclusive of any other remedy, and each and every such remedy shall be in addition to, and not in limitation of or substitution for, every other remedy available at law or in equity or by statute or otherwise.

35. Headings.

The headings contained in these Terms are for convenience of reference only and shall not affect the meaning or construction of any of its provisions.

36. Dispute Resolution.

These Terms shall be governed by and construed in accordance with the internal laws of the State of Michigan, without application of choice of laws principles. In the event of a controversy arising under these Terms, the Parties shall first consult and negotiate with each other in an attempt to reach a solution acceptable by both Parties. If such a solution is not achieved within sixty (60) days from the first day either party delivers notice in writing that such consultations or negotiations must occur, then any dispute, controversy, or claim arising out of these Terms, including their interpretation, performance, or termination shall be finally resolved by binding arbitration. The arbitration, including the rendering of the award, shall take place in Detroit, Michigan by a single arbitrator. Buyer waives any objection that it may have based on improper venue or forum non conveniens to conducting the arbitration in Detroit, Michigan. The decision of the arbitrator shall be binding upon the parties, and each party shall bear its own costs (including without limitation, attorneys’ fees). The decision of the arbitrator shall be executory, and judgment thereon may be entered by any court of competent jurisdiction. The arbitration shall be governed by the Commercial Arbitration Rules then in effect of the American Arbitration Association. The Arbitrator shall have no authority or jurisdiction or power to alter, amend, change, modify, add to or subtract from any provisions of these Terms or to decide any issues or controversies other than those set forth in the Notice of Arbitration. Notwithstanding the foregoing, the obligation herein to arbitrate shall not be binding upon any party with respect to requests for preliminary injunctions, temporary restraining orders, specific performance, or similar procedures in a court of competent jurisdiction to obtain interim relief when deemed necessary by such court to preserve the status quo or prevent irreparable injury pending resolution by arbitration of the actual dispute.