16. Application of the Sale Terms; Quotations and Orders

 

16.1 Application

Part II applies to all sales and supplies of Products by CuraSource to Buyer. Part II, together with the General Provisions in Part III, the relevant accepted Order, and any written supply, distribution, or framework agreement we execute with Buyer (a “Master Agreement”), constitutes the entire agreement between CuraSource and Buyer with respect to the relevant Products. In the event of any conflict, the order of precedence is as set forth in Section 36.

16.2 Quotations

Any quotation, price list, brochure, catalog, technical data sheet, or other communication issued by CuraSource is an invitation to treat and does not constitute an offer capable of acceptance. Unless otherwise stated in writing, quotations are valid for thirty (30) days from issuance and are subject to withdrawal, modification, or correction at any time before CuraSource accepts an Order.

16.3 Orders and Order Acceptance

Buyer submits Orders in writing (including by email) referencing the relevant quotation or Master Agreement. An Order constitutes an offer by Buyer to purchase Products on these Terms. No Order is binding on CuraSource until CuraSource issues a written order confirmation or otherwise expressly accepts the Order in writing. CuraSource may, in its sole discretion, decline any Order, in whole or in part, including where the Order does not meet applicable minimum order quantities, where credit or compliance screening cannot be completed satisfactorily, or where capacity, raw-material availability, or regulatory considerations so require.

16.4 Conflicting Terms in Buyer Documents

Any pre-printed or boilerplate terms appearing on Buyer’s purchase orders, vendor portals, acknowledgments, invoices, or other commercial documents are expressly rejected. Such terms have no legal effect and do not modify, supplement, or replace these Terms, even if CuraSource fails to object to them. Any acceptance by CuraSource of an Order is expressly conditioned on Buyer’s assent to these Terms.

16.5 Minimum Order Quantities

Each Product is subject to a minimum order quantity (“MOQ”) specified in the applicable quotation, price list, Documentation, or Master Agreement. Orders below the MOQ may be rejected or subject to an MOQ surcharge in CuraSource’s discretion.

16.6 Changes and Cancellations

Once accepted, Orders may not be changed or cancelled by Buyer except with CuraSource’s prior written consent. Where consent is given, Buyer is liable for all costs reasonably incurred by CuraSource as a result, including raw materials, work-in-process, finished goods, labor, freight, and a reasonable margin on cancelled volumes.

 

17. Product Specifications; Samples; Changes
 

17.1 Specifications

Products are supplied to the specifications set forth in the Documentation in effect on the date the Order is accepted. CuraSource may, at any time and without notice, make changes to Product specifications, materials, components, manufacturing processes, packaging, labeling, or country of origin, provided that any such change does not materially adversely affect the form, fit, function, or regulatory status of the Product. CuraSource will use commercially reasonable efforts to notify Buyer of changes that require regulatory notification or re-qualification by Buyer.

17.2 Samples

Any samples we provide are for evaluation and qualification purposes only. Samples are illustrative and Buyer acknowledges that minor variations between samples and production Products are inherent in the manufacturing process and do not constitute a breach of these Terms.

17.3 Tolerances

All quantities, weights, dimensions, and other specifications are subject to manufacturing tolerances customary in the medical-device industry. Quantities shipped within plus or minus ten percent (±10%) of the ordered quantity (or such other tolerance specified in the Order or Documentation) are deemed in conformity with the Order, with the invoice adjusted accordingly.

 

18. Pricing, Taxes, and Currency
 

18.1 Pricing

Prices are as set forth in the order confirmation. Unless otherwise specified, prices are in United States Dollars (USD) and are exclusive of value-added tax, goods-and-services tax, sales tax, use tax, customs duties, tariffs, import fees, freight, insurance, and any other taxes, duties, levies, or charges (collectively, “Taxes”).

18.2 Taxes and Duties

Buyer is responsible for all Taxes arising in connection with the Products, other than taxes on CuraSource’s net income. If CuraSource is required to collect any such Taxes, they will be added to the invoice. Buyer will provide any tax exemption certificates, importer-of-record information, customs documentation, and similar information CuraSource reasonably requires.

18.3 Currency and Currency Risk

All payments must be made in the currency specified on the invoice, without deduction, set-off, counterclaim, or withholding (other than withholding taxes Buyer is required by law to deduct, in which case Buyer will gross up the payment so that CuraSource receives the full invoice amount). Currency fluctuations between the date of quotation and the date of payment are at Buyer’s risk, except as expressly agreed in writing.

 

19. Payment Terms
 

19.1 Default Payment Terms — International Buyers

Unless a Master Agreement or order confirmation expressly provides otherwise, for international Buyers (Buyers outside the United States), payment is due as follows: thirty percent (30%) of the invoice amount as a non-refundable deposit within ten (10) business days after CuraSource accepts the Order, with the remaining seventy percent (70%) due before shipment from CuraSource’s facility. CuraSource may, in its discretion, require payment by irrevocable, confirmed, transferable letter of credit issued by a bank acceptable to CuraSource on terms acceptable to CuraSource.

19.2 Default Payment Terms — U.S. Buyers With Approved Credit

For U.S. Buyers that have been granted credit terms by CuraSource in writing, payment is due Net thirty (30) days from the date of CuraSource’s invoice. Approval of credit terms is at CuraSource’s discretion and may be revoked or modified at any time, including in response to changes in Buyer’s credit standing.

19.3 Method of Payment

Payment must be made by wire transfer in immediately available funds to the bank account designated by CuraSource in the invoice or order confirmation. Buyer is responsible for all bank charges, intermediary-bank fees, and correspondent-bank deductions, and must make payment in such amount that CuraSource receives the full invoice amount net of those fees.

19.4 Late Payment

Without prejudice to any other rights or remedies, if Buyer fails to make any payment by the due date, CuraSource may (i) charge interest on the overdue amount at the rate of one and one-half percent (1.5%) per month (or the maximum rate permitted by applicable law, if lower), accruing daily from the due date until payment in full; (ii) suspend further deliveries until all overdue amounts are paid; (iii) require pre-payment or additional security for further Orders; (iv) recover all collection costs, including reasonable attorneys’ fees; and (v) cancel any unfulfilled Orders and terminate any Master Agreement.

19.5 Set-Off

Buyer shall pay all amounts due to CuraSource without set-off, counterclaim, deduction, or withholding. CuraSource may, at any time, apply any amount owed by CuraSource to Buyer or its Affiliates against amounts owed by Buyer or its Affiliates to CuraSource.

 

20. Delivery; Incoterms; Title and Risk of Loss
 

20.1 Default Delivery Term

Unless the order confirmation specifies otherwise, Products are delivered FOB (Free on Board) Buyer’s named port of loading in the People’s Republic of China, in accordance with Incoterms® 2020. For Buyers that request ex-works delivery, the applicable term is EXW (Ex Works) CuraSource’s designated facility in the People’s Republic of China, Incoterms® 2020. Other Incoterms may apply only if expressly stated in the order confirmation.

20.2 Title and Risk

Title to the Products passes to Buyer upon CuraSource’s receipt of payment in full of the invoice amount and all related charges. Risk of loss passes to Buyer at the delivery point specified by the applicable Incoterm. The passage of risk in advance of title is solely for security purposes, and Buyer obtains no ownership rights in the Products until payment in full is received.

20.3 Delivery Dates

Delivery dates are estimates only and are not of the essence. CuraSource will use commercially reasonable efforts to meet quoted delivery dates but is not liable for any delay, and Buyer may not refuse delivery on account of delay. CuraSource is not liable for any delay caused by Force Majeure Events, by Buyer’s acts or omissions, or by changes Buyer requests after Order acceptance.

20.4 Partial Shipments

CuraSource may make partial shipments of any Order, with each partial shipment treated as a separate sale. Buyer may not refuse partial shipments or delay payment for delivered Products on the ground that the Order has not been completely filled.

20.5 Storage

If Buyer fails or refuses to take delivery on the agreed date, or to provide shipping instructions or documents reasonably required by CuraSource, CuraSource may (i) store the Products at Buyer’s expense and risk, or (ii) sell the Products at the best price reasonably obtainable in the circumstances and account to Buyer for any excess over the contract price (or recover from Buyer any shortfall, plus selling costs).

 

21. Inspection and Acceptance; Claims for Shortages or Defects
 

21.1 Inspection

Buyer must inspect Products upon receipt for visible damage, shortages, or non-conformity with the Order. Any claim for visible damage, shortage, or non-conformity must be notified to CuraSource in writing within ten (10) business days after receipt of the Products at the delivery point, together with supporting documentation reasonably required by CuraSource. Failure to notify within this period constitutes irrevocable acceptance of the Products.

21.2 Latent Defects

Claims for latent defects (those not reasonably discoverable on receipt) must be notified in writing within ten (10) business days after Buyer becomes aware, or reasonably should have become aware, of the defect and in any event before the expiration of the warranty period in Section 22.1.

21.3 Returns

Products may not be returned without CuraSource’s prior written authorization (a “Return Material Authorization” or “RMA”). Products returned without an RMA may be refused or returned at Buyer’s expense. Approved returns must be in original, unopened packaging, must be shipped freight prepaid in accordance with CuraSource’s instructions, and remain at Buyer’s risk until received and inspected by CuraSource.

 

22. Limited Warranty
 

22.1 Warranty

CuraSource warrants to Buyer that, at the time of delivery, the Products will (i) conform in all material respects to the specifications set forth in the applicable Documentation; (ii) be free from material defects in materials and workmanship; and (iii) have been manufactured in accordance with CuraSource’s documented quality-management system, which is maintained substantially in accordance with ISO 13485 and applicable medical-device regulatory requirements.

The warranty period for each Product is the shorter of (a) twelve (12) months from the date of delivery and (b) the labeled shelf life of the Product. No warranty applies after the warranty period.

22.2 Exclusive Remedy

Buyer’s sole and exclusive remedy, and CuraSource’s entire liability, for a breach of the warranty in Section 22.1 is, at CuraSource’s option and expense, (i) replacement of the non-conforming Products, (ii) repair, or (iii) refund of the price paid for the non-conforming Products. CuraSource is not obligated to provide warranty service unless Buyer has paid all amounts due to CuraSource and complies with the claim procedures in Section 21.

22.3 Warranty Exclusions

The warranty in Section 22.1 does not apply to any Product that:

• Has been used beyond the labeled shelf life or after the warranty period;

• Has been altered, modified, repackaged, relabeled, repaired, or repurposed by anyone other than CuraSource or its authorized representative;

• Has been damaged due to misuse, abuse, negligence, accident, improper storage, mishandling, or use other than in accordance with the Documentation and applicable clinical practice;

• Has been re-sterilized or re-processed (single-use devices are not designed for reprocessing);

• Has been combined with goods or components not supplied or approved by CuraSource;

• Has been damaged in transit after risk of loss passed to Buyer; or

• Has been subjected to environmental conditions outside the limits stated in the Documentation.

22.4 Pass-Through Only

The warranty in Section 22.1 runs to the immediate Buyer only and is not transferable to any downstream purchaser, end-user, distributor, or patient, except with CuraSource’s prior written consent. Buyer is responsible for the warranties it offers to its own customers, and Buyer’s warranties to its customers will not impose obligations on CuraSource beyond those expressly set forth in these Terms.

 

23. Disclaimers of Warranty
 

EXCEPT FOR THE LIMITED WARRANTY EXPRESSLY SET FORTH IN SECTION 22.1, CURASOURCE MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WITH RESPECT TO THE PRODUCTS, AND HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, AND ANY WARRANTIES ARISING FROM COURSE OF DEALING, COURSE OF PERFORMANCE, OR USAGE OF TRADE. CURASOURCE DOES NOT WARRANT THAT THE PRODUCTS WILL ACHIEVE ANY PARTICULAR CLINICAL OUTCOME OR THAT THEIR USE WILL BE UNINTERRUPTED OR ERROR-FREE.

 

24. Regulatory Compliance; Recalls and Field Safety Corrective Actions
 

24.1 Regulatory Status

Products are intended for sale only in countries where CuraSource (or, where applicable, an authorized in-country representative or importer) has obtained the necessary clearances, approvals, or registrations to place them on the market. Buyer must not import, re-export, sell, distribute, market, or use any Product in any country where doing so would violate any applicable law or where the necessary regulatory authorizations are not in place. The regulatory status of any Product in a particular country may change; Buyer is responsible for verifying the current status before importing or distributing.

24.2 Buyer’s Regulatory Responsibilities

Buyer is responsible for compliance with all laws applicable to its import, distribution, sale, use, and disposal of the Products in its territory, including (without limitation):

• Maintaining importer, distributor, wholesaler, or other licenses required in the destination country;

• Acting as importer of record for customs purposes and paying applicable duties and Taxes;

• Maintaining traceability and distribution records as required by applicable medical-device laws;

• Conducting any required pharmacovigilance, vigilance, or post-market-surveillance activities for which Buyer is responsible as importer or distributor in its territory;

• Promptly notifying CuraSource of any adverse event, malfunction, complaint, or other safety concern of which Buyer becomes aware;

• Cooperating with CuraSource in any field-safety corrective action or recall.

24.3 Recalls and Field Safety Corrective Actions

Buyer must cooperate with any recall, withdrawal, advisory, or field safety corrective action (each, a “FSCA”) initiated by CuraSource or required by a regulator. This includes (i) ceasing distribution of affected Products promptly upon notice, (ii) providing distribution records reasonably required to trace affected Products, (iii) notifying affected sub-distributors and end-customers in the manner instructed by CuraSource or the relevant authority, and (iv) returning or disposing of affected Products as instructed. CuraSource will reimburse Buyer’s reasonable, documented, direct out-of-pocket costs of implementing an FSCA caused by a non-conformity for which CuraSource is responsible, up to the limitation of liability in Section 26.

24.4 No Off-Label or Investigational Use

Buyer must not promote, market, or sell Products for any use other than the uses cleared, approved, or registered in the destination country. Buyer must not use Products for investigational, research, or clinical-trial purposes without CuraSource’s prior written agreement.

 

25. Export Control, Sanctions, and Anti-Corruption
 

25.1 Export and Sanctions Compliance

The Products may be subject to export-control and trade-sanctions laws of the United States (including the Export Administration Regulations administered by the U.S. Commerce Department’s Bureau of Industry and Security and the regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control), the European Union, the United Kingdom, the People’s Republic of China, and other jurisdictions. Buyer represents, warrants, and covenants that it will (i) comply with all such laws; (ii) not import, re-export, sell, distribute, or otherwise transfer the Products, directly or indirectly, to any country, person, or entity in respect of which such transfer is restricted or prohibited; and (iii) not use the Products for any prohibited end-use, including any end-use related to chemical, biological, nuclear, or missile weapons of mass destruction.

25.2 Anti-Corruption

Buyer represents, warrants, and covenants that it will comply with all applicable anti-corruption and anti-bribery laws, including the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010, the Anti-Unfair Competition Law of the People’s Republic of China, and equivalent laws of other jurisdictions. Buyer will not, directly or indirectly, offer, promise, pay, authorize, or accept any bribe, kickback, or other improper payment or benefit in connection with the Products.

25.3 Audits and Cooperation

Buyer will, on reasonable notice, provide CuraSource with information reasonably required to demonstrate Buyer’s compliance with this Section 25, and will cooperate with CuraSource’s reasonable compliance inquiries. CuraSource may suspend or terminate any Order or Master Agreement immediately if it believes in good faith that performance would violate any law described in this Section 25.

 

26. Limitation of Liability for Sales
 

26.1 Exclusion of Indirect Damages

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT WILL CURASOURCE OR ITS AFFILIATES BE LIABLE TO BUYER OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, ENHANCED, OR PUNITIVE DAMAGES, OR FOR ANY LOSS OF PROFITS, REVENUE, GOODWILL, BUSINESS OPPORTUNITY, DATA, ANTICIPATED SAVINGS, OR REPUTATION, OR FOR THE COST OF SUBSTITUTE GOODS OR SERVICES, ARISING OUT OF OR RELATING TO THE PRODUCTS, THE SALE OF THE PRODUCTS, OR THESE TERMS, WHETHER ARISING IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, OR OTHERWISE, EVEN IF CURASOURCE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

26.2 Aggregate Liability Cap

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, CURASOURCE’S TOTAL CUMULATIVE LIABILITY TO BUYER ARISING OUT OF OR RELATING TO ANY PRODUCTS OR ORDER, WHETHER ARISING IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, OR OTHERWISE, WILL NOT EXCEED THE AMOUNTS ACTUALLY PAID BY BUYER TO CURASOURCE FOR THE SPECIFIC PRODUCTS GIVING RISE TO THE CLAIM DURING THE TWELVE (12) MONTHS PRECEDING THE EVENT FIRST GIVING RISE TO THE LIABILITY.

26.3 Carve-Outs

Nothing in these Terms excludes or limits any liability that cannot be excluded or limited under applicable law, including (where applicable) liability for (i) death or personal injury caused by negligence; (ii) fraud or fraudulent misrepresentation; (iii) the indemnification obligations in Section 27; and (iv) any other liability that applicable law expressly prohibits being limited.

26.4 Basis of the Bargain

Buyer acknowledges that the pricing of the Products reflects the allocation of risk in these Terms, that the limitations and exclusions of liability in this Section 26 are an essential basis of the bargain between the parties, and that these limitations and exclusions apply even if any limited remedy is found to have failed of its essential purpose.

 

27. Indemnification by Buyer
 

Buyer will defend, indemnify, and hold harmless CuraSource and its Affiliates and their respective directors, officers, employees, contractors, agents, licensors, and service providers from and against any and all claims, liabilities, damages, judgments, awards, losses, costs, expenses, and fees (including reasonable attorneys’ fees) arising out of or relating to:

• Any breach by Buyer of these Terms, including the representations, warranties, and covenants in Sections 24 and 25;

• Any negligent act, omission, or willful misconduct of Buyer or its employees, agents, or sub-distributors in connection with the Products;

• Any misrepresentation by Buyer (or its sub-distributors or customers) regarding the regulatory status, intended use, performance, or compliance of any Product;

• Any modification, repackaging, relabeling, reprocessing, or repair of a Product by Buyer or any third party;

• Any combination of a Product with goods or components not supplied or approved by CuraSource;

• Any use of the Products outside the scope of the Documentation or beyond the regulatory clearance, approval, or registration in the destination country;

• Any violation of applicable law by Buyer, including export-control, sanctions, anti-corruption, customs, tax, employment, and medical-device laws.
  
   

28. Confidentiality
 

Each party (the “Receiving Party”) acknowledges that, in connection with these Terms, it may receive information from the other party (the “Disclosing Party”) that is non-public, proprietary, or confidential, including pricing, specifications, manufacturing know-how, regulatory documentation, customer lists, business plans, and similar information (“Confidential Information”). The Receiving Party will (i) use the Confidential Information solely for the purpose of performing under these Terms; (ii) protect the Confidential Information using at least the same degree of care it uses to protect its own confidential information of similar sensitivity, but in no event less than reasonable care; and (iii) not disclose the Confidential Information to any third party, except to its employees, Affiliates, and professional advisors who have a need to know and who are bound by confidentiality obligations at least as protective as those in this Section. These obligations do not apply to information that (a) is or becomes generally known to the public without breach of these Terms; (b) was rightfully in the Receiving Party’s possession before disclosure; (c) is received from a third party without a duty of confidentiality; or (d) is independently developed without use of the Confidential Information. The Receiving Party may disclose Confidential Information to the extent required by law, court order, or regulatory request, provided that it gives the Disclosing Party reasonable advance notice (to the extent legally permitted) and cooperates in seeking protective treatment.

 

29. Intellectual Property in Products
 

Buyer acknowledges that CuraSource and its licensors own all intellectual-property rights in the Products, the Documentation, the manufacturing processes, and any improvements thereto. No license, express or implied, to any such intellectual-property rights is granted other than the limited license to use the Products for their intended purpose, as documented. Buyer must not (i) reverse engineer, disassemble, decompile, or otherwise attempt to derive the design, formulation, or manufacturing process of any Product; (ii) remove, obscure, or alter any proprietary, trademark, regulatory, or other notice on any Product or its packaging; or (iii) use any CuraSource trademark, trade name, or logo other than in the form, manner, and contexts approved by CuraSource in writing.

 

30. Buyer Insurance
 

Buyer will maintain, at its own cost, insurance appropriate to the nature and scale of its business and its activities under these Terms, including (without limitation) commercial general liability (including products and completed-operations coverage) and, where applicable, professional/medical-malpractice and clinical-trials insurance, with reputable insurers and at limits customary in the medical-device industry. Buyer will provide certificates of insurance upon request.