Procurement Terms & Conditions

All products and services supplied to DGK Brother Investments LLC (DBA “USA MedPremium”), including its affiliates and subsidiaries (“USA MedPremium”), by the Supplier are governed by the following terms and conditions:

ACCEPTANCE: The Procurement Terms and Conditions, along with the Purchase Order and/or any other contracts they are part of (jointly referred to as this “Agreement”), do not serve as an acceptance by USA MedPremium of any previous proposal, quotation, or sales offer. Such references are made solely to integrate the descriptions and/or specifications of the products and services from those documents, but only insofar as those descriptions or specifications do not contradict the ones outlined in this Agreement.

FULL AGREEMENT: This Agreement is the definitive accord between the parties and cannot be changed or modified except through a written agreement formally signed by both parties. USA MedPremium will automatically reject any supplementary terms or conditions mentioned in the Supplier's order acknowledgment or any other documents from the Supplier, eliminating the need for an explicit notice of rejection. These additional terms will not be valid or obligate USA MedPremium unless USA MedPremium explicitly approves them in writing. The approval or disapproval by USA MedPremium of certain supplementary terms or conditions does not imply consent to any other extra terms or conditions. This Agreement nullifies any trade customs, practices, previous dealings, or historical performances and will not be employed to interpret its terms.

MODIFICATIONS: USA MedPremium reserves the right to modify its order at any point, including changes to quantities, specifications, drawings, instructions, or the delivery timeline. Should such modifications significantly affect the Supplier's timeline or cost of delivery, either the Supplier or USA MedPremium may request an equitable adjustment. Nonetheless, additional charges will only be considered if the Supplier submits a claim within ten (10) days following the modification and receives written approval from USA MedPremium. Any technical advice or instructions provided to the Supplier by USA MedPremium's representatives related to the Supplier's performance should not be interpreted as an amendment under this clause or as authorization to deviate from the agreed terms of this Agreement.

ORDER TERMINATION: USA MedPremium reserves the right to terminate its order, either partially or entirely, by notifying the Supplier, without incurring any liability on the part of USA MedPremium. Such termination does not relinquish USA MedPremium's right to claim damages it may be entitled to. Any products dispatched subsequent to the termination notice will be sent back to the Supplier at the Supplier's cost.

MEDIA RESTRICTIONS: The Supplier is prohibited from releasing or causing the release of any press statements, public declarations, or any form of disclosure whatsoever, or from revealing the existence of the transactions outlined herein, unless there is mutual written consent from both parties for such a release, announcement, or disclosure in advance.

TIMELY DELIVERY: Prompt delivery is crucial for shipments to USA MedPremium. The Supplier is required to immediately inform USA MedPremium in writing about any potential or actual delays in fulfilling the order, including detailed reasons for the delay. However, such notification does not exempt the Supplier from its responsibilities under this Agreement. Should delivery not occur by the agreed-upon deadline, USA MedPremium reserves the right to seek alternatives and may charge the Supplier for any price discrepancies, or USA MedPremium may terminate the whole order or any part not yet delivered. Any payments owed to the Supplier may be deducted from amounts the Supplier owes to USA MedPremium. All deliveries must strictly adhere to the agreed schedule and quantities specified in this Agreement. USA MedPremium will not be responsible for accepting any surplus products delivered by the Supplier. USA MedPremium also retains the right to return, at the Supplier's cost, any products delivered that do not comply with USA MedPremium's order specifications and the terms of this Agreement.

ASSURANCE OF QUALITY: The Supplier assures and guarantees that its products and services ("Products") will:

• Meet all specified requirements and standards.
• Possess merchantable quality, devoid of any hidden or obvious flaws.
• Be safe and suitable for their designated purpose.
• Accurately reflect the stated weights, measures, dimensions, legends, or descriptions.
• Match or exceed the quality of any samples previously provided to USA MedPremium; and adhere to all relevant laws, regulations, licenses, permits, ordinances, codes, and standards. This assurance is in addition to any legal or implied warranties, including broader warranties and service commitments made to USA MedPremium by the Supplier, and will remain valid through inspection, testing, approval, and payment, benefiting USA MedPremium, its successors, delegates, and clientele.

NON-COMPLIANCE: USA MedPremium reserves the right to refuse any products or services that fail to meet this Agreement's standards. The Supplier will bear all costs related to the repair, replacement, or refund of such non-compliant products, including expenses for packing, packaging, and shipping. Furthermore, the Supplier is required to quickly address any Product Improvement Reports issued by USA MedPremium and implement all required and suitable corrective measures.

INTELLECTUAL PROPERTY RIGHTS: The Supplier acknowledges that USA MedPremium's designs, specifications, formulas, and manufacturing details are confidential and proprietary, and agrees not to disclose or use them for any purposes other than those specified in this agreement. The Supplier must return all such proprietary information and any copies to USA MedPremium upon fulfilling their obligations or upon USA MedPremium's earlier request. The Supplier recognizes USA MedPremium's ownership of any trademarks and trade names associated with USA MedPremium or its products, understanding they have no rights to these trademarks and trade names. The Supplier commits not to use USA MedPremium's name, trade name, or trademarks without USA MedPremium's explicit written permission. The Supplier grants USA MedPremium a royalty-free license to use the Supplier's trademarks on the Products, with the understanding that USA MedPremium will use these trademarks appropriately during the agreement term and cease their use in new materials after its termination. After this agreement ends, USA MedPremium retains the right to use the Supplier's trademarks as needed for the sale or service of Products bought during the agreement term. The Supplier guarantees it holds all necessary rights to the intellectual property required to sell the Products to USA MedPremium under this agreement, ensuring that USA MedPremium's use of such intellectual property will not violate or infringe on any third-party rights.

ACTIVITIES ON BUYER’S PROPERTY: When the Supplier needs to access premises owned or controlled by USA MedPremium for service provision or other purposes, the Supplier must assess the site, implement all necessary safety measures for its personnel, and shield, indemnify, and absolve USA MedPremium, along with its successors, assigns, and employees, from all claims, losses, costs, damages, and liabilities, whether direct, incidental, or consequential, that arise from property damage or loss caused by the Supplier, its employees, or others, or from personal injuries or fatalities of the Supplier, its employees, or others incurred due to their presence on the site, REGARDLESS OF WHETHER SUCH INCIDENTS ARE CAUSED IN WHOLE OR IN PART BY USA MedPremium’s NEGLIGENCE OR OTHER ACTIONS OR INACTIONS, OR THOSE OF USA MedPremium’s EMPLOYEES, WITH THE AIM OF THIS CLAUSE BEING TO EXEMPT AND PROTECT USA MedPremium AND ITS SUCCESSORS, ASSIGNS, AND EMPLOYEES FROM ALL LOSSES DUE TO THE SUPPLIER’S OPERATIONS ON USA MedPremium’s PROPERTY. The Supplier will also ensure that workers' compensation insurance covers all employees engaged in activities related to this Agreement on properties owned or controlled by USA MedPremium. The Supplier explicitly consents to forgo any aspects of the relevant workers' compensation legislation that would allow it to prevent being joined as an additional defendant or to evade liability for damages, contributions, or indemnity.

PACKAGING & TRANSPORTATION: USA MedPremium will not cover charges for handling, packaging, crating, drayage, or storage unless there is a written agreement to that effect. Products must be packed in a manner that ensures their preservation and protection against damage or deterioration, prepared for shipping by the Supplier according to recognized commercial practices and all relevant regulations. The Supplier is responsible for labeling and marking the goods in compliance with all pertinent federal, state, and local regulations, including CE markings where applicable. For deliveries to a USA MedPremium warehouse, the Supplier must include USA MedPremium's purchase order number on the invoice, packing list, bill of lading, and all packages. For direct shipments to customers, the customer's purchase order number should be noted on the packing slip. A copy of the invoice should be sent to USA MedPremium. Unless specified differently in this Agreement, all transactions within the USA and Canada are FOB Destination, while international sales are DDP (USA MedPremium’s specified location) according to Incoterms 2010. When required by legislation, the Supplier must ensure packaging meets U.N. performance testing standards. Furthermore, irrespective of legal requirements for U.N. testing, all packaging must comply with International Safe Transportation Association (ISTA) 3A standards.

COMPLIANCE WITH TRADE REGULATIONS: The Supplier is responsible for supplying USA MedPremium with the necessary trade compliance information, including:

1. The Harmonized Tariff Schedule (HTS) Code
2. The Export Control Classification Number (ECCN)
3. The International Traffic in Arms Regulations (ITAR) Category, if relevant
4. Nuclear Regulatory Commission (NRC) controls, if relevant
5. Country of Origin

Should there be any updates or changes to the provided information, the Supplier commits to promptly inform USA MedPremium of these changes.

PRICING AGREEMENT: USA MedPremium's orders should be fulfilled and billed at prices not exceeding those specified in the corresponding Purchase Order. The Supplier asserts that the prices charged to USA MedPremium will not surpass the lowest prices offered to any of its other customers for similar goods or services. The Supplier is obligated to cover all applicable federal, state, and local taxes, including but not limited to sales, use, income, excise, property, employment taxes, or any others related to the production of goods, delivery of services, or pertaining to the Supplier's property. USA MedPremium will only bear taxes that stem from its possession of the Products. The Supplier commits to compensating USA MedPremium for any losses, liabilities, or expenses (including attorney fees) arising from the Supplier's non-payment of such taxes, fees, duties, assessments, or charges.

PAYMENT TERMS: Payment made by USA MedPremium under this agreement does not constitute an acceptance of the goods or services provided by the Supplier.

OWNERSHIP GUARANTEE: The Supplier guarantees that it holds complete and unencumbered ownership of all goods and services provided under this agreement, free from any liens, security interests, and encumbrances. The responsibility, custody, and ownership of all Products remain with the Supplier until USA MedPremium takes physical possession or a written agreement states otherwise. The Supplier is responsible for the safety and integrity of the Products during production and up until their completion and acceptance by USA MedPremium. Should any damage, destruction, or loss occur to the Products before their final completion and acceptance, the Supplier is obligated to repair or replace such Products at its own cost to meet USA MedPremium’s standards.

HAZARDOUS SUBSTANCES COMMUNICATION: The Supplier will inform USA MedPremium in writing at the time of this Agreement's execution or sooner if any of the supplied Products fall under regulations related to hazardous or toxic materials, whether concerning shipping, usage, or disposal, including laws on hazardous waste or any other relevant environmental, health, or safety regulations. The Supplier is to provide USA MedPremium with digital versions of the most current Safety Data Sheets (SDSs). Should any SDSs be updated or revised, they must be promptly sent to USA MedPremium. All labels and SDSs must adhere to all relevant legislation, including but not limited to California’s Proposition 65, OSHA Hazard Communication, WHMIS 2015, EU-CLP, REACH, and RoHS, as applicable. Detailed instructions for shipping, handling, warnings, and safety information must accompany each delivery. The Supplier will supply USA MedPremium and its customers, upon request, with the latest SDS for all hazardous Products and any product details needed by USA MedPremium for accurate regulatory classification. The Supplier commits to collaborating with USA MedPremium to ensure SDSs are included in product packaging or provided as USA MedPremium requests. The Supplier also agrees to receive back any unsold or expired Products containing hazardous chemicals, materials, or substances at its facility for disposal, recycling, or reuse. While USA MedPremium will cover packing and transport costs to the Supplier, the Supplier will bear all other expenses, including but not limited to, costs related to disposal, recycling, or reuse of the Products.

INTELLECTUAL PROPERTY RIGHTS: The Supplier guarantees that the production, utilization, and distribution of the Products do not violate any patents, trademarks, trade names, copyrights, or any other property rights of third parties. The Supplier commits to defend, indemnify, and protect USA MedPremium (along with its agents, representatives, employees, officers, directors, affiliates, successors, assigns, and clients) against all claims, demands, lawsuits, damages, and liabilities (including attorney's fees) related to any infringement of third-party patents, trademarks, copyrights, or other intellectual property rights, or the misappropriation of any trade secrets, due to the manufacturing, use, or sale of the Products by USA MedPremium. Should any Product be subject to, or in USA MedPremium’s view likely to become subject to, any infringement claim, suit, or proceeding, the Supplier will, at USA MedPremium’s discretion and solely at the Supplier’s expense:

• Secure for USA MedPremium the rights to continue using, leasing, or selling the Product.
• Substitute the Product.
• Alter the Product to avoid infringement, or retrieve the Product and reimburse USA MedPremium the entire purchase price paid.

LAWFUL COMPLIANCE: The Supplier is obligated to adhere to all relevant international, federal, state, county, and city laws, regulations, codes, standards, ordinances, and directives in its operations under this agreement and will cover all costs related to compliance, including but not limited to licenses, permits, certifications, bonds, taxes, duties, tariffs, and other necessary fees. Specifically, the Supplier must follow all customs laws and regulations of the U.S. (notably the U.S. Export Administration Act) and each country where the Products are manufactured or expected to pass through, concerning:

1. (a) the labeling of the Products and their packaging,

   (b) the export, import, and further distribution of the Products to USA MedPremium and/or directly to USA MedPremium’s customers, which includes handling all necessary paperwork and covering all taxes, duties, tariffs, and similar charges. Furthermore, the Supplier confirms, declares, and guarantees:

   (i) it WILL NOT supply any Products that have been transferred, exported, or imported, directly or indirectly, from any country or entity under restriction by applicable laws and regulations, including but not limited to those listed on the Export Administration Regulations’ Denied Party List or any analogous list by U.S. or international bodies;

   (ii) it is not based in, controlled by, or a national or resident of any such sanctioned country;

   (iii) the Products are not manufactured, wholly or partly, through prison labor, forced labor, child labor, slavery, or any other labor practices that violate legal standards; and

   (iv) unless specifically agreed upon in writing by USA MedPremium and the Supplier, the Supplier will act as the Importer of Record for the Products, adhering to all relevant laws, bearing all related fees, and accepting all responsibilities associated with being the Importer of Record.

DELEGATION OF DUTIES: The Supplier is prohibited from transferring this Agreement or any associated rights or obligations without the explicit written approval of USA MedPremium. Any attempt to assign this Agreement without such authorization will be considered invalid and void, providing USA MedPremium with just cause to terminate this Agreement.

FORBEARANCE: Any lack of action or postponement in asserting a right, power, or privilege by USA MedPremium shall not be construed as a waiver. Moreover, neither a singular nor a partial use of any right, power, or privilege will hinder its subsequent enforcement or the exercise of any other right, power, or privilege.

NON-WAIVER: The absence of action or postponement in utilizing any right, power, or privilege by USA MedPremium does not serve as a waiver. Additionally, the isolated or partial use of any right, power, or privilege does not prevent its subsequent application or the use of any other right, power, or privilege.

PROVISIONS' ENFORCEABILITY: Should any section, or any part thereof, within this Agreement be deemed invalid, void, or unenforceable, such determination will not impact the validity and enforceability of the remaining sections or provisions.

CONFIDENTIALITY AGREEMENT: Each party (“Recipient”) commits to maintaining the confidentiality of specific information provided by the other party (“Discloser”) (“Confidential Information”). The Supplier acknowledges that USA MedPremium's customer details, including names, addresses, key contacts, purchasing history, and any information related to the marketing, sale, or distribution of products, constitute USA MedPremium's Confidential Information, irrespective of whether it is explicitly labeled as "confidential." Furthermore, the terms of this Agreement are deemed Confidential Information. The Supplier will restrict the Confidential Information shared with USA MedPremium to details about sources, new product developments, and financial data unless additional disclosure is approved by USA MedPremium. Any exchange of Confidential Information under these conditions will be kept confidential by the Recipient throughout the duration of this Agreement and for five (5) years post-termination. The sharing of such information is strictly for fulfilling this Agreement's purposes; the Recipient is prohibited from using, revealing, or publishing the information for any unrelated purposes. The stipulations regarding non-disclosure and non-use do not apply to information that the Recipient can prove, through written documentation, was already known prior to disclosure, is available from third parties not under confidentiality obligations with the Discloser, is publicly known, or is independently developed without relying on the Confidential Information.

HAZARDOUS MATERIALS HANDLING:

• For products that include, contain, or are packaged with lithium batteries, the supplier confirms compliance with the UN Model Regulations on the Transport of Dangerous Goods Chapter 2.9.4 and all applicable tests in the Manual of Tests and Criteria Part III subsection 38.3. The supplier also commits to providing the lithium battery test summary as mandated by the referenced UN documentation upon request.
• The supplier ensures that UN3480, Lithium Ion Batteries (stand-alone lithium ion batteries), will be delivered to USA MedPremium with a state of charge (SOC) not exceeding 30% of their rated capacity, in line with IATA Packing Instruction 965.
• Packaging designed for the containment of hazardous goods for end-user use, including but not limited to, empty containers, boxes, and spill kits, must be accompanied by closure instructions as per 49 CFR 178.2, either printed directly on the packaging or provided as a paper insert with the product.
• Should the end user of the Products or Services be in any manner associated with federal healthcare programs, the following condition will be enforced:

QUALITY STANDARDS: The Supplier agrees to adhere to the following requirements (or ensure the manufacturer of the Products complies with the following):

1. USA MedPremium may request a thorough investigation and response for any complaint. If an investigation is necessary, a response within 25 business days is expected, detailing the root cause, containment actions, and corrective/preventive measures.
2. Regarding any changes to the product and/or process, the Supplier must notify USA MedPremium of any alterations in raw materials, formulations, or processes before their implementation, via email to [email protected].
3. The Supplier is required to coordinate any customer notifications through USA MedPremium’s Quality and Regulatory Departments. Such communications might include:

• Quality concerns.
• Product recalls.
• Medical Device Reporting requirements.
• Notices of corrections and removals, and Medical Device Tracking obligations.

Communications should be directed to USA MedPremium via email at [email protected]. The Quality Assurance (QA) team will reply with a list of USA MedPremium customers that the Supplier needs to contact. The Supplier is tasked with swiftly issuing recall notifications to all listed USA MedPremium customers.

If the Products supplied are to be privately labeled for USA MedPremium, the following conditions shall be observed:

PRIVATE LABEL PACKAGING AND BRANDING: Products bearing a private label will feature USA MedPremium’s trademarks and labels as specified by USA MedPremium and communicated to the Supplier. The Supplier is prohibited from altering any of USA MedPremium’s designs, labels, or packaging without securing USA MedPremium's prior written approval. The Supplier is expected to conduct regular assessments of the packaging and labeling of Products that are privately labeled for USA MedPremium to ensure compliance with this section's requirements and the sufficiency of Product warnings and instructions. The Supplier agrees to comply with any modifications to the Product labeling and packaging as reasonably requested by USA MedPremium.

PRODUCT STANDARDS: USA MedPremium and the Supplier will jointly establish the fundamental features, specifications, and industrial design (including the chosen manufacturing facility for the product or product line) for each Product or product series before any manufacturing begins. Furthermore, each Product must adhere to the specifications mutually agreed upon in writing between USA MedPremium and the Supplier. The Supplier is required to secure written approval from USA MedPremium before implementing any alterations to the specifications, industrial design, or production location of any Product. The Supplier must also furnish product specification and certification documents as requested by USA MedPremium. All proposed changes must be reported to USA MedPremium Quality Assurance in advance of their execution, via email at [email protected].

SALES RIGHTS FOR PRIVATELY LABELED PRODUCTS: USA MedPremium (and its designated affiliates, as notified by USA MedPremium to the Supplier) shall possess the exclusive global rights to distribute Products under one or more of USA MedPremium’s names and/or trademarks. The Supplier is prohibited from selling any Products that carry USA MedPremium’s trademarks, trade names, and/or logos to any third parties without obtaining prior written permission from USA MedPremium, which USA MedPremium may refuse or revoke at any time, for any reason or no reason at all.

PRIVATE LABEL INTELLECTUAL PROPERTY RIGHTS: In addition to the intellectual property rights detailed in Paragraph 9 of these Procurement Terms and Conditions, USA MedPremium grants the Supplier a non-exclusive license to use its “USA MedPremium” trademark and any other trade names and/or logos as specified by USA MedPremium (collectively, the “Licensed Mark”) in association with the Products, under the conditions and limitations outlined below:

1. The Supplier is prohibited from using the Licensed Mark in any manner related to the sale of any Products to any party other than USA MedPremium (or its affiliates or assigns as designated by USA MedPremium);
2. The Supplier must secure prior written consent from USA MedPremium before employing any signage, labels, packaging materials, advertisements, or any other materials bearing the Licensed Mark;
3. The license for the use of the Licensed Mark will expire concurrently with the termination of this Agreement;
4. The Supplier agrees not to use any mark that is identical to or could be confused with the Licensed Mark for any purposes outside of selling the Products during and after the term of this Agreement;
5. The Supplier acknowledges that it acquires no ownership rights in the Licensed Mark through this Agreement, except for the usage rights as specified herein. The Licensed Mark remains the exclusive property of USA MedPremium, and any use of the Licensed Mark by the Supplier will benefit USA MedPremium. The Supplier will not challenge the validity of the Licensed Mark or USA MedPremium’s ownership rights;
6. The Supplier commits to not using the Licensed Mark in any way that could harm its value to USA MedPremium;
7. Upon the expiration or termination of this Agreement, the Supplier must cease all use of the Licensed Mark, except as necessary to meet remaining obligations. At USA MedPremium’s request, the Supplier must either return or destroy all materials featuring the Licensed Mark and provide a certificate of destruction if requested;
8. The Supplier will inform USA MedPremium of any unauthorized use of marks similar to the Licensed Mark that it becomes aware of;
9. This license is non-transferable and does not allow the Supplier to sub-license without explicit written consent from USA MedPremium. The Supplier acknowledges that any product designs, characteristics, distribution strategies, or models developed by USA MedPremium during or related to the term of this Agreement are owned exclusively by USA MedPremium.

MATERIAL SAFETY DATA: Safety Data Sheets (SDSs) and hazard warning labels will include the Supplier's emergency contact details, and the Supplier commits to promptly responding to all inquiries from USA MedPremium or directly from customers, as relevant. Should the Products supplied fall under the regulation of the United States Food & Drug Administration (FDA), the subsequent conditions shall be enforced:

FDA REGULATORY ADHERENCE: The Supplier commits to adhering to all relevant FDA Regulations as outlined in Title 21 C.F.R. (Food & Drugs) § 1-1499. If the Supplier is not the original manufacturer of the Products, it is required to ensure the manufacturer's compliance with these stipulations. Specifically, the Supplier agrees to the following, or will ensure the manufacturer's compliance with:

1. Ensuring all relevant establishments and products involved in the Products' development, manufacturing, and distribution are properly registered and comply with applicable laws.
2. Maintaining registration with the FDA as the Specification Developer and Manufacturer of the Products. If the Supplier is not the manufacturer, it will ensure the manufacturer's compliance with this requirement.
3. Listing all Medical Devices produced in their facilities with the FDA, ensuring compliance with FDA Federal Code of Regulations Title 21, Subchapter H, Part 807.
4. Registering all Foreign Establishments manufacturing FDA-regulated Products as per laws and regulations, and conducting routine audits of such establishments throughout this Agreement.
5. Timely addressing Product quality issues, Medical Device Reporting, corrections, removals, and Medical Device Tracking as mandated by federal laws, with appropriate notifications to USA MedPremium.
6. Ensuring any Products requiring sterilization meet all applicable laws and Good Manufacturing Practices as defined by FDA regulations.
7. Keeping all necessary documentation as required by FDA regulations and the Supplier’s Quality System, making such documentation available for USA MedPremium's review as per this Agreement.
8. Collaborating with USA MedPremium for audits of the Supplier or any manufacturers in the supply chain as requested.
9. Gaining USA MedPremium's prior approval for all labels and packaging, including Instructions for Use and packaging inserts, with FDA approval where legally necessary.
10. Promptly communicating any changes in raw materials, formulations, or processes to USA MedPremium.
11. Coordinating customer notifications related to quality issues, process changes, recalls, Medical Device Reporting, corrections, removals, and Medical Device Tracking with USA MedPremium’s Quality and Regulatory Departments as legally required.
12. As the Specification Developer and Manufacturer, taking responsibility for FDA notifications as required by 21 C.F.R. § 1-1499. If not the manufacturer, the Supplier will ensure the responsible parties provide such notifications.
13. Complying with the regulations of any other country that may have jurisdiction over the Products' manufacture or transport, in addition to U.S. FDA regulations, where applicable.

FDA PRODUCT DETAILS: The Supplier commits to furnishing the following details to USA MedPremium for each product regulated by the FDA:

1. The FDA medical device listing number (MDL)
2. The FDA Product Code (3-letter code)
3. A description of the FDA-regulated device.
4. The 510(k) number, when relevant.
5. The establishment registration number.

Should the Supplier not be the original manufacturer of the Products, it is required to verify the manufacturer's adherence to these requirements and to collect and relay this information to USA MedPremium.