These OX BioMed, LLC (“OX”) Terms and Conditions (“Terms and Conditions”) are incorporated by reference into any Customer Agreement between OX and any of its Customers that explicitly incorporates them by reference (the “Customer Agreement”). All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise. Capitalized terms used in these Terms and Conditions without definition shall have the meanings given to them in the Customer Agreement. References to this “Agreement” mean the Customer Agreement, together with these Terms and Conditions incorporated therein. In the event of a conflict between these Terms and Conditions and a Customer Agreement, the Customer Agreement shall control.
1.Customer Obligations
a.Compliance. Customer shall at its own expense (except as otherwise expressly provided in this Agreement) comply with all federal, state, and local laws, ordinances, regulations and rules applicable to its business. In addition, Customer shall comply with all applicable OX policies and procedures.
b.Product Responsibility. Customer shall strictly comply with the Product manufacturer (the “Manufacturer”) guidelines and instructions (including as contained in the product specifications, package inserts and other directions that the Manufacturer may deliver from time to time) regarding the storage, handling, and distribution-related activities pertaining to the Products to prevent deterioration, damage, and mix-ups.
c.Records. Customer shall maintain up-to-date and accurate records of distribution or use as requested by OX to enable implementation of an immediate Recall (as defined in OX’s Refund Policy) of any Products. These records shall include records of deliveries to any and all end users (including details of batch numbers, delivery date, end user’s name, address, email, telephone number and fax number if available).
d.Complaints and Notification. Customer shall collect, investigate and timely respond to all complaints or inquiries relating to Product safety, quality or efficacy and shall promptly forward each complaint and or inquiry to OX within three (3) calendar days of receipt. Customer shall maintain a complete record of each Product complaint and inquiry for at least two (2) years after it is received, or any longer period required by the Food and Drug Administration’s (“FDA’s”) then current requirements. Customer shall promptly notify OX in writing of any regulatory agency communications, actions or inquiries, whether oral or written, it receives or learns of that relate to the Products and shall promptly provide OX with copies of any such documentation relating to same.
e.Recall. In the event of a Recall, Customer shall strictly follow OX’s directions or the recalling authority’s instructions for conducting the Recall and for returning or destroying and certifying destruction of the recalled Products after completion of the Recall.
f.Clinical Decision Making. Customer acknowledges and agrees that Customer will at all times remain responsible for the clinical decision making with respect to the use and application of the Products. In no event will OX or any person acting on its behalf provide any recommendations or advice with respect to the care and treatment of patients.
2.OX Obligations
a.Compliance. OX nor any person acting on its behalf shall not directly or indirectly make, offer, promise or authorize any remuneration intended to improperly influence the purchasing decisions of healthcare providers in order to assist in the sale, marketing, promotion, licensing or distribution of the Products.
3.Product Orders and Delivery
a.Purchase Orders. Customer shall order Products by delivering firm orders to the Company, specifying the part number, product name, the quantity, the Purchase Price set forth in the Customer Agreement and the name and address where the product will be shipped along with any other relevant information in connection with the order. OX will issue a Delivery Slip in connection with each order and invoice Customer in accordance with the Customer Agreement.
b.Delivery. Subject to availability of inventory and Customer’s compliance with the terms of the Agreement, OX will use reasonable commercial efforts to confirm an estimated delivery date in its Purchase Order.
c.Shipping. OX will pay all shipping costs when OX ships Products, unless otherwise agreed to by the parties in writing.
d.Title and Loss. Title to Products and risk of loss will pass to Customer when Products are delivered to the customer from the carrier pursuant to a Purchase Order.
e.Rejections, Returns, and Refunds. Unless otherwise set forth in the Customer Agreement, any rejection or return of Product by Customer shall be in accordance with OX’s Refund Policy. Further unless otherwise set forth in the Customer Agreement, refunds will only be made in accordance with OX’s Refund Policy.
4.Payment Terms.
a.Purchase Price, Taxes and Shipping Charges. OX shall sell Products to Customer at the Discount of ASP set forth in the Customer Agreement. The Purchase Price does not include applicable sales, use or other taxes that Customer may owe in connection with the purchase of Products. Any discount adjustments shall be upon no less than seven (7) days advance written notice to Customer.
b.Invoicing and Payment. OX shall invoice Customer in accordance with the Customer Agreement. Customer agrees to pay OX upon receipt of invoice in accordance with the terms of the Customer Agreement.
5.Customer Representations and Warranties
a.Customer represents and warrants that it is qualified to purchase each Product it orders based on the intended use and labelling claims in the package insert applicable to that Product.
b.Customer represents and warrants that all Product will be used for its intended purpose and that no Product will be resold or redistributed to any third party.
c.Customer represents and warrants that Customer is a licensed provider with full scope of practice for treatment of the systemic disease process etiologic for the conditions treated in Customer’s medical practice.
d.Customer represents and warrants that all licensed providers applying Product fully comply with Medicare rules, regulations and opinions regarding wound application of cellular and/or tissue based products.
e.Customer represents and warrants that it is in the sole medical judgment of the licensed provider applying the Product to determine whether to use the Product, the amount of the Product that is medically necessary, and the duration of time to for use and application of the Product based on a patient’s clinical needs.
f.Customer represents and warrants that Customer understands that neither OX nor any person acting on its behalf are qualified to give advice on the medical necessity, use or billing practices of Customer related to the Product.
6.OX Representations and Warranties.
a.OX represents and warrants that it, nor any of its employees or contractors, have been debarred under Section 306(a) or 306(b) of the FDCA or excluded pursuant to 42 U.S.C. § 1320a-7 and that no debarred or excluded person will in the future be employed or utilized to perform any services under this Agreement.
b.OX warrants it has title to Products delivered hereunder and may properly sell such Products to Customer. The Product Manufacturer’s product warranty to end users is included with the documentation for its Products, and OX is not authorized to extend to end users on behalf of the Product Manufacturer any supplemental or different product warranty provisions. OX HEREBY DISCLAIMS ALL OTHER WARRANTIES AND REPRESENTATIONS, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR USE AND/OR PARTICULAR PURPOSES. OX’S SOLE LIABILITY FOR BREACH OF ANY PRODUCT WARRANTIES SHALL BE, AT OX’S SOLE DISCRETION, CREDIT, REPAIR OR REPLACEMENT OF THE NONCONFORMING PRODUCT.
7.Force Majeure Event. Either Party shall be excused from performing its obligations under this Agreement if its performance is delayed or prevented by any cause beyond such Party’s reasonable control, including, but not limited to, (a) acts of God, including pandemics or other public health emergencies; (b) flood, fire, earthquake, or explosion; (c) war, invasion, hostilities, terrorist threats or acts, riot, or other civil unrest, (d) actions, embargoes, or blockades in effect on or after the Effective Date; or (e) strikes, labor stoppages, supply shortages or slowdowns, utility failures or other industrial disturbances (each a “Force Majeure Event”). Performance shall be excused only to the extent of and during the reasonable continuance of such event of force majeure. Each Party shall promptly notify the other Party in writing of an event of force majeure as well as the expiration thereof. Notwithstanding the foregoing, no occurrence of an event of force majeure shall relieve Customer of its obligation to make payment for the Products already delivered hereunder and of all charges and expenses due and payable to the OX hereunder.