MIMEDX GROUP, INC. AND SUBSIDIARIES (COLLECTIVELY, “MIMEDX”) TERMS AND CONDITIONS OF SALE
Order Entry Policy: For most efficient handling, all orders and correspondence pertaining to shipments should be communicated to:
MIMEDX Customer Service Department, Tel: 866-477-4219 Fax: 770-590-3552
The Customer Service Department is open weekdays (excluding U.S. national holidays) between the hours of 8 a.m. and 7 p.m. Eastern Standard Time.
Customer agrees to purchase and accept MIMEDX Products in accordance with these terms and conditions. MIMEDX objects to and rejects any and all terms proposed by Customer, whether contained in Customer’s purchase order or elsewhere. If MIMEDX and Customer have signed a separate, written agreement governing Customer’s purchase of MIMEDX products, then the terms of that agreement shall govern.
- INSPECTION; PRODUCT RETURN.
Product Eligible for Return or Credit: With the exception of Non-Returnable Products or Product returns governed under a separate purchase agreement, Product returns will be accepted for return only under the following conditions:
a. MIMEDX Consigned Product. For return of MIMEDX consigned product, please contact your MIMEDX Sales Representative or email [email protected].
Damaged or Non-Conforming Product.
a. Damaged Product. Product shipped directly from Company that is damaged in transit from Company to Customer shall be processed exclusively by MIMEDX. Such damaged Product should be immediately reported to MIMEDX by contacting [email protected].
b. Non-Conforming Product. Product purchased directly from MIMEDX by direct purchasing accounts, or from a distributor that is unusable due to reasons related to Product quality arising out of the manufacturing of the Product (i.e., the physical characteristics of the Product deviate from the physical characteristics of the Product described in the Instructions for Use for the Product or the Product specifications) shall be processed exclusively by MIMEDX. Such Product should be immediately reported to MIMEDX by contacting [email protected].
Product Ordered in Error. Product ordered/received and purchased from MIMEDX in error is eligible for return. Such Product shall only be returnable if a Customer notifies MIMEDX of the error in writing within thirty (30) calendar days of receipt of the shipment pertaining to the ordering error and MIMEDX confirms receipt of request to return. Notification is completed by emailing the Returns Material Authorization Form to [email protected].
a. Product must be returned unused and in its original packaging with no additional labels or materials added to the package.
b. With the exception of Products returned in accordance with other sections of this Policy, MIMEDX will not accept returns of Products ordered in error after thirty (30) calendar days from Customer’s receipt.
Product Returned Due to FDA Recall, Voluntary Recall by Company or at Direction of Company. Product that the Company or a governmental entity (e.g. FDA) instructs Customers to return, including, but not limited to, Product recalls, natural disasters or regulatory requirements. These Product returns will only be eligible if authorized by Company’s Legal Department or by a governmental entity with authority to issue such instructions to Company and Customers.
Non-Returnable Products. Return of Products is not permitted for the following circumstances. Non-returnable products will not be eligible for authorized return and Customer will not receive credit nor release from payment obligations in the event of an unauthorized return that is outside of the eligible return criteria set forth above. For the avoidance of doubt, the following Product is not eligible for credit or replacement under the above, regardless of whether the Product otherwise satisfies the requirements in any of the sections previously specified:
a. Product that is not in its original packaging; or Product not in its original container and/or not bearing its original label; or lot numbers or expiration dates are missing; unless (a) a certification of return circumstances that would not require the return of physical Product (e.g. loss, damage, etc.) and proper disposal, if applicable, has been submitted and Company has approved and processed such certification or (b) Product is physically returned but is damaged (at time of shipment by Company) making fulfillment of this requirement impossible.
b. Product involved in a fire, flood, natural disaster, or obtained in a sacrifice or bankruptcy sale.
c. Product that is in a deteriorated condition due to improper storage by Customer (e.g., exposure to water, heat, cold, fire).
d. Product that Company has previously designated as “nonreturnable” by contract or notice to Customer outside of the Product Return Policy.
e. Product that has been repackaged.
f. Product purchased for research or clinical trials or shipped as a no cost item (e.g., physician sample, Product replaced through separate Company Product replacement program, etc.).
g. Product damaged or rendered unusable due to mishandling or error by Customer.
h. Any private-labeled products manufactured by Company, but sold by a third party. These products should be returned under the terms and conditions for return offered by the selling entity.
For more information, please see our Returns Page.
“Product” means a product that (i) has been ordered by a Customer via purchase order and (ii) invoiced by Company at the time of delivery.
“Consigned Product” means a Product that a Customer receives and stores in proper conditions, but the Company otherwise retains ownership and title to the Product until such Product is used by the Customer.
“Customer” means a direct purchaser of Company Products, including, but not limited to, a hospital, physician practice, distributor, wound care center, or other outpatient facility.
“Return Management Authorization” or “RMA” means an approval and associated return identification information issued by Company to Customer.
- SHIPMENT/RISK OF LOSS. Products shall be suitably packed for shipment in MIMEDX’s standard shipping cartons, marked for shipment to the destination specified in Customer’s purchase order, CIP MIMEDX shipping point (Incoterms 2010).
- PAYMENT. Payment terms shall be (a) as set forth in a written agreement signed by Customer and MIMEDX, if one exists; (b) if no written agreement signed by MIMEDX and Customer exists, then as set forth on the packing list, if specified there; (c) if no payment terms are specified on the packing list, then as set forth on the invoice, if set forth there; (d) if not provided in (a), (b), or (c), then net thirty (30) days from the date of shipment without regard to insurance reimbursement, if any. MIMEDX is unable to sell product contingent on insurance reimbursement and any representation to such effect may be a violation of federal law. Any unpaid balance as of the expiration of such 30 days shall bear interest at the rate of 1.5% per month, or, if lower, the highest rate allowed by applicable law, calculated on the basis of a 360-day year and actual days elapsed. Customer shall be responsible for any and all costs incurred or deemed to have been incurred by MIMEDX, including, without limitation, reasonable attorneys’ fees and costs, in collecting any sums due from Customer to MIMEDX. All payments will be applied first to fees, costs and expenses of MIMEDX, second, to the accrued and unpaid Interest, and third, to the outstanding principal balance.
- COMPLIANCE WITH LAW; LICENSES, ETC. MIMEDX and Customer shall comply with all applicable statutes, rules, regulations and standards of any and all governmental authorities and regulatory and accreditation bodies relating to practitioners, hospitals, the provision of healthcare services, and the practice of medicine. Any licenses, permits, certificates or other documents that are required by any governmental authority for the supply and use of the Products hereunder shall be the respective responsibility of MIMEDX and the Customer. MIMEDX is not responsible for any violations of applicable laws and regulations by Customer with regard to the use of the Products.
- WARRANTIES. Subject to the provisions of this Section 5, MIMEDX warrants for a period of one (1) year after shipment that each amnion-based Product has been collected, processed and stored in compliance with all applicable laws and standards, including the AATB Standards and Title 21, Code of Federal Regulations 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products, and has a shelf-life of at least two (2) years from the date of shipment to Customer. EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION, MIMEDX MAKES NO WARRANTIES OR CONDITIONS, EXPRESS, STATUTORY, IMPLIED, OR OTHERWISE, AND MIMEDX SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTWITHSTANDING THE FOREGOING, MIMEDX DOES NOT EXCLUDE LIABILITY TO THE EXTENT THAT SUCH LIABILITY MAY NOT BE EXCLUDED OR LIMITED BY LAW.
- EXCLUSIVE REMEDY/LIMITATION OF LIABILITY. If the Products delivered to Customer fail to conform to this Contract for any reason whatsoever, Customer’s sole and exclusive remedy shall be as provided herein. MIMEDX shall not under any circumstances be liable to Customer for (i) any special, exemplary or consequential damages, however caused and under any theory of liability whether based in contract or tort or otherwise or (ii) any claim or demand brought against Customer by any other party, even if MIMEDX has been advised of the possibility of such claim or demand. MIMEDX liability to Customer for any claim whatsoever related to the Products or this Contract, including any cause of action sounding in contract, tort, indemnity, contribution or strict liability, shall not exceed the amount of all payments received by MIMEDX for the Products that are subject of this Contract.
- INDEMNIFICATION. Customer shall defend, indemnify and hold harmless MIMEDX from and its respective members, directors, officers, employees and agents from and against any liability and claims of all kinds for any injury to persons or property or any other claims of injury, loss, expense or damage incurred by any employee or customer of Customer or any third party that arises out of the Customer’s breach of its obligations hereunder or is due to the negligent acts, omissions or intentional acts of Customer, its employees, agents, consultants, or subcontractors.
- FORCE MAJEURE AND DELAY. MIMEDX shall be excused for any delay in the shipment of any Products ordered due to acts of God, war, the public enemy, mobilization, riot, strike, lockouts, work stoppage or any other labor difficulties, blights, disease, excessive heat, explosion, shortage of cars or other materials, embargoes, acts of civil or military authorities, fires, floods, accidents, quarantine restrictions, carrier conditions, delays in transportation, or any other case of Force Majeure, or circumstances or cause beyond the reasonable control of MIMEDX. In the event of such an occurrence, MIMEDX shall give Customer reasonable notice that there will be a delay or non-delivery, upon which notification this Contract shall be deemed terminated and MIMEDX shall have no further obligation to ship the Products covered by this Contract. Notwithstanding the preceding sentence, if Customer agrees to a future delivery date in writing, this Contract shall continue and MIMEDX shall deliver the Products on such later delivery date. MIMEDX shall make every reasonable effort to meet the shipping date specified in this Contract. In no event, however, will MIMEDX be liable for its failure to meet such date if the delay is caused by reasons beyond the reasonable control of MIMEDX.
- ATTORNEY’S FEES. In the event MIMEDX brings an action to enforce any of the terms or conditions of this Agreement or protect its interests hereunder, whether in any bankruptcy, receivership or insolvency proceeding or otherwise, or otherwise utilizes an attorney to collect the amounts owing hereunder, MIMEDX shall be entitled to recover all reasonable costs and expenses incurred or deemed to have been incurred, including reasonable attorney’s fees prior to trial, at trial and on appeal, and for post-judgment proceedings. To the extent allowed by applicable law, interest shall accrue on any amounts owed by Customer to MIMEDX, whether before or after any legal judgment, at the rate provided in Section 3, above, or such lesser rate as allowed by law.
- PRODUCT RECALLS. In the event (a) any government authority issues a request, directive or order that any Product be recalled, (b) a court of competent jurisdiction orders such a recall, or (c) MIMEDX reasonably determines, after consultation with Customer, that any Product should be recalled, Customer shall cooperate with MIMEDX in effecting such recall as MIMEDX may reasonably request. MIMEDX shall have administrative responsibility for effecting any such recall.
- PROPRIETARY RIGHTS. Customer agrees that MIMEDX retains all right, title and interest in and to all patent rights, trademarks, trade names, inventions, copyrights, know-how and trade secrets relating to the Products and the design, processing, manufacture, operation or service of the Products. Customer shall not (and shall require that its customers, if any, do not) remove, alter, cover or obfuscate any proprietary rights notices placed or embedded by MIMEDX on or in any Product.
- RECORD KEEPING. MIMEDX and Customer will keep or cause to be kept in accordance with FDA/AATB regulatory requirements books and records regarding the purchases and sales of Products pursuant to this Agreement. All tissue utilization records will be returned to MIMEDX. Further, to the extent and only to the extent required by law, until the expiration of four years after the furnishing of the products and services provided under this Agreement, MIMEDX will make available to the Secretary of the U.S. Department of Health and Human Services, the U.S. Comptroller General, and their representatives, this Agreement and all books, documents, and records necessary to certify the nature and extent of the costs of any products or services provided hereunder. If MIMEDX subcontracts its duties hereunder through a subcontract worth $10,000 or more over a 12-month period with a related organization, the subcontract will also contain an access clause to permit access by the Secretary, Comptroller General, and their representatives to the related organization’s books and records.
- ENTIRE AGREEMENT/SEVERABILITY. In the event of a conflict between the provisions of this Contract and the provisions of a signed, separate written agreement between Customer and MIMEDX, the terms and conditions of the signed agreement shall prevail. In the event that any of the terms of this Contract is, becomes or is declared to be invalid or void by any court of competent jurisdiction, such term or terms shall be null and void and shall be deemed severed from this Contract and all of the remaining terms of this Contract shall remain in full force and effect.
- GOVERNING LAW; VENUE. This Contract shall be governed by and construed in accordance with the laws of the State of Georgia, without giving effect to its conflict of laws principles. Any demand, suit or cause of action arising out of this Contract shall be brought in a state or federal court located in Fulton County, Georgia. Customer hereby submits to the jurisdiction and venue of such court.
- NONASSIGNABILITY; AMENDMENTS. Customer shall not assign this Contract without the prior written consent of MIMEDX and any attempt to assign or transfer any of the rights, duties or obligations under this Contract without such consent shall render such assignment or transfer null and void. This Contract can be amended only in writing executed by MIMEDX and Customer.
- PRICING. The pricing on the invoice reflects the net price of supplies to the purchaser. This price is net after a discount or other reduction in price, and the net price as well as any discount may be reportable under federal regulations at 42 C.F.R. §1001.952(h). Customer is hereby informed that it may have received a discount. The price net of that discount is as stated on the invoice. Customer agrees that it shall fully and accurately report such discount on any claims or cost reports that it may submit to Medicare or any State Medicaid program.