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STABILITY BIOLOGICS, LLC, ITS SUBSIDIARIES AND BILLING PARTNER BREEZE MEDICAL, LLC

(COLLECTIVELY, “STABILITY”) TERMS AND CONDITIONS OF SALE

 

Order Entry Policy: For most efficient handling, all orders and correspondence pertaining to shipments should be communicated to:

 

Stability Biologics, LLC Customer Service Department, Tel: 855-267-5551, Fax:  855-267-4166, Email: cservice@stabilitybio.com

 

The Customer Service Department is open weekdays (excluding U.S. national holidays) between the hours of 8 a.m. and 5 p.m. Central Standard Time.

By accepting (in accordance with Section 1 below) or using any Stability Biologics, LLC (“Stability”) Products, Customer agrees that the purchase of such Products is exclusively in accordance with these terms and conditions (“Agreement") and that Stability may enforce this Agreement against Customer to the fullest extent of the law. Stability expressly objects to and rejects any and all terms not set forth in the Agreement or that differ from the Agreement that may be proposed by Customer, whether contained in Customer’s purchase order or elsewhere, and no such terms shall have effect. Notwithstanding the above, if Stability and Customer have signed a separate, written agreement governing Customer’s purchase of Stability products, then the terms of that agreement shall govern in lieu of this Agreement.

1.       INSPECTION; PRODUCT RETURN.  Customer shall inspect the Products immediately upon receipt.  In order to return Product that fails to conform to the warranty set forth herein, Customer shall (i) notify Stability in writing that such Product failed to conform with the warranty set forth herein and furnish a detailed explanation of any alleged nonconformity, as required by Stability’s then-current policy (which can be found at: https://www.stabilitybio.com/returns)  within three (3) days of receipt of the Product; (ii) obtain a Return Goods Authorization (RGA) number for the nonconforming Product from Stability; and (iii) within ten (10) days of receipt of the RGA number, return such Product to Stability at the address specified in the RGA with the RGA number prominently displayed on the shipping carton, FCA Customer’s shipping point (Incoterms 2010).  Stability may refuse to accept any Product not shipped as herein provided.  Stability shall return to Customer, freight prepaid, all repaired or replaced Products properly returned by Customer. In the event that any returned Product is reasonably determined by Stability to conform to the warranty set forth herein or to have been modified or subjected to stress, misuse or abuse, Customer shall reimburse Stability for all reasonable costs and expenses related to the shipping, insurance, inspection and return of such Product to and from Customer.

2.       SHIPMENT/RISK OF LOSS.  Products shall be suitably packed for shipment in Stability’s standard shipping cartons, marked for shipment to the destination specified in Customer’s purchase order, CIP Stability shipping point (Incoterms 2010).

3.       PRICING, PAYMENT AND INVOICES.  Purchase prices shall be negotiated prior to the time of sale and will be provided to Customer on a Pricing Sheet.  Payment terms and conditions are as follows: 

 

I. AmnioCore and Dermacyte.  Payment terms are net sixty (60) days.  The pricing on the invoice reflects the net price to the Customer.  Any discounted value for either product can be calculated by the Customer by subtracting the current published ASP less the invoiced amount.  The Customer is responsible for performing this calculation.  By accepting this discount, Customer agrees they will fully and accurately report any discount to Medicare, Medicaid, Tricare and any other federal or State program upon request by any such program or as required by law. Customer must claim the benefit of these discounts in the fiscal year in which the discounts are earned.   Accordingly, Customer should retain any documentation, including invoices or purchase orders, of discounts.  

 

II. Amnio Tri-Core, Amnio Quad-Core, AmnioCore Pro, AmnioCore Pro+ and AmnioAmp MP (collectively “Amnio Products”).  Payment terms are net sixty (60) days.  When these Amnio Products are utilized in States that fall under Medicare Administrative Contracts (“MACs”) where established reimbursement rates are not in effect, Stability offers contingent, volume-based rebates to Customers that make at least $10,000 in payments for the purchase of Amnio Products, based on the sum of all initial invoice prices of applicable purchases made in a single month. Customers who meet the minimum purchasing amount in a single month are eligible to receive the contingent, volume-based rebate for that month.  Eligible customers will receive a rebate as defined in the Pricing Sheet for the applicable month that they qualified for the rebate.  Rebates shall apply equally to all applicable Amnio Product purchases made during the applicable month.  Stability will calculate rebates at the end of the applicable month and issue rebates within ten (10) business days from the end of applicable month. When Amnio Products are used in States that fall under MACs where established reimbursement rates are in effect, the pricing on the invoice reflects the net price to the Customer.  Any discounted value for either product can be calculated by the Customer by subtracting the current published ASP less the invoiced amount.  The Customer is responsible for performing this calculation.  By accepting this discount, Customer agrees they will fully and accurately report any discount to Medicare, Medicaid, Tricare and any other federal or State program upon request by any such program or as required by law. Customer must claim the benefit of these discounts in the fiscal year in which the discounts are earned.  Accordingly, Customer should retain any documentation, including invoices or purchase orders, of discounts.  If Customer’s account is past due, Customer agrees that Stability first may apply the rebates earned by Customer to the past due amount before allocating any balance to a credit memo.  By accepting this rebate or price reduction, Customer agrees they will fully and accurately report any reduction in pricing to Medicare, Medicaid, Tricare and any other federal or State program upon request by any such program or as required by law. Customer must claim the benefit of these rebates or reduction in pricing in the fiscal year in which the rebates are earned.   Accordingly, Customer should retain any documentation, including invoices or purchase orders, of discounts. 

 

III. All other products.   Payment Terms are net thirty (30) days unless extended payment terms are explicitly stated on the invoice.  The pricing on the invoice reflects the net price to the purchaser.

 

Failure to obtain reimbursement for purchases does not release Customer from their obligation to pay for the product orders under this Agreement.  After thirty (30) days from the date that payment is due, any unpaid balance shall bear interest at the rate of 1.5% per month, or, the highest rate allowed by applicable law.  In addition, Customer shall be responsible for any and all costs actually incurred by Stability, including, without limitation, collections fees and reasonable attorneys’ fees and any other costs related to collecting any sums due to Stability.

 

4.     AVAILABILITY OF STABILITY REIMBURSEMENT HOTLINE; LIMITED WARRANTY. Stability offers customers and potential customers access to a hotline where Stability will assist with completing insurance verifications for the coverage of AmnioCore, Dermacyte, Amnio Tri-Core, Amnio Quad-Core, AmnioCore Pro, AmnioCore Pro+ and AmnioAmp MP products for any particular patient. This hotline is to help customers and prospective customers determine whether a Stability product may be right for a particular patient by helping to determine whether the patient will have applicable insurance coverage.  The purchase of Stability products is in no way contingent on the use of the reimbursement hotline.  However, Stability stands by the accuracy of our insurance verification process offered through the reimbursement hotline, such that Stability offers a limited warranty to customers who use and rely on the service in connection with product purchases.  Subject to the terms and conditions of the Reimbursement Hotline Warranty, Stability will provide a statement credit to customers for the value of the purchase price of the product that a third-party payor denied reimbursement for when the Stability reimbursement hotline had previously verified the insurance benefit for the specific patient and all other eligibility criteria for the Reimbursement Hotline Warranty program have been satisfied.  The full terms and conditions of the Reimbursement Hotline Warranty can be found at: https://www.stabilitybio.com/reimbursement-hotline-limited-warranty

 

5. CUSTOMER OBLIGATIONS.

I. Customer agrees only to use Product when Product is medically necessary.  Customer and Stability acknowledge that use of any Product is at the sole discretion of the treating provider, pursuant to their professional medical judgment.
 

II.   Customer acknowledges and agrees that Product covered by this Agreement is for Customer’s internal use and consumption (including use for Customer’s patients) and is not for redistribution, resale, or transfer by Customer.
 

III. Customer agrees that it will promptly report any complaints or adverse events relating to Product to Stability. Customer agrees to provide Stability with timely information about Product complaints or adverse events reasonably necessary for Stability to meet its regulatory obligations.    
 

6.      COMPLIANCE WITH LAW; LICENSES, ETC. Customer represents and warrants that it maintains at all times during the term of this Agreement all necessary federal, state, and local licenses, permits, authorizations, certifications, registrations, or other approvals necessary for the lawful purchase, handling, storage, and dispensing of Products in all relevant jurisdictions.  Stability is not responsible for any violations of applicable laws and regulations by Customer with regard to the use of the Products.  Additionally, each Party shall comply with all laws, regulations, and ordinances applicable to its performance under the Agreement.  Applicable laws include, without limitation, the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and the U.S. Foreign Corrupt Practices Act of 1977.    

7.       WARRANITES.  Subject to the provisions of this Section 5, Stability warrants that each Product has been collected, processed, stored and distributed in compliance with all applicable laws and standards, including the AATB Standards, States, and Title 21, Code of Federal Regulations Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products.  EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION, STABILITY MAKES NO WARRANTIES OR CONDITIONS, EXPRESS, STATUTORY, IMPLIED, OR OTHERWISE, AND STABILITY SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.  NOTWITHSTANDING THE FOREGOING, STABILITY DOES NOT EXCLUDE LIABILITY TO THE EXTENT THAT SUCH LIABILITY MAY NOT BE EXCLUDED OR LIMITED BY LAW.

8.       EXCLUSIVE REMEDY/LIMITATION OF LIABILITY.  If the Products delivered to Customer fail to conform to this Agreement for any reason whatsoever, Customer’s sole and exclusive remedy shall be as provided herein.  Stability 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 Stability has been advised of the possibility of such claim or demand.  Stability’s liability to Customer for any claim whatsoever related to the Products or this Agreement, including any cause of action sounding in contract, tort, indemnity, contribution or strict liability, shall not exceed the amount of all payments received by Stability for the Products that are subject of this Agreement.

9.       INDEMNIFICATION.  Customer shall defend, indemnify and hold harmless Stability 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.

 

Stability shall defend, indemnify and hold harmless Customer 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 of Stability or any third party that arises out of Stability’s breach of its obligations hereunder or is due to the negligent acts, omissions or intentional acts of Stability, its employees, agents, consultants, or subcontractor

10.       FORCE MAJEURE AND DELAY.  Stability 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 or supply chain 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 Stability.  In the event of such an occurrence, Stability shall give Customer reasonable notice that there will be a delay or non-delivery, upon which notification this Agreement shall be deemed terminated and Stability shall have no further obligation to ship the Products covered by this Agreement.  Notwithstanding the preceding sentence, if Customer agrees to a future delivery date in writing, this Agreement shall continue and Stability shall deliver the Products on such later delivery date.  Stability shall make every reasonable effort to meet the shipping date specified in this Agreement or otherwise agreed to between the Parties.  In no event, however, will Stability be liable for its failure to meet such date if the delay is caused by reasons beyond the reasonable control of Stability.

11.       ATTORNEY’S FEES.  In the event legal action is pursued with respect to this Agreement, including, without limitation, actions to interpret or to enforce any of the provisions herein, the prevailing Party in such legal action shall be entitled to recover from other Party, attorney’s fees and costs reasonably incurred by prevailing Party in such action, unless prohibited by applicable law.

 

12.   PRODUCT RECALLS.  In the event (a) Stability voluntarily recalls any Product, (b) any government authority issues a request, directive or order that any Product be recalled, (c) a court of competent jurisdiction orders such a recall, or (d) Stability reasonably determines, after consultation with Customer, that any Product should be recalled, Customer shall cooperate with Stability in effecting such recall and effectiveness verification as Stability may reasonably request.  Stability shall have administrative responsibility for effecting any such recall.

13.   PROPRIETARY RIGHTS.  Customer agrees that Stability 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 Stability on or in any Product.

14.   RECORD KEEPING.  Stability and Customer will keep or cause to be kept in accordance with FDA/AATB/States regulatory requirements books and records regarding the purchases, sales, distribution and/or utilization of Products pursuant to this Agreement.  All tissue utilization records will be returned to Stability.  Further, to the extent and only to the extent required by law, after the furnishing of the products and services provided under this Agreement, Stability will make available to the Secretary 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 Stability 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.

15.   ENTIRE AGREEMENT/SEVERABILITY.  In the event of a conflict between the provisions of this Agreement and the provisions of a signed, separate written agreement between Customer and Stability, the terms and conditions of the signed agreement shall prevail.  In the event that any of the terms of this Agreement 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 Agreement and all of the remaining terms of this Agreement shall remain in full force and effect.

 

16.   GOVERNING LAW; VENUE.  This Agreement shall be governed by and construed in accordance with the laws of the State of Tennessee, without giving effect to its conflict of laws principles.  Any demand, suit or cause of action arising out of this Agreement shall be brought in a state or federal court located in Davidson County, Tennessee.  Customer hereby submits to the jurisdiction and venue of such court.

17.   NONASSIGNABILITY; AMENDMENTS.  Customer shall not assign this Agreement without the prior written consent of Stability and any attempt to assign or transfer any of the rights, duties or obligations under this Agreement without such consent shall render such assignment or transfer null and void.  This Agreement can be amended only in writing executed by Stability and Customer.

 

18. INDEPENDENT CONTRACTORS.  Nothing in this Agreement is intended to create any relationship between Customer and Stability other than as independent contractors and neither Party, nor any of their employees, staff, agents, officers, or directors shall be construed to be the agent, fiduciary, employee, or representative of the other.

19. TERM AND TERMINATION.  This Agreement shall have a term of five (5) years.  Either Party shall have the right to terminate this Agreement upon thirty (30) calendar days written notice.

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