Terms and Conditions

Effective August 14, 2019

Terms and Conditions
This document sets forth terms and conditions of sale that shall govern all purchases (“General Terms and Conditions”) by any entity that orders products directly (“Customer”) from Pacira CryoTech, Inc. (“Pacira”). Pacira may amend the General Terms and Conditions from time to time without notice. The version of Pacira’s General Terms and Conditions in effect at the time of a sale, together with any invoice, credit application or other written agreement executed by Customer and Pacira relating to Pacira products (“Products”) shall constitute the complete and entire agreement between the parties. In the event of a conflict between the General Terms and Conditions and any individual written, fully-executed agreement between Pacira and Customer, the terms and conditions of the individual written agreement shall supersede the terms and conditions contained in the General Terms and Conditions. Any statement contained on any purchase order or similar document, which is not specifically approved by Pacira in writing, will not be considered an agreement between the parties. EXCEPT AS SET FORTH ABOVE, BY PLACING AN ORDER FOR ANY PACIRA PRODUCT, CUSTOMER ACCEPTS, WITHOUT EXCEPTION, ALL OF THE TERMS AND CONDITIONS CONTAINED IN THE GENERAL TERMS AND CONDITIONS.

 

Own Use
Unless otherwise agreed in writing by Pacira, Customer agrees that it will restrict the use of the Products to the United States, including its possessions and territories. Customer represents and warrants that all purchases made by Customer are for use solely by Customer and that Customer will not sell or distribute Products other than in accordance with the conditions set forth below. 

Hospitals, Health Systems, Ambulatory Surgical Centers, and other Sites of Care
Customer represents and warrants that each facility owned or operated by Customer (“Customer Facility”) will (i) only distribute Products to other Customer Facilities, (ii) dispense/administer treatment only to patients being cared for within a Customer Facility, and (iii) not sell, or distribute Products to any other entity.

Healthcare Providers
Customer will only dispense/administer treatment using Products to patients being cared for by Customer. Customer will not sell or distribute Products to any other entity, except, as necessary, to the medical facility in which Customer will dispense/administer treatment to patients.

Orders & Delivery
Customer may place orders by contacting Customer Service at 1-800-442-0989 or iovera.CustomerService@Pacira.com

All orders are subject to acceptance by Pacira. Pacira reserves the right to reduce, defer, backorder, or decline orders. Pacira reserves the right to cancel backorders at any time.

Nothing herein will be construed as requiring Pacira to accept any order, ship any Product, offer any pricing, or extend any credit to any Customer. Nothing contained herein will be construed to limit or restrict Pacira’s right, in its sole discretion, to discontinue the manufacture, sale, or distribution of any of its Products, without notice, at any time without penalty or liability to Customer. Pacira reserves the right not to sell any Products necessary for the continued use of any Products previously purchased if Pacira believes Customer has violated these General Terms and Conditions.

All orders will be shipped F.O.B. Shipping Point. Risk of loss will pass from Pacira to Customer upon shipment of Products to the destination specified by the Customer. Pacira will determine the time, route, and carrier of all shipments. Customer will be responsible for all shipping, clearance, and forwarding costs. Pacira will not be liable for any delay in delivery.

Upon delivery of Products, Customer will immediately inspect the Products and notify Pacira of any damages, shortages, or overages within five (5) business days. If Customer does not notify Pacira within five (5) business days, the delivery will be considered accepted in good condition, and Customer’s failure to comply with the foregoing time period shall constitute a waiver by Customer of all claims with respect to such Product.

 

Prices
Products will be invoiced at the price in effect on the date of the invoice. Pacira reserves the right to implement price changes at any time without notice. Pacira reserves the right to rebill Customer if Pacira determines Customer was billed an incorrect price. Quoted prices are exclusive of federal, state, and local taxes of any type.

Customer will pay directly, or reimburse Pacira, for any use tax, sales tax, duty, inspection or testing fee, or any other tax, fee or charge of any nature imposed by any governmental authority on purchases of Products by Customer. If Customer claims an exemption from any tax, it must promptly inform Pacira and provide copies of all applicable exemption certificates.

 

Extension of Credit
Some Customers may be eligible for credit terms, subject to Pacira’s review and approval. Customer agrees to furnish all financial information requested by Pacira prior to initial shipment of Product, and thereafter upon request. By requesting credit terms, Customer authorizes Pacira to conduct such investigations as it may deem necessary to verify Customer’s creditworthiness and agrees to release all person, companies, or corporations using or supplying such information, including Pacira, from any claims and/or losses that may result therefrom. 

Customer must notify Pacira, in writing, of any sales or transfer of majority ownership, voting power or controlling interested in Customer and any change of address of any of Customer’s direct-purchasing locations at least thirty (30) days before taking such action.

Pacira may, in its sole discretion, at any time, without prior notice, discontinue service, change Customer’s credit terms, and/or require payment before shipment of any Product. Customer waives all claims against Pacira for said conduct.

 

Payment Terms
Payments for Products are payable pursuant to the terms set forth in the applicable invoice, calculated from the date of invoice. Standard payment terms for Customers with credit terms are net thirty (30) days’ from date of invoice, with payment required via check, wire or ACH payment. Customers without credit terms must pay for Products prior to shipment. 

Pacira’s acceptance of any payment less than the full amount of indebtedness will not constitute a waiver of Pacira’s right to collect the balance, and will not be deemed an accord and satisfaction. If, for any reason, Customer is unable to pay for purchases when due, Pacira may charge interest, computed at the maximum legal rate, to pay such additional collection costs, charges and expenses, including reasonable attorneys’ fees.

Customer is not permitted to take a deduction unless authorized by a prior credit memo, or as otherwise agreed to by Pacira in writing.

Credit Card Payments
The following terms will govern all credit card payments.

  1. Credit card payments will only be accepted to pay for Products prior to shipment.
  2. Pacira may keep Customer’s credit card information on file and submit a request for payment from such credit card company on the payment due date.
  3. Pacira will use Customer’s authorized signature for such payment authorization and may keep it on file for all subsequent credit card transactions. Customer must notify Pacira of any change of credit card to be used prior to purchase. 
  4. Customer agrees that in the event Customer’s credit card payment fails to clear the collection process or is denied for any reason whatsoever, Pacira may revoke acceptance of all current and future orders, or require other payment methods. Any charge to be contested must first be brought to Pacira for resolution.

 

Storage and Handling
Customer is fully responsible for complying with all applicable federal, state, and local laws and regulations relating to the storage, handling, and distribution of such Products. Customer warrants that it will maintain, at all times, the proper licenses required to receive, handle, sell, and store Pacira’s Products. Customer will, at all times, maintain proper procedures and controls to ensure proper handling, storage, and shipment of each Product in accordance with all handling, maintenance, storage, transportation, delivery and distribution requirements as labeled on the Products. Customer will not tamper with, modify or assist any third party in modifying any Products. Customer shall not take any action or allow any action to be taken that would adversely affect (a) the integrity of any Product and/or (b) the safety and security of the supply chain. In addition, Customer shall take such precautions as are necessary to prevent Products from falling into the hands of those who may not lawfully possess or handle such Products.

 

Training
Customer will ensure that Customer and its employees and agents, including Authorized Users as defined below, are fully trained with respect to the Products, and that Customer and its employees and agents comply with all applicable laws and regulations, including those of medical agencies and certification boards. Customer will ensure that its Authorized Users attend all training offered by or on behalf of Pacira that relates to safe use of the Products

 

Use of Products

  1. Products will be used only by a medical doctor in good standing who is licensed to practice medicine in the relevant jurisdiction at the time of the sale of the Products (“Licensed Physician”) or by a healthcare professional authorized under their license to use the Products and if applicable, under the active supervision of a licensed healthcare professional, (each an “Authorized User”).  Allowing the use of any Products by any person other than an Authorized User may violate applicable law and may endanger patient safety.  For purposes hereof, “active supervision” means having a duly licensed healthcare professional available during the performance of any procedure using the Products.
  2. Customer will use, and will ensure that its employees and agents use, the Products only for their intended and approved uses, in accordance with these General Terms and Conditions, and pursuant to all Pacira documentation and any updates thereto.
  3. Customer will not sell, donate or otherwise transfer any Product to any third party or export or re-export any Product or any software contained therein, without Pacira’s prior written consent and without all necessary United States and foreign government consents and licenses.

 

Warranty
Pacira warrants that Products will be free from significant manufacturing defects in materials and workmanship for a period of twelve (12) months from the date of delivery to Customer. If within the warranty time period, Customer discovers a failure of the Product to conform to this warranty, it must promptly notify Pacira in writing, no later than twelve (12) months from the date of delivery. The sole and exclusive remedy of Customer for Pacira’s breach of the foregoing warranty will be, at Pacira’s option, the repair or replacement of a confirmed defective unit, and such replacement may be with new or refurbished units or parts. The foregoing warranty is contingent upon proper use of the Products by trained and authorized Customer personnel in their intended and approved uses, and the foregoing warranty will not apply to items that were (i) modified or otherwise altered or changed by Customer without Pacira’s prior written approval;(ii) repaired by persons not authorized by Pacira; (iii)subjected to unusual physical, electrical or environmental stress; or (iv) damaged during shipment to Customer. Except for the foregoing warranty, Pacira makes no warranty, express, implied or statutory, as to any matter whatsoever, including any warranty of merchantability, fitness for a particular purpose or non-infringement. The foregoing warranty is effective only upon payment in full for the Products and applies only in favor of Customer who is the end user and original purchaser of the Products and is not transferable. Return of defective Products must be made according to Pacira’s then-current return goods authorization procedures. THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, OR AS STATED IN ANY LITERATURE, SALES BROCHURE OR OTHER DOCUMENT OF PACIRA, IN CONNECTION WITH THE PRODUCTS SOLD OR ON ANY PARTS OR LABOR FURNISHED DURING THE SALE, DELIVERY OR SERVICING OF THE PRODUCTS. 

 

Limitation of Liability
IN NO EVENT WILL PACIRA BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY, SPECIAL, OR ANY OTHER INDIRECT DAMAGES OF ANY KIND (WHETHER ARISING UNDER CONTRACT, TORT, OR OTHERWISE) INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, LOSS OF BUSINESS OPPORTUNITY, OR OTHER FINANCIAL LOSSES, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL PACIRA’S LIABILITY UNDER ANY CLAIM MADE BY CUSTOMER EXCEED THE PURCHASE PRICE OF THE PRODUCTS IN RESPECT OF WHICH DAMAGES ARE CLAIMED. 

 

Returns
Except with respect to confirmed defective Products in breach of the foregoing warranty, Pacira conveys no right of return to Customer and no returns will be accepted.

 

Indemnification
Pacira will indemnify, defend, and hold harmless Customer, its officers, directors, employees, agents, and insurers against any and all claims, demands, actions, damages, expenses, costs, judgments, and liabilities (including, without limitation, interest, penalties, and reasonable attorneys’ fees and investigative costs) incurred by Customer caused solely by Pacira’s breach of Pacira’s express warranty. 

Customer will indemnify, defend, and hold harmless Pacira, its officers, directors, employees, agents, and insurers from and against any and all third party claims, demands, actions, damages, expenses, costs, judgments, and liabilities (including, without limitation, interest, penalties, and reasonable attorneys’ fees and investigative costs) incurred by Pacira, arising from, in connection with, or as a consequence of (i) any negligence, wrongful act, or omission by Customer, (ii) a failure to comply with any applicable law, or (iii) Customer’s use or sale of Products, except to the extent that such suit or demand arises out of the failure of Products to meet Pacira’s express warranty.

The party seeking indemnification will give the other party prompt notice of the assertion of the claim, or service of a complaint, and fully cooperate in the defense thereof by counsel of the indemnifying party’s choice. 

 

Force Majeure
Pacira shall not be liable for any default or delay in performance if caused, directly or indirectly, by acts of God; war; force of arms; fire; the elements; riot; labor disputes; picketing or other labor controversies; sabotage; civil commotion; accidents; any governmental action, prohibition or regulation; delay in transportation facilities; shortages or breakdown of or inability to obtain or non-arrival of any labor, material or equipment used in the manufacture of the Products; failure of any party to perform any contract with Pacira relative to the production of the Products; or from any cause whatsoever beyond Pacira’s control, whether or not the cause is similar or dissimilar to those enumerated. Pacira shall notify Customer of the happening of any contingency and of the contemplated effect thereof on the manufacture and delivery of the Products. 

 

Compliance with Laws
The parties represent and warrant that each shall comply with all applicable standards, provisions and stipulations of all pertinent federal, state and local laws, rules, regulations ordinances and executive orders (“Applicable Laws”). Customer further represents and warrants that it has, currently is and for the duration of these General Terms and Conditions will, operate its business in compliance with all Applicable Laws. 

Pacira assumes no liability or responsibility for any acts, misuse of Product, advertising, violations of any Applicable Laws violated by the Customer. Customer assumes all responsibility for its acts and is responsible for researching local, state or federal regulations relating to the sale or use of Pacira’s Product. Pacira is not responsible for obtaining any permit, inspection or license that is required for installation or operation of the Products.

 

Federal Healthcare Program Participation
Customer represents and warrants that neither it nor any of its current directors, officers, or key personnel: (i) are currently excluded, debarred or otherwise ineligible to participate in federal healthcare programs as defined in 42 U.S.C. §1320a-7b(f) (the “Federal Healthcare Programs”); (ii) have been convicted of a criminal offense related to the provision of healthcare items or services during the last five (5) years; or (iii) have been excluded, debarred or otherwise declared ineligible to participate in Federal Healthcare Programs during the last five (5) years. Customer will notify Pacira of any change in the status of the representations and warranties set forth above. 

 

Intellectual Property
All inventions (whether or not patentable), devices, technologies, ideas, improvements, processes, systems, software and other works and matters that Pacira creates or develops in the course of Pacira’s design, development or manufacture of the Products and all drawings and specifications that Pacira provides to Customer (“Intellectual Property”) shall be Pacira’s sole property, and Customer assigns, and agrees to assign, to Pacira all right, title and interest that Customer now has or in the future acquires in the Intellectual Property. Customer shall not disclose or use any of the Intellectual Property or any information about Pacira’s business, operations or activities, except to the extent necessary for Customer to use the Products.

Customer agrees that it will not directly or indirectly create, or attempt to create, by disassembling, reverse engineering or otherwise, or from any instructions, manuals, schematics, or other information provided or made available by or on behalf of Pacira, any Products, parts, systems, software, technologies, ideas, items, or concepts comparable to or competing with those provided hereunder, or any part thereof, or disclose or use any such information for commercial purposes or in a manner detrimental to Pacira. Customer shall not remove, alter, or obscure any copyright, trademark, trade name, logo, government restricted rights, or other proprietary or confidentiality notices or legends from any Products, packaging, labels, documentation, or other materials provided by Pacira, and shall not, directly or indirectly, take, authorize or permit any action, or use any procedure or process in any jurisdiction, to assert, register, file, publish, confirm, perfect or claim any right in any intellectual property or proprietary rights of Pacira, its suppliers or licensors.

 

Product Complaints/Adverse Events
Customer will promptly (and in any event within two (2) business days of receiving the complaint) report to Pacira, at 1-855-793-9727 or MedInfo@Pacira.com, any Product complaint, report of a malfunction of a Product or any injury arising out of use of a Product and provide all related information requested by Pacira. Each party shall reasonably cooperate with the other in sharing any information that may constitute a complaint related to the Products and shall designate a representative responsible for the exchange of such information and all other regulatory information required to be shared under these General Terms and Conditions. Customer shall at all times reasonably cooperate with any Pacira investigation, inspection, or inquiry regarding the Products.

 

Confidentiality
Customer agrees to maintain the confidentiality of, and not disclose, Pacira’s Confidential Information. All non-publicly available information provided to Customer concerning Pacira and/or its Products, including, without limitation, pricing, credit terms, Product lists, providers, purchasing requirements, specifications, drawings, plans, notes, instructions, engineering notices, technical data or company policies and correspondence (collectively “Confidential Information”) will remain the sole and exclusive property of Pacira. Customer will not use, allow the use of, duplicate, reproduce or copy any Confidential Information for any purpose other than in connection with the purposes of these General Terms and Conditions.

 

Export Restrictions
Customer will not export or re-export, directly or indirectly, any equipment, materials or technical data (as defined by the U.S. Export Administration regulations, or their successors) to a destination to which such export or re-export is restricted or prohibited by U.S. or non-U.S. law without obtaining prior authorization from the U.S. Department of Commerce and/or other competent government agencies to the extent required by law; or export or re- export, directly or indirectly, any equipment, materials, component or Product of such technical data, including software, to a destination to which such export or re-export is restricted or prohibited by U.S. or non-U.S. law without obtaining prior authorization from the U.S. Department of Commerce and/or other competent government agencies to the extent required by law. Customer shall cooperate fully with Pacira in any official or unofficial audit or inspection related to applicable export or import control laws or regulations, and shall indemnify and hold Pacira harmless from, or in connection with, any violation of this Section by Customer or its employees, consultants, agents, or customers.

 

Discount Disclosure
Customer acknowledges that the offer may include a discount or other price reduction that must be properly and accurately accounted for and reported by Customer in accordance with all federal and state laws, including without limitation the federal anti-kickback law (42 C.F.R. § 1320a-7b(b)(3)(A)) and regulations thereunder (42 C.F.R. §1001.952(h)) (“AKS”). Pursuant to the AKS discount safe harbor, Customer is required by law to fully and accurately disclose the discounts, premiums, credits or other value received from Pacira in cost reports or claims submitted for reimbursement to Medicare, Medicaid, or other healthcare programs requiring such disclosure, and to provide such documentation to the Secretary of the Department of Health and Human Services and state agencies upon request. Pacira will provide the value of any discounts or other price concessions to Customer so that Customer can comply with its obligation to properly disclose and appropriately reflect the same on applicable cost reports or in charges to federal healthcare programs in accordance with the AKS.

 

Time For Bringing Action.
Any action that Customer brings against Pacira for breach of these General Terms and Conditions or for any other claim that arises out of or relates to the Products or their design, manufacture, sale or delivery must be brought within one (1) year after the cause of action accrues.

 

Miscellaneous.
These General Terms and Conditions set forth the entire agreement of the parties regarding its subject matter, and supersedes all prior agreements and understandings relating to such subject matter.

These General Terms and Conditions will be governed by the laws of the State of New Jersey, without reference to principles of conflicts of law of any jurisdiction. Any dispute arising from these Terms or General Conditions or from the business relationship between Pacira and Customer shall be decided solely and exclusively by State courts located in Morris County, New Jersey, or the United States District Court for the District of New Jersey. 

These General Terms and Conditions may not be assigned by Customer, by operation of law or otherwise, without Pacira’s prior written consent. Pacira has the right to assign these General Terms and Conditions without notice or consent. Any attempted assignment in violation of the foregoing will be null and void. 

No amendment of these General Terms and Conditions, nor any waiver of any rights under these General Terms and Conditions, will be effective unless in writing signed by both parties. 

If any provision of these General Terms and Conditions is found to be invalid or unenforceable, the remainder of these General Terms and Conditions will remain in full force and effect and be interpreted so as best to reasonably effect the intent of the parties.

 

Customer Service Contact
Phone: 1-800-442-0989
Fax: 1-510-933-1501
E-mail: iovera.CustomerService@Pacira.com

Product Complaints / Adverse Events
Phone: 1-855-793-9727
E-mail: MedInfo@Pacira.com

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