Effective May 20, 2020

iovera° General Terms and Conditions

Terms and ConditionsThis document sets forth terms and conditions of sale that shall govern all purchases (“General Terms and Conditions”) by any entity that orders (“Customer”) directly from Pacira CryoTech, Inc. (“Pacira”) any products manufactured by Pacira (“Products”). 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 the 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 UseUnless 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 CareCustomer 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 ProvidersCustomer will only dispense/administer treatment using Products to patients being cared for by Customer. Customer will not sell or distribute Products to any entity other than a facility owned or operated by Customer that is licensed to dispense and administer treatment to patients.

Orders & DeliveryCustomer may place orders by contacting Customer Service at 1-800-442-0989 or ioveraCS@icsconnect.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.

Product ShipmentAll 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.

Product DeliveryUpon 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.

PricesProducts 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 exclude all applicable taxes. Any sales and use tax, goods and services tax or similar indirect taxes that are properly due under applicable law, regulation or otherwise, shall be charged by Pacira and payable by Customer. Such taxes will be separately stated in the invoice and will be paid by Customer based on these General Terms and Conditions unless Customer provides Pacira with valid exemption documentation allowing Pacira not to charge and collect the relevant tax(es).

Extension of CreditSome 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 persons, 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 interest 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 TermsStandard payment terms for Customers with credit terms are net thirty (30) days from the date of invoice, unless Customer disputes a charge therein. The invoice shall be paid by Customer by way of electronic transfer or check (to an account specified by Pacira in writing) within thirty (30) days of the date of Pacira’s invoice. Customer will notify Pacira of any invoice amount it disputes within seven (7) days of receipt of invoice, and the Parties will cooperate in good faith to resolve any such dispute. 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, and 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 PaymentsThe 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.

Diverted ProductCustomer agrees and certifies that one hundred percent (100%) of Product purchased, owned or dispensed by Customer shall be procured directly from Pacira or its Authorized Distributor of Record for use by Customer and Customer Facilities only and pursuant to the terms and conditions set forth in these General Terms and Conditions, unless otherwise mutually agreed upon in writing by the Parties. Customer shall promptly notify Pacira if Customer knowingly comes into possession of diverted Product. Also, if and when Customer has knowledge of any entity or person offering, selling or purchasing diverted Product, Customer shall promptly provide written notice to Pacira describing all information that Customer has learned concerning the diverted Product.

Storage and HandlingCustomer shall maintain Product in accordance with all Product storage requirements and specifications, including, without limitation, the Product labeling instructions from Pacira. Customer shall not take any action or allow any action to be taken that would adversely affect:

  • The integrity of any Product, and/or
  • The safety and security of the supply chain.

Notwithstanding anything to the contrary herein, Customer shall not sell or return for credit damaged Product as a result of Purchaser’s noncompliance with the storage and handling requirements set forth in this Section.

Product LabelingCustomer shall not without Pacira’s prior written consent, alter, modify, replace, or reproduce any Product labeling, packaging (except to remove Product from the shipping containers), or advertising, except to add a prescription label to Product, as permitted or required by applicable law.

Purchaser LicensingCustomer represents and warrants that it has and shall maintain all federal, state and local licenses and registrations necessary for the lawful handling, storage, dispensing and shipping of Product, as applicable, and Customer shall notify Pacira immediately of any denial, revocation or suspension or any adverse action taken against any such license or registration, or material changes in the license or registration.

TrainingCustomer 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.

WarrantyPacira warrants that the Products delivered to Customer will be free from defects in materials and workmanship for a period of twelve (12) months from the date of shipment. If within such twelve-month period, Customer discovers a defect of the Product, it must promptly notify Pacira in writing, within thirty (30) days from such discovery but in all cases no later than twelve (12) months from the date of shipment. If Pacira agrees that there is a defect of the Product, the Customer’s sole and exclusive remedy for Pacira’s breach of the foregoing warranty will be, in Pacira’s sole discretion, the repair or replacement of a confirmed defective Product (or a component thereof) with a Product (or component thereof) of the same or equivalent type, and such repair or replacement may be with new or refurbished units or parts of a Product of the same or equivalent type.

The foregoing warranty will not apply to items that were:

  • modified or otherwise altered or changed by Customer or used with any product or hardware without Pacira’s prior written approval; or
  • reconstructed, repaired, altered or maintained by persons not authorized by Pacira in writing.

Except for the foregoing express limited warranty, neither Pacira (nor any person on Pacira’s behalf) makes any warranty, express, implied or statutory, as to any matter whatsoever, including any warranty of merchantability, fitness for a particular purpose, title or non-infringement, whether arising by law, course of dealing, course of performance, usage of trade or otherwise, all of which are expressly disclaimed.

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. Customer acknowledges that it has not relied on any representation or warranty made by Pacira (or any person on Pacira’s behalf). 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 LiabilityIN 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.

ReturnsExcept 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.

IndemnificationCustomer will defend, indemnify, and hold harmless Pacira and its parent company, subsidiaries, members, directors, officers, employees and representatives from and against any and all third- party claims, liabilities, losses, damages, costs, and expenses (including without limitation reasonable attorneys’ fees) arising directly or indirectly out of:

  • A breach of these General Terms and Conditions;
  • Negligence, wrongful act or willful misconduct or omission by Customer;
  • Customer’s use or sale of Products; or
  • Violation of applicable laws by Customer or any of its employees, representatives or agents.

Pacira will defend, indemnify, and hold harmless Customer and its parent company, subsidiaries, members, directors, officers, employees and representatives from and against any and all third party claims, liabilities, losses, damages, costs, and expenses (including without limitation reasonable attorneys’ fees) arising directly or indirectly out of breach of these General Terms and Conditions, negligence, willful misconduct or violation of applicable law by Pacira, or any of its employees, representatives or agents.

The indemnified Party shall give prompt notice to the indemnifying Party of any claims for which it intends to seek indemnification hereunder, provided that the indemnified Party’s failure to notify shall not relieve the indemnifying Party from its obligations hereunder unless it is materially prejudiced by such failure. Neither Party will be responsible for any settlement or payment of any claim without the prior written approval of the other Party. Without relieving the indemnifying Party of any of its obligations hereunder, the indemnified Party may elect to defend or participate in the investigation and/or defense of any related lawsuit at its own expense.

Force MajeurePacira shall not be liable or deemed in default for any delay or failure in performance in the event such performance is prevented by a cause beyond the reasonable control of either Party, including without limitation, acts of God, natural disasters, government regulations or action, acts of war, insurrection, civil commotion, destruction of production facilities or materials by earthquake, fire or flood, or storm, labor disturbance, epidemic, pandemic, epidemic, terrorism, or failure of public utilities or common carriers, material curtailment of transportation, compliance with laws or regulations, network failures, error in the coding of electronic files, software limitations, material disruptions in telecommunications or electronic communications systems, or other causes beyond Pacira’s reasonable control. Pacira shall use commercially reasonable efforts thereafter to minimize delay and damages attributable to such event.

Compliance with LawsEach Party will perform all of its obligations hereunder in compliance with all applicable laws, rules and regulations, including any federal, state or local law or regulation applicable to these General Terms and Conditions, or applicable to either Party’s performance of its obligations under these General Terms and Conditions, including without limitation and to the extent applicable:

  • Healthcare or insurance fraud or abuse laws, including the following statutes and the regulations promulgated thereunder: the federal anti-kickback statute (42 U.S.C. §1320a-7b(b)), the Federal False Claims Act (31 U.S.C. §§3729, et seq.), the Federal Civil Monetary Penalties Law (42 U.S.C. §1320a-7a), the Federal Program Fraud Civil Remedies Act (31 U.S.C. §3801 et seq.) and the Federal Health Care Fraud Law (18 U.S.C.§1347);
  • Laws concerning unfair and deceptive trade practices;
  • The federal Food Drug & Cosmetic Act (21 U.S.C. §§301, et seq.) (the “FDCA”);
  • The HIPAA and HITECH privacy and security laws;
  • The Medicaid Drug Rebate Laws (42 U.S.C. § 1396-r8);
  • The 340B Drug Discount laws (42 U.SC. § 256b);
  • Each of their respective implementing regulations, and
  • Any other similar state and local laws, and any successor laws and regulations to any of the foregoing relating to the terms of this Agreement.

Federal Healthcare Program ParticipationCustomer warrants that is not currently excluded, debarred, suspended or otherwise ineligible to participate in any federal health care programs or in federal procurement or non-procurement programs, nor is it subject to a pending debarment proceeding. Customer shall immediately notify Pacira in the event Customer is or becomes the subject of any such exclusion, debarment, suspension or ineligibility, or, to Customer’s knowledge, is threatened with any such exclusion, debarment, suspension or ineligibility.

Intellectual PropertyAll inventions (whether or not patentable), devices, technologies, ideas, improvements, processes, systems, software and other works and matters that Pacira creates or develops, either on its own or jointly with Customer, in the course of Pacira’s design, development, marketing, sale 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 EventsCustomer 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.

Confidential InformationDuring the course of operating under these General Terms and Conditions, each Party, its respective agents, employees and representatives (collectively, the “Receiving Party”) may receive or have access to confidential materials and information of the other Party (the “Disclosing Party”). All such materials and information (including, but not limited to information regarding Products, operations, methods, strategies, formulas, price lists, discount programs, incentives, rebates, records of unit movement of Products, shipping and warehousing, and confidential proprietary information from third parties) are collectively referred to herein as “Confidential Information” and constitute the property of the Disclosing Party. Each Party will use all commercially reasonable efforts to protect the other Party’s Confidential Information against unauthorized disclosure. Confidential Information does not include information that can be demonstrated by competent proof that it was generally available to the public or otherwise disclosed by the Disclosing Party without an obligation of confidentiality. In the event a receiving Party is required to disclose the terms and conditions of this Agreement or any other Confidential Information by law, regulation, rule, act, subpoena, court or agency, other than disclosures required under this section, the Receiving Party shall:

  • Give the Disclosing Party sufficient advance written notice to permit it to seek a protective order or other similar order with respect to such disclosure, and
  • Thereafter disclose only the minimum information required to be disclosed in order to comply with such law, regulation, rule, act, subpoena, court or agency.

Export RestrictionsCustomer 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 DisclosureThe Parties acknowledge and agree that any discount provided on the sale of the Products covered by these General Terms and Conditions constitutes a “discount or other reduction in price,” as defined under the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)(3)(A)) and the discount safe harbor (42 C.F.R. § 1001.952). Customer agrees to report and provide complete and accurate information concerning any discounts provided by Pacira hereunder, upon the request of any government agency, including the Secretary of the Department of Health and Human Services or applicable State agency. The Parties agree that, pursuant to 42 C.F.R. § 1001.952, Pacira has informed Customer of its federal statutory and regulatory reporting obligations.

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 between the Parties, and supersedes all prior drafts, documents, and understandings pertaining to the subject matter hereof.

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 General Terms or 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.

The rights and obligations of Customer under these General Terms and Conditions are personal to Customer and may not be assigned to others without Pacira’s written consent, which shall not be unreasonably withheld. In the event Customer acquires, is acquired by, or merges with another business entity, Pacira shall have the right, in its sole discretion, to terminate or modify these General Terms and Conditions.

The amendment of these General Terms and Conditions or the failure of any Party to enforce at any time any provision of these General Terms and Conditions shall not be deemed a waiver of such provision and shall not affect the right of such Party thereafter to enforce such provision. No such waiver shall be deemed a waiver of any other subsequent breach, whether of the same or another provision.

If any provision of these General Terms and Conditions is found to be illegal or unenforceable by a court of competent jurisdiction or government agency, both Parties shall be relieved of all obligations arising under such provisions, but the remainder of these General Terms and Conditions shall not be affected by such declaration or finding.

Customer Service Contact

Product Complaints / Adverse Events

IndicationThe iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. The iovera° system’s “1x90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Important Safety Information

ContraindicationsThe iovera° system is contraindicated for use in patients with the following:

  • Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud’s disease, and open and/or infected wounds at or near the treatment site

Potential ComplicationsAs with any surgical treatment that uses needle-based therapy and local anesthesia, there is a potential for site-specific reactions, including, but not limited to:

  • Ecchymosis, edema, erythema, local pain and/or tenderness, and localized dysesthesia

Proper use of the device as described in the User Guide can help reduce or prevent the following complications :

  • At the treatment site(s): injury to the skin related to application of cold or heat, hyper- or hypopigmentation, and skin dimpling
  • Outside the treatment site(s): loss of motor function
SEE MORE

The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain.

Important Safety Information