Terms and Conditions of Sale

1.  Prices and Terms.  Price, terms, and availability of merchandise are subject to change without notice, including but not limited to changes caused by the fluctuations in market price, availability or quality of any of the items employed in the manufacture of the goods described herein. Aero Healthcare may increase the prices for goods under this contract by providing the buyer (the “Buyer”) with at least five (5) days prior written notice.  Such increased prices shall be deemed to be accepted by the Buyer unless, before the effective date of such increase, the Buyer notifies Aero Healthcare in writing to the contrary, whereupon Aero Healthcare shall have the right to terminate this contract with respect to such goods or to continue shipments without such increase.  Unless otherwise specified, payment hereunder shall be due net thirty (30) days from the date of shipment.  All amounts past due shall bear interest at the rate equal to the lower of (a) 1.5% per month or (b) the maximum rate allowable by applicable law.  Aero Healthcare’s obligation to produce or deliver hereunder is conditioned upon the continued good credit of Buyer and upon Buyer’s payment when due of any sum owing by Buyer to Aero Healthcare under any agreement between the parties.  Based on Aero Healthcare’s reasonable judgment, if Buyer’s financial condition at the time the merchandise is ready for shipment does not justify the terms specified, Aero Healthcare reserves the right to change these terms, to require full or partial payment in advance, or to ship the goods C.O.D.

2.  Taxes.  Any taxes or other government levy or charge (or any increase in same) which Aero Healthcare may be required to pay or collect, under any existing or future law, upon or with respect to the sale, purchase, delivery, storage, processing, use or consumption of any of the material covered hereby, including taxes upon or measured by the receipts from the sale thereof, shall be for the account of Buyer, and may, at Aero Healthcare’s option, be added to the price of good shipped hereunder.

3.   Shipments.  Shipment dates are based upon Aero Healthcare’s best judgment and are subject to factory schedules and production limitations, and hence are not guaranteed.

4.   Delivery in Installments.  Aero Healthcare reserves the right to make delivery in installments, unless otherwise expressly stipulated herein.  All such installments shall be separately invoiced and paid for when due, without regard to subsequent deliveries.  Delay in delivery of any installment shall not relieve Buyer of its obligation to accept remaining deliveries.

5.   Delay; Force Majeure.  Aero Healthcare shall not be liable for delays in performance caused by force majeure, act of God, fire or other casualty, accident, strike, boycotts, shortage of labor or materials, governmental action or other cause beyond Aero Healthcare’s reasonable control; and the time for Aero Healthcare’s performance shall be extended by the period of any such delay.  Aero Healthcare reserves the right to apportion its production among its customers as it may determine.

6.  Limited Warranty.  EXCEPT AS SPECIFICALLY SET FORTH HEREIN OR IN ANY SEPARATE WRITTEN WARRANTY PROVIDED BY AERO HEALTHCARE WITH RESPECT TO A SPECIFIC PRODUCT, IF ANY, AERO HEALTHCARE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.  No agent, employee, or representative of Aero Healthcare has any authority to bind Aero Healthcare to any affirmation, representation or warranty concerning the goods sold pursuant to the terms hereof, and unless an affirmation, representation or warranty made by an agent, employee or representative is specifically included herein, it is not deemed part of the basis of this bargain and shall not in any way be enforceable.

7.   Liability.  Except to the extent that such is solely and directly caused by Aero Healthcare’s breach of its obligations hereunder, Buyer assumes all liability arising out of compliance with any laws, rules or regulations relating to any product or container therefor.  In no event shall Aero Healthcare be liable for incidental, consequential or other damages from alleged negligence, breach of warranty, strict liability or any other theory arising from the use or handling of the products it sells.  The sole liability, if any, of Aero Healthcare for any claims arising out of the manufacture, use or sales of its products shall be for the return of the Buyer’s purchase price.

In accepting the products described herein, Buyer shall be deemed to have declared itself familiar with the nature, hazards and use of the products and shall assume all liability resulting from or in any way connected with the unloading, discharge, storage, handling, possession, use and disposal of any product therefore, including, without limitation, the use of such product alone or in combination with other substances, except to the extent that such liability results from Aero Healthcare’s gross negligence or willful misconduct.  Aero Healthcare shall not be liable for any damage, injury or loss of any indirect or consequential nature suffered by Buyer, however and whenever caused, including, without limitation, loss of sales, revenue or profit. 

8.   Indemnification.  Buyer shall defend, indemnify and hold Aero Healthcare and its officers, directors, employees and agents harmless from and against any and all claims, actions, liability, expenses, costs (including, without limitation, reasonable attorneys’ fees), or losses arising from (i) Buyer’s improper use of the product; (ii) Buyer’s combination or use of the products with third party products; (iii) misuse of any product by an end-user; (iv) the acts or omissions of Buyer hereunder; and (v) any breach by Buyer of its obligations hereunder.  This Section shall survive termination and cancellation of this contract.

9.   Inspection; Claims.  Buyer shall examine goods upon receipt and shall notify Aero Healthcare, in writing, of any non-conforming goods within fifteen (15) days of receipt thereof at destination.  Failure to timely give such notice shall constitute an irrevocable acceptance of the goods.  No claims, of any kind, by Buyer shall be valid without notice, as specified.  Buyer shall afford Aero Healthcare a reasonable opportunity to inspect the material and repair or replace any materials determined by Aero Healthcare to be non-conforming.  No goods shall be returned without Aero Healthcare’s consent.

10.  Remedy for Non-Conforming Goods.  If the goods furnished to Buyer shall fail to conform to this contract, Aero Healthcare, at its discretion, shall, within thirty (30) days of notice of said non-conformity, issue credit for or shall replace such non-conforming goods at the original point of delivery and shall furnish instructions for the disposition of the non-conforming goods.  Any transportation charges involved in such disposition shall be for Aero Healthcare’s account.  Buyer’s exclusive and sole remedy on account of or in respect to the furnishing of goods that do not conform to this contract shall be to secure credit or replacement thereof as aforesaid.  Aero Healthcare shall not, in any event, be liable for any special, direct, indirect, incidental or consequential damages to anyone by reason of the fact that such goods do not conform to this contract, or to any express or implied warranty herein.

11.  Governing Law.  This contract and any disputes relating hereto shall be governed by and construed under the laws of the State of New Jersey, without regard to the conflicts of law principles.

12.  Non-Waiver.  Waiver by Aero Healthcare of the breach of any of the terms and conditions of this contract shall not be construed as a waiver of any other breach.

13.  Risk of Loss.  Unless otherwise specified, all shipments will be F.O.B. departure origin. Risk of loss of or damage to the goods passes to Buyer upon F.O.B. departure origin.  Title remains with Aero Healthcare until Aero Healthcare receives payment for said goods.

14.  Responsible Care.  Both parties agree to handle, store, transport, and dispose of the products in reasonable manner with appropriate regard for the safety of their employees and the general public, and agree to comply with all applicable environmental, transportation and safety regulations. 

15.  Termination.  Without prejudice to any other remedy, Aero Healthcare may immediately terminate this contract and any other agreement with Buyer should Buyer fail to timely perform any obligation hereunder.

16. COVID-19 Pandemic Related Products. Unless otherwise specified, any order of products related to COVID-19 pandemic, including, but not limited to, Hand Sanitizer, Flowflex Rapid Antigen COVID 19 tests, etc. may not be cancelled and the product may not be returned except due to the receipt of incorrect product.

17.  Assignment.  This contract shall inure to the benefit of and be binding upon the parties and their respective successors and assigns.  This contract is not assignable by Buyer without the Aero Healthcare’s prior written consent, but may be assigned by Aero Healthcare without Buyer’s consent.

18.  Credit Card Payments.  All credit card payments are subject to a processing fee.

19.  Acceptance Of These Terms.  The specifications on the face hereof, together with terms and conditions contained herein constitute the entire agreement between Aero Healthcare and Buyer.  Neither Aero Healthcare’s correspondence nor shipment of any goods is an expression of acceptance or a written confirmation of Buyer’s purchase order.  If buyer does not agree to these terms and conditions, written notice must be provided to Aero Healthcare within 48 hours of the Purchase Order date. Failure to provide written notice in this timeframe is an expression of Buyers acceptance of these terms and conditions.

Additional Terms & Conditions for orders of ACON FLowflex Covid 19 Antigen Rapid Test and FDA EUA Reporting Requirements:

Distributor shall adhere to the conditions and responsibilities of the FDA Emergency Use Authorization (EUA) as shown as Exhibit A below.

Distributor shall not alter, remove, or modify any ACON trademarks, labelling, or packaging, nor affix any other trademarks, labels, instructions, warnings, or markings to or on the Products or the packages or boxes used for the Products without written consent from AERO’s Regulatory Department. Distributor will notify AERO of all complaints regarding product performance, but in all events within five (5) business days after distributor has knowledge of the complaints. Distributor shall cooperate and assist AERO in any investigation of facts concerning an inquiry or complaint. Distributor takes all responsibility for complying with all governmental regulatory requirements.

Customer Issues. Distributor shall promptly notify AERO in writing of any inquiry or complaint from its customers or from governmental agencies concerning the Products and of any safety related cases, so that AERO can initiate corrective actions as needed. Such notice shall be within five (5) business days after DISTRIBUTOR has knowledge thereof.

Discrepancies:

All discrepancies including shipping damages must be reported within 48 hours of receipt. If the Distributor receives the incorrect product, or incorrect quantity of product, Aero Healthcare will cover the freight cost to rectify the error.

Damages:

PLEASE DO NOT SIGN THE FREIGHT BILL until you are sure that there is no damage to the merchandise and the number of pieces received agrees with the BILL OF LADING. ALL SHORTAGES AND/OR DAMAGES MUST BE NOTED ON THE FREIGHT BILL BY THE CARRIER’S AGENT.

Aero Healthcare will process claims for prepaid account shipments if the damaged goods were noted on the Freight Bill and signed by the carrier’s agent at the time of delivery. The Distributor is responsible to file claims for all shipments sent on their freight account. The Distributor is responsible for all damaged goods accepted at delivery. Claims for loss, damage, or transportation charges must not be deducted from our invoices, nor payment of invoices withheld awaiting adjustment of such claims, since it is a function of the carrier to guarantee safe delivery. We will assistance the Distributor to trace and recover lost goods.

Returns:

All sales are final for the Flowflex COVID -19 Antigen Home Test and no returns will be accepted.

 

EXHIBIT A

AUTHORIZED DISTRIBUTOR RESPONSIBILITIES FOR ACON LABORATORIES FLOWFLEX™ COVID-19 ANTIGEN HOME TEST IN ACCORDANCE WITH FDA EMERGENCY USE AUTHORIZATION (EUA)

Each authorized distributor is required to provide the “Flowflex™ COVID-19 Antigen Home Test Package Insert” lay user instructions for use (https://www.fda.gov/media/152699/download) in the shipped kit using the “Flowflex™ COVID-19 Antigen Home Test” box labels and provide the Fact Sheet for Healthcare Professionals (https://www.fda.gov/media/152697/download), and make these two documents electronically available on your website.

Each authorized distributor must maintain records of customer complaint files and report to the FDA any significant complaints about usability or deviations from the established performance characteristics of which the authorized distributor become aware.

 

Each authorized distributor must inform relevant public health authorities of this EUA, including the terms and conditions herein, and any updates made to the product and/or the authorized labeling.

 

Through a process of inventory control, each authorized distributor must maintain records of the locations (e.g., pharmacies, doctor’s offices, etc.) to which the product is distributed, and the number of tests distributed to each location.

 

Each authorized distributor must collect information on the performance of the product and have a process in place to track adverse events, including any occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the product of which you become aware and report any such events to the FDA in accordance with 21 CFR Part 803. Serious adverse events, especially unexpected biosafety concerns, should immediately be reported to the Division of Microbiology (DMD)/Office of Health Technology 7 (OHT&) – Office of In Vitro Diagnostics and Radiological Health (OIR)/Office of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH) (via email: CDRH-EUAReporting@fda.hhs.gov).

Each authorized distributor is authorized to make available additional information relating to the emergency use of the product that is consistent with, and does not exceed, the terms of the letter of authorization.

 

Each authorized distributor using the product must ensure that any records associated with the EUA are maintained until otherwise notified by the FDA. Such records will be made available to the FDA for inspection upon request.

Aero shall notify DISTRIBUTOR of any legal actions or Product recalls taken by government agencies, within five (5) business days after Aero has knowledge thereof. Throughout the process, DISTRIBUTOR shall consult and fully cooperate with Aero and assist in facilitating any and all corrective action the Parties have determined to take in accordance with all regional, national, and/or local regulations and requirements.

All descriptive printed matter, advertising, and promotional materials relating to the use of this product shall be consistent with the authorized labeling, as well as the terms set forth in the EUA and meet the requirements set forth in section 502(a), (q)(1), and (r) of the Act, as applicable, and FDA implementing regulations.

No descriptive printed matter, advertising, or promotional materials relating to the use of the product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.

All descriptive printed matter, advertising, and promotional materials relating to the use of the product shall clearly and conspicuously state that:

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;

This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,

This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.