AEROGEN STANDARD TERMS AND CONDITIONS OF SALE
These standard Customer Terms and Conditions (“Terms”) apply to all orders received from and all sales made to customer (“Customer”) by Aero US Inc., a Delaware corporation (“Aerogen”), for products (“Products”) (each a “party” to and collectively “parties” to these Terms). Aerogen’s offer to sell Products to the Customer and acceptance of any purchase order (“Order”) is conditioned on Customer’s acceptance of these Terms. For purposes of these Terms, the term “Product” or “Products” shall refer to the goods set forth in the invoice or any applicable pricing agreement between the Parties., . Aerogen rejects all other Customer terms, in any form, that are different or additional to these Terms; save for where a written agreement is in place between Aerogen and the Customer for purchase of the Products and in that context the terms of that contract shall prevail where in conflict with these Terms. Aerogen reserves the right at any time to change these Terms without notice and orders placed after such a change will be subjected to the amended Terms available at https://www.aerogen.com/us-customer-terms-conditions/
1. Products. Subject to Section 4 of these Terms, Aerogen shall make the Products available to Customer at the initial prices set forth on the invoice or the applicable pricing agreement between the Parties ((“Product Listing”). Customer acknowledges and agrees that Aerogen may, from time to time, upon written notice to Customer, supplement a Product Listing to add Products at list price. If Customer does not provide written notice of rejection of the updated Product Listing within thirty (30) days after Customer’s receipt of the written notice from Aerogen, the updated Product Listing shall be deemed accepted by Customer, without a need for a formal amendment to these Terms.
2. Payment; Pricing. Payment terms are net thirty (30) days. Past due balances may be subject to a service charge of one and one-half percent (1.5%) per month, or the highest rate allowed by law, if lower. If Aerogen determines that Customer has unfavorable credit, Aerogen retains the right to require payment in advance or payment with the purchase order to release shipment. Aerogen may, upon sixty (60) days prior written notice, increase prices for the Products by an amount equal to the percentage increase based upon the Consumer Price Index for Medical Care, not seasonally adjusted, over the twelve (12) month period immediately preceding the increase; provided, however, such price increases shall not occur more than once annually.
3. Taxes. Unless Customer is fully exempt from all taxes, Customer shall pay all federal, state and local taxes, which may be imposed upon the use, possession, ownership, or lease of any Product (“Taxes”). Aerogen shall add all applicable Taxes to the invoice. Customer shall promptly reimburse Aerogen for any Taxes paid by Aerogen. If Customer is tax exempt, Customer must provide a tax-exempt certification to Aerogen prior to the Effective Date of these Terms.
4. Product Supply. Notwithstanding anything to the contrary in these Terms (i) at any time and from time to time, Aerogen may have limited inventory or no inventory of one or more Products, and Aerogen shall not incur any liability to Customer for any failure to supply or any delayed supply of Products; and (ii) Aerogen reserves the right, in its sole discretion and without liability, to allocate supply of the Products and to immediately discontinue supplying any Product (“Discontinued Product”), and any such action will not constitute a breach by Aerogen under these Terms. Discontinued Products will be replaced with a mutually acceptable Aerogen product, if available (“Replacement Product”). If the net price for the Replacement Product is higher than the Discontinued Product, the parties shall mutually agree on the price of the Replacement Product.
5. Ordering. To the extent purchases directly through Aerogen, Customer may place an Order at any time with Aerogen for any Products by contacting Aerogen at the address set forth below and utilizing a purchase order. All Orders are subject to acceptance by Aerogen, which may be in writing or electronic record delivered to customer or by shipping Products. Aerogen shall deliver the Products in accordance with these Terms to the attention of the individual and address identified on the purchase order. Any request to cancel an Order after processing is subject to Aerogen’s written approval and Aerogen reserves to the right to apply a restocking fee.
USAorders@aerogen.com
(P) (866) 423-7643
(F) (866) 706-9098
All purchase orders hereunder may be submitted by Customer by e-mail, telephone, fax, or electronic order entry directly to Aerogen.
6. Product Returns and Acceptance. Unless Customer provides written notice to Aerogen, no later than ten (10) calendar days after delivery of the applicable Product, of (i) any discrepancy between the type or quantity of Products ordered and the type or quantity of Products delivered or (ii) any failure of such Product to materially comply with the warranty set forth in Section 9 below, Customer shall be deemed to have accepted the Products (“Acceptance”). All returns shall be governed by Aerogen’s return policy as set forth on Appendix A, attached and incorporated in these Terms.
7. Shipping. Products shipped by Aerogen to Customer shall be shipped Free On Board Aerogen’s Shipping Point (FOB, Brownsburg, Indiana). For purposes of this Agreement, ‘FOB Brownsburg, Indiana’ shall mean that risk of loss to the Products shall pass to Customer when the Products are placed are at the disposal of the Customer (or the carrier for the Customer) at Aerogen’s Brownsburg, Indiana or other Aerogen facility for shipping to the Customer. Shipping charges are prepaid and added to each invoice. Customer is responsible for all applicable freight upgrades, including but not limited to any special level of service, handling or packaging or expedited freight charges requested by Customer Aerogen shall apply a charge of $10.00 (ten dollars) per shipment or $50 (fifty dollars) per pallet for use of the Customer’s third-party freight account.
8. Title. Title to Product shall not pass to Customer until Aerogen receives payment in full (in cash or cleared funds) for Product due to Aerogen in which case title to Product pass at the time of payment. Until title to the Product has passed to the Customer, Customer shall (i) store Product separately from all other goods held by Customer so that they remain readily identifiable as Aerogen property, (ii) not remove, deface or obscure any identifying mark or packaging on or relating to Product; and (iii) maintain Product and/or in satisfactory condition and keep them insured on Aerogen behalf for their full price against all risks with an insurer that is reasonably acceptable to Aerogen. On request Customer shall allow Aerogen to inspect Product and the insurance policy.
9. Limited Warranty. Aerogen warrants and represents that Products delivered to carrier for shipment to Customer, or delivered directly to Customer shall at time of shipment : (1) materially conform to published specifications set forth in the applicable Aerogen package insert(s) for such Product; (2) not be adulterated or misbranded within the meaning of the U.S. Food, Drug, and Cosmetic Act; and (3) shall be manufactured in accordance with the applicable laws and regulatory requirements and (4) shall have an expiry date of not less than 18 months at date of shipment or (if there is no expiry date) a remaining shelf life of not less than 18 months after the shipment date. Except as to warranties specifically set forth in this paragraph, the only other warranties made by Aerogen with respect to Products are those specifically and expressly stated as warranties in the Aerogen package insert specifications and manuals. The foregoing warranty will not apply to Products that are or have been (a) misused, altered, damaged or used other than in accordance with applicable Aerogen package insert and/or operating manual (including product dating); (b) used in combination with other articles, substances or materials not provided or recommended for use by Aerogen; (c) the serial number of any Product has been altered, defaced, or removed; or if any repair is attempted by personnel who has not been authorized by Aerogen to perform such repair; or (d) purchased from an unauthorized distributor (subsections (a) through (d), collectively, “Warranty Exclusions”). If any Product does not comply with the warranty set forth in this paragraph, as Customer’s sole and exclusive remedy, Aerogen shall, at Aerogen’s discretion, repair or replace the applicable Product at no additional expense to the Customer. EXCEPT FOR THE ABOVE LIMITED WARRANTY, AEROGEN MAKES NO, AND EXPRESSLY DISCLAIMS, ANY OTHER WARRANTY, EXPRESS, IMPLIED OR STATUTORY, WITH RESPECT TO ITS DISPOSABLE PRODUCTS, INCLUDING WITHOUT LIMITATION NON-INFRINGEMENT, OR ARISING FROM COURSE OF PERFORMANCE, DEALING, USAGE OR TRADE. EXCEPT FOR THE ABOVE LIMITED WARRANTY, AEROGEN DOES NOT WARRANT THAT AEROGEN’S DISPOSABLE PRODUCTS WILL MEET CUSTOMER’S REQUIREMENTS. THIS LIMITED WARRANTY EXTENDS ONLY TO CUSTOMER.
10. Product Performance. If Customer experiences any issues with a Product, Customer may call Aerogen’s technical support at 866-423-7643. If Customer experiences a problem with an order or shipment, Customer may call Aerogen’s customer service at 866-423-7643.
11. Indemnification. Customer shall indemnify, defend and hold harmless Aerogen, its subsidiaries, affiliates and divisions, and their respective officers, directors, shareholders and employees, from and against any and all damages, liabilities, actions, causes of action, suits, claims, demands, losses, costs and expenses (including without limitation reasonable attorneys’ fees and disbursem*nts and court costs) to the extent arising from or in connection with (i) the negligence or willful misconduct of Customer, its agents, employees, representatives or contractors; (ii) use of a Product in combination with equipment or software not supplied by Aerogen where the Product itself would not be infringing; (iii) Aerogen’s compliance with designs, specifications or instructions supplied to Aerogen by Customer; (iv) use of a Product in an application or environment for which it was not designed; or (v) modifications of a Product by anyone other than Aerogen without Aerogen’s prior written approval.
12. Limitation of Liability. THE LIABILITY OF AEROGEN IN THE AGGREGATE UNDER AND WITH RESPECT TO THESE TERMS AND THE PERFORMANCE OR NONPERFORMANCE OF THESE TERMS AND ANY PRODUCTS FURNISHED UNDER THESE TERMS SHALL BE LIMITED TO THE VALUE OF THE PRODUCTS PURCHASED BY CUSTOMER IN THE CALENDAR YEAR IN WHICH THE LIABILITY ARISES. AEROGEN SHALL NOT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, LOSS OF PROFIT, LOSS OF DATA, OR LOSS OF USE.
13. Regulatory Compliance.The parties in good faith believe that these Terms fully comply with the provisions of 42 U.S.C. 1320a-7b (the Medicare/Medicaid “Anti-Kickback Statute”). The parties are not, by virtue of these Terms or otherwise, willfully offering, paying, soliciting, or receiving remuneration in return for referring an individual to or from each other for the furnishing of any item or service reimbursed under the Medicare or state health care programs. Pricing hereunder does not consider the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare or a state health care program. The parties shall utilize best efforts to comply with the reporting requirements of 42 C.F.R. §1001.952(h), regarding “safe harbor” protection for discounts under the Anti-Kickback Statute. Upon Customer’s written request, Aerogen shall provide detail pertaining to such discounts and the allocation of total net purchase dollars for Products, equipment, services, and miscellaneous purchases, as applicable. Customer may have an obligation to report such discounts to any state or federal health care program that provides reimbursem*nt to Customer for the Products to which the discount applies, and if so, Customer must fully and accurately report such discounts. Further, Customer should retain invoices and other price documentation and make them available to state or federal officials upon request. To the extent that Section 952 of the Omnibus Reconciliation Act of 1980 (the “Act”) and the regulations promulgated there under are applicable to these Terms, Aerogen and the organizations related to it, if any, performing any of the duties pursuant to these Terms valued at Ten Thousand Dollars ($10,000) or more in any twelve (12)-month period shall, until four (4) years after the furnishing of Products or services pursuant to these Terms, comply with requests by the Comptroller General, the Secretary of the Department of Health and Human Services, and their duly authorized representatives for access (in accordance with Section 952 of the Act) to any contract or agreement between Aerogen and Customer for Products, and to any contract or agreement between Aerogen and such related organizations, as well as the books, documents and records of Aerogen and its related organizations, if any, which are necessary to verify the cost of the Products or services provided. Aerogen is not a Business Associate as defined by HIPAA and that in the provision of Products from Aerogen to Customer, Customer shall not provide any protected health information to Aerogen. Each party represents that it has never been debarred, excluded or suspended by the Office of Inspector General of the Department of Health and Human Services; otherwise deemed ineligible to participate in federal healthcare or procurement programs, or to the extent applicable, state healthcare or procurement programs; or convicted of a criminal offense regarding health care reimbursem*nt.14. Device Tracking. Customer shall maintain adequate tracking for the Products to enable Aerogen to meet any applicable legal and regulatory requirements in the respect of tracking the Products. If Aerogen recalls the Products, Customer shall cooperate fully in recall implementation, including but not limited to, returning Products to Aerogen.15. Confidentiality. These Terms are confidential and, except as otherwise required by law, Customer shall not disclose such terms, including the pricing offered to Customer hereunder, to any third party without Aerogen’s prior written consent, provided that Customer shall be permitted to disclose the terms of these Terms to the extent required by applicable law or as reasonably required by Customer’s attorneys, accountants, and other professional advisors who are under an obligation of confidentiality to Customer. The provisions of this paragraph shall survive termination or expiration of these Terms.16. Choice of Law; Venue; Waiver of Jury Trial. These Terms shall be governed by, and construed in accordance with, the laws of the State of Delaware. Each party irrevocably agrees that any claim brought by it in any way arising out of these Terms must be brought solely and exclusively in state or federal courts located in the State of Delaware, and each party irrevocably accepts and submits to the sole and exclusive jurisdiction of each of the aforesaid courts in personam, generally and unconditionally with respect to any action, suit, or proceeding brought by it or against it by the other party. EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THESE TERMS OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).17. Force Majeure. Aerogen will be excused from the performance of its obligations under these Terms for so long as, and it will not be liable to the Customer or to any third party in the event that, its performance under these Terms is prevented or delayed due, in whole or in part, to circ*mstances or events beyond the reasonable control of one or more of Aerogen, or any of its vendors, suppliers or shipping carriers of any of the foregoing, including any (a) acts of God, (b) natural disaster or severe weather condition (e.g., lightning, earthquakes, hurricanes, floods, tornadoes, drought, blizzards, ice storms, volcanic eruption, epidemic, pandemic, etc.), fire or explosion, (c) war, invasion, hostilities (whether war is declared or not), terrorist threat or act, riot, rebellion, mutiny, sabotage or other civil unrest, (d) act or decision of any governmental authorities or change in applicable law or regulation, (e) sinking, crashing, embargo or blockade, (f) strikes, labor disturbances, stoppages or slowdowns or other industrial disturbances, (g) failure or delay of public utilities or common carriers, (h) batch failure, supply failure or outage, equipment failure or malfunction, shortages of fuel, power or raw materials or (i) any other circ*mstance or event which is not under the reasonable control of Aerogen (each, individually, a “Force Majeure Event”). Any time for Aerogen’s performance under these Terms will be extended by the actual time of delay caused by any such Force Majeure Event.18. Notices. All notices related to this Agreement will be in writing and will be effective upon (a) personal delivery, (b) the second business day after mailing, or (c), except for notices of termination or an indemnifiable claim (“Legal Notices”), which shall clearly be identifiable as Legal Notices, the day of sending by email. Billing-related notices to Customer will be addressed to the relevant billing contact designated by Customer. All other notices to Customer will be addressed to the relevant contact designated by Customer. Notices to Aerogen should be addressed to Aero US Inc (Attn Legal), 410 North Michigan Ave, Suite 920, Chicago, IL 60611.19. General. These Terms, including all appendices, exhibits, and attachments referenced herein, constitutes the entire understanding and agreement between the parties concerning the subject matter hereof, and supersedes all prior negotiations, agreements and understandings between the parties, whether oral or in writing, concerning the subject matter, save where a written agreement is in place between Aerogen and the Customer for purchase of the Products and in that context the terms of that contract shall prevail where in conflict with these Terms. These Terms may only be amended by a written agreement bearing signatures of authorized agents of each of the parties and expressing an intent to be bound by the terms of such an amendment. Any waiver of a breach of any provision(s) of these Terms shall not (i) be deemed effective unless in writing and signed by the party against whom enforcement of the waiver is sought, or (ii) operate as, or be construed to be, a waiver of any subsequent breach of the same or other provisions hereof. Neither party shall assign any rights or obligations under these Terms without prior written consent of the other; provided that either party may assign these Terms to any direct or indirect subsidiary or affiliate without the prior written consent of the other party and provided further that either party may assign these Terms to any third party acquirer in connection with an asset sale of the business underlying these Terms without the prior written consent of the other party. These Terms shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. If any part of these Terms shall be determined to be invalid, illegal or unenforceable by any valid act of Congress or act of any state legislature or by any regulation duly promulgated by the United States or a state acting in accordance with the law, or declared null and void by any court of competent jurisdiction, then such part shall be reformed, if possible, to conform to the law and, in any event, the remaining parts of these Terms shall be fully effective and operative insofar as reasonably possible.APPENDIX A
AEROGEN RETURN POLICYAll returns of products purchased from Aerogen must be authorized by Aerogen. To request Aerogen’s Return Goods Authorization Form contact Aerogen customer service at (866) 423-7643.A. Reasons for Returns. Customer may return to Aerogen a Product purchased directly from Aerogen for 100% credit, refund, or exchange, at the Customer’s option, up to thirty (30) days after purchase, if the Customer carries out an inspection of the Product within thirty (30) days after purchase, issues written notice to Aerogen during such period specifying the reason for the rejection and determines in good faith that any of the following conditions are met:(i). The Product does not materially perform to performance specifications provided by Aerogen or the manufacturer of the Product or the Product fails to conform to the warranty for the particular Product (“Defective Products”);(ii). The Product does not meet industry quality standards related to performance specifications and data submissions required by the FDA or FDA approval of the Product (“Recalls”);or(iii). Aerogen gives prior written approval.B. Restocking Fees. Save for returns return of Defective Products or Recalls any returns accepted by Aerogen must be unopened and saleable and shall be subject to a restocking fee of 20% and such other conditions as Aerogen may impose including, without limitation, payment of transportation costs, and other costs incurred by Aerogen.C. Returns Process. Any Products accepted for return will be returned to Aerogen as soon as practicable. Products returned due to an alleged breach of warranty must be returned not later than three (3) months after the end of the warranty period provided in Aerogen’s DFU for the Products. Any warranty return will be accompanied by evidence of the date of purchase by the Customer, date of shipment to the Customer and serial number of the Product, for Aerogen to be able to monitor the applicable warranty period.Before returning any Product, Customer must notify Aerogen’s Customer Service Department, which, if it approves the return, will issue “Aerogen’s Return Goods Authorisation Form”. No return will be accepted unless accompanied by a Returned Goods Authorisation Form. For warranty returns, Customer must have notified Aerogen in writing that the Products do not conform with the warranty included in Aerogen’s DFU for the Products. Aerogen will only accept returns directly from Customer. All returns other than Recall and Defective Products returns will be shipped at Customer’s expense.
