Last update on October 17, 2023.
Effective: June 5th, 2023
UNLESS OTHERWISE EXPRESSLY AGREED IN WRITING, ALL SALES ARE SUBJECT TO THE FOLLOWING TERMS AND CONDITIONS:
Except for any modifications that are expressly agreed in a signed writing by Aptitude Medical, Inc. (“Supplier”), these Terms and Conditions of Sale ("Terms and Conditions") shall govern the sale or other transfer by Supplier to a buyer or other recipient ("Buyer") of certain products listed or referenced on a purchase order submitted by Buyer and accepted by Supplier (“PO”) or as otherwise expressly agreed between Buyer and Supplier (the "Products"). Any provisions contained in any document issued by Buyer are expressly rejected and if the terms and conditions in these Terms and Conditions differ from the terms of Buyer's offer or any other documents or communications provided by Buyer, this document shall be construed as a counteroffer and shall not be effective as an acceptance of Buyer's document. Buyer's receipt of Products will constitute Buyer's acceptance of these Terms and Conditions. This is the complete and exclusive statement of the contract between Supplier and Buyer with respect to Buyer's purchase of the Products. No waiver, consent, modification, amendment or change of the terms contained herein shall be binding unless in writing and signed by Supplier and Buyer. Supplier's failure to object to terms contained in any subsequent communication from Buyer will not be a waiver or modification of the terms set forth herein. All orders are subject to acceptance in writing by an authorized representative of Supplier.
All prices are exclusive of (a) any applicable sales, value-add or other taxes, levies, duties or similar charges and (b) freight, transportation, insurance and similar costs and expenses. All payments to Supplier shall be made without withholding, deduction, or reduction for taxes, levies, duties or similar charges, which shall be the sole responsibility of Buyer. If exemption from any taxes or similar charges is claimed, Buyer must provide a certificate of exemption or similar documentation at the time the PO is submitted to Supplier. In the event Supplier elects in its sole discretion to procure insurance for any Product shipment, Buyer shall be responsible for the cost of such insurance and such procurement shall not be interpreted as an obligation by Supplier to procure such insurance for such shipment or any preceding or subsequent shipments.
Buyer represents that it will fully disclose any discounts, rebates or other incentive received from Supplier (“Discounts”) when seeking reimbursement for such product from any government or private payor as may be required by law or contract and allow agents of any federal or state health care agency access upon request to invoices and other information concerning any Discounts.
Payment will be made by Buyer in USD, prior to shipment, without deduction, withholding, offset, set-off or other reduction by Buyer.
Any amounts not paid when due will bear interest at the rate of one and a half percent (1.5%) per month or the maximum rate permitted by law, whichever is less. Interest is payable for the period from the date on which such payment was due through the date on which payment in full, together with all interest due, is actually made. In addition, without limiting any other rights or remedies of Supplier, Buyer must reimburse Supplier for all of its costs and expenses, including attorney fees and legal expenses, incurred in the collection of late payments from Buyer.
Supplier shall use commercially reasonable efforts to deliver Product in accordance with the requested delivery timeframe set forth in the applicable PO. Supplier shall notify Buyer as promptly as reasonably possible upon becoming aware that Supplier will be unable to supply the quantity of Product to Buyer that Supplier is required to supply under any PO within the requested delivery window set forth in the PO. The Parties agree that time is not of the essence with respect to delivery dates, and any such delivery dates contained within a PO or other communications between the Parties shall be deemed as good faith estimates only.
Buyer shall take delivery of, store, transport, handle, use and dispose of the Products (and if applicable, recommend, advertise, market, sell, distribute or provide the Products for use) solely in accordance with all applicable laws and regulations, the Product labeling, and with any written instructions from Supplier. Buyer acknowledges that the Products have been approved for sale and use under one or more Emergency Use Authorizations issued by the U.S. Food and Drug Administration (“FDA”) (each, an “EUA”), and in particular, the EUA dated 10/18/2022. Buyer acknowledges having reviewed and understood the EUA, as made available on the fda.gov website. Accordingly, if applicable, Buyer and its customers shall comply with all Conditions of Authorization applicable to health care providers and/or Point-of-Care settings in (i) the EUA with respect to any Products distributed or sold for health care provider Use and (ii) the EUA with respect to any Products distributed or sold for OTC Use.
If Buyer is a distributor or reseller, Supplier hereby authorizes Buyer on a non-exclusive basis to distribute or resell Products within the United States as permitted by the EUA. Buyer shall not: (a) actively seek prospective purchasers for any Product outside the Territory; (b) engage in any advertising or promotional activities relating to any Product directed to purchasers outside the Territory; or (c) knowingly solicit or accept any order for any Product from any person outside of the Territory or knowing or having a knowledge of facts that would lead a reasonable person to believe that the Product sold or otherwise transferred is likely to be used outside of the Territory. Buyer will use commercially reasonable efforts to promote, market, sell and distribute each Product within the Territory. Buyer will resell and distribute each Product in the form received by Buyer without further modification and prior to any expiration date or use by date as designated by Supplier. Buyer will make the instructions for using the Products available electronically on their website. Buyer will not attempt to repackage, process, modify, experiment with, use as part of another product, or reverse-engineer any Product. To the maximum extent permitted by applicable laws, Buyer will prohibit (through binding contract restrictions or otherwise) any person to which Buyer provides any quantity of Product from using, reselling or distributing any Product for any application other than the Product’s approved labeling and other than as permitted by these Terms and Conditions.
Buyer shall maintain customer complaint files and report to Supplier any significant complaints about usability or deviations from the established performance characteristics of which Buyer becomes aware.
Through a process of inventory control, Buyer must maintain records of the locations (e.g. pharmacies, doctor’s offices, etc.) to which the Products is distributed, and the number of tests distributed to each location.
Buyer shall collect information on the performance of the products 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 products of which Buyer becomes aware, and report any such events to Supplier and/or FDA in accordance with 21 CFR Part 803.
Buyer shall not make any statements, warranties or representations regarding the Products that are inconsistent with these Terms and Conditions. Buyer will accurately represent the qualities of each Product in its advertising and promotion thereof. Buyer shall submit all Product advertising or promotional materials to Supplier for Supplier’s review and approval prior to the initial use of such materials. No substantive changes to, and no changes to any Product or Supplier names or logos contained within, any Product advertising or marketing materials without Supplier’s prior written consent.
Buyer acknowledges and agrees that Supplier is not, and shall not be deemed to be, a provider of patient health care services by virtue of its sale of Products. If Buyer further distributes Products, Buyer is solely responsible for any medical decision(s), advice, act(s), and/or omission(s) made with respect to the treatment of any patient, including without limitation any use of any patient data generated through the use of the Product (and shall indemnify Supplier against third party, including without limitation patient or governmental, claims, suits or actions arising out of the foregoing); and Buyer acknowledges that its or its customers’ use of the Product does not relieve Buyer or its customers from using its or their best medical judgment to determine the appropriate course of treatment for patients.
Delivery. Supplier shall deliver Products to the location specified in the PO. All Products shall be shipped EX WORKS (as defined in Incoterms 2020). Title to Products and risk of loss shall pass from Supplier to Customer at the time the Products are made available for pickup at Supplier’s facility. Customer shall be responsible for all shipping, freight and handling fees and charges incurred in connection with the delivery of Products (and shall reimburse Supplier for such costs incurred by Supplier on behalf of Customer). Products are not subject to contractual acceptance; provided, however, that Supplier’s Product warranties (and Customer’s remedies for Supplier’s breach thereof) set forth herein shall survive delivery, transfer of title and risk of loss. Unless otherwise agreed in writing by an authorized representative of Supplier, and subject to credit approval as determined by Supplier, all payments for Product shall be made in U.S. dollars and shall be due in accordance with the payment terms defined in these Terms and Conditions.
Returns; Return Authorizations. Buyer may submit a claim for any Products that do not conform to the Product Warranty (as defined below) or that were shipped in error (e.g., in excess quantities, shortages, or in a damaged condition unrelated to shipping, or shipped to the incorrect location) (“Non-Conforming Products”) by requesting a Returned Materials Authorization (“RMA”) from Supplier with an explanation of the alleged warranty breach or shipping error. Buyer may not return Products to Supplier without having obtained an RMA. If a return is made without obtaining an RMA, Supplier reserves the right to destroy the returned Product at the Buyer’s expense. Within ten (10) days after Buyer’s receipt of an RMA, Buyer shall return the applicable Products (“Returned Products”) together with the RMA to Supplier FCA destination in accordance with Supplier’s instructions (including without limitation as to delivery location, packing of the Product, method of shipment and carrier). Title to Returned Products and risk of loss shall pass to Supplier at the time of delivery of the Products to such destination location. Buyer shall pay all shipping costs in connection with the delivery of Returned Products. If Supplier determines that the Returned Products are Non-Conforming Products, then as Buyer’s sole remedy and Supplier’s sole and exclusive liability with respect to the Non-Conforming Products, Supplier shall (i) reimburse Buyer for such shipping costs that are reasonably documented to Supplier for returning the Non-Conforming Product (and for initial shipment of such Non-Conforming Product to Buyer) and (ii) at Supplier’s sole, reasonable discretion (and in good faith taking account of Buyer’s stated preference) either (x) replace the Returned Product at no charge to Buyer or (y) credit Buyer’s account for the Returned Product at the price paid therefor. If Supplier determines that the Returned Products are conforming, then Supplier may retain the Returned Products and Buyer may submit a Purchase Order for replacement Products. The parties acknowledge and agree that Supplier’s reasonable determination as to whether Returned Products are Non-Conforming Products shall be binding on the Parties. Except as expressly set forth under these Terms and Conditions, Products delivered under these Terms and Conditions are non-returnable and non-refundable.
Supplier represents and warrants to Buyer that all Products supplied by Supplier shall comply with all applicable laws, rules and regulations for medical devices promulgated by the FDA. Supplier warrants to Buyer that, at the time of delivery of the applicable Product and through the expiration (“use by”) date of such Product as stated on the Product labeling, the Product will substantially conform to the applicable Product specifications published by Supplier as of the date of delivery in all material respects and be free from material defects in design, material and workmanship (the “Product Warranty”). The Product Warranty shall not apply to any claimed non-conformity caused by (i) modification of the Product by any person other than Supplier, (ii) shipment of the Product, (iii) storage, handling, use or operation of the Product other than as instructed by Supplier (including in any documentation provided with the Product); or (iv) Buyer’s or any third party’s (including any end user’s) negligence or fault, accident or improper use of the Product. Buyer shall not provide any representation or warranty to any customer or any other third party with respect to Products that are in any way inconsistent with or in excess of the scope of the foregoing warranties provided by Supplier to Buyer above. Subject to the foregoing, Buyer shall be responsible for (A) providing any warranties to its customers and any other downstream purchasers or users of Product delivered to Buyer under these Terms and Conditions and (B) handling warranty claims and returns for allegedly non-conforming Product from such customers or other downstream purchasers or users. EXCEPT AS EXPRESSLY STATED IN THESE TERMS AND CONDITIONS OR TO THE EXTENT PROHIBITED BY LAW, THE PRODUCTS ARE PROVIDED “AS IS” WITHOUT WARRANTIES, GUARANTEES, CONDITIONS OR REPRESENTATIONS OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.
Buyer agrees to provide to the Supplier, within three (3) days of the initial receipt thereof, notice of any complaints received by it regarding the Product. Buyer shall work in good faith with Supplier to review, investigate and resolve all Product complaints.
In the event any governmental agency having jurisdiction requests or orders any corrective action, or Supplier determines in its sole discretion that a corrective action is warranted, with respect to any Product (or any finished product containing or contained in any Product), including any recall, corrective action or market action (collectively "Recall"), Buyer shall cooperate with Supplier in the conduct of any such Recall. In the event of a Product Recall by Supplier, provided that the events leading to the recall were not proximately caused by the acts or omissions of Buyer or any persons acting under the authority of Buyer or its customers or transferees, Supplier shall be responsible for Product replacement and expenses for communications related to managing the Recall process. Buyer shall not comment publicly on any actual or potential recall, but shall refer all inquiries to Supplier. Buyer may not initiate or conduct a Product Recall without Supplier’s prior written consent. For a period of three (3) years after the last delivery to Buyer of each Product, Buyer shall maintain records of all Product sales and customers sufficient to adequately administer a Recall.
Buyer hereby agrees to indemnify, defend and hold harmless Supplier and its affiliates and subsidiaries, and its and their shareholders, officers, directors, employees, agents, representatives, subcontractors, successors and assigns (for purposes of this Section 3, each, a “Supplier Indemnitee") from and against any and all liabilities, losses, costs, reasonable attorneys' fees, expenses, judgments and damages (collectively, the "Losses"), resulting from any claim, suit, action or demand made or brought (each, a "Claim") against any Supplier Indemnitee which results or arises from, or is attributable to: (i) Buyer's or any of its customers’ or other transferees’ negligence, intentional misconduct, or failure to comply with all applicable laws, rules, and regulations; (ii)any breach by Buyer of any obligations, covenants, duties or responsibilities under these Terms and Conditions; or (iii) the handling, storage, use, transportation, advertising, promotion or sale of any Product by Buyer or any customer or any other downstream purchaser or user of Product delivered to Buyer under these Terms and Conditions other than pursuant to Product labeling and Supplier’s instructions.
Buyer shall assume and control the defense of such Claim(s) with counsel selected by Buyer and reasonably acceptable to the Supplier Indemnitee; provided, however, that the Supplier Indemnitee shall have the right to assume and control the defense of such Claim and retain its own counsel, with the costs, fees and expenses thereof to be paid by Buyer, if the defense of the Claim(s) by Buyer or its designated counsel would create a conflict with the interests of the Supplier Indemnitee, or if Buyer fails to conduct the defense of such Claims) actively and diligently. If the Supplier Indemnitee assumes control of the defense of such Claims) as permitted above, Buyer will reimburse the Supplier Indemnitee promptly and periodically (but no less often than monthly) for the costs of defending against the Claim(s), including reasonable attorneys' fees and expenses. The failure of the Supplier Indemnitee to notify Buyer promptly after the commencement of any such action will not relieve Buyer from any obligation arising hereunder, unless (and then solely to the extent) Buyer is materially prejudiced by such failure. The Supplier Indemnitee and its employees and agents shall reasonably cooperate with Buyer and its legal representatives in the investigation of any Claim(s). No settlement of any Claim(s) involving the asserted liability of the Supplier Indemnitee under this Section 3 shall be made without the prior written consent of, or on behalf of, the Supplier Indemnitee, which consent shall not be unreasonably withheld or delayed. If Buyer assumes the defense of such Claims): (1) no compromise or settlement thereof may be effected by Buyer without the indemnified party's prior written consent thereto unless: (i) there is no finding or admission of any violation of law or any violation of the rights of any person and there is no effect on any other claim that may be made against the Supplier Indemnitee; (ii) the sole relief provided is monetary damages that are paid in full by Buyer; and (iii) the compromise or settlement includes, as an unconditional term thereof, the giving by the claimant or the plaintiff to the Supplier Indemnitee of a release, in form and substance satisfactory to the Supplier Indemnitee, from all liability in respect of such Claim(s); and (2) the Supplier Indemnitee shall have no liability with respect to any compromise or settlement thereof effected without its written consent.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, SUPPLIER'S ENTIRE LIABILITY AND BUYER'S TOTAL REMEDY ARISING OUT OF OR RELATED TO SALE OR USE OF THE PRODUCTS SHALL NOT EXCEED, REGARDLESS OF THE NUMBER OF CLAIMS, THE PURCHASE PRICE RECEIVED BY SUPPLIER FOR THE PRODUCTS GIVING RISE TO SUCH LIABILITY. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL SUPPLIER BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS; OR FOR PUNITIVE DAMAGES, FOR LOST PROFITS OR BUSINESS OPPORTUNITIES OR ANY OTHER INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR RELIANCE DAMAGES, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY), OR OTHERWISE. THESE LIMITATIONS SHALL APPLY REGARDLESS OF WHETHER BUYER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
Neither Buyer nor Supplier shall act or represent or hold itself out as having authority to act as agent, employee or partner of the other party, or in any way bind or commit the other party to any obligations. Nothing contained in these Terms and Conditions shall be construed as creating a partnership, joint venture, agency, trust or other association of any kind, each party being individually responsible only for its obligations as set forth in these Terms and Conditions. All activities by either party under the terms hereof shall be carried on by such Party as an independent contractor.
Neither these Terms and Conditions, nor any of the rights or obligations of the parties hereunder, may be assigned, transferred, or conveyed by operation of law or otherwise without the prior written consent of the other party, which consent shall not be unreasonably withheld or delayed, except in connection with the acquisition of either party, including an acquisition by any (i) sale, issuance, exchange or transfer, in a single transaction or a series of related transactions, of greater than fifty percent (50%) of the outstanding capital stock of either party hereto to a third party, (ii) sale of all or substantially all of the assets of either Party to which these Terms and Conditions relate, or (iii) merger, consolidation or other reorganization involving either party and one or more other entities in which the shares of that party's outstanding capital stock immediately prior to such transaction are converted into, exchanged for or represent less than a majority of the voting power of the surviving or resulting entity.
In the event that either party is prevented from performing or is unable to perform any of its obligations under these Terms and Conditions due to any act of God, acts or decrees of governmental or military bodies, fire, casualty, flood, earthquake, war, strike, lockout, epidemic, destruction of production facilities, riot, insurrection, or any other cause beyond the reasonable control of the party invoking this clause (collectively, a "Force Majeure"), such party shall give prompt written notice to the other party, and if such party shall have used its commercially reasonable efforts to mitigate the Force Majeure event effects, its performance shall be excused, and the time for the performance shall be extended for the period of delay or inability to perform due to such Force Majeure event.
These Terms and Conditions and any PO constitute the entire understanding between the parties with respect to the subject matter hereof and supersedes and replaces all prior agreements, understandings, writings and discussions between the parties relating to said subject matter. In the event of a conflict between the terms and conditions of a PO and these Terms and Conditions, these Terms and Conditions shall govern except insofar as the parties have expressly agreed otherwise in writing referencing the specific aspects of these Terms and Conditions that do not apply.
These Terms and Conditions shall be governed and viewed under the laws of the State of California without reference to its conflict of laws provisions. Supplier and Buyer specifically agree that any action relating to the relationship between the parties, these Terms and Conditions or Products provided, purchased or otherwise transferred hereunder, shall be brought and tried in the Courts of California. Buyer hereby waives all objections to, and consents to the jurisdiction of the California Courts.