Program Purchase Policy
[Covid-related testing supplies and products]
As used in this Program Purchasing Policy, “we,” “us,” and “Genera” means the applicable Genera contracting party and any of its applicable Affiliates, and ”you” means the Buyer of any Covid-related testing supplies or products, and any of its Affiliates, including employees, officers, directors and partners. Capitalized terms used but not defined herein are used as defined in the Genera Terms of Service Agreement, which also governs the relationship between You and Genera.
By placing an order through our platform for Covid-related supplies and testing products (“Testing Product”) governed by the Food and Drug Administration (“FDA”) or Center for Medicare & Medicaid Services (“CMS”), You understand, acknowledge and agree as follows:
In the event the Testing Product is subject to the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency issued by the FDA on March 16, 2020 (as revised from time to time, the “Policy”), all uses of the Testing Product shall be consistent with the Policy.
In the event the Testing Product is governed by an Emergency Use Authorization (EUA), all uses of the Testing Product shall be consistent with the EUA.
The Testing Product has not been cleared or approved by the FDA, unless specifically stated on the Product Page.
The Testing Product has only been authorized by the FDA under an EUA (such EUA accessible for each Testing Product on its Product Page) for use by laboratories authorized by CMS, unless specifically stated otherwise on the Product Page.
For Covid antibody testing products, the testing products has been authorized to detect for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
For Covid antigen testing products, the testing products has been authorized to detect for the presence of Covid antigens against SARS-CoV-2, not for any other viruses or pathogens.
There may be occurrences of false positive or false negative results and significant deviations from the established performance characteristics of the Testing Product. As such, results from the Testing Products should not be used as the sole basis to diagnose or exclude current or past infection of SARS-CoV-2.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the Covid virus. Follow up testing with a molecular diagnostic should be strongly considered to rule out infection in these individuals.
Unless otherwise noted on the Product Page, all Testing Products are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
You further agree as follows:
a. To not alter, modify, remove, or deface the labeling on the Testing Product. At any point in time, You should be able to provide the location and disposition or assist with the traceability of the Testing Product and ensure that any records associated with any EUA are maintained until otherwise notified by the FDA.
b. To review all Instructions for Use, and use the Testing Product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
c. Have a process in place for reporting test results to all relevant public health authorities, as appropriate.
d. appropriately train all personnel using a Testing Product in immunoassay techniques and interpretation of results of the Testing Product, use appropriate laboratory and personal protective equipment when handling the Testing Product, and use the Testing Product in accordance with the authorized labeling.
f. review the EUA to determine if authorization of use for this Testing Product is limited to high complexity laboratories, and if so, qualify your facility to perform high complexity tests.
You agree to indemnify, defend and hold us harmless and our officers, directors, shareholders, employees, agents, representatives, successors and assigns from any and all claims, demands, losses, liabilities, judgments, awards and costs (including attorney’s) fees arising out of or relating to the Testing Product, or Your breach of this Agreement by You or any Affiliate.