This Emergency Use Test Purchase Agreement (“Agreement”) is entered into by and between Confirm Biosciences, Inc., a Delaware corporation (“Company”) and the purchaser identified below (“Purchaser”) and is effective as of date set forth next to the Purchaser’s signature.
The Purchaser agrees that the tests purchased by Purchaser from the Company (“Tests”) are for emergency use test purposes only and have not been approved, reviewed, cleared or licensed for sale or use in the U.S. by the U.S. Food and Drug Administration (“FDA”). The Tests are provided by Company to Purchaser pursuant to the P olicy for Diagnostic T ests for Coronavirus Disease-2019 during the Public Health Emergency issued on the web on March 16, 2020 by U.S.
Food and Drug Administration (FDA”) which may be found here h ttps://www.fda.gov/media/135659/download
(collectively the “Policy”). All uses of the Tests by the Purchaser shall be consistent with the Policy.
The Purchaser shall comply with the Policy guidance including, but not limited to, validation, FDA notification, reporting of results, Emergency Use Authorization (“EUA”), clinical testing and distribution. Collection and interpretation of the
Tests shall only be performed by a health care professionals. The Tests are N OT approved or intended for use by
individuals at home and the Purchaser shall not sell single Tests or sell the Tests in such a manner that would facilitate or encourage the use of the Tests by individuals at home. The Tests shall not be made available, sold, distributed or marketed, directly or indirectly, to the general public or to anyone who the Purchaser knows or has any reason to believe will resell the Tests to persons for individual for home use. Purchaser shall not make any written or verbal statements regarding the Products that are inconsistent with or exceed the statements provided in writing by the Company to the Purchaser.
THE TESTS SHALL ONLY BE USED FOR PRELIMINARY SCREENING PURPOSES AND SHALL ONLY BE USED TO DETERMINE IF ADDITIONAL TESTING IS REQUIRED.
All tests will be provided with labeling which states “The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.” The Purchaser shall not alter, modify, remove or deface the labelling on the Tests.
The Purchaser acknowledges that there is no uniform standard for the use of Covid 19 tests. The Purchaser shall be responsible for verifying and complying with all laws and regulations applicable where the Tests are sold and used including, but not limited to, all rules and regulations promulgated by the FDA and CLIA. The Purchaser shall not sell or make the Tests available to any person who will resell or use the Tests in violation of any applicable law or regulation in the jurisdiction where the Tests are sold or used.
Due to the nature of these tests, once these tests are shipped they will not be refundable or exchangeable for any reason. If you were asked to put a deposit to get tests committed to your account, those deposits will be subject to fees If orders cancelled before the shipment.
If symptoms such as colds or fever appear, regardless of whether the result of the Test is positive or negative, the person should seek immediate medical advice to prevent delay in treatment. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Positive results may be due to past or present infection with non-SARS- CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. When the Covid 19 virus infects the human
body, the detection window of antibodies will vary from individual to individual. The detection can be anywhere from 1 to 3 weeks after infection
The Purchaser agrees to indemnify, defend and hold harmless Company and its 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 breach of this Agreement by the Purchaser or any person affiliated with the Purchaser.