Commercial Test definition
Commercial Test means a test based on measurement or detection of cell-free donor-derived DNA (a “cfDNA Test”) in a solid organ transplant recipient that is provided outside of a Clinical Trial. For such purposes, a “Clinical Trial” shall mean a prospective clinical trial to demonstrate clinical benefit, accuracy and precision of a cfDNA Test or other bona fide research study, in each case in which neither Parent, its Affiliate nor other Milestone Obligor receives compensation (other than reimbursement of expenses), directly or indirectly, based on the sale or use of such cfDNA Test, AlloMap or any other product or service for use in or in connection with such clinical trial or research study, or for use in parallel with patients who are also involved in such trial or research study. By way of example, if a cfDNA Test is bundled with a compensated AlloMap test and distributed by Parent for research purposes and without any additional compensation, such test will be considered a Commercial Test. As a further example, if a cfDNA Test is provided as part of a clinical study where Parent, its Affiliate or a Milestone Obligor receives compensation for AlloMap or other services, but without additional compensation identified for the cfDNA Test, such study will not be considered a “Clinical Trial’ and such cfDNA Test will be considered a Commercial Test. A Commercial Test will be deemed “completed” for purposes of Section 1.9 upon the earlier of (a) the time that results from the cfDNA Test are communicated to a health care professional (including a nurse, physician’s or nurse’s assistant, or other person or entity involved in delivering healthcare services) or a patient, or are used for purposes related to a patient or (b) upon the sale of a kit or product for the performance of a cfDNA Test, and, in either case, regardless of whether the cfDNA Test is reimbursed or otherwise paid for by a third party. Each patient cfDNA Test result reported shall be deemed a single test for purposes of calculating the number of tests completed. For any kit or product, the number of tests for such calculations shall be the maximum number of cfDNA Tests performable according to its labeling and instructions for use.
Commercial Test means a test developed by a vendor and required by the department for a state program but not owned, developed or copyrighted by the department. These tests follow the requirements set up by the test vendor and agreed upon by the department.
Commercial Test means a test to determine if the equipment has been manufactured in accordance with the Specifications, within permitted tolerances and that all normal safety and quality assurance procedures have been met.
Examples of Commercial Test in a sentence
Advance Notice: Effective January 1st 2013 - Self-test Registration will apply only to Host Devices, and will have an additional criteria to require Licensee to have purchased and used the official Commercial Test Tool from Test Partner in order to gain the Self- Test Registration status.