CLIA Clause Samples
The CLIA (Clinical Laboratory Improvement Amendments) clause establishes that any laboratory testing services provided under the agreement must comply with federal CLIA regulations. This means that the laboratory must be properly certified and maintain quality standards for testing human specimens, ensuring accuracy and reliability of results. By including this clause, the agreement ensures that all laboratory work meets legal and quality requirements, thereby protecting both parties from regulatory violations and ensuring the integrity of test results.
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CLIA. The Company shall have provided the Purchaser with documentation, in form and substance acceptable to the Purchaser and as of a date acceptable to the Purchaser, to the effect that the operations of the Seller and the Company have complied with CLIA and all HCFA regulations.
CLIA. (a) With respect to the Business as currently conducted, Seller has been and is currently in material compliance with the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. § 263a) (“CLIA”), 42 C.F.R. part 493, applicable Law of states and other jurisdictions governing the operation of clinical laboratories, and, to the extent applicable, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and its implementing regulations, including provisions related to manufacturing, marketing, sale, and distribution of medical devices, and clinical research. With respect to the Business as currently conducted, Seller performs clinical tests that are either (a) U.S. Food and Drug Administration (“FDA”)-approved or FDA-cleared in vitro diagnostic devices used in accordance with the device manufacturer’s instructions for use, or (b) laboratory developed tests intended for clinical use and designed, manufactured and used within a single CLIA-certified facility that meets the requirements high-complexity testing under CLIA as described in 42 C.F.R. §§ 493.17(c)(4) and 493.25.
(b) With respect to the Business as currently conducted, Seller has no outstanding surveys or inspections by any Governmental Authority or any accreditation organization, including, without limitation, all corrective action plans or other responses to such survey or inspections except as set forth in Schedule 3.11(b)
(c) Any current employees and contractors of the Business as currently conducted, including, without limitation, each current laboratory director or other clinical-based management and technical personnel are in material compliance with all licensure, certification, and Permit requirements under CLIA and applicable Laws of states and other jurisdictions governing the operation of clinical laboratories and laboratory personnel.
CLIA. The Company is in compliance with the applicable requirements of CLIA and other similar laws and requirements. No suspension, revocation, termination, sanction, corrective action or limitation of any currently existing CLIA certification or accreditation of the Company is pending or, to the Company’s Knowledge, threatened.
CLIA. The term “