Common use of Research Use Only Clause in Contracts

Research Use Only. You acknowledge that the Goods do not have United States Food and Drug Administration (“FDA”) or equivalent non-U.S. regulatory agency approval (“Approval”). Accordingly, You acknowledge that the Goods are labeled and intended FOR RESEARCH USE ONLY and NOT FOR USE IN DIAGNOSTIC, THERAPEUTIC, OR CLINICAL PROCEDURES and agree that You shall only use the Goods for Your Research Use. You acknowledge that You have not obtained the Goods for personal, family, domestic, household or other similar use that would trigger the applicability of the consumer protection laws of the jurisdiction in which You are located. The Goods should be used in strict accordance with the Documentation and applicable instructions, warnings and other information in user manuals accompanying such Goods or on their packaging or on the Oxford Website. Unless otherwise expressly stated by Oxford Nanopore in writing, no claim or representation is made or intended by Oxford Nanopore (i) as to any diagnostic, therapeutic, or other clinical use of the Goods; (ii) that any of the Goods has any Approval for use in any diagnostic, therapeutic, or other clinical procedure, or for any other use requiring compliance with any law, regulation or governmental policy concerning medical devices, laboratory tests or the like (collectively, “Regulatory Laws”); (iii) that any of the Goods will satisfy the requirements of the FDA or any other regulatory agency; or (iv) that any of the Goods or their performance is suitable or has been validated for clinical, therapeutic, or diagnostic use, for safety and effectiveness, for any specific use or application, or for importation into Your jurisdiction. You agree that if You elect to use the Goods for a purpose that would subject You or any of the Goods to the application of Regulatory Laws or any other law, regulation or governmental policy, You shall be solely responsible for obtaining any required Approvals and otherwise ensuring that the importation of the Goods into Your jurisdiction and Your use of the Goods complies with all such laws, regulations and policies. The burden of proof for safe use and handling of the Goods is entirely Your responsibility.