Compliance with Applicable Laws - General Clause Samples

Compliance with Applicable Laws - General. (a) Each Party shall comply in all material respects with all Applicable Laws that relate to the performance of such Party’s obligations under this Agreement and, except as provided for herein, shall bear their own cost and expense of complying therewith. (b) The termination or expiration of this Agreement shall not relieve either Party of its responsibility to comply in all material respects with any statutory or regulatory requirements associated with the Device(s). (c) Each Party shall be responsible for compliance, as applicable, with FDA’s establishment registration and device listing requirements set forth in 21 C.F.R. Section 807.25. (d) Access shall be responsible for compliance, as applicable, with FDA’s medical device reporting requirements set forth in 21 C.F.R. Part 803.25. (e) Each Party shall be responsible for compliance, as applicable, with FDA’s corrections and removals requirements as set forth in 21 C.F.R. Part 806.