Products; Compliance; Medical Regulations. (a) Schedule 3.15(a) sets out a list of all of the Products.
(b) Except as set out on Schedule 3.15(b), each Company is in material compliance with all applicable Laws administered or issued by the FDA or any other applicable Medical Device Regulator. Each Product, where required by Laws applicable thereto, is being manufactured and marketed under a valid market authorization issued by the FDA or another applicable Medical Device Regulator, including a Section 510(k) clearance or exemption from the requirement therefor (“510(k) Clearance”), de novo classification order, or valid premarket approval application (“PMA”). Except as set out on Schedule 3.15(b), each Product is manufactured and marketed in all material respects in accordance with applicable ISO sections and, where applicable, with required XX Xxxxx or other comparable certification marks in other jurisdictions. Schedule 3.15(b) sets out each market authorization, including each 510(k) Clearance, de novo classification order, or PMA, for the Products, and each CE Mark and other certification marks applied by the Companies to the Products.
(c) Except as set out on Schedule 3.15(c):
(i) no significant false information has been submitted, nor has any significant omission been made, in any products application or products-related submission to the FDA or any other Governmental Entity by or, with the Knowledge of the Companies, on behalf of any Company or the Business;
(ii) all market authorizations, all PMA, de novo classification, and Section 510(k) documents and related documents for each Product are in compliance with applicable Laws administered or promulgated by the FDA or other applicable Medical Device Regulator and the FDA or other applicable Medical Device Regulator has not indicated any intent to limit, suspend or revoke the market authorizations, including any PMA, de novo classification order, and Section 510(k) approvals or clearances or materially changing the marketing classification or labeling of any Product;
(iii) all pre-clinical and clinical studies, if any, conducted by any Company or the Business related to each Product have been in accordance in all material respects with recognized good clinical and good laboratory practices and are in material compliance with applicable Laws administered or promulgated by the FDA or other applicable Medical Device Regulator regarding pre-clinical and clinical studies;
(iv) each Company has obtained all necessary regulatory approvals from all...
Products; Compliance; Medical Regulations. (a) Except as would not reasonably be expected to result in an Event of Default or have a material adverse effect on the Businesses, each Loan Party and its Subsidiaries are in compliance with all Laws administered or issued by the FDA or any other applicable Medical Product Regulator. Each Product, where required by Laws applicable thereto, is manufactured and marketed under a valid market authorization issued by the FDA. Each Medical Product is manufactured and marketed in accordance with current Good Manufacturing Practices applicable ISO sections, USP formularies, and, where applicable, other regulatory requirements:
(i) No materially false information has been submitted, nor has any significant omission been made, in any products application or products-related submission to the FDA or any other Governmental Authority by or, on behalf of a Loan Party.
(ii) All market authorizations, documents and related documents for each Medical Product are in material compliance with applicable Laws administered or promulgated by the FDA or other applicable regulator and the FDA or other applicable Medical Product.
(iii) As of the Effective Date and as of the Closing Date, Regulator has not indicated any intent to limit, suspend or revoke the market authorizations, approvals or clearances or materially changing the marketing classification or labeling of any Product.
(iv) All pre-clinical and clinical studies, if any, conducted by any Loan Party and its Subsidiaries related to each Medical Product have been in accordance with recognized good clinical and good laboratory practices and are in material compliance with applicable Laws administered or promulgated by the FDA or other applicable Regulator regarding pre-clinical and clinical studies.
(v) Each Loan Party and its Subsidiaries have obtained all necessary regulatory approvals from all Governmental Authorities (whether foreign or domestic) related to each Product required in any jurisdiction where that Medical Product is manufactured, marketed, sold or used.
(vi) Each Loan Party and its Subsidiaries are in material compliance with applicable Laws regarding manufacturing requirements, including the testing of incoming materials, in process product, equipment validation and maintenance, complaint file requirements, complaint investigation requirements, process validation, document retention, change controls, and batch file documentation.
(vii) As of the Effective Date and as of the Closing Date, each Loan Party a...
