Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) The Company has obtained and maintains all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the FDA and any other Applicable law which regulates the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of its products in jurisdictions where it currently conducts such activities with respect to each product (collectively, the "Company Licenses"). The Company is in compliance in all material respects with the terms and conditions of each Company License. The Company is in compliance in all material respects with all Applicable Laws regarding registration, license, certification for each site at which a product is manufactured, labeled, sold, or distributed. To the extent any product has been exported from the United States, the Company has exported such product in compliance in all material respects with Applicable Laws. All manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the Quality Systems regulations of the FDA. All non-clinical laboratory studies of products sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States. The Company is in compliance in all material respects with all applicable reporting requirements for all Company Licenses or plant registrations including, but not limited to, applicable adverse event reporting requirements in the United States under Applicable Law. The Disclosure Schedule sets forth a list of all Company Licenses. (b) The Company is in compliance in all material respects with all FDA and other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company's products. The Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Products, including any Medical Device Reports (as defined in 21 CFR 803). The Company has made available to Parent all complaint review and analysis reports of the Company, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) The Company has not received any written notice or other written communication from the FDA (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company's products, or (ii) otherwise alleging any violation of Applicable Law by the Company. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or, to the Company's knowledge, threatened by the FDA or any other Governmental Authority with respect to any of the Company's products, or, to the Company's knowledge, any facilities where any such products are produced, processed, packaged or stored. The Company has not within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any product or provided post-sale warnings regarding any product. (e) All clinical studies of Products sponsored by the Company have been and are being conducted with reasonable care and in all material respects in accordance with all Applicable Laws and the stated protocols for such clinical trials. The Company has provided to Parent all pertinent patient data, excluding patient identifiers, from clinical and non-clinical studies of the Products sponsored by the Company. (f) All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made by the Company with regard to the Products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

FDA and Regulatory Matters. In connection with the Business: (a) The Company Seller has obtained and maintains all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the FDA and any other Applicable law which regulates United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of its products the Argon-Based Cryoablation Devices in jurisdictions where it currently conducts such activities or contemplates conducting such activities with respect to each product an Argon-Based Cryoablation Device except where failure to obtain the same would not have a Material Adverse Effect on Seller (collectively, the "Company “Seller Licenses"”). The Company Seller is in compliance in all material respects with the terms and conditions of each Company Seller License. The Company Seller is in compliance in all material respects with all Applicable Laws regarding registration, license, certification for each site at which a product an Argon-Based Cryoablation Device or Console is manufactured, labeled, sold, or distributed. To the extent any product has been exported from the United States, the Company has exported such product in compliance in all material respects with Applicable Laws. All manufacturing operations performed by or on behalf of the Company Seller have been and are being conducted in all material respects in compliance with the Quality Systems Quality, Standards and Training regulations of the FDA. All non-clinical laboratory studies of products sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's Good Laboratory Practice for Non-Clinical Studies regulations FDA (21 CFR Part 58Parts 808 and 820) as applicable and, to the extent applicable to Seller, counterpart regulations in the United StatesEuropean Union and all other countries where compliance is required. The Company Seller is in compliance in all material respects with all applicable reporting requirements for all Company Seller Licenses or plant registrations including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under Applicable Law. The Section 2.10(a) of the Disclosure Schedule Letter sets forth a list of all Company Seller Licenses. (b) The Company Seller is in compliance in all material respects with all FDA and non-United States equivalent agencies and other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to an Argon-Based Cryoablation Device or Console. Section 2.10(b) of the Company's products. The Disclosure Schedule Letter sets forth a list of all material applicable adverse event reports related to the Products, including any Medical Device Reports (as defined in 21 CFR 803). The Company has made available to Parent Section 2.10(b) of the Disclosure Letter sets forth a list of all complaint review and analysis reports of the CompanySeller pertaining to an Argon-Based Cryoablation Device or Console, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) The Company Seller has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company's products, Seller’s Argon-Based Cryoablation Devices or Consoles or (ii) otherwise alleging any violation of Applicable Law by the CompanySeller. (d) There Except as set forth on Section 2.10(d) of the Disclosure Letter, there have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or, to the Company's knowledgeSeller’s Knowledge, threatened by the FDA or any other Governmental Authority with respect to any of the Company's productsSeller’s Argon-Based Cryoablation Devices or Consoles, or, to the Company's knowledge, including any facilities where any such products are produced, processed, packaged or stored. The Company , and Seller has not within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any product Argon-Based Cryoablation Devices or Consoles or provided post-sale warnings regarding any productArgon-Based Cryoablation Devices or Consoles. (e) All Seller has not directly conducted any clinical studies of Products sponsored by trials in connection with the Company have been and are being Business. For greater certainty all clinical evaluations conducted with reasonable care and in all material respects in accordance with all Applicable Laws and respect to the stated protocols for such clinical trials. The Company has provided to Parent all pertinent patient data, excluding patient identifiers, from clinical and non-clinical studies of the Products sponsored Business were conducted by the Companythird parties. (f) All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made by the Company Seller with regard to the ProductsSeller’s Argon-Based Cryoablation Devices or Consoles, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

FDA and Regulatory Matters. (a) The Company has obtained and maintains all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the FDA and any other Applicable law which regulates United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of its products in jurisdictions where it currently conducts such activities with respect to each product (collectively, the "“Company Licenses"”). The Company is in compliance in all material respects with the terms and conditions of each Company License. The Company is in compliance in all material respects with all Applicable Laws regarding registration, license, certification for each site at which a product is manufactured, labeled, sold, or distributed. To the extent any product has been exported from the United States, the Company has exported such product in compliance in all material respects with Applicable Laws. All manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the Quality Systems regulations of the FDA. All non-clinical laboratory studies of products sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's Good Laboratory Practice ’s good laboratory practice for Nonnon-Clinical Studies clinical studies regulations (21 CFR Part 58) in the United StatesStates and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries. The Company is in compliance in all material respects with all applicable reporting requirements for all Company Licenses or plant registrations including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under Applicable Law. The Disclosure Schedule sets forth a list of all Company Licenses. (b) The Company is in compliance in all material respects with all FDA and non-United States equivalent agencies and other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company's products’s Products. The Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Products, including any Medical Device Reports (as defined in 21 CFR 803). The Company has made available to Parent Disclosure Schedule sets forth a list of all complaint review and analysis reports of the Company, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (c) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company's products, Products or (ii) otherwise alleging any violation of Applicable Law by the CompanyCompany in connection with development or marketing of the Product. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or, to the Company's knowledge’s Knowledge, threatened by the FDA or any other Governmental Authority with respect to any of the Company's productsProduct, or, to the Company's knowledge, including any facilities where any such products are the Product is produced, processed, packaged or stored. The , and the Company has not not, within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any product the Product or provided post-sale warnings regarding any productthe Product. (e) All The Company has conducted all of its clinical studies of Products sponsored by the Company have been and are being conducted trials with reasonable care and in all material respects in accordance with all Applicable Laws and the stated protocols for such clinical trials. The Company has provided to Parent all pertinent patient data, excluding patient identifiers, from clinical and non-clinical studies of the Products sponsored by the Company. (f) All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made by the Company with regard to the ProductsCompany’s products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

FDA and Regulatory Matters. In connection with the Urology Business: (a) The Company Seller has obtained and maintains all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the FDA and any other Applicable law which regulates Government Authorities to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution manufacture and promotion labeling of its products within the Field of Use in jurisdictions where it currently conducts such activities with respect to each product (collectively, the "Company “Seller Licenses"”). The Company Seller is in compliance in all material respects with the terms and conditions of each Company Seller License. The Company Seller is in compliance in all material respects with all Applicable Laws regarding registration, license, licensing and certification for each site at which a product within the Field of Use is manufactured, labeled, sold, sold or distributed. To the extent any product has been exported from the United States, the Company has exported such product in compliance in all material respects with Applicable Laws. All manufacturing operations performed by or on behalf of the Company Seller have been and are being conducted in all material respects in compliance with the Quality Systems applicable quality systems regulations governing the production of medical devices within the FDAField of Use in the European Union and all other countries where such compliance is required. All non-clinical laboratory studies of products sponsored by the Company Seller and intended to be used to support regulatory clearance or approval, approval have been and are being conducted in compliance in all material respects with the FDA's Good Laboratory Practice for Non-Clinical Studies applicable regulations (21 CFR Part 58) in the United StatesEuropean Union and all other countries where such compliance is required, governing the conduct of non clinical laboratory investigations. The Company Seller is in compliance in all material respects with all applicable reporting requirements for all Company Seller Licenses or plant registrations including, but not limited to, applicable adverse event reporting requirements requirements. Seller does not yet hold a Seller License in the United States under States, does not conduct any activities described in this Section 2.9 in the United States, and does not represent that its products satisfy Applicable LawLaws in the United States. The Disclosure Schedule sets forth a list of all Company Seller Licenses. (b) The Company Seller is in compliance in all material respects with all FDA the requirements of Governmental Authorities and other Applicable Laws relating to the maintenance, compilation and filing of reports, including medical device reports, with regard to Seller’s products within the Company's products. The Disclosure Schedule sets forth a list Field of all applicable adverse event reports related to the Products, including any Medical Device Reports (as defined in 21 CFR 803). The Company has made available to Parent all complaint review and analysis reports of the Company, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respectsUse. (c) The Company Seller has not received any written notice or other written communication from the FDA any Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company's products, Seller’s products or (ii) otherwise alleging any violation of Applicable Law by the CompanySeller. (d) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken or, to the Company's knowledgeSeller’s Knowledge, threatened by the FDA or any other Governmental Authority with respect to any of the Company's Seller’s products, or, to the Company's knowledge, including any facilities where any such products are produced, processed, packaged or stored. The Company , and Seller has not within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any product or provided post-sale warnings regarding any product. (e) All Seller has conducted all of its clinical studies of Products sponsored by the Company have been and are being conducted trials with reasonable care and in all material respects in accordance with all Applicable Laws and the stated protocols for such clinical trials. The Company has provided to Parent To the extent that there have been any deviations from the clinical protocols, such deviations have been handled in all pertinent patient data, excluding patient identifiers, from clinical and non-clinical studies of the Products sponsored by the Companymaterial respects in compliance with Applicable Laws. (f) All filings with and submissions to the FDA and any corollary entity in any other jurisdiction Governmental Authority made by the Company Seller with regard to the ProductsSeller’s products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.