Common use of Health Care Products Manufacturing Clause in Contracts

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any subsidiary has had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA EMA, MOPH and TGA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s its subsidiaries’ products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary of its subsidiaries is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, neither the Company nor any subsidiary has of its subsidiaries have had any manufacturing site (whether owned by the Company or a subsidiary any of its subsidiaries or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s its subsidiaries’ products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s its subsidiaries’ products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s Senseonics’ products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary Senseonics is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Prospectus, neither the Company nor any subsidiary has Senseonics have had any manufacturing site (whether owned by the Company or a subsidiary Senseonics or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s Senseonics’ products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s Senseonics’ products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s 's products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s 's regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA EMA, TGA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s 's products) subject to an FDA, European Commission, EMA EMA, TGA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” ”" alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s 's products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA EMA, the TGA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA EMA, the TGA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s products candidates by or any subsidiary’s products by oron behalf of the Company, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA EMA, TGA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Prospectus, the Preliminary Prospectus and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s products) subject to an FDA, European Commission, EMA EMA, TGA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any written FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s products, processes or operations, or similar written correspondence or notice from the FDA, the European Commission, the EMA EMA, the TGA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA EMA, the TGA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Information and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s 's products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s 's regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA EMA, TGA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s 's products) subject to an FDA, European Commission, EMA EMA, TGA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “"warning letters,” " or “"untitled letters” " alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s 's products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA EMA, the TGA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA EMA, the TGA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any its subsidiary’s products by or, to the knowledge of the Company, on behalf of the Company or any its subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, neither Neither the Company nor any its subsidiary has have had any manufacturing site (whether owned by the Company or a its subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a its subsidiary’s products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a its subsidiary’s products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s 's products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s 's regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA EMA, TGA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s 's products) subject to an FDA, European Commission, EMA EMA, TGA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “"warning letters,” " or “"untitled letters” " alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s 's products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA EMA, the TGA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA EMA, the TGA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s Senseonics’ products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary Senseonics is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any subsidiary Senseonics has had any manufacturing site (whether owned by the Company or a subsidiary Senseonics or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s Senseonics’ products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s Senseonics’ products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s Senseonics’ products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary Senseonics is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, neither the Company nor any subsidiary has Senseonics have had any manufacturing site (whether owned by the Company or a subsidiary Senseonics or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s Senseonics’ products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s Senseonics’ products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics at 21 CFR Part 600, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA EMA, or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Prospectus, neither the Company nor any subsidiary has not had any manufacturing site (whether owned by the Company or a subsidiary or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s products) subject to an FDA, European Commission, EMA EMA, or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA EMA, or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA EMA, the TGA or any other Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s or any subsidiary’s its subsidiaries’ products by or, to the knowledge of the Company, on behalf of the Company or any subsidiary of its subsidiaries is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s regulation pertaining to Biologics current good manufacturing practice regulations at 21 CFR Part 600820, and, to the extent applicable, the respective counterparts thereof promulgated by the European Commission, the EMA or other Health Regulatory Agencies. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the Prospectus, neither the Company nor any subsidiary has of its subsidiaries have had any manufacturing site (whether owned by the Company or a subsidiary any of its subsidiaries or, to the knowledge of the Company, that of a third party manufacturer for the Company’s or a subsidiary’s its subsidiaries’ products) subject to an FDA, European Commission, EMA or other Health Regulatory Agency shutdown or import or export prohibition, nor received any FDA, European Commission, EMA or other Health Regulatory Agency “warning letters,” or “untitled letters” alleging or asserting material noncompliance with any applicable Health Care Laws, requests to make material changes to the Company’s or a subsidiary’s its subsidiaries’ products, processes or operations, or similar correspondence or notice from the FDA, the European Commission, the EMA or other Health Regulatory Agency alleging or asserting material noncompliance with any applicable Health Care Laws, other than those that have been satisfactorily addressed and/or closed with the FDA, the European Commission, the EMA or other Health Regulatory Agency. To the knowledge of the Company, none of the FDA, the European Commission, the EMA or any other Health Regulatory Agency is considering such action.