Common use of Health Care Products Manufacturing Clause in Contracts

Health Care Products Manufacturing. The manufacture of the Company’s product candidates by the Company or, to the knowledge of the Company, on behalf of the Company, is being conducted in compliance with all applicable Health Care Laws pertaining to the manufacture and post market surveillance of Drugs, Devices, and Biologics, including, without limitation, the FDA’s current good manufacturing practice regulations pertaining to drugs (21 CFR Parts 210 and 211 et seq.), and, to the extent applicable, the respective counterparts governing manufacturing operations promulgated by other applicable regulatory agencies. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether owned by the Company or, to the knowledge of the Company, that of a third party manufacturer of the Company’s products) subject to an FDA or other applicable regulatory agency consent decree, seizure, import alert, or export prohibition, nor received any FDA or other applicable 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 products, processes or operations from the FDA or other applicable regulatory agency, other than those that have been satisfactorily addressed and/or closed with the FDA or other applicable regulatory agency. To the knowledge of the Company, none of the FDA or any other applicable regulatory agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s product candidates by the Company or, to the knowledge of the Company, on behalf of the Company, is being conducted in compliance with all applicable Health Care Laws pertaining to the manufacture and post market surveillance of Drugs, Devices, and Biologics, including, without limitation, the FDA’s current good manufacturing practice regulations pertaining to drugs (21 CFR Parts 210 and 211 et seq.), and, to the extent applicable, the respective counterparts governing manufacturing operations promulgated by other applicable regulatory agenciesHealth Regulatory Agencies. Except as disclosed in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, the Company has not had any manufacturing site (whether owned by the Company or, to the knowledge of the Company, that of a third party manufacturer of the Company’s products) subject to an FDA or other applicable regulatory agency Health Regulatory Agency consent decree, seizure, import alert, or export prohibition, nor received any FDA or other applicable regulatory agency 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 products, processes or operations from the FDA or other applicable regulatory agencyHealth Regulatory Agency, other than those that have been satisfactorily addressed and/or closed with the FDA or other applicable regulatory agencyHealth Regulatory Agency. To the knowledge of the Company, none of the FDA or any other applicable regulatory agency Health Regulatory Agency is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s product candidates by the Company or, to the knowledge of the Company, on behalf of the Company, is being conducted in compliance with all applicable Health Care Laws pertaining to the manufacture and post market surveillance of Drugs, Devices, and Biologics, including, without limitation, the FDA’s current good manufacturing practice regulations pertaining to drugs (21 CFR Parts 210 and 211 et seq.), and, to the extent applicable, the respective counterparts governing manufacturing operations promulgated by other applicable regulatory agenciesHealth Regulatory Agencies. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether owned by the Company or, to the knowledge of the Company, that of a third party manufacturer of the Company’s products) subject to an FDA or other applicable regulatory agency Health Regulatory Agency consent decree, seizure, import alert, or export prohibition, nor received any FDA or other applicable regulatory agency 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 products, processes or operations from the FDA or other applicable regulatory agencyHealth Regulatory Agency, other than those that have been satisfactorily addressed and/or closed with the FDA or other applicable regulatory agencyHealth Regulatory Agency. To the knowledge of the Company, none of the FDA or any other applicable regulatory agency Health Regulatory Agency is considering such action.