Common use of PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT Clause in Contracts

PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT. (a) Section 7.27 of the Disclosure Schedule contains a complete and correct copy of (i) each pending application or registration for governmental approval and each governmental approval held by the Company to develop, manufacture, test (including, without limitation, preclinical tests and clinical trials), import, export, store, market and sell the Company's products or drug candidates, (ii) the most recent report by or on behalf of the FDA or any other governmental body involving or relating to any facility inspection of the Company's facilities, and (iii) a description of all ongoing proprietary internal research and development programs included in the CytoMed Programs. Except as are set forth in Section 7.27 of the Disclosure Schedule, (i) the Company possesses such governmental approvals from all governmental bodies including, without limitation, all FDA approvals, necessary to permit the operation of its business in the manner as the same is currently conducted, and to operate, own or occupy its properties, (ii) there have been no product recalls, field corrective activity, medical device reports, warning letters or administrative actions by the FDA or any other governmental body, and (iii) to the knowledge of the Company, (aa) there is no administrative action pending or threatened for the revocation of any such governmental approval and (bb) assuming the obtaining of the authorizations, consents, approvals and other actions listed in Section 7.27 of the Disclosure Schedule, no governmental approvals and other actions listed in Section 7.27 of the Disclosure Schedule of the Disclosure Schedule, no governmental approval by any governmental body having jurisdiction over the operation of the Company's business, whether in whole or in part, will be revoked, or become ineffective or subject to revocation, as a consequence of the transactions contemplated by this Agreement. (b) The Company (i) has not been debarred or received notice of action or threat of action with respect to its debarment under the provisions of the Generic Drug Enforcement Act of 1992, 31 U.S.C. Section 335(a) and (b), or (ii) to the best of the Company's knowledge, has used in any capacity the services of any individual, corporation, partnership or association which has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b).

PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT. (a) Section 7.27 Schedule 4.27 of the Company Disclosure Schedule contains a complete and correct copy of (i) each pending application or registration for governmental approval and each governmental approval held by the Company to develop, manufacture, test (including, without limitation, preclinical tests and clinical trials), import, export, store, market and sell the Company's products Products or drug candidates, (ii) the most recent report by or on behalf of the FDA or any other governmental body involving or relating to any facility inspection of the Company's facilities, and (iii) a description of all ongoing proprietary internal research and development programs included in the CytoMed Programsprograms. Except as are set forth in Section 7.27 on Schedule 4.27 of the Company Disclosure Schedule, (i) the Company possesses such governmental approvals from all governmental bodies including, without limitation, all FDA approvals, necessary to permit the operation of its business in the manner as the same is currently conducted, and to operate, own or occupy its properties, (ii) there have been no product recalls, field corrective activity, medical device reports, warning letters or administrative actions by the FDA or any other governmental body, and (iii) to the knowledge of the Company's knowledge, (aaA) there is no administrative action pending or threatened for the revocation of any such governmental approval and (bbB) assuming the obtaining of the authorizations, consents, approvals and other actions listed in Section 7.27 on Schedule 4.27 of the Company Disclosure Schedule, no governmental approvals and other actions listed in Section 7.27 on Schedule 4.27 of the Disclosure Schedule of the Company Disclosure Schedule, no governmental approval by any governmental body having jurisdiction over the operation of the Company's business, whether in whole or in part, will will, to the knowledge of the Company, be revoked, or become ineffective or subject to revocation, as a consequence of the transactions contemplated by this Agreement. (b) The Company (i) has not been debarred or received notice of action or threat of action with respect to its debarment under the provisions of the Generic Drug Enforcement Act of 1992, 31 U.S.C. Section 335(a) and (b), or (ii) to the best of the Company's knowledge, has used in any capacity the services of any individual, corporation, partnership or association person which has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b).

PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT. (a) Section 7.27 Schedule 4.28 of the Company Disclosure Schedule contains a complete and correct copy of (i) each pending application or registration for governmental approval and each governmental approval held by the Company to develop, manufacture, test (including, without limitation, preclinical tests and clinical trials), import, export, store, market and sell the Company's ’s products or drug candidates, (ii) the most recent report by or on behalf of the FDA or any other governmental body involving or relating to any facility inspection of the Company's ’s facilities, and (iii) a description of all ongoing proprietary internal research and development programs included in the CytoMed Programsprograms. Except as are set forth in Section 7.27 on Schedule 4.28 of the Company Disclosure Schedule, (i) the Company possesses such governmental approvals from all governmental bodies including, without limitation, all FDA approvals, necessary to permit the operation of its business in the manner as the same is currently conducted, and to operate, own or occupy its properties, (ii) except as contained in Schedule 4.28 there have been no product recalls, field corrective activity, medical device reports, warning letters or administrative actions by the FDA or any other governmental body, and (iii) to the knowledge of the Company’s knowledge, (aaA) there is no administrative action pending or threatened for the revocation of any such governmental approval and (bbB) assuming the obtaining of the authorizations, consents, approvals and other actions listed in Section 7.27 on Schedule 4.28 of the Company Disclosure Schedule, no governmental approvals and other actions listed in Section 7.27 on Schedule 4.28 of the Disclosure Schedule of the Company Disclosure Schedule, no governmental approval by any governmental body having jurisdiction over the operation of the Company's ’s business, whether in whole or in part, will be revoked, or become ineffective or subject to revocation, as a consequence of the transactions contemplated by this Agreement. (b) The Company (i) has not been debarred or received notice of action or threat of action with respect to its debarment under the provisions of the Generic Drug Enforcement Act of 1992, 31 U.S.C. Section 335(a) and (b), or (ii) to the best of the Company's ’s knowledge, has used in any capacity the services of any individual, corporation, partnership or association person which has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b).

PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT. (aA) Section 7.27 Schedule 6.27 of the Company Disclosure Schedule contains a complete and correct copy of (i) each pending application or registration for governmental approval and each governmental approval held by the Company to develop, manufacture, test (including, without limitation, preclinical tests and clinical trials), import, export, store, market and sell the Company's products or drug candidates, (ii) the most recent report by or on behalf of the FDA or any other governmental body involving or relating to any facility inspection of the Company's facilities, and (iii) a description of all ongoing proprietary internal research and development programs included in the CytoMed Programsprograms. Except as are set forth in Section 7.27 on Schedule 6.27 of the Company Disclosure Schedule, (i) the Company possesses such governmental approvals from all governmental bodies including, without limitation, all FDA approvals, necessary to permit the operation of its business in the manner as the same is currently conducted, and to operate, own or occupy its properties, (ii) there have been no product recalls, field corrective activity, medical device reports, warning letters or administrative actions by the FDA or any other governmental body, and (iii) to the knowledge of the Company's knowledge, (aa) there is no administrative action pending or threatened for the revocation of any such governmental approval and (bb) assuming the obtaining of the authorizations, consents, approvals and other actions listed in Section 7.27 on Schedule 6.27 of the Company Disclosure Schedule, no governmental approvals and other actions listed in Section 7.27 on Schedule 6.27 of the Disclosure Schedule of the Company Disclosure Schedule, no governmental approval by any governmental body having jurisdiction over the operation of the Company's business, whether in whole or in part, will be revoked, or become ineffective or subject to revocation, as a consequence of the transactions contemplated by this Agreement. (bB) The Company (i) has not been debarred or received notice of action or threat of action with respect to its debarment under the provisions of the Generic Drug Enforcement Act of 1992, 31 U.S.C. Section 335(a) and (b), or (ii) to the best of the Company's knowledge, has used in any capacity the services of any individual, corporation, partnership or association person which has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b).

PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT. (aA) Section 7.27 Schedule 7.26 of the ABI Disclosure Schedule contains a complete and correct copy of (i) each pending application or registration for governmental approval and each governmental approval held by the Company ABI or any of its Subsidiaries to develop, manufacture, test (including, without limitation, preclinical tests and clinical trials), import, export, store, market and sell the Company's its products or drug candidates, (ii) the most recent report by or on behalf of the FDA or any other governmental body involving or relating to any facility inspection of the CompanyABI's or any of its Subsidiaries' facilities, and (iii) a description of all ongoing proprietary internal research and development programs included in the CytoMed Programsprograms. Except as are set forth in Section 7.27 on Schedule 7.26 of the ABI Disclosure Schedule, (i) the Company each of ABI and its Subsidiaries possesses such governmental approvals from all governmental bodies including, without limitation, all FDA approvals, necessary to permit the operation of its respective business in the manner as the same is currently conducted, and to operate, own or occupy its properties, (ii) there have been no product recalls, field corrective activity, medical device reports, warning letters or administrative actions by the FDA or any other governmental body, and (iii) to the knowledge of the CompanyABI's knowledge, (aa) there is no administrative action pending or threatened for the revocation of any such governmental approval and (bb) assuming the obtaining of the authorizations, consents, approvals and other actions listed in Section 7.27 on Schedule 7.26 of the ABI Disclosure Schedule, no governmental approvals and other actions listed in Section 7.27 on Schedule 7.26 of the Disclosure Schedule of the ABI Disclosure Schedule, no governmental approval by any governmental body having jurisdiction over the operation of the CompanyABI's or any of its Subsidiaries' business, whether in whole or in part, will be revoked, or become ineffective or subject to revocation, as a consequence of the transactions contemplated by this Agreement. (bB) The Company Neither ABI nor or any of its Subsidiaries (i) has not been debarred or received notice of action or threat of action with respect to its debarment under the provisions of the Generic Drug Enforcement Act of 1992, 31 U.S.C. Section 335(a) and (b), or (ii) to the best of the CompanyABI's knowledge, has used in any capacity the services of any individual, corporation, partnership or association person which has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b).

PERMITS, LICENSES, AND PROGRAMS; NO DEBARMENT. (a) Section 7.27 of the Disclosure Schedule contains a complete and correct copy of (i) each pending application or registration for governmental approval and each governmental approval held by the Company to develop, manufacture, test (including, without limitation, preclinical tests and clinical trials), import, export, store, market and sell the Company's products or drug candidates, (ii) the most recent report by or on behalf of the FDA or any other governmental body involving or relating to any facility inspection of the Company's facilities, and (iii) a description of all ongoing proprietary internal research and development programs included in the CytoMed ProScript Programs. Except as are set forth in Section 7.27 of the Disclosure Schedule, (i) the Company possesses such governmental approvals from all governmental bodies including, without limitation, all FDA approvals, necessary to permit the operation of its business in the manner as the same is currently conducted, and to operate, own or occupy its properties, (ii) there have been no product recalls, field corrective activity, medical device reports, warning letters or administrative actions by the FDA or any other governmental body, and (iii) to the knowledge of the Company, (aa) there is no administrative action pending or threatened for the revocation of any such governmental approval and (bb) assuming the obtaining of the authorizations, consents, approvals and other actions listed in Section 7.27 of the Disclosure Schedule, no governmental approvals and other actions listed in Section 7.27 of the Disclosure Schedule of the Disclosure Schedule, no governmental approval by any governmental body having jurisdiction over the operation of the Company's business, whether in whole or in part, will be revoked, or become ineffective or subject to revocation, as a consequence of the transactions contemplated by this Agreement. (b) The Company (i) has not been debarred or received notice of action or threat of action with respect to its debarment under the provisions of the Generic Drug Enforcement Act of 1992, 31 U.S.C. Section 335(a) and (b), or (ii) to the best of the Company's knowledge, has used in any capacity the services of any individual, corporation, partnership or association which has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335(a) and (b).