Common use of Compliance with Regulatory Authorities Clause in Contracts

Compliance with Regulatory Authorities. (i) Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the pre-clinical trials and other tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated, that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable, were, and if still pending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and its subsidiaries and all applicable statutes and all applicable rules, regulations and guidance documents of the U.S. Food and Drug Administration (“FDA”) and comparable regulatory agencies outside of the United States to which they are subject, including the European Commission and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Prospectus of the results of such studies and tests are materially accurate and complete descriptions and fairly present the material data derived therefrom; (iii) the Company has no knowledge of any other trials or tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated that are not described in the Prospectus, the results of which are materially inconsistent with or raise questions concerning the validity of the results described or referred to in the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) except as described in the Prospectus, the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials or other clinical or pre-clinical tests that are described in the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials and tests, and there are no reasonable grounds for the same. The Company and its subsidiaries have not failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company’s product candidates or pre-clinical trials or other tests that are described or referred to in the Prospectus; all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed; and no deficiencies regarding compliance with applicable law have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions.

Compliance with Regulatory Authorities. (i) Except as described in the Registration StatementThe clinical, the General Disclosure Package and the Prospectus, the pre-clinical trials and other studies and tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated, Subsidiary that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable, were, Disclosure Package and if still pending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and its subsidiaries and all applicable statutes and all applicable rules, regulations and guidance documents of the U.S. Food and Drug Administration (“FDA”) and comparable regulatory agencies outside of the United States to which they are subject, including the European Commission and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Prospectus of the results of such studies and tests are materially accurate and complete descriptions and fairly present the material data derived therefrom; (iii) the Company has no knowledge of any other trials or tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated that are not described in the Prospectus, the results of which are materially inconsistent with or raise questions concerning the validity of the results described or referred to in the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) except as described in the Prospectus, the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials or other clinical or pre-clinical tests that are described in the Prospectus or the results of which are referred to in the ProspectusDisclosure Package and the Prospectus were and, other than ordinary course communications if still pending, are being conducted in accordance, in all material respects, with respect to modifications standard medical and scientific research procedures; the descriptions in connection with the design Disclosure Package and implementation the Prospectus of the results of such trials studies and tests are accurate and complete in all material respects and fairly present the data derived from such studies and tests; the Company and the Subsidiary have no knowledge of any other studies or tests conducted by third parties the results of which contest or contradict, and there are have no reasonable grounds for knowledge of any other studies or tests conducted by third parties that unsuccessfully attempted to replicate, the same. The Company and its subsidiaries have not failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company’s product candidates or pre-clinical trials or other tests that are results described or referred to in the Prospectus; all such filingsexcept to the extent disclosed in the Disclosure Package and the Prospectus, declarations, listings, registrations, reports or submissions were the Company and the Subsidiary have operated and currently are in compliance in all material respects with all applicable laws when filedrules, regulations and policies of the U.S. Food and Drug Administration (the "FDA") and comparable drug regulatory agencies outside of the United States (collectively, the "Regulatory Authorities"); and no deficiencies regarding compliance with applicable law have been asserted except for the partial clinical hold placed on the Company's D9902B trial in May 2002, which hold was lifted in October 2002, or otherwise to the extent disclosed in the Disclosure Package and the Prospectus, the Company has not received any notices or other correspondence from the Regulatory Authorities or any other governmental agency requiring the termination or suspension of any clinical or pre-clinical study or test sponsored by any applicable regulatory authority with respect the Company or the Subsidiary and that is described in the Disclosure Package and the Prospectus or the results of which are referred to any such filings, declarations, listings, registrations, reports or submissionsin the Disclosure Package and the Prospectus.

Compliance with Regulatory Authorities. (i) Except as described in the Registration StatementThe clinical, the General Disclosure Package and the Prospectus, the pre-clinical trials and other studies and tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated, Subsidiary that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable, were, Disclosure Package and if still pending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and its subsidiaries and all applicable statutes and all applicable rules, regulations and guidance documents of the U.S. Food and Drug Administration (“FDA”) and comparable regulatory agencies outside of the United States to which they are subject, including the European Commission and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Prospectus of the results of such studies and tests are materially accurate and complete descriptions and fairly present the material data derived therefrom; (iii) the Company has no knowledge of any other trials or tests conducted by or (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated that are not described in the Prospectus, the results of which are materially inconsistent with or raise questions concerning the validity of the results described or referred to in the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) except as described in the Prospectus, the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials or other clinical or pre-clinical tests that are described in the Prospectus or the results of which are referred to in the ProspectusDisclosure Package and the Prospectus were and, other than ordinary course communications if still pending, are being conducted in accordance, in all material respects, with respect to modifications standard medical and scientific research procedures; the descriptions in connection with the design Disclosure Package and implementation the Prospectus of the results of such trials studies and tests are accurate and complete in all material respects and fairly present the data derived from such studies and tests; the Company and the Subsidiary have no knowledge of any other studies or tests conducted by third parties the results of which contest or contradict, and there are have no reasonable grounds for knowledge of any other studies or tests conducted by third parties that unsuccessfully attempted to replicate, the same. The Company and its subsidiaries have not failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company’s product candidates or pre-clinical trials or other tests that are results described or referred to in the Prospectus; all such filingsexcept to the extent disclosed in the Disclosure Package and the Prospectus, declarations, listings, registrations, reports or submissions were the Company and the Subsidiary have operated and currently are in compliance in all material respects with all applicable laws when filedrules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States (collectively, the “Regulatory Authorities”); and no deficiencies regarding compliance with applicable law have been asserted except to the extent disclosed in the Disclosure Package and the Prospectus, since the Company’s fiscal year ending December 31, 2002, the Company has not received any notices or other correspondence from the Regulatory Authorities or any other governmental agency requiring the termination or suspension of any clinical or pre-clinical study or test sponsored by any applicable regulatory authority with respect the Company or the Subsidiary and that is described in the Disclosure Package and the Prospectus or the results of which are referred to any such filings, declarations, listings, registrations, reports or submissionsin the Disclosure Package and the Prospectus.