Product Registration Files. The product registration files and dossiers of the Company and its Subsidiaries have been maintained in accordance with reasonable industry standards. The Company and each of its Subsidiaries has in its possession copies of all the material documentation filed in connection with filings made by the Company or any of its Subsidiaries for regulatory approval or registration of the compounds and products of the Company or any of its Subsidiaries, as the case may be. To the knowledge of the Company, the filings made by the Company and its Subsidiaries for regulatory approval or registration of the products of the Company or any of its Subsidiaries did not contain any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein not misleading.
Product Registration Files. The product registration files and dossiers of the Company and each of its Subsidiaries have been maintained, in all material respects, in accordance with applicable Law. To the knowledge of the Company, the filings made by the Company and its Subsidiaries for regulatory approval or registration of the candidates, compounds or products of the Company or any of its Subsidiaries were, at the time of such filings, true and correct in all material respects.
Product Registration Files. The product and product candidate registration files, dossiers and supporting materials of the Acquired Corporations, and to the knowledge of the Company, each of its Collaboration Partners (with respect to the Company Products), have been maintained in all material respects in accordance with reasonable industry standards. Each of the Acquired Corporations and, to the knowledge of the Company, each of its Collaboration Partners (with respect to the Company Products), has in its possession copies of all the material documentation filed in connection with filings made by the Acquired Corporations or such Collaboration Partners in all jurisdictions for regulatory approval or registration of the Company Products, as the case may be.
Product Registration Files. To the Company’s Knowledge, all of the Company’s Pharmaceutical Product registration files and dossiers have been maintained in accordance with applicable Law. The Company own all right, title and interest to these files, and no other Person has any right or claim of right to these files anywhere in the world. The Company has in its possession (and the same are included in the Company’s assets) copies of all the material documentation filed in connection with filings made by the Company for regulatory approval or registration of any of its Company Pharmaceutical Products.
Product Registration Files. The Pharmaceutical Product registration files and dossiers of the Company have been maintained in accordance with reasonable industry standards. The Company owns all right, title and interest to these files and no other person has any right or claim of right to these files anywhere in the world. The Company has in its possession copies of all the material documentation filed in connection with filings made by the Company for regulatory approval or registration of the compounds and products of the Company. The filings made by the Company for regulatory approval or registration of the Pharmaceutical Products or compounds of the Company did not contain, at the time filed and have not at any time since such filing contained, any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein not misleading (subject, after the filing was first made to any subsequently filed amendments or supplements).
Product Registration Files. The NDA and IND have been maintained in accordance with all Laws and guidance documents in all material respects.
Product Registration Files. The product registration and approval files and the investigational new drug submissions and files of the Company and each of the Subsidiaries have at all times been maintained in all material respects in accordance with all applicable legal and regulatory requirements. The Company and each of the Subsidiaries have made available to the Buyer or its agents copies of all material documentation filed in the last three years in connection with the regulatory approval or registration of the Product, and investigational new drug applications and submissions for any pharmaceutical product candidate in development.
Product Registration Files. To Seller’s Knowledge, all of Seller’s Pharmaceutical Product registration files and dossiers have been maintained in accordance with good industry standards and all applicable Legal Requirements. Seller owns all right, title and interest to these files, and no other Person has any right or claim of right to these files anywhere in the world. Seller has in its possession (and the same are included in the Purchased Assets) copies of all the material documentation filed in connection with filings made by Seller for regulatory approval or registration of any of its Pharmaceutical Products. No filing made by Seller for regulatory approval or registration of any Pharmaceutical Product contained any untrue statement of a material fact or omitted to state any material fact necessary to make the statements therein not misleading.
Product Registration Files. The product registration files and dossiers of Seller in respect of the Product have been maintained in accordance with all Applicable Laws and guidance documents in all material respects. Seller has in its possession copies of any material documentation, if any, filed in connection with filings made by Seller for regulatory approval or registration of the Product. The filings made by Seller for regulatory approval or registration of the Product, if any, did not, at the time of filing, contain any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein not misleading.
Product Registration Files. The product registration files and dossiers of the Company and each Company Subsidiary have at all times during the last three years been maintained in all material respects in accordance with all applicable legal and regulatory requirements. The Company and each Company Subsidiary has in its possession copies of all the material documentation filed in the last three years in connection with filings made by the Company or any Company Subsidiary for regulatory approval or registration of the candidates or Pharmaceutical Products of the Company or any Company Subsidiary, as the case may be. To the knowledge of the Company, the filings made by the Company and the Company Subsidiaries for regulatory approval or registration of the candidates or Pharmaceutical Products of the Company or any Company Subsidiary did not contain any untrue statement of a material fact or omit to state any material fact necessary to make the statements therein not misleading.
