FDA Approval. After due investigation, (i) the Company has no knowledge that any Governmental Authority, including, but not limited to, the FDA, will ultimately prohibit the marketing, sale, license or use in the United States or elsewhere of any product (including, but not limited to, EFAPROXYN) proposed to be developed, produced or marketed by the Company (each, a "Product"), (ii) to the Company's knowledge, the FDA has not prohibited any product or process from being marketed or used in the United States which product or process is substantially similar in function or composition to the Company's lead product candidate, EFAPROXYN, (iii) the Company has no Product on clinical hold nor does the Company have any reason to expect that any Product is reasonably likely to be placed on clinical hold, (iv) the Company has made available to WP all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company or any agent thereof relative to the development of its Products, including, but not limited to, EFAPROXYN, (v) none of the Company or its Affiliates or, to the Company's knowledge, its employees or agents, has ever been sanctioned, formally or otherwise, by the FDA, and (vi) there has not been any suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the Company or, to the knowledge of the Company, any current or former employee of the Company.
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Samples: Securities Purchase Agreement (Allos Therapeutics Inc), Securities Purchase Agreement (Warburg Pincus Private Equity Viii L P)
FDA Approval. After due investigation, (i) the Company Neurologix has no knowledge that any Governmental AuthorityEntity, including, but not limited to, the United States Food and Drug Administration (the "FDA"), will ultimately prohibit the marketing, sale, license or use in the United States or elsewhere any other jurisdiction in which Neurologix expects to exploit its Intellectual Property of any product (including, but not limited to, EFAPROXYN) proposed to be developed, produced or marketed by the Company Neurologix, or with third parties (each, a "ProductPRODUCT"), (ii) to the Company's knowledge, the FDA has not prohibited any product or process from being marketed or used in the United States which product or process is substantially similar in function or composition to the Company's lead product candidate, EFAPROXYN, (iii) the Company has no Product is on clinical hold nor and Neurologix does the Company not have any reason to expect that any Product is reasonably likely to be placed on clinical hold, (iviii) the Company Neurologix has made available to WP CTP all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company Neurologix or any agent thereof relative to the development of its Products, including(iv) to the knowledge of Neurologix, but the FDA has not limited to, EFAPROXYNprohibited any product or production process from being marketed or used in the United States which product or process is substantially similar to any Product in composition, (v) none of the Company or its Affiliates orneither Neurologix nor, to the Company's knowledgeknowledge of Neurologix, its employees or agentsthe employees, consultants, contractors, and sub-contractors of Neurologix, has ever been sanctioned, formally or otherwise, by the FDA, and (vi) there has not been any suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the Company Neurologix, or, to the knowledge of the CompanyNeurologix, any current or former employee, consultant, contractor or subcontractor of Neurologix. Neither Neurologix, nor to its knowledge any officer, employee or agent of Neurologix, has knowingly made an untrue statement of a material fact or fraudulent statement to the CompanyFDA or other Governmental Entity.
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FDA Approval. After due investigation, (i) the Company has no knowledge that any Governmental Authority, including, but not limited to, the United States Food and Drug Administration (the "FDA"), will ultimately prohibit the marketing, sale, license or use in the United States or elsewhere of any product (including, but not limited to, EFAPROXYNRSR13) proposed to be developed, produced or marketed by the Company or with third parties (each, a "Product"), (ii) to the Company's knowledge, the FDA has not prohibited any product or process from being marketed or used in the United States which product or process is substantially similar to any Product in function or composition to the Company's lead product candidate, EFAPROXYNcomposition, (iii) the Company has no Product on clinical hold nor does the Company have any reason to expect that any Product is reasonably likely to be placed on clinical hold, (iv) the Company has made available to WP the Purchaser all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company or any agent thereof relative to the development of its Products, including, but not limited to, EFAPROXYNRSR13, (v) none of the Company or its Affiliates or, to the Company's knowledge, its employees or agents, has ever been sanctioned, formally or otherwise, by the FDA, and (vi) there has not been any suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the Company or, to the knowledge of the Company, any current or former employee of the Company.
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FDA Approval. After due investigation, (i) the Company has no knowledge that any Governmental Authority, including, but not limited to, the FDA, will ultimately prohibit the marketing, sale, license or use in the United States or elsewhere of any product (including, but not limited to, EFAPROXYN) proposed to be developed, produced or marketed by the Company (each, a "“Product"”), (ii) to the Company's ’s knowledge, the FDA has not prohibited any product or process from being marketed or used in the United States which product or process is substantially similar in function or composition to the Company's ’s lead product candidate, EFAPROXYN, (iii) the Company has no Product on clinical hold nor does the Company have any reason to expect that any Product is reasonably likely to be placed on clinical hold, (iv) the Company has made available to WP all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company or any agent thereof relative to the development of its Products, including, but not limited to, EFAPROXYN, (v) none of the Company or its Affiliates or, to the Company's ’s knowledge, its employees or agents, has ever been sanctioned, formally or otherwise, by the FDA, and (vi) there has not been any suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the Company or, to the knowledge of the Company, any current or former employee of the Company.
Appears in 1 contract
Samples: Securities Purchase Agreement (Allos Therapeutics Inc)