Common use of FDA Approval Clause in Contracts

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.

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.

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.