Common use of FDA Matters Clause in Contracts

FDA Matters. After due investigation, (i) the PARENT currently ------------ has no reasonable basis to believe 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 developed, produced or marketed by the PARENT or with third parties (each, a "Product"), (ii) the PARENT knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the PARENT has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the PARENT has disclosed to the TARGET all submissions to the FDA made by the PARENT and the FDA responses (and other material correspondence received from or submitted to the FDA by the PARENT), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the PARENT or any agent thereof relative to the development of its Products, (v) none of the PARENT or, to the PARENT's Knowledge, its employees, its Affiliates or its 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 PARENT or, to the PARENT's Knowledge, any current or former employees of the PARENT.

FDA Matters. After due investigation, (i) the PARENT TARGET currently ------------ has no reasonable basis to believe 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 developed, produced or marketed by the PARENT TARGET or with third parties (each, a "Product"), (ii) the PARENT TARGET knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the PARENT TARGET has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the PARENT TARGET has disclosed to the TARGET PARENT all submissions to the FDA made by the PARENT TARGET and the FDA responses (and other material correspondence received from or submitted to the FDA by the PARENTTARGET), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the PARENT TARGET or any agent thereof relative to the development of its Products, (v) none of the PARENT TARGET or, to the PARENTTARGET's Knowledge, its employees, its Affiliates or its 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 PARENT TARGET or, to the PARENTTARGET's Knowledge, any current or former employees of the PARENTTARGET.

FDA Matters. After due investigation, (i) the PARENT Company currently ------------ has no reasonable basis to believe 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 developed, produced or marketed by the PARENT Company or with third parties (including, without limitation, Ilex) (each, a "Product"), (ii) the PARENT Company knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the PARENT Company has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the PARENT Company has disclosed to the TARGET Purchaser all submissions to the FDA made by the PARENT Company and the FDA responses (and other material correspondence received from or submitted to the FDA by the PARENTCompany), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the PARENT Company or any agent thereof relative to the development of its Products, (v) none of the PARENT Company or, to the PARENTCompany's Knowledgeknowledge, its employees, its Affiliates or its 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 PARENT Company or, to the PARENTCompany's Knowledgeknowledge, any current or former employees of the PARENTCompany.

FDA Matters. After due investigation, (i) the PARENT Company currently ------------ has no reasonable basis to believe 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 developed, produced or marketed by the PARENT Company or with third parties (including, without limitation, Ilex) (each, a "ProductPRODUCT"), (ii) the PARENT Company knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the PARENT Company has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the PARENT Company has disclosed to the TARGET Purchaser all submissions to the FDA made by the PARENT Company and the FDA responses (and other material correspondence received from or submitted to the FDA by the PARENTCompany), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the PARENT Company or any agent thereof relative to the development of its Products, (v) none of the PARENT Company or, to the PARENTCompany's Knowledgeknowledge, its employees, its Affiliates or its 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 PARENT Company or, to the PARENTCompany's Knowledgeknowledge, any current or former employees of the PARENTCompany.

FDA Matters. After due investigation, (i) the PARENT currently ------------ has no reasonable basis to believe 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 developed, produced or marketed by the PARENT or with third parties (each, a "ProductPRODUCT"), (ii) the PARENT knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the PARENT has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the PARENT has disclosed to the TARGET all submissions to the FDA made by the PARENT and the FDA responses (and other material correspondence received from or submitted to the FDA by the PARENT), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the PARENT or any agent thereof relative to the development of its Products, (v) none of the PARENT or, to the PARENT's Knowledge, its employees, its Affiliates or its 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 PARENT or, to the PARENT's Knowledge, any current or former employees of the PARENT.

FDA Matters. After due investigation, (i) the PARENT TARGET currently ------------ has no reasonable basis to believe 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 developed, produced or marketed by the PARENT TARGET or with third parties (each, a "ProductPRODUCT"), (ii) the PARENT TARGET knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the PARENT TARGET has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the PARENT TARGET has disclosed to the TARGET PARENT all submissions to the FDA made by the PARENT TARGET and the FDA responses (and other material correspondence received from or submitted to the FDA by the PARENTTARGET), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the PARENT TARGET or any agent thereof relative to the development of its Products, (v) none of the PARENT TARGET or, to the PARENTTARGET's Knowledge, its employees, its Affiliates or its 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 PARENT TARGET or, to the PARENTTARGET's Knowledge, any current or former employees of the PARENTTARGET.