Common use of FDA Matters Clause in Contracts

FDA Matters. After due investigation, (i) the 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 TARGET or with third parties (each, a "Product"), (ii) the 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 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 TARGET has disclosed to the PARENT all submissions to the FDA made by the TARGET and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGET), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET or any agent thereof relative to the development of its Products, (v) none of the TARGET or, to the TARGET'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 TARGET or, to the TARGET's Knowledge, any current or former employees of the TARGET.

FDA Matters. After due investigation, (i) the TARGET 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 TARGET PARENT or with third parties (each, a "Product"), (ii) the TARGET 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 TARGET 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 TARGET PARENT has disclosed to the PARENT TARGET all submissions to the FDA made by the TARGET PARENT and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGETPARENT), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET PARENT or any agent thereof relative to the development of its Products, (v) none of the TARGET PARENT or, to the TARGETPARENT'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 TARGET PARENT or, to the TARGETPARENT's Knowledge, any current or former employees of the TARGETPARENT.

FDA Matters. After due investigation, (i) the 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 TARGET or with third parties (each, a "ProductPRODUCT"), (ii) the 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 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 TARGET has disclosed to the PARENT all submissions to the FDA made by the TARGET and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGET), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET or any agent thereof relative to the development of its Products, (v) none of the TARGET or, to the TARGET'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 TARGET or, to the TARGET's Knowledge, any current or former employees of the TARGET.

FDA Matters. After due investigation, (i) the TARGET 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 TARGET PARENT or with third parties (each, a "ProductPRODUCT"), (ii) the TARGET 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 TARGET 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 TARGET PARENT has disclosed to the PARENT TARGET all submissions to the FDA made by the TARGET PARENT and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGETPARENT), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET PARENT or any agent thereof relative to the development of its Products, (v) none of the TARGET PARENT or, to the TARGETPARENT'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 TARGET PARENT or, to the TARGETPARENT's Knowledge, any current or former employees of the TARGETPARENT.

FDA Matters. After due investigation, (i) the TARGET 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 TARGET Company or with third parties (including, without limitation, Ilex) (each, a "ProductPRODUCT"), (ii) the TARGET 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 TARGET 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 TARGET Company has disclosed to the PARENT Purchaser all submissions to the FDA made by the TARGET Company and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGETCompany), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET Company or any agent thereof relative to the development of its Products, (v) none of the TARGET Company or, to the TARGETCompany'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 TARGET Company or, to the TARGETCompany's Knowledgeknowledge, any current or former employees of the TARGETCompany.

FDA Matters. After due investigation, (i) the TARGET 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 TARGET Company or with third parties (including, without limitation, Ilex) (each, a "Product"), (ii) the TARGET 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 TARGET 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 TARGET Company has disclosed to the PARENT Purchaser all submissions to the FDA made by the TARGET Company and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGETCompany), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET Company or any agent thereof relative to the development of its Products, (v) none of the TARGET Company or, to the TARGETCompany'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 TARGET Company or, to the TARGETCompany's Knowledgeknowledge, any current or former employees of the TARGETCompany.