Common use of Adverse Drug Experience Reporting Clause in Contracts

Adverse Drug Experience Reporting. Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit C attached hereto (as the same may be amended from time to time by notice in writing from ALTRAZEAL to ULURU; provided that such amendment shall not conflict with any of the provisions of this Agreement). ULURU shall determine whether such information is required to be reported to the FDA and any other Regulatory Authority.

Adverse Drug Experience Reporting. Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit C attached hereto (as the same may be amended from time to time by notice in writing from ALTRAZEAL ORADISC to ULURU; provided that such amendment shall not conflict with any of the provisions of this Agreement). ULURU shall determine whether such information is required to be reported to the FDA and any other Regulatory Authority.

Adverse Drug Experience Reporting. Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit C D attached hereto (as the same may be amended from time to time by notice in writing from ALTRAZEAL WYETH to ULURUACCESS; provided that such amendment shall not conflict with any of the provisions of this Agreement). ULURU WYETH shall determine whether such information is required to be reported to the FDA and any other Regulatory Authority.

Adverse Drug Experience Reporting. Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit C attached hereto (as the same may be amended from time to time by notice in writing from ALTRAZEAL DEXO to ULURU; provided that such amendment shall not conflict with any of the provisions of this Agreement). ULURU DEXO shall determine whether such information is required to be reported to the FDA and any other Regulatory Authority.