Documentation for Governmental Authority Requirements. Innocoll shall maintain complete and accurate documentation of all validation data, stability testing data, Batch records, quality control and laboratory testing, and any other data required under cGMPs, Laws and other requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing hereunder. Innocoll shall provide EUSA with access to such documentation at Innocoll’s Manufacturing Facility promptly upon EUSA’s request (but no later than seven (7) Business Days after such request).
Documentation for Governmental Authority Requirements. Supplier shall maintain complete and accurate documentation of all validation data, stability testing data, batch records, quality control and laboratory testing and any other data required under cGMPs and other requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing Activities hereunder. Supplier shall provide Adolor with such documentation promptly upon Adolor’s request.
Documentation for Governmental Authority Requirements. Alphatec, at its sole cost and expense, shall maintain complete and accurate documentation of all validation data, stability testing data, batch records, quality control and laboratory testing and any other data or records required under cGMPs and other requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing Services hereunder for a period of five (5) years after such activities are completed, or such longer period as required by Applicable Law. Alphatec, at its sole cost and expense, shall make such records available to Globus, as Globus may reasonably request, and shall also make these records available to any Governmental Authority, upon its request, and advise Globus in writing in a timely manner of such request.
Documentation for Governmental Authority Requirements. CRL shall maintain complete and accurate documentation of all validation data, stability testing data, batch records, quality control and laboratory testing and any other data required under cGMPs and other requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing Activities hereunder. CRL shall provide Client with such documentation promptly upon Client’s request.
Documentation for Governmental Authority Requirements. PII shall maintain complete and accurate documentation of all validation data, stability testing data, batch records, quality control and laboratory testing and any other data required under cGMPs and other requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing Activities hereunder. PII shall provide Adolor with such documentation promptly upon Adolor’s request.
