Common use of Recordkeeping / Reporting Clause in Contracts

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries has maintained records relating to the research, development, testing, manufacture, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of each of the Products in compliance in all material respects with FDA Laws, DEA Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries has submitted to the FDA and other Governmental Bodies in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reports, for each of the Products.

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries Subsidiaries, has maintained records relating to the research, development, testing, manufacture, recall, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of each of the Products Product in compliance in all material respects with FDA Laws, DEA Health Care Laws and other applicable Requirements of LawLaw (and any foreign equivalents), and each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries Subsidiaries, has submitted to the FDA and other Governmental Bodies in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reports, for each Product save to the extent that could not reasonably be expected to have a materially adverse impact on such Credit Party’s or Subsidiary’s rights in respect of the ProductsProduct.

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Borrowersuch Credit Party, each of its Subsidiaries Subsidiaries, has maintained records relating to the research, development, testing, manufacture, recall, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of each of the Products Product in compliance in all material respects with FDA Laws, DEA Health Care Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of Borrowersuch Credit Party, each of its Subsidiaries Subsidiaries, has submitted to the FDA and other Governmental Bodies Regulatory Authorities in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reportsreports (including annual reports specific to holders of Orphan Drug designations), for each Product save to the extent that could not reasonably be expected to have a materially adverse impact on such Credit Party’s or Subsidiary’s rights in respect of the ProductsProduct.

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Borrowersuch Credit Party, each of its Subsidiaries Subsidiaries, has maintained records relating to the research, development, testing, manufacture, recall, production, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export and sale of each of the Products Product in compliance in all material respects with FDA Laws, DEA Health Care Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of Borrowersuch Credit Party, each of its Subsidiaries Subsidiaries, has submitted to the FDA and other Governmental Bodies in a timely manner all notices and annual or other reports required to be made by it, including adverse experience reports and annual reportsreports (including annual reports specific to holders of Orphan Drug designations), for each Product save to the extent that could not reasonably be expected to have a materially adverse impact on such Credit Party’s or Subsidiary’s rights in respect of the ProductsProduct.