Common use of Recordkeeping / Reporting Clause in Contracts

Recordkeeping / Reporting. Except as could not, whether individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, within the past five (5) years, each Credit Party and, to the Knowledge of Borrower, each of its 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 Product in the Territory in compliance with applicable FDA Laws, Health Care Laws and other applicable Requirements of Law (and any applicable foreign equivalents), and each Credit Party and, to the Knowledge of Borrower, each of its Subsidiaries, has submitted to the FDA and other Governmental Authorities in a timely manner all notices and annual or other reports required to be made by it, including any required adverse experience reports and annual reports, for Product in the Territory.