Recordkeeping / Reporting Clause Samples

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of Parent, 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 or lease of Product in compliance in all material respects with FDA Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of Parent, 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 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 Product.

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has maintained records relating to any aspect of 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 in all material respects with FDA Laws, EU Laws, Japanese Laws, Health Care Laws and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has submitted to the FDA (or foreign equivalents) and other Governmental Authorities in a timely manner all material notices and annual or other reports required to be made, including adverse experience reports, annual reports (including annual reports specific to holders of Orphan Drug designation), and safety reports (including post-marketing safety reports for combination products) required to be made for Product.

Recordkeeping / Reporting. The Affiliate will respond in a timely manner to reasonable and necessary requests for records or information from SNA, and on an annual basis will provide the following information to SNA headquarters by the following deadlines:

Recordkeeping / Reporting. Praxis and Ionis will prepare and maintain complete and accurate records regarding their respective activities under the Research Plan. At each meeting of the JSC, or if otherwise requested by a Party, each Party will deliver a written report to the other (along with any requested copies of data or reports) describing the activities conducted by such Party under the Research Plan.

Recordkeeping / Reporting. Each Credit Party and, to the Knowledge of such Credit Party, 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 the Product in the Territory in compliance in all material respects with FDA Laws, Health Care Laws, and other applicable Requirements of Law, and each Credit Party and, to the Knowledge of such Credit Party, each of its Subsidiaries, has submitted to the FDA (or foreign equivalents) and other Governmental Authorities (including Regulatory Agencies) in a timely manner all material notices and annual or other reports required to be made, including adverse experience reports, annual reports specific to holders of Orphan Drug designations and safety reports for the Product.

Recordkeeping / Reporting. Franchisee shall make available to Franchisor for review annual reports regarding the services provided under this Agreement. The Franchisor shall have the right, during normal business hours and upon reasonable (at least three (3) business days') advance notice given to Franchisee by the Franchisor, to inspect the records of Franchisee to ensure compliance with the services provided under this Agreement. Franchisee shall maintain billing records, customer lists, compliance records, and customer complaints for a period of two (2) years or as required by law, whichever is the greater.

Recordkeeping / Reporting. Each Supplier site must comply with record-keeping, data-transmission, incident-reporting, and audit requirements set out in Section 4 of this Exhibit.

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.

Recordkeeping / Reporting. ACCESS 3. ZÁZNAMY, VÝKAZY, PŘÍSTUP (a) Zmocnění zástupci Zadavatele, případně jeho pověřenými studijními monitory, jsou oprávněni na základě přiměřeného předchozího oznámení v přiměřené lhůtě a během obvyklé pracovní ▇▇▇▇: (i) provádět audit a prověřit vybavení řešitelského centra potřebné k provedení studie; a (ii) zkontrolovat a vytvořit si kopie veškerých údajů, záznamů a výsledků práce souvisejících s prováděním studie, a jestliže to je potřebné, pořizovat si kopie takových údajů, záznamů a výsledků práce, za předpokladu, že takové kopie neobsahují nepovolené individuálně identifikovatelné informace o subjektu studie. Řešitelské centrum je povinno vést úplné a správné záznamy týkající se studie, a záznamy vzniklé ze ▇▇▇▇▇▇ ▇▇ povinno archivovat v souladu s ICH GCP po dobu, jakou stanoví příslušné zákony a právní předpisy. (a) The Investigator will deliver CRFs to PRA within fourteen (14) days of Investigator’s review or in accordance with PRA’s reasonable written instructions, as the case may be. Site will ensure that its Study Team members assist Sponsor in resolving any queries regarding discrepancies or missing information in CRFs. The Investigator shall be available at reasonable times during normal business hours to meet with Study monitors and answer questions regarding the conduct of the Study. If PRA or Sponsor or its designees must perform check of data against data in the Site’s computer systems with medical data, they will do so in accordance with the Site’s instructions and only under supervision of some of the study personel and will only use acquired information for the purpose of the Study and in accordance with applicable laws. PRA or Sponsor or its designees will not have (b) Zkoušející vyplní a zašle záznamy e-CRF společnosti PRA do čtrnácti (14) pracovních dní od příslušné návštěvy a revize zkoušejícího nebo v souladu s přiměřenými písemnými pokyny PRA podle okolností. Řešitelské centrum zajistí, že členové studijního týmu pomohou Zadavateli řešit jakékoli dotazy týkající se nesrovnalostí nebo chybějících údajů v CRF. Zkoušející bude v přiměřených hodinách v běžné pracovní době k dispozici ke schůzkám s monitory studie a odpovídat na jejich otázky týkající se provádění studie. Pokud musí PRA nebo Zadavatel nebo jeho zástupci provést kontrolu dat s daty v elektronickém systému lékařských záznamů řešitelského centra, učiní tak v souladu s pokyny řešitelského centra a pouze za dohledu některého z členů studijního týmu, kdy získané infor...