Regulatory Inspection. Where a regulatory inspection is conducted of the Supplier's facilities and that inspection touches on Goods that are supplied to Silver Fern Farms, then the Supplier must provide a copy of the final report of that inspection to Silver Fern Farms upon request.
Regulatory Inspection. If any governmental or regulatory authority notifies PPD that it will inspect PPD’s records, facilities, equipment, or procedures, or otherwise take action related to this Agreement or a Project Addendum, PPD shall notify Sponsor within two (2) business days and prior to the inspection or action, allow the authority to conduct an inspection or take other legal action, allow Sponsor to be present at the inspection or participate in any response to the action, and provide Sponsor with copies of any reports issued by the authority and PPD’s proposed response for Sponsor’s prior review and approval, such approval not to be unreasonably withheld.
Regulatory Inspection. NDD shall permit representatives of any regulatory agency having jurisdiction over the manufacture and/or marketing of the ASICs (or of any other product in which the ASIC is incorporated) to inspect its facilities in conjunction with the manufacture, testing, packaging, storage, handling and shipping of the ASICs. Further, NDD shall advise CMS immediately if NDD receives notice of an impending inspection or if an authorized agent of the FDA or other governmental agency visits any of NDD's manufacturing facilities concerning the ASICs. NDD shall furnish to CMS any report, including any FDA Form 483 notices (or comparable notices of other agencies), regulatory letters or similar documents received from such agency and the application of such report to the ASICs, if any, within seven (7) days of NDD's receipt of such report.
Regulatory Inspection. The Site shall notify Sponsor and its designee immediately by telephone or facsimile of any inquiries, correspondence, or communications with or from the FDA or any other governmental or regulatory authority relating to the Study. If a regulatory authority, including without limitation the FDA, requests permission to or does inspect the Site’s facilities or research records relating to the Study, the Site will cooperate with the regulatory authority’s representative(s) and permit such inspection, and will make all reasonable efforts to permit Sponsor to review the records before the inspection and be present and available during such inspections. The Institution shall provide sufficient and appropriate space as deemed needed by the Investigator and/or Sponsor for such inspections without delay at no additional cost to Sponsor. Investigator and appropriate Study personnel will be available during such inspection to comply with the legitimate requirements of the inspection and to explain and discuss records and documentation related to the Study. The Site shall provide to Sponsor or its designees, in writing and in an organized manner, copies of all materials, correspondence, statements, forms, and records that the Site receives, obtains, or generates in connection with any such inspection or in connection with any inquiries, communications, or correspondence from the FDA or any other governmental or regulatory authorities. The Site will make reasonable efforts to segregate, and not disclose, all documents and materials that are not required to be disclosed during such an inspection, including financial data and pricing information.
Regulatory Inspection. (i) Pfenex shall promptly (and in any event within one (1) Business Day of becoming aware thereof) notify Jazz of any Regulatory Authority inspections relating to any HemOnc Product or related activities under the applicable Development Plan. Jazz shall have the right to be present at any such inspections and shall have the opportunity to provide, review and comment on any responses that may be required. Pfenex shall provide Jazz with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection. In addition to such obligations with respect to Regulatory Authority inspections, Pfenex shall promptly (and in any event within one (1) Business Day following receipt thereof) notify Jazz of any information it receives regarding any threatened or pending action or communication by or from any Third Party, including a Regulatory Authority, that may materially affect the Development, manufacturing, Commercialization or regulatory status of HemOnc Products.
(ii) Jazz shall promptly (and in any event within one (1) Business Day of becoming aware thereof) notify Pfenex of any Regulatory Authority inspections relating specifically to the manufacturing process developed by Pfenex for any HemOnc Product (or any modified version of such manufacturing process for such HemOnc Product) and conducted by Jazz, its Affiliate or any Third Party manufacturer. Jazz shall provide Pfenex with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection to which it has access and authority to disclose; provided that Jazz shall only provide Pfenex with any such materials received by a Third Party to the extent permitted under Jazz’s agreement with such Third Party. In addition to such obligations with respect to Regulatory Authority inspections, Jazz shall promptly (and in any event within one (1) Business Day following receipt thereof) notify Pfenex of any information it receives regarding any threatened or pending action or communication by or from any Third Party, including a Regulatory Authority, that may materially affect the manufacturing or regulatory status of HemOnc Products; provided that Jazz shall only provide Pfenex with any such information received by a Third Party to the extent permitted under Jazz’s agreement with such Third Party.
Regulatory Inspection. The Institution and/or the Investigator shall notify Sponsor and its Designee promptly of any inquiries, correspondence, or communications with or from the FDA, the State Institute for Drug Control or any other governmental or regulatory authority relating to the Study. If a regulatory authority requests permission to or does inspect the Institution’s facilities or research records relating to the Study, the Institution and Investigator will cooperate with the regulatory authority’s representative(s) and permit such inspection. The Institution shall provide to Sponsor copies of all materials that the Institution and/or Investigator receives, obtains, or generates in connection with any such inspection or in connection with any communications from regulatory authorities. A. Kontroly prováděné kontrolními úřady. Zdravotnické zařízení a/nebo Zkoušející okamžitě vyrozumí Zadavatele a jeho Pověřeného zástupce o veškerých dotazech, korespondenci a sděleních, které v souvislosti se Studií obdrží od FDA, Státního ústavu pro kontrolu léčiv nebo kterýchkoli jiných státních nebo kontrolních úřadů nebo které jim bude předkládat. Jestliže si kontrolní úřad vyžádá svolení ke kontrole nebo provádí kontrolu zařízení Zdravotnického zařízení nebo záznamů o výzkumu týkajících se Studie, Zdravotnické zařízení a Zkoušející bude se zástupcem (zástupci) kontrolního úřadu spolupracovat a tuto kontrolu umožní. Zdravotnické zařízení a/nebo Zkoušející poskytne Zadavateli kopie všech materiálů, které obdrží, získá nebo vytvoří v souvislosti s jakoukoli takovou inspekcí nebo v souvislosti s jakoukoli komunikací s kontrolními úřady.
Regulatory Inspection. In connection with a request from a Regulatory Authority related to obtaining and maintaining Regulatory Approval with respect to a Product, each Party shall permit the other Party, or an authorized representative of the other Party reasonably acceptable to such Party, to enter the relevant facilities of such Party and its Affiliates during normal business hours and upon reasonable advance notice to inspect and verify compliance with applicable regulatory and other requirements as well as with this Agreement, with respect to all matters relating to the Development of the Products under this Agreement. Each Party shall give the other Party or its authorized representative, all necessary and reasonable assistance for a full and correct carrying out of the inspection. Such inspection shall not relieve a Party of any of its obligations under this Agreement. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Regulatory Inspection. In the event of any inspections or audits by any governmental authority of Distributor’s premises or, if applicable, any of its Affiliates’ premises to the extent related to any Product, Distributor promptly shall notify Company and shall furnish to Company any reports by such authority to the extent applicable to any Product as promptly as practicable following receipt thereof by Distributor. Distributor shall provide Company the opportunity to review and approve any and all submissions to any governmental authority to the extent related to any Product prior to the submission thereof.
Regulatory Inspection. Licensor shall allow the FDA and other Regulatory Authorities, with or without prior notice, to visit the facility where the Product is manufactured, processed or tested, and to review records and conduct audits and inspections related to the manufacture and supply of the Product. Licensor shall notify the Licensee of all inspections by FDA and other Regulatory Authority that are related to the Product. If areas of concern exist that relate to the Product, Licensor will notify Licensee, to the extent possible, prior to the inspection and as soon as possible after Licensor receives notice of such inspection. In all other cases, Licensor will provide Licensee with information on the results of the inspection to the extent applicable. Licensor notification will include, without limitation: (a) written notification of any observation, if any, that may impact the manufacture of the Product; (b) written notification of all related corrective actions and planned completion dates related to the manufacture of the Product or the facility or equipment used to manufacture, process or test the Product; (c) any further correspondence with the FDA and other Regulatory Authority regarding the manufacture, processing, testing, or validation of the Product, or any process or procedure related thereto.
Regulatory Inspection. SMSI shall permit representatives of any regulatory agency having jurisdiction over the manufacture and/or marketing of the Oxygen Sensors (or of any other product in which the Oxygen Sensor is incorporated) to inspect its facilities in conjunction with the manufacture, testing, packaging, storage, handling and shipping of the Oxygen Sensors. Further, SMSI shall advise CMS immediately if SMSI receives notice of an impending inspection or if an authorized agent of the FDA or other governmental agency visits any of SMSI's manufacturing facilities concerning the Oxygen Sensors. SMSI shall furnish to CMS any report, including any FDA Form 483 notices (or comparable notices of other agencies), regulatory letters or similar documents received from such agency and the application of such report to the Oxygen Sensors, if any, within seven (7) days of SMSI's receipt of such report.
