Inspection by Regulatory Agencies. The Collateral Trustee shall make available, and shall cause each custodian and agent acting on its behalf in connection with this Agreement to make available, all Collateral in such Person’s possession at all times for inspection by the auditor of a Grantor or any regulatory agency having jurisdiction over any Grantor to the extent required by such regulatory agency in its discretion.
Inspection by Regulatory Agencies. The Collateral Agent shall make available, and shall cause each custodian and agent acting on its behalf in connection with this Agreement to make available, all Collateral in such Person's possession at all times for inspection by any regulatory agency having jurisdiction over a Grantor to the extent required by such regulatory agency in its discretion.
Inspection by Regulatory Agencies. Each party shall promptly notify the other party upon being contacted by the FDA for any purpose or reason directly relating to the manufacture of the Product, including without limitation, any announced or unannounced FDA inspection. At BLP's request, ISTA will provide BLP with copies of all correspondence and documentation provided to the FDA which relate to BLP's scale-up manufacturing activities. At ISTA's request, BLP will provide ISTA with copies of all correspondence and documentation provided to the FDA which relate to the Product or the manufacture of the Product. BLP shall permit an ISTA representative to be present at BLP's facilities during any such inspection directly relating to manufacture of the Product. Duly authorized representative(s) from the FDA or other applicable regulatory agencies shall be permitted access, at reasonable times during BLP's normal business hours, to visit, in the company of a BLP representative, the manufacturing and/or packaging facility or facilities where the Product will be or is being manufactured and/or packaged for the purposes of auditing BLP's processes to ensure that the Product is being manufactured, packaged, stored and handled in accordance with the Specifications, Applicable Laws, and BLP policies and procedures to the extent that such policies and procedures do not conflict with any terms or conditions of this Agreement or with Applicable Laws.. BLP shall, at its own expense, promptly respond to all inquiries and questions resulting from such visits and inspections and, at its own expense, promptly correct any deficiencies reported as a result of such inspections. BLP shall immediately notify ISTA if an authorized agent of the FDA or other governmental agency visits BLP's manufacturing facility for the purposes of inspecting the manufacturing and testing of the Products.
Inspection by Regulatory Agencies. The Administrative Agent shall make available, and shall cause each custodian and agent acting on its behalf in connection with this Agreement to make available, all Collateral in such Person’s possession upon prior written notice and during regular business hours for inspection by any regulatory agency in its discretion.
Inspection by Regulatory Agencies. The Security Agent shall make available, and shall cause each custodian and agent acting on its behalf in connection with this Deed to make available, all Collateral in such Person’s possession at all times for inspection by any regulatory agency having jurisdiction over the Security Agent or an Obligor to the extent required by such regulatory agency in its discretion.
Inspection by Regulatory Agencies. Work performed under this contract is subject to inspection by State and Federal Government Regulatory agencies including those described below.
Inspection by Regulatory Agencies. Dynal shall notify Xcyte of any inspection of its facilities related to the Products by any regulatory agency, and, if it is able and has the right to do so, Dynal shall send Xcyte copies of any material written reports relating to such inspection within seven days after receipt or preparation of such reports.
Inspection by Regulatory Agencies. Xcyte shall notify Dynal, and shall require the Antibody Manufacturers to notify Xcyte, of any inspection of any of Xcyte’s or Antibody Manufacturer’s facilities related to the Antibodies by any regulatory agency, and, if it is able and has the right to do so, Xcyte shall send Dynal copies of any material written reports relating to such inspection within seven days after receipt or preparation of such reports. EXECUTION COPY Attachment G to Development and Supply Agreement dated as of August 1, 1999 between Xcyte Therapies, inc. and Dynal A.S. (the “Agreement”) (Terms used herein and not otherwise defined below have the meanings defined in the Agreement)
Inspection by Regulatory Agencies. Xcyte shall notify Dynal, and shall require the Antibody Manufacturers to notify Xcyte, of any inspection of any of Xcyte’s or Antibody Manufacturer’s facilities related to the Antibodies by any regulatory agency, and, if it is able and has the right to do so, Xcyte shall send Dynal copies of any material written reports relating to such inspection within seven days after receipt or preparation of such reports
Inspection by Regulatory Agencies. Each party shall promptly notify the other party upon being contacted by the FDA or other Regulatory Agency for any purpose or reason directly relating to the manufacture of the Product, including without limitation, any announced or unannounced FDA or other Regulatory Agency inspection. At B&L’s request, AERIE will provide B&L with copies of all correspondence and documentation provided to the FDA or other Regulatory Agency which relate to B&L’s scale-up manufacturing activities. At AERIE’s request, B&L will provide AERIE with copies of all correspondence and documentation provided to the FDA or other Regulatory Agency which relate to the Product or the manufacture of the Product. B&L shall permit one or more AERIE representative(s) to be present at B&L’s facilities during any such inspection directly relating to manufacture of the Product. Duly authorized representative(s) from the FDA or other Regulatory Agency or other applicable regulatory agencies shall be permitted access, at reasonable times during B&L’s normal business hours, to visit, in the company of a B&L representative, the manufacturing and/or packaging facility or facilities where the Product will be or is being manufactured and/or packaged for the purposes of auditing B&L’s processes to ensure that the Product is being manufactured, packaged, stored and handled in accordance with the Specifications, Applicable Laws, and B&L policies and procedures to the extent that such policies and procedures do not conflict with any terms or conditions of this Agreement or with Applicable Laws.. B&L shall, at its own expense, promptly respond to all inquiries and questions resulting from such visits and inspections and, at its own expense, promptly correct any deficiencies reported as a result of such inspections. B&L shall immediately notify AERIE if an authorized agent of the FDA or other Regulatory Agency visits B&L’s manufacturing facility for the purposes of inspecting the manufacturing and testing of the Products.
