Access to Facilities. Each Party shall have the right to inspect those portions of the manufacturing, finish processing or storage facilities and testing labs of the Manufacturing Party where Collaboration Products are being manufactured, finished, stored or tested, or any subcontractor who is manufacturing, finishing, storing or testing Collaboration Products for the Manufacturing Party, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the Good Manufacturing Practices of the FDA or other applicable regulatory authority, as the same may be amended from time to time. Any confidential information disclosed to or otherwise gathered by the Party conducting such inspection during any such inspection shall be deemed "Information" as defined in Section 10.1 below.
Appears in 4 contracts
Samples: Collaboration Agreement (Dyax Corp), Collaboration Agreement (Genzyme Corp), Collaboration Agreement (Dyax Corp)
Access to Facilities. Each Party shall have the right to inspect those -------------------- portions of the manufacturing, finish processing or storage facilities and testing labs of the Manufacturing Party where Collaboration Products are being manufactured, finished, stored finished or testedstored, or any subcontractor who is manufacturing, finishing, finishing or storing or testing Collaboration Products for the Manufacturing Party, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the Good Manufacturing Practices of the FDA or other applicable regulatory authority, as the same may be amended from time to time. Any Subject to the terms and conditions of Section 10.1 below, confidential information disclosed to or otherwise gathered by the Party conducting such inspection during any such inspection shall be deemed "Information" maintained as defined in Section 10.1 belowconfidential.
Appears in 2 contracts
Samples: Collaboration Agreement (Biomarin Pharmaceutical Inc), Collaboration Agreement (Biomarin Pharmaceutical Inc)
Access to Facilities. Each Party shall have the right to inspect those portions of the manufacturing, finish processing or storage facilities and testing labs of the Manufacturing Party where Collaboration Products are being manufactured, finished, stored finished or testedstored, or any subcontractor who is manufacturing, finishing, finishing or storing or testing Collaboration Products for the Manufacturing Party, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the Good Manufacturing Practices of the FDA or other applicable regulatory authority, as the same may be amended from time to time. Any confidential information disclosed to or otherwise gathered by the Party conducting such inspection during any such inspection shall be deemed "Information" as defined in Section 10.1 below.
Appears in 2 contracts
Samples: Collaboration Agreement (GTC Biotherapeutics Inc), Collaboration Agreement (Genzyme Transgenics Corp)
Access to Facilities. Each Party shall have the right to inspect audit annually those portions of the manufacturing, finish processing or storage facilities and testing labs of the Manufacturing Party where Collaboration Products are being manufactured, finished, stored finished or testedstored, or any subcontractor who is manufacturing, finishing, finishing or storing or testing Collaboration Products for the Manufacturing Party, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the Good Manufacturing Practices of the FDA or other applicable regulatory authority, as the same may be amended from time to time. Any Subject to the terms and conditions of Section 10.1 below, confidential information disclosed to or otherwise gathered by the Party conducting such inspection during any such inspection shall be deemed "Information" maintained as defined in Section 10.1 belowconfidential.
Appears in 2 contracts
Samples: Collaboration Agreement (Genzyme Corp), Collaboration Agreement (Biomarin Pharmaceutical Inc)
Access to Facilities. Each Party Party, or its agents, shall have the right to inspect those portions of the manufacturing, finish processing or storage facilities and testing labs of the Manufacturing Party where Collaboration Products are being manufactured, finished, stored finished or testedstored, or any subcontractor who is manufacturing, finishing, finishing or storing or testing Collaboration Products for the Manufacturing Party, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the Good Manufacturing Practices of the FDA or other applicable regulatory authorityRegulatory Authority, as the same may be amended from time to time. Any Subject to the terms and conditions of Section 11.2 below, confidential information disclosed to or otherwise gathered by the Party or its agent conducting such inspection during any such inspection shall be deemed "Information" maintained as defined in Section 10.1 belowconfidential.
Appears in 1 contract
Samples: Collaboration Agreement (Mirati Therapeutics, Inc.)