Licensed Product Manufacturing. In connection with any audit by a Regulatory Authority relating to the Clinical Trial or the Licensed Product, [[Organization A:Organization]] (or its Third Party manufacturer) will reasonably accommodate requests to allow representatives of any Regulatory Authority to inspect the relevant parts of facilities where the Manufacture of the Licensed Product is carried out and to inspect batch records and related documentation to verify compliance with cGMP and Applicable Law, and will promptly notify [[Agenus:Organization]] of any deficiencies identified and remediation plans with respect thereto. To the extent allowable under Applicable Law, Persons inspecting or auditing such facilities, books or records shall be required to enter into separate confidentiality agreements and to abide by the safety protocols and 36165924.6

#[[Agenus:Organization]] Antibody Manufacturing. In connection with any audit by a Regulatory Authority relating to the Clinical Trial or the Licensed Product, [[Agenus:Organization]] will reasonably accommodate requests to, and will use Commercially Reasonable Efforts to ensure that its Third Party manufacturers will, allow representatives of any Regulatory Authority to inspect the relevant parts of facilities where the Manufacture of the [[Agenus:Organization]] Antibody is carried out and to inspect batch records and related documentation to verify compliance with cGMP and Applicable Law, and will promptly notify [[Organization A:Organization]] of the scheduling of any such inspection directly relating to the Manufacture of [[Agenus:Organization]] Antibody being supplied under this Agreement, as well as any deficiencies identified and remediation plans with respect thereto. Persons inspecting or auditing such facilities, books or records shall be required to enter into separate confidentiality agreements and to abide by the safety protocols and standard operating procedures of the audited facility while on site.