Current Good Manufacturing Practices. Spectrum shall carry out its responsibilities hereunder, and shall use its Commercially Reasonable Efforts to cause the Third Party Manufacturers to carry out their responsibilities relating to the API, NPP Product and Bulk Product, in conformance with cGMPs, and any other Applicable Laws. In the event that Spectrum receives a formal regulatory notice or any other notice from a Regulatory Authority or Third Party manufacturer that identifies a material deficiency associated with the manufacturing process for the API, NPP Product or Bulk Product, or Spectrum itself or its Third Party manufacturers identifies such a material deficiency, Spectrum shall promptly advise Topotarget thereof and keep Topotarget apprised of Spectrum’s efforts to address the concerns of such Regulatory Authority as set forth in Section 11.1 of the Quality Agreement.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Spectrum Pharmaceuticals Inc), License and Collaboration Agreement (Spectrum Pharmaceuticals Inc)