Safety and Efficacy. Allos has informed Mundipharma of all adverse drug reactions known to Allos relating to the Product or its use and Allos has not received any written communication from any Regulatory Authority raising questions concerning the safety or efficacy of the Product (including any of its ingredients);
Safety and Efficacy. Licensor is not aware of any problems, questions or challenges concerning the safety, tolerability or efficacy of any Compound or Product (including any of their ingredients) or of any questions raised by any Regulatory Authority with respect thereto, and Licensor has informed Licensee of all adverse drug reactions and other safety and tolerability matters known to Licensor relating to any Compound or Product or their use.
Safety and Efficacy. Except as disclosed on Schedule 7.18 and except as would not have a Material Adverse Effect, since April 1, 2012, (i) there have not been any problems concerning the safety or efficacy of the Licensed Product (including any of its ingredients) or of any questions raised by any Governmental Authority with respect thereto, (ii) Spectrum has informed Purchaser of all adverse drug reactions known to Spectrum relating to the Product or its use and (iii) there has not been any occurrence of any product recall, market withdrawal or replacement, or post-sale warning by or on behalf of Spectrum concerning Licensed Product.
Safety and Efficacy. SIGA is not aware of any problems concerning the safety or efficacy of the Product (including any of its ingredients) or of any questions raised by any Regulatory Authority with respect thereto, and SIGA has provided relevant information to MMT of all adverse drug reactions known to SIGA relating to the Product or their use;
Safety and Efficacy. Licensor is not aware of any problems concerning the safety or efficacy of CX-01 or any Product (including any of their ingredients) or of any questions raised by any Regulatory Authority with respect thereto, and Licensor has informed Licensee of all adverse drug reactions known to Licensor relating to CX-01 and each Product or their use; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Safety and Efficacy. Seres has no Knowledge of any material safety issues arising in the Development of the Collaboration Products (including with respect to any of its ingredients) and Seres has informed NHSc of all adverse drug reactions reported in all Clinical Trials that are known to Seres relating to the Collaboration Products or their use.
Safety and Efficacy. CABG shall be solely responsible for the safety and efficacy of all SURMODICS-coated Product to be used in human clinical trials.
Safety and Efficacy. Seller is not aware of any material problems concerning the safety or efficacy of the Designated Assets or of any questions raised by any Governmental Authority with respect thereto that has not been disclosed to the Purchaser, and Seller has informed Purchaser of all adverse drug reactions known to Seller relating to the Designated Assets or its use.
Safety and Efficacy. Cidara has (i) allowed Mundipharma access to all material information in Cidara or its Affiliates’ possession and Control concerning the safety and efficacy of Compound or Licensed Product; (ii) informed Mundipharma of all drug-related adverse reactions relating to the Product or its use of which Cidara and its Affiliates are aware; and (iii) carried out GLP Studies of Compound and Licensed Product in accordance with GLP and clinical trials of Licensed Product in accordance with GCP.