Drug definition
Examples of Drug in a sentence
Executive shall ensure that the Company complies with all applicable requirements of the U.S. Food and Drug Administration (the “FDA”) and other regulatory authorities, including requirements related to the Company’s medical device products, clinical trials, adverse event reporting, and promotional activities.
Kemwell shall [***] provide to the Client any necessary information regarding each Product including any changes made to the Drug Product or Drug substance within [***], so as to conduct appropriate evaluation on a periodic basis.
Company shall retain exclusive ownership of any and all inventions, ideas, discoveries, developments, methods, processes, formulations, improvement or innovations Controlled by Company as of the Effective Date or made or acquired by or on behalf of Company independent of this Agreement, in each case together with all intellectual property rights arising therefrom, including, for clarity, API or Drug.
Client shall insure against personal injury, physical injury or property damage arising out of the pre-clinical, clinical (upon filing of an Investigational New Drug application or Clinical Trial Application or similar application) and commercial (upon acceptance of a Biologics License Application or Marketing Authorization Application or similar application) manufacture, sale, use, distribution or marketing of Client Product manufactured in connection with this CMSA.
LTI shall in no way be held responsible for any refusal by any Regulatory Authority or ethics committee to grant permission to conduct a clinical trial(s) and/or for any refusal by any Regulatory Authority to grant approval under an Investigational New Drug Application (IND), under a Biological License Application (BLA), under a Marketing Authorization Application (MAA), or for compassionate use of Client Product.