Examples of Single Agent Compound in a sentence
Each Party represents and warrants that, to the best of its knowledge, it is not aware of any material safety or toxicity issue with respect to its Single Agent Compound that are not reflected in the investigator’s brochure for its Single Agent Compound existing as of the Effective Date.
The Recipient shall be the sole holder of all legal interests in the Combined Therapy IND; provided, however, that the Recipient may not grant any Third Party any Right of Cross- Reference with respect to any portion of the Combined Therapy IND pertaining to BMS’s Single Agent Compound for use as monotherapy or for use in combination with any molecules, agents, antibodies or compounds other than with the Recipient Study Drug.
If the charged Party does not commence actions to defend such claim within [***] after request by the other Party to do so, then the other Party shall have the right, but not the obligation, to defend any such claim to the extent such claim pertains to the other Party’s Single Agent Compound.
For the avoidance of doubt, each Party shall be responsible for 12 (x) drafting and updating as necessary the investigator’s brochure for its respective Single Agent Compound, and(y) filing all necessary Regulatory Documentation to the existing IND for its respective Single Agent Compound, including the submission to such existing IND of serious adverse event and adverse drug reaction cases emerging from any Combined Therapy Trial.
Each Party shall provide a Right of Cross-Reference to their respective INDs for their respective Single Agent Compound as necessary to allow the Combined Therapy Trials to be conducted under the Combined Therapy IND.