Product Candidate definition
Examples of Product Candidate in a sentence
Neither Party shall seek approvals from any Regulatory Authority or submit any Regulatory Materials for the Product Candidates or Products outside its respective Territory, and nor shall any Party communicate with any Regulatory Authority outside its respective Territory regarding any Product Candidate or Product, unless necessary for regulatory purposes in its Territory or if so ordered by a Regulatory Authority, in which case, such Party shall immediately notify the other Party.
During the Term and for [*] thereafter, each Party shall procure and maintain insurance with respect to its activities hereunder which is consistent with normal business practices of prudent companies similarly situated at all times during which any Product Candidate or Product is being clinically tested in human subjects or commercially distributed or sold, which insurance shall include products and completed operations liability insurance and clinical trial liability insurance.
Each Party shall promptly notify the other Party of any clinical hold, audit or inspection of it or its Related Parties by any Regulatory Authority, relating to a Product or Product Candidate or recall of any Product or Product Candidate and shall promptly comply with all requirements of the applicable Regulatory Authorities in connection therewith.
Lyell has no other obligation to Develop, or seek or obtain Marketing Approval for, any Product Candidate or Product under this Agreement.