Clinically-Approved Product definition
Clinically-Approved Product means any Licensed Product for which (i) FDA approval or clearance (or any foreign equivalent thereof), which is granted or withheld on the basis of the results of human clinical trials of such Licensed Product, is required prior to sale of such Licensed Product for human therapeutic, diagnostic, or prophylactic use, or for such Licensed Product’s use as a human medical device and (ii) the costs directly related to conducting such human clinical trials incurred by Licensee or any Affiliate or Sublicensee are greater than one million dollars ($1,000,000).
Clinically-Approved Product means any Product for which FDA approval or clearance (or any foreign equivalent thereof), which is granted or withheld on the basis of the results of human clinical trials of such Product, is required prior to Sale of such Product for use by humans.
Clinically-Approved Product means any Licensed Product for which (i)