definiens: means, with respect to a [COMPANY] Product, the sum of t he following costs to the extentincurred after the exercise by [COMPANY] of an Option wit h respect to the [COMPANY] Development Program containing such [COMPANY] Product:1.18.1 All direct internal and external Research and Devel opment costs incurred by or on behalf of [COMPANY] or itsAffiliates or Sublicensees or Dynavax and/or their respective Affiliates during such period in the con duct of the GSKDevelopment Program ( including but not limited to b oth Clinical Trials and any non - clinical activities or studies ) that arerequired by a Regulatory Authority to support and o btain Regulatory Approval for such [COMPANY] Product in t he U.S. ( collectively, the ), and for product material, comparator drug and pl acebo used in the Co - Development Studies