definiens: means a delay in the completion of a clinical sta ge Diligence Milestone that results from the FDA either ( a ) putting a clinical hold on one or more classes of Licensed Products that Licen see or a Sublicensee is developing pursuant to this Agr eement, ( b ) requiring additional data related to th e Licensed Product that Licensee or a Sublicensee is developing pursuant to this Agreement based on FDA guidelines or regulations and such guidelines or re gulations were only implemented after initiation of a human clinical trial for such Licensed Product or ( c ) determining that there is a potential safety ris k associated with such Licensed Product ; provided, ho wever, that with respect to ( a)-(c ) ( i ) such delay is not primarily due to Licensee ’s actions or inactions th at were counter to the guidance provided to License e or otherwise published by the FDA, and ( ii ) such delay is not primarily due to Licensee ’s failure to prov ide data to the FDA in a form, amount and quality commo nly used in the pharmaceutical industry or to undertake preclinical and clinical development in a form and of a quality that would be commonly used in the pharmaceutical industry