Development and Commercialization Matters Clause Samples

Development and Commercialization Matters. Section 3.1.1 of the License Agreement is hereby amended to add the following at the end thereof: “Notwithstanding the foregoing, at least thirty (30) days prior to using any new formulation of a Licensed Product or placebo in a clinical trial, Dermata shall deliver to Licensor a reasonable quantity of both Licensed Product and related placebo, together with documentation of its formulation for purposes of evaluation and comment. Further, thirty (30) days prior to submitting any substantive communication regarding any License Products to the FDA, Dermata shall provide Licensor a copy of such draft submission for Licensor’s review and comment. Within thirty (30) days following the date of this Amendment, Dermata shall provide Licensor a copy of any IND applications and study protocols submitted to the FDA prior to such date. However, Dermata, in its absolute and sole discretion, may accept or reject any comments of suggestions provided by Licensor. Licensor’s time spent evaluating Licensed Products and related placebo, and reviewing regulatory submissions relating to Licensed Products and commenting thereon shall not be subject to the Consulting Agreement, which is no longer in effect pursuant to the terms of the License Agreement. For the avoidance of doubt, all such Licensed Products samples and documents, placebo samples and documents, IND, NDA, or protocols provided to Licensor shall remain Dermata Confidential Information subject to Section 6 and the definition of Confidential Information.”