RAP Responsibilities Clause Samples

RAP Responsibilities. Consistent with its responsibilities under this Agreement and the RAP Plan (particularly, those recited in Article 11), each Party agrees to perform the following, subject to applicable law, including confidentiality, data protection and privacy restrictions, (a) provide to the other Party all preclinical data, assays and associated materials, protocols, procedures and any other information in such Party’s possession that the other Party deems reasonably necessary for the RAP of Product; (b) conduct all agreed studies and other activities assigned to the respective Party, including human clinical studies for Product; and (c) file required communications with Regulatory Authorities in either the OMP Territory or the EU as applicable and, as provided for by Section 11.6 and as otherwise reasonably requested by the other Party, consult with the other Party in preparing such Drug Approval Applications and communications with the relevant Regulatory Authorities in the Territory.