Common use of Preparation of Regulatory Documentation Clause in Contracts

Preparation of Regulatory Documentation. Following completion of the R&D Technology Transfer, Provention shall be solely responsible, at its own cost and expense, for all regulatory affairs related to the Compound and Products in the Field in the Territory, including (i) developing and implementing the overall regulatory strategy with respect to obtaining Regulatory Approval of Products in the Field in the Territory (it being understood that the regulatory strategy for the Territory shall be consistent with the terms of this Agreement); (ii) preparing, submitting and maintaining all Regulatory Documentation related to the Compound or Products in the Territory; and (iii) conducting communications with the relevant Regulatory Authority in furtherance of subsection (ii) or otherwise related to the Exploitation of the Compound and Products in the Territory.