Obtaining Regulatory Approval Clause Samples

Obtaining Regulatory Approval. BioMarin will continue to act as regulatory agent for and be responsible for all ongoing communications with the FDA regarding obtaining Regulatory Approvals for Orapred ODT and Orapred RT in the United States and will bear all costs associated with obtaining such Regulatory Approvals. After FDA grants Regulatory Approvals for Orapred ODT and Orapred RT, Alliant will act as regulatory agent for and be responsible for maintaining Regulatory Approvals for Orapred ODT and Orapred RT, including all costs associated with such maintenance. For Orapred in all of North America, for Orapred ODT and Orapred RT in all of North America other than the United States, and for all other Licensed Products in all of North America, BioMarin shall use commercially reasonable efforts to cause Alliant to be named as regulatory agent for and be responsible for obtaining and maintaining Regulatory Approvals, including all costs associated with those activities, provided that if Alliant is not permitted to act as a regulatory agent under the terms and conditions of the Ascent License, then BioMarin will continue to act as a regulatory agent for the Licensed Products on behalf of Alliant and pursuant to the instructions provided by Alliant; provided that Alliant shall be responsible for preparing, at its expense, all regulatory filings that are required by Law or deemed desirable by Alliant. While acting as a regulatory agent with respect to Licensed Products, each Party will comply with all requirements under 21 CFR Part 203 (Prescription Drug Marketing Act), 21 CFR Part 314.70 (Supplements and Other Changes to an Approved Application), 21 CFR Part 314.80 (Post-Marketing Reporting of Adverse Drug Experiences) and 21 CFR Part 314.81 (Other Post-Marketing Reports). After the Acquisition Date, during the License Term, BioMarin will transfer to Alliant all FDA Licenses for the Orapred Products that the FDA grants to BioMarin or its Affiliate.