Common use of Regulatory Support Clause in Contracts

Regulatory Support. 2.2.1.1 BI RCV agrees to co-operate with VIDARA in obtaining and maintaining all US governmental approvals and registrations relevant to the CMC section of the registration dossier (and their foreign equivalents) as requested by VIDARA. 2.2.1.2 The Parties shall consult with each other concerning the scope and content of all regulatory filings, and shall jointly define the requirements for the necessary PRODUCT registration with the FDA so that BI RCV shall be able to fulfill its obligations under this AGREEMENT with respect to the CMC portion of such PRODUCT registration. With respect to any part of the CMC portion which contains BI RCV and/or BI Pharma KG INFORMATION, BI RCV shall be provided an opportunity to review and comment on such parts prior to submission to a HEALTH AUTHORITY as set forth in the QUALITY AGREEMENT.