Ownership of Regulatory Filings. (i) For a given POC Program, the POC Lead Regulatory Party or its Affiliates shall own, maintain, file and hold in its name, all Regulatory Filings (other than DMFs), including INDs or CTAs, for the applicable Collaboration Products. The POC Lead Regulatory Party shall provide the POC Committee with regular updates regarding the status of Regulatory Filings and correspondences for the applicable Collaboration Products, and such Regulatory Filings and correspondences shall be reviewed by the POC Committee. If Merck pays the Participation Election Payment for a given Program, Moderna shall assign and transfer ownership of all relevant INDs or CTAs and Regulatory Filings (other than DMFs) then held by Moderna (or any of its Affiliates) for Collaboration Products for such Program to Merck in accordance with Section 4.3(b).
Appears in 4 contracts
Samples: Vaccine Collaboration and License Agreement, Vaccine Collaboration and License Agreement, Vaccine Collaboration and License Agreement (Moderna, Inc.)
