Regulatory Interactions Defined. For purposes of this Agreement, “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Products.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Lannett Co Inc), Development and Collaboration Agreement (BioAtla, Inc.), Collaboration and License Agreement (Lannett Co Inc)
Regulatory Interactions Defined. For purposes of this Agreement, “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Shared Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Shared Products.
Appears in 2 contracts
Samples: License Agreement (Vividion Therapeutics, Inc.), License Agreement (Vividion Therapeutics, Inc.)
Regulatory Interactions Defined. For purposes of this Agreement, “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Products a Program and (ii) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Productsa Program.
Appears in 2 contracts
Samples: Discovery and Development Collaboration and License Agreement (Agios Pharmaceuticals Inc), Discovery and Development Collaboration and License Agreement (Agios Pharmaceuticals Inc)
Regulatory Interactions Defined. For purposes of this Agreement, “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities in the US Territory with respect to the Licensed Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities in the US Territory with respect to the Licensed Products.
Appears in 1 contract
Samples: Collaboration and License Agreement (Agios Pharmaceuticals Inc)
Regulatory Interactions Defined. For purposes of this Agreement, “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Licensed Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Licensed Products.
Appears in 1 contract
Regulatory Interactions Defined. For purposes of this Agreement, “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities in the ROW Territory with respect to the Licensed Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities in the ROW Territory with respect to the Licensed Products.
Appears in 1 contract
Samples: Collaboration and License Agreement (Agios Pharmaceuticals Inc)
