Common use of Regulatory Submissions and Approvals Clause in Contracts

Regulatory Submissions and Approvals. Bayer shall be solely responsible for filing for and shall own all Regulatory Approvals and submissions therefor. To the extent permitted by applicable Laws, Bayer shall permit Dimension to attend in an observatory capacity only all meetings with Regulatory Authorities in the U.S., to the extent related to a Licensed GT Product, including, but not limited to, all in-person meetings and all telephone conferences.

Appears in 4 contracts

Samples: Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Dimension Therapeutics, Inc.), Collaboration and License Agreement (Dimension Therapeutics, Inc.)

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Regulatory Submissions and Approvals. Bayer shall be solely (except as stated in Exhibit D-4) responsible for filing for and shall own all Regulatory Approvals and submissions therefor. To the extent permitted by applicable Laws, Bayer shall permit Dimension to attend in an observatory capacity only all meetings with Regulatory Authorities in the U.S., to the extent related to a GT Product or Licensed GT Product, including, but not limited to, all in-person meetings and all telephone conferences.

Appears in 1 contract

Samples: Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.)

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