Review of Correspondence. The Lead Regulatory Party shall provide the other Party with drafts of any material documents and other material correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a Collaboration Product.
Appears in 5 contracts
Samples: License and Collaboration Agreement (Seagen Inc.), License and Collaboration Agreement (Genmab a/S), License and Collaboration Agreement (Genmab a/S)
Review of Correspondence. The Lead Regulatory Party shall provide the other Party with drafts of any material documents and other material correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a Collaboration Product.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Seagen Inc.), Collaboration and License Agreement (Seattle Genetics Inc /Wa)
Review of Correspondence. The Lead Regulatory Party shall regularly inform the other Party of its current and planned regulatory activities and shall provide the other Party with drafts of any material documents and other material correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a Collaboration Product.
Appears in 2 contracts
Samples: License and Collaboration Agreement (BioNTech SE), License and Collaboration Agreement (BioNTech SE)
