Ownership of Regulatory Approvals. Unless otherwise proposed by the JSC and agreed to by the Parties, the Lead Regulatory Party shall own all INDs, BLAs and other Regulatory Approvals for a Collaboration Product in its territory for which it is responsible. The Lead Regulatory Party shall promptly license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and Commercialization obligations hereunder. SGI shall, in all cases, prepare, own and be responsible for the section of the applicable DMF that describes the Drug Conjugation Technology. Genmab may reference such section, but shall have no right, and SGI shall have no obligation, to provide any information contained in such DMF to Genmab and may require the applicable Regulatory Authority to maintain such information as confidential.
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Samples: License and Collaboration Agreement (Genmab a/S), License and Collaboration Agreement (Genmab a/S)
Ownership of Regulatory Approvals. Unless otherwise proposed by the JSC and agreed to by the Parties, the Lead Regulatory Party shall own all INDs, BLAs and other Regulatory Approvals for a the Collaboration Product in its territory for which it is responsible. The Lead Regulatory Party shall promptly license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and Commercialization obligations hereunder. SGI shall, in all cases, prepare, own and be responsible for the section of the applicable DMF that describes the Drug Conjugation Technology. Genmab Agensys may reference such section, but shall have no right, and SGI shall have no obligation, to provide any such information contained in such DMF to Genmab Agensys and may require the applicable Regulatory Authority to maintain such information as confidential.
Appears in 1 contract
Samples: Collaboration and License Agreement (Seattle Genetics Inc /Wa)
Ownership of Regulatory Approvals. Unless otherwise proposed by the JSC and agreed to by the Parties, the Lead Regulatory Party shall own all INDs, BLAs and other Regulatory Approvals for a the Collaboration Product in its territory for which it is responsible. The Lead Regulatory Party shall promptly license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and Commercialization obligations hereunder. SGI shall, in all cases, prepare, own and be responsible for the section of the applicable DMF that describes the Drug Conjugation Technology. Genmab Agensys may reference such section, but shall have no right, and SGI shall have no obligation, to provide any such information contained in such DMF to Genmab Agensys and may require the applicable Regulatory Authority to maintain such information as confidential.. Section 7.3 Regulatory Coordination. 7.3.1
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