Transfer of Regulatory Documents. Promptly after the Closing Date or promptly after its availability pursuant to Section 5.4, EVOTEC shall transfer and assign to ROCHE all INDs in its possession and control and shall provide to ROCHE copies of all correspondence relating to Products with the Regulatory Authorities. In addition, at a date defined by ROCHE, EVOTEC shall transfer and assign to ROCHE any regulatory dossiers containing information necessary or useful to ROCHE in connection with its regulatory filings for all Products, including, but not limited to clinical trial dossiers, regulatory correspondence, Regulatory Authority meeting minutes and study reports from completed non-clinical and clinical studies. For all completed study reports, EVOTEC shall provide necessary documentation to confirm data reliability, including but not limited to original author signatures, raw data lists, GLP and GCP compliance information. All documentation is to be provided in English. Promptly after the Closing Date, EVOTEC shall transfer to ROCHE the historical clinical safety data prior to ROCHE starting clinical trial enrollment activities. It is agreed that after transfer of historical clinical safety data (Safety information on serious adverse events shall be provided in CIOMS format and Safety information on non-serious adverse events shall be provided in English Line Listing format). ROCHE shall be solely responsible for maintaining the global safety database for the Product.
Transfer of Regulatory Documents. CoLucid shall immediately transfer possession and ownership (and shall cause all contractors used by CoLucid to provide services hereunder to transfer possession and ownership) to Lilly (and in Lilly’s name where appropriate) of all Clinical Trial data and information, all Clinical Trial databases, all data generated in support of Applications for Marketing Authorization, Regulatory Approvals or other regulatory commitments (e.g., toxicology and stability data) and regulatory documents (including, but not limited to, Applications for Marketing Authorization, Regulatory Approvals and any correspondence between CoLucid and any sublicensee or contractor of CoLucid and any regulatory agency) that were created and/or developed under the terms of this Agreement for Compound or Product (collectively, the “Regulatory Documents”); provided, however, that if the termination relates only to a specific country, then only the Regulatory Documents pertaining to such country will be transferred to Lilly hereunder. In such case, CoLucid will maintain possession and ownership of all other Regulatory Documents. Should Lilly elect to sublicense, or to co-market or co-promote Product with a Third Person in the Territory, pursuant to Lilly’s rights under this Section 11.3, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Application for Marketing Authorization, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person. Except as contemplated by subsection (c) above, CoLucid shall not be entitled to any compensation for the use of Regulatory Materials.
Transfer of Regulatory Documents. To the extent requested by Xxxxx, Xxxxx shall promptly thereafter transfer possession and the exclusive license under (and shall cause all contractors used by Magen to provide services hereunder to transfer possession and license) to Lilly (and in Lilly’s name where appropriate) of all Clinical Trial data and information, all Clinical Trial databases, all data generated in support of Marketing Applications, Regulatory Approvals or other regulatory commitments (e.g., toxicology and stability data) and regulatory documents (including any correspondence between Magen and any sublicensee or contractor of Magen and any regulatory agency relating thereto) that were created and/or developed under the terms of this Agreement for Licensed Compound or Licensed Product (collectively, the “Regulatory Documents”). Lilly shall compensate Magen for its access to and use of such Regulatory Documents, in accordance with the agreed terms as above. Should Lilly elect to sublicense, or to co-market or co-promote Licensed Product with a Third Person in the Territory, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Marketing Application, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person, subject to payment of the compensation amounts as agreed for any such access and use by such Third Person.
Transfer of Regulatory Documents. If this Agreement is terminated by Lilly under Sections 10.2 or 10.5, Neurogenetics shall promptly transfer possession and ownership (and shall cause all contractors used by Neurogenetics to provide services hereunder to transfer possession and ownership) to Lilly (and in Lilly’s name where appropriate) of all Clinical Trial data and information, all Clinical Trial databases, all data generated in support of Applications for Marketing Authorization, Regulatory Approvals or other regulatory commitments (e.g., toxicology and stability data) and regulatory documents (including, but not limited to, Applications for Marketing Authorization, Regulatory Approvals and any correspondence between Neurogenetics and any sublicensee or contractor of Neurogenetics and any regulatory agency) that were created and/or developed under the terms of this Agreement for Compound or Product (collectively, the “Regulatory Documents”). Should Lilly elect to sublicense, or to co-market or co-promote Product with a Third Person in the Territory, Lilly *** Confidential Treatment Requested shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Application for Marketing Authorization, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person.
