Transferred Regulatory Documentation has the meaning set forth in Section 2.2(a)(vii).
Transferred Regulatory Documentation means (i) all Existing Regulatory Filings and (ii) all other Regulatory Documentation owned by any Seller Party or any of their Affiliates (including any copies (electronic or otherwise) thereof) that was acquired, developed, compiled, collected or generated in connection with the Lead Compound or the Additional Compound.
Transferred Regulatory Documentation means all Regulatory Documentation that relates solely and exclusively to the Licensed Compound and/or the Licensed Products.
Examples of Transferred Regulatory Documentation in a sentence
There are no Proceedings pending or, to the knowledge of Seller, threatened, which could result in the revocation, cancellation or suspension of any registration listed in the Transferred Regulatory Documentation.
From and after the Closing Date, Buyer will assume control of, and responsibility for all costs and Liabilities arising from or related to any Transferred Regulatory Documentation, including any commitments or obligations to any Governmental Authority involving the Business arising after the Closing Date.
Seller is the sole and exclusive owner of each registration listed in the Transferred Regulatory Documentation and has not granted any right of reference with respect thereto.
More Definitions of Transferred Regulatory Documentation
Transferred Regulatory Documentation means all Regulatory Documentation that is used or held for use in connection with the Licensed Products in the Galapagos Territory or related to the Transferred Clinical Trials to the extent Controlled by Gilead or any of its Affiliates.
Transferred Regulatory Documentation means all Regulatory Documentation that relates exclusively to the Territory, including, without limitation, the Transferred Regulatory Documentation described as set forth in Schedule 7.
Transferred Regulatory Documentation means all Regulatory Documentation that relates to Crofelemer API, the Licensed IP and/or any Licensed Product.
Transferred Regulatory Documentation means (a) all documentation comprising the Transferred Approvals, and all reports, regulatory applications, submissions and filings in connection therewith and (b) all correspondence and reports submitted to or received from Governmental Authorities in the Regeneron Territory to the extent related to any such Approvals or to the Commercialization of any Existing Praluent Product for any Existing Indication in the Regeneron Territory, and all relevant supporting documents with respect thereto, in each case ((a) and (b)), in the possession or Control of Sanofi or any of its Affiliates as of the Transition Date. For clarity, the term “Transferred Regulatory Documentation” shall only refer to the embodiments of such documentation, reports, applications, submissions, filings or correspondence and expressly excludes any Sanofi Core Know-How or any of Sanofi’s rights in or to the Existing Joint Know-How included or referenced therein, which shall be subject to the license grants in Section 2.2. The transfer to Regeneron of the Transferred Regulatory Documentation under Section 2.6 shall not operate to vest or result in any assignment or transfer of any rights, title or interest in and to such Know-How. For the avoidance of doubt, the term “Transferred Regulatory Documentation” shall not include any Trademark or Domain Name registration documentation, prosecution or enforcement files or Trademark clearance searches or conflict or opposition records and files.
Transferred Regulatory Documentation means (a) any Regulatory Documentation owned by Mereo or its Affiliates with respect to any Drug Substance or Licensed Product in the UGNX Territory existing as of the Effective Date and (b) any Regulatory Documentation owned by Mereo or its Affiliates with respect to any Drug Substance or Licensed Product in the Mereo Territory existing as of the Effective Date that is necessary for UGNX to perform its obligations under the Core Development Plan in the Mereo Territory (including clinical trial applications), but for clarity, excluding, with respect to countries in the Mereo Territory, (i) pediatric investigation plans (“PIP”), (ii) priority medicine (“PRIME”), orphan drug and similar designations granted by the applicable Regulatory Authorities in the Mereo Territory, and (iii) all other Regulatory Documentation primarily related to Section 1.168(b)(i) & (ii) existing at any time during the Term ((i) through (iii), the “Specified EMA Documentation”).