Regulatory Filings and Regulatory Approvals. (a) Licensee shall be responsible for preparing and filing Drug Approval Applications and seeking and maintaining Regulatory Approval for the Product in the Field in each jurisdiction in the Licensee Territory, including preparing all documentation and reports necessary in connection therewith, as well as securing data and market exclusivity where applicable in compliance with Applicable Laws in the Licensee Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a comprehensive summary in English and a copy in its original language of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Except as expressly set forth in this Agreement, all costs and expenses incurred by Licensee in connection with the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the Licensee Territory shall be borne solely by Licensee. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the Licensee Territory to be provided to OPKO by Licensee shall be borne by OPKO, while any costs and expenses related to the translation to Chinese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by Licensee.
Regulatory Filings and Regulatory Approvals. (a) Existing Regulatory Filings and Regulatory Approvals. BRIDGE shall promptly transfer and assign to ALGORX any Regulatory Filings and Regulatory Approvals (including any data or information contained or referenced therein), including but not limited to any draft IND documents and IND filings, and copies of all correspondence with Regulatory Authorities regarding any Compound or any Licensed Product. BRIDGE agrees to perform within sixty (60) days of the Effective Date all such acts, and execute such further instruments, documents or certificates, as may be required to more effectively transfer the Regulatory Filings to which reference is made above. EXECUTION COPY
Regulatory Filings and Regulatory Approvals. With respect to each Licensed Antibody Product, in a manner consistent with its obligations set out in this Licence Agreement, Amgen shall have the sole and full control, discretion authority and right to prepare, file and pursue and shall own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to each said Licensed Antibody Product in the Territory.
Regulatory Filings and Regulatory Approvals. Before making any submission to any Regulatory Authority, the Sponsor Party shall consult with and provide the other Party the opportunity to review draft Regulatory Filings with respect to a Joint Global Study (e.g., Type B meeting packages, key documents in INDs, NDAs, fast track, breakthrough designation and orphan drug application) to be submitted to the Regulatory Agency in its Sponsored Territory in advance of submission. Such other Party shall provide any comments within [***] ([***]) Business Days after receipt, but such Sponsor Party shall not be required to delay any planned submissions if it does not receive timely comments from such other Party. As between the Parties, AxxxXxxx shall prepare the first draft of the global submission dossier for the Parties’ review and comments. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Regulatory Filings and Regulatory Approvals. All Regulatory Filings and Regulatory Approvals will be held in the name of Amgen. On behalf of Amgen, BeiGene shall be responsible for obtaining and maintaining Regulatory Filings and Regulatory Approvals, including any renewal thereof, via the Amgen systems.
Regulatory Filings and Regulatory Approvals. With respect to each Licensed Product, at its discretion Hyseq will prepare, file and own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to each said Licensed Product in the Territory.
Regulatory Filings and Regulatory Approvals. 5.1.1 General Responsibilities; Ownership of Regulatory Approvals. [***].
Regulatory Filings and Regulatory Approvals. (a) In accordance with the Global Development Plan, [Seres] shall be responsible for [***].
Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies, Immatics CMC Activities, and Immatics GDP Trial.
Regulatory Filings and Regulatory Approvals. If any regulatory filings or Regulatory Approvals for the Compound or any Product are required for any of Licensee’s (or its Affiliate’s, sublicensee’s or subcontractor’s, as applicable) activities hereunder (including INDs, NDAs and other Regulatory Approvals, as applicable) with respect to the Compound or any Product in the Field in the Territory, then as between the Parties, Licensee will be solely responsible for obtaining, maintaining and complying with such regulatory filings or Regulatory Approvals and for communicating with Regulatory Authorities. All such regulatory filings and regulatory approvals will be filed in the name of and owned by Licensee or its designee, and Licensee or its designee will hold all Regulatory Approvals for Products throughout the Territory for use in the Field.
