Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly provided herein, as between the Parties, TRANSCEPT (itself or through its sublicensees) shall have the sole right to and be responsible for preparing and submitting to applicable Regulatory Authorities any and all Regulatory Materials for the Product and obtaining and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for the Field within the Territory. Except as expressly set forth [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. in this Agreement or otherwise mutually agreed by the Parties in writing, SNBL shall not be ob...
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. 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. 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. 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.
Regulatory Filings and Regulatory Approvals. After the Effective Date of this Assignment and License Agreement, all regulatory filings and regulatory approvals will be filed in the name of and owned by GeoVax. GeoVax will own and solely Control all Regulatory Filings and Approvals for all Licensed Products throughout the Territory for use in the Field.
Regulatory Filings and Regulatory Approvals. (a) In accordance with the Global Development Plan, [Seres] shall be responsible for [***].
Regulatory Filings and Regulatory Approvals. Bayer will prepare, file and own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to Licensed Product in each country in the Bayer Territory. Nuvelo will prepare, file and own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to Licensed Product in the Nuvelo Territory.
