Existing Regulatory Materials for the Rituximab Licensed Products Clause Samples

The 'Existing Regulatory Materials for the Rituximab Licensed Products' clause defines the set of regulatory documents, approvals, and filings that pertain to Rituximab products already licensed for use. This typically includes items such as marketing authorizations, product dossiers, and correspondence with regulatory authorities that have been previously submitted or approved. By clearly identifying and referencing these materials, the clause ensures that both parties understand which regulatory assets are available for use or reliance in the context of the agreement, thereby facilitating compliance and streamlining future regulatory submissions or product development activities.
Existing Regulatory Materials for the Rituximab Licensed Products. (A) Promptly after the Effective Date, Innovent shall transfer, or cause to be transferred to the extent not owned by Innovent, to Coherus (or its designee), any and all Regulatory Materials for the Rituximab Licensed Products in the Territory held by or on behalf of Innovent, its Affiliates or contractors as of or prior to the Effective Date (the “Rituximab Existing Regulatory Materials”), including providing true, accurate, and complete hard or electronic copies thereof to Coherus that may include key reports, information and data including sections of any BLA submitted by Innovent to the NMPA, clinical reports, patient data, chemistry, manufacturing and control data and analytics, immunogenicity data, and any additional materials mutually determined by the Parties through the JSC. To the extent any Rituximab Existing Regulatory Materials are not in the English language, Innovent shall provide to Coherus no later than [***] ([***]) months from the Effective Date formal English translations of such Rituximab Existing Regulatory Materials that the Parties through the JSC determine need to be translated (with the Parties having an obligation to make such determination through the JSC within [***] ([***]) days of the Effective Date, unless otherwise agreed by the Parties), such translations to be performed by certified translators in the medical and/or scientific field for such Rituximab Existing Regulatory Materials sufficient for Coherus to hold meetings with the FDA to discuss filing an IND, aBLA and other Regulatory Materials for the Rituximab Licensed Product in the Territory. The cost of translating the Rituximab Existing Regulatory Materials into English shall be borne [***], which shall include any costs and expense incurred by Innovent prior to the Effective Date directly in connection with such translation, to the extent reasonably documented.
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Related to Existing Regulatory Materials for the Rituximab Licensed Products

  • Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Existing Products Except as set forth below, Contractor shall retain all rights, title and interest in Existing Products.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall ▇▇▇▇, and shall cause its Affiliates and Sublicensees to ▇▇▇▇, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.