Transferred Product Registrations Sample Clauses

The Transferred Product Registrations clause defines the process by which ownership or control of product registrations, such as regulatory approvals or licenses, is transferred from one party to another, typically in the context of a business sale or asset transfer. This clause outlines the specific registrations included, the obligations of each party to facilitate the transfer, and any required notifications to regulatory authorities. Its core practical function is to ensure that the acquiring party can legally market or distribute the products post-transfer, thereby preventing business disruption and ensuring compliance with applicable regulations.
Transferred Product Registrations. (a) The Transferred Product Registrations constitute all material registrations, applications, approvals, licenses or permits granted by any Governmental Authority to develop and market the Product, other than any Product Registrations held by Immedica or its Subsidiaries. (b) Except as set forth in Schedule 4.6(b), prior to the transfer of any Transferred Product Registration in accordance with this Agreement, Aeglea is the sole and exclusive owner of such Transferred Product Registration other than any Product Registrations held by Immedica or its Subsidiaries, and has not granted any right of reference with respect thereto.
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Transferred Product Registrations. (a) The Transferred Product Registrations constitute all material registrations, applications, approvals, licenses or permits granted by any Governmental Authority to develop and market the Product. (b) Except as set forth in ‎Section 3.09 of the Seller Disclosure Schedule, the Product is manufactured and marketed in accordance with the specifications and standards contained in the Transferred Product Registrations, except where the failure to comply therewith would not reasonably be expected to be material to the Business, the Purchased Assets and the Product, taken as a whole. (c) Except as set forth in ‎Section 3.09 of the Seller Disclosure Schedule, prior to the transfer of any Transferred Product Registration in accordance with this Agreement, Seller or one of its Subsidiaries is the sole and exclusive owner of such Transferred Product Registration and has not granted any right of reference with respect thereto.
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Transferred Product Registrations. All Transferred Product Registrations are in full force and effect and have been validly issued to Seller, and Seller has complied in all material respects with all terms and conditions thereof. None of Seller or its Affiliates has received written notice relating to the revocation, withdrawal, suspension, cancellation, termination or modification of any Transferred Product Registration and to the knowledge of Seller there are no circumstances currently existing that would reasonably be expected to lead to any withdrawal of, loss of or refusal to renew any Transferred Product Registration. No Action is pending or, to the knowledge of Seller, threatened regarding the suspension, cancellation, termination, or revocation of any Transferred Product Registration. Seller has delivered to Purchaser via being made available in the Data Room complete and correct copies of all the Transferred Product Registrations. Except as set forth in Section 3.08 of the Seller Disclosure Schedule, the Product sold under the Transferred Product Registrations was designed, developed, formulated, processed, Manufactured, tested and Exploited in accordance with the specifications and standards contained in such Transferred Product Registrations, and is not adulterated or misbranded within the meaning of any applicable Law.
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Related to Transferred Product Registrations

  • Product Trademarks BMS shall be solely responsible for the selection (including the creation, searching and clearing), registration, maintenance, policing and enforcement of all trademarks developed for use in connection with the marketing, sale or distribution of Products in the Field in the Territory (the “Product Marks”). BMS shall own all Product Marks, and all trademark registrations for said marks.

  • 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.

  • 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.

  • 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.

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