Licensed Vir Programs Sample Clauses

Licensed Vir Programs. Notwithstanding anything to the contrary in this Section 7.1, if, and solely for so long as, Brii Bio is not permitted under Applicable Law in the China Territory to make Regulatory Submissions and to obtain and maintain Regulatory Approvals for Licensed Products for a Vir Program in the China Territory, then this Section 7.1(e) shall apply in addition to the foregoing provisions of Section 7.1 and, in the event of conflict between this Section 7.1(e) and the rest of this Section 7.1, this Section 7.1(e) shall
Sample 1
AutoNDA by SimpleDocs
Licensed Vir Programs. Brii Bio may use such right of reference to Vir’s Regulatory Submissions for Vir Programs solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products for Vir Programs in the Field in the China Territory. Vir may use the right of reference to Brii Bio’s Regulatory Submissions for Vir Programs, if any, solely for the purpose of seeking, obtaining and maintaining regulatory approval of Licensed Products for a Vir Program outside the China Territory.
Sample 1
Licensed Vir Programs. (i) Brii Bio shall report to the applicable Regulatory Authorities in the China Territory all quality complaints, applicable adverse events, and safety data related to Licensed Products in a Vir Program for all Clinical Trials conducted in the China Territory under the China Development Plan or the Vir Global Plan, as well as responding to safety issues and to all requests of Regulatory Authorities related to Licensed Products in a Vir Program in the China Territory. Brii Bio shall provide to Vir access to Brii Bio’s adverse event database for the China Territory for such Licensed Vir Programs. Vir shall maintain a global pharmacovigilance database (including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) for Clinical Trials conducted under the Global Development Plan at Vir’s cost and expense, and Brii Bio shall use such database and related processes for the handling and reporting of SAEs and SUSARs for Clinical Trials for a Licensed Vir Program conducted in the China Territory. If there is no development of Licensed Products for such Licensed Vir Program outside of the China Territory, then Brii Bio shall maintain an adverse event database for Clinical Trials conducted in the China Territory under the China Development Plan for such Licensed Vir Program, at its sole cost and expense, and Brii Bio shall provide to Vir access to Brii Bio’s pharmacovigilance database for the China Territory for such Licensed Vir Program. (ii) Brii Bio shall comply with all Applicable Laws governing adverse events in the China Territory. Brii Bio shall notify Vir in a timely manner and in any event within [***] hours of receiving notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material information relevant to the safety or efficacy of Licensed Products in a Vir Program.
Sample 1
Licensed Vir Programs. Upon reasonable prior notice to Brii Bio, Vir or its representatives may conduct an audit of safety and regulatory systems, procedures or practices of Brii Bio, its Affiliates, sublicenses, or subcontractors (including Clinical Trial sites) relating to Licensed Products of a Vir Program. Brii Bio shall promptly notify Vir of any inspection of Brii Bio, its Affiliates, sublicenses, or subcontractors (including Clinical Trial sites) by any Regulatory Authority relating to Licensed Products of a Vir Program and shall provide Vir with all information pertinent thereto. Vir may be present at any such inspection. Brii Bio shall also permit Regulatory Authorities outside the China Territory to conduct inspections of Brii Bio, its Affiliates, sublicenses, or subcontractors (including Clinical Trial sites) relating to Licensed Products of a Vir Program, and shall ensure that such Affiliates, and shall use Commercially Reasonable Efforts to ensure that such sublicensees and subcontractors, permit such inspections. Brii Bio shall provide Vir with a written summary in English of any findings of a Regulatory Authority following a regulatory audit within [***] following any such audit, and shall provide Vir with an unredacted copy of any report issued by such Regulatory Authority, including a English translation thereof, as soon as reasonably practicable, but in all events within [***] following such audit.
Sample 1
Licensed Vir Programs. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Brii Bio relating to any Licensed Product of a Licensed Vir Program, then Brii Bio shall notify Vir of such contact, inspection, or notice or action within [***] hours thereof. Vir may review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product of a Licensed Vir Program. The costs and expenses of any regulatory action in the China Territory shall be borne solely by Brii Bio. Brii Bio shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit the Parties to trace the distribution, sale and use of Licensed Products of a Licensed Vir Program in the China Territory. In addition, each Party shall promptly notify the other of any information it receives regarding any threatened or pending action, inspection or communication by or from a Third Party that would reasonably be expected to materially affect the Development of Licensed Products of a Licensed Vir Program.
Sample 1
Licensed Vir Programs. Brii Bio shall and hereby does grant to Vir a worldwide non-exclusive, perpetual, irrevocable, sublicensable through multiple tiers, royalty-free license under all of Brii Bio’s Sole Inventions, and all intellectual property contained therein, that relate specifically to the Licensed Product in a Vir Program, solely for Vir’s use in the development, Manufacture or commercialization of any Product or Licensed Product of the Vir Program.
Sample 1

Related to Licensed Vir Programs

  • Third Party Programs This Licensed Software may contain third party software programs (“Third Party Programs”) that are available under open source or free software licenses. This License Agreement does not alter any rights or obligations You may have under those open source or free software licenses. Notwithstanding anything to the contrary contained in such licenses, the disclaimer of warranties and the limitation of liability provisions in this License Agreement shall apply to such Third Party Programs.

  • 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.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Third Party Products and Services Any third-party hardware, software and/or services that is delivered by ResMed for use either standalone or in conjunction with ResMed products and/or services, shall be subject to the third-party terms and conditions and/or license agreements between Customer and the third party. Such third-party hardware, software and/or services is provided by ResMed "AS IS," without any warranty of any kind. Any representations or warranties as to such hardware, software and/or services shall only be as granted by the applicable third parties, if any, that accompany such products and/or software and/or services. Any representations, warranties, or other similar obligations with respect to such third-party hardware, software and/or services flow directly from the third party to Customer and ResMed shall have no responsibility at all for any such representations, warranties, obligations or lack thereof.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • 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.

  • Company Products Schedule 2.10(d) of the Company Disclosure Letter lists all Company Products, and for each such product or feature (and each version thereof) identifying its release date.

  • Third Party Products 12.1 Third-party products provided to you by NCR Voyix for use with your subscription to the Service are subject to any terms provided by their supplier, including but not limited to those terms and conditions set forth in the exhibits attached hereto. Third-party terms and conditions are subject to change at any time by the supplier, and you agree that your use of such third-party products and services is governed by such supplier’s terms and conditions. You hereby release NCR Voyix from any and all liability associated with any damages or claims arising out of or related to third-party products. UNLESS NCR Xxxxx SPECIFICALLY AGREES OTHERWISE IN WRITING, YOU ACKNOWLEDGE AND AGREE THAT SUCH THIRD-PARTY PRODUCTS ARE PROVIDED “AS-IS” WITHOUT A WARRANTY FROM NCR Voyix. ACCORDINGLY, NCR Voyix EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY NATURE WITH RESPECT TO ANY SUCH THIRD-PARTY PRODUCTS, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF ANY THIRD-PARTY RIGHTS. 12.2 Third-party products and services may be advertised or made available to you for purchase directly from their supplier by email or other electronic communications, including notifications made through the Service or the Account Portal. Any representations or warranties that may be provided in connection with any such third-party products or services are provided solely by their supplier. NCR Voyix will not be responsible for any of your dealings or interactions with any of those third-party suppliers.

  • Licensed Technology (a) LICENSOR is not aware of any interference, infringement, misappropriation, or other conflict with any intellectual property rights of third parties, and LICENSOR has never received any charge, complaint, claim, demand, or notice alleging any such interference, infringement, misappropriation, or violation (including any claim that LICENSOR must license or refrain from using any intellectual property rights of any third party). To the knowledge of LICENSOR, no third party has interfered with, infringed upon, misappropriated, or otherwise come into conflict with any of the LICENSED TECHNOLOGY. (b) Exhibit A identifies each patent or registration which has been issued to LICENSOR with respect to any of the LICENSED TECHNOLOGY and identifies each pending patent application or application for registration which LICENSOR has made with respect to any of the LICENSED TECHNOLOGY. LICENSEE acknowledges that LICENSOR has previously made available to LICENSEE correct and complete copies of all such patents, registrations and applications (as amended to-date) in LICENSOR’s possession and has made available to LICENSEE correct and complete copies of all other written documentation in LICENSOR’s possession evidencing ownership and prosecution (if applicable) of each such item. (c) Exhibit A identifies each item of LICENSED TECHNOLOGY that is assigned to LICENSOR or that LICENSOR uses pursuant to license, sublicense, agreement, or permission. LICENSOR has made available to LICENSEE correct and complete copies of all such licenses, sublicenses, agreements, patent prosecution files and permissions (as amended to-date) in LICENSOR’s possession. With respect to each item of LICENSED TECHNOLOGY required to be identified in Exhibit A and to the knowledge of LICENSOR: (i) the license, sublicense, agreement, or permission covering the item is legal, valid, binding, enforceable, and in full force and effect; (ii) the license, sublicense, agreement, or permission will continue to be legal, valid, binding, enforceable, and in full force and effect on identical terms following the consummation of the transactions contemplated hereby; (iii) no Party to the license, sublicense, agreement, or permission is in breach or default, and no event has occurred which with notice or lapse of time would constitute a breach or default or permit termination, modification, or acceleration thereunder; (iv) no party to the license, sublicense, agreement, or permission has repudiated any provision thereof; (v) the underlying item of LICENSED TECHNOLOGY is not subject to any outstanding lien or encumbrance, injunction, judgment, order, decree, ruling, or charge; (vi) no action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand is pending or is threatened which challenges the legality, validity, or enforceability of the underlying item of LICENSED TECHNOLOGY; and (vii) except as provided in Exhibit A, LICENSOR has not granted any license or similar right to the LICENSED TECHNOLOGY within the GENERAL FIELD or PARTHENOGENESIS FIELD.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!