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.
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

  • 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.

  • 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.

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • 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.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Licensed Technology The term "Licensed Technology" shall mean the ------------------- Licensed Patents, plus all improvements thereto developed by Licensor, and all related data, know-how and technology.

Time is Money Join Law Insider Premium to draft better contracts faster.