Vir Program definition
Examples of Vir Program in a sentence
Notwithstanding anything to the contrary, Vir shall solely own all right, title, and interest in and to all Inventions generated by or on behalf of either Party in the conduct of any Pre-Option Development Activities for a Vir Program (“Vir Pre-Option Inventions”).
In addition, if following a change in Applicable Law during the Term, Brii Bio is permitted to own and hold the Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, held by Vir for Licensed Products for a Vir Program in the China Territory, then, promptly following Brii Bio’s request, Vir shall transfer such Regulatory Submissions and Regulatory Approvals for such Vir Program to Brii Bio.
Vir may review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product of a Licensed 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 shall be the sponsor for any Clinical Trials conducted by Brii Bio under a Pre-Option Development Plan for a Vir Program, and Brii Bio shall be the Sponsor for any Clinical Trials conducted by Vir under a Pre-Option Development Plan for a Brii Bio Program (such sponsoring Party, the “Sponsor”).
If [***] desires to obtain rights under such Third Party Vir Program IP, then the Parties shall reasonably cooperate with respect to the negotiation of such license by [***].
Brii Bio shall conduct all Commercialization of Licensed Products in a Licensed Vir Program in the Field in the China Territory in accordance with the Commercialization Plan for such Licensed Product, at its sole cost and expense.
Either Party may elect to exercise an Option for a Vir Program or Brii Bio Program, as applicable, during the applicable Option Period prior to delivery of a complete Option Data Package pursuant to Section 4.2, including where the Controlling Party elects to [***] Pre-Option Development Activities in accordance with Section 3.10 (an “Early Option Exercise”).
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.
Vir hereby grants to Brii Bio a right of reference to all Regulatory Submissions pertaining to compounds and Products of a Vir Program that is the subject of a Pre-Option Development Plan.