Examples of HBV Licensed Product in a sentence
Gilead shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Commercialize following Regulatory Approval [***] HBV Licensed Product in the Field in: [***].
Beginning at such time as the first HBV Licensed Product becomes Development-Ready, Gilead shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop for purposes of achieving Regulatory Approval [***] HBV Licensed Product in: [***].
Gilead shall pay Hookipa the following one (l)-time Milestone Payments under this Section 9.2(c) upon the first achievement of the corresponding development milestone event for: (i) the first HBV Licensed Product to achieve the corresponding development milestone event; and (ii) the first HIV Licensed Product to achieve the corresponding development milestone event.
Gilead shall pay Hookipa the following one (l)-time Milestone Payments under this Section 9.2(d) upon the first achievement of the corresponding commercial milestone event for the first HBV Licensed Product and for the first HIV Licensed Product.
Commercial Sale of such HBV Licensed Product in such country; (B) the expiration of the last-to-expire Valid Claim of a Patent Right within the Licensed Technology in such country that would be infringed by the sale of such HBV Licensed Product in such country in the absence of the licenses granted to Gilead under this Agreement; or (C) the expiration of any Regulatory Exclusivity in such country with respect to such HBV Licensed Product (the “HBV Royalty Term”).
Upon Alnylam HBV Program Completion, subject to the exercise by Alnylam of its Profit-Sharing Option pursuant to Section 4.2 with respect to an HBV Licensed Product and Alnylam’s responsibilities for HBV Licensed Product Manufacturing at Vir’s expense pursuant to Article V, Vir shall assume all responsibility for the further Development, Manufacture and Commercialization of HBV Licensed Products.
Effective upon the JSC’s approval thereof, such HBV Licensed Product shall be considered “Development-Ready” and shall thereafter be outside the scope of the applicable HBV Program and subject to Development, Manufacture, and Commercialization by or on behalf of Gilead, its Affiliates, or its sublicensees in accordance with this Agreement.
Except as set forth in Section 5.1(a)(i) above and subject to Section 5.4 below, Vir shall have the right and responsibility, at Vir’s expense, to Manufacture and supply HBV Licensed Product for Development and Commercialization in the Territory under the applicable Development Plan for the HBV Program following the successful completion of the transfer of Alnylam Know-How to Vir or its designated Third Party contract manufacturers pursuant to Section 5.3 and the applicable Development Supply Agreement.
As between the Parties, during the HBV Collaboration Term, Hookipa shall be responsible for preparing all non-clinical and CMC reports, in each case, as reasonably required by Gilead for inclusion in any IND filing for an HBV Licensed Product arising from the HBV Program.
With respect to each HBV Licensed Product and any ID Licensed Product, Vir shall provide Alnylam with written notice of all Regulatory Approvals [***] and the filing of any IND for such Licensed Product within [***] after such event; provided, however, that to the extent reasonably practicable and except as required by Law, Vir shall [***].