WRN Product definition
Examples of WRN Product in a sentence
The JSC shall meet in accordance with Section 5.7.2 for so long as either (a) the Parties are conducting activities under any Collaboration Program or (b) GSK or its Affiliates or Sublicensees are Commercializing the MAT2A Product or WRN Product in the Profit-Sharing Territory.
Following Regulatory Approval of the first WRN Product, GSK shall pay all such Patent Costs in the Net Sales Territory and the Parties shall share such Patent Costs with respect to Profit Sharing Territory as set forth in the Pre-Tax Profit or Loss Schedule.
GSK will have sole decision-making authority with respect to the determination of whether or not to submit IDEAYA Existing Patents, IDEAYA Arising Patents, Patents within the Joint Arising Technology, or any GSK Patent, in each case, which Patents claim or cover a POLQ Product, WRN Product, or, and solely as of and after the Option Closing Date, if applicable, the MAT2A Product to the applicable regulatory authorities for listing in the Orange Book as required under the H▇▇▇▇-▇▇▇▇▇▇ Act.
For clarity, the Development Costs shared under the preceding sentence include Development Costs incurred in the conduct of any pre-clinical or clinical Development activities regarding a combination of a MAT2A Compound, MAT2A Product, WRN Compound or WRN Product, on the one hand, and a compound or product Controlled by GSK or its Affiliate (other than by way of this Agreement), on the other hand (e.g., a GSK PRMT Product).
Each of the JCC for the WRN Product and the JCC for the MAT2A Product shall meet in accordance with Section 5.7.2 until the expiration or termination of the Profit-Sharing Term with respect to the applicable JCC’s Licensed Product.
No later than the Initiation of the first Registration Study for the WRN Product and the first Registration Study for the MAT2A Product, respectively, and in each case with respect to the United States, the JSC will establish separate joint commercialization committees (each a “Joint Commercialization Committee” or “JCC”) for each of the WRN Product and the MAT2A Product.
The Parties shall share all Patent Costs as Shared Development Costs with respect to Subject Patents covering or claiming, or arising in connection with, the WRN Program during the Term until the Regulatory Approval of the first WRN Product.
GSK shall prepare and submit to the applicable JCC a Commercialization Plan for the MAT2A Products (solely if the Option Closing Date occurs) and a Commercialization Plan for the WRN Products, with a corresponding Commercialization Budget at least [***] ([***]) months prior to [***] (solely if the Option Closing Date occurs) or WRN Product for review by the applicable JCC.
The Financial Working Group shall meet in accordance with Section 5.7.2 for so long as either (a) the Parties are engaging in sharing of Development Costs for the WRN Program, or for the WRN Development Program or MAT2A Development Program, respectively, or (b) GSK or its Affiliates are Commercializing the MAT2A Product or WRN Product in the Profit-Sharing Territory.
Each JCC shall be the forum through which GSK keeps IDEAYA informed about its Commercialization activities related to the WRN Product and MAT2A Product to facilitate transparency for planning purposes with respect to the anticipated Pre-Tax Profit and Loss.