Examples of TAK-385 Licensed Product in a sentence
Each Party will provide to the other Party all reasonably requested assistance with respect to such Labeling activities for each TAK-385 Licensed Product in such Party’s Territory.
Each Party (the “Notifying Party”) shall promptly notify the other Party of any request for a meeting or substantive telephone conference call with a Regulatory Authority with respect to any TAK-385 Licensed Compound or TAK-385 Licensed Product in the Notifying Party’s Territory.
Takeda will have the sole right, but not the obligation, to bring at its own expense and in its sole control such action in the Takeda Territory related to the TAK-385 Licensed Compound or a TAK-385 Licensed Product.
During the Term, upon the receipt of Regulatory Approval in the Takeda Territory for a TAK-385 Licensed Product in the Men’s Health Field, Takeda will use [***] to Commercialize each TAK-385 Licensed Product in the Men’s Health Field in the Takeda Territory (the “Takeda Diligence Obligations”).
Unless otherwise agreed by the JRC, the JRC will meet at least [***] each Calendar Year until the First Commercial Sale of the first TAK-385 Licensed Product; provided that the JRC will hold an in-person meeting to establish the JRC’s operating procedures no more than [***] days after the Effective Date.
Following the [***] anniversary of the First Commercial Sale of the first TAK-385 Licensed Product in the Men’s Health Field in the Takeda Territory, Takeda’s obligation to perform all Commercialization activities in accordance with the Takeda Commercialization Plan, and to update and provide such plan as set forth in this Section 7.3 (Commercialization Plans), will end.
Thereafter, for the first [***] years after the First Commercial Sale of a TAK-385 Licensed Product in the Men’s Health Field in the Takeda Territory, Takeda will submit an updated Takeda Commercialization Plan for each TAK-385 Licensed Product to the JRC for review and discussion at least [***] each Calendar Year.
Takeda will have the sole right, but not the obligation, to bring an appropriate suit or other action against any Third Party engaged in any existing, alleged, or threatened infringement, or other violation of a Licensee Patent Right, Takeda Patent Right, or Joint Patent Right related to a compound or product that competes with the TAK-385 Licensed Compound or a TAK-385 Licensed Product in the Field in the Takeda Territory (a “Takeda Licensed Product Infringement”).
The Parties shall discuss in good faith appointment of a single outside counsel for Prosecution of both the Takeda Patent Rights and the Licensee Patent Rights that Cover the TAK-385 Licensed Compound or any TAK-385 Licensed Product.
Takeda shall promptly notify Myovant if Myovant is required pursuant to Applicable Law to make any changes to the TAK-385 Licensed Product INDs related to the appointment of a Third Party to Manufacture of the Drug Substance or Drug Product.