Licensee Territory. Licensee shall have the right to decide for which, if any, of the Patent Rights within the Licensee Patent Rights, Joint Patent Rights, and Takeda Patent Rights, the Parties should seek patent term extensions in the Licensee Territory. Licensee shall inform Takeda of its decision. Licensee shall be responsible for applying for the patent term extension, unless, with respect to Takeda Patent Rights, the applicable patent authority requires Takeda to file such application; in such event, Takeda shall cooperate with Licensee and shall apply for the patent term extension, at Licensee’s expense. Licensee shall be responsible for all expenses associated with any such patent term extension, including any Third Party expenses incurred by Takeda in furtherance of such filing. Licensee shall have the right to decide for which, if any, of the Patent Rights relating to the TAK-448 Licensed Compound or TAK-385 Licensed Products within the Licensee Patent Rights, Joint Patent Rights, and Takeda Patent Rights, the Parties should seek patent term extensions worldwide.
Licensee Territory. (i) In General. Licensee shall be responsible for any communications with the Regulatory Authorities occurring or required in connection with performing its responsibilities set forth in Section 2.4.2 and shall designate a representative to serve as the designated regulatory representative with respect to such communications.
Licensee Territory. Subject to the oversight of the JSC and the JDC and the other terms of this Article 3 and this Agreement, Licensee will be responsible, at its sole cost and expense, for conducting or having conducted, in accordance with the Development Plans, the Development of the Licensed Products in the Field anywhere in the world but solely for purposes of obtaining and maintaining Regulatory Approval of Licensed Products in the Licensee Territory and for Commercialization of such Licensed Products in the Licensee Territory.
Licensee Territory. (i) In General. Licensee shall be solely responsible for any communications with the Regulatory Authorities occurring or required in connection with performing its responsibilities set forth in Section 3.4.1 and shall designate a representative to serve as the designated regulatory representative with respect to such communications. (ii) Major Communications. Licensee will keep Licensor informed of any other significant interface or communication with the FDA or other Regulatory Authority which might affect efforts to obtain Regulatory Approval for the Licensed Products. (iii) Regulatory Contacts. During the Co-Promotion Period, Licensee shall provide Licensor with prior notice of all meetings and teleconferences with representatives of Regulatory Authorities regarding any Licensed Product intended for sale in Europe. Licensor shall have the right to have representatives present as observers at all such meetings and teleconferences, to the extent not prohibited by such Regulatory Authority. During the Co-Promotion Period, Licensee shall use reasonable
Licensee Territory. Japan [***] the following countries may be added to the Licensee Territory no later [***] following execution of this Agreement: Brunei, Cambodia, Hong Kong, Indonesia, Korea, Laos, Malaysia, Myanmar, Philippines, Singapore, Taiwan, Thailand, and Vietnam. [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Schedule 1.47 [***] [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Schedule 1.55 [***] [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Schedule 1.56 [***] [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Schedule 3.1 [***] [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. FIRST AMENDMENT to LICENSE AGREEMENT by and between MERCK SHARP & DOHME CORP. and UROVANT SCIENCES GMBH THIS AMENDMENT is made and entered into this April 27, 2017, by and between Merck Sharp & Dohme Corp. (“Merck”) and Urovant Sciences GmbH (“Urovant”) to amend the terms of that LICENSE AGREEMENT entered into between Merck and Urovant dated February 3, 2017.
Licensee Territory. Licensee or its designee shall have the first right, but not the obligation, to bring and control any legal action to enforce the [*] in the Licensee Territory with respect to a Competitive Infringement (such action an “Enforcement Action”), [*]. Licensee shall obtain Day One prior approval (not to be unreasonably delayed or withheld) to start an Enforcement Action and keep Day One reasonably informed as to the status of any such Enforcement Action and shall consider in good faith the comments of Day One with respect thereto. If Licensee or its designee fails to file an Enforcement Action with respect to, or fails to take steps to xxxxx, a Competitive Infringement with respect to the [*] in the Licensee Territory [*] after receiving or giving notice pursuant to Section 8.4.1, then Day One shall have the right, but not the obligation, to bring and control an Enforcement Action with respect to, or take steps to xxxxx, such Competitive Infringement in the Licensee Territory, [*] provided that Day One shall keep Licensee reasonably informed as to the status of such Enforcement Action.
