Shire Responsibilities Clause Samples

Shire Responsibilities. In consideration of its responsibilities, the Shire agrees to: (a) Provide sponsorship funding on the following dates: 2024/25 $20,000 December 2024 October 2025 2025/26 $20,000 December 2025 October 2026 2026/27 $20,000 December 2026 October 2027

Shire Responsibilities. Shire will maintain all regulatory filings and Regulatory Approvals in the ROW Territory for each Collaboration Product Developed pursuant to this Agreement, including all INDs and Drug Approval Applications. As between the Parties, Shire will be solely responsible for all activities in connection with maintaining Regulatory Approvals required for the Commercialization of Collaboration Product in the ROW Territory, including communicating and preparing and filing all reports (including adverse drug experience reports) with the applicable Governmental Authorities, as described in further detail in Section 3.4.3.

Shire Responsibilities. Shire shall file, prosecute and maintain Patents to cover Shire Inventions conceived pursuant to this Agreement or the ROW Agreement (the “Shire Collaboration Patents”). Shire shall keep New River informed of the status of each such Patent and shall give reasonable consideration to any suggestions or recommendations of New River concerning the preparation, filing, prosecution and maintenance thereof, including the suggestions of the JIPC pursuant to the terms set forth in Sections 2.5 and 2.7.4. The Parties shall cooperate reasonably in the prosecution of all Shire Patents under this Section 11.3.2 and shall share all material information relating thereto promptly after receipt of such information. If, during the Term, Shire intends to allow any Shire Patent to which New River has a license under this Agreement to expire or intends to otherwise abandon any Shire Patent, Shire shall notify New River of such intention at least sixty (60) days prior to the date upon which such Shire Patent shall expire or be abandoned, and New River shall thereupon have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution or maintenance thereof.

Shire Responsibilities. During the Term: (a) Subject to Subsections 5.1(b) and 5.4(a), Shire shall be solely responsible for and have sole discretion over (i) the planning and conduct of, and expenses associated with, clinical trials of Shire ZF Products; (ii) all regulatory filings and interactions with regulatory agencies with respect to such Shire ZF Products, except those filings and interactions in connection with any IND/CTA under a Research Plan; (iii) the selection of the countries in which Shire will pursue and maintain Marketing Approvals for such Shire ZF Products and expenses related to obtaining and maintaining such Marketing Approvals; and (iv) commercialization of such Shire ZF Products in the Territory and expenses associated with the commercialization of such Shire ZF Products. (b) For each Shire Target for which Sangamo has filed an IND or CTA for a Shire ZF Product directed to such Shire Target, or for which Shire has assumed the applicable Research Plan pursuant to Section 4.6, Shire shall use Commercially Reasonable Efforts to obtain Marketing Approval for at least one therapeutic Shire ZF Product directed to such Shire Target in each of the United States and at least one Major European Country. For the avoidance of doubt, if [***] Shire may [***]. (c) In the event that a Shire Target for which Sangamo has filed or intends to file an IND, CTA, or other foreign equivalent qualifies for an orphan drug designation, that designation will be in the name of Shire or one of its Affiliates.

Shire Responsibilities. During the Research Term, Shire shall be solely responsible for the costs set forth in the budgets for the Research Plans, which budgets shall be developed and approved by the JSC. Upon request by Sangamo, Shire shall provide reasonable consulting and technical support in order to assist Sangamo in carrying out its Research Program obligations. For the avoidance of doubt, the JSC shall have the right to prioritize Shire Targets within the Research Program and make final decisions as to whether and when to proceed with particular activities under the Research Program, provided that, during the Research Term, for so long as there are [***] in the Shire Exclusive Target Pool, Shire shall be required to fund the budget for a [***] Research Plans, each of which will attempt, where commercially and scientifically reasonable, to achieve an IND or CTA filing for a Shire ZF Product within [***] after the initiation of activities under such Research Plan.

Shire Responsibilities. Subject to the terms of this Agreement, Shire shall be solely responsible for the management and direction of the Shire Programs in its sole discretion and at its sole cost and expense. Without limitation, Shire shall be responsible for oversight of the Research Program during the Research Term and Development Plans, including activities conducted pursuant to the Research Plans, Development Plans, preclinical work, and IND/CTA submissions for each Shire Target.

Shire Responsibilities. After Development Candidate Selection, other than any Services to be provided by Sangamo, subject to Section 5.1, Shire shall assume sole responsibility for and have sole discretion over all development, regulatory, manufacturing and commercialization activities for Shire ZF Products (including any Shire ZF Compounds included therein), including (a) the planning, execution and submission of, and expenses associated with, IND-Enabling Studies and clinical trials of such Shire ZF Products; (b) the selection of the countries in which Shire will pursue and maintain Marketing Approvals for such Shire ZF Products and expenses related to obtaining and maintaining such Marketing Approvals; and (c) commercialization of such Shire ZF Products in the Territory and expenses associated with the commercialization of such Shire ZF Products. Shire and its Affiliates shall comply with all applicable laws, regulations and guidelines in conducting its clinical development, manufacturing and commercialization activities under this Agreement; provided, however, that Sangamo’s sole remedy for Shire’s or its Affiliate’s breach of this last sentence of Section 5.3 will be [***], and Sangamo will have [***].

Shire Responsibilities