Roche’s Responsibilities Sample Clauses

Roche’s Responsibilities. From and after the Effective Date, subject to the remainder of this paragraph and Regeneron’s obligations in Section 6.1.1, Roche shall be solely responsible [* * *] for all regulatory affairs specifically with respect to any Product in the Roche Territory, including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, manufacture, have manufactured, import, have imported, sell and have sold Products in the Roche Territory. Roche shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all Products throughout the Roche Territory. To the extent permitted by Applicable Law, (i) Roche shall provide Regeneron reasonable advance notice of any meeting with any Regulatory Authority in a Major Country related to the preparation or filing of such applications, and Regeneron may appoint [* * *] Regeneron employees to attend any such meeting with Regulatory Authorities in such Major Country; and (ii) Roche shall seek input from Regeneron in preparing such regulatory materials and interactions, and Regeneron shall have the right to review and comment on all material filings and submissions prepared and exchanged with Regulatory Authorities in support of obtaining or maintaining Regulatory Approval for the Products in each Major Country, and Roche shall consider such comments in good faith. Without limiting the foregoing, in preparing regulatory filings with Regulatory Authorities with respect to the Products in the Roche Territory, Roche shall not disclose any Sensitive Information to any Regulatory Authority without Regeneron’s prior written approval, [* * *]. Roche shall not submit to a Regulatory Authority, or otherwise agree to any Product labeling (or any modification thereto) that is not consistent with the CCDS, without the prior written consent of Regeneron. During the Agreement Term, Roche or its Affiliates shall own, maintain and file in their discretion all regulatory filings and Regulatory Approvals for all Products throughout the Roche Territory. Notwithstanding the foregoing, Regeneron shall be responsible for the First Approval Activities and the Regeneron Regulatory Responsibilities, in each case, as described in Section 6.1.1 and Regeneron and its Affiliates shall own, maintain and file all regulatory filings and Regulatory Approvals w...
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Related to Roche’s Responsibilities

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  • Joint Responsibilities In performing the Development Efforts, each party shall

  • Company Responsibilities The Company will undertake responsibilities as set forth below:

  • Client Responsibilities During the Term and subject to the provisions of this Schedule, Client shall at its expense (unless otherwise provided for herein) fulfill, or cause to be fulfilled by the Funds or otherwise, the Client obligations, if any, set forth in each Service Exhibit to this Schedule. Client hereby represents, warrants and covenants that the execution and delivery of this Schedule by Client and the performance of Client’s obligations under this Schedule have been duly authorized by all necessary action on the part of Client. Client must comply with the provisions of this Schedule. Client agrees that DST may seek relief from Client for any infringement of this Schedule such as, but not limited to, a material violation, breach, act of negligence or gross negligence, willful misconduct, misfeasance or malfeasance committed by Client or its officers, agents and assigns, in connection with Client’s obligations and responsibilities under this Schedule.

  • Position Duties Responsibilities 3.01 It is contemplated that at all times during the Period of Employment the Executive shall continue to serve as a principal officer of the Company with the office and title of Vice President, General Counsel of the Company and continue to have duties and responsibilities commensurate with those duties and responsibilities imposed on the Executive immediately prior to the Effective Date.

  • Contractor Responsibilities It shall be Tenant’s responsibility to cause each of Tenant’s contractors and subcontractors to:

  • Other Responsibilities The delivery of any notices to, and the obtaining of any consents from, any Permitted Transferee with respect to any provision of this Agreement, including, but not limited to, Sections 7.1 and 7.4, shall be your sole responsibility, unless otherwise agreed to in writing between such Permitted Transferee and the Sponsor. Neither the Company nor the Sponsor shall be liable to any Permitted Transferee for your failure to deliver a notice to, or obtain a consent from, any Permitted Transferee with respect to any provision of this Agreement, including, but not limited to, Sections 7.1 and 7.4.

  • Customer Responsibilities (a) The Customer agrees to (i) promptly notify the Bank of any change that the Customer wishes to make to Exhibit B, (ii) promptly notify the Bank if any information contained in the Customer Information Sheet becomes inaccurate or untrue and (iii) indemnify the Bank for any losses resulting from the Customer's failure to adhere to the provisions of Subsection (a) of this Section 11.

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