Regulatory Responsibilities definition
Examples of Regulatory Responsibilities in a sentence
The Administrator shall post on the website any information or notice of interest to the agricultural community relating to the GEMAA, including any Notice of Discontinuation of Regulatory Responsibilities, notice of Last Sale, or Notice of Patent Expiration received by the Administrator.
Regulatory Responsibilities With Respect to Licensee Territory; Preparation of Regulatory Submissions.
Except for the Torii Regulatory Activities, which will be conducted by or on behalf of Torii for the Licensed Product in the Field in the Territory in accordance with Section 3.1 (Regulatory Responsibilities) and any Torii Development Activities, BioCryst, at its sole cost and expense unless otherwise agreed by the Parties, will have sole control over and decision-making authority with respect to all Development activities for the Licensed Product inside and outside of the Territory.
KALITTA's responsibility and risk for any such loss or damage is limited to actual direct physical loss of or damage to the Aircraft and or Engine, its parts, items of Customer's Property or items of CUSTOMER Furnished Parts and excluded special, incidental, or consequential damages, as provides for in Article 11.2 6 REGULATORY REQUIREMENTS 6.1 KALITTA Regulatory Responsibilities KALITTA shall: A.
For the avoidance of doubt, ▇▇▇▇▇’ performance under this Section 6.4.1 (Regulatory Responsibilities; Major Regulatory Submissions) shall be at no cost to Novartis.
The Parties acknowledge that (i) Lex has acquired the Rights from M▇▇▇▇▇▇▇▇▇▇ as of the date hereof on the basis of representations and warranties regarding the Rights made by M▇▇▇▇▇▇▇▇▇▇ for the benefit of Lex and (ii) pursuant to the Regulatory Responsibilities Agreement, M▇▇▇▇▇▇▇▇▇▇ shall be responsible for maintaining and performing all Legal Requirements relating to the Rights.
Such costs may include, but are not limited to, Services requested by Buyer as per the following Sections: 3.7 Regulatory Responsibilities; 3.8 Agencies; 4.2 Procurement, Assembly and Test Responsibility; 4.3 Product Changes, Support and Sustaining Engineering; 5.5 Product Orders, Forecasts, and Schedule Changes; 7.6 Recalls; 7.7.2 Decontamination; 7.
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 with respect to the Regeneron Regulatory Activities in the Roche Territory.
Except as set forth in Section 4.3 (Regulatory Responsibilities), VGX shall be solely responsible for Developing and Commercializing Licensed Products in the Licensed Field during the Term.
Without limiting Partner’s responsibility for the Partner Regulatory Activities, which will be conducted by or on behalf of Partner for the Licensed Products in accordance with Section 3.1 (Regulatory Responsibilities) and, except for any uniQure Development Activities, Partner, at its sole cost and expense and subject to the terms of this Agreement, will be solely responsible for all Development activities for the Licensed Products in the Territory.