Designated Regulatory Party definition
Examples of Designated Regulatory Party in a sentence
Upon the request of the other Party, the Designated Regulatory Party will permit the other Party to attend particular meetings between the Designated Regulatory Party and the applicable Governmental Authority.
In order to assist the Designated Regulatory Party, the Manufacturing Lead will prepare [*] in English for the relevant Product, and the Designated Regulatory Party will modify as appropriate such module for use in Regulatory Filings in the Collaboration Territory.
The other Party will cooperate with the Designated Regulatory Party, at its reasonable request, with respect to any regulatory matters for which the Designated Regulatory Party is responsible.
Upon request of the other Party, the Designated Regulatory Party will provide to the other Party copies of all final Regulatory Filings it submits.
The Designated Regulatory Party will consult with the other Party reasonably in advance of the date of any anticipated meeting with a Governmental Authority and will consider any timely recommendations made by the other Party in preparation for such meeting.
The Designated Regulatory Party will request that the applicable Governmental Authority allow at least one (1) representative of the other Party to attend, solely as an observer, such meetings; provided, that the foregoing will not apply to informal meetings or unscheduled teleconferences or meetings or teleconferences otherwise intended by the Governmental Authority to be between it and the Designated Regulatory Party’s representatives only.
Except as set forth in Section 3.2.4 (Manufacturing Matters), the JSC will allocate, on a Product-by-Product and country-specific basis, operational responsibility for regulatory activities to a Party (the “Designated Regulatory Party”) although there will be a presumption that the Development Lead will also be the Designated Regulatory Party.
The Designated Regulatory Party will consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Regulatory Filings it submits, Governmental Authority review of any such Regulatory Filings, and all Regulatory Approvals that it obtains with respect to a Product.
The other Party will strictly follow the Designated Regulatory Party’s instructions with respect to any meeting which it attends, and will not discuss the contents of any such meeting with any Governmental Authority except as required by Applicable Law or authorized by the Designated Regulatory Party in writing.
The Designated Regulatory Party will prepare, submit and maintain all Regulatory Filings and obtain all Regulatory Approvals for which it is responsible in accordance with the applicable Development Plan.