Regulatory Interactions definition

Regulatory Interactions means (i) monitoring and coordinating all regulatory actions, preparing, submitting, and coordinating all communications and filings with, and submissions to, any Regulatory Authority with respect to Emricasan or any other Product, and (ii) interfacing, corresponding, and meeting with any Regulatory Authority with respect to Emricasan and other Products.

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Regulatory Interactions means (a) all regulatory actions, communications and filings with, and submissions to, all Regulatory Authorities with respect to a Product, and (b) interfacing, corresponding and meeting with the Regulatory Authorities with respect to a Product.

Regulatory Interactions means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Development, Manufacture and Commercialization of Licensed Candidates, Licensed Products and Licensed Diagnostic Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Examples of Regulatory Interactions in a sentence

As of and after the date upon which the transfer described in Section 5.1 is effected, Celgene shall have sole responsibility for all Regulatory Interactions with Regulatory Authorities with respect to each Licensed Product.
Prior to submission of material correspondence to any Regulatory Authority with respect to the Licensed Products, the Party having the lead responsibility for Regulatory Interactions shall, sufficiently in advance for the other Party to review and comment, provide the other Party any material correspondence with the Regulatory Authority related to such meetings.
Each Party shall keep the JDC reasonably informed in connection with all Regulatory Interactions, preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, and any subsequent variations and changes to labeling, in each case with respect to the Licensed Products.
The Lead US Party shall have lead responsibility for all Regulatory Interactions with Regulatory Authorities in the US Territory for each Shared Product.
The Parties shall have joint responsibility for all Regulatory Interactions with Regulatory Authorities with respect to each Licensed Product, as and to the extent Developed under a Development Plan or under an Additional Study for which the Non-Proposing Party is co-funding.
During the PD-1 Term, Celgene shall keep Jounce reasonably informed of all Regulatory Interactions, preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, Regulatory Approvals, annual reports, including annual safety reports to the respective health authorities, annual re-assessments, and any subsequent variations and changes to labeling, in each case with respect to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products.
During the Research Program and until such time as a Strategic Partner assumes responsibility pursuant to a Qualifying Strategic Partnership, Histogen, in collaboration with Amerimmune, shall be responsible for and shall control all Regulatory Interactions relating to any Phase I or Phase II Study of Emricasan conducted pursuant to the Research Program, including the Initial Trials.
Celgene shall be responsible for Regulatory Interactions for any Monotherapy Product in the ROW Territory and any of its Non-Collaboration Combination Products anywhere in the Territory.
Jounce shall be responsible for Regulatory Interactions for any Monotherapy Product in the United States and any of its Non-Collaboration Combination Products anywhere in the Territory.
Promptly following the Discovery Term, Celgene shall have sole responsibility for all Regulatory Interactions with respect to the Collaboration Compounds, Licensed Compounds and Licensed Products Developed or Commercialized under each Picked Validated Program selected by Celgene.

More Definitions of Regulatory Interactions

Regulatory Interactions has the meaning set forth in Section 4.1(b)(vi).

Regulatory Interactions has the meaning set forth in Section 4.1(b)(iii).

Regulatory Interactions means (A) monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, all Regulatory Authorities with respect to a Compound or Licensed Product, (B) interfacing, corresponding and meeting with the Regulatory Authorities with respect to a Compound or Licensed Product, and (C) sole responsibility for pre- and post-authorization pharmacovigilance activities (including, but not limited to, preparation of PSUR, DSUR, IB, signal detection, etc.). Each Party shall use Commercially Reasonable Efforts to conduct Regulatory Interactions in the Shared Territory hereunder in accordance with the Development Plan and Joint Commercialization Plan, as applicable. Roche shall use Commercially Reasonable Efforts to conduct Regulatory Interactions for which Roche is responsible in the Roche Territory hereunder in accordance with the Development Plan and Roche Operational Plan, as applicable.