Regulatory Communications definition

Regulatory Communications means, collectively, whether existing before or after the NDA Transfer Date: (a) all written or electronic filings or submissions made with Regulatory Authorities in satisfaction of applicable regulatory and notification requirements with respect to Products in the Territory (including, without limitation, Annual Periodic Reports, Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports, and filings and submissions regarding recalls); (b) all written or electronic correspondence to or from the FDA with respect to any of the foregoing; (c) minutes of any meeting between a party and the FDA regarding the Regulatory Approvals, or Manufacture or Commercialization of the Products in or for the Territory; and (d) written summaries of oral communications between a party and the FDA that would impact, or would reasonably be expected to be material to, the development, Manufacture, commercialization of the Products and/or any ROR Product.

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Regulatory Communications has the meaning set forth in Section 6.1(b) hereof.

Regulatory Communications means, collectively, whether existing before or after the Closing Date: (a) all written or electronic filings or submissions made with Regulatory Authorities in satisfaction of applicable regulatory and notification requirements with respect to Products in the Territory (including, without limitation, Annual Periodic Reports, Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports, and filings and submissions regarding recalls); (b) all written or electronic correspondence to or from the FDA Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions marked [***]. with respect to any of the foregoing; (c) minutes of any meeting between a party and the FDA regarding the Regulatory Approvals, or Manufacture or Commercialization of the Products in or for the Territory; and (d) written summaries of oral communications between a party and the FDA that would impact, or would reasonably be expected to be material to, the development, Manufacture or commercialization of the Products.

Examples of Regulatory Communications in a sentence

Prior to responding to any Regulatory Communications, You will provide a copy of any such responses to Us for Our review and comment.
Prior to responding to any Regulatory Communications, PROVIDER will provide a copy of any such responses to MYLAN for ▇▇▇▇▇’s review and comment.
Depomed may provide all such Regulatory Communications and Regulatory Data to the applicable Third Parties under the Existing Rights of Reference Agreements and Additional Rights of Reference Agreements as Depomed determines is reasonably necessary to comply with the Existing Rights of Reference Agreements and Additional Rights of Reference Agreements.
Manager shall catalog and maintain copies of all Criticisms, Regulatory Communications, Legal Documents, Executive Complaints and Cardholder Complaints received by Manager (collectively, “Complaints”), and responses thereto for the period required by Applicable Law or such longer period as specified by ▇▇▇▇▇▇ Bank in a written notice to Manager.
Prior to responding to any Regulatory Communications, supplier will provide a copy of any such responses to Mylan for ▇▇▇▇▇’s review and comment.
Prior to responding to any Regulatory Communications, Seller will provide a copy of any such responses to Mylan for Mylan’s review and comment.
Except as expressly provided in Section 10.1.1 (Regulatory Communications and Filings) GSK will cooperate with Amgen, at its request, with respect to any regulatory matters related to Ivory.
Depomed shall have the right to request review and approve, with reasonable notice, any and all Regulatory Communications, Regulatory Approvals, and related regulatory documents that pertain to the Product NDAs before they are submitted to FDA or other Regulatory Authorities by Collegium or Newco.
Prior to responding to any Regulatory Communications, supplier will provide a copy of any such responses to Viatris for Viatris’ review and comment.
Gilead shall use Transition Activity Commercially Reasonable Efforts to provide a full copy of any material Regulatory Communications to Galapagos within […***…] of receipt by Gilead.

More Definitions of Regulatory Communications

Regulatory Communications has the meaning set forth in Section 11.2.

Regulatory Communications means any action, request, order, instruction, communication, complaint, notice, public announcement or inquiry by a Regulatory Authority or any submission, filing, letter or other communication by Pharmos, BLP or any manufacturer of Drug Substance to a Regulatory Authority, with respect to Drug Product, Placebo Product, Development Product or Drug Substance which is sent by or is received by either party (or, in the case of Pharmos, by any manufacturer of Drug Substance), or which comes to either party's or its agent's attention, including, but not limited, to field actions, investigations or recalls of Drug Product or Placebo Product in the New Territories.

Regulatory Communications any meetings, submissions, filings by CASI with any Regulatory Authority in a Region and any notices, correspondences, communications, or other filings received by CASI from any Regulatory Authority in a Region relating to the Development, manufacture, packaging, obtaining marketing authorization, marketing, selling or otherwise Commercialization of the Licensed Product in such Region.