Regulatory Agent definition

Regulatory Agent means that Party designated by an appropriate ---------------- authorization to the FDA or its regulatory equivalent to be the primary contact with and receiving party of all correspondence from the FDA in connection with any regulatory matter or filing.
View Source
Regulatory Agent shall have the meaning set forth in Section 5.1.2.2.
View Source
Regulatory Agent means Epic Pharma LLC and its respective successors and permitted assigns.
View Source

Examples of Regulatory Agent in a sentence

  • In addition, to the extent that Citius receives any other communication or correspondence from any Regulatory Authority that may require a response or other action by Licensee, Citius will promptly provide Licensee and the Regulatory Agent with a copy of such communication or correspondence.

  • This Power of Attorney is in addition to and does not revoke or replace any prior Power of Attorney issued to the Regulatory Agent which is on file with the R.O.C. authorities.

  • Regulatory Agent: Gland will be the sole Regulatory Agent for the Products in North America for the term of the License.

  • Until the Registrations are transferred to Buyer, Buyer, as the Regulatory Agent, shall have responsibility for all communications with FDA and corresponding foreign bodies relating to the Products, and Company shall, and shall cause each of the Sellers to, promptly provide Buyer with copies of all communications to or from the FDA with respect to each Product and/or the manufacture thereof.

  • Following such designation, the Regulatory Agent will be the sole point of contact with Regulatory Authorities with respect to all matters relating to the Regulatory Filings and Approvals.

  • Citius shall remain responsible for preparation of annual reports to FDA and for any required updates to the CMC section of the Regulatory Approval and shall timely provide copies of these documents to Licensee and the Regulatory Agent for filing.

  • In connection with all Drug Approval Applications with respect to which ORTHO is Regulatory Agent, ORTHO agrees to provide CTI with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies that it makes hereunder.

  • Unless prohibited by Applicable Law, Hutchmed, itself or with or through any other Hutchmed Entity, shall be the Authorized Regulatory Agent of each Joint Global Trial in the Territory.

  • The Customer has appointed the Bank to act as the Regulatory Agent of the Customer under the Investment Regulations.

  • Other than to the extent Hutchmed serves as an Authorized Regulatory Agent as provided in this Agreement, neither Party is, nor will be deemed to be a partner, employee, agent or representative of the other Party for any purpose.