Regulatory Filings definition

Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

Regulatory Filings means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, and Commercialize Licensed Products in each country or jurisdiction in the Territory.

Regulatory Filings has the meaning set forth in Section 5.03(g).

Examples of Regulatory Filings in a sentence

• The names of the members of the Board of Directors may be obtained from:Sr. Manager, Regulatory Filings Blue Shield of California50 Beale StreetSan Francisco, CA 94105 Phone: 1-415-229-5065Please follow the following procedure:1.

• The names of the members of the Board of Directors may be obtained from the Sr. Manager, Regulatory Filings as listed above.

• The names of the members of the Board of Directors may be obtained from:Sr. Manager, Regulatory Filings Blue Shield of California50 Beale StreetSan Francisco, CA 94105 Phone: 1-415-229-5065Please follow the following procedure:1) Recommendations, suggestions or comments should be submitted in writing to the Sr. Man- ager, Regulatory Filings, at the above address, who will acknowledge receipt of your letter.

• Recommendations, suggestions or comments should be submitted in writing to: Sr. Manager, Regulatory Filings Blue Shield of California 000 00xx Xxxxxx Xxxxxxx, XX 00000 Phone: (000) 000-0000 Please include your name, address, phone number, Subscriber number, and group number with each communication.

• The names of the members of the Board of Directors may be obtained from:Sr. Manager, Regulatory Filings Blue Shield of California50 Beale StreetSan Francisco, CA 94105Phone Number: 1-415-229-5065 Please follow the following procedure:1.

More Definitions of Regulatory Filings

Regulatory Filings means all applications, filings, dossiers and the like (excluding routine adverse event expedited or periodic reporting), submitted to a Regulatory Authority for the purpose of obtaining Regulatory Approval from that Regulatory Authority.

Regulatory Filings means, with respect to the Product, any submission to a Regulatory Authority of any appropriate regulatory application, including, without limitation, any IND, NDA, any submission to a regulatory advisory board, any marketing authorization application, and any supplement or amendment thereto.

Regulatory Filings has the meaning set forth in Section 7.3 hereof.

Regulatory Filings means, with respect to Product, any submission to a Regulatory Authority of any regulatory application together with any material related correspondence and documentation (including minutes of any meetings, telephone conferences or material discussions with any Regulatory Authority) and shall include, without limitation, any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any IND, MAA or the corresponding application in any other country or group of countries.

Regulatory Filings shall have the meaning set forth in Section 3.4(e).

Regulatory Filings means, collectively: (a) all INDs, establishment license applications, drug master files, applications for designation as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)), NDAs and BLAs and all other similar filings (including, without limitation, counterparts of any of the foregoing in any country or region in the Territory); (b) all supplements and amendments to any of the foregoing; and (c) all data and other information contained in, and correspondence relating to, any of the foregoing.

Regulatory Filings shall have the meaning set forth in Section 4.6.5.