Existing IND definition

Existing IND means the IND for the conduct of Phase 1 Clinical Trials under the Licensed Program as more particularly identified on Schedule 1.27.

Existing IND shall have the meaning set forth in Section 3.1(b).

Existing IND means the existing Investigational New Drug Application (including any amendments thereto) for Product in the Field in the Territory, as filed by Vical with the FDA pursuant to 21 C.F.R. §312 and Controlled by Vical on the Effective Date.

Examples of Existing IND in a sentence

• The Existing IND is in full force and good standing, and neither Prothena nor its Affiliates have received any notice in writing, or otherwise has knowledge of any facts, which have, or reasonably could have, led Prothena to believe that the Existing IND is not currently in, or may not remain in, good standing with the FDA or other applicable Regulatory Authority.

• Promptly after the Effective Date, FivePrime shall transfer and assign to HGS the Existing IND, so that after such transfer and assignment, HGS shall be the exclusive owner of the Existing IND.

• MedImmune hereby assigns to Kolltan all of MedImmune’s right, title and interest in and to any Regulatory Documentation relating to the Licensed Antibody or Licensed Products Controlled by MedImmune as of the Effective Date, including the Existing IND.

• As of the Effective Date, FivePrime plans to complete the FP-1039 Phase 1 Trial, and to continue conducting the FP-1039 Endometrial Trial (FP-1039-002) in the U.S. under the same IND and in other countries under INDs to be filed in such other countries that are substantially foreign equivalents of the Existing IND (such future INDs, the “Endometrial Foreign INDs”).

• Promptly after the Effective Date, MedImmune shall (a) transfer and/or disclose to Kolltan all such Regulatory Documentation and (b) provide Kolltan with an executed copy of a letter notifying the FDA of the assignment of the Existing IND to Kolltan.

More Definitions of Existing IND

Existing IND is defined in Section 5.1(a).

Existing IND means application number 116023 for the treatment of advanced solid tumors, filed with the FDA and effective as of January 11, 2013.

Existing IND has the meaning set forth in Section 5.2.

Existing IND means the IND for the conduct of the PRX019 Phase 1 Clinical Trial as more particularly identified on Schedule 1.38.

Existing IND shall have the meaning given to such term in Section 2.9.2. [**] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Existing IND shall have the meaning given to such term in Section 2.9.2.

Existing IND means the IND for the conduct of the BeiGene Ongoing Clinical Trial as more particularly identified on Schedule 1.58.