Lead Product definition

Lead Product means a product incorporating the Lead Compound.

Lead Product has the meaning set forth in Section 2.2.2.

Lead Product means the Company’s lead product candidate known as PB-101 (zabofloxacin).

Examples of Lead Product in a sentence

• With respect to Patents (other than any provisional patent applications) covering subject matter directed to Lead Product Candidates, to the knowledge of the Company, there is no material prior art, prior use, prior sale or other novelty defeating acts that were not submitted to relevant Governmental Entities that applicable law would require to be submitted.

• Any designation of a Lead Product will also specify the indications for which the Parties intend to develop such Lead Product.

• Alternatively, if a Curis Plan provides for development of a Compound in the Hair Growth Prevention Field, such Compound may, at Genentech’s option, be developed as a “Collaboration Product” (instead of a Lead Product) for purposes of this Agreement in accordance with the provisions of Article 4.

• In particular, Zai shall (i) lead and conduct the Phase 1 Clinical Trial activities of the Lead Product in the Territory, (ii) lead all NDA-enabling studies (other than the Pivotal Study) required by the CFDA for Regulatory Approval in the Territory, and (iii) provide to Entasis or its contract research organization clinical support solely to the extent set forth in the Development Plan or as otherwise agreed for Clinical Trials conducted by or on behalf of Entasis.

• Thereafter, Roche shall be responsible for all interactions with Regulatory Authorities for the Lead Product.

More Definitions of Lead Product

Lead Product means [***].

Lead Product means any Product that, after reasonable evaluation by the JSC pursuant to Section 3.2 using mutually agreed upon criteria, has been selected by the JSC for clinical development.

Lead Product means the Product containing AC220 being developed by Ambit as of the Effective Date as the candidate for initial approval of an NDA, together with any modifications thereto that may be approved pursuant to Article 2.

Lead Product means the pharmaceutical preparation of ETX2514SUL with the composition set forth on Exhibit 1.70, in any presentation or formulation.

Lead Product means: (i) Pieris’ Anticalin protein specific to the IL-4 alpha receptor with the amino acid sequence set forth in Exhibit 1.135, which shall be the amino acid sequence to be submitted in the IMPD and also referred to as PRS-060; and (ii) the Lead Product Back-Up Hits.

Lead Product has the meaning set forth in Section 1.11 (Back-Up Candidate).

Lead Product means a Bispecific Product directed against PD-1 and [***]. The Lead Product contains at least [***] Anticalin Building Blocks directed against [***] and a PD-1 Antibody Building Block, as will be agreed between the Parties. The Lead Product may also be referred to as “PRS-332”.