Candidate Drug definition

Candidate Drug means each of (a) Ispronicline, (b) each Active+ Compound that is not a Terminated Compound, (c) each Collaboration Compound for which AstraZeneca commences GLP Toxicology Studies as provided in Section 5.1.2 or for which AstraZeneca does not commence GLP Toxicology Studies but Initiates a Clinical Trial, (d) each Option Compound for which AstraZeneca exercises an Option, (e) each Licensed Derivative with respect to (i) any such Option Compound made by or on behalf of AstraZeneca or its Affiliates or Sublicensees or (ii) Ispronicline or any such Active+ Compound or Collaboration Compound made by or on behalf of (A) AstraZeneca, Targacept or any of their respective Affiliates or Sublicensees during the Research Program Term or the Tail Period or (B) AstraZeneca or its Affiliates or Sublicensees after the Tail Period and (f) in each case ((a) through (e)), any salt form, polymorph, crystalline form, hydrate, solvate or formulation thereof.

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Candidate Drug means a Product satisfying the relevant technical pharmacological and pharmaceutical criteria that will be defined for each Collaboration Product in accordance with the Technical Candidate Drug Criteria. Such Technical Candidate Drug Criteria shall be consistent with the guidelines described in Exhibit 1.40.

Candidate Drug means a compound suitable for commercial development for use in the Field that has been selected in accordance with Section 2.6 of P&U Agreement for further pre-clinical and clinical development by P&U, or selected under Section 3.5 of the KH Agreement for further preclinical and clinical development by KH. * Certain portions of this Exhibit have been omitted for which confidential treatment has been requested and filed separately with the Securities and Exchange Commission.

Examples of Candidate Drug in a sentence

• If a Party shall dispute the existence, extent or nature of any matter underlying a right of termination (whether of this entire Agreement or part of this Agreement, including with respect to the Research Program or to a particular Candidate Drug, Product or Major Market Country, as applicable, in accordance with Section 11.2.2(b), 11.2.4, 11.2.5 or 11.2.7) the matter shall be referred to the ESC and the ESC shall use good faith efforts to resolve the dispute.

• Upon AstraZeneca’s request, Targacept shall, and shall cause any Third Party that Manufactures Ispronicline Capsules, Ispronicline API, any Collaboration Compound or any Candidate Drug under contract with Targacept to, provide AstraZeneca with all reasonable assistance required by AstraZeneca in order to transfer the Manufacturing process for Ispronicline Capsules, Ispronicline API, such Collaboration Compound or such Candidate Drug to AstraZeneca or its designee.

• Upon such exercise by AstraZeneca, such Option Compound shall become an IND-Ready Option Candidate Drug and subject to AstraZeneca’s obligations pursuant to Section 5.5.1(c).

• AstraZeneca shall use reasonable efforts to provide Targacept with at least [********] advance notice of any meeting with the FDA regarding a Drug Approval Application relating to, or Product Regulatory Approval for, any Candidate Drug or Product and Targacept may elect to send one person reasonably acceptable to AstraZeneca to attend such meeting as an observer (at Targacept’s sole expense) unless [********].

• For purposes of clarity, notification by AstraZeneca to the JRC, JDC or ESC that AstraZeneca plans to terminate or otherwise cease Development of a Candidate Drug or Product shall not constitute notice of termination with respect to such Candidate Drug or Product for purposes of this Section 11.2.3.

More Definitions of Candidate Drug

Candidate Drug or “CD” means a Dynavax ISS or a Collaboration ISS that is a Lead Candidate satisfying the relevant Candidate Drug Target Profile and [ * ] as a candidate for further Development and Commercialization as the Product or a Combination Product pursuant to Section 3.10; provided, however, upon the commencement of [ * ], such Collaboration ISS shall be deemed a Candidate Drug regardless of whether such Collaboration ISS meets the Candidate Drug Target Profile.

Candidate Drug means a Compound nominated for further development by AstraZeneca in accordance with AstraZeneca’s internal processes.

Candidate Drug or "CD" means any compound selected hereunder for GLP -------------- -- safety and/or other studies necessary for IND filing in the Field.

Candidate Drug means a Compound selected for clinical development in accordance with Section 2.5 below.

Candidate Drug means a Lead that (a) has been sufficiently optimized, and (b) Astra has decided to enter into Astra Development Program pre-clinical studies.

Candidate Drug has the meaning set forth in Section 2.7.1.

Candidate Drug or 'CD' means a Collaboration Compound satisfying ASTRAZENECA's pharmacological and pharmaceutical criteria for clinical testing, as outlined in the Research Plan, and which compound has been selected for clinical testing by the JEC or ASTRAZENECA.