Development Back-Up Compound definition

Development Back-Up Compound means, with respect to each Compound designated as a Development Compound, an additional Lead Compound suitable for clinical development designated in accordance with Section 3.4.3 below.
Sample 1

Examples of Development Back-Up Compound in a sentence

  • Celgene shall have the option to acquire an exclusive, worldwide license to develop and commercialize a Development Compound and a Development Back-Up Compound (the “Celgene Product Option”), all in accordance with the terms and conditions set forth in this Article 4.

  • The JDC, for a particular Development Compound and, if required pursuant to 3.7.4 below, a corresponding Development Back-Up Compound, shall have the responsibility for establishing a comprehensive, multi-year plan for the development of such Development Compound and, if applicable, Development Back-Up Compound (a “Development Plan”).

  • Celgene shall [ * ] of a Development Back-Up Compound that is selected as a substitute for the corresponding Development Compound [ * ] in the development of the substituted Development Compound, [ * ].

  • Subject to the terms and conditions of this Agreement, Celgene hereby grants Array an exclusive, worldwide, royalty-free license under the Celgene Technology and Celgene’s interest in any Collaboration Technology to develop, make, have made, use, sell, offer for sale and import (i) the Development Compound and the Development Back-Up Compound for which the Celgene Product Option has expired or been terminated, and (ii) Abandoned Products, in each case alone or as incorporated in products.

  • During the Option Term following designation of a Development Compound, Array shall use Diligent Efforts to continue pre-clinical development of such Development Compound and, to the extent required pursuant to Section 3.7.4 below, a corresponding Development Back-Up Compound, with the goal of submitting an IND with the FDA on such Development Compound.

  • Any such sublicense to a Third Party (and any right of a Third Party to obtain such a sublicense) of a Development Compound, Development Back-Up Compound or Abandoned Product shall be granted no earlier than the date the Celgene Product Option has expired or been terminated for such Development Compound and Development Back-Up Compound or the date such Abandoned Product becomes same as set forth in Section 12.3.2, respectively.

  • Except for sublicenses granted under Section 9.6.2, any sublicensee of Celgene must have reasonable capabilities to support the further development and commercialization of such Development Compound and/or Development Back-Up Compound, as applicable.

  • As used herein, “Compound Improvement” means any invention or other subject matter (including Information) comprising the composition of matter of any Compound, Development Compound, Collaboration Compound, Back-Up Compound, Development Back-Up Compound, Collaboration Back-Up Compound, Abandoned Compound or Licensed Product, or method of use or manufacture thereof (together with all intellectual property rights therein, including Patents).

  • In such case, the de-selected Compound shall cease to be a Development Compound for the purposes of this Agreement, but shall continue to be a Lead Compound and may be selected by Celgene as a Development Back-Up Compound.

  • In such case, the discontinued Development Compound shall cease to be a Development Compound, the proposed Development Back-Up Compound shall be deemed a Development Compound, and the discontinued Development Compound shall be deemed a Development Back-Up Compound to such substitute Development Compound.

Related to Development Back-Up Compound

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Licensed Compound means [***].

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Development Plan has the meaning set forth in Section 3.2.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Phase means the period before a vehicle type is type approved.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • Development Program means the implementation of the development plan.

  • Research Program has the meaning set forth in Section 2.1.