Option Compound Development Plan definition

Option Compound Development Plan means, with respect to each Option Compound for which AstraZeneca pays the Option Maintenance Fee set forth in Section 6.3, the written plan prepared jointly by Targacept and AstraZeneca pursuant to Section 5.10.2(b)(3) that describes in detail the development activities to be carried out by Targacept with respect to such Option Compound, as may be amended from time to time by mutual written agreement of the Parties in accordance with the terms hereof. For purposes of clarity, a Targacept Option Compound Development Plan is not an Option Compound Development Plan.
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Examples of Option Compound Development Plan in a sentence

  • On 7 July, NDC elements, led by Cheka himself, attacked the Congolese armed forces in Luvungi, Walikale territory, reportedly killing two soldiers and displacing over 500 civilians.

  • The Option Maintenance Fee contemplated by Section 5.10.2(b)(3) shall be [********] Dollars (US $[********]) (subject to [********] such Option Maintenance Fee [********] Option Compound Development Plan for an Option Compound [********].

  • Each Option Compound Development Plan shall specify the standards or criteria that, if achieved, constitute Option Compound Proof of Concept for the Option Indication (i) specified in the applicable IND-Ready Option Notice or (ii) otherwise agreed to by the Parties.

  • The fair value of the developed product rights for Auryxia was determined using the multi-period excess earnings method which is a variation of the income approach, and is a valuation technique that provides an estimate of the fair value of an asset based on the principle that the value of an intangible asset is equal to the present value of the incremental after-tax cash flows attributable to the asset, after taking charges for the use of other assets employed by the business.

  • If AstraZeneca elects to complete the Option Compound Development Plan in accordance with Section 5.10.2(b)(4), Targacept shall, at the request and sole expense of AstraZeneca, provide AstraZeneca with such assistance as is reasonably necessary to effectuate a smooth and orderly transition of such Option Compound Development Plan so as to minimize any disruption of activities being conducted pursuant to such plan.

  • If the Parties are unable to agree to an Option Compound Development Plan, Section 5.10.2(b)(6) shall apply.

  • Each Option Compound Development Plan shall be commercially reasonable.

  • If AstraZeneca wishes to complete the Option Compound Development Plan, it shall notify Targacept of such decision in writing within [********] of receiving such information.

  • Subject to the terms and conditions of this Article 16, Targacept shall supply to AstraZeneca such quantities of (a) each [********] as may be necessary for AstraZeneca to conduct, or have conducted, any [********]; (b) each Option Compound that is the subject of an Option Compound Development Plan that AstraZeneca has elected to complete pursuant to Section 5.10.2(b)(5) and (c) each IND-Ready Option Candidate Drug, in each case ((a), (b) and (c)), as AstraZeneca from time to time may order from Targacept.

  • Thereafter, the Parties shall work in good faith and with sufficient diligence to prepare a mutually acceptable Option Compound Development Plan within [********] after AstraZeneca gives the Option Maintenance Notice or such longer period as the Parties may agree in writing (the “Option Compound Development Plan Period”).

Related to Option Compound Development Plan

  • 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)).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

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

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • 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.

  • Planned development means a real property development other than a community apartment project, a condominium project, or a stock cooperative, having either or both of the following features:

  • 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.

  • Development Program means the implementation of the development plan.

  • 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.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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.

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

  • 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).

  • 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.

  • 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.

  • 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Licensed Compound means [***].

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