DEVELOPMENT PHASE II definition

DEVELOPMENT PHASE II means the development work to be conducted by BC under ***** Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission
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Examples of DEVELOPMENT PHASE II in a sentence

  • SCIOS NOVA may also terminate this Agreement any time during or after DEVELOPMENT PHASE II if it believes the clinical results for NATRECOR warrant such termination so that SCIOS NOVA finally decides not to market directly or indirectly NATRECOR.

  • After DEVELOPMENT PHASE II, future orders will be initiated by written purchase order from SCIOS NOVA and the manufacture, delivery, acceptance and purchase of all such orders shall be governed by the provisions of this Article 6, and the other applicable provisions of this Agreement.

  • After DEVELOPMENT PHASE II the parties may elect to enter into the COMPREHENSIVE AGREEMENT as an updated statement reflecting the terms of this Agreement, including Article 6.1 through 6.9, Article 7, Article 8, and Article 10, and such additional terms as they may then deem to be reasonable and customary in such agreements.

  • If the parties are unable to agree on the four matters in Article 4.1 or SCIOS NOVA shall otherwise elect not to proceed to DEVELOPMENT PHASE II then, in exchange for having funded the development of such process, BC does hereby grant to SCIOS NOVA a royalty-free, exclusive license to use, or allow others to use, all or any part of the 150 liter PROCESS solely for the manufacture of BNP.

  • Pursuant to Article 4.1, the parties shall determine whether or not to proceed to DEVELOPMENT PHASE II after reviewing the results of DEVELOPMENT PHASE I.

  • As provided in Article 5.5, at the conclusion of DEVELOPMENT PHASE II the parties shall have established and documented by mutual agreement certain key matters, including, (a) the Standard Operating Procedure for the 3,000 liter PROCESS, (b) any revision to the SPECIFICATIONS FOR BULK SOLUTION, (c) any revision to the BNP SPECIFICATIONS, and (d) the COMMERCIAL PRICE.

  • In addition, THE COMPANY will retain 100% of the net amount at risk corresponding to the face amount in excess of the First Layer of Coverage.

  • SCIOS NOVA shall promptly assay the BULK SOLUTION produced in DEVELOPMENT PHASE II for conformity with the SPECIFICATIONS FOR BULK SOLUTION, (as established by the parties under Article 4.1) and provide the results of its analysis to BC.

  • The first and third Phases of the revitalization have been completed.ALEXANDER HAMILTON DEVELOPMENT PHASE II - VI Phase II, includes the Development of 50 Units of mixed-finance, tax credit rental units.

  • Not later than 30 days after receipt of the BC DELIVERABLES, SCIOS NOVA shall notify BC whether SCIOS NOVA wishes BC to conduct DEVELOPMENT PHASE II.

Related to DEVELOPMENT PHASE II

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

  • Development Project means a project for the development of land within a

  • Development Program means the implementation of the development plan.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • 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.

  • Development Area means that area to which a development plan is applicable.

  • Development Plan 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).

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • 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 Works means the external development works and internal development works on immovable property;

  • Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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 Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • 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.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • 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).

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

  • 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.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.