DEVELOPMENT STEPS definition

DEVELOPMENT STEPS means the activities specified in Exhibit hereto to be undertaken by the parties during the Development Period.
DEVELOPMENT STEPS means those activities to be undertaken by Fovea for each Collaboration Combination or Licensed Combination, as applicable. Fovea must follow these Development Steps: (a) The Collaboration Combination or Licensed Combination shall enter formulation development; (b) If the Collaboration Combination or Licensed Combination can be formulated for ophthalmic use, it shall be advanced to animal ocular tolerability experiments; (c) If the Collaboration Combination or Licensed Combination has acceptable ocular tolerability properties, it shall be advanced to animal proof-of-concept efficacy models; (d) If the Collaboration Combination or Licensed Combination is efficacious in animal models it shall be advanced to ocular toxicity and pharmacokinetic studies; and (e) If the Collaboration Combination or Licensed Combination is tolerable, non-toxic, efficacious, and can be formulated for ophthalmic use, it shall be advanced to a Phase I human safety/pharmacokinetic study.

Examples of DEVELOPMENT STEPS in a sentence

  • A sound justification and an III-1 JOINT DOCTRINE DEVELOPMENT STEPS AND TIMELINE‌ III-2 Publliish Prrogrram Diirrecttiive Distribute First DraftDistribute Second Draft Chapter IIIDistribute Final Coordination Pub Approval 21 MONTHS JP 1-01Figure III-1.

  • SECTION II: FACILITY POLLUTION PREVENTION PLAN DEVELOPMENT STEPS INTRODUCTIONThis discussion translates all of the requirements (summarized in Section I) into specific activities that will help you define, develop, and implement a pollu- tion prevention program at your Federal facility.

  • SECTION II: FACILITY POLLUTION PREVENTION PLAN DEVELOPMENT STEPS INTRODUCTION tent of the plan and the environmental issues targeted will depend upon yourThis discussion translates all of the goals and facility’s requirements from requirements (summarized in Section I) your headquarters, EPA region, and State into specific activities that will help you environmental regulators.

  • DEVELOPMENT STEPS The following table outlines the steps required to be carried out by the Records Officer and ORCS developer during the development, review, legislative approval, and publication of an ORCS.

  • Demand and Supply 65 FOUNDERS' PRESPECTIVE 67 DEVELOPMENT STEPS 72 ROADMAP 74 TEAM 77 ADVISORS 79 LEGAL DISCLAIMER 81 APPENDIX 88 INTRODUCTION‌ When Bitcoin first appeared in 2008, it was only supported by a small group of enthusiasts.

  • EBM DEVELOPMENT STEPS TO ACHIEVE A STABLE PROCESS 239APPENDIX VII.

Related to DEVELOPMENT STEPS

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

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

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

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Program means the implementation of the development plan.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Development Milestone is defined in Section 5.3.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Work means any work carried out in relation to the physical construction of a mine;

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

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Research Program has the meaning set forth in Section 3.1.

  • 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)).

  • Development Well means a well drilled inside the established limits of an oil or gas reservoir, or in close proximity to the edge of the reservoir, to the depth of a stratigraphic horizon known to be productive.

  • 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.

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

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Manufacturing Process means any process for—

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

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

  • Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.