Development Batch definition

Development Batch has the meaning set forth in Section 4.6.
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Development Batch has the meaning set forth in the Development Agreement.
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Development Batch means a Batch or Lot produced from a Development Run.
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Examples of Development Batch in a sentence

  • Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications therefor, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch.

  • Customer shall be responsible for the cost of each Development Batch that fails to meet the Specifications unless Cardinal Health was grossly negligent in the manufacture of the out-of-Specification batch.

  • This work is an extension of the Development Batch - Inquiry No. 807836c Currently, [ * ] of [ * ] intermediate [ * ] ([ * ]) was prepared and [ * ] shipped to GTx for development work.

  • Where Nuvelo elects to cancel Development Batch Manufacture, Avecia shall not be obliged to carry out the Validation Campaign, and except with respect to any cancellation resulting from or arising out of an Avecia Default or failure of the centrifuge trials, the Validation Campaign shall also be deemed cancelled with effect from the date of notice of Nuvelo’s intention to cancel Development Batches Manufacture and the Validation Campaign.

  • For each Development Batch [*]manufactured by not later than [*]and in compliance with this Agreement, and conformance to cGMP, the Bulk Drug Specifications, and the warranties in Section 7.1, Genentech shall pay Lonza an amount equal to [*] per Batch and, subject to Section 4.5, the Acquisition Cost of raw materials used to manufacture such Batch.

  • The approximate overall 18-acre site is located east of the Chambers Road and the private road known as E 25th Drive intersection and is zoned Planned Development (Batch Plant), which is equivalent to an industrial zoning classification.

  • In the case of a delay resulting from an Avecia default, if Nuvelo decides to have Avecia proceed with Development Batch Manufacture and/or the Validation Campaign, Avecia shall carry out the delayed Development Batch Manufacture or Validation Campaign in accordance with the terms and conditions set forth in Clauses 2.3 and 2.4.

  • Paragon shall provide analytical testing of the Process Development Batch as agreed by the Parties in each SOW/Project Plan and will report the results to Client.

  • The Parties shall use reasonable commercial efforts to commence discussions regarding possible key principles of any Supply Agreement after the first successful Release of a Development Batch.

  • The QA approved the API and was then listed in the approved vendor list for Product Development Batch.


More Definitions of Development Batch

Development Batch shall include any batch manufactured following (A) a change in Specifications, or (B) a scale-up in the manufacturing process to produce greater quantities of Drug Product, until Catalent has manufactured [***] batches of Drug Product meeting the new Specifications. [***]. Catalent and Vaccinex shall cooperate in good faith to resolve any problems causing the out-of-Specification batch.
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Development Batch means a Batch or Lot produced from a Development Run. Development Batches are intended for testing only and are not saleable.
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Development Batch means a Batch or Lot produced from a Development Run. -----------------
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Development Batch has the meaning provided in Section 3.4 of this Agreement.
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Related to Development Batch

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

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

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

  • 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.

  • Development Program means the implementation of the development plan.

  • 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 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;

  • 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)).

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

  • Development Milestone is defined in Section 5.3.

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

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • 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 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.

  • 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.

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

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

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

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

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

  • 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.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • 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).