Development and Manufacturing Services definition

Development and Manufacturing Services means the services to be performed by Identita hereunder, which shall be comprised of Identita to create the Product by modifying the Technology to incorporate the Concept, in accordance with the Specifications;

Examples of Development and Manufacturing Services in a sentence

  • Alison introduced colleagues who provided an overview of their work.

  • APPENDIX A SAMPLE WORK ORDER THIS WORK ORDER is by and between RHYTHM METABOLIC, INC., (“Rhythm”) and PEPTISYNTIIA, Inc (“Manufacturer”), and upon execution will be incorporated into the Development and Manufacturing Services Agreement between Rhythm and Manufacturer dated as of July , 2013 (the “Agreement”).

  • This Eighth Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated October 21, 2016, between Lonza and Vaxcyte (at that time known as SutroVax, Inc.), as amended (the “Original Agreement”).

  • Commitments Effective September 2017, the Company entered into a Development and Manufacturing Services Agreement as amended (“DMSA”) with Lonza Sales AG (“Lonza”) for the development and manufacture of biologic products.

  • This Ninth Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated October 21, 2016, between Lonza and Vaxcyte (at that time known as SutroVax, Inc.), as amended from time to time (the “Original Agreement”).

  • This Tenth Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated October 21, 2016, between Lonza and Vaxcyte (at that time known as SutroVax, Inc.), as amended from time to time (the “Original Agreement”) and amends and restates in its entirety that certain Tenth Amendment dated May 2, 2022 (the “Original Tenth Amendment”) by and between Lonza and Vaxcyte.

  • Our Company has entered into a Master Development and Manufacturing Services Agreement (―Development Agreement‖) dated July 01, 2021 with Encube Ethicals Pvt.

  • This First Amendment is to be incorporated as part of the Development and Manufacturing Services Agreement, dated March 22, 2022, between Lonza and Vaxcyte (the “Original Agreement”).

  • MassBiologics Contract Development and Manufacturing Services was to a degree impacted by a slowdown of client clinical programs due to COVID-19.

  • Please revise to describe the material terms of your Development and Manufacturing Services Agreement with Lonza Ltd.

Related to Development and Manufacturing Services

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Manufacturing Process means any process for—

  • Development Services “Target Market”; “Investment Areas”; and “Targeted Populations” have the meanings ascribed to such terms in 12 C.F.R. 1805.104.

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

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

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • 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.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Development Program means the implementation of the development plan.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, 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.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Diagnostic Services means services provided for the purpose of determining the nature and cause of a condition, ill- ness, or injury.

  • 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.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

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

  • 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.

  • Collaborative pharmacy practice agreement means a written and signed

  • DEVELOPMENTAL SERVICES means therapies, typically provided by a qualified professional using a treatment plan, that are intended to lessen deficiencies in normal age appropriate function. The therapies generally are meant to limit deficiencies related to injury or disease that have been present since birth. This is true even if the deficiency was detected during a later developmental stage. The deficiency may be the result of injury or disease during the developmental period. Developmental services are applied for sustained periods of time to promote acceleration in developmentally related functional capacity. This plan covers developmental services unless specifically listed as not covered.

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