Fill/Finish definition

Fill/Finish means the fill and finish, bulk packaging, testing and release of Drug Product to be performed by Supplier hereunder, including (a) filling the Drug Substance into vials and (b) testing, including in process release to Labeling and Packaging and ongoing stability testing of the Drug Product. For the avoidance of doubt, Fill/Finish shall not include any activities included in the definition of Labeling 3 and Packaging. When used as a verb, “Fill/Finish” means to conduct Fill/Finish, and “Fill/Finished” has a correlative meaning.
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Examples of Fill/Finish in a sentence

  • Fill/Finish of 100M Vaccine Doses 100M doses of finished vaccine in [***] vials will be manufactured at Baxter (Bloomington, IN, USA).

  • In March 2017, we entered into, and in December 2020, we amended the Technology Transfer, Validation and Commercial Fill/Finish Services Agreement with Ajinomoto Althea, Inc.

  • Essex Capital Notes On December 20, 2013, the Company signed a Loan and Lease Agreement (Original Agreement) to borrow up to $10.8 million in the form of Secured Promissory Notes from Essex Capital, or the Essex Notes, to finance the completion and installation of the Company’s RT001 topical commercial fill/finish line, or the Fill/Finish Line.

  • Purchase Commitments On March 14, 2017, the Company entered into a Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (the “Services Agreement”) and Statement of Work ("SoW") with Ajinomoto Althea, Inc., a contract development and manufacturing organization (“Althea”).

  • Raw Materials – Obtain Critical Starting Materials for Antigen and Fill/Finish Manufacturing Sufficient materials (vials, stoppers, other consumables) to manufacture up to 100M vaccine doses will be purchased (sources TBD).

  • During the Term, each Party shall promptly notify the other Party in writing upon learning of any actual or threatened investigation, inquiry, action or proceeding by or before the FDA or any other Regulatory Authority with respect to the conduct of Fill/Finish activities hereunder.

  • At Kiniksa’s request, to the extent Product is supplied in Filled Product form, Regeneron shall request that its Third Party Fill/Finish Provider package and label such Filled Product in accordance with Kiniksa’s instructions and shall use reasonable efforts to facilitate the transfer of Kiniksa’s packaging and labeling instructions to such Third Party Fill/Finish Provider.

  • Upon reasonable request of either Party, the Parties agree to discuss in good faith the potential for Fill/Finish of any such excess quantities of Drug Product.

  • In addition, at Kiniksa’s request, Regeneron will use reasonable efforts (which efforts will not, unless otherwise agreed by the Parties, include any obligation to make any payment or incur economic burden) to facilitate a direct relationship between Kiniksa and Regeneron’s Third Party Fill/Finish Provider.

  • Supplier shall [***] to consult with Customer in advance of any meeting or discussion, either in person or by telephone or videoconference, with the FDA or Regulatory Authority in connection with the Drug Substance, Drug Product or conduct of Fill/Finish hereunder.

Related to Fill/Finish

  • Fabrication means making up data or results and recording or reporting them.

  • Antenna coating means a coating labeled and formulated exclusively for application to equipment and associated structural appurtenances that are used to receive or transmit electromagnetic signals.

  • Faux finishing coating means a coating labeled and formulated as a stain or a glaze to create artistic effects including, but not limited to, dirt, old age, smoke damage, and simulated marble and wood grain.

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

  • Assembly means the Assembly of Heads of State and Government of the African Union;

  • Defoliant means any substance or mixture of substances intended for causing the leaves or foliage to drop from a plant, with or without causing abscission.

  • Boot camp means a short term secure or nonsecure juvenile residential facility with highly

  • Filling means any depositing or stockpiling of earth materials.

  • Grinding means to reduce to powder or small fragments and includes mechanical chipping or drilling.

  • Bathroom and tile cleaner means a product designed or labeled to clean tile or surfaces in bathrooms. “Bathroom and Tile Cleaner” does not include “Toilet/Urinal Care Product.”

  • Patch means minor modifications to the Licensed Product made by Registry Operator during the performance of error correction services. A Patch does not constitute a Version.

  • Architectural coating means a coating applied to stationary structures and their appurtenances, to mobile homes, to pavements, or to curbs.

  • Freeboard means a factor of safety usually expressed in feet above a flood level for purposes of floodplain management. "Freeboard" tends to compensate for the many unknown factors that could contribute to flood heights greater than the height calculated for a selected size flood and floodway conditions, such as wave action, blockage of bridge or culvert openings, and the hydrological effect of urbanization of the watershed.

  • Blasting means changing the level or grade of land or rendering, tearing, demolishing, moving, or removing earth, rock, buildings, structures, or other masses or materials by seismic blasting or the detonation of dynamite or any other explosive agent.

  • Flat coating means a coating that is not defined under any other definition in this section and that registers gloss less than 15 on an 85-degree meter or less than 5 on a 60-degree meter.

  • Encapsulant means a substance that forms a barrier between lead-based paint and the environment using a liquid-applied coating (with or without reinforcement materials) or an adhesively bonded covering material.

  • HDPE means high density polyethylene;

  • Enamel means a coat of colored material, usually opaque, that is applied as a protective topcoat over a basecoat, primer, or a previously applied enamel coat. In some cases, another finishing material may be applied as a topcoat over the enamel.

  • Fabricating means to make, build, create, produce, or assemble components or property to work in a new or different manner.

  • storey means that portion of a building which is situated between the top of any floor and the top of the floor next above it, and if there is no floor above it, that portion between the top of such floor and the ceiling above it.

  • Outdoor cultivation means the cultivation of mature cannabis without the use of artificial lighting or light deprivation in the canopy area at any point in time. Artificial lighting is permissible only to maintain immature plants outside the canopy area.

  • Filler means either a person or a photograph of a person who is not suspected of the offense in question and is included in an identification procedure.

  • Cold Weather Alert means the notice that PJM provides to PJM Members, Transmission Owners, resource owners and operators, customers, and regulators to prepare personnel and facilities for expected extreme cold weather conditions.

  • Machinist means an employee who cuts out and fits uniforms or dresses to measure or pattern.

  • Hood means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

  • Automotive windshield washer fluid means any liquid designed for use in a motor vehicle windshield washer system either as an antifreeze or for the purpose of cleaning, washing, or wetting the windshield. Automotive windshield washer fluid does not include fluids placed by the manufacturer in a new vehicle.