Commercial Manufacturing and Supply Agreement definition

Commercial Manufacturing and Supply Agreement has the meaning set forth in Section 9.10 (Commercial Manufacturing and Supply Agreement).
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Examples of Commercial Manufacturing and Supply Agreement in a sentence

  • In addition, Dermavant and Thermo Fisher Scientific (“TFS”) entered into a Commercial Manufacturing and Supply Agreement for which TFS will provide a supply of tapinarof to Dermavant at an agreed upon price.

  • On May 30, 2018, we entered into a Commercial Manufacturing and Supply Agreement with Takeda, or the Takeda Commercial Supply Agreement, pursuant to which Takeda will manufacture and supply us with relugolix drug substance to support the commercial launch of relugolix, if marketing authorization is granted.

  • As the amount and timing of any potential future payments under the Takeda License Agreement are not probable and estimable, no such potential commitments have been included in the condensed consolidated balance sheet.In May 2018, the Company entered into a Commercial Manufacturing and Supply Agreement with Takeda, or the Takeda Commercial Supply Agreement.

  • This screen is similar to theMaximum total outflowone, but referred to the Minimum total outflow.

  • CONFIDENTIAL Exhibit D Key Commercial Manufacturing and Supply Agreement Terms See attached.

  • Motion: Abdul Sabir Second: Kevin Mitchell Carried: Yes Notes: Mayor informed the board that Mr. McGhee (the administrator) took care of the proposals and the deadline for engineer submissions was today, June 17, 2021, at 2:00 p.m. The mayor received one packet from an engineer, and that was Bryan Hammett and Associates.

  • In May 2018, the Company entered into a Commercial Manufacturing and Supply Agreement with Takeda, or the Takeda Commercial Supply Agreement.

  • Contractual Obligations During the three months ended June 30, 2018, we entered into a Commercial Manufacturing and Supply Agreement with Takeda, or the Takeda Commercial Supply Agreement.

  • Brammer Manufacturing Agreement In June 2018, the Company entered into a Development, Commercial Manufacturing and Supply Agreement (“Brammer Manufacturing Agreement”), with Brammer Bio MA, LLC (“Brammer”).

  • In addition, we received cash proceeds of $0.5 million from the exercise of stock options under our 2016 Equity Incentive Plan.For the six months ended September 30, 2017, cash provided by financing activities consisted of cash proceeds from the exercise of stock options.Contractual ObligationsIn May 2018, we entered into a Commercial Manufacturing and Supply Agreement with Takeda, or the Takeda Commercial Supply Agreement.

Related to Commercial Manufacturing and Supply Agreement

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Commercial Supply Agreement has the meaning set forth in Section 4.1 (Supply Agreement).

  • Supply Agreement has the meaning set forth in Section 7.1.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • Collaborative pharmacy practice agreement means a written and signed

  • 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.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Manufacturing Process means any process for—

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

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Supply Agreements has the meaning set forth in Section 7.1.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

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

  • Technology License Agreement means the Technology License Agreement dated as of the date hereof between Allergan and ASTI.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • 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.

  • 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.

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • Development Agreement has the meaning set forth in the Recitals.

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.