Clinical Manufacturing and Supply Agreement definition

Clinical Manufacturing and Supply Agreement means the Clinical Manufacturing and Supply Agreement between [***] and Dermavant, to be executed at Closing, in the form attached hereto as Exhibit B.
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Clinical Manufacturing and Supply Agreement is defined in Section 6.6 (Related Agreements).
Sample 1

Examples of Clinical Manufacturing and Supply Agreement in a sentence

  • Similarly, Sanofi shall [***], as set forth in greater detail in the applicable Clinical Quality Agreement and Clinical Manufacturing and Supply Agreement.

  • Subject to the terms and conditions of this Agreement, pursuant to this Agreement and the applicable Clinical Manufacturing and Supply Agreement and Clinical Quality Agreement, which [***] shall [***] the applicable Licensed Compounds and Licensed Products.

  • In the event of any inconsistency between this Agreement, on one hand, and the applicable Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, on the other hand, the terms of this Agreement will prevail except to the extent the Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, as applicable, expressly references the provisions of this Agreement to be superseded.

  • If the Milestone Data Package delivered by IGM pursuant to Section 9.3.2(a) (Immunology Milestone Data Package Review) for a [***] conducted by IGM for any Lead Candidate Directed to an Immunology Target Construct establishes that [***] in accordance with the applicable Clinical Manufacturing and Supply Agreement; provided that Sanofi shall promptly [***].

  • In the event of any inconsistency between a Global Manufacturing Plan, on one hand, and this Agreement or the applicable Clinical Manufacturing and Supply Agreement, on the other hand, the terms of this Agreement or such Clinical Manufacturing and Supply Agreement, as the case may be, will prevail.

  • Any Clinical Manufacturing and Supply Agreement will contain terms and conditions with respect to [***].

  • IGM will use Commercially Reasonable Efforts to conduct and to timely complete the Manufacturing activities for which IGM is responsible under each Global Development Plan or Global Manufacturing Plan, or the applicable Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, in each case, pursuant to the timelines set forth therein (as such timelines may be amended from time to time by the JMC) and under the oversight of the JMC.

  • For clarity, such pharmaceutical ingredient under the Takeda Clinical Manufacturing and Supply Agreement shall not be included herein.

  • For clarity, such pharmaceutical product under the Takeda Clinical Manufacturing and Supply Agreement shall not be included herein.

  • Amongst these criteria, the following could be mentioned: • It is a set of relevant indicators, since they allow the conciliation of national and international priorities, focused to evaluate the current status of VAW and to establish actions for its prevention, attention, sanction and eradication.

Related to Clinical Manufacturing and Supply Agreement

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

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

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

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

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

  • Manufacturing Process means any process for—

  • Collaborative pharmacy practice agreement means a written and signed

  • 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.

  • 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.

  • 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.

  • 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):

  • Distillery manufacturing license means a license issued in accordance with

  • 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.

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

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

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

  • 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 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.

  • 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.

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

  • 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.

  • Collaborative practice agreement means a written agreement

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