Manufacturing Technology Transfer Completion definition

Manufacturing Technology Transfer Completion has the meaning set forth in Section 7.2(a).
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Manufacturing Technology Transfer Completion means (a) delivery by Arbutus (or Arbutus’ CMO(s) on behalf of Arbutus) to Qilu (or its permitted CMO or permitted Sublicensee) of the Manufacturing Technology in accordance with the Manufacturing Technology Transfer Plan, and (b) using the Manufacturing Technology transferred from Arbutus, completion of manufacturing of at least [***] by Qilu (or its permitted CMO or permitted Sublicensee) at scale of at least [***] of the Licensed Compound that is Manufactured timely and without regard to supply needs, with the quality of the manufactured Licensed Compound meeting the specifications approved by NMPA.
Sample 1

Examples of Manufacturing Technology Transfer Completion in a sentence

  • If the Manufacturing Technology Transfer Completion occurs prior to the effective date of such termination, to the extent permitted by Applicable Laws, Beijing SL shall transfer to Gemphire or its designee, at Gemphire’s cost, all Know-How Controlled by Beijing SL that is necessary or reasonably useful for the Manufacture of Licensed Products.

  • Following Manufacturing Technology Transfer Completion, the Clinical Supply Agreement and Commercial Supply Agreement, if any, shall terminate, and Epizyme shall have no further obligation to supply Drug Substance or Drug Product for Development or Commercial use by Hutchmed.

  • For clarity, (i) Beijing SL shall not have the right to Manufacture or have Manufactured any Compound or Licensed Product for clinical use prior to the Manufacturing Technology Transfer Completion, and (ii) following Regulatory Transfer Completion for the first Licensed Product, Gemphire’s clinical supply obligations under this Section 7.1(a) shall cease.

  • Following Manufacturing Technology Transfer Completion, Hutchmed shall be responsible for producing, at its sole expense, Drug Substance and Drug Product, including labeling and packaging activities, for Development and Commercial use in the Field and in the Territory.

  • This scepticism is increased when there is a common belief that corruption is spread across government institutions.

  • Within two (2) Business Days of Manufacturing Technology Transfer Completion, Qilu shall provide notice to Arbutus of the Manufacturing Technology Transfer Completion.

  • In addition to the Manufacturing Technology Transfer, Arbutus shall provide reasonable technical assistance and support for Qilu to Manufacture or have Manufactured the Licensed Compound and Licensed Products until Manufacturing Technology Transfer Completion in accordance with the terms of this Section 5.5(a) (“Technical Assistance”).

  • For clarity, (i) Beijing SL shall not have the right to Manufacture or have Manufactured any Compound or Licensed Product for commercial use prior to the Manufacturing Technology Transfer Completion, and (ii) following Regulatory Transfer Completion for a Licensed Product, Gemphire’s commercial supply obligations under this Section 7.1(b) for such Licensed Product shall cease.

  • Agenus will invoice Betta for the Tech Transfer Fee following its receipt of Betta’s notice of the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b) and Betta will make the payment [*] following receipt of such invoice.

  • In such an event, if the system is small and easy to understand it will be easier to restore even under extreme conditions.

Related to Manufacturing Technology Transfer Completion

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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.

  • Technology Transfer Plan has the meaning set forth in Section 4.1.5.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Technology Transfer has the meaning set forth in Section 5.2.

  • Manufacturing Process means any process for—

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

  • 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).

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Technology Transfer Agreement has the meaning given in Section 2.2(a).

  • 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).

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • 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 Technology means all Collaboration Patents and Collaboration Know-How.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

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

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

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

  • Development Schedule shall have the meaning set forth in Section 1.1.

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

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Development Program means the implementation of the development plan.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.