Manufacturing Technology Transfer Agreement definition

Manufacturing Technology Transfer Agreement has the meaning set forth in Section 7.4 (Manufacturing Technology Transfer).
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Manufacturing Technology Transfer Agreement means an agreement to be executed and delivered by Xxxxx and Seller at the Closing with respect to the anti-PD-L1 antibody identified as H6B1L-EM in US provisional patent application No. 62/288,912 manufacturing technology transfer to the JVC and/or a contract manufacturing organization identified by Buyer after the Closing, the objective of, and the material technology information to be transferred in, which are listed on Schedule I.5, substantially in the form in Exhibit E.
Sample 1
Manufacturing Technology Transfer Agreement has the meaning set forth in Section 4.3.3 (Manufacturing Technology Transfer). ​
Sample 1

Examples of Manufacturing Technology Transfer Agreement in a sentence

  • Hutchmed shall offer reasonable cooperation to Epizyme (and other Epizyme Entities designated by Epizyme) in investigating any complaint and the circumstances surrounding it and shall comply with any operating procedures that the Parties may agree upon in their Safety Data Exchange Agreement, Clinical Supply Agreement, Commercial Supply Agreement or Manufacturing Technology Transfer Agreement.

  • Hutchmed shall ensure that any Manufacturing of Licensed Compound or Licensed Products conducted by Hutchmed or a Permitted Subcontractor CMO is to specifications attached to the Manufacturing Technology Transfer Agreement, as such specifications may be updated in accordance with the terms of the Manufacturing Technology Agreement and is consistent with the license granted to Hutchmed in Section 2.1(f).

  • As more fully described in the Clinical Supply Agreement, Commercial Supply Agreement, and Manufacturing Technology Transfer Agreement, in the event Epizyme undertakes any Manufacturing Activity in its discretion, as mutually agreed, or as required by any Regulatory Authority in the Territory, and it results in a Dosage Form Change or Manufacturing Improvement, then such Dosage Form Change or Manufacturing Improvement, as applicable shall automatically be included within the Epizyme Manufacturing Know-How.

  • The Manufacturing Technology Transfer Agreement shall include the option for Epizyme to obtain DS from Hutchmed’s Permitted Subcontractor CMO as a secondary supplier on commercially reasonable terms to be mutually agreed.

  • The Parties shall initiate and use Commercially Reasonable Efforts to promptly transfer to the Assuming Party, in accordance with the Manufacturing Technology Transfer Agreement, the Transferring Party’s Manufacturing Process and technology that is [***].

  • Hansoh shall pay Keros’[***] providing such information or assistance pursuant to this Section 7.2, except as otherwise set forth in the Manufacturing Technology Transfer Agreement.

  • The Manufacturing Technology Transfer Agreement will include […***…] and in any event within […***…] thereafter; […***…].

  • The Manufacturing Technology Transfer Agreement will provide that (i) at the written request of Novartis from time to time, BeiGene shall […***…] to Novartis and its designees and to assist Novartis and its designees in its Manufacture of the Licensed Compound and Licensed Product.

  • Each Party will use reasonable efforts to effect such transfer as soon as reasonably practicable following the Parties entering into the Manufacturing Technology Transfer Agreement regarding such transfer and, in any event, within any timeline contemplated in Schedule 4.3.3 (Terms of Manufacturing Technology Transfer).

  • The Manufacturing Technology Transfer Agreement will provide that (i) at the request of Novartis from time to time, BeiGene shall […***…] to Novartis and its designees and to assist Novartis and its designees in its Manufacture of the Licensed Compound for up to an aggregate of […***…] and (ii) to the extent that BeiGene provides Novartis with such consultation and assistance […***…] of […***…], Novartis will reimburse BeiGene for […***…].


More Definitions of Manufacturing Technology Transfer Agreement

Manufacturing Technology Transfer Agreement means an agreement to be executed and delivered by Buyer and Seller at the Closing with respect to the anti-PD-L1 antibody identified as H6B1L-EM in US provisional patent application No. 62/288,912 manufacturing technology transfer to the JVC and/or a contract manufacturing organization identified by Buyer after the Closing, the objective of, and the material technology information to be transferred in, which are listed on Schedule I.5, substantially in the form in Exhibit E.
Sample 1

Related to Manufacturing Technology Transfer Agreement

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

  • 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.

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

  • Technology License Agreement means the agreement in the form of Exhibit H hereto.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • 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.

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

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

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

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Sublicense Agreement means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.

  • Manufacturing Process means any process for—

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • End User License Agreement means a license grant or end user license agreement governing software as further described in this Agreement or any applicable Appendix.

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

  • Software License Agreement means the Motorola Software License Agreement (Exhibit A).

  • Research Agreement means a new written contract, grant or cooperative agreement entered into between a person and a college or research corporation for the performance of qualified research; however, all qualified research costs generating a rebate must be spent by the college or research corporation on qualified research undertaken according to a research agreement.

  • 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 [***].

  • 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.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • 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.

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

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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;