Manufacturing Transfer Date definition

Manufacturing Transfer Date means the date on which [***].
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Manufacturing Transfer Date has the meaning set forth in Section 6.3 (Transfer of Manufacturing Responsibility).
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Manufacturing Transfer Date has the meaning set forth in Section 7.1.
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Examples of Manufacturing Transfer Date in a sentence

  • Prior to the Manufacturing Transfer Date, Company will have the sole responsibility to Manufacture and supply to Vertex quantities of ENTR-701 reasonably requested by Vertex for Development activities at Vertex’s cost and expense.

  • Following the Manufacturing Transfer Date and except as set forth in the Research Plan or any Additional Research Plan, Vertex will have sole and exclusive control over all matters related to the Manufacture and supply of Licensed Agents and Products for Exploitation in the Field in the Territory.

  • If Vertex determines that such supply will be needed prior to the Manufacturing Transfer Date, then, at Vertex’s request, the Parties will negotiate and enter into a clinical supply agreement (the “Supply Agreement”) and a quality agreement regarding such clinical supply on commercially reasonable terms.

  • Until the Manufacturing Transfer Date, Perception or its CMO shall also provide to Otsuka [***], (i) the open part of the DMF, such as the sections containing general information, control of drug substance, container closure system, and stability, (ii) [***].

  • For clarity, the terms of this Section 6 shall only apply prior to the Manufacturing Transfer Date.

  • Prior to the Manufacturing Transfer Date, at Otsuka’s reasonable request and, if applicable, as required by any Regulatory Authority in the Otsuka Territory, Perception shall conduct validation, analytical, stability and any other specific testing of API and Clinical Samples Manufactured and supplied by or on behalf of Perception for the Otsuka Territory, and [***].

  • The Parties shall in good faith agree on the commercial and other terms of such Manufacturing and supply, provided that such terms shall not be less beneficial for Santhera, its Affiliates or Santhera’s licensees than the commercial and other terms applicable to the Manufacturing and supply of Product to Catalyst as per this Agreement or any amendment hereto immediately prior to the Manufacturing Transfer Date.

  • Millennium hereby agrees that it shall assume, insofar as they relate to the time period beginning on and including the day following Lonza Transfer Date and Radiolabel Manufacturing Transfer Date, all the obligations and liabilities of BZL under the Lonza Agreement and the Radiolabel Manufacturing Agreement, respectively.

  • Centessa’s obligations to provide assistance under this Section 3 without reimbursement from AnaptysBio, are capped at a maximum of [***] FTE hours to be utilized within [***] following the Manufacturing Transfer Date.

  • Santhera shall be free to decide, in its discretion, whether to maintain, after the Manufacturing Transfer Date, capabilities to Manufacture or have Manufactured the Compound and the Product for territories other than the Territory.

Related to Manufacturing Transfer Date

  • Signaling Transfer Point (“STP”) means a signaling point that performs message routing functions and provides information for the routing of messages between signaling points within or between CCIS networks. An STP transmits, receives and processes CCIS messages.

  • Servicing Transfer Date The date on which a Servicing Transfer occurs.

  • Risk Transfer Date means the date when the risk of loss or damage to the Works passes from the Contractor to the Employer in accordance with sub Clauses 38.2 and 39.1.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Employee Transfer Date means in respect of any particular Transferring Employee the date on which the part of the Services to which they are assigned transfers from the Previous Contractor to the Contractor;

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

  • 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.

  • the transfer date means 1 September 1989;

  • Transfer Date means, in relation to a transfer, the later of:

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

  • 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.

  • Servicing Transfer Event means any of the events specified in the Servicing Agreement, whereby the servicing of the Mortgage Loan is required to be transferred to the Special Servicer from the Master Servicer.

  • Three-Month Term SOFR Conventions means any determination, decision or election with respect to any technical, administrative or operational matter (including with respect to the manner and timing of the publication of Three-Month Term SOFR, or changes to the definition of “Floating Interest Period”, timing and frequency of determining Three-Month Term SOFR with respect to each Floating Interest Period and making payments of interest, rounding of amounts or tenors, and other administrative matters) that the Company decides may be appropriate to reflect the use of Three-Month Term SOFR as the Benchmark in a manner substantially consistent with market practice (or, if the Company decides that adoption of any portion of such market practice is not administratively feasible or if the Company determines that no market practice for the use of Three-Month Term SOFR exists, in such other manner as the Company determines is reasonably necessary).

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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.

  • 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.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Initial Transfer Date means the Series Issuance Date for the first Series of Securitization Bonds.

  • Service Transfer Date means the date of a Service Transfer;

  • 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.

  • Servicing Transfer Costs All reasonable costs and expenses incurred by the Trustee in connection with the transfer of servicing from a predecessor servicer, including, without limitation, any costs or expenses associated with the complete transfer of all servicing data and the completion, correction or manipulation of such servicing data as may be required by the Trustee to correct any errors or insufficiencies in the servicing data or otherwise to enable the Trustee to service the Mortgage Loans properly and effectively.