Manufacturing Technology Transfer Completion definition

Manufacturing Technology Transfer Completion has the meaning set forth in Section 7.2.
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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.
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Examples of Manufacturing Technology Transfer Completion in a sentence

  • 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.

  • 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.

  • 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.

  • Betta will pay to Agenus an additional one-time, non-refundable, non-creditable, and not subject to set-off fee of [*] (“Tech Transfer Fee”) upon the Manufacturing Technology Transfer Completion pursuant to Section 5.2(b).

  • Arbutus and Qilu shall each use Commercially Reasonable Efforts to perform their respective obligations necessary to achieve Manufacturing Technology Transfer Completion as soon as reasonably possible.

  • 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.

  • 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”).

  • 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.