Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. As soon as practicable, but in no case later than fifteen (15) Business Days after the Effective Date, the Parties shall meet in person to agree upon a written transition plan that will, at a minimum, include the current inventory of MGD010 in MacroGenics’ Control, and the inventory, drug substance and materials set forth on Exhibit E (the “Transferred Materials”). Beginning on the Effective Date and for a period of one hundred five (105) days from the Effective Date, MacroGenics shall use Commercially Reasonable Efforts to transfer, or cause to be transferred, to Provention or its designee, and Provention shall cooperate in good faith to support MacroGenics’ transfer of, such Manufacturing-related Know-How and inventory related to the Compound and the Products set forth in, and in accordance with, a transition plan to be agreed by the Parties on a commercially reasonable basis and in good faith after the Effective Date (such plan, the “Manufacturing Transition Plan”; such transfer, the “Manufacturing Technology Transfer”). The Manufacturing Transition Plan shall be designed to effect an efficient transfer from MacroGenics to Provention, or its designee, of (a) all MacroGenics Know-How that is reasonably necessary or useful for Provention’s Manufacture of Compound and Products in accordance with the terms of this Agreement and (b) all Compound and Products in finished form or in process on the Effective Date in MacroGenics’ inventory, including master cell banks and working cell banks, on the Effective Date. Provention shall fund (i) all of the reasonable FTE Costs incurred by MacroGenics in the performance of the Manufacturing Transition Plan after the Transition Period and (ii) all of the third party out-of-pocket expenses incurred by MacroGenics in the performance of the Manufacturing Transition Plan, to the extent such third-party out-of-pocket expenses are approved in advance by Provention. The Parties shall enter into such quality agreements, supply transfer agreements or other agreements as are deemed as are necessary to effectively execute the Manufacturing Technology Transfer in accordance with all Applicable Laws. Provention shall pay such FTE Costs and approved third-party out-of-pocket expenses within thirty (30) days following receipt of an invoice therefor.

Appears in 4 contracts

Samples: License Agreement, License Agreement (Provention Bio, Inc.), License Agreement (Provention Bio, Inc.)

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Manufacturing Technology Transfer. As soon as practicable, but in no case later than fifteen (15) Business Days after reasonably practicable following the Effective Date, the Parties Allist shall meet in person to agree upon a written transition plan that will, at a minimum, include the current inventory of MGD010 in MacroGenics’ Control(a) transfer, and thereafter continue, during the inventoryTerm as may be reasonably requested by ArriVent from time to time, drug substance the transfer (from Allist, its Affiliates, or its Third Party contract manufacturers) to ArriVent and materials set forth its designees copies in English (in an electronic format) of all Know-How Controlled by Allist or its Affiliates (or any of its Third Party contract manufacturers, to the extent Allist has the right to do so under its agreements with such Third Party contract manufacturers, in order to enable ArriVent and its designees to manufacture the Licensed Products, including, if desired by ArriVent, to replicate the process employed by or on Exhibit E (the “Transferred Materials”). Beginning on behalf of Allist prior to the Effective Date and for a period of one hundred five (105) days from to manufacture the Effective Date, MacroGenics shall use Commercially Reasonable Efforts to transfer, or cause to be transferred, to Provention or its designee, and Provention shall cooperate in good faith to support MacroGenics’ transfer of, such Manufacturing-related Know-How and inventory related to the Licensed Compound and the Products set forth in, and in accordance with, a transition plan to be agreed by the Parties on a commercially reasonable basis and in good faith after the Effective Date (such plan, the “Manufacturing Transition Plan”; such transfer, the “Manufacturing Technology Transfer”). The Manufacturing Transition Plan shall be designed to effect an efficient transfer from MacroGenics to Provention, or its designee, of (a) all MacroGenics Know-How that is reasonably necessary or useful for Provention’s Manufacture of Compound and Products in accordance with the terms of this Agreement and (b) all Compound and Products in finished form or in process on the Effective Date in MacroGenics’ inventory, including master cell banks and working cell banks, on the Effective Date. Provention shall fund (i) all of the reasonable FTE Costs incurred by MacroGenics in the performance of the Manufacturing Transition Plan after the Transition Period and (ii) all of the third party out-of-pocket expenses incurred by MacroGenics in the performance of the Manufacturing Transition Plan, to the extent that Allist does not have the right to so transfer under its agreements with such thirdThird Party contract manufacturers, use good faith efforts to obtain such right. Such transfers shall include all process, analytical, and formulation development data, all technical memoranda, all process evolution data, and all batch records. In addition, at the reasonable request of ArriVent from time to time, Allist shall make its employees and consultants (including personnel of its Affiliates and Third-party out-of-pocket expenses are approved Party contract manufacturers) available to ArriVent and its designees to provide reasonable consultation and technical assistance in advance by Proventionorder to ensure an orderly transition of the manufacturing technology and operations to ArriVent and its designees and to assist ArriVent and its designees in its manufacture of Licensed Products. The Parties shall enter into such quality agreements[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, supply transfer agreements or other agreements as are deemed as are necessary to effectively execute the Manufacturing Technology Transfer in accordance with all Applicable Laws. Provention shall pay such FTE Costs and approved third-party out-of-pocket expenses within thirty MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (30I) days following receipt of an invoice thereforIS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

Appears in 3 contracts

Samples: Global Technology Transfer and License Agreement (ArriVent Biopharma, Inc.), Global Technology Transfer and License Agreement (ArriVent Biopharma, Inc.), Global Technology Transfer and License Agreement (ArriVent Biopharma, Inc.)

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