Manufacturing Technology Transfer Clause Samples

Manufacturing Technology Transfer. Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Res...

Manufacturing Technology Transfer. In order to enable the Parties to have Manufactured the Compound and Licensed Product by the mutually-designated Third-Party manufacturer(s) consistent with the terms of Section 6.2(a) (Potential Alternative Suppliers), or if such mutually agreed Third-Party manufacturer cannot be found by the [*****], to enable EverInsight to Manufacture or have Manufactured the Compound and Licensed Product for the Territory pursuant to Section 6.2(b), VistaGen shall (a) perform or facilitate technology transfer to such mutually-designated Third Party manufacturer, EverInsight or the Third Party manufacturer selected by EverInsight (the “Designated Manufacturer(s)”) as is necessary or reasonably useful in the Manufacture of the Compound and Licensed Product and as of such date are being used by VistaGen or VistaGen CMO (as defined below) to Manufacture the Compound and Licensed Product (the “Licensed Manufacturing Know-How”) solely for the Designated Manufacturer(s) to Manufacture the Compound and Licensed Products in accordance with the terms and conditions of this Agreement; (b) identify in writing all Subcontractors who Manufacture Compounds or Licensed Product for VistaGen (each, an “VistaGen CMO”); and (c) provide technical assistance (both on site and otherwise) in the transfer and demonstration of the Licensed Manufacturing Know-How that is necessary to Manufacture the Compound and Licensed Product. To the extent that any Licensed Manufacturing Know-How is in the Control of VistaGen but is in the possession of a VistaGen CMO (and is not in VistaGen’s possession), then during the Manufacturing Transfer Period, VistaGen will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such VistaGen CMO to the Designated Manufacturer(s), and/or cause such VistaGen CMO to make such Licensed Manufacturing Know-How available to the Designated Manufacturer(s). VistaGen shall be solely responsible for the cost and expense of such technology transfer and no payment shall be due from EverInsight to VistaGen or any Third Party (including VistaGen CMO) for such technology transfer.

Manufacturing Technology Transfer. Within [...***...] following Company’s written request, Licensor will transfer (“Manufacturing Technology Transfer”) to Company, at Licensor’s cost and expense, written or electronic copies of all Licensor Know-How and reasonable quantities of Licensor Materials, including such Know-How that relates to the Development and Manufacture of the Collaboration Compound and Product, including related documentation and all such information as is reasonably anticipated to become a part of the Chemistry, Manufacturing and Controls section of a regulatory submission document included in an MAA (collectively, “CM&C Know-How”) or otherwise related to the formulation of the Collaboration Compound and Product (including all information necessary or useful for operation of the transferred process and all biochemical and biophysical analytical assays, in vitro assays and in vivo assays (including all proprietary materials necessary or useful for performing such assays), pharmacokinetic analytics, pharmacodynamics markers, bioanalytical methods for anti-drug antibodies (neutralizing antibodies and binding antibodies), including standard operating procedures, and data received thereon).

Manufacturing Technology Transfer. Upon Allergan’s request, initiated no earlier than [*] after the Effective Date and no later than the completion of the first Phase II Clinical Trial for a Licensed Product conducted by Allergan or its authorized designee, UroGen shall effect a full transfer to Allergan or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all UroGen Know-How relating to the then-current process for the Manufacture of the RTGel Component (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by Allergan. The transfer of the Manufacturing Process from UroGen shall be deemed complete when Allergan is able to, either itself or via its designee, Manufacture Licensed Products that meet established specifications. Following completion of the transfer of the Manufacturing Process in accordance with this Section 5.2, as between the Parties, (a) Allergan shall be responsible for securing the manufacture of its future needs of RTGel Components not then subject to an outstanding purchase order including, for the avoidance of doubt, any Phase I or Phase II Clinical Trials conducted by Allergan after the completion of such transfer, and (b) except with respect to purchase orders placed by Allergan in accordance with Section 5.1.1 for RTGel Component prior to the completion of transfer, Section 5.1.1 and Section 5.1.3 shall cease to apply in their entirety. Upon Allergan’s reasonable request following the transfer of the Manufacturing Process for the RTGel Component, UroGen shall provide (i) up to [*] hours of reasonable technical assistance [*] following the transfer of the Manufacturing Process to enable Allergan (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Allergan and (ii) such additional technical assistance (including access to its technical personnel) as may be requested by Allergan for compensation at the rate of [*] per hour, in each case of (i) and (ii) subject to reimbursement of UroGen’s documented travel and other out-of-pocket expenses incurred in providing such assistance within [*] days of invoice therefor. Notwithstanding the anything to the contrary, Allergan shall be responsible at all times during the Term for manufacture of all [*] of the Licensed Product.

Manufacturing Technology Transfer. In addition to the Zymeworks Know-How provided to Jazz pursuant to the Initial Technology Transfer, upon Jazz’s written request, Zymeworks will promptly work with Jazz to prepare and submit to the JSC, for its review, a plan (“Manufacturing Technology Transfer Plan”) for the transfer to Jazz or its designee of all Zymeworks Know-How and certain biological materials Controlled by Zymeworks with respect to the manufacture of Licensed Antibody or Licensed Product (“Zymeworks Manufacturing IP”), including, without limitation, [***] and the conduct by Zymeworks of such consultation activities, as are necessary or useful to enable Jazz or any Third Party contract manufacturing organization (a “CMO”) designated by Jazz to manufacture for the Territory Licensed Antibody and Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC of the applicable Manufacturing Technology Transfer Plan, Zymeworks will perform (or cause one or more applicable Third Parties (including, as applicable, any CMO engaged by Zymeworks to manufacture Licensed Antibody or Licensed Product) to perform) the requested Manufacturing Technology Transfer in accordance with such Manufacturing Technology Transfer Plan to Jazz or to a CMO designated by Jazz[***]. Zymeworks will complete the Manufacturing Technology Transfer promptly (and in any event within [***] after the Parties’ agreement on the Manufacturing Technology Transfer Plan) in accordance with the timeline agreed by the Parties, following Jazz’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks will provide Jazz with additional Zymeworks Manufacturing IP as part of the Continuing Technology Transfer in accordance with Section 4.1, and Jazz shall disclose Jazz Manufacturing IP in accordance with Section 7.4(c). All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed Product.

Manufacturing Technology Transfer. To the extent a technology transfer to GSK or a Third Party contract manufacturer is required pursuant to Sections 9.1 or 9.2 above, then Liquidia shall conduct such technology transfer in accordance with a reasonable plan to be agreed between the Parties, and shall pay for such technology transfer during the agreed upon technology transfer period. Thereafter, GSK shall bear the cost of such technology transfer; provided, that Liquidia has used Commercially Reasonable Efforts to comply with the technology transfer plan within the agreed period of time; and provided further that if Liquidia does not use Commercially Reasonable Efforts to comply with the technology transfer plan within the agreed period of time, then Liquidia shall bear the costs of the remaining period of time applicable to such technology transfer. Notwithstanding the foregoing, if GSK has determined that it or a Third Party will be responsible for manufacture as set forth in Sections 9.2 and 5.2(c)(ii)(C)(2), then GSK shall bear the cost of such technology transfer, subject to Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Liquidia’s use of Commercially Reasonable Efforts to comply with the agreed technology transfer plan. Liquidia’s obligation to transfer PRINT or PRINT Tooling (as applicable) shall only apply in the event that GSK has the right to make or have made the Research Materials, Liquidia Respiratory Product, Research Product and/or Inhaled Product using PRINT or PRINT Tooling under this Article 9 and Section 5.2.

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.

Manufacturing Technology Transfer. Without limiting Article 4, upon ZAI’s reasonable request, TESARO shall transfer to ZAI or its designated Third Party contract manufacturer all material TESARO Know-How necessary to manufacture the Licensed Compound and Licensed Product. In connection with such technology transfer, TESARO shall provide reasonable technical assistance, at ZAI’s cost, to enable ZAI or its designated Third Party contract manufacturer to manufacture the Licensed Compound and Licensed Product.

Manufacturing Technology Transfer. In addition to the initial technology transfer set forth in Section 4.1 (Technology Transfer), upon Metsera’s request, D&D will and will cause its Affiliates to work with Metsera to transfer to Metsera, at Metsera’s reasonable cost and expense, (a) all Licensed Know-How that is necessary or useful to enable the Manufacture of the Licensed Compounds and Licensed Products, to the extent not previously transferred to Metsera under this Agreement, by providing copies or samples of relevant documentation, materials, and other embodiments of such Know-How, and by making available its and its Affiliates’ and Subcontractors’ qualified technical personnel on a reasonable basis to consult with Metsera with respect to such Know-How, and (b) any materials (as well as any intermediates and impurities of such materials) used by D&D and/or its Affiliates or Subcontractors in the Manufacture of such Licensed Compounds and Licensed Products. To facilitate such transfer, the Parties will negotiate in good faith a manufacturing technology transfer plan, and the Parties will coordinate and ensure that such transfer has been completed under the applicable technology transfer plan.