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. Without limiting the provisions of Section 5.10 (Information Sharing to Enable Exploitation of Licensed Compounds and Licensed Products), on a Research Program-by-Research Program basis, at the request of BMS, Avidity shall provide, and shall use Commercially Reasonable Efforts to cause its Third Party manufacturers to provide to BMS (or its designee), a full manufacturing technology transfer (including providing assistance as reasonably requested by BMS in connection with such transfer) of Avidity Know-How to enable BMS (or its Affiliate or designated Third Party manufacturer, as applicable) to implement the Avidity Manufacturing Process for, and to otherwise Manufacture, Licensed Products (including any Licensed Compound contained therein) from such Research Program at the facilities designated by BMS (each, a “Manufacturing Technology Transfer”). Prior to initiating such Manufacturing Technology Transfer, the Parties (through the JTTSSC) will promptly develop and agree upon a plan for conducting such Manufacturing Technology Transfer, including a timeline for completing activities set forth therein (the “Manufacturing Technology Transfer Plan”). Avidity shall initiate such requested Manufacturing Technology Transfer promptly (and in all cases within [***]) after the Manufacturing Technology Transfer Plan is agreed upon by the Parties and shall complete such transfer in accordance with the Manufacturing Technology Transfer Plan on the timeline set forth therein. If requested by BMS, such Manufacturing Technology Transfer Plan shall include (a) facilitating BMS (or its Affiliate) entering into agreements with applicable Third Party suppliers relating to Licensed Compounds or Licensed Products, and (b) Avidity (and its Affiliates and Third Party manufacturers) providing to BMS (or its Affiliate or designated Third Party manufacturer, as applicable) all test results, records and other documentation related to the Manufacture of Licensed Compounds and Licensed Products, which shall be provided in English. Without limiting the generality of the foregoing, until such time as BMS (or its designee) is able to Manufacture GMP-grade clinical quantities of the applicable Licensed Compound or Licensed Product, as applicable (the “Manufacturing Transition Period”), (i) at the request of BMS, Avidity shall make available its (and its Affiliates’) employees (subject to the reasonable availability of such employees) and consultants (including using Commercially Reasonab...

Manufacturing Technology Transfer. Without limiting the provisions of Section 3.1, as soon as reasonably practicable following the Effective Date (but in all cases within thirty (30) days after Chimerix’s receipt of the upfront payment pursuant to Section 5.1), Chimerix shall transfer or cause to be transferred (including from its Third Party contract manufacturers) to Merck, or a Third Party manufacturer designated by Merck, copies in English (in writing and in an electronic format, or in written format to the extent that electronic format is not available) of all data, information and other Know-How Controlled by Chimerix (or any of its Affiliates or its Third Party contract manufacturers) that is related to the manufacture of the Compounds and/or Products, in order to enable Merck (or its designee) to manufacture the Compounds and Products, including to replicate the process employed by or on behalf of Chimerix to manufacture Compounds and Products. In addition, at the request of Merck from time to time during the eighteen (18) month period following the Effective Date, Chimerix shall make its (and its Affiliates’) employees and consultants (including personnel of its Third Party contract manufacturers) available to Merck to provide consultation and technical assistance in order to ensure an orderly transition of the manufacturing technology and operations to Merck (or its designee) and to assist Merck (or its designee) in the start-up of its manufacture of Compound and Product (such consultation, the “Manufacturing Consultation”). For clarity, the Manufacturing Consultation shall be at no cost or expense to Merck during the Transfer Period; provided, however, that Merck shall at all times (including during the Transfer Period) reimburse Chimerix (within thirty (30) days after a receipt of an itemized invoice from Chimerix) for those reasonable out-of-pocket costs payable by Chimerix to its Third Party contract manufacturer for the use of such Third Party contract manufacturer’s personnel in providing such Manufacturing Consultation to Merck to the extent applicable (but solely to the extent that Merck has agreed to the amount of such costs in writing prior to such Manufacturing Consultation, and for clarity, Chimerix shall be solely responsible for any costs incurred in excess of such agreed upon amount but shall not be obligated to incur such excess costs for Merck’s benefit).

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. 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. 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. If Zai […***…]; and (b) […***…], then (1) the Parties would enter into an amendment to this Agreement pursuant to which TPTX would grant to Zai a non-exclusive, sublicenseable (subject to the same terms as a sublicense under Licensed Technology pursuant to Section 2.3) license under Manufacturing Technology to Manufacture and have Manufactured (through a qualified CMO mutually acceptable to the Parties) the Product in the Territory solely for use in Development and Commercialization of the Product in the Field in the Territory, where “Manufacturing Technology” means any and all (i) Patents Controlled by TPTX or its Affiliates as of the date of grant of such license or thereafter during the Term that cover the method of manufacture of the Product in the Territory, and (ii) Know-How Controlled by TPTX or its Affiliates as of the date of grant of such license or thereafter during the Term that is used by or on behalf of TPTX for the Manufacture of the Products in the Field in the Territory; provided that, notwithstanding the foregoing, in the event a Change of Control of TPTX occurs after Effective Date, Patents or Know-How Controlled by any Affiliate of TPTX that was not an Affiliate of TPTX immediately prior to such Change of Control transaction shall not be Manufacturing Technology except to the extent such Patents or Know-How falls within the definition of Manufacturing Technology and (A) is also Controlled by TPTX or its Affiliate existing immediately prior to such transaction or (B) is generated or used by such Affiliate in the Manufacture of the Licensed Compound or Product after such transaction; and (2) at Zai’s sole cost, TPTX shall (A) transfer all Know-How within the Manufacturing Technology to Zai or its permitted CMO; and (B) provide any and all necessary assistance to Zai or such permitted CMO at Zai’s cost (clauses (A) and (B), the “Manufacturing Technology Transfer”).

Manufacturing Technology Transfer. In addition to Benitec’s obligations under Section 2.4 (Transfer of Know-How and Materials for BB-301) and Section 3.7 (Transfer of Know- How and Materials for Collaboration Programs), Benitec shall (itself or through its Affiliate(s)) transfer to Axovant or its designee all process development work conducted by Benitec as of the Effective Date or during the Term to the extent that it is reasonably necessary or useful for the manufacture of any of Compound or Licensed Product at any time that such work is completed and ready to be transferred, solely for Axovant or its CMO to manufacture or have manufactured Compounds or Licensed Products in accordance with the terms and conditions of this Agreement. Such transfer shall include copies of the Benitec Know-How and any tangible materials that are necessary for the implementation of such process development work in manufacture of Compounds or Licensed Products. Upon Axovant’s reasonable request, Benitec shall (itself or through its Affiliate(s)) provide reasonable technical assistance by making appropriate personnel available to Axovant at reasonable times, places, and frequency, and upon reasonable prior notice for up to an aggregate of ****, which shall be free of charge to Axovant, for the purpose of assisting Axovant to understand and use such Benitec Know-How for the manufacture of Compounds and Licensed Products. Thereafter, if requested by Axovant, Benitec shall continue to make its personnel available to Axovant and continue to perform such technology transfer obligations, provided that Axovant will reimburse and pay Benitec for its time incurred in performing such technology transfer obligations and providing such assistance at the Benitec FTE Rate. The following costs and fees for the manufacturing and technology transfer assistance described in this Section 6.2 (Manufacturing Technology Transfer) shall be reimbursed and paid by Axovant pursuant to Section 8.2(b) (Reimbursement of Benitec Manufacturing Technology Transfer Costs): (a) the Out-of-Pocket Costs incurred by Benitec or its Affiliate(s), and (b) the product of the Benitec FTE Rate multiplied by the number of Benitec FTE hours provided in excess of the above-referenced free ****, in each case of (a) and (b) that are directly related to such technology transfer or assistance (collectively, the “Benitec Technology Transfer Costs”). The Benitec Technology Transfer Costs shall be reimbursed by Axovant in accordance with Section 8.2(b) (Reimburse...