Manufacturing Technology Transfer Clause Samples
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Manufacturing Technology Transfer. During the [*] Period, ▇▇▇▇▇▇▇ shall transfer to Forest or its designee (which designee may be an Affiliate or a Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Product) all ▇▇▇▇▇▇▇ Know-How constituting the then-current process for the Manufacture of the Licensed Compounds and Licensed Products (the “Manufacturing Process”) and necessary or reasonably useful to implement the Manufacturing Process at facilities designated by Forest. ▇▇▇▇▇▇▇ shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Effective Date), all reasonable assistance requested by Forest to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, including (a) to the extent not already provided pursuant to Section 2.6.1, making available all Manufacturing-related ▇▇▇▇▇▇▇ Know-How, Information and documentation and materials that are necessary or reasonably useful to enable Forest (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Forest, and (b) assisting Forest (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities that are specific for the Manufacture of the Licensed Compounds and the Licensed Products at the applicable facilities. If requested by Forest, ▇▇▇▇▇▇▇’▇ assistance shall include (x) assigning to Forest any existing agreement between ▇▇▇▇▇▇▇ or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products to the extent permitted under such existing agreement (any such agreement that is assigned to Forest, a “Transferred Agreement”), (y) if (i) the terms of any existing agreement between ▇▇▇▇▇▇▇ or any of its Affiliates and any Third Party supplier that pertains solely to one or more Licensed Compounds or Licensed Products prohibits ▇▇▇▇▇▇▇ from assigning it to Forest, or (ii) any existing agreement between ▇▇▇▇▇▇▇ or any of its Affiliates and any Third Party supplier tha...
Manufacturing Technology Transfer. With respect to the Category 2 Programs and Category 3 Programs, at any time after the Effective Date, and, with respect to the Category 1 Programs, only if Arrowhead is unable or unwilling to Manufacture for Sarepta any Licensed C1 Compound or Licensed C1 Product, or Arrowhead is in material breach of, or there is a supply failure (as defined therein) under, the relevant clinical or commercial supply agreement with respect to such Licensed C1 Compound or Licensed C1 Product, Sarepta may request in writing the transfer from Arrowhead or Arrowhead’s CMO to Sarepta or (a) any CMO set forth on Schedule 5.4 (Approved Sarepta CMO) or (b) with Arrowhead’s prior written consent (not to be unreasonably withheld, conditioned or delayed) any other CMO designated by Sarepta (the CMOs set forth on Schedule 5.4 (Approved Sarepta CMO) and any such other Arrowhead approved CMOs, each, an “Approved Sarepta CMO”), copies or samples of all Arrowhead Know-How that is necessary or reasonably useful to enable the Manufacture of the Licensed Compounds and Licensed Products (the “Arrowhead Manufacturing Know-How”). Promptly following any such written request by ▇▇▇▇▇▇▇ and within [***] days after such written request, the JMC will prepare, and submit to the JSC to review, discuss, and determine whether to approve, a written Manufacturing technology transfer plan that provides for (i) Arrowhead or Arrowhead’s Third Party CMO transferring copies of relevant documentation, samples of Drug Substance, and copies of other embodiments of such Arrowhead Manufacturing Know-How (including data within reports, notebooks, and electronic files), and (ii) Arrowhead making available its technical Personnel on a reasonable basis and as more specifically specified therein to consult with Sarepta with respect to such transferred Arrowhead Manufacturing Know-How (such plan, the “Manufacturing Technology Transfer Plan”). The Manufacturing Technology Transfer Plan will include a budget of the Out-of-Pocket Costs (including any amounts that Arrowhead will pay to its Subcontractors, including CMOs) to be incurred by Arrowhead in the performance of the activities set forth in the Manufacturing Technology Transfer Plan (the “Manufacturing Technology Transfer Budget”). Pursuant to the timelines set forth in the Manufacturing Technology Transfer Plan that is agreed to by the Parties, and in any event no later than [***] days thereafter, Arrowhead will work with Sarepta to complete the transfer of the Arro...
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 the generality of the obligations in Section 2.4, Lexicon shall commence, as and when reasonably requested by Sanofi, the transfer to Sanofi or its designee (which designee may be an Affiliate, Sublicensee, Lexicon CMO or other Third Party manufacturer) of the Lexicon Know-How necessary or useful to perform the then-current process for the Manufacture of the Licensed Compound and Licensed Products, as well as any improvements or enhancements to such processes via a cGMP-compliant technology transfer (the “Manufacturing Process”) and provide such support as may be necessary or reasonably useful to Sanofi or its designee to use and practice the Manufacturing Process, including by (i) if permitted under the terms and conditions thereof, assigning to Sanofi, at its request, any agreements (including any open purchase orders) with Lexicon CMOs that are necessary or useful to perform Manufacturing activities related to the Licensed Compound or the Licensed Products or (ii) if such assignment is prohibited by the terms thereof or Applicable Law and if requested by Sanofi, by reasonably assisting Sanofi or its designee to enter into agreements with such Lexicon CMOs (the “Technology Transfer”). The Technology Transfer shall be conducted in accordance with reasonable timelines as mutually agreed by the Parties with the goal of completing the Technology Transfer within a reasonable time. Lexicon shall or shall cause its CMOs to allocate the necessary resources to ensure the Technology Transfer occurs in a timely and efficient manner in accordance with such deadlines. All costs and expenses of Lexicon’s internal personnel incurred by Lexicon pursuant to such Technology Transfer or any subsequent technology transfer, as provided in Section 6.3, shall be the responsibility of Lexicon, and all out-of-pocket expenses paid to Lexicon CMOs shall be the responsibility of Sanofi.
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. 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. 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. 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. Any manufacturing technology transfer activities to be conducted by the Parties will be set forth in the Research Plan or Development Plan, as applicable; provided that, if the Parties have not yet entered into an Out-Licensing Transaction, then Odyssey will take the lead role in Manufacturing the Licensed Compounds and Licensed Products (unless the Parties mutually agree otherwise) in accordance with the Research Plan or Development Plan, as applicable.
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”).