Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. In order to enable Everest to Manufacture or have Manufactured the Compound and Licensed Products consistent with the terms of Section 6.3 (Manufacturing Responsibilities), upon a written request from Everest, NPLH shall perform or facilitate technology transfer to Everest as follows: during a mutually agreed time period of no more than [***] days (the “Manufacturing Transfer Period”), NPLH shall (a) make available and transfer to Everest, copies of existing embodiments of the Licensed Know-How in NPLH’s possession that are necessary or reasonably useful in the Manufacture of the Compound and Licensed Products and as of such date are being used by NPLH to Manufacture the Compound and Licensed Products (the “Licensed Manufacturing Know-How”) solely for Everest and/or its Subcontractor 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 Products for NPLH (each, an “NPLH 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 Products. To the extent that any Licensed Manufacturing Know-How is in the Control of NPLH but is in the possession of a NPLH CMO (and is not in NPLH’s possession), then during the Manufacturing Transfer Period, upon Everest’s request, NPLH will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such NPLH CMO to Everest, and/or cause such NPLH CMO to make such Licensed Manufacturing Know-How available to Everest, at Everest’s cost. Everest, in its sole discretion and at its sole expense, may contract with any such NPLH CMO for technical Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Appears in 1 contract

Samples: License Agreement (Spero Therapeutics, Inc.)

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Manufacturing Technology Transfer. In order to enable Everest the Parties to have Manufactured the Compound and Licensed Product by the mutually-designated Third-Party CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*****], HAS BEEN OMITTED BECAUSE VISTAGEN THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO SUPER LEAGUE GAMING, INC. IF PUBLICLY DISCLOSED. 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 Products consistent with Product for the terms of Territory pursuant to Section 6.3 (Manufacturing Responsibilities6.2(b), upon a written request from Everest, NPLH VistaGen shall (a) perform or facilitate technology transfer to Everest as follows: during a mutually agreed time period of no more than [***] days such mutually-designated Third Party manufacturer, EverInsight or the Third Party manufacturer selected by EverInsight (the “Manufacturing Transfer PeriodDesignated Manufacturer(s)), NPLH shall (a) make available and transfer to Everest, copies of existing embodiments of the Licensed Know-How in NPLH’s possession that are as is necessary or reasonably useful in the Manufacture of the Compound and Licensed Products Product and as of such date are being used by NPLH VistaGen or VistaGen CMO (as defined below) to Manufacture the Compound and Licensed Products Product (the “Licensed Manufacturing Know-How”) solely for Everest and/or its Subcontractor 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 Products Product for NPLH VistaGen (each, an “NPLH 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 ProductsProduct. To the extent that any Licensed Manufacturing Know-How is in the Control of NPLH VistaGen but is in the possession of a NPLH VistaGen CMO (and is not in NPLHVistaGen’s possession), then during the Manufacturing Transfer Period, upon Everest’s request, NPLH VistaGen will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such NPLH VistaGen CMO to Everestthe Designated Manufacturer(s), and/or cause such NPLH VistaGen CMO to make such Licensed Manufacturing Know-How available to Everest, at Everest’s costthe Designated Manufacturer(s). Everest, in its sole discretion VistaGen shall be solely responsible for the cost and at its sole expense, may contract with expense of such technology transfer and no payment shall be due from EverInsight to VistaGen or any Third Party (including VistaGen CMO) for such NPLH CMO for technical Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedtechnology transfer.

Appears in 1 contract

Samples: License and Collaboration Agreement (VistaGen Therapeutics, Inc.)

Manufacturing Technology Transfer. In order addition to enable Everest to Manufacture or have Manufactured the Compound and Licensed Products consistent with the terms Benitec’s obligations under Section 2.4 (Transfer of Section 6.3 (Manufacturing Responsibilities), upon a written request from Everest, NPLH shall perform or facilitate technology transfer to Everest as follows: during a mutually agreed time period of no more than [***] days (the “Manufacturing Transfer Period”), NPLH shall (a) make available and transfer to Everest, copies of existing embodiments of the Licensed Know-How in NPLH’s possession 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 are it is reasonably necessary or reasonably useful in for the Manufacture manufacture of the any of Compound or Licensed Product at any time that such work is completed and Licensed Products and as of such date are being used by NPLH ready to Manufacture the Compound and Licensed Products (the “Licensed Manufacturing Know-How”) be transferred, solely for Everest and/or Axovant or its Subcontractor CMO to Manufacture the Compound and manufacture or have manufactured Compounds or Licensed Products in accordance with the terms and conditions of this Agreement; (b) identify . 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 writing all Subcontractors who Manufacture manufacture of Compounds or Licensed Products for NPLH Products. Upon Axovant’s reasonable request, Benitec shall (each, an “NPLH CMO”itself or through its Affiliate(s); and (c) provide reasonable technical assistance (both on site by making appropriate personnel available to Axovant at reasonable times, places, and otherwise) in frequency, and upon reasonable prior notice for up to an aggregate of ****, which shall be free of charge to Axovant, for the transfer purpose of assisting Axovant to understand and demonstration of the Licensed Manufacturing use such Benitec Know-How that is necessary to Manufacture for the Compound manufacture of Compounds and Licensed Products. To 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 extent that any Licensed Benitec FTE Rate. The following costs and fees for the manufacturing and technology transfer assistance described in this Section 6.2 (Manufacturing KnowTechnology Transfer) shall be reimbursed and paid by Axovant pursuant to Section 8.2(b) (Reimbursement of Benitec Manufacturing Technology Transfer Costs): (a) the Out-How is in the Control of NPLH but is in the possession of a NPLH CMO (and is not in NPLH’s possessionof-Pocket Costs incurred by Benitec or its Affiliate(s), then during and (b) the Manufacturing Transfer Period, upon Everest’s request, NPLH will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such NPLH CMO to Everest, and/or cause such NPLH CMO to make such Licensed Manufacturing Know-How available to Everest, at Everest’s cost. Everest, in its sole discretion and at its sole expense, may contract with any such NPLH CMO for technical Portions product of the exhibit, indicated Benitec FTE Rate multiplied by the xxxx “[number of Benitec FTE hours provided in excess of the above-referenced free ***],” were omitted *, in each case of (a) and have been filed separately (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 the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 Section 8.2(b) (Reimbursement of the Securities Exchange Act of 1934, as amendedBenitec Manufacturing Technology Transfer Costs).

Appears in 1 contract

Samples: License and Collaboration Agreement (Benitec Biopharma LTD/ADR)

Manufacturing Technology Transfer. In Everest and Sxxxx acknowledge that, in order to enable Everest to Manufacture or have Manufactured the Compound and Licensed Products consistent with the terms of Section 6.3 7.3 (Manufacturing Responsibilities), upon a written request from EverestEverest dated [***], NPLH shall perform or facilitate Sxxxx has commenced the technology transfer to Everest as follows: during a mutually agreed time period of no more than [***] days (the “Manufacturing Transfer Period”), NPLH Sxxxx shall (a) make available and transfer to Everest, copies of existing embodiments of the Licensed Know-How in NPLH’s Sxxxx’x possession that are necessary or reasonably useful in the Manufacture of the Compound and Licensed Products and as of such date are being used by NPLH Sxxxx to Manufacture the Compound and Licensed Products (the “Licensed Manufacturing Know-How”) solely for Everest and/or its Subcontractor 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 Products for NPLH Sxxxx (each, an “NPLH Sxxxx 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 Products. To the extent that any Licensed Manufacturing Know-How is in the Control of NPLH Sxxxx but is in the possession of a NPLH Sxxxx CMO (and is not in NPLH’s Sxxxx’x possession), then during the Manufacturing Transfer Period, upon Everest’s request, NPLH Sxxxx will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such NPLH Sxxxx CMO to Everest, and/or cause such NPLH Sxxxx CMO to make such Licensed Manufacturing Know-How available to Everest, at Everest’s cost. Everest, in its sole discretion and at its sole expense, may contract with any such NPLH Sxxxx CMO for technical Portions assistance (both on site and otherwise) in the transfer and demonstration of the exhibitLicensed Manufacturing Know-How that is necessary to Manufacture the Compound and Licensed Products. After the Manufacturing Transfer Period, indicated if requested by Everest, Sxxxx will in good faith endeavor to provide additional technical assistance in the xxxx “transfer of Licensed Manufacturing Know-How to Everest. For all activities or assistance provided from and after the Effective Date under the Original Agreement or this Agreement by Sxxxx employees or advisors to Everest under this Section 7.2 or under Section 3.5, (i) Sxxxx shall be responsible for only the costs associated with the first [***] FTE hours of activities by such employees and advisors and (ii) Everest shall be responsible for the costs and expenses of any such activities under this Section 7.2 and Section 3.5 once such [***],” were omitted -FTE threshold is used, and have been filed separately with shall pay or reimburse Sxxxx at the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedReimbursement Rate following a written invoice in reasonable detail.

Appears in 1 contract

Samples: Amended and Restated License Agreement (Spero Therapeutics, Inc.)

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Manufacturing Technology Transfer. In order Within [***], the Parties will enter into a separate agreement setting forth the terms and conditions under which HUTCHMED will transfer, or have transferred by its contract manufacturing organizations, to enable Everest Company or its designee, the Licensed Know-How and materials that are necessary or useful to Manufacture or have Manufactured the Licensed Compound and Licensed Products consistent with in the Territory (the “HUTCHMED Manufacturing Know-How”), the terms of Section 6.3 which agreement shall include the terms set forth in the Manufacturing Technology Transfer Term Sheet attached hereto as Schedule 4.3.3 (Terms of Manufacturing ResponsibilitiesTechnology Transfer) and such other terms and conditions as the Parties shall mutually agree upon (the “Manufacturing Technology Transfer Agreement”). Each Party will use reasonable efforts to effect such transfer as soon as reasonably practicable following the Parties entering into the Manufacturing Technology Transfer Agreement regarding such transfer and, upon a in any event, within any timeline contemplated in Schedule 4.3.3 (Terms of Manufacturing Technology Transfer). Any materials provided by XXXXXXXX in connection with the transfer of the HUTCHMED Manufacturing Know-How will remain the sole property of HUTCHMED, and Company will (a) use such HUTCHMED Manufacturing Know-How, including any materials transferred in connection therewith, only in the fulfillment of obligations or exercise of rights under this ​ Agreement, and (b) not use such HUTCHMED Manufacturing Know-How, including any materials received from HUTCHMED, or deliver the same to any Third Party, other than permitted Sublicensees, Subcontractors and Third Party consultants solely for the purpose of Manufacturing the Licensed Compound or Licensed Products in the Territory in accordance with this Agreement, without HUTCHMED’s prior written request from Everest, NPLH shall perform or facilitate technology transfer to Everest as follows: during a mutually agreed time period of no more than consent. HUTCHMED will provide [***] days (the “Manufacturing Transfer Period”), NPLH shall (a) make available and transfer to Everest, copies of existing embodiments of the Licensed Know-How in NPLH’s possession that are necessary or reasonably useful in the Manufacture of the Compound and Licensed Products and as of such date are being used by NPLH to Manufacture the Compound and Licensed Products (the “Licensed Manufacturing Know-How”) solely for Everest and/or its Subcontractor 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 Products for NPLH (each, an “NPLH CMO”); and (c) provide technical assistance (both on site and otherwise) in the transfer and demonstration of the Licensed HUTCHMED Manufacturing Know-How that is necessary transfer support free of charge. Within thirty (30) days after the end of each Calendar Quarter, XXXXXXXX shall deliver a report to Manufacture Company of the Compound and Licensed Products. To the extent that any Licensed HUTCHMED Manufacturing Know-How is in the Control of NPLH but is in the possession of a NPLH CMO transfer support provided pursuant to this Section 4.3.3 (and is not in NPLH’s possessionManufacturing Technology Transfer), then during which report shall include a description of activities conducted, the Manufacturing Transfer Periodnumber of hours devoted by each individual performing such activities (regardless of whether or not 1,800 working hours of transfer support has been provided), upon Everest’s requesta calculation of the actual FTE Costs applicable to each such individual (if applicable pursuant to the immediately following sentence), NPLH and any reasonable out-of-pocket expenses incurred (together with supporting documentation). Company will use Commercially Reasonable Efforts to facilitate reimburse HUTCHMED for (x) the transfer FTE Costs in excess of such Licensed [***] (if any) and (y) all reasonable out-of-pocket costs, charges, and expenses, in each case clauses (x) and (y), incurred by XXXXXXXX and its Affiliates in connection with any HUTCHMED Manufacturing Know-How from such NPLH CMO transfer support. XXXXXXXX will invoice Company for any costs, charges and expenses payable by Company pursuant to Everestthe immediately preceding sentence quarterly, and/or cause such NPLH CMO and, subject to make such Licensed Manufacturing Know-How available to Everest, at Everest’s cost. Everest, in its sole discretion and at its sole expense, may contract with any such NPLH CMO for technical Portions receipt of the exhibitreports of the transfer support provided by XXXXXXXX and the audit rights of Company contemplated in Schedule 4.3.3 (Terms of Manufacturing Technology Transfer), indicated Company will pay all invoices submitted by the xxxx “HUTCHMED within [***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 ] of the Securities Exchange Act date of 1934, as amendedreceipt of the invoice.

Appears in 1 contract

Samples: License Agreement (HUTCHMED (China) LTD)

Manufacturing Technology Transfer. (a) Upon request by Qilu made after receipt by Arbutus of the Upfront Payment, Arbutus shall, and shall use Commercially Reasonable Efforts to cause its CMO(s) to, commence the Manufacturing technology transfer (the “Manufacturing Technology Transfer”) to Qilu or its permitted CMO or permitted Sublicensees in accordance with a manufacturing technology transfer plan (“Manufacturing Technology Transfer Plan”) to be negotiated in good faith and entered into by the Parties, which shall set forth the process by which Arbutus shall transfer to Qilu (or its permitted CMO or permitted Sublicensees) all of the Arbutus IP that is necessary or reasonably useful for the Manufacturing of the Licensed Compound and Licensed Products (“Manufacturing Technology”). In order addition to enable Everest 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 consistent with the terms of Section 6.3 (until Manufacturing Responsibilities), upon a written request from Everest, NPLH shall perform or facilitate technology transfer to Everest as follows: during a mutually agreed time period of no more than [***] days (the “Manufacturing Technology Transfer Period”), NPLH shall (a) make available and transfer to Everest, copies of existing embodiments of the Licensed Know-How in NPLH’s possession that are necessary or reasonably useful in the Manufacture of the Compound and Licensed Products and as of such date are being used by NPLH to Manufacture the Compound and Licensed Products (the “Licensed Manufacturing Know-How”) solely for Everest and/or its Subcontractor to Manufacture the Compound and Licensed Products Completion in accordance with the terms and conditions of this Agreement; Section 5.5(a) (b) identify in writing all Subcontractors who Manufacture Compounds or Licensed Products for NPLH (each, an NPLH CMOTechnical Assistance”); . Arbutus 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 Products. To the extent that any Licensed Manufacturing Know-How is in the Control of NPLH but is in the possession of a NPLH CMO (and is not in NPLH’s possession), then during the Manufacturing Transfer Period, upon Everest’s request, NPLH will Qilu shall each use Commercially Reasonable Efforts to facilitate perform their respective obligations necessary to achieve Manufacturing Technology Transfer Completion as soon as reasonably possible. Qilu shall be responsible for reimbursing Arbutus for any out-of-pocket costs, including any fees charged by any CMO or other Third Party service provider, required to perform the transfer Manufacturing Technology Transfer or the Technical Assistance, to the extent not otherwise reimbursed under this Agreement. Upon the request of such Licensed Manufacturing KnowQilu, Arbutus shall provide the Technical Assistance to Qilu, subject to the following terms and conditions: (1) the Technical Assistance shall not require any Arbutus employee to travel in-How from such NPLH CMO person to Everest, and/or cause such NPLH CMO to make such Licensed Manufacturing Know-How available to Everest, at Everest’s cost. Everestthe Territory (except as may be agreed by the Parties otherwise, in its sole discretion which case, the Parties shall also agree on the specific travel arrangements and at its sole expense, may contract Qilu’s responsibility for the costs therefor); (2) the Technical Assistance shall include the time spent by Arbutus employees to oversee any activities in connection with the Manufacturing Technology Transfer and the Technical Assistance provided by any such NPLH CMO for technical Portions or other Third Party service provider; (3) [***]; and (4) [***](the “Technical Assistance Cap”). If Qilu requires Technical Assistance in excess of the exhibitTechnical Assistance Cap, indicated by the xxxx Arbutus agrees not to unreasonably withhold its agreement CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” were omitted ”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL to provide such additional Technical Assistance. Within thirty (30) days after the end of each Calendar Quarter when the Manufacturing Technology Transfer is ongoing or the Technical Assistance is provided, Arbutus shall deliver to Qilu an invoice setting forth the number of hours of Technical Assistance provided during the prior Calendar Quarter and have been filed separately the amounts owed to Arbutus with respect thereto, including any out-of-pocket costs to be paid by Qilu, together with any out-of-pocket costs incurred by Arbutus in connection with the Securities and Exchange Commission pursuant Manufacturing Technology Transfer to be paid by Qilu, in each case to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 extent not otherwise reimbursed or paid for by Qilu under this Agreement. Each such invoice shall be paid by Qilu within thirty (30) days of the Securities Exchange Act date of 1934such invoice and otherwise in accordance with Sections 7.5(g), as amended7.5(h) and 7.6.

Appears in 1 contract

Samples: Technology Transfer and Exclusive License Agreement (Arbutus Biopharma Corp)

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