Manufacturing Technology Transfer Plan Sample Clauses

Manufacturing Technology Transfer Plan. The Parties agree that the principles set forth on Schedule 7.2 shall form the basis for the Manufacturing Technology Transfer from Epizyme to Hutchmed which shall be conducted to enable Hutchmed to Manufacture clinical and commercial quantities of Drug Product and to enable Hutchmed or a Permitted Subcontractor CMO to Manufacture clinical and commercial quantities of Drug Substance, and which shall include the ongoing transfer of Manufacturing Activities under Section 7.4. At the first meeting of the JMC, the Parties shall commence formulating the detailed plan and budget based on Schedule 7.2 for the Manufacturing Technology Transfer to Hutchmed, which plan will be agreed upon by the JMC and set forth in an agreement to be executed by the Parties (the “Manufacturing Technology Transfer Agreement”). The Manufacturing Technology Transfer shall begin as soon as is practicable and continue until Hutchmed’s facilities for DP or Hutchmed’s or its Permitted Subcontractor CMO’s facilities for DS have been qualified and otherwise received all Regulatory Approvals required to Manufacture DS or DP, as applicable (“Manufacturing Technology Transfer Completion”). The Parties agree to use Commercially Reasonable Efforts to achieve Manufacturing Technology Transfer Completion within [**] after commencement of the Manufacturing Technology Transfer (subject to the ongoing transfer of Manufacturing Activities under Section 7.4). Except for the ongoing transfer of Manufacturing Activities under Section 7.4, Epizyme shall not be obligated to provide a Manufacturing Technology Transfer for Drug Substance and Drug Product more than [**], unless otherwise agreed upon by the Parties. All Drug Substance and Drug Product Manufactured by Hutchmed or a Permitted Subcontractor CMO shall be used solely in the Development and Commercialization of Licensed Compounds and Licensed Products in the Territory by Hutchmed Entities in accordance with the terms of this Agreement. Hutchmed and its Permitted Contractor CMO shall not Manufacture any quantity of Drug Substance or Drug Product co-formulated with an Other Combination Drug. The Manufacturing Technology Transfer shall be at Hutchmed’s cost and expense to the extent incurred in accordance with the budget to be included in the Manufacturing Technology Transfer Agreement, and shall be at Epizyme’s costs and expense to the extent in excess of such budget. Hutchmed shall pay to Epizyme an amount equal to all of Epizyme’s and its Affiliates...
Sample 1
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Manufacturing Technology Transfer Plan. The plan for the one-time technology transfer plan for the Product from Lilly to Buyer (or its designated manufacturer), is attached hereto as Exhibit B (Manufacturing Technology Transfer Plan).
Sample 1
Manufacturing Technology Transfer Plan. Antigenics MA will use commercially reasonable efforts to execute the Manufacturing Technology Transfer Plan (and to [**] to execute its activities under the Manufacturing Technology Transfer Plan), in an efficient and timely manner and in accordance with schedule as set forth in the Manufacturing Technology Transfer Plan. In particular, Antigenics MA will [**] under the Manufacturing Technology Transfer Package (other than the [**]) within [**] after the Effective Date and the Parties shall use commercially reasonable efforts to complete the Phase 1 of the Manufacturing Technology Transfer Plan with the goal of reaching Completion of the Transfer of the Manufacturing Technology Package by the later of [**] or [**]. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Sample 1
Manufacturing Technology Transfer Plan. The Parties shall conduct Manufacturing technology transfer of the Compound and the Products in accordance with this Manufacturing Technology Transfer Plan and Section 3.7(c) (Technology Transfer to KKC) of the Agreement. MEI will provide subject matter expertise including making appropriate employees available at reasonably agreed times and frequency, for the purpose of enabling KKC’s CMO to Manufacture the Compound and the Product and supply the JP and RoW Supply Items. [*CONFIDENTIAL*] Confidential EXECUTION VERSION Schedule 4.1(a) U.S. Development Plan [*CONFIDENTIAL*] [8 PAGES HAVE BEEN REDACTED] Confidential EXECUTION VERSION Schedule 4.3 Co-Promotion Terms [*CONFIDENTIAL*] [5 PAGES HAVE BEEN REDACTED] Confidential EXECUTION VERSION Schedule 5.1(a) JP Development Plan [*CONFIDENTIAL*] [4 PAGES HAVE BEEN REDACTED] Confidential EXECUTION VERSION Schedule 10.6 Joint Press Release MEI Pharma and Kyowa Kirin Announce Global License, Development and Commercialization Agreement for ME-401 • MEI Pharma and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S.; MEI to book U.S. sales on 50-50 profit and cost sharing • Kyowa Kirin obtains exclusive commercialization rights ex-U.S.; MEI to receive escalating tiered royalty payments on ex-U.S. sales • MEI to receive $100 million in an upfront cash payment and is eligible to receive up to an additional $582.5 million based on the achievement of specified development, regulatory and commerical milestones • MEI to host conference call on April 15 at 8:00 a.m. ET SAN DIEGO, and TOKYO, April 15, 2020 – MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today jointly announced that the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kd), in clinical development for the treatment of B-cell malignancies. MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S., with MEI booking all revenue from U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S. ME-401 is being studied in the ongoing Phase 2 TIDAL clinical trial evaluating patients with relapsed or refractory follicular lymphoma which, subject to results, may support an accelerated approval of a marketing application with the U.S. Food and Drug Administration (FDA). An ongoing Phase 1b study...
Sample 1
Manufacturing Technology Transfer Plan. The Manufacturing Technology Transfers will be conducted pursuant to and will be subject to a written plan prepared by the Manufacturing Committee and approved by the JSC in good faith prior to the anticipated commencement of the Initial Manufacturing Technology Transfer (the “Manufacturing Technology Transfer Plan”), [**]. The Parties will use [**] efforts to agree upon the Manufacturing Technology Transfer Plan within [**] following the Effective Date. Without limiting the foregoing, in connection with the development of the Manufacturing Technology Transfer Plan, LogicBio will use [**]. For each Manufacturing Technology Transfer, each Party will use [**] to effect the full Manufacturing Technology Transfer as soon as possible following the commencement of such technology transfer activities. If requested by CANbridge, LogicBio will use [**].
Sample 1
Manufacturing Technology Transfer Plan. The Parties will use commercially reasonable efforts to update the Manufacturing Technology Transfer Plan and perform their respective activities thereunder, in an efficient and timely manner and in accordance with any schedule that may be set forth in the Manufacturing Technology Transfer Plan. The Parties acknowledge that Antigenics MA has transferred to GSK all documents under the Manufacturing Technology Package and the Parties have completed the Phase 1 of the Manufacturing Technology Transfer Plan in accordance with the timelines set forth in the 2006 Supply Agreement. The Parties shall use commercially reasonable efforts to complete their obligations under the Manufacturing Technology Transfer Plan.
Sample 1

Related to Manufacturing Technology Transfer Plan

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Technology Transfer Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Technology Research Analyst Job# 1810 General Characteristics Maintains a strong understanding of the enterprise’s IT systems and architectures. Assists in the analysis of the requirements for the enterprise and applying emerging technologies to support long-term business objectives. Responsible for researching, collecting, and disseminating information on emerging technologies and key learnings throughout the enterprise. Researches and recommends changes to foundation architecture. Supports research projects to identify and evaluate emerging technologies. Interfaces with users and staff to evaluate possible implementation of the new technology in the enterprise, consistent with the goal of improving existing systems and technologies and in meeting the needs of the business. Analyzes and researches process of deployment and assists in this process.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

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