Manufacturing Transition Plan definition

Manufacturing Transition Plan means the manufacturing transition plan attached hereto as Exhibit C, which plan will include, among other things, terms relating to pricing, freight, cash discounts, volume rebates, credit terms and other material terms of sale.
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Manufacturing Transition Plan shall have the meaning assigned to it in Section 5.23.
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Manufacturing Transition Plan shall have the meaning set forth in Section 2.6(b).
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Examples of Manufacturing Transition Plan in a sentence

  • Notwithstanding any provision of this Agreement, the parties agree that (i) RBX may sell the RBX Inventory Products in accordance with the Manufacturing Transition Plan and Marketing Transition Plan; and (ii) RBX may manufacture and sell the RBX Transition Products in accordance with the Manufacturing Transition Plan and during the Manufacturing Transition Period.

  • Each party shall cooperate in the transition of manufacturing responsibilities to Nomaco during the Manufacturing Transition Period and perform its respective obligations under the Manufacturing Transition Plan.

  • Payment of each party's costs and expenses incurred in connection with such activities shall be in accordance with the Manufacturing Transition Plan.

  • 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 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.

  • The Parties shall use Commercially Reasonable Efforts to effect the Manufacturing Technology Transfer to Incyte or its designee pursuant to this Section 7.1. The implementation of the Manufacturing Technology Transfer and Manufacturing Transition Plan shall be subject to the Incyte Facility being suitable for the Manufacture of the Licensed Compound Bulk Drug Substance as determined in accordance with this Section 7.1(a), as applicable, using the Manufacturing Process in compliance with Applicable Laws.

  • Within thirty (30) days after the end of each month during the performance of the Manufacturing Transition Plan, MacroGenics shall submit an invoice to Takeda detailing its Internal Expenses (limited as provided below) and reasonable out of pocket Third Party expenses incurred in fulfilling its obligations under the Manufacturing Transition Plan.

  • Protalix shall provide the proposed Manufacturing Transition Plan to Pfizer for Pfizer’s written approval, which shall not be unreasonably withheld, within [***] following Pfizer’s request.

  • Each Party shall use Commercially Reasonable Efforts to implement the Manufacturing Transition Plan and complete the transition of Manufacturing contemplated by this Section 6.3.1 as promptly as practicable, and in any event within the timelines contemplated therein.

  • The Parties shall perform each activity allocated to such Party under the Manufacturing Transition ​ Plan and shall use Commercially Reasonable Efforts to implement the Manufacturing Technology Transfer to Gilead or its designee in accordance with the Manufacturing Transition Plan.


More Definitions of Manufacturing Transition Plan

Manufacturing Transition Plan has the meaning set forth in Section 10.4 below.
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Manufacturing Transition Plan has the meaning set forth in Section 8.11.2 (Manufacturing Transition Period).
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Manufacturing Transition Plan means the plan for the transfer of Licensed Technology, Regulatory Approvals and responsibilities for the Manufacture of Ridaforolimus from ARIAD to MERCK pursuant to the Manufacturing Transition Plan set forth in Schedule 6 attached hereto.
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Manufacturing Transition Plan is defined in Section 8.3 (Manufacturing Technology Transfer).
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Manufacturing Transition Plan has the meaning set forth in Section 6.4.
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Related to Manufacturing Transition Plan

  • Transition Plan means a transition plan, acceptable to the LHIN that indicates how the needs of the HSP’s clients will be met following the termination of this Agreement and how the transition of the clients to new service providers will be effected in a timely manner; and

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Manufacturing Process means any process for—

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Plan has the meaning set forth in Section 3.2.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Implementation Plan means the schedule included in the Statement of Work setting forth the sequence of events for the performance of Services under the Statement of Work, including the Milestones and Milestone Dates.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Supply Plan has the meaning set forth in the CAISO Tariff.