Product Master Plan definition

Product Master Plan means a written plan executed by the Parties in conjunction with this Agreement relating to Product Produced hereunder, which may include, without limitation, Product, Product Specifications, Components, Component Specifications, Regulatory Authorities, the countries where such Product will be used in clinical trials or sold commercially, Presentations, and pricing for such Product Produced under this Agreement.
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Product Master Plan means, collectively, the following:
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Product Master Plan or “PMP” shall mean an addendum to this Agreement for Product Produced hereunder, which may include, without limitation, the Product, Product Specifications, Components, Component Specifications, Raw Materials, Regulatory Authorities, the countries where such Product will be sold, Presentations, and pricing for such Product Produced under this Agreement. Each involved Product shall have its specific PMP.
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Examples of Product Master Plan in a sentence

  • In general, Baxter is responsible for performing tests and assays directly related to the filling operation; i.e., identity testing, uniformity by unit weight variation, pre-filtration bioburden, bulk and finished Product sterility, etc., or as otherwise determined by agreement between Halozyme and Baxter in the Product Master Plan.

  • In the event that the terms of the Product Master Plan or Quality Agreement are inconsistent with the terms of this Agreement, this Agreement shall control, unless otherwise explicitly agreed to in writing by the parties.

  • None of the provisions of this Agreement (including the Exhibits hereto) or the Product Master Plan shall be considered waived by any party hereto unless such waiver is agreed to, in writing, by authorized agents of such party.

  • The Steering Committee shall have the oversight and responsibility to review and propose changes to the Product Master Plan, to propose and plan clinical programs for the Product, and to propose Other Products in accordance with the terms and conditions of this Agreement.

  • Prior to the Agreement Date, the parties have mutually agreed upon each of the exhibits attached to this Agreement comprising the Product Master Plan.

  • In accordance with the Product Master Plan, Halozyme shall pursue regulatory approval of marketing licenses for Products Produced by Baxter for Halozyme hereunder.

  • The Product Master Plan and Quality Agreement shall be incorporated herein and by reference and made a part of this Agreement.

  • Halozyme further warrants that the API provided to Baxter hereunder (1) conforms to the API Specifications, (2) has been produced in accordance with cGMP and all applicable laws and regulations set forth in the Product Master Plan as relating to the API and in accordance with the applicable Certificates of Analysis (provided in accordance with the Quality Agreement) accompanying each Lot of API and (3) is not adulterated or misbranded within the meaning of the FD&C Act.

  • The parties hereto acknowledge that this Agreement, together with the Product Master Plan, the Confidentiality Agreement, the Quality Agreement and the Exclusive Distribution Agreement sets forth the entire agreement and understanding of the parties and supersedes all prior written or oral agreements or understandings with respect to the subject matter hereof.

  • Except as otherwise set forth in Sections 2.2.2 and 2.4, the Product Master Plan may be amended from time to time, as the parties experience with the Production, testing and use of the Product warrants, only upon recommendation of the Steering Committee and upon mutual written agreement of Halozyme and Baxter.


More Definitions of Product Master Plan

Product Master Plan means, collectively, the following: • the Quality Agreement; • the Kit Specifications; • the Kit Component Specifications; • the Master Batch Records; • the Project Plans; • the Regulatory Authorities and Countries where Products will be sold, set forth on [CONFIDENTIAL TREATMENT REQUESTED], as amended, supplemented or restated from time to time in accordance with Section 2.2.2; • the Regulatory Plan; • the Cancellation Fees; • the Purchase Prices; and • the Shipping Instructions. 1.25 "Project Plans" shall mean, collectively, the plans containing the parameters for the Production of Products set forth on [CONFIDENTIAL TREATMENT REQUESTED] 6, as amended, supplemented or restated from time to time by mutual written agreement of the parties. 1.26 "Purchase Order" shall mean written orders from CLIENT to BAXTER which shall specify (a) the quantity of Kit Component or Kit ordered, (b) Delivery Dates, and (c) delivery destinations.
Sample 1
Product Master Plan means, collectively, the following: - the Quality Agreement (Exhibit C) *** Confidential material redacted and submitted separately to the Commission - the Product Specifications; incl. API, Final Product, Components, Excipient (HSA) as in effect upon the Agreement date (Exhibit D) - the Development Plan (Exhibit B) - Territories (as per Distribution Agreement) - the API Price (Exhibit A).
Sample 1
Product Master Plan means, collectively, the following: • the Quality Agreement; • the Kit Specifications; • the Kit Component Specifications; • the Master Batch Records; • the Project Plans; • the Regulatory Authorities and Countries where Products will be sold, set forth on Exhibit 5, as amended, supplemented or restated from time to time in accordance with Section 2.2.2; • the Regulatory Plan; • the Cancellation Fees; • the Purchase Prices; and • the Shipping Instructions.
Sample 1
Product Master Plan means an addendum to this Agreement for each Product Produced hereunder, which may include, without limitation, the Product, Product Specifications, Components, Component Specifications, Regulatory Authorities and BAXTER SOPs related to the Production of the Product, the countries where such Product will be sold, Presentations, Cancellation Fees and pricing for such Product Produced under this Agreement, developed as described in Section 2.1. The Product Master Plan for the first Product to be Produced under this Agreement is set forth in Exhibit 1.
Sample 1

Related to Product Master Plan

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

  • Master Plan means a subcontracting plan that contains all the required elements of an individual contract plan, except goals, and may be incorporated into individual contract plans, provided the master plan has been approved.

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

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

  • Collaborative pharmacy practice agreement means a written and signed

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

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

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Development Program means the implementation of the development plan.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • Manufacturing Process means any process for—

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • 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.

  • Training program means a standardized medication

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

  • Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.