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.
Product Master Plan means, collectively, the following:
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. PMP will be a separate document to the CPA. Each Product will have a CPA and a PMP.

Examples of Product Master Plan in a sentence

  • In the event Baxter is unable to fill such open capacity, Baxter may charge Celator a Reservation Fee as set forth in the Product Master Plan.

  • On receipt of the Components, Baxter shall test such materials as set forth in the Product Master Plan.

  • All prices quoted by Baxter, e.g. in the Product Master Plan, are ex value added taxes and in Euros.

  • Client shall bear the costs of Regulatory Authority Inspections as set forth in the Product Master Plan.

  • As set forth in the Product Master Plan, Celator shall purchase and supply Celator-supplied Components which Celator, at its sole cost and expense (including, without limitation, shipping costs), shall supply to Baxter, in a timely manner, required to satisfy the terms of this Agreement.

  • Celator shall bear the costs of non-routine Regulatory Authority Inspection or inspections directly relating to the Product as set forth in the Product Master Plan.

  • A monetary default shall be deemed to occur if an undisputed payment is not made by the date such payment is due and payable under the terms of this Agreement or the Product Master Plan.

  • In the event any material or equipment to be supplied by Celator in accordance with the Product Master Plan is imported into Germany for delivery to Baxter (“Imported Goods”), such Imported Goods shall be imported DDP Halle/Künsebeck (Incoterms 2000).

  • If, during the Production of any Batch of Product, any reprocessing, rework, reproduction, or change is required in order to meet the Product Specifications, or if Celator requests any change with respect to any matter set forth in the Product Master Plan, Baxter shall conduct such reprocessing, rework, or reproduction and implement such change in compliance with cGMP’s.

  • The Quality Agreement and the Product Master Plan shall be deemed to be incorporated herein by reference and made an integral part of this Agreement.


More Definitions of Product Master Plan

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.
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.
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).
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.

Related to Product Master Plan

  • 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;

  • 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 has the meaning set forth in Section 4.3(a).

  • 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.

  • 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.

  • 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 any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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 Existing Product but which is substantially similar to an of this Agreement, "New Product" or "New Products" shall mean 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:

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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 Project Implementation Plan referred to in paragraph 3 (a) of Schedule 4 to this Agreement, as same may be amended from time to time in agreement with the Association, and such term includes any schedules to the Project Implementation Plan;

  • Training program means an NCA-approved Iowa college, the Iowa law enforcement academy or an Iowa hospital approved by the department to conduct emergency medical care training.

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