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:

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.

• Client shall bear the costs of Regulatory Authority Inspections 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.

• In no event shall Baxter be required to schedule any Production until a Product Master Plan for such Product has been approved in writing by both Baxter and Client.

• Such testing shall be performed in accordance with the procedures set out in the Product specific ▇▇▇▇▇▇ SOPs for the stability protocol and 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).

• 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.

• 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.

• For Product to be Produced by Baxter hereunder, the Parties shall agree in writing upon a Product Master Plan.

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.

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.

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.