Manufacturing Budget definition

Manufacturing Budget has the meaning set forth in Section 7.2 (Manufacturing Plans).
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Manufacturing Budget has the meaning set forth in Section 6.3(a).
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Manufacturing Budget shall have the meaning set forth in Section 9.1. I.51
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Examples of Manufacturing Budget in a sentence

  • The Parties, in accordance with the allocation of responsibilities determined by the JMC, shall be responsible for Manufacturing or having Manufactured all pre-clinical, clinical and commercial supplies of the Products in accordance with the Global Manufacturing Plan and subject to the Manufacturing Budget, subject to the oversight of the Manufacturing Working Group and the JMC in consultation with the JDC or JCC, as applicable.

  • Once approved by the JSC, an amended Manufacturing Plan (including its corresponding Manufacturing Budget) will become effective and supersede the previous Manufacturing Plan (including its corresponding Manufacturing Budget).

  • Confidential Treatment Requested by MeiraGTx Holdings plc shall not be obligated to pay for any Clinical Development Manufacturing Costs in excess of the Clinical Development Manufacturing Budget except as otherwise set forth in this Section 10.4(b).

  • All [**] incurred pursuant to the approved Joint Development Plan to support receipt of Regulatory Approvals in the Territory and in accordance with the Manufacturing Budget shall be [**].

  • The most popular clauses in import are EXW, FCA and DAP according to all metrics.

  • Each such amended or updated Clinical Development Manufacturing Budget will automatically replace the respective Clinical Development Manufacturing Budget previously in effect, and will be automatically incorporated into this Agreement by reference and form a part of this Agreement.

  • The costs for Manufacturing Products in accordance with Section 8.1(a) shall be set forth in the Clinical Development Manufacturing Budget.

  • Each such amended Manufacturing Plan will specify the information described in this Section 7.2 (Manufacturing Plans) for the next Calendar Year (and additional periods as reasonably determined by the Parties) and the Manufacturing Budget included therein will appropriately itemize the costs and expenses for the activities undertaken pursuant to such Manufacturing Plan.

  • With respect to any Calendar Quarter, in no event will a Party be responsible for any Clinical Development Manufacturing Costs that exceed the respective portion of the then-current Clinical Development Manufacturing Budget recommended and proposed by the JMC and approved by the JSC, except as otherwise provided in Section 10.4(b).

  • The persons accused in publication of the advertisements indicated in the provision 19.2. of the current Law, shall bear responsibility in accordance with the legislation of the Republic of Azerbaijan.

Related to Manufacturing Budget

  • 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 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.

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

  • Development Budget means the cost categories listed on Pages 8 - 11 in Form 3 that are directly related to the proposed Project as submitted in the Application. Indirect or off-site costs not directly related to the development of the project are not valid or eligible costs.

  • Research Budget has the meaning set forth in Section 2.2.

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

  • 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;

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

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Manufacturing Cost means ***

  • 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 Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

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

  • Operating Budget has the meaning given in Section 3.11(a).

  • 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;

  • Budget means a resource, expressed in financial terms, proposed by the Board for the purpose of carrying out, for a specific period, any or all of the functions of the Trust.

  • Manufacturing Process means any process for—

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Timeline means the list of critical dates and actions included in the Introductory Materials.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Distillery manufacturing license means a license issued in accordance with

  • Project Plans mean the plans for the Project that are attached to this Agreement as Exhibit “B.”

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.